Not everyone understands the science of chemical PHARMA we have used for a century and these new biologics that use living interventions for treatment. THAT'S OK. What is important is to understand that chemical PHARMA went through long studies creating basic science data on how all those chemicals acted in our bodies in all kinds of ways. Then, if a business wanted to come along to make a generic version by making a small change in the drugs formula---it did not have to go through all kinds of clinical trials all over again. THIS IS WHY GENERICS ARE CHEAPER. Biologics are far more complicated then chemical PHARMA and they have done very little basic science studies----and the clinical trials being done are not the quality Americans are used to and are required by law. One change in biologic formula makes it a completely different product that can act completely differently in our bodies. Since sophisticated lab facilities are needed----there will be no 'generics' for biologics. Biosimilars are not the same as chemical PHARMA generics.
The Affordable Care Act was written to end all public subsidy and public health trusts like Medicare because its all about the profit. Just in the few years since ACA was installed----what were thousands of generic-producing facilities have consolidated into a monopoly and this is why generics are now soaring in price. THIS WILL IMPLODE THE GENERICS INDUSTRY AS IS THE GOAL OF ACA.
Prices of generic drugs soar as mergers reduce competition
By Dan Dundon Tue, Jul 8, 2014 @ 4:35 pm | updated Tue, Jul 8, 2014 @ 4:43 pm
Prices have spiked for some generic medications because of industry mergers resulting in fewer manufacturers. In the 34 years Gary Roberts has been a pharmacist, he has never witnessed such large percentage increases in the cost of many generic drugs.
Roberts, president of Roberts’ South Bank Pharmacy in Jacksonville, doesn’t pretend to know all the reasons, but suspects one factor may be the recent rash of consolidations and mergers in the pharmaceutical industry.
He isn’t alone in his suspicions.
Many other observers of the pharmaceutical industry see consolidation as a troubling indicator of continued price increases, which will have a dramatic impact on consumers.
Hardly a week goes by without news of another acquisition in the pharmaceutical industry. The airline and the cable industries are prime examples of how those consolidations lead to higher prices. But while consumers can choose to travel by car or cut their cable cord, they are frequently compelled to pay higher generic drug prices to treat their ailments.
A generic drug must contain the same active ingredients as the brand-name product and must be comparable in quality, dosage form, strength and performance. When the patent of a brand-name drug expires, competition increases, hence the far lower prices of generics.
Much, much lower prices — until now. That’s troubling for Roberts and other pharmacists because more than 85 percent of all prescriptions are for generics.
The rise in generic drug prices first became evident in 2013 and the increases are continuing this year, Roberts said.
“Generic drug inventories that have been plentiful for years suddenly won’t be available for a time,” he said. “When they come back on the market, the price is exorbitant compared to what it used to be.”
One example is the eye drop Pred Forte, the brand name for a generic equivalent of prednisolone acetate ophthalmic suspension. It is prescribed as an anti-inflammatory drug for eye surgery patients.
Roberts said he had been able to acquire the generic drops for $6 per bottle as recently as last year. Today, that price has shot up to nearly $90 a bottle.
“Our biggest problem is patients who simply walk away when they learn of the price increase,” he said. “Even if they have insurance, the new plans have high deductibles. Years ago, if you had a deductible, it was usually on major medical expenses. Now they are all lumped together.”
Pacific Pharma Inc., a generic manufacturer, produces the eye drops ordered by Roberts. The company is owned by the pharmaceutical giant Allergan USA Inc. based in California, which developed the brand Pred Forte.
Allergan therefore controls both the branded and a generic manufacturer of the drug. Allergan is in the midst of a hostile takeover battle with Valeant Pharmaceuticals. An Allergan representative did not respond to repeated email and telephone requests to comment on the price increases.
But in a transcript of May 7 earnings teleconference, Allergan’s CEO David E.I. Pyott discussed Pred Forte with industry analysts. He said after competitor Sandoz increased the price of its generic drug, Allergan “increased our prices of the generic to parity with Sandoz as well as increasing the price for branded Pred Forte by 80 percent.” Allergan reported first-quarter sales increases of 12 percent, marking the fourth sequential quarter of year-over-year double-digit growth for the company.
Sandoz is the generics unit of pharmaceutical giant Novartis. Leslie Pott, vice president of communications at Sandoz, confirmed price increases for the eye drops, citing supply issues caused by equipment problems at the Sandoz manufacturing plant. Nevertheless, she said, even with the increase, their generic drops were 50 percent less expensive than the brand price.
“Pricing of key products is reviewed regularly, taking into account all relevant factors including regulatory and production costs,” she said.
Sandoz and Pacific Pharma are the only two generic manufacturers of the eye drops. Large brand-name pharmaceutical companies therefore control both generic companies and consequently the market for these drops.
The eye drops aren’t an unusual example of what is happening with many generic drugs. According to the National Community Pharmacists Association, 77 percent of their members experienced 26 instances of a large increase in the acquisition price of a generic drug within the last six months.
More than 84 percent of pharmacists said price fluctuations resulted in some patients refusing their prescriptions because of costs. For independent pharmacists already squeezed by large chain pricing, this trend has raised concerns about some of them remaining in business.
“There is no question that with generic drugs with multiple manufacturing sources, there are much lower price increases because competition is a factor. Generally, we find the more competitors in the market, the lower the price. Today, we are seeing fewer manufacturers and consequently the competition decreases,” said Robert Navarro, clinical professor in Pharmaceutical Outcomes and Policy at the University of Florida. Navarro has practiced pharmacy as a medical center pharmacy co-owner, hospital clinical pharmacist, medical school geriatrics pharmacology instructor and a long-term care consultant pharmacist.
Another university pharmaceutical expert, Robert Kemp, an economist at the University of Louisiana at Monroe, sees price increases occurring in particular generic therapeutic areas.
“If you have one company with multiple products in one therapeutic area such as hypertension you will see improved capability to get and maintain premium prices,” Kemp said.
The Department of Justice and the FTC have been active in the pharmaceutical industry. Pharmaceutical companies have agreed to pay more than $13 billion to resolve allegations of fraudulent marketing practices. One of the largest settlements ever was paid by a pharmaceutical company. In 2009, Pfizer agreed to pay $2.3 billion to settle charges that it illegally promoted certain drugs.
The FTC also has also filed actions forcing pharmaceutical companies to divest interest in certain generics before a merger. In Fiscal 2012, for example, the agency challenged proposed mergers by Valeant, Novartis and Teva Pharmaceutical Industries because it alleged competition in the generic drug area would be harmed by the proposed acquisition.
Despite these actions, merger activity in the pharmaceutical industry continues. And at the current pace, Roberts fears his pharmacy and his customers will likely see price increases for generic drugs well into the future.
______________________________________
We already see what a profit-driven health care system will do----it will move corporations away from medical products and procedures that are the least profitable and everyone will move to 'innovative' high-cost medicine. It's just like the movement away from a family doctor that did everything to medicine with all kinds of specialists that cost more. The problem comes when these global corporate health systems sit around and talk about what makes health care less costly----they don't say well, let's keep chemotherapy and radiation therapy for those not affording biologic cancer treatment----they don't even tool hospitals with equipment to do cancer radiation treatment. Now we are seeing global cancer centers popping up that do only cancer and we are now expected to travel to that state for cancer treatment that is if our heath plan even allows for this. We already know global health insurance will not be funding this process very long and so, cancer treatment for main street is disappearing. If you do not have an expensive private health plan---you will not access cancer treatment. This same thing is happening for many of the most common diseases.
HEALTH COST ARE CONTAINED BY NOT OFFERING EXPENSIVE TREATMENTS AND IF YOU DO---YOU ARE CATERING TO THE GLOBAL WEALTHY TOURISM INDUSTRY
Below you see a simple description of a biologic for cancer that will become the only game in town for treatment and below that you see where ordinary cancer treatment from the drugs used to the equipment needed to do chemo and radiation see costs soaring to a point they will be declared too expensive for health insurance corporations to pay .
HILLARY TRIED TO DO ALL THIS WHILE BILL WAS DEREGULATING AND CONSOLIDATING AND GLOBALIZING THE FINANCIAL INDUSTRY BUT OBAMA AND A CLINTON NEO-LIBERAL CONGRESS DID IT----AND IT IS ALL REPUBLICAN POLICY-----WRITTEN IN REPUBLICAN THINK TANKS. YOUR POLS KNEW ALL THIS WOULD HAPPEN JUST AS THEY KNEW THE WALL STREET MESS THAT WOULD COME FROM THE SAME DEREGULATION AND GLOBALIZATION. None of this has to do with cost containment---it will suck the Medicare Trust dry by 2020 at which point the Affordable Care Act ends the Federal Medicare.
Biologic Therapy for Breast Cancer Breast Cancer
Monoclonal Antibody Therapy-Herceptin and Avastin
Monoclonal antibodies are laboratory-produced substances that are directed against cancer cells. They can be used to deliver drugs, toxins or radioactive material directly to the cancer cells. Many monoclonal antibodies are used in cancer therapy. Each one recognizes a different protein on a variety of cancer cells. Herceptin Trastuzumab (Herceptin) is an antibody directed against the HER-2/neu receptor on the surface of the breast cancer cells of some patients. Not all cancers have this characteristic. HER-2 (human epidermal growth factor receptor 2) is a gene that helps control how cells grow, divide and repair themselves. The HER-2 gene directs the production of special proteins, called HER-2 receptors. Because heart muscle cells also have the HER-2/neu receptor, trastuzumab can cause heart damage. It should be used cautiously when combined with other heart-damaging drugs such as anthracyclines (doxorubicin and epirubicin). Trastuzumab is given to women whose breast cancers have tested positive for the HER-2/neu receptor and who have metastatic cancer (that has spread). It is used in combination with chemotherapy as adjuvant treatment in women with HER-2/neu breast cancers and who are node-positive (cancer found in the lymph nodes). It may be considered for women with node-negative (cancer not found in the lymph node) tumors greater than or equal to 1 centimeter. Avastin The results of a recent clinical trial showed that bevacizumab (Avastin) is an effective addition to chemotherapy in women with metastasized breast cancer. Bevacizumab blocks the growth of blood vessels that can feed the tumor and promote growth. Targeted therapy with novel (newly discovered) therapies is in the forefront of ongoing research. -
*************************************************************************
National leaders from labor and justice to news media knew where all this Affordable Care Act led and all we heard was ----it will protect the poor and it will give all Americans access to health insurance. All voices like mine were silenced. Labor unions were brought out to support it-----NAACP and National Organization of Women were brought out to support it----all led by Clinton neo-liberal leadership knowing it would keep over 80% of Americans from ordinary health care. People of color and women are hurt most as usual-----labor unions are going to join them as their pensions and benefits end. So, what is now 1/3 of Americans on Medicare and Medicaid will soar to 2/3 and grow from there all having what will be called A SINGLE PAYER SYSTEM THAT WILL BE GUTTED OF FUNDING ------MEDICAID FOR ALL. This is the goal of Affordable Care Act. Republican voters are fighting this as hard as they can thinking this is ObamaCare and not Republican policy. The Democrats with the Democratic base of labor and justice are silent and supporting it because they do not know to where all this is going.
Making costs soar will give these health systems excuses for not offering these medical products and procedures and it will allow them to move to these 'new, innovative' designer medicine policies tied to global health tourism and telemedicine.
None of this is good for anyone other than Wall Street and the executives at the top. It's not good for the nations that should be building our first world public health structures and not telemedicine----it is not good for any American ----even the affluent -----as quality will fall no matter what you pay for private insurance.
Exclusive: Americans overpaying hugely for cancer drugs - study
By Ben Hirschler
A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, Britain July 15, 2013. Reuters/Stefan Wermuthleft
A man buys cancer drug Glivec for a relative who is suffering from cancer at a pharmacy in Ahmedabad, India April 2, 2013. Reuters/Amit Daveleft1 of 2right A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, Britain July 15, 2013. Reuters/Stefan Wermuthleft2 of 2right A man buys cancer drug Glivec for a relative who is suffering from cancer at a pharmacy in Ahmedabad, India April 2, 2013. Reuters/Amit Daveleft1 of 2right Americans are paying way over the odds for some modern cancer drugs, with pharmaceutical companies charging up to 600 times what the medicines cost to make, according to an independent academic study.
The United States also pays more than double the price charged in Europe for these drugs - so-called tyrosine kinase inhibitors (TKIs), a potent class of cancer pills with fewer side effects than chemotherapy.
The analysis by pharmacologist Andrew Hill of Britain's University of Liverpool, who will present his findings at the Sept. 25-29 European Cancer Congress in Vienna, is likely to fuel a growing storm over U.S. drug costs.
ADVERTISING Democratic presidential candidate Hillary Clinton's declared aim to lower the cost of prescription drugs by ending what her campaign describes as "excessive profiteering" triggered a sell-off in drug stocks this week.
Hill told Reuters he had shared his work on the cost of producing TKIs with the World Health Organization (WHO), which is keen to add such treatments to its list of medicines deemed essential for a basic healthcare system. WHO officials have used the findings in determining that the drugs can be made at low cost, he said.
The first such TKI was added to the WHO's latest draft Essential Medicines List earlier this year.
Several widely-used TKIs are expected to become available as generics within the next five years, as patents expire. Hill calculated that large-scale production could achieve treatment prices in the range of $159 to $4,022 per person a year, against current U.S. prices of around $75,000 to over $100,000.
"It shows there is a lot of scope for prices to come down," he said. "There has to be some middle ground between the prices that companies are charging, which may not even be cost-effective by the standards set by some healthcare authorities, and the actual production cost."
RESEARCH COSTS
Drug companies argue that they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines.
But the high prices charged for modern drugs is generating increasing push-back from healthcare providers, patients and some doctors.
Hill used Indian government data on the cost of pharmaceutical ingredients and allowed for a 50-percent profit margin - but no money for investment in research - to work out the costs of producing certain drugs.
On this basis, he found that Novartis' leukemia drug Glivec actually cost $159 for a year's treatment, against the $106,000 charged in the United States.
Roche's Tarceva for lung cancer cost $236, against a U.S. price of $79,000, and Novartis' Tykerb cost $4,000 against a price of $74,000.
In all these cases the U.S. cost was far above that charged in certain western European countries, where Glivec costs approximately $29,000-35,000, Tarceva $26,000-29,000 and Tykerb around $35,000, Hill reported.
Novartis said the price of medicines was determined by many factors beyond manufacturing costs, including their value to patients and healthcare systems.
"We invest in developing novel and current treatments to find ways to make more cancers survivable. This is challenging and risky and needs to be taken into consideration when discussing pricing of treatments," a spokeswoman said.
Roche declined to comment.
The issue is not unique to cancer drugs. Earlier this month, for example, Amgen launched its new injectable cholesterol drug Repatha in Europe at around half the U.S. price.
"Why should the U.S. bear this huge burden cost? It is not as if the GDP of the United States is so much higher than that of European countries, but they just seem to pay these big premiums," Hill said.
The future pricing of TKIs could also have major implications for developing countries, Hill believes, since mass production could open the way to widespread cancer treatment in the same way that cheap generic drugs helped fight HIV/AIDS.
***********************************************************************
The biologic industry likes to paint the picture of well-researched and tested products and they are lobbying hard for dismantling of all Federal regulations and standards that would try to provide oversight and accountability. As the article shows here for one state---Utah----it will fall to states and cities to enforce existing health laws and provide the oversight of this industry until we can get rid of Clinton neo-liberals and Bush neo-cons in Congress.
Baltimore City is becoming a progressive social democratic city getting rid of the very, very neo-conservative Johns Hopkins and Wall Street Baltimore Development from our government. In doing so we will install the platform for EXPANDED AND IMPROVED MEDICARE FOR ALL rebuilding the public health sector and this will be where Medicare and Medicaid patients will fall to escape these repressive and exploitative health policies.
The only reason the BIO----Biotechnology Industry Organization is lobbying NOW for access to main street patients is there has been no clinical trial or basic science done in this industry and they want to include all of us during this research stage and then -----GOODBYE----THE PRICES WILL SOAR. Given how quickly they feel proof of safety can be found----main street may have access to biologics for a handful of years if they want them.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Below BIO is telling us there will be open and transparent processes for the public to see what is being used et al and I ask you----DO YOU SEE ANY OPENNESS SO FAR? Do you think I could go to Johns Hopkins and ask to see the data of J-CHIP? I could not even see data taken from a community garden survey for goodness sake.
BIO Urges Governor Herbert to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines
Posted: March 17, 2015 American Laboratory
The Biotechnology Industry Organization (BIO) has called upon Governor Herbert to sign important legislation that serves to update existing Utah laws governing substitution of interchangeable biologic medicines.
“When they become available, these therapies will be safe, effective, and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
The Utah Senate unanimously passed House Bill 279 last week, a bill that amends provisions of the 2013 Pharmacy Practice Act. This action follows House passage of the same bill earlier this month.
House Bill 279 represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with BIO’s principles on biologic substitution. Therefore, BIO supports this important legislation and encourages Governor Herbert to sign the bill when it reaches his desk.
“House Bill 279 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer.
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. House Bill 279 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.
While the FDA recently approved the first biosimilar product for sale in the U.S., the agency continues to develop a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. In fact the FDA has indicated they expect to see applications for interchangeable biosimilar product approvals this year. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.
As the Utah State Legislature continues to address issues related to biologic medicines, BIO encourages policy makers to continue to put patients first.
_________________________________________________
'On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this legislation. Included therein is a provision (Section7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated biological license application (ABLA) submitted to the Food and Drug Administration (FDA).'
Below you see there is really no expectation that main street will access these new, 'innovative' medical technologies that are receiving tons of Federal funding to build private research facilities for processing and manufacturing. You see as well where the Affordable Care Act was used to deregulate the FDA process by giving an abbreviated license application. In 2009 Democrats has a super-majority in House, Senate, and Obama so the Republicans did not make them do it. They did it because the Democratic Party is controlled by a small percentage of people running as Clinton neo-liberals. The only people affording these health plans that will include health care access all Americans had will initially families earning over $200,000 a year but they will soon be priced out as the global rich become the consumers of American health care. For the rest of Americans pushed into ever-lower poverty---we get remote controlled microchips and telemedicine. I will escape most of this as a baby boomer---but if left unchecked all of this could be happening in little over a decade. So, it is our children and grandchildren that will feel the brunt of Wall Street global predatory, profit-driven health care. JUST GET RID OF THE GLOBAL CORPORATE POLS AND REBUILD OUR PUBLIC HEALTH IN STATES AND CITIES TO REVERSE THIS MESS.
The article below is long but please glance through----it gives a clear look at why over 80% of Americans AND HIGHER will only be accessing preventative health care and much of that will be remotely=====it looks like this agency for oversight-----CER will act as the SEC does---it will work for the BIO industry, not the American people. You don't create a public private partnership or quasi-governmental status unless you are killing transparency and public voice.
a public-private partnership that will commission CER.
*******************************************************************
'What do current trends in biologics coverage suggest about access in the PPACA era?
In the run-up to 2014, plans are placing greater access restrictions on biologics'
*********************************************************************
Biotechnol Healthc. 2011 Winter; 8(4): 6–10. PMCID: PMC3278131
How Will Biologics Fit Into Healthcare Reform?
With so many variables, it’s hard to predict what kind of market will exist for biologics and other specialty drugs in 2014. Current trends may provide some insight
.MICHAEL D. DALZELLAuthor
This article has been cited by other articles in PMC.Oct. 6, 2011, could become a red-letter day in the annals of healthcare policy. On that day, the Institute of Medicine took a big step forward in the national discussion about the finite quality of healthcare resources. In its recommendations to the Department of Health and Human Services on how to develop a minimum benefit package for health plans to be offered through the coming state healthcare exchanges, the IOM took the view that the scope of the benefits should be determined not by services but by costs.
If HHS follows through on the IOM’s recommendations, we could get as close to the R word as we have ever gotten in this country. Then again, nobody wants to hear about rationing.
Although the IOM report on “essential health benefits” touches on just one of the many moving parts of healthcare reform, it gets to the question: How will access to and coverage of biologics be affected by healthcare reform? The eventual makeup of the essential benefit set is an important factor in how biologics will fare under reform, but it’s only one factor.
Employer concerns about the so-called Cadillac tax, comparative effectiveness research, and biosimilar development and its potential effect on innovation all represent both threats and opportunities for biologics — and are causing some lost sleep among health plans, providers, and manufacturers.
“Everyone’s got a bull’s eye on biologics because they are the fastest-growing trend in the healthcare sector,” says Dea Belazi, PharmD, MPH, vice president of payer and health-care solutions for Wolters Kluwer Health and a consultant for MCOs and biopharma companies. “The scare is, what happens when they come out with a biotech drug for asthma or diabetes — something that targets a common chronic condition — for $25,000 a year? What is going to be the repercussion that might come from the government?”
Go to:Lots of moving parts
Arguably, the biggest questions about healthcare reform’s effects on biologics zero in on barriers to access.
Several provisions of the Patient Protection and Affordable Care Act (PPACA) are intended to keep premiums down:
All this raises several questions: Will insurers be able to maintain current levels of coverage for biologics after 2013? Given the IOM’s focus on cost-efficiency and the PPACA’s squeeze on premiums, will biologics be considered essential? Or will they be deemed too expensive and placed outside the core benefit set?
“Biologics are likely to be considered for inclusion in the definition of essential benefits but will carry a hefty price tag,” says Jim Parker, president and founder of Health Market Strategies, an Indianapolis-based healthcare consultancy, and former president of Anthem Blue Cross and Blue Shield of Maine.
If biologics are not included in the definition of essential benefits, then, Parker says, MCOs and government programs will likely consider the cost of the biologic and balance that cost with the efficacy of the treatment; “A biologic that costs $80,000 to fight cancer will receive a hard look before being included in a health benefit.”
Considering that many groups — oncologists, manufacturers, and patient advocacy organizations among them — are affected by what’s included and what’s left out of the essential benefit set, politics will almost certainly play a role, Parker believes. HHS Secretary Kathleen Sebelius has promised the public will get its say before HHS issues a proposed rule.
“This is going to be high stakes for many people,” says Ian Spatz, JD, senior adviser in the national health care practice of Manatt, Phelps, & Phillips, in Washington. And, he notes, the degree of specificity in the HHS regulation will be an important determinant of coverage.
“The law says that pharmaceuticals have to be covered. Well, what does that mean? Which pharmaceuticals? When do they have to be covered? What’s the cost sharing related to their coverage?” asks Spatz. “If you’re producing a cholesterol-lowering medicine, there’s a good chance it’s going to be covered. But what if it is a new, expensive treatment — let’s say for cancer where there hasn’t been a lot of proof of its life-extending or curative powers?”
Without changes in their benefit packages, 60 percent of employers will face the Cadillac tax in 2018.
Exclusion from the essential benefits package doesn’t mean that buy-up options won’t be available. “I think there will be some variations around ‘You can have this kind of pizza, but if you want 10 toppings on it, it might cost a little extra,’ that will go beyond the essential benefits requirement,” says Belazi.
But a buy-up option could be out of reach for many people, curtailing their access to costlier benefits. This could especially affect those just entering the health benefit market — including individuals with poor health literacy, low incomes, or both, who are at greater risk for chronic disease.
“I think there’s going to be a lot of discretion left to the state health benefit exchanges” about the scope of affordable coverage, says Ian Spatz, JD, at Manatt, Phelps, & Phillips. Healthcare reform, he believes, will not impose “a complete, top-down, command-and-control effort that specifies the same content for every plan in the United States.”
Go to:The same — and more of it
What do current trends in biologics coverage suggest about access in the PPACA era?
In the run-up to 2014, plans are placing greater access restrictions on biologics. In The Zitter Group’s Spring 2011 “Managed Care Benefit Design Index: Emerging Trends in Access,” 74 percent of payers and employers thought healthcare reform would have a significant impact on their costs. As such, 35 percent of payers increased deductibles, out-of-pocket maximums, and nonfinancial access restrictions on biologics this year, and 35 percent said they would do it again in 2012. “Neither payers nor employers waited for all provisions of healthcare reform to become applicable before reducing access and increasing patients’ costs,” the authors wrote. “Payers are having current consumers pay more for the same or less access in anticipation of their reduced ability to manage the risk pool.”
Meanwhile, if existing trends hold, new and existing biologics will drive two thirds of drug spending increases, according to the Medco “2011 Drug Trend Report.” In oncology alone, drug treatment costs will balloon from $125 billion in 2010 to $207 billion by the end of the decade, fueled in part by a 31 percent jump in the number of cancer survivors among us.
Go to:A perfect storm gathers
And so, Belazi says, what we see now, we will continue to see in 2014 — just more of it.
“We’re going to see higher out-of-pocket coverage. Rather than 30 or 40 percent of the market using co-insurance for specialty products, I think we’ll see 60 percent,” he says. “Utilization management will be much more prevalent in the biotech space — things like prior authorization, utilizing a diagnostic, or anything to help tailor therapeutics around these products.”
Though it restricts access, shifting costs to the consumer may reduce premiums enough to support the inclusion of wider biologic coverage within the essential benefit set. Indeed, cost sharing is built into the PPACA’s requirement that insurers offer bronze, silver, gold, and platinum plans — that is, plans whose average enrollee out-of-pocket liability is 40, 30, 20, and 10 percent across all benefits. Insurers operating in the exchanges must offer at least one silver and one gold plan. Each variation must cover the essential benefits; the degree of cost sharing attached to a particular benefit will differ, depending on the plan level.
“This all depends on what rules the government comes back with,” says Belazi. “If they create funky benefit designs like they did with Medicare Part D — where there was the donut hole and variations on out-of-pocket — then that’s what we’ll get from payers.”
The funky benefit design we could see from HHS could well be a biologics benefit carved out of the essential benefit set. “I think that’s exactly what they’ll do,” says Belazi. “I keep going back to Medicare, because I think that’s our blueprint. As the rules come out, I think we’ll see some very interesting things: ‘These are the drugs we will not cover. These are the benefit designs that payers have to adhere to.’ We don’t know what HHS will do until those rules are released, but it’s a fair assumption to say, ‘Yes, that’s probably what they will do.’”
Go to:Employers are wary
Concerns about the scope and cost of benefits are not limited to small-group and individual plans sold through the exchanges. Though the PPACA doesn’t specifically hold employer-sponsored plans to the same minimum benefit requirement as plans offered through the exchanges, the law’s definition of what constitutes a “qualified health plan” has caused benefit consultants to differ on whether employers will ultimately have to conform to it. At the very least, employers are expected to view the essential benefit package as a benchmark; anything in excess may risk being too generous — an issue that looms large, given the threat of the Cadillac tax.
“It’s an opportunity [for biotechs] to build CER into clinical trial design.... It does nobody any good to have a product that nobody will pay for.”
— Matthew Hudes, Deloitte Life Sciences and Healthcare
“Once premiums become unaffordable, we’re forced to look at the costs and ask, ‘What should our priorities be?’” says Jim Parker, of Health Market Strategies.
“Employers want to provide these benefits, but they’re bound by the limitations of the marketplace,” says Parker. “Employers will do whatever they need to do to remain competitive, even if it means cutting benefits. As long as the cost of benefits increases faster than the rate of competitive growth, an inducement will exist to do that.”
A Towers Watson survey released in August suggests that unless they change their benefit offerings, 60 percent of employers will be subject to the excise tax. These employers face the challenge of curtailing some benefits in order to avoid the tax while retaining those that provide value to beneficiaries. Most employers don’t even know what they spend on biologics, according to a survey done by the Biologics Finance and Access Council published in Biotechnology Healthcare last summer.
Go to:The short, medium, and long of evidence
The IOM recommended that HHS take an evidence-based approach to benefit selection. The evidence might include data on the efficacy and safety of long-term use of biologics in patients with chronic diseases or whether their use can achieve meaningful downstream cost avoidance. The rap on biologics, though, is that longitudinal data to justify their cost is often lacking.
Although 38 tests for biomarkers in oncology have reached the market in the last five years, their clinical utility is not well understood, leading payers to reserve judgment.
In the short-term, the lack of evidence could push health plans to limit the market for biologics. Parker thinks the economic environment that healthcare reform creates will intensify payer efforts to clamp down on off-label uses of biologics when the benefit is unclear.
“These types of real-life experiments should be part of a randomized, controlled test. We should deal with this in an orderly, organized, and scientifically driven fashion,” says Parker. “Without application of the scientific method, we really aren’t learning much at all. And real-life experimentation is a very expensive form of experimentation.”
Over time, though, healthcare reform could prompt scientific discovery and generate research to support the inclusion of benefits for a range of biologic therapies.
The medium-term perspective gives a nod to pharmacogenomics as a means for effectively targeting biologic interventions. Scientific refinement of this promising area continues in earnest — more than 1,600 articles on pharmacogenomics were published in 2010 alone.
Later this year, the U.S. Food and Drug Administration is expected to issue regulations for the development of companion diagnostics. Currently, companion tests are being developed in conjunction with biologic therapies for solid and blood cancers, cystic fibrosis, multiple sclerosis, and Alzheimer’s disease.
“Healthcare reform will encourage pharmaceutical companies to develop molecular diagnostic capabilities to support the precise application of their therapies,” says Parker, noting that doing so can open access to targeted uses of biologic therapies. “In the future, manufacturers won’t claim that a new drug will work effectively on 40 percent of a population; they’ll say that the therapy works 100 percent of the time on 40 percent of the population. But they’ll have to demonstrate which 40 percent that is.”
The long-term effects of health-care reform on the evidence-based approach may hinge on comparative effectiveness research (CER). The American Recovery and Reinvestment Act of 2009 set aside $1.1 billion for CER. One year later, the PPACA established the Patient-Centered Outcomes Research Institute, a public-private partnership that will commission CER.
Matthew Hudes, U.S. managing principal for biotechnology with Deloitte’s Life Sciences & Health Care practice, says CER could have a significant impact on creating market access to biologics.
“I think it’s an opportunity for certain companies to take advantage of this, to build CER into clinical trial design and protocols and, therefore, not have to redo work or do a lot of postmarket studies,” he says. “It’s important to look at that because it does nobody any good to have a product that nobody will pay for.”
Hudes says that CER will force a more holistic approach to healthcare. “It introduces a deliberate process to look at the medical impact that each product will have and to evaluate that process in terms of the optimal course of care. It not only looks at one pharmaceutical product versus another, but at the context of the total care of the patient.”
The biggest questions about CER are about limited resources and whether biologics-oriented CER will be a funding priority. The stakes are high — according to a Deloitte analysis, by 2014, biologics will comprise up to 60 percent of the 10 top-selling drugs. Those stakes are raised even higher, says Hudes, by the fact that biosimilars won’t put that big a dent in total spending on specialty pharmacy. (See “What’s the Effect of Biosimilars?” on page 9.)
What’s the effect of biosimilars?Biosimilars represent another aspect of healthcare reform with profound implications for the biologics market. Most of the discussion in the popular media has focused on cost reduction, though insiders say what’s really at stake is whether the PPACA environment will hurt or help innovation — and with it, access.
“There’s still a lot of definition and work to be done,” says Matthew Hudes, U.S. managing principal for biotechnology with Deloitte’s Life Sciences & Health Care practice, “but I think this is both an opportunity and a threat for the biopharmaceutical industry.”
HHS will need until late 2012, at the earliest, to develop a pathway for generics manufacturers to follow. Until then, manufacturers and would-be generics manufacturers will have to wrestle with the question, “How similar is similar enough?”
“I’m particularly concerned about the area of immunogenicity,” says Hudes. “What kind of testing has to be provided to determine safety and efficacy?”
Dea Belazi, PharmD, MPH, vice president of payer and healthcare solutions for Wolters Kluwer Health, says a lot is riding on what the FDA pathway will eventually look like. “If the FDA makes it easy for a biosimilar product to come out, that’s the last nail in the coffin where there will be little to no innovation,” he says. “But if they make it pretty tough for a copycat to come onto the market, then I think patent-life issues become a little less important.”
The answers to questions about scientific concerns will also determine the impact that biosimilars will have on costs, says Hudes.
“Follow-on biologics will have some impact on slowing the growth rate of biologic [costs], but it may be only in the range of 6 to 8 percent,” he says, quashing more optimistic predictions.
“There may be a 30 or 40 percent price reduction on an individual product, but if you look at the overall biologics market, those are older products that are being replaced with more effective products. That’s why if you look at the growth rate of the spend on biologics, it may slow it a bit, but there’s still a lot of innovation and development that’s going on in this very vibrant area.”
Go to:Update with care
Few expect HHS to find the perfect balance between cost containment and coverage, and the PPACA requires HHS to update the minimum benefit package annually. Those annual revisions make the evidence question imperative, because advances in medical technology account for more than half of healthcare spending growth.
“If we fix a definition of what’s essential, meaning that it’s a technology that works, we might still get ourselves into a position where the essential benefits become more expensive and the individual mandate becomes less binding,” says Gerard Wedig, PhD, an economist and associate professor of business administration at the University of Rochester Simon School of Business. “Even if we use cost-effectiveness as a criteria for essential, premiums can outstrip inflation over time.”
Wedig stresses the importance of using clinical or financial outcomes or applying some other evidence-based criteria in revising benefit packages, because the alternative may lead to a political circus. “Let’s say something is shown to be over time less cost-effective than we initially thought. Then think about the politics of pulling that out of the essential benefit package. On one hand, HHS can say ‘cost, cost, cost,’ and on the other hand there is the emotional appeal that ‘People are going to be deprived of this service.’ It may be hard to get benefits out once they’re in there because of the emotional appeal that can be made.”
In a recent article in the UCLA Law Review, Jessica Mantel provided an example, recapping the U.S. Preventive Services Task Force’s 2009 evidence-based recommendation to drop routine screening mammograms in women aged 40 to 49. Powerful interest groups swiftly condemned the recommendation, prompting the Senate to amend its healthcare reform bill to include coverage for annual screenings for women age 40 and older.
“Rather than assuming a hands-off approach as HHS develops national coverage standards, federal lawmakers will often support efforts to mandate coverage of certain conditions or treatments in response to public or interest group pressure, no matter how misguided, for fear that opposing these efforts would alienate voters,” Mantel wrote.
What patients want is to have access to the latest and best treatments, and they want insurance to pay for them. Healthcare reform efforts are forcing us to have a hard conversation about limited resources. Where that will leave biologics is unclear.
“The cost of a drug becomes more of a social and moral question: How much should society be willing to pay to extend the life of one individual?” says Parker. “Through the insurance mechanism, everyone pays for it. It’s a great mechanism for covering costs as long as the premiums are affordable, but once they become unaffordable, then we’re forced to ask: What should our priorities be?”
Spatz, at Manatt, Phelps, & Phillips, doesn’t think the discussion will go down that road — at least not now. “I don’t think this is the time that we will struggle in this country with what’s truly essential and should be shared among us in terms of the taxes we pay and the subsidies we provide or what we might have to do without because we can’t afford it. I don’t think we’re going to go that far at this stage because of PPACA’s guidance that these plans should look much like private plans.”
But the IOM report pushes us closer to that discussion. Ultimately, the consumer drives the market. Cost, evidence, and politics all will play a role in determining the fate of biologics under healthcare reform, but only time will tell if Oct. 6, 2011, was a red-letter day in the annals of healthcare policy or just another day and another false start.
The Affordable Care Act was written to end all public subsidy and public health trusts like Medicare because its all about the profit. Just in the few years since ACA was installed----what were thousands of generic-producing facilities have consolidated into a monopoly and this is why generics are now soaring in price. THIS WILL IMPLODE THE GENERICS INDUSTRY AS IS THE GOAL OF ACA.
Prices of generic drugs soar as mergers reduce competition
By Dan Dundon Tue, Jul 8, 2014 @ 4:35 pm | updated Tue, Jul 8, 2014 @ 4:43 pm
- McClatchy Newspapers
Prices have spiked for some generic medications because of industry mergers resulting in fewer manufacturers. In the 34 years Gary Roberts has been a pharmacist, he has never witnessed such large percentage increases in the cost of many generic drugs.
Roberts, president of Roberts’ South Bank Pharmacy in Jacksonville, doesn’t pretend to know all the reasons, but suspects one factor may be the recent rash of consolidations and mergers in the pharmaceutical industry.
He isn’t alone in his suspicions.
Many other observers of the pharmaceutical industry see consolidation as a troubling indicator of continued price increases, which will have a dramatic impact on consumers.
Hardly a week goes by without news of another acquisition in the pharmaceutical industry. The airline and the cable industries are prime examples of how those consolidations lead to higher prices. But while consumers can choose to travel by car or cut their cable cord, they are frequently compelled to pay higher generic drug prices to treat their ailments.
A generic drug must contain the same active ingredients as the brand-name product and must be comparable in quality, dosage form, strength and performance. When the patent of a brand-name drug expires, competition increases, hence the far lower prices of generics.
Much, much lower prices — until now. That’s troubling for Roberts and other pharmacists because more than 85 percent of all prescriptions are for generics.
The rise in generic drug prices first became evident in 2013 and the increases are continuing this year, Roberts said.
“Generic drug inventories that have been plentiful for years suddenly won’t be available for a time,” he said. “When they come back on the market, the price is exorbitant compared to what it used to be.”
One example is the eye drop Pred Forte, the brand name for a generic equivalent of prednisolone acetate ophthalmic suspension. It is prescribed as an anti-inflammatory drug for eye surgery patients.
Roberts said he had been able to acquire the generic drops for $6 per bottle as recently as last year. Today, that price has shot up to nearly $90 a bottle.
“Our biggest problem is patients who simply walk away when they learn of the price increase,” he said. “Even if they have insurance, the new plans have high deductibles. Years ago, if you had a deductible, it was usually on major medical expenses. Now they are all lumped together.”
Pacific Pharma Inc., a generic manufacturer, produces the eye drops ordered by Roberts. The company is owned by the pharmaceutical giant Allergan USA Inc. based in California, which developed the brand Pred Forte.
Allergan therefore controls both the branded and a generic manufacturer of the drug. Allergan is in the midst of a hostile takeover battle with Valeant Pharmaceuticals. An Allergan representative did not respond to repeated email and telephone requests to comment on the price increases.
But in a transcript of May 7 earnings teleconference, Allergan’s CEO David E.I. Pyott discussed Pred Forte with industry analysts. He said after competitor Sandoz increased the price of its generic drug, Allergan “increased our prices of the generic to parity with Sandoz as well as increasing the price for branded Pred Forte by 80 percent.” Allergan reported first-quarter sales increases of 12 percent, marking the fourth sequential quarter of year-over-year double-digit growth for the company.
Sandoz is the generics unit of pharmaceutical giant Novartis. Leslie Pott, vice president of communications at Sandoz, confirmed price increases for the eye drops, citing supply issues caused by equipment problems at the Sandoz manufacturing plant. Nevertheless, she said, even with the increase, their generic drops were 50 percent less expensive than the brand price.
“Pricing of key products is reviewed regularly, taking into account all relevant factors including regulatory and production costs,” she said.
Sandoz and Pacific Pharma are the only two generic manufacturers of the eye drops. Large brand-name pharmaceutical companies therefore control both generic companies and consequently the market for these drops.
The eye drops aren’t an unusual example of what is happening with many generic drugs. According to the National Community Pharmacists Association, 77 percent of their members experienced 26 instances of a large increase in the acquisition price of a generic drug within the last six months.
More than 84 percent of pharmacists said price fluctuations resulted in some patients refusing their prescriptions because of costs. For independent pharmacists already squeezed by large chain pricing, this trend has raised concerns about some of them remaining in business.
“There is no question that with generic drugs with multiple manufacturing sources, there are much lower price increases because competition is a factor. Generally, we find the more competitors in the market, the lower the price. Today, we are seeing fewer manufacturers and consequently the competition decreases,” said Robert Navarro, clinical professor in Pharmaceutical Outcomes and Policy at the University of Florida. Navarro has practiced pharmacy as a medical center pharmacy co-owner, hospital clinical pharmacist, medical school geriatrics pharmacology instructor and a long-term care consultant pharmacist.
Another university pharmaceutical expert, Robert Kemp, an economist at the University of Louisiana at Monroe, sees price increases occurring in particular generic therapeutic areas.
“If you have one company with multiple products in one therapeutic area such as hypertension you will see improved capability to get and maintain premium prices,” Kemp said.
The Department of Justice and the FTC have been active in the pharmaceutical industry. Pharmaceutical companies have agreed to pay more than $13 billion to resolve allegations of fraudulent marketing practices. One of the largest settlements ever was paid by a pharmaceutical company. In 2009, Pfizer agreed to pay $2.3 billion to settle charges that it illegally promoted certain drugs.
The FTC also has also filed actions forcing pharmaceutical companies to divest interest in certain generics before a merger. In Fiscal 2012, for example, the agency challenged proposed mergers by Valeant, Novartis and Teva Pharmaceutical Industries because it alleged competition in the generic drug area would be harmed by the proposed acquisition.
Despite these actions, merger activity in the pharmaceutical industry continues. And at the current pace, Roberts fears his pharmacy and his customers will likely see price increases for generic drugs well into the future.
______________________________________
We already see what a profit-driven health care system will do----it will move corporations away from medical products and procedures that are the least profitable and everyone will move to 'innovative' high-cost medicine. It's just like the movement away from a family doctor that did everything to medicine with all kinds of specialists that cost more. The problem comes when these global corporate health systems sit around and talk about what makes health care less costly----they don't say well, let's keep chemotherapy and radiation therapy for those not affording biologic cancer treatment----they don't even tool hospitals with equipment to do cancer radiation treatment. Now we are seeing global cancer centers popping up that do only cancer and we are now expected to travel to that state for cancer treatment that is if our heath plan even allows for this. We already know global health insurance will not be funding this process very long and so, cancer treatment for main street is disappearing. If you do not have an expensive private health plan---you will not access cancer treatment. This same thing is happening for many of the most common diseases.
HEALTH COST ARE CONTAINED BY NOT OFFERING EXPENSIVE TREATMENTS AND IF YOU DO---YOU ARE CATERING TO THE GLOBAL WEALTHY TOURISM INDUSTRY
Below you see a simple description of a biologic for cancer that will become the only game in town for treatment and below that you see where ordinary cancer treatment from the drugs used to the equipment needed to do chemo and radiation see costs soaring to a point they will be declared too expensive for health insurance corporations to pay .
HILLARY TRIED TO DO ALL THIS WHILE BILL WAS DEREGULATING AND CONSOLIDATING AND GLOBALIZING THE FINANCIAL INDUSTRY BUT OBAMA AND A CLINTON NEO-LIBERAL CONGRESS DID IT----AND IT IS ALL REPUBLICAN POLICY-----WRITTEN IN REPUBLICAN THINK TANKS. YOUR POLS KNEW ALL THIS WOULD HAPPEN JUST AS THEY KNEW THE WALL STREET MESS THAT WOULD COME FROM THE SAME DEREGULATION AND GLOBALIZATION. None of this has to do with cost containment---it will suck the Medicare Trust dry by 2020 at which point the Affordable Care Act ends the Federal Medicare.
Biologic Therapy for Breast Cancer Breast Cancer
Monoclonal Antibody Therapy-Herceptin and Avastin
Monoclonal antibodies are laboratory-produced substances that are directed against cancer cells. They can be used to deliver drugs, toxins or radioactive material directly to the cancer cells. Many monoclonal antibodies are used in cancer therapy. Each one recognizes a different protein on a variety of cancer cells. Herceptin Trastuzumab (Herceptin) is an antibody directed against the HER-2/neu receptor on the surface of the breast cancer cells of some patients. Not all cancers have this characteristic. HER-2 (human epidermal growth factor receptor 2) is a gene that helps control how cells grow, divide and repair themselves. The HER-2 gene directs the production of special proteins, called HER-2 receptors. Because heart muscle cells also have the HER-2/neu receptor, trastuzumab can cause heart damage. It should be used cautiously when combined with other heart-damaging drugs such as anthracyclines (doxorubicin and epirubicin). Trastuzumab is given to women whose breast cancers have tested positive for the HER-2/neu receptor and who have metastatic cancer (that has spread). It is used in combination with chemotherapy as adjuvant treatment in women with HER-2/neu breast cancers and who are node-positive (cancer found in the lymph nodes). It may be considered for women with node-negative (cancer not found in the lymph node) tumors greater than or equal to 1 centimeter. Avastin The results of a recent clinical trial showed that bevacizumab (Avastin) is an effective addition to chemotherapy in women with metastasized breast cancer. Bevacizumab blocks the growth of blood vessels that can feed the tumor and promote growth. Targeted therapy with novel (newly discovered) therapies is in the forefront of ongoing research. -
*************************************************************************
National leaders from labor and justice to news media knew where all this Affordable Care Act led and all we heard was ----it will protect the poor and it will give all Americans access to health insurance. All voices like mine were silenced. Labor unions were brought out to support it-----NAACP and National Organization of Women were brought out to support it----all led by Clinton neo-liberal leadership knowing it would keep over 80% of Americans from ordinary health care. People of color and women are hurt most as usual-----labor unions are going to join them as their pensions and benefits end. So, what is now 1/3 of Americans on Medicare and Medicaid will soar to 2/3 and grow from there all having what will be called A SINGLE PAYER SYSTEM THAT WILL BE GUTTED OF FUNDING ------MEDICAID FOR ALL. This is the goal of Affordable Care Act. Republican voters are fighting this as hard as they can thinking this is ObamaCare and not Republican policy. The Democrats with the Democratic base of labor and justice are silent and supporting it because they do not know to where all this is going.
Making costs soar will give these health systems excuses for not offering these medical products and procedures and it will allow them to move to these 'new, innovative' designer medicine policies tied to global health tourism and telemedicine.
None of this is good for anyone other than Wall Street and the executives at the top. It's not good for the nations that should be building our first world public health structures and not telemedicine----it is not good for any American ----even the affluent -----as quality will fall no matter what you pay for private insurance.
Exclusive: Americans overpaying hugely for cancer drugs - study
By Ben Hirschler
A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, Britain July 15, 2013. Reuters/Stefan Wermuthleft
A man buys cancer drug Glivec for a relative who is suffering from cancer at a pharmacy in Ahmedabad, India April 2, 2013. Reuters/Amit Daveleft1 of 2right A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, Britain July 15, 2013. Reuters/Stefan Wermuthleft2 of 2right A man buys cancer drug Glivec for a relative who is suffering from cancer at a pharmacy in Ahmedabad, India April 2, 2013. Reuters/Amit Daveleft1 of 2right Americans are paying way over the odds for some modern cancer drugs, with pharmaceutical companies charging up to 600 times what the medicines cost to make, according to an independent academic study.
The United States also pays more than double the price charged in Europe for these drugs - so-called tyrosine kinase inhibitors (TKIs), a potent class of cancer pills with fewer side effects than chemotherapy.
The analysis by pharmacologist Andrew Hill of Britain's University of Liverpool, who will present his findings at the Sept. 25-29 European Cancer Congress in Vienna, is likely to fuel a growing storm over U.S. drug costs.
ADVERTISING Democratic presidential candidate Hillary Clinton's declared aim to lower the cost of prescription drugs by ending what her campaign describes as "excessive profiteering" triggered a sell-off in drug stocks this week.
Hill told Reuters he had shared his work on the cost of producing TKIs with the World Health Organization (WHO), which is keen to add such treatments to its list of medicines deemed essential for a basic healthcare system. WHO officials have used the findings in determining that the drugs can be made at low cost, he said.
The first such TKI was added to the WHO's latest draft Essential Medicines List earlier this year.
Several widely-used TKIs are expected to become available as generics within the next five years, as patents expire. Hill calculated that large-scale production could achieve treatment prices in the range of $159 to $4,022 per person a year, against current U.S. prices of around $75,000 to over $100,000.
"It shows there is a lot of scope for prices to come down," he said. "There has to be some middle ground between the prices that companies are charging, which may not even be cost-effective by the standards set by some healthcare authorities, and the actual production cost."
RESEARCH COSTS
Drug companies argue that they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines.
But the high prices charged for modern drugs is generating increasing push-back from healthcare providers, patients and some doctors.
Hill used Indian government data on the cost of pharmaceutical ingredients and allowed for a 50-percent profit margin - but no money for investment in research - to work out the costs of producing certain drugs.
On this basis, he found that Novartis' leukemia drug Glivec actually cost $159 for a year's treatment, against the $106,000 charged in the United States.
Roche's Tarceva for lung cancer cost $236, against a U.S. price of $79,000, and Novartis' Tykerb cost $4,000 against a price of $74,000.
In all these cases the U.S. cost was far above that charged in certain western European countries, where Glivec costs approximately $29,000-35,000, Tarceva $26,000-29,000 and Tykerb around $35,000, Hill reported.
Novartis said the price of medicines was determined by many factors beyond manufacturing costs, including their value to patients and healthcare systems.
"We invest in developing novel and current treatments to find ways to make more cancers survivable. This is challenging and risky and needs to be taken into consideration when discussing pricing of treatments," a spokeswoman said.
Roche declined to comment.
The issue is not unique to cancer drugs. Earlier this month, for example, Amgen launched its new injectable cholesterol drug Repatha in Europe at around half the U.S. price.
"Why should the U.S. bear this huge burden cost? It is not as if the GDP of the United States is so much higher than that of European countries, but they just seem to pay these big premiums," Hill said.
The future pricing of TKIs could also have major implications for developing countries, Hill believes, since mass production could open the way to widespread cancer treatment in the same way that cheap generic drugs helped fight HIV/AIDS.
***********************************************************************
The biologic industry likes to paint the picture of well-researched and tested products and they are lobbying hard for dismantling of all Federal regulations and standards that would try to provide oversight and accountability. As the article shows here for one state---Utah----it will fall to states and cities to enforce existing health laws and provide the oversight of this industry until we can get rid of Clinton neo-liberals and Bush neo-cons in Congress.
Baltimore City is becoming a progressive social democratic city getting rid of the very, very neo-conservative Johns Hopkins and Wall Street Baltimore Development from our government. In doing so we will install the platform for EXPANDED AND IMPROVED MEDICARE FOR ALL rebuilding the public health sector and this will be where Medicare and Medicaid patients will fall to escape these repressive and exploitative health policies.
The only reason the BIO----Biotechnology Industry Organization is lobbying NOW for access to main street patients is there has been no clinical trial or basic science done in this industry and they want to include all of us during this research stage and then -----GOODBYE----THE PRICES WILL SOAR. Given how quickly they feel proof of safety can be found----main street may have access to biologics for a handful of years if they want them.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Below BIO is telling us there will be open and transparent processes for the public to see what is being used et al and I ask you----DO YOU SEE ANY OPENNESS SO FAR? Do you think I could go to Johns Hopkins and ask to see the data of J-CHIP? I could not even see data taken from a community garden survey for goodness sake.
BIO Urges Governor Herbert to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines
Posted: March 17, 2015 American Laboratory
The Biotechnology Industry Organization (BIO) has called upon Governor Herbert to sign important legislation that serves to update existing Utah laws governing substitution of interchangeable biologic medicines.
“When they become available, these therapies will be safe, effective, and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
The Utah Senate unanimously passed House Bill 279 last week, a bill that amends provisions of the 2013 Pharmacy Practice Act. This action follows House passage of the same bill earlier this month.
House Bill 279 represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with BIO’s principles on biologic substitution. Therefore, BIO supports this important legislation and encourages Governor Herbert to sign the bill when it reaches his desk.
“House Bill 279 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer.
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. House Bill 279 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.
While the FDA recently approved the first biosimilar product for sale in the U.S., the agency continues to develop a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. In fact the FDA has indicated they expect to see applications for interchangeable biosimilar product approvals this year. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.
As the Utah State Legislature continues to address issues related to biologic medicines, BIO encourages policy makers to continue to put patients first.
_________________________________________________
'On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this legislation. Included therein is a provision (Section7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated biological license application (ABLA) submitted to the Food and Drug Administration (FDA).'
Below you see there is really no expectation that main street will access these new, 'innovative' medical technologies that are receiving tons of Federal funding to build private research facilities for processing and manufacturing. You see as well where the Affordable Care Act was used to deregulate the FDA process by giving an abbreviated license application. In 2009 Democrats has a super-majority in House, Senate, and Obama so the Republicans did not make them do it. They did it because the Democratic Party is controlled by a small percentage of people running as Clinton neo-liberals. The only people affording these health plans that will include health care access all Americans had will initially families earning over $200,000 a year but they will soon be priced out as the global rich become the consumers of American health care. For the rest of Americans pushed into ever-lower poverty---we get remote controlled microchips and telemedicine. I will escape most of this as a baby boomer---but if left unchecked all of this could be happening in little over a decade. So, it is our children and grandchildren that will feel the brunt of Wall Street global predatory, profit-driven health care. JUST GET RID OF THE GLOBAL CORPORATE POLS AND REBUILD OUR PUBLIC HEALTH IN STATES AND CITIES TO REVERSE THIS MESS.
The article below is long but please glance through----it gives a clear look at why over 80% of Americans AND HIGHER will only be accessing preventative health care and much of that will be remotely=====it looks like this agency for oversight-----CER will act as the SEC does---it will work for the BIO industry, not the American people. You don't create a public private partnership or quasi-governmental status unless you are killing transparency and public voice.
a public-private partnership that will commission CER.
*******************************************************************
'What do current trends in biologics coverage suggest about access in the PPACA era?
In the run-up to 2014, plans are placing greater access restrictions on biologics'
*********************************************************************
Biotechnol Healthc. 2011 Winter; 8(4): 6–10. PMCID: PMC3278131
How Will Biologics Fit Into Healthcare Reform?
With so many variables, it’s hard to predict what kind of market will exist for biologics and other specialty drugs in 2014. Current trends may provide some insight
.MICHAEL D. DALZELLAuthor
This article has been cited by other articles in PMC.Oct. 6, 2011, could become a red-letter day in the annals of healthcare policy. On that day, the Institute of Medicine took a big step forward in the national discussion about the finite quality of healthcare resources. In its recommendations to the Department of Health and Human Services on how to develop a minimum benefit package for health plans to be offered through the coming state healthcare exchanges, the IOM took the view that the scope of the benefits should be determined not by services but by costs.
If HHS follows through on the IOM’s recommendations, we could get as close to the R word as we have ever gotten in this country. Then again, nobody wants to hear about rationing.
Although the IOM report on “essential health benefits” touches on just one of the many moving parts of healthcare reform, it gets to the question: How will access to and coverage of biologics be affected by healthcare reform? The eventual makeup of the essential benefit set is an important factor in how biologics will fare under reform, but it’s only one factor.
Employer concerns about the so-called Cadillac tax, comparative effectiveness research, and biosimilar development and its potential effect on innovation all represent both threats and opportunities for biologics — and are causing some lost sleep among health plans, providers, and manufacturers.
“Everyone’s got a bull’s eye on biologics because they are the fastest-growing trend in the healthcare sector,” says Dea Belazi, PharmD, MPH, vice president of payer and health-care solutions for Wolters Kluwer Health and a consultant for MCOs and biopharma companies. “The scare is, what happens when they come out with a biotech drug for asthma or diabetes — something that targets a common chronic condition — for $25,000 a year? What is going to be the repercussion that might come from the government?”
Go to:Lots of moving parts
Arguably, the biggest questions about healthcare reform’s effects on biologics zero in on barriers to access.
Several provisions of the Patient Protection and Affordable Care Act (PPACA) are intended to keep premiums down:
- Next year, HHS will issue regulations dictating the minimum, or essential, benefits that must be offered by individual and small-group plans sold through the exchanges. The bigger the benefit package, the more expensive the plan is likely to be.
- Health plans offered through the exchanges, which begin operating in 2014, are under pressure to limit premiums. Individuals who can’t find coverage at a cost of 8 percent or less of income are exempt from the individual mandate.
- Beginning in 2018, employers whose premiums exceed $10,200 for individual coverage and $27,500 for family coverage will be slapped with a 40 percent excise tax — the so-called Cadillac tax on benefits deemed too costly.
All this raises several questions: Will insurers be able to maintain current levels of coverage for biologics after 2013? Given the IOM’s focus on cost-efficiency and the PPACA’s squeeze on premiums, will biologics be considered essential? Or will they be deemed too expensive and placed outside the core benefit set?
“Biologics are likely to be considered for inclusion in the definition of essential benefits but will carry a hefty price tag,” says Jim Parker, president and founder of Health Market Strategies, an Indianapolis-based healthcare consultancy, and former president of Anthem Blue Cross and Blue Shield of Maine.
If biologics are not included in the definition of essential benefits, then, Parker says, MCOs and government programs will likely consider the cost of the biologic and balance that cost with the efficacy of the treatment; “A biologic that costs $80,000 to fight cancer will receive a hard look before being included in a health benefit.”
Considering that many groups — oncologists, manufacturers, and patient advocacy organizations among them — are affected by what’s included and what’s left out of the essential benefit set, politics will almost certainly play a role, Parker believes. HHS Secretary Kathleen Sebelius has promised the public will get its say before HHS issues a proposed rule.
“This is going to be high stakes for many people,” says Ian Spatz, JD, senior adviser in the national health care practice of Manatt, Phelps, & Phillips, in Washington. And, he notes, the degree of specificity in the HHS regulation will be an important determinant of coverage.
“The law says that pharmaceuticals have to be covered. Well, what does that mean? Which pharmaceuticals? When do they have to be covered? What’s the cost sharing related to their coverage?” asks Spatz. “If you’re producing a cholesterol-lowering medicine, there’s a good chance it’s going to be covered. But what if it is a new, expensive treatment — let’s say for cancer where there hasn’t been a lot of proof of its life-extending or curative powers?”
Without changes in their benefit packages, 60 percent of employers will face the Cadillac tax in 2018.
Exclusion from the essential benefits package doesn’t mean that buy-up options won’t be available. “I think there will be some variations around ‘You can have this kind of pizza, but if you want 10 toppings on it, it might cost a little extra,’ that will go beyond the essential benefits requirement,” says Belazi.
But a buy-up option could be out of reach for many people, curtailing their access to costlier benefits. This could especially affect those just entering the health benefit market — including individuals with poor health literacy, low incomes, or both, who are at greater risk for chronic disease.
“I think there’s going to be a lot of discretion left to the state health benefit exchanges” about the scope of affordable coverage, says Ian Spatz, JD, at Manatt, Phelps, & Phillips. Healthcare reform, he believes, will not impose “a complete, top-down, command-and-control effort that specifies the same content for every plan in the United States.”
Go to:The same — and more of it
What do current trends in biologics coverage suggest about access in the PPACA era?
In the run-up to 2014, plans are placing greater access restrictions on biologics. In The Zitter Group’s Spring 2011 “Managed Care Benefit Design Index: Emerging Trends in Access,” 74 percent of payers and employers thought healthcare reform would have a significant impact on their costs. As such, 35 percent of payers increased deductibles, out-of-pocket maximums, and nonfinancial access restrictions on biologics this year, and 35 percent said they would do it again in 2012. “Neither payers nor employers waited for all provisions of healthcare reform to become applicable before reducing access and increasing patients’ costs,” the authors wrote. “Payers are having current consumers pay more for the same or less access in anticipation of their reduced ability to manage the risk pool.”
Meanwhile, if existing trends hold, new and existing biologics will drive two thirds of drug spending increases, according to the Medco “2011 Drug Trend Report.” In oncology alone, drug treatment costs will balloon from $125 billion in 2010 to $207 billion by the end of the decade, fueled in part by a 31 percent jump in the number of cancer survivors among us.
Go to:A perfect storm gathers
And so, Belazi says, what we see now, we will continue to see in 2014 — just more of it.
“We’re going to see higher out-of-pocket coverage. Rather than 30 or 40 percent of the market using co-insurance for specialty products, I think we’ll see 60 percent,” he says. “Utilization management will be much more prevalent in the biotech space — things like prior authorization, utilizing a diagnostic, or anything to help tailor therapeutics around these products.”
Though it restricts access, shifting costs to the consumer may reduce premiums enough to support the inclusion of wider biologic coverage within the essential benefit set. Indeed, cost sharing is built into the PPACA’s requirement that insurers offer bronze, silver, gold, and platinum plans — that is, plans whose average enrollee out-of-pocket liability is 40, 30, 20, and 10 percent across all benefits. Insurers operating in the exchanges must offer at least one silver and one gold plan. Each variation must cover the essential benefits; the degree of cost sharing attached to a particular benefit will differ, depending on the plan level.
“This all depends on what rules the government comes back with,” says Belazi. “If they create funky benefit designs like they did with Medicare Part D — where there was the donut hole and variations on out-of-pocket — then that’s what we’ll get from payers.”
The funky benefit design we could see from HHS could well be a biologics benefit carved out of the essential benefit set. “I think that’s exactly what they’ll do,” says Belazi. “I keep going back to Medicare, because I think that’s our blueprint. As the rules come out, I think we’ll see some very interesting things: ‘These are the drugs we will not cover. These are the benefit designs that payers have to adhere to.’ We don’t know what HHS will do until those rules are released, but it’s a fair assumption to say, ‘Yes, that’s probably what they will do.’”
Go to:Employers are wary
Concerns about the scope and cost of benefits are not limited to small-group and individual plans sold through the exchanges. Though the PPACA doesn’t specifically hold employer-sponsored plans to the same minimum benefit requirement as plans offered through the exchanges, the law’s definition of what constitutes a “qualified health plan” has caused benefit consultants to differ on whether employers will ultimately have to conform to it. At the very least, employers are expected to view the essential benefit package as a benchmark; anything in excess may risk being too generous — an issue that looms large, given the threat of the Cadillac tax.
“It’s an opportunity [for biotechs] to build CER into clinical trial design.... It does nobody any good to have a product that nobody will pay for.”
— Matthew Hudes, Deloitte Life Sciences and Healthcare
“Once premiums become unaffordable, we’re forced to look at the costs and ask, ‘What should our priorities be?’” says Jim Parker, of Health Market Strategies.
“Employers want to provide these benefits, but they’re bound by the limitations of the marketplace,” says Parker. “Employers will do whatever they need to do to remain competitive, even if it means cutting benefits. As long as the cost of benefits increases faster than the rate of competitive growth, an inducement will exist to do that.”
A Towers Watson survey released in August suggests that unless they change their benefit offerings, 60 percent of employers will be subject to the excise tax. These employers face the challenge of curtailing some benefits in order to avoid the tax while retaining those that provide value to beneficiaries. Most employers don’t even know what they spend on biologics, according to a survey done by the Biologics Finance and Access Council published in Biotechnology Healthcare last summer.
Go to:The short, medium, and long of evidence
The IOM recommended that HHS take an evidence-based approach to benefit selection. The evidence might include data on the efficacy and safety of long-term use of biologics in patients with chronic diseases or whether their use can achieve meaningful downstream cost avoidance. The rap on biologics, though, is that longitudinal data to justify their cost is often lacking.
Although 38 tests for biomarkers in oncology have reached the market in the last five years, their clinical utility is not well understood, leading payers to reserve judgment.
In the short-term, the lack of evidence could push health plans to limit the market for biologics. Parker thinks the economic environment that healthcare reform creates will intensify payer efforts to clamp down on off-label uses of biologics when the benefit is unclear.
“These types of real-life experiments should be part of a randomized, controlled test. We should deal with this in an orderly, organized, and scientifically driven fashion,” says Parker. “Without application of the scientific method, we really aren’t learning much at all. And real-life experimentation is a very expensive form of experimentation.”
Over time, though, healthcare reform could prompt scientific discovery and generate research to support the inclusion of benefits for a range of biologic therapies.
The medium-term perspective gives a nod to pharmacogenomics as a means for effectively targeting biologic interventions. Scientific refinement of this promising area continues in earnest — more than 1,600 articles on pharmacogenomics were published in 2010 alone.
Later this year, the U.S. Food and Drug Administration is expected to issue regulations for the development of companion diagnostics. Currently, companion tests are being developed in conjunction with biologic therapies for solid and blood cancers, cystic fibrosis, multiple sclerosis, and Alzheimer’s disease.
“Healthcare reform will encourage pharmaceutical companies to develop molecular diagnostic capabilities to support the precise application of their therapies,” says Parker, noting that doing so can open access to targeted uses of biologic therapies. “In the future, manufacturers won’t claim that a new drug will work effectively on 40 percent of a population; they’ll say that the therapy works 100 percent of the time on 40 percent of the population. But they’ll have to demonstrate which 40 percent that is.”
The long-term effects of health-care reform on the evidence-based approach may hinge on comparative effectiveness research (CER). The American Recovery and Reinvestment Act of 2009 set aside $1.1 billion for CER. One year later, the PPACA established the Patient-Centered Outcomes Research Institute, a public-private partnership that will commission CER.
Matthew Hudes, U.S. managing principal for biotechnology with Deloitte’s Life Sciences & Health Care practice, says CER could have a significant impact on creating market access to biologics.
“I think it’s an opportunity for certain companies to take advantage of this, to build CER into clinical trial design and protocols and, therefore, not have to redo work or do a lot of postmarket studies,” he says. “It’s important to look at that because it does nobody any good to have a product that nobody will pay for.”
Hudes says that CER will force a more holistic approach to healthcare. “It introduces a deliberate process to look at the medical impact that each product will have and to evaluate that process in terms of the optimal course of care. It not only looks at one pharmaceutical product versus another, but at the context of the total care of the patient.”
The biggest questions about CER are about limited resources and whether biologics-oriented CER will be a funding priority. The stakes are high — according to a Deloitte analysis, by 2014, biologics will comprise up to 60 percent of the 10 top-selling drugs. Those stakes are raised even higher, says Hudes, by the fact that biosimilars won’t put that big a dent in total spending on specialty pharmacy. (See “What’s the Effect of Biosimilars?” on page 9.)
What’s the effect of biosimilars?Biosimilars represent another aspect of healthcare reform with profound implications for the biologics market. Most of the discussion in the popular media has focused on cost reduction, though insiders say what’s really at stake is whether the PPACA environment will hurt or help innovation — and with it, access.
“There’s still a lot of definition and work to be done,” says Matthew Hudes, U.S. managing principal for biotechnology with Deloitte’s Life Sciences & Health Care practice, “but I think this is both an opportunity and a threat for the biopharmaceutical industry.”
HHS will need until late 2012, at the earliest, to develop a pathway for generics manufacturers to follow. Until then, manufacturers and would-be generics manufacturers will have to wrestle with the question, “How similar is similar enough?”
“I’m particularly concerned about the area of immunogenicity,” says Hudes. “What kind of testing has to be provided to determine safety and efficacy?”
Dea Belazi, PharmD, MPH, vice president of payer and healthcare solutions for Wolters Kluwer Health, says a lot is riding on what the FDA pathway will eventually look like. “If the FDA makes it easy for a biosimilar product to come out, that’s the last nail in the coffin where there will be little to no innovation,” he says. “But if they make it pretty tough for a copycat to come onto the market, then I think patent-life issues become a little less important.”
The answers to questions about scientific concerns will also determine the impact that biosimilars will have on costs, says Hudes.
“Follow-on biologics will have some impact on slowing the growth rate of biologic [costs], but it may be only in the range of 6 to 8 percent,” he says, quashing more optimistic predictions.
“There may be a 30 or 40 percent price reduction on an individual product, but if you look at the overall biologics market, those are older products that are being replaced with more effective products. That’s why if you look at the growth rate of the spend on biologics, it may slow it a bit, but there’s still a lot of innovation and development that’s going on in this very vibrant area.”
Go to:Update with care
Few expect HHS to find the perfect balance between cost containment and coverage, and the PPACA requires HHS to update the minimum benefit package annually. Those annual revisions make the evidence question imperative, because advances in medical technology account for more than half of healthcare spending growth.
“If we fix a definition of what’s essential, meaning that it’s a technology that works, we might still get ourselves into a position where the essential benefits become more expensive and the individual mandate becomes less binding,” says Gerard Wedig, PhD, an economist and associate professor of business administration at the University of Rochester Simon School of Business. “Even if we use cost-effectiveness as a criteria for essential, premiums can outstrip inflation over time.”
Wedig stresses the importance of using clinical or financial outcomes or applying some other evidence-based criteria in revising benefit packages, because the alternative may lead to a political circus. “Let’s say something is shown to be over time less cost-effective than we initially thought. Then think about the politics of pulling that out of the essential benefit package. On one hand, HHS can say ‘cost, cost, cost,’ and on the other hand there is the emotional appeal that ‘People are going to be deprived of this service.’ It may be hard to get benefits out once they’re in there because of the emotional appeal that can be made.”
In a recent article in the UCLA Law Review, Jessica Mantel provided an example, recapping the U.S. Preventive Services Task Force’s 2009 evidence-based recommendation to drop routine screening mammograms in women aged 40 to 49. Powerful interest groups swiftly condemned the recommendation, prompting the Senate to amend its healthcare reform bill to include coverage for annual screenings for women age 40 and older.
“Rather than assuming a hands-off approach as HHS develops national coverage standards, federal lawmakers will often support efforts to mandate coverage of certain conditions or treatments in response to public or interest group pressure, no matter how misguided, for fear that opposing these efforts would alienate voters,” Mantel wrote.
What patients want is to have access to the latest and best treatments, and they want insurance to pay for them. Healthcare reform efforts are forcing us to have a hard conversation about limited resources. Where that will leave biologics is unclear.
“The cost of a drug becomes more of a social and moral question: How much should society be willing to pay to extend the life of one individual?” says Parker. “Through the insurance mechanism, everyone pays for it. It’s a great mechanism for covering costs as long as the premiums are affordable, but once they become unaffordable, then we’re forced to ask: What should our priorities be?”
Spatz, at Manatt, Phelps, & Phillips, doesn’t think the discussion will go down that road — at least not now. “I don’t think this is the time that we will struggle in this country with what’s truly essential and should be shared among us in terms of the taxes we pay and the subsidies we provide or what we might have to do without because we can’t afford it. I don’t think we’re going to go that far at this stage because of PPACA’s guidance that these plans should look much like private plans.”
But the IOM report pushes us closer to that discussion. Ultimately, the consumer drives the market. Cost, evidence, and politics all will play a role in determining the fate of biologics under healthcare reform, but only time will tell if Oct. 6, 2011, was a red-letter day in the annals of healthcare policy or just another day and another false start.
RSS Feed
