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Towards a More Intramural Approach to Biomarker Development

A recent article by Shashi Amur and FDA colleagues on the future of biomarker development (Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization) provides a solid foundation for ongoing development and review process for biomarker qualification. FDA should be applauded for their progress in agency collaboration with the Critical Path Institute (in biomarker consortia development), the recent total kidney volume and plasma fibrinogen prognostic marker approvals, and sponsorship of interactive sessions such as the recent CERSI meeting at University of Maryland, as well as their EMA partnership to facilitate collaborative review of drug development tool qualification.

We would encourage additional measures to hasten biomarker development, including:

  • Maximizing Expert Resources: FDA needs adequate resources to provide advice and oversee review and decision-making. One solution is to partner with an external entity (an Intramural Biomarker Consortium-IBC) to develop early advice and serve as an expert sounding board for nascent biomarker efforts.  The IBC could be a required or voluntary resource in the review process, especially for initial data package reviews. This approach would allow FDA staff to focus on their primary role of product review and regulatory oversight.
  • Refined Evidentiary Considerations: The product development and research community should collaborate to support FDA in developing a framework for the proper level of evidentiary substantiation required for qualification and the criteria used to evaluate them – such that FDA can issue guidance -standards which do not exist today.  The IBC could be charged with overseeing relevant workshops and the drafting of initial guidance documents (consistent with FDA’s Good Guidance Practice recommendations and provided FDA is actively participating and has final approval).
  • Qualification Plan: FDA should clarify the components of individual qualification plans and judge submitted data packages against them.  Decisions not to qualify a proposed biomarker for a particular context should be accompanied by an explanation of the evidentiary gaps between the agreed plan and the submitted qualification package. IBC could work with biomarker developers to build these plans and perform initial data package reviews.
  • Enhance Learning:  Give FDA the authority to share information about biomarker qualification programs that are being advanced through collaborative efforts. Much can be learned by reviewing successes and failures across ongoing biomarker programs, and would inform the broader research community to enable refined evidentiary standards.
  • Timeliness: FDA must clarify and communicate timelines for the qualification process in order to foster predictability and encourage participation.  Such resources could be provided via PDUFA VI.

FDA can further solidify its place squarely in the center of the innovation ecosystem by fostering collaborative alliances with all stakeholders, enhancing qualification planning, sharing developmental endeavors, and clarifying standards.

Peter J. Pitts
President, Center for Medicines in the Public Interest
Former FDA Associate Commissioner

Timothy R. Franson, M.D.
Chief Medical Officer – YourEncore
Immediate Past President- US Pharmacopeial Convention

Health plans and pharmacy benefit management firms are hiking co-insurance rates for new medicines.  As Adam Fein points out in his Drug Channels blog,  they are daring biopharma companies to NOT provide copay assistance which can amount up to 25 percent of the total cost of a drug.  (Federal programs like Medicare Part D don't allow patients to get such support directly.)  

Moreover, rebates cost biopharma about $40 billion each year.  Nearly 90 percent of that $40 billion ($36 billion) is passed on to health plans by PBMs.   In 2014,  health insurers generated  $663 billion in revenue, which means drug rebates are about 5 percent of total revenues.  

I now see another layer to the strategy of make drug prices, which are effectively set by PBMs and insurers with higher coinsurance, the issue and blaming drug companies.  It's all about making money coming and going.   PBMs and insurers can extract deeper discounts from companies whose products they carry AND get the innovator firms to pay for the chunk that consumers have to cover:

Adam discussed an IMS study " Emergence and Impact of Pharmacy Deductibles: Implications for Patients in Commercial Health Plans"  As he notes: "The report’s overarching theme is unsurprising: Higher out-of-pocket costs reduce patients’ adherence to drug therapy and increase prescription abandonment rates.

The report’s major contribution, however, links the growth in pharmacy deductibles to manufacturers’ copayment offset programs, which cover a beneficiary’s out-of-pocket costs for a brand-name drug. High deductible plans are shifting costs from payers to consumers and—in many cases—back to manufacturers.

The findings echo what payers have been doing by adding coinsurance rates to higher-tier products, per Employers Get Tougher About Pharmacy Benefits and Specialty Drug Management. Most people can’t afford to pay hundreds or thousands of dollars every month. Payers are therefore essentially daring pharmaceutical manufacturers not to pick up the patient’s coinsurance with a copayment offset program. This is the same dynamic that links the growth in four-tier benefit plans with copay offset program. See How the Fourth Tier Coinsurance Boom Drives Copay Offset Programs.

I’m not sure how many manufacturers have analyzed the codependent relationship between benefit design and their consumer-directed programs. This report suggests that such analysis would be truly therapeutic."


To which I would add.. maybe the innovators should show consumers how their drugs are priced by insurers to force them to cover the difference and suggest how patient hostile such an approach is.   This co-dependency undermines the doctor patient relationship and moves medicine away from the kind of personalized treatment selection medical innovation is making possible.  

Euro-Vigilance

  • 10.20.2015

Wither FDA?  Also, what about addressing incentives/responsibilities for enhanced physician/pharmacist/patient reporting?

From the pages of FDA News ...

EMA Releases Pharmacovigilance Program Update

Drugmakers must begin using a new centralized database for product safety update reports by mid-2016, the European Medicines Agency says.

The updated repository will also link the PSUR single assessment procedure number with products, making searches easier, and will allow for an automated two-way exchange between national authorities’ IT systems and the PSUR repository.

Use of the repository becomes mandatory on June 13, 2016. Until then, marketing authorization holders must continue to submit PSURs to national competent authorities.

The EMA is also finalizing revisions to its EudraVigilance Access Policy, which would give drugmakers greater access to adverse event reports, beginning in mid-2017. The agency’s management board is set to vote on the policy in December.

The EudraVigilance website will be updated in November with the publication of key documents such as the Stakeholder Change Management Plan, which details the IT and business changes companies need to make before reporting begins, the EMA says.

The EMA also plans to release a report this month on the launch of its Medical Literature Monitoring initiative, which allows drugmakers to easily search for information on adverse reactions associated with their products.

In addition, the EMA has launched an online invoice portal where companies can pay their annual pharmacovigilance fees. Under the fee program, which took effect in July, drugmakers must pay $70 for each product they market in the EU.

The agency has also updated its database of 500,000-plus drug products and is giving member states access to it. Drugmakers should enhance their in-house systems to allow for receipt of acknowledgment messages regarding new and modified marketing authorizations, beginning Nov. 4.

The changes were mandated in the 2012 pharmacovigilance legislation. View the EMA’s Pharmacovigilance Program Update at www.fdanews.com/10-14-15-PharmacovigilanceProgrameUpdate.pdf.
Today, the National Comprehensive Cancer Network released a set of flash cards  to solve a drug cost problem that doesn’t exist by adding to a problem – insurers shifting the cost of cancer treatment to patients -- that does.  In so doing, NCCN undervalues hope and could inadvertently increase the rate at which cancer patients choose to give up hope when in fact medical innovation increases the reasons for such feelings. 

NCCN, like the American Society for Clinical Oncology (ASCO) has create a framework telling doctors and patients that in selecting treatments some medicines are worth more than others.

 NCCN, like ASCO, claims choosing which medicines are most affordable will address “the combination of increasingly unsustainable rises in the costs of cancer care, the accelerating pace of expensive innovations in oncology, and persistent hope for rescue in patients with life-threatening disease.”  Apparently, persistent hope is something we should discourage because saving a few dollars is more important. 

However, the assertion that cancer costs are unsustainable is untrue.  New cancer drugs are expensive no doubt.  Yet they account for only account for 0.7 percent of the $2.9 trillion we spend on health care.  Cancer spending has increased in 1995 from $42 billion to about $130 billion today.  But its share of total health spending declined from 4.7 percent to 4.4 percent during the same time period.  

In fact, new medicines reduce the cost incurred by a cancer diagnosis, for instance in part by reducing hospitalization.  In 1996 drugs were 3.7 percent of cancer spending and 62.4 percent went to hospitalization. By 2012, drug spending was 9.3 percent of cancer costs while the share going to hospitalization dropped to 41.3 percent.  During the same time period the life of expectancy of cancer patients increased, mortality rates declined by 20 percent and the number of cancer survivorship grew from 9.8 million to 13 million.  The NCCN flashcards ignore these cost and life saving gains.

To be sure, the out of pocket cost of cancer drugs has increased.  But the huge jump is caused by insurers and pharmacy benefit managers who force patients to pay up to 40 percent of the cost of a drug that two years only cost a few dollars a month. More recently, the percentage of health plans placing all drugs in the highest cost sharing tier has nearly doubled.

Capping cost sharing would require about people paying 50 cents more in premiums every month.  Yet NCCN accepts insurer  cost shifting as a fait accompli.  It forces doctors and patients to choose treatments, not based on value, but on the insurer imposed cost of a medicine, a cost that is often based on how big a rebate other medicines generate. 

Further, each NCCN flashcard measures one drug for one disease for an average patient.  But often drugs must be used in combination to achieve results. Indeed, each “tumor may embody more than 100 different diseases, and multiple subtypes of each tumor exist. Even if some of these tumors have things in common, the individual landscape of each patient may be very distinct.”

Finally, the flashcards are to be used, it seems, to discourage the persistent hope for rescue in patients with life-threatening disease.

Hope is a valuable thing. For example, AZT, the first HIV drug, showed no additional survival in clinical trials.  NCCN flashcards would deem them expensive but ineffective.  In the real world, the use of such medicines kept enough people alive until the next generation of anti-AIDS extended life by years. The flashcard negates that value.

A survey of patients who chose assisted suicide in Oregon show that since 1998 the number of people citing the cost of care as a reason for their decision jumped 77 percent.   To the extent that the NCCN flashcards reinforce the impact of insurer cost shifting and are skewed against persistent hope, they may contribute to an increase in cancer patients thinking there is no longer a reason of a value for living.  Let's hope not!

Interesting and well-sourced article on the continuing saga of the CDC’s opioid guidelines and the conflicts of interest of the Core Expert Group.

The article is titled, Dysfunction, Lobbying, and Conflict of Interest in the Debate Over Opioids and here’s one quote to whet your appetite:

“I’m sure everyone on the committee is an expert, but you need to have a variety of opinions, otherwise why even bother having the meeting in the first place,” said Pitts, whose responsibilities at the FDA included overseeing the formation of FDA’s advisory committees. Referring to PROP’s role in creating the guidelines, Pitts said, “When you basically take one group that is considered the opioid lunatic fringe and allow them to create the basis of your policy almost verbatim is inexcusable. It’s bad policy. It’s bad science. It’s poorly serving the public health.”

The complete article is well worth a read.






California Governor Jerry Brown signed a “Right to Die” bill into law lastweek.  Meanwhile, a state ballot initiative to impose price controls on medicines will insure that lots of people will take advantage of the law that otherwise would be alive.

That’s because price controls create shortages of important medicines, especially for cancer.   And price controls add months, if not years for the time it takes to get medicines to patients.  And price controls are always combined with steps to coerce patients to take cheaper medicines. 






1.  There is a right to die using an off-label combination of lethal drugs if you have a fatal illness.  There is no corresponding right to try an experimental treatment if you are dying.  You can get an experimental drug if the company making it will cover the cost. Setting prices artificially low even as the cost of developing new medicines increases means that the right to die will trump the right to try.

2. Similarly, we force dying patients to wait years for new medicines to become available.   In addition to Food and Drug Administration regulations, insurers and health systems demand evidence that a drug is worth it.  That demand makes people wait for many new medicines. Price controls are based on such ‘evidence’.  It is self evident that the unnecessary delays in access contribute to the desire to take one’s own life.  Price controls will and do affect the decision to die.

3. Finally, we are developing cost control mechanisms that reinforce the desire for assisted suicide.  Price controls are accompanied by so called treatment pathways limit the use of new medicines until people fail on older, often more toxic drugs with more side effects.   In an age of personalized medicine, it is possible to customize treatments to patients to extend life.  Yet most pathways use average response to one drug.  In turn, that average response – which will be far below what many people with an illness would experience – is used to measure the “value” of treatment.  

Most people choosing assisted suicide have cancer.  And most of the cancer patients who make that decision have tumors or cancer types that have shown the least progress over the past 20 years.   At the same time, the percentage of cancer patients choosing assisted suicide has declined since 1998 as new treatments emerge.  Indeed, in 1997 sixty-three percent of HIV patient assisted suicide, and 55% acknowledged considering physician-assisted suicide as an option for themselves.  In Oregon the number of HIV patients chose patients choosing assisted suicide went from from 10 in 1998 to 0 in 2014.   The key variable is access to new drugs – many of which were shown to provide benefits deemed not worth it by treatment pathways put forth by physician groups and insurers – that extend and improve life.   So by delaying access to new medicines that might be effective we are encouraging assisted suicide.

Finally, the Oregon survey shows that the reason for assisted suicide with the biggest increase since 1998 is financial implications of treatment.   The percent citing this cause jumped 77 percent.   By extension, eliminating financial burdens would eliminate assisted suicide. 

However, our health system is moving in the opposite direction.  It is shifting the cost of medicines that offer hope to patients.  In many cases insurers are increase the effective price of medicines by more than the 5000 percent increase that has been a source of outrage.  Under price controls, insurers and government health programs would not be obliged to cover anyt medicine it believes is too expensive. What’s more, rather than fighting to eliminate that burden with copay limits, the leading cancer doctor and provider trade groups have made the insurer-imposed cost to the patient a key reason dying patients should choose one treatment or another or no treatment at all.  

A system that delays access to new treatments, underestimates survival and deliberately exposes the dying to the cost of the potential most effective treatments and then hits the patient over the head with the expense (instead of protecting them from it) essentially makes it easier for the the sick and disabled to die. As my colleague Peter Pitts has noted, in Oregon Medicaid denies coverage for certain cancer treatments for patients that have been deemed “too” sick, haven’t responded well to previous treatments, or can’t care for themselves.
Oregon state bureaucrats are severely restricting access to care and dooming potentially thousands of local patients to a premature death with medicines the state will gladly provide free of charge. 

We have a health system that is turning the right to die into a duty to die.  Price controls will make it virtual requirement to do so.

Much debate over the manner in which the CDC handled conflicts of interests with its opioid guideline development team.

And there’s going to be a lot more.

The Annals of Internal Medicine has just published its Principles for Disclosure of Interests and Management of Conflicts in Guidelines.

In the very first paragraph, the guidelines warn against …

 "Intellectual COIs, including attachment to ideas or academic activities that create the potential for an attachment to a specific point of view." Specific examples of this are listed as, “community standing,” “personal convictions or positions,” leadership or board committee memberships” and, “Leadership or board, or committee memberships.”

And who appears on the CDC’s Core Expert Group? Jane Ballantyne.

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing. And in her conflict disclosure (see page 39 of the CDC document), she discloses her services as a paid consultant to Cohen Milstein Sellers & Toll – the same law firm referenced by the New York Times as shopping around opioid litigation – and having guidelines from the CDC that recommend restrictions in opioid prescribing could certainly be advantageous to such an endeavor.

As Pain News Network has reported, “The CDC and PROP appear to have a close working relationship — a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found — unedited — on the CDC’s website.

According to Bob Twillman, Executive Director of the American Academy of Pain Management (one of the stakeholder groups that will be consulted by the CDC):

Clearly, this is PROP’s way of getting what FDA didn’t give them when they advocated for an ER/LA opioid label change. I don’t think it’s a coincidence that this sets a 90 mg MED dose limit, when PROP advocated for a 100 mg MED dose limit in their Citizen Petition to the FDA. That PROP’s president and one vice-president are part of the core expert group; their executive director and a board member are part of the stakeholder review group; and another board member is one of the three who will help edit the guidelines after the stakeholders report, all is not a coincidence, and clearly puts their fingerprints all over this guideline. But, of course, no one is supposed to know that.

On every count the CDC fails the test of intellectual conflict of interest. According to the CDC, they agency “aimed to minimize conflict of interest, enhance objective assessment of the evidence, and reduce bias.” Well, they may have aimed – but they missed badly. The members of this group do not represent a broad spectrum of thought on opioids. To put it nicely, the issue of normative bias needs to discussed –loudly and openly.

The complete guidelines from the Annals of Internal Medicine can be found here. It should be mandatory reading at the CDC.

From the pages of Fierce Biotech …

The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews

Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.

In an interview with Pharma & MedTech Business Intelligence, FDA Office of New Drugs Director John Jenkins said the agency's long-held problems with priority review vouchers have been "amplified" as more and more companies line up to redeem them. And the market value of the vouchers has skyrocketed over the past year, with one going for $350 million in August, suggesting the issue isn't going away.

The voucher program, created in 2007, works like this: Any drug company that wins approval for a new drug that treats a rare pediatric disorder or neglected tropical disease is given a one-time coupon, which, when redeemed, shortens the FDA review process from 10 months down to 6. And, in a move designed to encourage R&D into such under-served diseases, winning companies can sell their vouchers to anyone they please and at whatever price.

But what's not negotiable is that 6-month timeframe, and that's what worries Jenkins. "In effect, these programs allow sponsors to 'purchase' a priority review at the expense of other important public health work in FDA's portfolio," he told PMBI. The FDA has a finite amount of time and resources available at any given time, and allowing one company to cut in line inevitably affects the agency's ability to do its job elsewhere, he said.

And the universal applicability of a priority review voucher could also create problems, according to Jenkins. A drugmaker could--as Sanofi did--use its coupon on a primary care treatment that would be used by millions of patients. Such drugs require multiple large clinical trials to support approval, and thus their applications are complex and time-consuming. "Reviewing such an application in 6 months is very challenging," Jenkins told PMBI, and the voucher program does not provide any additional staff to follow through.

Despite regulators' concerns, however, the program is a hit with industry, which is paying more and more for the privilege of a quick review.

The first voucher to change hands came from BioMarin, which sold the coupon to Sanofi and Regeneron last year for $67.5 million, helping the pair leapfrog Amgen in the race to launch a new class of cholesterol treatments. Months later, Gilead Sciences paid $125 million for Knight Therapeutics' voucher in hopes of accelerating its HIV pipeline, followed by Sanofi splurging $245 million for Retrophin's priority ticket and AbbVie promising $350 million to United Therapeutics for the same asset. Last month, AstraZeneca paid an undisclosed sum for a voucher of its own.

Here’s the full Jenkins interview.

Donald Trumps PBMs?

  • 10.09.2015

Pharmacy benefit managers make money by denying care

By Peter J. Pitts

Special to the Mercury News

Donald Trump, Hillary Clinton and Bernie Sanders all think that healthcare is too expensive. But they're looking in the wrong places for savings. In 2012, the CEO of the nation's largest pharmacy benefit manager, Express Scripts, earned about $1 million every week.

PBMs can afford such rich compensation because they increasingly refuse to pay for patients' medicines. In 2016, Express Scripts will deny coverage to 124 medicines -- up from 95 drugs this year. America's second largest PBM, CVS Caremark, announced that it will banish an additional 14 drugs from its 2016 list of covered medications, in addition to the 66 forbidden medicines in 2015.

By refusing to cover specialized drugs, Express Scripts and CVS Caremark aren't just denying patients access to lifesaving medication. They're also driving up healthcare costs for patients.

PBMs design and maintain drug formularies, the lists of medications available under particular health plans. Their influence is massive because PBM-administered plans cover more than 210 million Americans insured through employers, unions, or government programs like Medicare Part D.

PBMs can play a valuable role as middlemen in the healthcare system. They streamline the drug purchasing process by supplying thousands of pharmacies and insurers with prescription contracts. They also hold healthcare spending in check by using their immense purchasing power to negotiate large discounts from pharmaceutical manufacturers. Their profit comes from pocketing any rebates they extract from drug makers that they don't pass on to pharmacies and insurers.

However, the largest PBMs -- particularly Express Scripts and CVS Caremark -- increasingly abuse their role and pad their bottom lines by simply refusing to cover certain lifesaving drugs.

CVS Caremark, for example, recently took to the Journal of the American Medical Association to promote the use of cheaper statin medications rather than specialized new drugs that can cut "bad" LDL cholesterol levels in half. Doctors have called the new medicines a "game-changer" in the fight against coronary artery disease.

Innovative drugs are often the groundbreaking ones that revolutionize treatment of serious diseases. Consider Sovaldi, which PBMs have attacked as "unreasonable" due to its $84,000 price tag. Yet the drug cures 90 percent of hepatitis C patients in a 12-week treatment with vastly reduced side effects. Previous treatments took up to a year and cured only half of patients.

Last year, pharmacies sued Express Scripts over its "scheme to deny all claims" for certain customized medications. "The scheme is forcing patients to go without treatment," the suit stated, "jeopardizing their health and causing bodily harm, or forcing them to pay out-of-pocket sums that they may or may not be able to afford for basic healthcare needs that have been prescribed by their doctors."

Without medicine, many patients grow sicker and require more expensive care in hospitals and nursing homes.

Prescriptions are almost always the most cost-effective treatment option. The Congressional Budget Office estimates that a 1 percent increase in prescription use by Medicare beneficiaries causes Medicare's total medical spending to fall by about one-fifth of 1 percent.

So in effect, PBMs are passing the buck to insurers and government healthcare programs, which are on the hook for pricier treatment regimes.

Most people would find it shameful to withhold medications from sick patients, especially since doing so raises the financial burden on consumers and taxpayers. Unfortunately, America's pharmacy benefit managers are adopting this callous strategy with increasing frequency.

Mountain Due

  • 10.09.2015

I’ve just returned from the glorious Mountain West (Salt Lake City to be precise) where I attended the Utah Employer Healthcare Summit.

One of the panels I attended, “Healthcare Consumerism,” included a regional exec from Aetna. He bragged on his firm’s “commitment to transparency.” As an example he described their new customer app. I commented that giving people access to their own data wasn’t transparency. That got things going. The next question came from a physician who asked why they don’t share information about the discounts they get from drug manufacturers. His response was classic, “because it’s confidential.”

The physician was not assuaged. Quite the contrary.

The issue of the role payers play also became a central theme on the panel I participated on, “The $84,000 Pill.” One of my main points was that payers regularly receive significant discounts on medicines – and then don’t pass along the savings to consumers. The audience was largely comprised of employers and I made sure they understood that the same issue holds true for PBMs and their consumers – employers.

Allow me to share one telling moment. Another panelist, an executive from a large regional PBM, was explaining why they can’t afford “$84,000 for Sovaldi.” I (politely) interrupted him to ask, “Many large payers are getting upwards of a 50% discount on Sovaldi.” He shot back, “We’re only getting a 38% discount.” “Well,” I said, “then maybe you should stop talking about an $84,000 pill and start talking about a $52,000 treatment that cures the patient 90+ percent of the time.” His snappy comeback? “It’s not that simple.

“The truth,” as Oscar Wilde quipped, “is rarely pure and never simple.”

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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