Health Technology Assessments

PCSK9 Sponsors, Payers In The Ring At ACC

Posted on Thursday, April 14, 2016

Cardiologists bemoaned high cost of new drugs and high hurdles for reimbursement at the American College of Cardiology annual meeting; will outcomes data save the day? The Pink Sheet, April 11, 2016, By Emily Hayes / Email the Author / View Full Issue Sponsors of the PCSK9 inhibitors have been having a hard time fighting their way into the cholesterol market in their first year of launch. Cardiologists are wary of high prices for new drugs and payers have reportedly created an obstacle course for the doctors who are on board. The build-up of investor excitement over anti-PCSK9 monoclonal antibodies in the post-Lipitor era was fast and heavy, despite some awareness early on in their development of the risks of launching injectables in a market dominated by oral generics (“Will New Injectables Sell In An Oral, Mainly Generic Cholesterol World?” — “The Pink Sheet,” Apr. 9, 2012). With high LDL-lowering potency, good tolerability and a genetically based mechanism of action that is similar to statins, the PCSK9 class looked like a game-changer in cholesterol reduction, despite all of the available generics, especially without outcomes data (“PCSK9 Mechanism Lends Confidence Ahead Of Outcomes Data” — “The Pink Sheet,” Mar. 23, 2015). But performance of Amgen Inc.’s Repatha (evolocumab), approved in August...

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How Can Migraine Drugmakers Avoid the PCSK9 Debacle?

Posted on Friday, April 8, 2016

The Timmerman Report, By Luke Timmerman, April 4, 2016 One of the big ideas in biotech today is that you can prevent severe, chronic migraine headaches. This story has a lot of juicy ingredients: intriguing biology, bona fide medical value, and a potentially broad impact on millions of people. But if the drugmakers in this emerging category overplay their hand, and don’t pay careful attention to the new drug pricing reality, it could become a train wreck. Think about the PCSK9 drugs. Not long ago, biologists and cardiologists were raving about the cholesterol-lowering power of these antibodies from Amgen and Sanofi/Regeneron Pharmaceuticals. Both drugs won FDA approval to much fanfare last summer. Months later, sales of these drugs are barely a rounding error for either company. The vast majority of prescriptions (about 75 percent by estimates from Amgen) are being denied by payers via prior authorization procedures. And the denials keep coming on appeal. Payers want to see whether these $14,000 list-priced drugs are any better than cheap generic statins at what really counts – reducing heart attack and stroke. Until cardiovascular outcomes data rolls in from clinical trials in 2017, and data accumulates on their long-term safety, payers have tucked these drugs in a tidy little box. They...

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Real Endpoints’ RxScorecard™ predicted launch failure of major new anti-cholesterol drugs

Posted on Thursday, February 11, 2016

Analysis from 2015 showed that because PCSK9 inhibitors had not proved more than incremental value for most patients, payers would dramatically restrict their usage. Poor Q4 sales show that’s exactly what happened. Westport, CT, February 11, 2016 In a press release issued July 7, 2015,  Real Endpoints LLC (RE) predicted that the two soon-to-be-launched PCSK9 inhibitors from Amgen and Regeneron/Sanofi would not get substantial market uptake. RE based this conclusion on its proprietary tool RxScorecard™, which assesses the relative value of marketed and pipeline drugs from a patient’s and payer’s point of view. RE defines value as a full assessment of a drug’s efficacy, safety, convenience, adherence and economic attributes in comparison to other therapies in the indication. RxScorecard indicated that while both products offered potential efficacy benefits, they demonstrated little incremental value for most patients because of their lack of meaningful outcomes data at launch and their expected high pricing. As a result RE said last July that “Payers will have an extraordinary opportunity to control costs in this class.” That’s exactly what they did. Now that Q4 sales are in for both Praluent and Repatha, the magnitude of their launch failure is clear. Praluent sold only $7 million in Q4; Amgen has not released data on Repatha,...

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‘DrugAbacus’, a Comparative Cancer Drug Pricing Platform Powered by Real Endpoints’ RxScorecard™, is Launched

Posted on Friday, June 19, 2015

Westport, CT, June 19, 2015 – Real Endpoints (RE) is pleased to announce that its RxScorecard™ is the information technology platform supporting Memorial Sloan Kettering Cancer Center’s DrugAbacus – an interactive tool for considering the basis of cancer drug prices. Conceived by Dr. Peter B. Bach, Director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering (MSK), DrugAbacus was launched at www.drugabacus.org. MSK’s DrugAbacus generates a dollar-value for cancer drugs available in the United States (beginning in 2001 with Gleevec) based on a user’s settings for six different domains of potential value including the treatment’s survival benefit, side effects, and the incidence of the condition targeted. Memorial Sloan Kettering licensed the Real Endpoints RxScorecard platform for research purposes so users can generate “Abacus prices” and compare them with actual prices of these drugs at the time of launch in a visual and intuitive format. “We believe RxScorecard is the only tool available that provides a 360 degree comparison of the multiple components of a drug’s value in an independent, objective and systematic approach. We developed the IT platform to make it very easy for users to access our analysis, and are delighted that Dr. Bach selected this platform for DrugAbacus,” said Julie Eskay Eagle, RE’s Vice...

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Wall Street Journal publishes article on new cancer pricing tool from Memorial Sloan Kettering using RE’s RxScorecard technology

Posted on Friday, June 19, 2015

June 19, 2015 – Memorial Sloan Kettering Cancer Center, one of the nation’s top cancer hospitals, has created an interactive calculator that compares the cost of more than 50 cancer drugs with what the prices would be if they were tied to factors such as the side effects the drugs produce, and the amount of extra life they give patients. Please click here to access the article....

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Evidence and Endpoints in Cancer: Can Both Payers and Regulators be Satisfied?

Posted on Wednesday, March 27, 2013

How can oncology drug developers design their trials to satisfy both regulators and payers, and thereby maximize both access and commercial success?  It’s an increasingly urgent question as cancer programs continue to dominate pipelines, and drugs bills. Yet “there’s a fundamental tension” between the clear evidentiary base required to get a drug approved, and the emerging, sometimes inconsistent data sought by payers to justify funding that drug, notes Roy Baynes, SVP Oncology Therapeutics at Gilead Sciences Inc. Above all, he emphasizes the need for close engagement with payers, at least in Europe, from an early stage. Collaborating prospectively with governmental payers may help address the reality that “individual sponsors have little leverage,” he says.  (In the US, it’s not at all clear to us that payers want much to do with pharmas before products get very close to market.  And in oncology specifically, payers still can’t really say “no” to paying for products approved by the FDA; European governments have no such inhibitions.) There are some rules that now beginning to hold across the board, though, notwithstanding often considerable differences in evidentiary standards across treatment-type, positioning, and disease area. Having a “meaningful comparator is obviously important,” point out Baynes, who will be speaking at NextLevel Pharma’s PharmAccess Leaders’ Forum in...

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The Drug Assessment Process: Inadequate and Costly

Posted on Wednesday, January 16, 2013

The more I study it, the more I believe the process of drug assessment by payers and providers needs some serious attention (we’ll pay plenty at the Real Endpoints Symposium, March 11-12). But driving action requires concern — and so, who cares?  Answer is: anyone interested in improving the dismal economics of healthcare.  As we noted here, drug-spend inflation is skyrocketing, thanks largely to the cost of new drugs and, in particular, new specialty drugs.  And the best mechanism we have for controlling those costs is the process, led by Pharmacy & Therapeutics committees, for assessing the value of drugs and establishing utilization guidelines.  But best, in this case, doesn’t mean adequate. Most obviously, the process is redundant.  Several hundred payers and several thousand hospitals all have P&T committees, with associated clinical pharmacy specialists and other research infrastructure, looking at the same materials about the same drugs…and by and large coming up with pretty similar answers. It’s slow and under-productive.  Based on our admittedly unscientific survey, P&T committees at most mid-sized and smaller plans meet quarterly and make decisions on, maybe, 13-15 new drugs per year.  They don’t have the time or bandwidth to re-assess new data on existing drugs that could change their formulary status. It’s oddly limited. ...

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Why Payers Don’t Really Control the Drug Benefit — and Why They Need to

Posted on Tuesday, January 8, 2013

It’s certainly the biggest change in healthcare in my business lifetime: the transformation from a fee-for-service economy fueled by abundant dollars to an essentially capitated world of financial tradeoffs.  The transformation will likely take longer than we expect. (What transformation doesn’t?) Still, payers and providers –and the various big and small service providers hoping to serve them — are already trying to improve  swaths business processes as diverse as connectivity, transparency, and consumer communication (see the David Shaywitz/Tony Wolff skeptical take on at least the digital aspect of all this) . But relatively little of this re-engineering aims at the purchase and management of drugs.  (We’ll be talking about the most important innovations at the Real Endpoints Symposium, March 11-12, in Philadelphia). There are a few experiments on the margin.  Some payers are playing with tougher formularies (e.g., UnitedHealth de-preferred major market leaders Januvia and Humira, with significant success in moving the former’s market share to Onglyza and less success with Humira).  “Pathways” in oncology (attempts to standardize physicians on specific drugs) show promise.  And now that Medicare, through its star ratings, is paying plans to improve adherence, there’s an opportunity for new models that predict when patients will adhere to their meds and when they won’t. (For the...

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