Guest Post

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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Medicaid May Offer Best Opportunity For Merck’s Zepatier

Posted on Wednesday, April 6, 2016

Newest hepatitis C entrant doesn’t have the best value in all subpopulations, according to analysis by Real Endpoints, but Medicaid’s mandatory discount could make up for those disadvantages. The Pink Sheet, March 28, 2016, By Cathy Kelly / Email the Author / View Full Issue Merck & Co. Inc.may find the unique drug pricing rules in Medicaid help create the best opportunity for its recently approved hepatitis C drug, Zepatier (grazoprevir/elbasvir), relative to prospects in the commercial and Medicare Part D markets. Zepatier is the third all-oral hepatitis C combination drug to reach the market and it has a narrower label than Gilead Sciences Inc.’s market-leading Harvoni (sofosbuvir/ledipasvir). To compensate for those challenges, Zepatier is positioned to compete mainly on price. Its wholesale acquisition cost is $54,600 for a treatment regimen, approximately 30% below Harvoni’s list price (“Merck’s Biggest Impact With Zepatier Approval May Be On HCV Pricing” — “The Pink Sheet,” Feb. 1, 2016). A recent analysis by RealEndpoints’ drug value and pricing tool RxScorecard highlights the complicated considerations that go into commercial strategies across the three major markets – Medicare, Medicaid and commercial plans – and shows how the pricing rules governing one sector, Medicaid, might offer advantages that the others do not. Merck is not indicating that its primarily focus for Zepatier will be Medicaid. The company told...

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Innovative Contracting: Healthcare Reform A Key Catalyst

Posted on Tuesday, January 17, 2012

By Katya Svoboda and Alexis Matos Given the difficulty of implementing risk-sharing deals in Europe, should manufacturers in the U.S. even bother setting up these complex arrangements? After all, these innovative contracts, typically tied to a drug’s performance, are notoriously tough to put in place. In many cases the systems required to capture the relevant data are missing, and the lack of coordination between medical and pharmacy benefits means conflicting incentives could be operating within the same payer organization. Still, we believe the Affordable Care Act is the necessary catalyst for more innovative contracting. Three features of the ACA have the greatest potential for stimulating interest in developing innovative contracts:  comparative effectiveness research, private health exchanges, and a biosimilar approval pathway. Let us explain. One of the sticking points of pay-for-performance (P4P) agreements is getting payers and product makers to agree on the actual standards against which a given drug or device should be measured. Since the ACA supports comparative effectiveness research efforts, the law facilitates the creation of outcomes-based standards that all parties can agree on when establishing contracts. Enhanced data systems will then help payers and manufacturers measure and share outcomes markers. New health care exchanges, which are expected to insure more than 17 million new patients...

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Building The Greater Real Endpoints Community

Posted on Tuesday, January 17, 2012

  You know that old saw “it takes a village”? Before you roll your eyes, consider this: the same underlying premise embodied by this oft-uttered phrase is what’s driving the new openness called “externalization” at drug and device makers. Simply put, in the past few years, product makers have realized that they don’t have a lock on innovation and need to find ways to access new ideas as they reshape their pipelines. So what are they doing? Partnering. We want to partner too. At Real Endpoints, we are well aware that the rapidly changing world of reimbursement makes it impossible to cover the news flow to the degree — and with the rigor– to which we aspire all the time. And we’re also well aware that while we may offer one take on an event, there may be other opinions and analysis that are valuable, both to the readership and to us. We want Real Endpoints to be a forum where ideas about reimbursement are exchanged and debated. That means opening RE to the wider community, not just in the comments section, but in terms of the actual content provided. As such, one of our goals is to bring you a steady stream of thoughtful guest posts on topics...

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