FDA’s Endocrinologic and Metabolic drugs advisory committee on Nov. 8 voted 8-4 in favor of recommending Novo’s latest insulin degludec (Tresiba) for approval. The detailed debate and deliberation underscored how unsuitably black-and-white the drug approval process is. In the end, FDA (just like the European Medicines Agency), will say either ‘yes’ or ‘no’. Yet the difference between acceptable risk and unacceptable risk among drug treatments isn’t a well-defined one. Nor is the threshold or criteria separating insufficient data from sufficient … Continue reading
Sanofi Blinks First: Zaltrap Price Cut Proves HTA Has Reached The US
Sanofi’s decision last week to cut the price of its colon cancer drug Zaltrap by up to 50% showed that the US market is no longer immune to European-style drug price pressure. Never mind that the move was partly a result of a messed-up calculation on Sanofi’s part: this was a defining moment in the evolution of America’s troubled health care system. That the price of a drug was cut at all, and voluntarily (albeit under pressure), is … Continue reading
Zaltrap: Now the Price is Right
Power to the payer. Just weeks after a team of Memorial Sloan Kettering Cancer Center physicians criticized the high price tag of Sanofi/Regeneron’s new angiogenesis inhibitor Zaltrap in a New York Times editorial, the manufacturers responded by cutting the drug’s price in half. In a statement sent to media outlets, Sanofi emphasized its decision to reduce Zaltrap’s price tag was rooted in a desire to ensure patient access to the medicine, and cited “market resistance” … Continue reading
Actelion’s Opsumit Will Test Whether Outcomes Data Can Replace Head-to-Head
Actelion pulled out all the stops in designing the Phase III trial of its pulmonary arterial hypertension drug Opsumit (macitentan), filed at FDA on Oct 22. And no wonder: the biotech’s future depends on it, as its own top-selling PAH treatment Tracleer faces patent expiry in 2015. But Opsumit’s regulatory and reimbursement path should also interest any other drug developer seeking to test what kinds of data payers require in order to prioritize a next-in-class … Continue reading
Risk-Shares Pop Up Again As Payers, Pharma Circle New Payment Models
Say you’re GSK, and a head-to-head trial pitting your drug against the market leader showed non-inferiority. Say, too, that even though you assembled some trial evidence that patients preferred your drug vs. the leader, this hadn’t convinced everyone. So, with 70% of prescriptions still favoring your competitor, what to do? Blunt rebating is one option – but hardly commercially attractive. So how about taking the risk of testing your tolerability claim in the real world? … Continue reading
Orphan vs Effectiveness: German Payers Win 11% Discount on Esbriet
InterMune’s orphan drug for idiopathic pulmonary fibrosis (IPF), Esbriet, on July 23 became the second product to be priced within Germany’s new reimbursement system. The result: an almost 11% discount on the drug’s initial ‘free’ price in Germany (in place since September 2011), on top of the 16% mandatory rebate that for now affects all drugs in Germany. Superficially, that looks like a clear win for payers. But it’s not entirely bad news for pharma either — … Continue reading
The Healthcare Round-Up: 1/24 -1/31
Even as politicos geared up for today’s Florida primary, healthcare wonks are still shaking their heads at the fact that the Affordable Care Act –or healthcare generally—didn’t get much air time in President Obama’s third SOTU address last week. In contrast to 2010, when Obama devoted 570 words to the concept – an all-time high—this year’s tribute to healthcare was considerably briefer at just 44 words. One of the more telling passages: “I will not go … Continue reading
AZ Takes RWE Deals To Europe With IMS Tie-Up
Less than a year after its tie-up with the outcomes division of U.S. insurer WellPoint, AZ’s now trying to increase its odds of gaining — and maintaining — healthy reimbursement for its new drugs in Europe. The Big Pharma’s latest real-world evidence partnership is a three-year deal with data-provider IMS Health to access pan-European economic and treatment pattern data from e-health records. The deals confirm that AZ’s serious about proving the value of its drugs. And so … Continue reading
Putting A Price On Eylea: Why Regeneron's Decision Matters
Kudos to the commercial team at Regeneron for understanding that reimbursement is an environment. That is: Regeneron doesn’t think that payers are the only ones who matter in the reimbursement decision. Just before Thanksgiving, the company took the unusual step of announcing it would price its newly approved wet AMD treatment Eylea at a discount to the standard-of-care Lucentis. “We feel the price is fair to physicians; it is also fair to Medicare,” SVP of … Continue reading
At the Shadowy Intersection of Payers and Product Companies
I suppose it’s understandable, given the history. Payers don’t trust the cost-effectiveness information pharma and device companies provide them about their products. (It does always somehow prove the supplier’s economic value.) Manufacturers, for their part, figure that whatever decision a payer makes, it’s always going to be driven by short-term economics. In fairness, it often is. This mutual distrust isn’t particularly problematic when a healthcare economy has plenty of room for growth. Generally, both groups … Continue reading