“Beware the Three Furies,” warns Citi analyst Andrew Baum. In a report for pharma investors published Nov. 29., Baum turns to classical mythology to describe shared savings models, drug pathways and ACOs — the forces that will soon dominate US health care plans. He’s chosen an interesting analogy: The Three Furies were goddesses of vengeance, who punished the wicked for their crimes; they’re also described as “tormenting those who have yet to atone for their sins”. … Continue reading
Want Better Access? Then Take Some More Risk
Biopharma is an industry seeped in an above-average concentration of risk. Scientific, clinical and regulatory uncertainties add to more typical commercial and market-driven risks. Given that, you’d think pharma execs would be a little more willing to stick their necks out and embrace (or at least explore) change. Some are. They get that payer cost-pressures and pipeline productivity challenges are forcing new, make-or-break approaches to clinical development, payer interactions, and commercial positioning. Yet toward the … Continue reading
Drug Approvals Need Shades Of Grey
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
Discounting For Access: The QALY Math Is Spreading
Last week, England & Wales’ cost-watchdog NICE approved reimbursement for two drugs for advanced melanoma, Roche’s Zelboraf and Bristol’s Yervoy. As is so often the case at NICE, both drugs had initially been rejected, and both in the end came through with confidential discounts to the list-price. But this isn’t just a story about discounting, nor is it just about the UK. Everyone knows that winning reimbursement in England & Wales boils down to math – math that culminates … 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
Sloan-Kettering Fires A Shot at High-Priced Marginal Cancer Drugs
No. It’s such a little word, but that doesn’t make it any easier to say. And nowhere is that more obvious that when it comes to cancer care, as Memorial Sloan-Kettering Cancer Center physicians Bach, Saltz, and Wittes point out in their provocative NY Times op-ed, “In Cancer Care, Cost Matters”. “Our medical culture equates ‘new’ with ‘better’ so unequivocally,” the authors note. Yet that hasn’t stopped them from outlining so convincingly how the evidence … Continue reading
Clinical Utility: An Ever Higher Bar To Clear For Molecular Diagnostics
Before covering a pricey molecular diagnostic, payers want proof that the test in question is both efficacious and adds new therapeutic value. As Dr. Ira Klein, Chief of Staff to Aetna’s Chief Medical Officer, told Real Endpoints in this recent podcast “we have to understand that the test gives the member or doctor actionable information.” What Klein and execs at other payers want are data concretely linking a particular test to improved outcomes and health … Continue reading
The Value Debate: Can Personalized Drugs Support Personalized Pricing?
“Personalized health care requires a new reimbursement model,” declared Roche’s VP Global Pricing & Market Access Jens Grueger in the elegant London county hall debating chamber on Monday, at the Office of Health Economics (OHE)-sponsored gathering of payers, pharma and economists. The venue was appropriate. Debate centered around whether the move towards more personalized medicine could reasonably support more personalized pricing. Roche, with plenty of targeted medicines at stake, thinks, perhaps wishfully, that more differential, ‘value-based’ pricing is … Continue reading