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 … Continue reading
The Drug Assessment Process: Inadequate and Costly
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. … Continue reading
Reimbursement “Furies” Real, But Won’t Avenge Pharma Til 2017, Says Citi
“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
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
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
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