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
UnitedHealth-Mayo: More Data, More Open. But Not Quite Neutral
UnitedHealth’s outcomes-focused research alliance with Mayo Clinic, announced Jan. 15, reminds us of big data’s central role in creating a value-driven US health care system. The tie-up claims to have created the biggest-yet trove of claims-plus-clinical patient records in the US, combining over 100 million claims records from United’s Optum’s health services division with over 5 million clinical records from Mayo. As such, it’s powerful. Collating top-level insurance claims with in-depth clinical reports is as good … Continue reading
As Pressure Builds on US Prices, Is Pharma Ready?
Free drug pricing in the US has fewer than five years to run, thanks to mounting pressure on health care spend and resulting efficiency drives. That’s the message to pharma investors, be it from fund-managers speaking at Bloomberg Industries Healthcare event in London on Dec. 10, or from analysts such as as Citi’s Andrew Baum. It’s tempting not to believe it. After all, for now, US drug price increases are actually at a five year … 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
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
Shifting Docs’ Incentives May Push Pharma Towards Portfolio Deals
As cost-of-care-focused experiments start — at last — to shift doctors’ incentives away from prescribing the most expensive treatment, there’s opportunity for pharma to offer ‘portfolio’ deals, spanning a range of drugs, and support services, across an entire therapeutic area. At least, that’s the view of Harvard Pilgrim’s CMO Michael Sherman, who is among the handful of payers testing new care delivery models with physician groups. You can hear more from him in this short … Continue reading
Sliding Away From Fee-For-Service: How CareFirst Does It
There’s been a lot of talk about the pros and cons of the standardization that comes from “Cheesecake Factory” style medicine since Atul Gawande published his thought provoking New Yorker piece. Like it or not, forward-thinking physician practices and payers are already embracing the concept. In oncology, look no further than John Sprandio, president of Consultants in Medical Oncology and Hematology and a pioneer in the oncology patient centered medical home movement, and Winston Wong, … Continue reading