The bottom line is that when it comes to global revenues for innovative medicines, US revenues for “winners” (the top selling drugs) matter most, since these come at the highest profit margin and launch more quickly, and serve as the primary incentive for biomedical innovation.

Many people who dedicate their lives to discovering, developing, and making new, lifesaving drugs don’t understand the extent to which the drug industry has failed to communicate its value proposition to society and to inspire its customers to pay for that value. That is to say, when the public and even legislators representing our biotech innovation hubs focus on the price of a breakthrough drug without a sense of its value or how it came into being and insist that innovators should not only invent medicines but pay for them, too, that’s a self-inflicted wound. Vertex’s Trikafta, one of our industry’s greatest success stories, provides an example.

As a pioneering PDAB takes its first baby steps in Colorado, we’re getting the impression that we’re watching the rules being made up as it goes along. Fortunately, we’re also witnessing the power of organized and impassioned patient advocacy to slow, reverse, and maybe someday reshape misinformed public policy.

European central planners should stop trying to talk the US out of incentivizing the development of better medicines that then also help Europeans and the rest of the world. It’s one thing to argue that any one country can’t afford to pay more for new drugs. It’s another thing entirely to put new drugs in jeopardy for everybody by exporting that thinking to the one country whose market-based system has underpinned the last several decades of pharmaceutical advances.

Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

It may surprise you to find out just how badly we’re failing to take a comprehensive approach to quantifying societal value from new innovations in medicine. The IRA’s investment in our climate future should be lauded; its treatment of medical innovation is unfortunately hobbled by its goal of lowering Medicare spending today at the expense of tomorrow’s patients – that is to say, all of us.

It’s long been assumed that as long as NICE-like cost-effectiveness analyses stay on the other side of the ocean, our US biotech ecosystem will be fine. But in recent years, toxic math has begun to make its way to US soil. Peter Kolchinsky sat down with Jayson Dallas to get his take on NICE’s tactics, their increasingly global reach, and how biopharma can fight back.

On February 22, CMS announced that they would not be reconsidering the National Coverage Determination (NCD) that effectively denies Medicare patients access to lecanemab, a drug with accelerated approval for Alzheimer’s disease. CMS’s rationale was that “there is not yet evidence meeting the criteria for reconsideration.” It’s worth pausing to consider the highly unusual CMS precedent that is playing out in Alzheimer’s.

Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

We are deeply concerned the new Senate drug bill fails to deliver adequate relief to the nation’s seniors and their families. It falls short of a generational opportunity to meaningfully lower Medicare beneficiary and taxpayer out-of-pocket costs. The revised language is not good enough for patients, bad for biopharma innovation, and provides no guarantee that PBMs and insurance plans will share savings with beneficiaries.

As the 2022 midterms loom, drug pricing reform is again at the forefront of the conversation. And with inflation at 8.6%, it’s undeniable – Americans are hurting, and paying less at the pharmacy counter may alleviate part of that burden. But not all drug pricing reforms are created equal. So how would price controls impact R&D?