Administration Guts Mandatory GLOBE Drug Pricing Model with Pharma Carveouts
The finalized GLOBE model is now projected to save just $440 million — a staggering 96% decrease from CMS’s original projection of $11.9 billion. Central to the dramatic reduction is the administration’s decision to allow drugmakers participating in voluntary deals, including the GENEROUS model, to receive waivers from mandatory participation, a fact that we warned would drastically limit patient savings and impact. The administration moved forward with the carveout anyway, and today only a few drugmakers are included in GLOBE, down from an initial 19. A mandatory model only works if drugmakers are actually required to participate. The administration should reverse course on these pharma-friendly carveouts and ensure GLOBE delivers the savings it was designed to achieve for patients and taxpayers — and as CMS finalizes GUARD, its corresponding model for Medicare Part D, it should not repeat the same mistake. — [P4AD, STAT News, Bloomberg Law, Fierce Healthcare]
56 Members of Congress Side with Big Pharma to Weaken Medicare Negotiation
56 members of Congress signed a letter urging CMS to withdraw a proposed policy designed to close a loophole in the Medicare negotiation program. This is the tried-and-tested industry playbook: if they can’t defeat negotiation in the courtroom, they’ll try to chip away at it piece by piece on Capitol Hill. Under current policy, a drugmaker can combine an existing drug with an additional ingredient that is not biologically active against the disease and have the resulting fixed-dose combination treated as a separate drug when CMS determines eligibility for negotiation — potentially resetting the negotiation clock and giving the new product a later eligibility date. CMS has identified this technicality as a program integrity risk, warning that manufacturers could use minor changes to existing drugs to avoid selection for negotiation which would keep prices high for patients for longer. Its proposed policy for the 2029 negotiation cycle would address the loophole by putting certain fixed-dose combinations together with the original drug when determining negotiation eligibility. We strongly support CMS’s proposal and submitted comments in August urging the agency to stand firm against Big Pharma’s efforts to weaken negotiation. — [Fox News, P4AD]
Patients Respond — CBP Importation Change Threatens Low-Cost Medications
Lawmakers on both sides of the aisle are pushing back on an upcoming Customs and Border Protection (CBP) rule taking effect October 22 that would create a significant new hurdle for Americans who buy lower-cost medications from pharmacies outside the U.S. In an informal survey of just over 100 patients in our community, 52 respondents said they receive medication shipped from a pharmacy abroad — and among those patients, 94% are concerned the new requirements could affect their access to medication and 79% said their medication costs more in the U.S. Several even told us that losing self-importation would mean going without their medication altogether. No patient should have to look outside the U.S. to afford the medicine they need, but disrupting a pathway patients currently rely on without addressing the high U.S. prices that drove them there leaves some patients without an affordable way to access their medication. — [STAT News]
Former House Majority Leader Eric Cantor to Lead PhRMA
Eric Cantor, Former Republican House Majority Leader from 2011 to 2014, was named the next president and CEO of PhRMA, the pharmaceutical industry’s lobbying group. Cantor takes the helm as drugmakers face mounting pressure in Washington over high drug prices and policies aimed at lowering them, including Medicare negotiation. This is the second time PhRMA has chosen a former Republican House member as its leader, after Congressman Billy Tauzin ran the group from 2005 to 2010. As chair of the Energy and Commerce Committee, Tauzin played a leading role in securing the pharma-backed non-interference clause that stopped Medicare from negotiating drug prices for two decades. — [P4AD, STAT News, Endpoints News, Axios, POLITICO, The Hill, Pink Sheet]
ICYMI: New research in JAMA finds no evidence that the Inflation Reduction Act accelerated the trend of pharmaceutical companies setting and raising launch prices. Drug companies were launching drugs at increasingly unaffordable prices long before Medicare negotiation — and contrary to industry fearmongering, the IRA did not make the problem worse. However, median launch prices climbed from roughly $39,000 between 2008 and 2013 to $254,000 between 2020 and 2025. Now policymakers need to tackle the part of the pricing system the IRA largely left untouched: what drug companies can charge at launch. — [JAMA, Managed Healthcare Executive]