Welcome to the Week in Review.

GLOBE & GUARD Face Industry Pushback as Details Take Shape

The proposed GLOBE and GUARD models are mandatory CMMI programs with savings potential for the Medicare program. The initiatives aim to use the rebate infrastructure of the Inflation Reduction Act to test alternative payment approaches for high-cost drugs and lower costs in Medicare Part B and Part D. However, key design choices warrant scrutiny. The models rely in part on manufacturer-submitted data to establish international pricing benchmarks, creating risk that incomplete or strategic reporting could blunt their impact. In addition, exemptions for manufacturers that enter into voluntary Most Favored Nation agreements could limit the programs reach if broadly applied. The GUARD model also runs the risk of increasing cost sharing for patients. P4AD submitted comments on both models recommending safeguards to strengthen transparency, durability, and affordability for patients. Early comments submitted by PhRMA and BIO suggest the industry is preparing legal challenges questioning CMS’s authority, leveraging their nearly-endless litigation resources in a standard pharma tactic that is currently being employed against Medicare Negotiation. GLOBE and GUARD have the potential to reduce Medicare spending, and the former could meaningfully lower out-of-pocket costs for patients — but their effectiveness will depend on both design integrity and the agency’s ability to withstand anticipated opposition. — [STAT News, P4AD, P4AD, STAT News, Endpoints News]

The State of Drug Pricing

While we welcomed President Trump’s strong rhetoric on drug prices during the State of the Union address, the administration’s current approach centers on voluntary direct-to-consumer and Most Favored Nation deals and falls short of systemic reform. These arrangements do not broadly lower drug prices across the market, and exclude many of the highest-cost and most widely used medications. The president called for Congress to codify an enforceable MFN-style policy, which could be a meaningful step toward bringing U.S. prices in line with those paid by other high-income countries, depending on the policy passed. However, any attempts at codification require the details of these MFN deals to be released — something PhRMA CEO Stephen Ubl has vehemently opposed as recently as last week. Lasting affordability requires structural reform that meaningfully constrains monopoly pricing power, including mandatory programs like Medicare negotiation that deliver measurable savings at the pharmacy counter. — [POLITICO, P4AD]

Novo to Lower Wegovy & Ozempic List Prices but Additional Action Still Needed

Novo Nordisk announced it will lower the list price of blockbuster GLP-1 drugs Ozempic and Wegovy to $675 a month starting January 1, 2027. While reductions in a drug’s list price are welcome — particularly for patients facing high deductibles or no coverage — many insurance plans still don’t cover GLP-1 drugs to treat obesity. This list price change is likely to benefit people with commercial insurance, as both drugs are included in the second round of Medicare negotiation, where the price will fall to $274 a month, roughly 60% lower than Novo’s announced list price — and on the same January 1, 2027 date. Unlike voluntary cuts, negotiated prices are enforceable, durable, and do not depend solely on the good will of the pharmaceutical industry. The contrast underscores a broader point: temporary discounts can shift headlines, but structural reform delivers more reliable savings for a broader swath of the population. — [Wall Street Journal, STAT News]

ICYMI

Last week, P4AD CEO Merith Basey joined The Washington Post Intelligence’s panel, “Washington’s New Push on Drug Pricing,” as well asPhRMA Executive Vice President of Policy and Research Elizabeth Carpenter for a discussion on drug pricing policies including Medicare negotiation, PBM reforms, rising launch prices, and the latest pricing proposals. You can watch the full briefing here. — [Washington Post]

Patient Advocate Spotlight: Susan Vigen

Condition: Severe overactive bladder and interstitial cystitis
Drug: Myrbetriq (Listed at $1,677 / 90 day supply, with a monthly copay that increased from $120 to $365 in 2024)
Background: Patient advocate from South Carolina

In Her Words: “Myrbetriq has a monthly copay responsibility for me that increased from $120 to $365 every 90 days starting in the fall of 2024. This is simply too expensive for me and while there is a generic version of the drug called Mirabegron, my insurance will not cover it. Thus, I am left constantly looking for cheaper pharmacies and ways to save.”

“As someone who used to work in the pharmaceutical industry for about 17 years on the data management side, I understand the cost of bringing a drug to market and the need for some profit making to be made, however, I am now the patient feeling the financial frustration.”

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