This cycle, the law instructed CMS to select 15 drugs, rather than 10. And the mix of selected drugs included many more specialty drugs, which are less highly rebated and where there may therefore be more room for savings. These structural differences from 2026 should lead to increased savings. 2/2

Pazdur, a longtime FDA employee, has taken issue with Commissioner Marty Makary's plans to reduce the number of research studies needed to justify more drug-related decisions — with Makary arguing just one study is sufficient.

Also has warned that new Trump drug voucher plan may not be legal.

Too many questions remain about the RHTP to name them here, but one - how many states will receive funding from the 50% that's application-based - might be worth highlighting. The statute on its face permits CMS to limit the number of states receiving such funding. TBD whether it will do so. 6/6

CMS also chose to limit provider payments to no more than 15% of total funding, a limitation which is in tension with some of the stated goals key Senators espoused in advocating for the fund's creation. 5/6

Instead, CMS chose in the funding notice to award points to states that make specific policy choices that align with the administration, like reestablishing the Presidential Fitness Test or adopting a waiver to restrict SNAP benefits for certain food products, like soda or candy. 4/6

But second, Congress granted CMS wide latitude to consider "any other factors that [CMS] determines appropriate" in determining allotments. CMS took advantage of this flexibility, and the statutorily-specified factors account for a relatively small portion of the overall points available. 3/6

First, to be sure, Congress did make key design choices (one initial application period, 50% of funding allocated equally and 50% by application, certain factors that CMS "shall" consider, statutory deadline for approval, etc.). Those choices do constrain CMS particularly in procedural ways. 2/6

Manufacturers agree to provide supplemental rebates, but states must adopt coverage/UM criteria proposed by the manufacturer (see p. 8) and negotiated between CMS and the manufacturer. 4/4

The model envisions that manufacturers will report to CMS international net prices (of a specific set of countries, see p. 7). It's not clear that other countries are thrilled with that. 3/4

This is a voluntary model, so it's not clear that a legal challenge is likely, but it's also not clear what this model is really "testing." As the model goes on to note, CMS is not waiving any legal authority to test the model. 2/4

This is just a small set of questions that should be asked. Remember that the baseline conditions here are somewhat unique, given 1) the limited insurance coverage (as a statutory matter), 2) the competition in the market, 3) the large number of eligible patients, and more. 6/6.

5. What are the interactions w/ other programs, ex. the FDA Priority Voucher, Medicaid best price, CMS Negotiation Program, etc.? Semaglutide (Novo) has reportedly reached an agreement for the 2027 negotiation cycle, with prices to be announced this month. www.reuters.com/business/hea... 5/6