Reporters flag gaps in tirzepatide and semaglutide pricing agreement

The Trump administration's deal to lower the cost of weight loss drugs has significant gaps that could limit its impact, according to reporting by NBC News ^[1]. Several products in the agreement have not yet received FDA approval, the lowest advertised self-pay prices appear to apply mainly to starter doses, and the deal does not expand Medicare coverage to people seeking treatment for weight loss alone ^[1].

The deal promises discounted prices for Wegovy (semaglutide) and Zepbound (tirzepatide), which carry list prices above $1,000 a month ^[1]. But officials said both pills and injection pens will be available at discounted prices for people who pay out of pocket — and some of those forms are not yet on the market ^[1].

Unapproved products

Several forms of the drugs included in the deal have not received FDA approval ^[1]. That includes oral versions, still under development or FDA review, and Eli Lilly's multidose injection pens for Zepbound, which the drugmaker says are the versions included in the pricing agreement ^[1].

Lawrence Gostin, director of the O'Neill Institute for National and Global Health Law at Georgetown University, said that makes the administration's promises premature. "It is reckless to negotiate pricing deals on products which the FDA have not yet approved as safe and effective," Gostin said. "The administration is getting way out ahead of its own safety agency" ^[1].

An oral version of Wegovy from Novo Nordisk is under FDA review, with a decision expected in the coming weeks ^[1]. A multidose version of Zepbound is also under review, Lilly said ^[1]. The company has not yet submitted its weight loss pill, orforglipron, to the FDA ^[1]. Lilly CEO David Ricks said the FDA agreed to an expedited review of the pill ^[1].

Dose pricing questions

The White House said starting doses of weight loss pills will cost $149 for a month's supply, and shots will cost an average of $350 a month ^[1]. The price of injections is expected to fall to about $250 within two years ^[1].

But patients may end up paying more. People typically start on the lowest dose and increase over several months to a dose that is effective for weight loss ^[1]. Wegovy comes in five doses and Zepbound in six, with the most weight loss generally seen at the highest doses ^[1].

Administration officials did not say what higher doses of the pills would cost ^[1]. For injections, the White House described a "weighted average" price of $350 a month, while Lilly said Zepbound would be available at the lowest dose for $299 a month, with additional doses priced up to $449 ^[1]. Novo Nordisk did not say whether doses would have different prices ^[1].

Medicare and Medicaid limits

Under the deal, Lilly and Novo Nordisk will charge Medicare and Medicaid $245 for a month's supply of the shots ^[1]. Medicare enrollees will have their costs capped at $50 a month, and Medicaid enrollees often do not have copays ^[1].

But not everyone on Medicare or Medicaid is eligible. Medicare will continue to cover the weight loss drugs for people who are overweight or obese and have another qualifying condition, such as heart or kidney disease ^[1]. The agreement does not expand coverage to people using the drugs for weight loss alone, and Medicare is barred by law from covering weight loss drugs, according to KFF's Juliette Cubanski ^[1].

"You would have to change the law or go through several regulatory steps to be able to offer coverage outside of an already covered indication," said Stacie Dusetzina, a health policy professor at Vanderbilt University ^[1].

Why it matters for patients

For people paying out of pocket, the advertised prices may not reflect what they actually pay over time. The $149 pill price and the $350 average injection price are tied to starting doses or weighted averages, and higher doses of Zepbound could cost up to $449 a month ^[1]. Patients who need to increase their dose — the standard approach for these drugs — may face costs well above the headline numbers ^[1].

For Medicare enrollees, the deal does not change the fact that the program cannot cover these drugs for weight loss alone ^[1]. Millions of patients could remain priced out even as the administration promotes lower costs, Dusetzina said ^[1]. Dr. Shauna Levy, medical director of the Tulane Weight Loss Center, said the deal is "a step in the right direction" but added: "As an obesity community, I think we will remain skeptical of this deal until we see how it actually plays out" ^[1].

What happens next

The lower prices through the self-pay platform TrumpRx are not expected to go live until the end of the year ^[1]. The Medicare and Medicaid changes will not roll out until mid-2026 ^[1]. The FDA is expected to decide on an oral version of Wegovy in the coming weeks ^[1]. Administration officials say there is still time to work out details before the lower prices take effect ^[1].