rare disease drugs
Orphan drugs get pushback
There’s a long history of Congress giving rare disease drugs special treatment, but industry is getting some pushback on whether they should be excluded from government price controls.
Drug companies are trying to get rare disease drugs excluded from the Trump administration’s pilot programs tying prices in Medicare to those in peer countries. But that would erase much of the savings from the most-favored nation programs, according to initial estimates by a Harvard researcher.
The pilots already are expected to exempt companies that cut most-favored nation deals with the administration, which would wipe out 71% of the potential savings. Exempting orphan drugs would eliminate half of the remaining savings in the Medicare Part D pilot.
Separately, Ed Silverman writes about a study on the impact of orphan drug exemptions in the Medicare drug price negotiation program. That study suggests the exemption is not warranted. Read more for why.
glp-1
Obesity drug sales up after Bridge launch
Makers of GLP-1 obesity drugs held their first investor call since the launch of the Medicare Bridge pilot that makes those drugs available to seniors for $50 each month.
The Medicare Bridge pilot program opens the obesity drug market to about 20 million more Americans, Eli Lilly executives said during an earnings call yesterday.
The process of identifying who is eligible and running them through prior authorization is going smoothly. Lilly has been informing doctors and pharmacists about who qualifies for the drugs.
“You can see an inflection point for both of our medicines, Zepbound and Foundayo, over the past few weeks,” said Ilya Yuffa, Lilly’s executive vice president. “Part of that is Bridge.”
Foundayo, which launched in April, accounts for a tiny fraction of Lilly’s GLP-1 sales. Although it’s a pill, about 80% of seniors in the Bridge program have chosen an injectable weight loss drug.
Lilly obesity drug sales are outstripping competitor Novo Nordisk, even though Novo executives said demand is growing for its GLP-1 drugs. Elaine Chen reports that investors were disappointed that sales of Novo’s Wegovy pill in the second quarter weren’t as high as some had hoped.
team trump
CDC director confirmed
After nearly a year without a permanent leader, the Senate confirmed Erica Schwartz yesterday as the director of the Centers for Disease Control and Prevention, Chelsea Cirruzzo reports.
Schwartz is a retired rear admiral in the U.S. Public Health Service Commissioned Corps and was the deputy surgeon general during the first Trump administration. During that time, she was responsible for standing up Covid-19 public testing drive-thrus and tents.
Read more for the challenges that await her at CDC.
vapes and kratom
Quid pro quo allegations
The top Democrat on the Senate Finance Committee is investigating the Trump administration’s recent actions on flavored nicotine vapes and kratom products, suggesting those industries received favors after making large donations to the presidential campaigns of Donald Trump and Robert F. Kennedy Jr., Sarah Todd reports.
As the minority party, Democrats lack the authority to force the administration or companies to respond. But it’s a way to bring attention to the allegations, and the companies know that political control goes back and forth between the parties.
Read more about the alleged pattern of quid pro quo’s.
hiv
HIV funding cliff
Community-based organizations that provide HIV prevention services are likely to see fewer financial resources under a new funding scheme by federal health officials that will divert grant money directly to state health departments.
That’s according to a new analysis by KFF, which analyzed the White House’s plan to not renew a 5-year program that gave approximately $210 million to more than 90 organizations for HIV testing, care linkage, and PrEP resources. HHS plans to give that funding directly to states, but advocates worry that the organizations will get less federal funding under the new approach, jeopardizing access to HIV prevention care, STAT previously reported.
According to the KFF analysis, half of the previously awarded funding went to Southern organizations, which account for more than half of all HIV diagnoses. For some of those organizations, these grants represented 18% to 31% of their revenue.
“Facing fewer resources, organizations may be less equipped to provide or support HIV prevention programs, which could in turn affect the HIV prevention response, increasing the vulnerability of some communities to additional HIV cases,” the analysis authors write. — Chelsea Cirruzzo
