Novo's subscription model raises questions about pharma-telehealth tie-ups

Novo Nordisk said yesterday that it will start selling its obesity drugs at a lower cash price to patients if they enroll in a subscription plan through certain telehealth providers.

Novo currently sells Wegovy injections for up to $349 a month and pills for up to $299 a month, but with a one-year subscription, patients can get either formulation for $249 a month. These plans are only available through telehealth companies Ro, WeightWatchers, LifeMD, and soon also Hims & Hers, Sesame, and other platforms.

Lawmakers have already raised concerns about the model of pharma companies partnering with telehealth providers to directly sell drugs to consumers. While the new subscription program from Novo may drive even more patients toward the selected telehealth companies, it raises questions of whether the telehealth providers will be influenced to prescribe Wegovy excessively or preferentially.

When asked why Novo doesn't make the subscriptions broadly available, instead of only through select telehealth platforms, a spokesperson said that many patients access obesity treatment through telehealth providers and "we'll continue to evaluate opportunities to expand access across multiple channels."

regulation

Scientists who helped Baby KJ are hitting FDA hurdles

Jeff Pinette for STAT

The FDA has said it wants to prioritize treatments for rare diseases, and even recently introduced a new "plausible mechanism pathway" for bespoke therapies. But the scientists behind the custom treatment for Baby KJ say FDA staff are imposing requirements on future treatments that would be prohibitive.

The agency's high bar for manufacturing and quality control could make it too expensive and complicated for academics to bring bespoke gene therapies to market, the scientists said. Those requirements can be onerous even for well-funded gene therapy companies.

The issue highlights the difficult balance regulators will have to strike as they try to accelerate new treatments to market while maintaining standards for safety and efficacy.

biotech

FDA decision on Orca Bio's therapy is delayed

From my colleague Adam Feuerstein: The FDA has extended by three months the review of a T-cell therapy for blood cancers from Orca Bio, the privately held biotech said today. Chief executive Nate Fernhoff told STAT that FDA requests for additional information regarding the methods used to manufacture and characterize Orca's therapy, called Orca-T, required extra time for review.

The FDA's approval decision date is now July 6. The company had been expecting a decision by April 6.

"It's disappointing. We were ready to supply Orca-T commercially. We've been in research mode for a long time, and this would have been our step into the commercial market," Fernhoff said. "But three months is not the end of the world. We'll get to the other side of it, and we'll get Orca-T to patients. I don't see anything in this extension that lessens my confidence in that eventual approval."

Orca is seeking approval for Orca-T as a safer alternative to a conventional, matched-donor stem-cell transplant for patients with three different types of blood cancer.

biotech

The biggest events to watch out for in Q2

We are already in the second quarter! Once you recover from the shock of it all, my colleague Adam Feuerstein has got a rundown of the biggest biotech catalysts to watch this quarter.

They include the Phase 3 readout of a cardiovascular outcomes study testing an lp(a)-targeting drug that Ionis licensed to Novartis, as well as the potential approval of Eli Lilly's GLP-1 pill orforglipron.