Are new bone drugs from Amgen and Radius cost-effective? Not even close, ICER says

Radius Health's osteoporosis med Tymlos will compete against Eli Lilly's Forteo and Amgen's currently unapproved romosozumab in the anabolic space.

It was only a few days ago that Radius Health came out with Tymlos, a new competitor to Eli Lilly osteoporosis medication Forteo. And one prominent cost watchdog already has something to say about it.

Wednesday, the Institute for Clinical and Economic Review released a draft evidence report examining anabolic players Tymlos, Foreto and Amgen candidate romosozumab. Its findings? The new meds are much too pricey to be considered cost-effective.

RELATED: Can Radius fight off big guns Lilly, Amgen with new bone drug Tymlos? One analyst says no

According to ICER, which compared each medication with generically available zoledronic acid, each of the three meds spurred an increase in both life years and quality-adjusted life years, favorite metrics among cost gatekeepers. But each of them also increased costs, and they “far exceeded the commonly-cited cost effectiveness threshold” of $150,000 per quality-adjusted life year, ICER concluded.

Amgen, for its part, said in an emailed statement that it "strongly believes that compared to current bone building agents, Evenity (romosozumab) will deliver both clinical and economic value to patients, providers, payers and society, once approved," noting that it disagrees "with ICER’s approach, methodology and assumptions." In particular, the big biotech flagged the comparison with zoledronic acid, a bisphosphonate "used for chronic therapy in patients with very different clinical characteristics than patient who need short-term bone builder therapy." 

"We are concerned that ICER’s … short-term budgetary focus will be used to create access barriers to innovative medicines like Evenity for appropriate patients," Amgen added. Lilly and Radius had not responded to requests for comment by press time.

ICER, as it’s wont to do, suggested package prices for each anabolic med that would keep them below that $150,000-per-QALY benchmark, with the disclaimer that Amgen hasn’t yet released the list price for its unapproved candidate.

Radius’ Tymlos would need to bear a $692.83 monthly sticker, while Forteo would need to cost $323.65 per pen and romosozumab would need to ring up at just $65.96 per month. To get down to the even more reasonable $50,000-per-QALY target would mean bringing Amgen’s monthly price all the way down to $29.10. Those figures are a long way off the $1,186.25-per-month Tymlos price, which factors in a 27% discount estimated by ICER, and the $1,628.45-per-pen Forteo price that ICER assumes Amgen will match.

As ICER noted, though, its study has some limitations. For one, it remains to be seen whether Amgen will actually match Lilly’s price or undercut it, as Radius did. By pricing Tymlos at $19,500 per year, the company set up what CEO Bob Ward in an interview called “a very attractive value proposition” for payers, and that’s a distinction Amgen will likely aim for, too.

ICER also assumed 100% adherence to all treatments, which “would not occur in actual practice,” it acknowledged.

RELATED: Facing a new assessment of Kyprolis, Amgen castigates cost-effectiveness team's methods

Over the past couple of years, ICER has begun to regularly make waves in the pharma world with its analyses—and more than once, it’s ruffled the feathers of Amgen in particular. Last year, after criticizing ICER’s reviews of both its multiple myeloma med Kyprolis and its PCSK9 contender Repatha, the California drugmaker called the institute’s models "black boxes that cannot be replicated by the groups ICER thinks should consume and consider them.”

Editor's note: This story has been updated with comments from Amgen.