ICER Issues Draft Evidence Report on Biologics for Osteoporosis

The Institute for Clinical and Economic Review (ICER) has released a draft report evaluating the evidence supporting the use of 3 biologic drugs for osteoporosis.

The report evaluated abaloparatide, which was recently approved by the FDA; romosuzumab, which is currently being reviewed by the FDA; and teriparatide, which was approved over 15 years ago. The 3 biologic drugs are all anabolic, meaning that they build bone; the other agents approved for osteoporosis are antiresorptive, as they prevent the bone from breaking down. The ICER report compared the 3 anabolic agents to one another, to no therapy, and to intravenous zoledronic acid, which is a commonly used antiresorptive.

As the foremost goal of osteoporosis treatment is to prevent fractures, that was the primary outcome measured in the ICER report, but it also took into account other outcomes, including quality of life, side effects, pain, and bone density. Additionally, the report modeled the long-term cost-effectiveness and potential budget impact of each drug.

Following a thorough review of the available clinical evidence, the report indicated that the anabolic drugs, particularly abaloparatide, were more effective at preventing vertebral fractures compared with no therapy. However, there were no significant differences in fracture occurrence when comparing the agents to each other or to zoledronic acid. Therefore, the researchers found the evidence of net health benefit for each of the 3 drugs to be promising but inconclusive compared with zoledronic acid, and “judged with moderate certainty that the anabolic agents provided a small or substantial net health benefit compared with no therapy.”

The report states that each of the 3 biologic therapies resulted in increased life-years and quality-adjusted life years (QALYs), but also higher costs, compared with zoledronic acid. “The cost per additional QALY was estimated to be above $150,000 per QALY for each anabolic agent, assuming parity pricing with teriparatide for romosozumab and a 40% and 27% discount on prices of teriparatide and abaloparatide, respectively,” it wrote.

Furthermore, “budget impact analyses for abaloparatide and romosozumab indicate that use of both agents in place of teriparatide+zoledronic acid are not likely to generate access or affordability alerts.”

According to a press release announcing the newly published report, ICER will be accepting public comments on the report until May 31. At the end of June, the report will be the subject of a meeting of the California Technology Assessment Forum, which will “publicly deliberate the evidence and vote on key questions raised in the report, and an expert policy roundtable will discuss recommendations to apply the evidence to policy and practice.”

Abaloparatide is sold as Tymlos by Radius Health, while teriparatide is sold as Forteo by Eli Lilly. Romosozumab is manufactured by Amgen and UCB, and should receive a decision on its approval from the FDA by this July.