— Policy recommendations highlight need for prices to align with clinical benefit, clear guidelines to define highest fracture risk, and broad coverage criteria for patients who may benefit from earlier treatment with anabolic agents — 

Boston, Mass., June 17, 2017 – The Institute of Clinical and Economic Review (ICER) has issued a Final Evidence Report assessing the comparative clinical effectiveness and value of teriparatide (Forteo®, Eli Lilly and Co.) and abaloparatide (Tymlos, Radius Health Inc.). The report also includes a summary of a public meeting of the California Technology Assessment Forum (CTAF), during which the independent CTAF Panel deliberated and voted on evidence presented in ICER’s report.

“Evidence suggests that, for the right patients, both teriparatide and abaloparatide provide benefit over no treatment, but the limited availability of data from head-to-head trials makes it difficult to ascertain whether the agents are more effective than existing alternatives, such as bisphosphonates,” noted David Rind, MD, MSc, Chief Medical Officer of ICER. “More research is needed on the most clinically important outcomes, particularly hip fractures, along with further data on patient-centered outcomes to understand the full impact of anabolic therapies. Even when assuming a clinical benefit over treatment with bisphosphonates, which are relatively inexpensive, the prices of anabolic agents are too high in proportion to the benefit they provide, contributing to potential access barriers for patients.”

Comparative Clinical Effectiveness and Value

During the public meeting, the CTAF Panel voted on key questions related to the clinical effectiveness and value of abaloparatide and teriparatide in treatment of osteoporosis in postmenopausal women with a high risk of fracture. The Panel found evidence is not adequate to demonstrate that the net health benefit of treatment with teriparatide or abaloparatide is greater than that of treatment with zoledronic acid, or to distinguish between the net health benefit of the two anabolic agents.

The Panel further voted that, based on available evidence on comparative effectiveness and incremental cost-effectiveness, treatment with either agent followed by zoledronic acid, compared to treatment with zoledronic acid alone, represents a low value.

Policy Recommendations

The Panel also discussed policy implications of the evidence votes with a panel of subject-matter experts, including a patient with osteoporosis, clinical experts, drug manufacturer representatives, and payer representatives. Among the key conclusions:

  • Manufacturers should reduce prices of the anabolic agents to align with the clinical benefit they provide.
  • If prices are reduced, payers should ease restrictions on access. Without such reductions, payers should work to develop step therapy policies that ensure the patients at highest risk of fracture are able to access anabolic therapies, and ensure that prior authorization processes are clear and efficient for providers.
  • Patient groups should advocate for inclusion of patient-centered outcomes in clinical trials.
  • Specialty societies should develop clinical guidelines that clearly define the level of fracture risk that would merit use of anabolic therapies.
  • Regulatory agencies should promote hip fracture as the most important outcome to be studied in trials, and require use of an active comparator in pivotal trials.

For the full list of key policy implications, along with more in-depth descriptions, please see ICER’s full report.