Interventions of Interest:
- Abaloparatide (Tymlos®, Radius Health, Inc.)
- Teriparatide (Forteo®, Eli Lilly and Co.)
Osteoporosis, the weakening of the bones through loss of bone mineral content and a decrease in bone quality, is a common disease of aging that affects approximately 10 million Americans. Approximately half of women and one quarter of men will suffer at least one fracture due to osteoporosis during their lifetimes. Experts estimate that there are approximately two million osteoporotic fractures each year, which results in $19 billion in related costs. By 2025, these figures are predicted to grow to approximately three million fractures and $25 billion in costs annually as the population of older Americans increases.
Policy recommendations from the June 2017 meeting highlight the 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.
Below you will find the final documents from the assessment review process:
“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. 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.”