Abstract
ABSTRACTTeriparatide, currently only available in brand form in the United States, is a costly drug approved for the treatment of postmenopausal osteoporotic women who are at high risk of fracture. Because market exclusivity for brand teriparatide expired in August 2019 in the US, we sought to understand the potential health economic impact of the availability of generic or biosimilar (generic/biosimilar) teriparatide. We examined the cost‐effectiveness of daily teriparatide for 2 years followed by weekly alendronate for 10 years (ie, sequential teriparatide/alendronate) compared with alendronate alone for 10 years in community‐dwelling white osteoporotic women with prior vertebral fracture at ages 65, 70, 75, and 80. Using an updated version of previously validated Markov microsimulation models, we obtained incremental cost‐effectiveness ratios (ICERs) (dollars [$] per quality‐adjusted life year [QALY]) with a willingness‐to‐pay (WTP) of $150,000 per QALY from a societal perspective with a lifelong time horizon. In the base case, we estimated the annual cost of teriparatide to be $20,161, based on the assumption of 10% brand usage (at a cost of $27,618) and 90% generic/biosimilar usage (priced 30% lower than brand). The ICERs of sequential teriparatide/alendronate compared with alendronate alone were greater than $280,000 per QALY at all ages examined. In deterministic sensitivity analyses, results were sensitive to teriparatide's cost, with the cost of a generic/biosimilar product needing to be 65% to 85% lower than brand for sequential teriparatide/alendronate to be cost‐effective. In probabilistic sensitivity analyses, under the assumption that the annual cost of teriparatide was $20,161, the probabilities of sequential teriparatide/alendronate being cost‐effective were less than 4% at a WTP of $150,000 per QALY. In conclusion, among community‐dwelling older osteoporotic women with prior vertebral fracture in the US, even with the potential availability of generic/biosimilar teriparatide, sequential teriparatide/alendronate would not be cost‐effective unless the cost of generic/biosimilar teriparatide were heavily discounted with respect to the current brand cost. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
Highlights
Teriparatide is a recombinant form of parathyroid hormone that stimulates bone formation and activates bone remodeling
It has been approved by the US Food and Drug Administration (FDA) since 2002 for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture, defined as a history of osteoporotic fracture or multiple risk 1 of 11 n factors for fracture.[1]. Teriparatide is the most expensive drug for osteoporosis treatment in the United States, with a wholesale acquisition cost (WAC) for the daily form of $3426.50 for a 28-day supply as of June 2019.(2) only the brand version of teriparatide was available in the US at the time of this writing, the patent for teriparatide use did expire in August 2019.(3)
To understand the potential health economic impact of the availability of generic/biosimilar teriparatide after August 2019 in the US, we examined the cost-effectiveness of sequential teriparatide/alendronate compared with alendronate alone among community-dwelling older osteoporotic women with prior vertebral fractures
Summary
Teriparatide is a recombinant form of parathyroid hormone that stimulates bone formation and activates bone remodeling It has been approved by the US Food and Drug Administration (FDA) since 2002 for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture, defined as a history of osteoporotic fracture or multiple risk 1 of 11 n factors for fracture.[1] Teriparatide is the most expensive drug for osteoporosis treatment in the United States, with a wholesale acquisition cost (WAC) for the daily form of $3426.50 for a 28-day supply as of June 2019.(2) only the brand version of teriparatide was available in the US at the time of this writing, the patent for teriparatide use did expire in August 2019.(3). Assuming that teriparatide becomes less expensive after generic/biosimilar versions become available on the market, we sought to understand the potential economic impact of the availability of generic/biosimilar teriparatide in the US
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