Abstract
Orthopedic indications collectively represent a large clinical and economic burden, especially given the aging world population. To meet this area of unmet need, a wave of regenerative medicine therapies, including stem cells and other cell-based therapies, is currently in clinical development and anticipated to inundate the global market over the next few years. Although intended to be transformative, orthopedic cell therapies face several practical opportunities and challenges. Such therapies could reduce the health care burden, in part by replacing traditional drug therapies and highly-invasive surgical interventions with single-dose treatments. However, therapy developers and providers must address hurdles from regulatory to reimbursement to commercial challenges before successful orthopedic cell therapies are available to patients. Regulatory policies, reimbursement processes, and commercial requirements for orthopedic cell therapies differ across markets, and key health care stakeholders must address these differences well before a product launch. Pricing and reimbursement models for innovative therapies, like cell-based therapies in orthopedics, grow unclear, especially how health care systems will absorb potentially transformative and highly-needed, but costly, therapies. Single administration therapies with relatively high upfront cost require more evidence to support their value for pricing and reimbursement than other health care products, and orthopedic cell therapies must do so based on patient quality of life and health care resource use, as opposed to improved survival, which is especially challenging. In addition, alternative financing and reimbursement models may be needed to support ongoing patient access and innovation. In the current article, we discuss global health policy issues and considerations for orthopedic cell therapy development and adoption.
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