Jacobs Journal of Regenerative Medicine

Regenerative Medicine and Health Technology Assessment: Vision and Challenges

Published on: 2018-07-16

Abstract

Cell sheet engineering technology, a form of regenerative medicine that uses tissue regeneration technology to cure or reduce disease in patients, has the potential to dramatically improve health outcomes world-wide. Cell sheet engineering therapy represents a potential cure, with possibly high one-time costs of cell sheet manipulation but improved health outcomes versus the long-term costs of many traditional ongoing symptom-management therapies. Research is increasing into clinical applications of cultured cell products as well as into the automation of multi-disciplinary integrated processes of manufacturing and distributing living cell sheets to treat large numbers of patients. Because this technology is neither pharmaceutical nor a traditionally-defined medical treatment, issues of regulation, value, reimbursement, investment, and global access must be addressed as clinical research continues. Comparative research showing the technology’s value compared to standard of care will become increasingly important for acceptance into budgets, guidelines, and policies. Patent issues, which vary widely from country to country, must be addressed internationally, requiring experts trained in regenerative medicine intellectual property rights. Pricing and payment decisions must balance development, manufacturing, and delivery costs with affordability, encourage and reward innovation, and provide access for countries with fewer resources. With cell sheet engineering technology still in early stages of development, now is the appropriate time to begin addressing these issues, and these discussions must include government, industry, clinical, and patient representatives on an international level. In addition, these discussions may help define acceptance paths for future innovations in regenerative medicine.

Keywords

Health Technology Assessment;Regulatory; Health Economics; Cost-Effectiveness Analysis ;Regenerative medicine; Cell Sheet Engineering Technology; Reimbursement; Pricing