Comparing the US Drug Development, Pricing, Access, and Reimbursement Strategies for COVID-19 Vaccines as a Potential Model for Novel Oncology Therapies
Author(s)
Lee Y1, Lee K1, Park H1, Neese M2, Khan ZM1
1Rutgers University, Piscataway, NJ, USA, 2Bayer Pharmaceuticals, Whippany, NJ, USA
| OBJECTIVES: Research and development (R&D) and pricing, access, and reimbursement (PAR) barriers often prevent innovative therapies from reaching patients in a timely manner. Rapid R&D and PAR strategies have allowed COVID-19 vaccines to become available globally. We compare COVID-19 vaccines with other innovative therapies with expedited approvals to learn from and potentially model future frameworks when bringing new therapies to market. METHODS: As a comparative exploratory case, two innovative therapies, tisagenlecleucel, and pembrolizumab, with expedited approval designation, variable profitability, and adequate public data were identified. Each therapy lifecycle was outlined through a targeted literature review from 2006 to 2021. A descriptive analysis was conducted for concept elicitation and the identified categories were interpreted accordingly. Key features of product lifecycles and barriers were compared. Finally, potential adaptation strategies for future innovative therapies were outlined. RESULTS: Each comparator had notable differences in R&D and PAR such as therapeutic expansion strategy for pembrolizumab and safety program hurdle for tisagenlecleucel. Likewise, various strategies were implemented for COVID-19 vaccines. Existing and novel stakeholders shared data to accelerate R&D through global collaborations. Risk-pooling, government development funds, and early contracted purchases ensured limited profitability and mitigated associated risk. Various phases of clinical trials and manufacturing processes occurred in parallel with ongoing pooled data analysis of outcomes, compared to the traditional method of the interim and final analysis of clinical trial endpoints. The need for paradigm shift during the pandemic highlighted the important evolution of digitalization, advanced technologies, and reconsideration of evidence acceptability criteria in rapid R&D and PAR strategies. CONCLUSION: Findings suggest it may be valuable to further investigate the possibilities of following similar R&D and PAR strategies as those used for COVID-19 vaccines for future innovative therapies with expedited approval designations. |
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA225
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Infectious Disease (non-vaccine), Oncology, Rare and Orphan Diseases