OBJECTIVE: This article introduces an Evidence Framework for Off-Patent Pharmaceutical
Review (EFOR), which establishes value-based criteria in a template that manufacturers
use to provide evidence showing how their products meet those criteria. Health authorities
in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent
pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to
support policy decisions, including pricing, reimbursement, formulary listing, and
drug procurement. METHODS: A literature search found no multi-criteria evidence framework
for evaluating OPPs in emerging markets. An International Outcomes Research Board
(IORB) of academia and industry experts conducted extensive research, meetings, and
workshops to define high-priority criteria to incorporate into an evidence-based health
technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA)
technique. The resulting framework was further tailored for country-specific needs
in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). RESULTS:
The IORB defined nine criteria four categories (Product, Manufacturing, Service, and
Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement
and health policy decision making. Then the IORB developed the EFOR as a base case
document, which can be adapted and used as a template by health authorities in emerging
countries. CONCLUSIONS: Emerging countries have a significant need for an HTA tool
that balances affordability with accurate evidence showing the value differentiation
of OPPs. The value attributes in this setting often are different from those in developed
markets, which emphasize new products and have high regulation and manufacturing standards.
The EFOR is an easy-to-use, adaptable framework that emerging countries can use to
increase the consistency, transparency, and effectiveness of drug decision making.
The open source EFOR is available as Supplemental Materials.
