BEACON: A Summary Framework to Overcome Potential Reimbursement Hurdles

Area of Science:

• Health Economics
• Pharmaceutical Development
• Market Access

Background:

• Payer criteria significantly influence pharmaceutical development and market access.
• Existing frameworks may not comprehensively capture all essential payer requirements.
• A structured approach is needed to align drug development with payer expectations.

Purpose of the Study:

• To develop a framework that addresses key payer criteria during pharmaceutical development.
• To create a mnemonic device for easy recall of these criteria.

Main Methods:

• A conceptual framework was presented to health economic experts.
• A systematic literature search (2010-2015) and grey literature search identified payer criteria.
• Commonly reported criteria were collated and incorporated into the framework.

Main Results:

• 41 publications were initially identified; 26 were excluded after full-text review.
• Key criteria identified include unmet need, safety, efficacy, quality of life, environment, evidence quality, budget impact, and comparator.
• The BEACON mnemonic (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence) was developed.

Conclusions:

• The BEACON framework encapsulates essential payer requirements for new pharmaceuticals.
• This framework aids in addressing payer demands during the pharmaceutical development lifecycle.