BIOSIMILAR-ENABLED ACCESS AND REPOSITIONING (BEAR): A FRAMEWORK FOR LIFECYCLE ASSESSMENT AND REPOSITIONING OF BIOLOGIC THERAPIES INFORMED BY CROSS-COUNTRY EVIDENCE AND STAKEHOLDER RECOMMENDATIONS
Author(s)
PAUL OYALO, MSc1, Mikel Berdud, PhD1, Libby Tungate, OHE Fellow1, Susana Guitar Jiménez, MBA2, Delphine Courmier, PhD3, Lou Garrison, PhD4, Amanda Cole, BSc, PhD1.
1Office of Health Economics, London, United Kingdom, 2Organon, Plymouth meeting, PA, USA, 3Organon, Jersey City, NJ, USA, 4The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, Seattle, WA, USA.
1Office of Health Economics, London, United Kingdom, 2Organon, Plymouth meeting, PA, USA, 3Organon, Jersey City, NJ, USA, 4The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, Seattle, WA, USA.
OBJECTIVES: Biosimilar entry and price competition generate procurement savings, yet their potential to expand patient access through lifecycle HTA reassessment remains underexplored. This study develops a structured framework, the Biosimilar-Enabled Access and Repositioning (BEAR), describing how biosimilar entry can trigger reimbursement, guideline, and formulary changes that broaden value-based treatment eligibility and generate value beyond affordability gains. It also derives implementation recommendations through expert elicitation.
METHODS: A structured narrative review identified 23 BEAR examples across different reimbursement systems (CEA-driven, budget-impact, clinical added-value, market-based, hybrid). Seven case studies from England, the US, Australia, New Zealand, and Sweden were mapped to five BEAR channels: severity-threshold broadening, treatment-line advancement, population or indication expansion, removal of administrative restrictions, and liberalised prescribing. Two were modelled to quantify health and economic value. An international expert panel validated the framework and identified barriers, opportunities, and implementation recommendations.
RESULTS: The case studies demonstrated access expansion through all five channels. In England, biosimilar pricing brought bevacizumab within the NICE cost-effectiveness threshold, enabling funding for a previously unreimbursed indication and generating 2,170 QALYs and £20.8 million in net monetary benefit. In New Zealand, PHARMAC reinvested savings to expand adalimumab eligibility. In the US, denosumab was modelled to prevent 492,366 fractures, saving $22.9 billion in fracture costs and generating a further $10.5 billion in net monetary benefit. Despite access gains in all case studies, implementation remained ad hoc. Experts identified four priorities: coordinated reassessment across HTA bodies, guideline developers, and payers; public support for evidence generation; stakeholder education; and early dialogue with horizon scanning.
CONCLUSIONS: BEAR-driven access expansion can deliver benefits beyond, and comparable to, savings from biosimilar price competition. However, systematic lifecycle assessment remains absent, with implementation predominantly ad hoc and case-by-case.
METHODS: A structured narrative review identified 23 BEAR examples across different reimbursement systems (CEA-driven, budget-impact, clinical added-value, market-based, hybrid). Seven case studies from England, the US, Australia, New Zealand, and Sweden were mapped to five BEAR channels: severity-threshold broadening, treatment-line advancement, population or indication expansion, removal of administrative restrictions, and liberalised prescribing. Two were modelled to quantify health and economic value. An international expert panel validated the framework and identified barriers, opportunities, and implementation recommendations.
RESULTS: The case studies demonstrated access expansion through all five channels. In England, biosimilar pricing brought bevacizumab within the NICE cost-effectiveness threshold, enabling funding for a previously unreimbursed indication and generating 2,170 QALYs and £20.8 million in net monetary benefit. In New Zealand, PHARMAC reinvested savings to expand adalimumab eligibility. In the US, denosumab was modelled to prevent 492,366 fractures, saving $22.9 billion in fracture costs and generating a further $10.5 billion in net monetary benefit. Despite access gains in all case studies, implementation remained ad hoc. Experts identified four priorities: coordinated reassessment across HTA bodies, guideline developers, and payers; public support for evidence generation; stakeholder education; and early dialogue with horizon scanning.
CONCLUSIONS: BEAR-driven access expansion can deliver benefits beyond, and comparable to, savings from biosimilar price competition. However, systematic lifecycle assessment remains absent, with implementation predominantly ad hoc and case-by-case.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR113
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
Biologics & Biosimilars