Health Technology Assessment, Reimbursement, and Funding Landscape Challenges for Oncology Companion Diagnostics in Europe and Canada
Author(s)
Fabrizio Gianfrate, PhD1, Thomas McLean, MSc2, Victoria Unmuessig, MSc3, James Armstrong, MBA4, Lynn Replogle, MBA5, Sabina Schadyew, MSc6, Josep Darba, PhD7.
1University of Ferrara, Ferrara, Italy, 2Astellas Pharma Europe Ltd., London, United Kingdom, 3Astellas Pharma GmbH, Munich, Germany, 4Astellas Pharma Inc., Northbrook, IL, USA, 5Veranex, Inc., Raleigh, NC, USA, 6Veranex Germany GmbH, Munich, Germany, 7University of Barcelona, Barcelona, Spain.
1University of Ferrara, Ferrara, Italy, 2Astellas Pharma Europe Ltd., London, United Kingdom, 3Astellas Pharma GmbH, Munich, Germany, 4Astellas Pharma Inc., Northbrook, IL, USA, 5Veranex, Inc., Raleigh, NC, USA, 6Veranex Germany GmbH, Munich, Germany, 7University of Barcelona, Barcelona, Spain.
OBJECTIVES: Access to precision oncology medicines requires patient selection through biomarker testing. However, there is limited up-to-date research on the HTA, reimbursement, and funding landscape for oncology CDx in Europe and Canada. We aimed to describe the current landscape and highlight associated challenges in timely access to and funding for oncology biomarker testing.
METHODS: A hybrid, comprehensive targeted web and literature search was conducted using publicly accessible sources from government and HTA agency websites, as well as guidelines and policies from France, Germany, Italy, Spain, UK, Belgium, Switzerland, and Canada. Data were extracted based on predefined research questions and criteria for oncology CDx HTA, reimbursement, and funding. The research was validated and supplemented with qualitative interviews of stakeholders, including payers and pathologists.
RESULTS: Five of the 8 countries required HTA for CDx reimbursement and had broadly consistent evidence requirements. In 3 countries (Belgium, Italy, and Canada), drug and CDx reimbursement timelines were not automatically aligned, which can lead to substantial delays in access to testing. Additionally, 3 countries (Italy, Spain, and Canada) had geographic disparities in access to testing due to regional HTA/local assessments or siloed budget constraints. In all countries assessed, current reimbursement rates or budgets failed to cover the anticipated costs of CDx testing, which has forced laboratories to seek alternative funding sources or request additional budget. Pharmaceutical industry sponsorship of CDx testing was permitted as a funding bridge in Belgium, Italy, Spain, Canada, and the UK but not in France and Germany.
CONCLUSIONS: Healthcare systems should work toward harmonizing drug and CDx reimbursement processes/timelines to ensure timely access for patients to drugs and CDx. Additionally, healthcare systems should provide sufficient coverage for biomarker testing (particularly given the low cost of testing vs treatment) to avoid the need for other stakeholders (eg, laboratories, hospitals, patients, and/or industry sponsorship) to close funding gaps.
METHODS: A hybrid, comprehensive targeted web and literature search was conducted using publicly accessible sources from government and HTA agency websites, as well as guidelines and policies from France, Germany, Italy, Spain, UK, Belgium, Switzerland, and Canada. Data were extracted based on predefined research questions and criteria for oncology CDx HTA, reimbursement, and funding. The research was validated and supplemented with qualitative interviews of stakeholders, including payers and pathologists.
RESULTS: Five of the 8 countries required HTA for CDx reimbursement and had broadly consistent evidence requirements. In 3 countries (Belgium, Italy, and Canada), drug and CDx reimbursement timelines were not automatically aligned, which can lead to substantial delays in access to testing. Additionally, 3 countries (Italy, Spain, and Canada) had geographic disparities in access to testing due to regional HTA/local assessments or siloed budget constraints. In all countries assessed, current reimbursement rates or budgets failed to cover the anticipated costs of CDx testing, which has forced laboratories to seek alternative funding sources or request additional budget. Pharmaceutical industry sponsorship of CDx testing was permitted as a funding bridge in Belgium, Italy, Spain, Canada, and the UK but not in France and Germany.
CONCLUSIONS: Healthcare systems should work toward harmonizing drug and CDx reimbursement processes/timelines to ensure timely access for patients to drugs and CDx. Additionally, healthcare systems should provide sufficient coverage for biomarker testing (particularly given the low cost of testing vs treatment) to avoid the need for other stakeholders (eg, laboratories, hospitals, patients, and/or industry sponsorship) to close funding gaps.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO128
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology, Personalized & Precision Medicine