Market Access Strategies for the Global Healthcare Environment mktxs linkedin 1-908-864-4090

Current and Future Payer Landscape Assessment of Metastatic Breast Cancer in US and EU-4: HTA Analogues

Challenges

An oncology-focused manufacturer wanted to explore the current health technology assessment (HTA) environment in Europe for metastatic breast cancer therapies:

  • Efficacy endpoints needed for evaluation, separated by relevant sub-populations
  • Pharmacoeconomic evidence requirements
  • Impact of patient selection/biomarker on evidence needs
  • Safety concerns and role of QoL

Approach

  • Conducted in-depth Payer interviews and focus groups (between Payers and KOLs) with ex- or former members of relevant HTA agencies

Solutions

Key learnings from previous evaluations and expectations regarding how future high-cost drugs will be assessed from HTA perspective

  • Identified implications of AMNOG on pricing and reimbursement of oncology therapies, including recent trends on study population segmentation
  • OS was found to be the mandatory primary endpoint in all submissions to obtain favorable HTA rulings
  • Outlined necessity to demonstrate efficacy advantages in head-to-head clinical trials
  • QoL was determined to be a valuable secondary endpoint in Phase 3 clinical trials

 Area of focus

US, France, Germany, Italy, Spain. Metastatic Breast Cancer (MBC)