Market Entry Agreements for Innovative Pharmaceuticals Subject to Indication Broadening: A Case Study for Pembrolizumab in The Netherlands
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View abstract on PubMed
Summary
This summary is machine-generated.Managed entry agreements for cancer drugs like pembrolizumab can improve access. This study analyzed its cost-effectiveness in the Netherlands, finding it varies by indication and confidential pricing.
Area Of Science
- Health economics
- Pharmaceutical policy
- Oncology
Background
- Managed entry agreements (MEAs), particularly financial-based ones, are common in Europe for innovative cancer drugs.
- These agreements balance patient access to novel treatments with payer financial risk management.
- This study examines a confidential price agreement for pembrolizumab in the Netherlands.
Purpose Of The Study
- To assess the cost-effectiveness of pembrolizumab across multiple indications under a confidential pricing agreement.
- To evaluate the impact of expanding indications on the drug's cost-effectiveness.
- To determine the viability and desirability of the existing agreement.
Main Methods
- Developed partitioned survival models for five pembrolizumab indications.
- Utilized published trial data for survival and progression-free survival to create individual patient data.
- Extrapolated outcomes over 30 years using parametric models, incorporating quality of life and cost data from literature.
Main Results
- Incremental cost-effectiveness ratios (ICERs) ranged from €35,313 to €322,349 per QALY without discounts.
- Only one indication met the €80,000/€100,000 cost-effectiveness threshold initially.
- After applying a typical Dutch pharmaceutical discount, ICERs ranged from €20,881 to €252,934 per QALY, meeting the threshold in three of five indications.
Conclusions
- Pembrolizumab's cost-effectiveness is contingent on the specific confidential price agreement and indication.
- Reimbursing non-cost-effective care is possible if pricing is based on a single indication.
- Indication-based pricing could better align the value and cost of innovative drugs with expanding indications.
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