Current Barriers and Strategies for Optimizing Access to Onco-Hematological Drug Combinations in Spain: Multidisciplinary Delphi Consensus

OBJECTIVES: Combination therapies have become the standard treatment in onco-hematology due to their greater efficacy compared to monotherapy. However, current evaluation, pricing, and reimbursement (P&R) mechanisms are not well-suited for these therapies. Typically involving multiple innovative drugs from different pharmaceutical companies with multiple indications, these combinations face lower funding and greater delays. This study aims to identify current barriers and develop strategies to optimize access to onco-hematological drug combinations.

METHODS: A national two-rounds Delphi study was conducted. A questionnaire was developed based on a literature review and advice from a multidisciplinary expert committee (including two hospital pharmacists, a hematologist, a decision-maker, and a representative from the Spanish Cancer Patient Group), with 32 questions divided into two sections: 1. Barriers, and 2. Strategies/actions to access onco-hematological combination therapies in Spain. A 7-point Likert scale was used (1 = “strongly disagree” to 7 = “strongly agree”), with consensus defined as ≥ 75% agreement (6-7) or disagreement (1-2).

RESULTS: 27 participants (12 hospital pharmacists, 10 hematologists/oncologists, 3 patient representatives, and 2 decision-makers) responded. Consensus barriers included lack of clarity in P&R criteria and resolution justification (85.2% each), inability to implement price per indication (77.8%), and absence of patient involvement in therapy evaluation (81.5%). Key strategies/actions included: defining a specific evaluation framework (justified financing resolution, 100%; clear P&R criteria, 96.3%; specific evaluation framework, 85.2%; multi-party negotiations, 88.9%; differential pricing by use, 81.5%), facilitating health outcomes use for decision-making (collecting health outcomes, 96.3%; integrated information system, 92.6%; providing tools to regions and hospitals, 85.2%), and national consensus on pharmacotherapeutic guidelines and protocols (85.2%).

CONCLUSIONS: Adapting the evaluation framework for onco-hematological drug combinations in Spain is necessary. Key strategies include defining evaluation and financing criteria, joint laboratory negotiations, value-based decision-making using health outcomes, and national consensus on guidelines and protocols.