Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned
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View abstract on PubMed
Summary
This summary is machine-generated.Tumor-agnostic drug approvals for larotrectinib and entrectinib show promise but highlight challenges. European decision-makers need clearer guidelines on trial design, NTRK gene fusions, and testing strategies for future therapies.
Area Of Science
- Oncology
- Pharmacoeconomics
- Regulatory Science
Background
- Tumor-agnostic drug approvals, such as for larotrectinib and entrectinib, represent a paradigm shift in cancer treatment indication setting.
- European healthcare decision-makers acknowledge the therapeutic potential of these agents.
Purpose Of The Study
- To identify and analyze the divergences in European healthcare decision-makers' assessments of tumor-agnostic therapies.
- To highlight key uncertainties and challenges in the evaluation of novel, disruptive cancer treatments.
Main Methods
- Analysis of decision-making processes and identified uncertainties among European healthcare bodies regarding tumor-agnostic therapies.
- Review of differing perspectives on basket trial designs, endpoints, NTRK gene fusions, resistance mechanisms, comparators, unmet medical needs, and testing strategies.
Main Results
- Key areas of divergence included uncertainties in basket trial design and endpoints, the prognostic value of neurotrophic tropomyosin receptor kinase (NTRK) gene fusions, and resistance mechanisms.
- Disagreements were also noted in the assessment of relevant comparators, unmet medical needs, and the implementation of NTRK-testing strategies.
- Tumor-specific reimbursement recommendations and guidelines currently do not align with tumor-agnostic principles.
Conclusions
- The identified differences underscore the complexities and challenges in assessing innovative, tumor-agnostic therapies.
- Early, multi-stakeholder dialogues involving clinicians are crucial for establishing minimum evidence requirements and facilitating future disruptive therapies.
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