Danish Medicines Council Methods Guide for assessing new pharmaceuticals (Medicinrådet)
This guide outlines how new medicines are assessed in Denmark using a structured approach that considers health benefits, costs, and broader societal impacts. It uses quality-adjusted life years (QALYs) to measure health outcomes and compares new drugs to existing treatments, while also looking at budget effects and uncertainty.
At a glance
Use when
Assessing the value of new pharmaceuticals for reimbursement or pricing decisions in Denmark; conducting HTA aligned with national reference-case methods.
Avoid when
Evaluating non-pharmaceutical technologies; applying in jurisdictions with different HTA frameworks or perspectives; when a full societal perspective is required.
Inputs
Clinical trial data, health-related quality of life (HRQoL) evidence, cost data (healthcare and societal), epidemiological parameters, comparator treatment patterns, pricing information.
Outputs
Assessment report including effectiveness, cost-effectiveness (ICER), budget impact, and recommendation for reimbursement or further evidence generation.
How it works
The Medicinrådet Methods Guide defines Denmark's reference-case methodology for pharmaceutical HTA, employing a limited societal perspective. It mandates the use of QALYs as the primary outcome measure, requires comparative effectiveness and cost analysis versus relevant comparators, incorporates uncertainty analysis (e.g., sensitivity analyses), and includes budget impact analysis. The framework supports decision-making on reimbursement and pricing of new pharmaceuticals.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Aspects Beyond HTA
- Assumptions
- Health benefits can be adequately captured in QALYs; appropriate comparators reflect real-world practice; long-term outcomes can be modeled reliably from short-term data; willingness-to-pay thresholds inform value judgments.
- Strengths
- Transparent, standardized framework aligned with national decision-making; incorporates both efficiency (QALYs) and affordability (budget impact); includes structured uncertainty analysis; supports consistent evaluations across drugs.
- Limitations
- Limited societal perspective may exclude some relevant costs/benefits; reliance on modeling introduces potential bias; applicability of international data to Danish context may vary; QALY metric may not capture all patient-relevant outcomes.
- Also known as
- Medicinrådet Methods Guide, Danish HTA Methods Guide for Pharmaceuticals, Medicines Council Denmark Assessment Framework
Questions this answers
- › What is the clinical effectiveness of a new pharmaceutical compared to current standard of care?
- › What is the incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained?
- › What are the expected budget impacts of adopting the new medicine on the healthcare system?
- › How robust are the results to uncertainty in key parameters?
- › What is the appropriate comparator for evaluating the new drug?
- › What broader societal effects (e.g., productivity, informal care) should be considered?
References & sources
- websitemedicinraadet.dk ↗
Similar by meaning
- Danish EQ-5D-5L value set (hybrid cTTO + DCE)
- Dutch Guideline for Economic Evaluations in Healthcare
- Guideline for the economic evaluation of medicines (CAPF / Spanish NHS Advisory Committee for Pharmaceutical Financing)
- Danish value sets for the EORTC QLU-C10D (cancer utility)
- Guidelines for the Economic Evaluation of Health Technologies in Ireland (HIQA)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.