SMC Decision Modifiers Framework
A framework used by the Scottish Medicines Consortium to help decide whether to fund new medicines, especially for end-of-life and rare conditions. It includes special considerations that allow for additional input from patients and clinicians, and allows for revised commercial agreements to improve access.
At a glance
Use when
Evaluating funding for new medicines in Scotland, particularly for end-of-life, rare, or ultra-rare conditions
Avoid when
When a fully quantitative, standardized HTA process without discretionary modifiers is required
Inputs
Drug submission dossiers, clinical evidence, cost-effectiveness analyses, patient and clinician input, proposed commercial agreements
Outputs
Funding recommendation (accept, reject, accept with advice), including any special modifiers applied
How it works
The SMC Decision Modifiers Framework is a structured evaluation process applied when initial assessment suggests non-recommendation of a drug. It incorporates modifiers for end-of-life, orphan, and ultra-orphan indications, allowing supplementary evidence submission, patient and clinician input, and revised pricing agreements. The framework aims to improve access to high-cost medicines for rare or terminal conditions within NHS Scotland.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Assumptions
- Additional societal value may be attributed to treatments for end-of-life or very rare conditions; non-quantitative inputs (e.g., patient testimony) can justify funding despite high cost or uncertain clinical benefit
- Strengths
- Increases access to innovative therapies for small patient populations; incorporates real-world stakeholder perspectives; allows flexibility in pricing negotiations
- Limitations
- Lack of transparency in how non-quantitative inputs influence decisions; unclear contribution of individual framework components to final outcomes; potential for inconsistency across similar drugs
- Also known as
- SMC Decision Modifiers, SMC Special Considerations Framework
Questions this answers
- › How does the SMC decide whether to fund a new cancer or rare disease drug?
- › What factors allow a drug to be reconsidered after initial rejection?
- › How do patient and clinician inputs influence funding decisions?
- › How does the SMC handle drugs for end-of-life conditions?
- › What role do commercial agreements play in drug funding decisions?
- › How do SMC decisions compare with NICE in England for similar drugs?
References & sources
Similar by meaning
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