SMC New Product Assessment Form (NPAF)
A standard form used by medicine manufacturers to submit evidence for new medicines being assessed for use in NHS Scotland. It includes information on how well the medicine works, its cost, impact on the healthcare budget, and reasons for special considerations.
At a glance
Use when
Submitting a new medicine for appraisal by the Scottish Medicines Consortium for potential adoption in NHS Scotland.
Avoid when
Assessing medicines outside the Scottish context or when a less structured, exploratory submission is sufficient (e.g., early dialogue).
Inputs
Clinical trial data, health economic models (e.g., Markov models), unit costs, epidemiological data, patient-reported outcomes, and contextual information on Scottish healthcare delivery.
Outputs
Structured manufacturer submission dossier for SMC appraisal, informing decisions on acceptance, restriction, or rejection of a medicine in NHS Scotland.
How it works
A structured submission template mandated by the Scottish Medicines Consortium (SMC) for manufacturer dossiers during the appraisal of new medicines. Requires detailed clinical efficacy and safety data, a cost-utility analysis reporting cost per QALY, budget impact analysis, and justification of modifiers (e.g., innovation, unmet need, equity). Ensures consistent and comprehensive evidence submission for decision-making in the Scottish healthcare context.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- The medicine provides a net health benefit within acceptable cost-effectiveness thresholds; submitted data are robust, relevant to the Scottish population, and compliant with SMC guidelines.
- Strengths
- Standardises evidence submission, promotes transparency, ensures comprehensive appraisal across clinical, economic, and social dimensions, and incorporates Scottish-specific healthcare priorities.
- Limitations
- Reliant on manufacturer-provided data which may be biased; limited flexibility for early or uncertain evidence; may not fully capture real-world effectiveness at time of submission.
- Also known as
- NPAF, SMC NPAF, New Product Assessment Form
Questions this answers
- › What clinical evidence supports the efficacy and safety of the medicine?
- › What is the incremental cost-effectiveness (cost per QALY) compared to current treatments?
- › What is the expected budget impact on NHS Scotland?
- › Does the medicine address an unmet need or offer significant innovation?
- › Are there equity or access considerations justifying acceptance despite higher cost?
- › How does the medicine fit within current clinical pathways in Scotland?
References & sources
- websitescottishmedicines.org.uk ↗
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.