Pharmacoeconomic Guidelines: Scotland

Country/Region: Scotland
Submission Guidelines

Guidance to submitting companies for completion of New Product Assessment Form (NPAF) April 2022

Submission Guidelines Source:

Scottish Medicines Consortium

Additional Information:

Information current as of Tuesday, August 9, 2022

Key Features

Type of Guidelines Submission Guidelines
Title and year of the document Guidance to submitting companies for completion of New Product Assessment Form (NPAF) April 2022
Affiliation of authors Healthcare Improvement Scotland
Purpose of the document Assist submission to Scottish Medicines Consortium
Standard reporting format included No
Disclosure Not stated
Target audience of funding/ author's interests Manufacturers. Scottish Medicines Consortium
Perspective The perspective on outcomes should be all direct health effects whether for patients or, where relevant, other individuals (principally carers). The perspective adopted on costs should be that of the NHS in Scotland and social work (referred to as Personal Social Services (PSS) in England).
Indication The manufacturer should state the indication(s) for the product that is detailed in the submission, as described in the Summary of Product Characteristics
Target population If applicable the manufacturer must state explicitly that the SMC is asked to consider the use of the medicine when positioned for use in a sub-group of the population covered by the marketing authorisation. The focus of the submission must be clear and refer to a single population i.e. either the full licensed population or a sub-population.
Subgroup analysis Yes
Choice of comparator The comparator should be the treatment most likely to be displaced in Scotland. Comparator medicines must be specified as precisely as the medicine being appraised. There are frequently several potential comparator medicines as, for example, practice is not necessarily consistent across Scotland or the UK and between the UK and elsewhere. All relevant comparators must be identified, although a full comparison will not always be appropriate for every one of these comparators.
Time horizon The time horizon for estimating clinical and cost effectiveness should be sufficiently long to reflect any differences in costs or outcomes between the medicines being compared.
Assumptions required Yes
Preferred analytical technique In general, cost-utility analysis is the appropriate form of economic evaluation, with health effects expressed in terms of quality adjusted life years (QALYs). Cost-minimisation analysis may be appropriate if the proposed medicine is demonstrated by studies to be therapeutically equivalent to the relevant comparator(s), as assessed using an adequately designed and powered non-inferiority or equivalence or superiority study. Alternative approaches can be considered in those circumstances in which the QALY may not to be the most appropriate outcome measure.
Costs to be included Costs should relate to resources that are under the control of the NHS in Scotland and social work (equivalent to Personal Social Services in England) where differential effects on costs between the medicines under comparison are possible. These resources should be valued using costs relevant to the NHS in Scotland and social work. There will be occasions where non-NHS/social work costs will be differentially affected by the medicines under comparison. In these situations, the SMC needs to be made aware of the implications of taking a broader perspective on costs for the decision about cost effectiveness. When sensitivity analyses include these broader costs, explicit methods of valuation are required. In all cases, these costs should be reported separately from NHS/social work costs.
Source of costs Medicine costs should be based on unit prices listed in the BNF or MIMS. Costs should reflect Scottish context
Modeling Modelling provides an important framework for synthesising available evidence and generating estimates of clinical and cost effectiveness relevant to the SMC’s decision making process.
Systematic review of evidences Yes
Preference for effectiveness over efficacy Yes
Preferred outcome measure In order to make clear comparisons of the value of new medicines, the SMC has a preference for cost-utility analyses using QALYs as the primary outcome measure.
Preferred method to derive utility The SMC guidance regarding the use of QALYs has largely adopted the NICE guidance (section 5.3 of the NICE Methods of Technology Appraisal Guide to Manufacturers) but specifies this in terms of a preference (rather than a requirement) for utility estimates from a validated generic utility instruments.
Equity issues stated Yes
Discounting costs An annual discount rate of 3.5% should be used for analyses with a time horizon of less than 30 years. Sensitivity analysis should vary the rate between 0% and 6%.
Discounting outcomes An annual discount rate of 3.5% should be used for analyses with a time horizon of less than 30 years. Sensitivity analysis should vary the rate between 0% and 6%.
Sensitivity analysis-parameters and range No specific range stated.
Sensitivity analysis-methods Consideration should be given to one and two-way sensitivity analyses, supported by graphical representation including threshold values. Each alternative analysis should present separate results.Probabilistic sensitivity analyses may be submitted in support of the application, but are not considered mandatory.
Presenting results Each alternative analysis should present separate results. Appropriate ways of presenting uncertainty are confidence ellipses and scatter plots on the cost effectiveness plane and cost effectiveness acceptability curves.
Incremental analysis Yes
Total costs vs effectiveness (cost/effectiveness ratio) Yes
Portability of results (Generalizability) Yes, reflect Scottish context
Financial impact analysis Yes
Mandatory or recommended or voluntary Recommended


Ailsa Brown NHS Scotland, Scottish Medicines Consortium, Glasgow, Scotland, contributed to the key feature form.
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