Country/Region: Scotland
Submission Guidelines

Guidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (Revised 2019) 

Submission Guidelines Source:

Scottish Medicines Consortium

Additional Information:
Information up to date as of Tuesday, January 21, 2020

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Guidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (Revised 2019) 
Affiliation of authors
Healthcare Improvement Scotland  
Purpose of the document
Assist submission to Scottish Medicines Consortium 
Standard reporting format included
Not stated 
Target audience of funding/ author's interests
Manufacturers. Scottish Medicines Consortium 
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). 
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
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
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 
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
Preference for effectiveness over efficacy
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
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
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
Yes, reflect Scottish context 
Financial impact analysis
Mandatory or recommended or voluntary

Acknowledgement: Noreen Downes, Anne Lee, BPharm, and Brian O’Toole, MSc, Scottish Medicines Consortium, Glasgow, Scotland, contributed to the key feature form.

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