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Patient Access Schemes

A Patient Access Scheme (PAS) is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost-effective innovative medicines. The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHS Scotland on the feasibility of proposed schemes for implementation.  It operates separately from SMC to maintain the integrity and independence of the assessment process. 

The process for the submission, assessment and implementation of PAS in Scotland can be found in the following guidance document and standard terms:

Pharmaceutical companies wishing to submit a PAS proposal to PASAG should complete one of the following PAS application packs (depending on the nature of the scheme):

The PAS application pack for a proposed scheme should be submitted to the SMC Secretariat along with the New Product Assessment Form (NPAF) and associated documents. From 1 October 2017, National Institute for Health and Care Excellence (NICE) Multiple Technology Appraisals (MTAs) will no longer be assessed by Healthcare Improvement Scotland (HIS) for applicability to NHSScotland.  Any new medicines that are going through the NICE MTA process and have not been assessed by the Scottish Medicines Consortium (SMC) will require a submission to SMC. This change has no bearing on MTAs that have been endorsed by HIS to date; the advice from these MTAs will continue to apply.  Details of NICE MTA that have been endorsed by HIS within Scotland can be viewed here.

Pharmaceutical companies may contact the PASAG Secretariat (NSS.NP-PASAG@nhs.net) in advance of submission for general advice and guidance on the operational feasibility of proposed scheme types. 

Guidance for manufacturers on comparator medicines accepted for use on the basis of a confidential Patient Access Scheme (PAS).

It should be noted that if the NDC’s advice for an end of life, orphan or ultra-orphan medicine is ‘not recommended’, the company also has the option to offer a new or revised Patient Access Scheme aimed at making their product better value for the NHS in Scotland. Find out more. 

The SMC advice for medicines accepted with a PAS is accessed via the “Patient Access Scheme” filter within the SMC Advice Directory.