Comparator medicines with a PAS

SMC submissions for products where the comparator medicine has been accepted for use on the basis of a confidential Patient Access Scheme (PAS)

• As a consequence of current interpretation of commercial confidentiality and competition law issues, SMC can no longer report on cost effectiveness results that take account of a Patient Access Scheme (PAS) for a comparator medicine in the detailed  advice document (DAD).
• We will implement new reporting arrangements for submissions received from October 2016.
• Inter-company confidential disclosure agreements (CDAs) will no longer be requested during the assessment process. Other submission requirements will remain unchanged.
• The New Drugs Committee (NDC) and SMC will continue to consider cost effectiveness estimates that take account of comparator PAS discounts in decision making, however, the DAD issued following the NDC meeting and the final SMC advice will include only the estimates based on the list price of the comparator.
• The DAD will continue to highlight any weaknesses in the economic case and provide rationale for the NDC / SMC decision.
• The same approach will apply to submissions where another medicine is given together with the submitted medicine as part of a combination regimen, where the other medicine is marketed by another company and available on the basis of a confidential PAS. 
• Our guidance document provides more detail about these changes. 
• In the interim, SMC is continuing to work with our User Group Forum to seek an alternative viable solution to this challenging issue.