Rotterdam, The Netherlands – Given limited health care resources and rising expenditures on pharmaceuticals, policy makers are increasingly confronted with the challenging task to improve patient outcomes and reimburse new pharmaceutical interventions. Arguably, Scotland is often one of the first European countries where manufacturers file a submission dossier requesting public reimbursement for their product since the Scottish Medicines Consortium (SMC) advisory process is transparent, in that all decisions and argumentations are published on the SMC’s website. The SMC considers questions such as: Will the medicine be effective? Are the current treatments better? Does the medicine give value for money compared to an existing treatment? Hence, feedback of the SMC on a submission might have implications on decisions of other health authorities and impact the product’s pricing in Europe on the grounds of the reference pricing system.

Researchers from Pharmerit International reviewed SMC appraisal decisions since 2006 to identify the evidence that substantially influences the SMC recommendation decision. The results of the research showed that a submission supported by a cost-minimization analysis had significantly higher chances of the product being recommended for use; while a submission showing a product not being cost-effective (i.e. ICER above £30,000/QALY gained) substantially decreased the probabilities of a positive outcome. The products indicated for a nervous system disease demonstrated lower chances of recommendation, while products for non-chronic use and submissions performed by big companies (defined as companies with total revenues ≥ 1.5 billion) were shown to positively influence the SMC decision.

The results of this study present (at least) three important implications for future reimbursement submissions: (1) the ICER and the uncertainty around the ICER are significant factors for a successful reimbursement submission in the SMC; (2) a performance of cost-minimization analyses was associated with a high probability of positive recommendation, suggesting that the SMC may prefer a case which can be backed up by a simple pharmacoeconomic analysis, like a cost-minimization one; and (3) trial design is taken into consideration by the SMC and an active-controlled trial is preferred over the placebo one. Therefore, manufacturers should take this into consideration when trying to fulfil the reimbursement requirements along with the marketing authorization needs, as this tends to be a hurdle for a product’s introduction in the market.

This research makes the importance or weight of different variables (e.g. clinical, health economic, burden of illness) on the reimbursement recommendation in Scotland transparent. This is relevant for the understanding of all stakeholders of the Scottish reimbursement process (e.g. SMC, manufacturers, patient interest groups and clinicians). For manufacturers and lobbying organizations, it could help to further improve their reimbursement submissions and claims regarding their products. Moreover, this transparency can be used for further refinement of the current reimbursement process and criteria.

“Based on our experience with the health technology assessment (HTA) process and requirements, we acknowledge that cost-effectiveness evidence is a major factor being considered during the appraisal process. Through our research, we have now quantified the impact of this and other pieces of evidence, gaining even greater insights into the SMC’s criteria.” said authors Istvan Majer, PhD, and Mata Charokopou, PharmD, MSc.

The full study, “Which Factors Enhance Positive Drug Reimbursement Recommendation in Scotland? A Retrospective Analysis 2006–2013,” is published in Value in Health.

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