Abstract
BackgroundThe Scottish Medicines Consortium evaluates new drugs for use in the National Health Service in Scotland. Reforms in 2014 to their evaluation process aimed to increase patient access to new drugs for end-of-life or rare conditions; the changes include additional steps in the process to gain further information from patients and clinicians, and for revised commercial agreements. This study examines the extent of any impact of the reforms on funding decisions.MethodData on the Scottish Medicines Consortium’s funding decisions during 24 months post-reform were extracted from published Advice, for descriptive statistics and thematic analysis. Comparison data were extracted for the 24 months pre-reform. Data on decisions for England by the National Institute for Clinical and Health Excellence for the same drugs were extracted from published Technology Appraisals.ResultsThe new process was used by 90% (53/59) of cancer submissions. It is triggered if the initial advice is not to recommend, and this risk-of-rejection level is higher than in the pre-period. Thirty-eight cancer drugs obtained some level of funding through the new process, but there was no significant difference in the distribution of decision types compared to the pre-reform period. Thematic analysis of patient and clinician input showed no clear relationship between issues raised and funding decision. Differences between SMC’s and NICE’s definitions of End-of-Life did not fully explain differences in funding decisions.ConclusionsThe Scottish Medicines Consortium’s reforms have allowed funding of up to 38 cancer drugs that might previously have been rejected. However, the contribution of specific elements of the reforms to the final decision is unclear. The process could be improved by increased transparency in how the non-quantitative inputs influence decisions. Some disparities in funding decisions between England and Scotland are likely to remain despite recent process convergence.
Highlights
Introduction of a Patient And ClinicianEngagement (PACE) meeting; purpose is to clarify aspects of value perceived by patients and clinicians that are not fully captured in the Quality-Adjusted Life Year (QALY), implicitly supporting acceptance of medicines with a cost per QALY above the standard threshold.Option for the submitting company to propose or modify a Patient Access Scheme (PAS) at the Patient And ClinicianEngagement (PACE) stage.An additional framework of non-scored criteria for evaluating ultra-orphan drugs.The Scottish Medicines Consortium (SMC) definitions are different from the end-of-life criteria used by National Institute for Health and Care Excellence (NICE), both structurally and numerically (Table 1), and are more permissive than NICE’s current criteria.The 2014 SMC changes are significant in the context of United Kingdom (UK) health technology appraisal, as a novel approach to incorporating broader aspects of value into costeffectiveness analysis
Thirty-eight cancer drugs obtained some level of funding through the new process, but there was no significant difference in the distribution of decision types compared to the pre-reform period
Thematic analysis of patient and clinician input showed no clear relationship between issues raised and funding decision
Summary
Introduction of a Patient And ClinicianEngagement (PACE) meeting; purpose is to clarify aspects of value perceived by patients and clinicians that are not fully captured in the QALY, implicitly supporting acceptance of medicines with a cost per QALY above the standard threshold.Option for the submitting company to propose or modify a Patient Access Scheme (PAS) at the PACE stage.An additional framework of non-scored criteria for evaluating ultra-orphan drugs.The SMC definitions are different from the end-of-life criteria used by NICE, both structurally and numerically (Table 1), and are more permissive than NICE’s current criteria.The 2014 SMC changes are significant in the context of UK health technology appraisal, as a novel approach to incorporating broader aspects of value into costeffectiveness analysis. Reforms in 2014 to their evaluation process aimed to increase patient access to new drugs for end-of-life or rare conditions; the changes include additional steps in the process to gain further information from patients and clinicians, and for revised commercial agreements. The Scottish Medicines Consortium (SMC) did not make similar adjustments at that time; in 2012 ‘modifiers’ were introduced which allow SMC greater flexibility under specific conditions, in their acceptance of uncertainty in the economic case or a high cost per Quality-Adjusted Life Year (QALY); the uncertainty modifier applies to orphan drugs, but end of life is not mentioned [4]. The changes take the form of an add-on process that is triggered only if the initial advice of SMC’s New Drug Committee (NDC) is not to recommend funding [5, 6] and include: Definitions of end of life, orphan, and ultra-orphan conditions. A drug may qualify under rarity, end-oflife, or both (for example a rare cancer)
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