Review of Access to New Medicines

Appendix 1: Task & Finish Group Recommendations

Task & Finish Group Recommendations

1 SMC should introduce new, more flexible approaches for the assessment of EoL medicines, orphan medicines and ultra-orphan medicines;

2 SMC should adopt the following methodologies, which will substantially improve access to these new medicines:

• Medicines for EoL and orphan medicines - If the SMC New Drugs Committee ( NDC) advises that a medicine does not meet the conventional thresholds for cost-effectiveness, a PACE Meeting may be convened to allow SMC to clearly establish the views of clinicians and Patient Interest Groups on the need for the medicine, its clinical benefits, optimal place in therapy and the patient perspective. The output of the PACE Meeting will play a significant part in informing the SMC decision for the medicine, with a more powerful influence than the current modifiers;
• Ultra-orphan medicines - Recognising that under current SMC processes ultra-orphan medicines are unlikely to be accepted for use, SMC should introduce a decision-making framework that is not based on the cost per QALY for these medicines. A new framework of explicit criteria for evaluating these medicines, without performing weighting and scoring, will be introduced. A PACE Meeting may also be convened for these medicines;

3 SMC should work with stakeholders to introduce these new approaches as quickly as possible;

4 SMC should encourage early resubmissions for medicines that have been 'not recommended' for use under the current system;

5 SMC should ensure that any changes to how SMC works must be clear and understandable to the public. It was also agreed that the definitions should be applied in an enabling way, to allow flexibility;

6 SMC should work with patients and clinicians to ensure there is understanding of the new processes and to enable and maximise their contributions;

7 Scottish Government should engage with the NHS to give further consideration to mechanisms of monitoring patient outcomes after treatment with EoL, orphan and ultra-orphan medicines;

We note the Scottish Government's intention that the SMC's system of medicines appraisal is given time to establish itself. On this basis, the following two recommendations are made:

8 There should be an independent review of the experience with the new SMC approaches, and a decision on when this should be initiated would be taken no later than 12 months after the new approaches are introduced;

9 SMC should work with the Scottish Government to determine and enable the research required to underpin an evidence-based approach to a Scottish Model of Value.