Review of Access to New Medicines

6.12 Whether the progress made to date provides a solid basis for developing further a Scottish Model of Value

6.12.1 In the course of the engagement undertaken by the Review there was limited awareness of the concept of a Scottish Model of Value and no sense that any particular progress had been made with the issue since the introduction of SMC's new approach.

6.12.2 There was doubt that the experience of the new approach in relation to end-of-life, orphan and ultra-orphan medicines would provide a solid basis for the further development of a Scottish Model of Value because of the highly specific considerations of this particular agenda. There was strong agreement though that the experience could and should inform any developmental of a model.

6.12.3 The situation with end-of-life, orphan and ultra-orphan medicines is highly unusual and may even be unique. Many of the medicines transcend the conventional measures of cost effectiveness but these considerations are displaced by others such as the extreme rarity of the conditions and the lack of alternative treatment options. The view obtained through this Review is that, in the current situation, there is justification for considering these medicines according to different parameters and using different weightings from other treatments. A future Scottish Model of Value ideally would provide a framework that makes this unnecessary.

6.12.4 Any framework has to develop an accepted model of value that is sophisticated enough to deal in multiple currencies of which money is only one. Discussions in this Review moved between cost, cost-effectiveness, affordability and value accepting that they are all different but inter-related. The most challenging to define is value and in a Scottish Model of Value it will be important to ensure that it is measured and expressed in broad but consistent terms. These terms cannot be confined to clinical effectiveness and medical outcomes but need to take account of personal considerations and wider societal factors. The metrics need to be applicable not just to this small group of medicines but to an array of treatments and interventions in a way that informs and supports meaningful comparisons and difficult choices.

6.12.5 Each of the stakeholder groups spoken to had helpful and interesting perspectives on what constituted meaningful measures of success in relation to treatment with medicines. The measures extended beyond traditional, often binary outcome measures and looked at qualitative information such as patient reported outcomes, real world data, societal impact such as ability to work and maintain physical and financial independence, preservation of function, prevention of deterioration whether of the primary condition or through prevention of the development of co-morbidities and wider impact on families. The list is long and complex but there is a need to work with stakeholders to agree meaningful frameworks and metrics that stand up to repeated use and comparison. A system that developed a new framework and metrics for every new medicine that required ongoing evaluation would be neither efficient nor effective.

6.12.6 In keeping with the comment made in Paragraph 6.10.7 about the high level of scrutiny applied to medicines, the principles outlined should be applicable not just to the evaluation of new medicines but to other non-medicines health technologies.

6.12.7 Ideally a Scottish Model of Value would not be confined to health or healthcare interventions but could be used across all aspects of public life in circumstances where informed choices have to be made about the use of finite and increasingly scarce resources.

Recommendations

28 Consider how the experience of NHSScotland's systems for the assessment and managed introduction of new medicines can inform the development of a Scottish Model of Value. This is likely to be through the establishment of a multi-agency taskforce or equivalent group.