6.2 How the views from the Patient and Clinician Engagement process are taken into account in decision making
6.2.1 The introduction of PACE has been welcomed by all stakeholders, however many feel that it has not been clear how PACE has impacted on SMC decision making and that further development is required. Several patients involved in PACE meetings reported leaving meetings with a sense of strong support from PACE for the medicine under consideration that did not influence SMC to reach a positive recommendation.
6.2.2 There were repeated suggestions for the development of a framework that would allow the PACE contribution to decision making to be quantified and better understood. When the T&FG made its recommendations it proposed a decision making framework but specifically excluded weighting and scoring. At the crux of this matter is the conflict which has its origins in attempting to include less concrete, qualitative considerations in a new revised decision making process yet at the same time wanting to somehow quantify the impact of these considerations in the ways applied to more traditional quantitative measures. While attempts may be made to better articulate the impact of PACE, by its very nature it is unlikely to be measurable in a way that stands up to consistent replication.
6.2.3 While a weighted decision framework may not be possible attempts should be made to better communicate the considerations that lie behind SMC's decisions and the reasons for these decisions.
6.2.4 While the opportunity for patients, patient groups and clinicians to contribute to the PACE process has been welcomed concern was expressed by some of the patients and patient groups about the role of the SMC Public Partners. It was felt that the role was conflicted between the responsibility to represent the wider public while at the same time acting as an advocate for specific patients or patient groups when reporting on PACE at SMC meetings. There was no criticism of any of the individual public partners but rather a concern about the role the partners were being asked to fulfil.
6.2.5 The comment was made that the patients' message as expressed via PACE was being filtered and diluted by the way that information from PACE was reported to SMC. While the main responsibility for reporting back lies with the chair of the PACE meeting, patients, patient groups and the pharmaceutical industry all have high expectations of the Public Partner to act as the patients' advocate in this part of the process. In some instances, where SMC had reached a not recommended decision despite a supportive PACE statement this was attributed by patients and their representatives, in part at least, to the Public Partner not accurately and adequately conveying the message from the PACE meeting. Patients were also concerned that the Public Partners and other SMC members involved in the PACE process had been unable to deal with some of the questions raised at SMC meetings. As a result, it was felt that there were instances where SMC's decisions may have been influenced by inaccurate or incomplete information.
6.2.6 A different view was expressed by the Public Partners spoken to and by other members of SMC. The conflict referred to above was not seen to pose difficulties and the ability of Public Partners to report objectively and dispassionately on relevant aspects of PACE deliberations to SMC meetings was welcomed and valued. There do appear to be differing expectations of the role and contribution of the Public Partners and this situation needs to be addressed.
6.2.7 There was a strong feeling that the process would be significantly improved by having the patients and clinicians involved in the PACE meeting as active participants in the relevant part of the SMC meeting. This message came not just from patients and patient groups but also from the pharmaceutical industry.
6.2.8 The crux of the issue discussed in the preceding four sections is how to achieve the most acceptable way of working that meets the needs of SMC, allowing it to undertake its business in an effective and efficient way while reassuring patients, their representatives and involved clinicians that their case is being given fair and accurate consideration.
6.2.9 One potential limitation of PACE was felt to be the ability to access clinical expertise from within NHSScotland given the rarity of some of the conditions under consideration and the limited experience with the medicine being assessed. A plea was made for more frequent engagement of experts from elsewhere in the United Kingdom and beyond. There are examples where this has happened but the main problem seems to relate to getting access to scarce clinical time.
6.2.10 The view was expressed by some that PACE should be an automatic part of the assessment of all end-of-life, orphan and ultra-orphan submissions, however it was recognised that PACE carries with it a significant opportunity cost in terms of the time required to prepare submissions and support the meeting. It also introduces a delay in the overall process and taking account of these factors the majority view was that the current arrangements for deciding when PACE should be activated should stand.
8 Review communications of SMC's decisions to patients, patient groups and the pharmaceutical industry with a view to achieving greater transparency.
9 Review and clarify the role of the SMC Public Partner.
10 Consider key participants at PACE meetings being actively involved in the relevant parts of SMC meetings to enhance the quality of discussion and decision making.