6.10 Whether there have been unintended consequences of any aspect of the new approach, the potential of which was noted by the Task and Finish Group Report
6.10.1 A number of sources felt that there had been unintended consequences associated with the introduction of the new approach. Most of the comments came from sources within the NHS.
6.10.2 It was felt that the new approach poses significant challenges for the capability and capacity of the system particularly if the demand for assessments continues to grow as anticipated. This is impacting not just on SMC and its associated processes but also patient groups, clinicians and the pharmaceutical industry. The time involved in preparing and assessing submissions is significant and makes substantial calls on a sometimes small cohort of professionals and lay experts. This can impact on clinical activity and carries a significant opportunity cost. Continuing to properly resource the system will be challenging as the required resource is not just financial.
6.10.3 The introduction of the new approach has had the unintended consequence of creating a system where access to ultra-orphan medicines used in the treatment of rare conditions has not increased. This has resulted in an increase in the use of IPTR and, in the pilot Boards PACS, with the experience being that the majority of requests are supported despite SMC's original assessment. This is discussed in Sections 2, 6.3, 6.7, 6.8 and 7.
6.10.4 The approach to the use of medicines may have changed. The improved access brought about by the new approach, whether by SMC decision or IPTR/ PACS, has given clinicians more options and often treatments are being applied more aggressively and for longer periods of time than current evidence would justify. Several clinical stakeholders commented that current clinical practice associated with end-of-life medicines was at odds with the principles underpinning Realistic Medicine 1. It was felt that in some cases the use of medicines aimed at extending life was at the cost of pursuing alternative non-drug treatments aimed at enhancing quality of life and providing high-quality supportive care.
6.10.5 There was a view that the new approach has actually weakened the negotiating position of NHSScotland. Because there is an expectation that higher costs will be tolerated it was felt that this removed incentives for the pharmaceutical companies to offer reduced prices. This is discussed in more detail in Paragraph 6.9.9.
6.10.6 More generally, concern was expressed that medicines were increasingly being treated differently from other types of care in relation to cost and cost effectiveness or prioritisation. Comparisons were drawn with a number of new and emerging non-medicines technologies. In May 2016 HIS and the Scottish Health Technology Group ( SHTG) followed a consultation paper published in January 2016 with an action plan entitled, "Driving improvement in non-medicine technologies." 4 Both publications resonated with this Review.
6.10.7 The point was made that medicines have always been subject to greater scrutiny than other technologies because data is more readily available and that one aspiration should be to replicate the rigour applied to the introduction of new medicines to other new technologies.
6.10.8 Some stakeholders saw that the introduction of secret voting at SMC meetings had clouded transparency in a way that had not been intended. This is discussed in Section 6.5 above.
6.10.9 Several clinical stakeholders voiced concern about the impact of the introduction of the new approach on the morale of SMC members. In some quarters there were concerns that by inference a highly-regarded process had been criticised and even undermined. This feeling has been further compounded by the apparently large proportion of SMC decisions which have been "overturned" by the high success rates for requests made via IPTR and PACS. It was seen as a significant success that the high level of clinical engagement both through direct involvement with SMC and in support of its decisions had been maintained through the implementation of the new approach.
6.10.10 Several of the highlighted unintended consequences cannot be readily addressed as discrete issues. Mitigation will be dependent on further change to the system for access to new medicines. The unintended consequences identified will have to be borne in mind as this Review's recommendations are considered and taken forward to ensure that, as much as is possible, they are not replaced by a new and different set of unintended consequences.
26 Monitor the demands made on SMC and its associated processes and ensure that the available capacity and capability and support mechanisms are adequate for SMC's needs.