6.6 How NHS Boards are implementing SMC decisions under the new approach (both accepted and not recommended) including utilisation of the New Medicines Fund
6.6.1 It has always been the case that when a medicine is approved for use by SMC it should be made available by Health Boards for use by their clinicians. However, it is not always understood or accepted that this does not automatically equate to a medicine being incorporated into a Board's formulary. This is because formularies generally deal with common treatments for common conditions and many of the end-of-life, orphan and ultra-orphan medicines are by definition indicated only in rare or highly specialist circumstances and may not represent first, second or even third line therapy.
6.6.2 Health Boards have in place mechanisms whereby clinicians can access and use non-formulary medicines but this may require a case to be made that the medicine is more effective than an established alternative. In certain quarters, particularly the pharmaceutical companies, this is perceived as failure to implement SMC decisions however, from a Board perspective, SMC acceptance does not equate to automatic use or incorporation into Board formularies.
6.6.3 For the purposes of the Review it was not possible to obtain comparative data on Board formularies. Neither is comparative data available in relation to processes for non-formulary requests, the number of requests submitted or the outcome of such requests because Boards do not have standardised data systems. Formularies are discussed further in Section 6.8.
6.6.4 The situation for SMC not recommended medicines is different. Where a medicine is not recommended by SMC it can still be accessed via an IPTR or PACS. In these cases, the onus is on the treating clinician to make a case for their patient being treated with the medicine despite SMC advice. This route is discussed in more detail in the next section ( 6.7) but the experience seems to be that a much greater proportion of IPTR (90%) are being supported compared with the rate prior to the introduction of the new approach (69%). The experience of those Boards involved in the pilot of PACS has been that it is extremely unlikely for a medicine not to be made available.
6.6.5 The NMF is available to meet the costs of the introduction of new medicines as detailed in Paragraph 3.9. There was a concern expressed by patient groups and the pharmaceutical industry that clinicians were unaware of the Fund or the mechanism by which funding could be accessed and consequently they felt reluctant or unable to recommend new medicines for fear that they would not be funded. This was not borne out in discussion with Health Boards and clinicians however there was a lack of clarity on the part of at least one Board as to the full range of exigencies covered by the Fund.
6.6.6 While the NMF and its predecessor the RCMF have served their purpose to date, concerns have been expressed about the lack of clarity regarding arrangements for the future. The agreement on PPRS receipts is set to run in Scotland until 2018/19. So far the monies available have covered the calls made on the Fund but it is anticipated that demands will grow and that maintaining the current level of access to new medicines will only be achievable if the current funding arrangements are maintained and availability of funds keeps pace with demand. Comparisons were regularly made with the Cancer Drugs Fund in England and while the operation of the fund differs from Scotland the trend there has been one of significant growth in demand that has out-stripped the available budget year on year.
6.6.7 While high level data is available on the utilisation of the NMF, limitations are posed on the data and the purposes to which it can be put by the confidential nature of some of the pricing agreements reached with pharmaceutical companies for specific medicines.
6.6.8 The NMF has been welcomed because it has provided a dedicated funding stream which has ensured that patients can access end-of-life, orphan and ultra-orphan medicines while Health Boards are protected from the wider-system impact of funding these medicines.
6.6.9 PPRS has been a welcome source of funds to date but, as highlighted in Sections 3.9 and 6.6.6, the future of this funding stream is unclear however the real point at issue is the willingness to maintain a funding source to cover the costs incurred by Health Boards in providing access to end-of-life, orphan and ultra-orphan medicines. Without such a source Boards will be unable to maintain access for patients without adverse impact on other aspects of service delivery, particularly in the face of the anticipated growth in demand for these medicines.
6.6.10 A number of stakeholders expressed concern that the NMF has resulted in medicines being treated differently from other developments and innovations in healthcare the costs of which have to be met from core funding available to Health Boards.
15 Standardise data collection at Board level in relation to systems and process for requests to access non-formulary medicines.
16 Clarify the future arrangements for the funding of end-of-life, orphan and ultra-orphan medicines.