Further changes must be made to create a better and more transparent system for accessing new medicines, according to a report by the Health and Sport Committee.
Two recent reviews of the system commissioned by the Scottish Government and undertaken by Professors Swainson and Routledge were welcomed by the Committee. However, it remains concerned that these recommendations do little to address the clear barriers to access new medicines by patients.
It is today calling on the Scottish Government to address issues around individual patient treatment requests (IPTR), value based pricing, area drug and therapeutic committees and clinical trials.
Committee Convener Duncan McNeil MSP said:
“Firstly, we welcome the Scottish Government’s approach to trying to gain consensual, cross party support in making changes to how patients access new medicines. This has always been a contentious issue and let’s be clear that there are no easy answers or quick fixes.
“However, the reviews set up by the Scottish Government to come up with suggestions to improve the system have done little to address the barriers that currently exist.
“The Committee believes that the recommendations outlined in this report have the potential to create a better and more transparent system for patients to access new medicines.”
Deputy Convener Bob Doris MSP said:
“Our Committee very much supports the reviews conclusions that would increase transparency, make the system less complex and allow specialist clinicians a say.
“But we need a more transparent system that patients have trust in and can be reassured that decisions are made on the basis of a consistently applied process.
“That is why we are asking the Scottish Government to review issues around individual patient treatment requests, how medicines are approved locally and also how we deal with issues around orphan conditions.”
In summary the report recommends:
- Operation of Scottish Medical Consortium (SMC). The Committee remains concerned that, welcome though the changes proposed in the reviews are, they do very little to address the clear barriers to access to new medicines experienced by patients.
- One of the central difficulties with the IPTR system expressed in the evidence given to the Committee was proving the exceptionality of patients’ circumstances, particularly with orphan and ultra-orphan conditions. It is believed that, in its current form, this approach acts as a barrier to accessing drugs clinicians believe their patients need. The Scottish Government must outline steps that will improve the process.
- The Committee believes that, in the interests of improving transparency of the Individual Patient Treatment Request (IPTR) system, the Scottish Government should review and analyse previous IPTR decisions and look to improve monitoring of applications and consistency of future IPTR decisions. The number of applications, negative and positive decisions, among other relevant details, should be published regularly.
- Area Drug and Therapeutic Committees (ADTC). The recommendation that decisions on whether to include a medicine on the local formulary be made and announced within three months of an SMC recommendation should help to promote consistency and transparency. There may also be a further case to be argued that all ADTCs should put new SMC approved medicines on their formulary within three months, whether or not the prescribing and clinical guidelines had been fully completed by that time. Clinicians can therefore use their professional judgement whether to use medicines on a nationally available formulary or to await guidance locally.
- The Committee notes Professor Swainson’s findings in relation to ADTCs and heard arguments put forward for the retention of all 14 ADTCs in their current form. However, there may well also be arguments that have not, so far, been fully explored, in favour of a smaller number, or even a single national body, particularly in relation to patient treatment requests. Moving towards a national patient treatment request body may be the most effective way to ensure both a consistent application of individual patient treatment requests and group patient treatment requests criteria as well as consistency in decision making.
- Do these proposals go far enough? The Committee remains concerned that these recommendations will not entirely address the issues that have given rise to most concern over the last few years. SMC’s methodologies will remain largely unchanged, even though it may meet, at least partially, in public. But decisions on whether to recommend a medicine for use in NHS Scotland will still be based on the cost of the additional quality adjusted life years (QALY) that a drug treatment might provide.
- No one argued that there was a better system than the QALY for assessing the value offered by competing treatments, despite its limitations. The committee has already considered the complexities around the cost per QALY. It is clear that the way in which modifiers are applied is a crucial element in determining the cost effectiveness of medicines by SMC. The committee therefore calls on the SMC and Scottish Government to review as a matter of priority how modifiers and thresholds are applied to better take account of orphan and ultra-orphan conditions, end of life and innovation and to bring a higher degree of transparency.
- Orphan and ultra-orphan conditions. The Committee is conscious that its work on this issue started with a number of petitions relating to orphan and ultra-orphan diseases. The Committee therefore welcomes the decision of the Cabinet Secretary, based on advice from Professor Swainson, to establish the £21m rare conditions medicines fund.
- However, questions remain about the extent to which this fund will, in practice, result in improving access to these medicines, given that it will still be necessary for the patient’s clinician to have made a successful IPTR or been part of a Group Patient Transfer Request in order to access the fund. The Committee notes that clear guidance is to be published and hopes that this will lead to greater understanding of how the fund works.
- The cancer question. The Committee agrees that, although SMC decisions about specific cancer medicines may be unpopular, they are soundly made and should continue to be made on the same basis as they are for medicines for other conditions, and that cancer should not be singled out for special treatment in comparison to other life-shortening conditions. The Committee accepts that there are difficult issues in relation to individual patient’s treatments, and that it can be difficult for patients and their families to accept that medicines may not be available on the same basis in all parts of the UK.M Nevertheless, the establishment of a cancer drugs fund in Scotland would not be the answer to these problems.
- Clinical trials. The Committee recognises the concerns of clinicians and others about the impact of the latest innovative medicines not being available routinely in Scotland and its possible effect on the number of clinical trials taking place in Scotland. The Committee also notes the general trend within the industry for fewer larger-scale clinical trials to take to take place in Scotland and the rest of Western Europe, which could not compete on price with eastern European nations. The Committee calls on the Scottish Government to urgently investigate and report back to the Committee on whether there is a decline in the number of phase 3 trials being placed in Scotland and consider any steps that may be needed to increase their number as well as maximising the overall number of clinical trials.
- Value based pricing. The Committee considers that, should it indeed turn out that certain aspects of value-based pricing could, in fact, be undertaken by the devolved administrations, it is unfortunate that this confusion has persisted for such a long time – time that could have been used to establish new Scottish arrangements. It is going to be challenging for such arrangements to be established in time for VBP's commencement date of January 2014.
- Nevertheless, the Committee considers that, should the health technology aspects of value based pricing indeed be devolved, this may present a unique opportunity to develop a Scottish solution to these matters that could be much more flexible than the current arrangements.
- Next steps. Stakeholders in both written and oral evidence have demonstrated an enthusiasm for all interested groups to work constructively with the Scottish Government to develop the system for accessing new medicines further in a way which is able to take account of a wider assessment of their value; the committee notes the variety of submissions in this area from a wide range of groups including Myeloma UK, ABPI, Beating Bowel Cancer and Cancer Research UK.
- While it welcomes the recommendations within the Swainson and Routledge reviews, describing the improvements as “incremental”, the Committee makes a number of recommendations that go beyond both reviews. It believes that these recommendations have the potential to significantly improve both the Patient Treatment Request and SMC processes and, in doing so, would ensure a better and more transparent system for the accessing of new medicines.
The Committee’s work began on this issue in response to three petitions to the Parliament on behalf of patients suffering from rare and orphan illnesses.