8.1 As might be expected this Review has raised a number of issues that have their origins in the Review but have ramifications not just for the wider healthcare system but for health and social care and other publicly funded services.
8.2 At the core of these issues is the challenge of how to manage the tension between optimising the use of finite resources in a way that ensures that difficult choices are made with confidence and an acceptable balance is reached between providing individual patients with the best experience of care and investing in the health and wellbeing of the wider population. This is in essence the tension articulated in the Institute for Healthcare Improvement's Triple Aim 5 which lies at the heart of Scotland's 20:20 Vision for Health & Social Care 6 and the associated Route Map 7 .
8.3 All expectations are that the challenges highlighted in this Review with respect to ongoing access to new medicines will be replicated across a wide range of healthcare and other technologies to which clinicians and patients will seek access in coming years. The rate of development of often costly innovative technologies is seemingly exponential and is accompanied by expectations in some quarters that these innovations will be introduced at earlier stages of their development. This will often be without a traditional evidence base but instead with the expectation that the evidence base will continue to be accumulated as part of managed introduction and managed access schemes.
8.4 Suggestions of a new paradigm may not be overstated and the consensus view of the stakeholders contributing to this Review is that the existing structures, processes and relationships are unlikely to meet the challenge going forward. There are however significant strengths within the existing paradigm. SMC and its associated systems and processes function effectively, are highly regarded and enjoy the confidence of patients, the public, clinicians and the pharmaceutical industry. The new approach has had the sought after impact for end-of-life and orphan medicines. There is a need though for reflection and further evolution of a system already based on a philosophy of continuous improvement.
8.5 The suggested new paradigm needs to have at its heart a different set of relationships between all of the stakeholders. These include patients and the wider public, organisations representing patients' interests, NHSScotland including SMC, Territorial Health Boards, Special Health Boards such as HIS and NSS and their constituent parts, the pharmaceutical industry, academia including organisations like the Farr Institute and Scottish Government.
8.6 The new relationship has to be positioned further upstream in relation to the introduction of medicines than previously. To date the interaction between the various players, and certainly that between NHSScotland and the pharmaceutical industry has tended to begin only once a medicine has been granted a license and a submission to SMC is being considered. All spoken to consider this to be too late, missing as it does the opportunity to collaborate on issues such as horizon scanning, the optimal use of specific medicines, wider assessments of impact and value and more pragmatic pricing strategies.
8.7 Even within groups of stakeholders there will be a need to behave differently. NHS Boards and clinicians involved in developing treatment strategies will have to share intelligence to better inform horizon scanning. Pharmaceutical companies will have to move to greater collaboration with their competitive rivals particularly in the area of the introduction of new medicines which will be used as part of combination therapies or multi agent regimens.
8.8 The new relationships have to acknowledge and deal with the tensions created by being both collaborators and customers and this will be challenging. There is evidence of a willingness to change and move away from what has been seen as an adversarial role where SMC's expectation of the pharmaceutical industry has been to make submissions capable of meeting SMC's criteria, while the pharmaceutical industry has had an expectation that SMC has to justify not recommending medicines for use in NHSScotland. In this latter regard there has been a repeatedly expressed frustration on the part of the industry that SMC does not provide adequate explanation for its decisions. Arguably the introduction of the new approach laid the way for a shift from a competitive to a more enabling process but further progress will require a more fundamental rethink on the quality and positioning of the relationships.
8.9 Discussions that took place in the course of the Review demonstrated a willingness on the part of all stakeholders to collaborate on developing new ways of working. A repeated theme was for the need to begin that collaboration much earlier in the process of bringing new medicines to market but also to continue it after medicines had been accepted for use to ensure there was ongoing evaluation of the impact of medicines. The approach was characterised as a collaboration informed and driven by data. This collaboration and the involvement of academic partners such as the Farr institute was seen as a way of addressing some of the challenges of optimising the use of medicines, agreeing affordable pricing strategies and coping with the revisions to the regulatory framework for new medicines.
8.10 During evidence gathering from stakeholders much was made of the need to take a more sophisticated approach to benefits that includes patient-reported outcomes, wider societal benefits such as the ability to continue working or a reduction in care or support requirements. The term "overall budget impact" was used on several occasions and requires the application of sophisticated health economic modelling which takes account not just of medicine costs but of whole system value and impact and introduces the concept of multiple "currencies" not just financial cost. The integration of health and social care presents Scotland with a particular opportunity in this regard.
8.11 One of the key findings of this Report is that despite the new approach, access to true ultra-orphan medicines used in the treatment of very rare conditions has not increased as measured by SMC recommending such medicines for use. It is unlikely that any further revision to SMC processes is likely to change this. In other words, in terms of process, one size no longer fits all but every attempt must be made to restrict the number of alternatives to one rather than have a series of exemptions on a case-by-case or medicine-by-medicine basis. This will require the development of an alternative pathway with a revised contribution from SMC in relation to true ultra-orphan medicines.
8.12 Mention has to be made of the difficulty highlighted by several contributors in reconciling the direction outlined in Realistic Medicine 1, particularly when it comes to the challenge to reduce the harm associated with over-investigation and over-treatment, with the drive from both clinicians and patients and their advocates to access new medicines at the earliest opportunity. It was suggested that in relation to end-of-life, orphan and ultra-orphan medicines this was influenced by the lack of alternative management strategies. It does confirm the need to pursue as a matter of priority the discussion initiated by the publication of Realistic Medicine 1 in Scotland and comparable initiatives such as Prudent Healthcare 8 in NHS Wales.
8.13 As the recommendations are progressed there will be additional sources of expertise from which NHSScotland can benefit. Boards should work with PHI on developing and refining datasets. The Farr Institute could add further expertise and rigour to the development of revised datasets and systems to undertake evaluation of new medicines both prior to launch and as part of the ongoing evaluation following introduction to clinical practice. The expertise of National Procurement at NSS will be essential in developing a different approach to affordable pricing.
8.14 There is a danger that in trying to address the issues raised in this Review and its recommendations that actions are taken at the wrong level or on too small a scale. At the heart of the Review are a number of fundamental questions about NHSScotland and its continuing ability to deliver the healthcare that the people of Scotland want and expect. This is in large part down to agreeing the priorities for funding from a finite resource. This will involve difficult choices but these choices have to be made by the correct stakeholders armed with the correct information. In this regard initiatives such as "Creating a Healthier Scotland - What Matters to You?" 9 will be key.
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