1.1. Medicines are vital therapeutic tools in modern healthcare, controlling many conditions and in some conditions, achieving cures. Every year, approximately 70 new medicines or new formulations receive a Marketing Authorisation (MA) from the European Medicines Agency (EMA) and the NHS must then decide whether the additional cost in purchasing them is justified by the likely benefit to patients. This process is termed medicines appraisal, a specific type of health technology appraisal (HTA), and central processes for this activity have existed in Scotland, England and Wales for over ten years in the Scottish Medicines Consortium (SMC), National Institute for Health and Clinical Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG), respectively.
1.2. SMC is a national collaboration between the Area Drug and Therapeutics Committees (ADTCs) in the Scottish Health Boards to reduce duplication and improve consistency of advice. Its subcommittee, the New Drugs Committee (NDC), and SMC itself meet monthly in Glasgow. It first began its work in 2001, under the chairmanship of Professor David Lawson. Since that time, it has conducted appraisals of individual newly licensed medicines (licensed from January 2002), (including new indications for medicines with an existing license) on behalf of the Scottish Health Boards. It also considers new formulations of existing medicines. It does not appraise vaccines, branded generic medicines, blood products or diagnostic drugs. Device-containing medicines are appraised if they are licensed as medicines by the MHRA/EMEA.
1.3. The process employed by SMC is often termed a "single technology assessment" or "single technology appraisal" (STA). SMC's role is to recommend for routine use, those newly licensed medicines which it considers represent good value for money for NHS Scotland. The manufacturer submits a clinical and economic case, which is first considered by the New Drugs Committee (NDC), a sub committee of SMC (see later) and then by the main Committee (SMC). The recommendations are then forwarded to the ADTCs in the Scottish Health Boards.
1.4. The ideal medicines appraisal process should be transparent, timely, relevant, in-depth and usable (Cox Report, cited by Garrido et al 2008). Transparency of the process is important if disagreements about the process itself rather than scientific issues are not to predominate. It also encourages greater trust in the HTA body and its processes. It requires full declaration of interests over the appropriate period of time by participants. Timeliness ensures that medicines which are both clinically effective and cost effective can be made available to patients as soon as possible after launch. Relevance is important in ensuring that the advice produced is appropriate and applicable to the needs of the user and therefore usable. The HTA process needs to be in-depth, to ensure that it is as robust and reliable as possible. In addition, there are other important attributes of the ideal process. Advice needs to be accessible (a large number of pieces of advice available in common format on a database that is easy to navigate). The process should be efficient (value for money and avoidance of duplication of effort). Scientific Independence of the organisation conducting the HTA process from interested parties, including policy-makers and government is vital (Garrido et al 2008) and ensures that the advice produced is accepted by health professionals as well as patients, the public and pharmaceutical manufacturers.
1.5. SMC aims to provide a decision on all new medicines within three to four months of launch, so that early access to new medicines is possible for Scottish patients (Kohli 2005, Cairns 2006, Webb et al 2006, Dear et al 2007). SMC is the only HTA body to consider STAs of all new medicines. AWMSG in Wales reviews those medicines not on the NICE work programme and NICE appraises only selected medicines referred to it by the Department of Health. SMC's advice is published rapidly (Dear et al 2007, Ford et al 2012) and used and referenced internationally (OFT 2007, Lexchin et al 2008, Vegter et al 2010). SMC, like AWMSG, only appraises medicines whilst NICE also considers selected healthcare interventions. SMC and NICE recommend a similar proportion of medicines (Ford et al 2012),
1.6. The standards achieved by SMC and the other UK HTA bodies were highlighted in a report by the Office of Fair Trading (OFT) on the Pharmaceutical Price Regulation Scheme (PPRS) in 2007. Discussing the role of NICE, the SMC and AWMSG it noted that, "The technical expertise that these bodies bring to bear in conducting cost effectiveness assessments is of world class standard." It also stated that they have made a significant contribution to the cost-effective use of NHS resources and have "shown themselves able to adapt to changing needs" (Office of Fair Trading 2007). Specifically in relation to SMC, the report commented that "SMC decisions are highly regarded and the body has managed to establish a strongly collaborative approach with industry throughout its evaluation process"
1.7 Despite SMC's progress in adapting to changing needs in Scotland over the last decade, there have been recent concerns expressed by some clinicians, charities and pharmaceutical industry about difficulties in patients being able to access effective medicines in Scotland, prompting the decision to institute a review of SMC processes and access arrangements.
2. Remit of the review
2.1. New Medicines Review
The New Medicines Review announced by the Cabinet Secretary for Health and Wellbeing on the 14 November 2012 responds to concerns raised in the Scottish Parliament and the media regarding concerns of patients, clinicians and other stakeholders regarding access to new medicines - particularly cancer medicines and medicines to treat rare diseases.
The New Medicines Review will examine every aspect of the processes for introducing new medicines within the NHS in Scotland to assess their effectiveness and to identify what further improvements can be made.
The review comprises three main strands of work:
(i) an independent examination of the Scottish Medicines Consortium (SMC) appraisal processes; (Annex A);
(ii) an examination of the role and remit of NHS Board Area Drug and Therapeutics Committees (ADTCs) and a separate examination of the current Individual Patient Treatment Request (IPTR) arrangements (Annex B); and
(iii) An audit of NHS Board formulary decisions regarding medicines which have been accepted or accepted for restricted use by the SMC (Annex C).
A key aim of the review will be to achieve consistency in the application of national policy throughout NHS Scotland. A fuller description and the scope of each strand of work are set out in the attached annexes.
2.2. This report aims to address the first of these three strands, an independent examination of the Scottish Medicines Consortium (SMC) appraisal processes.
2.3. Annex A (below) outlines the terms of reference of that particular strand:
Professor Philip Routledge, Professor of Clinical Pharmacology at Cardiff University and Mrs Karen Samuels, Head of HTA and Medicines Management in the All Wales Therapeutics and Toxicology Centre, Cardiff, Wales will examine the current Scottish Medicines Consortium (SMC) appraisal processes and methodology from horizon scanning of new pharmaceutical products in the pipeline through to provision of SMC advice to NHS Scotland to see what further improvements can be made.
This will include a broader view of the cost and benefits of new, innovative medicines - specifically to assess whether the Quality Adjusted Life Year (QALY) methodology represents an effective tool to calculate cost-effectiveness of these in terms of off-setting the cost of the medicine against potential savings.
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