New Medicines Reviews 2013

SUMMARY

THE AVAILABILITY OF NEW MEDICINES FOR PATIENTS IN SCOTLAND:

The role of the Scottish Medicines Consortium (SMC)

April 2013

Many medicines provide major benefits by enabling patients with a wide range of illnesses to live longer and/ or experience a better quality of life. While many of the new medicines which are marketed each year are available to all NHS patients in the UK, some are not. Medicines appraisal, the process by which the NHS in Scotland decides whether the benefit to patients justifies any additional cost in their purchase, is conducted by the Scottish Medicines Consortium (SMC).

Since 2001, SMC has been tasked with appraising all medicines launched on the UK market in a timely, efficient, robust and independent fashion, an achievement of which health professionals in Scotland are quite justifiably proud, and a process in which they have confidence. Comparisons with NICE have shown that while the proportion of medicines recommended for NHS use are similar to NICE, SMC publishes advice more quickly (Dear et al 2007, Barbieri et al 2009, Ford et al 2012). Their advice is conveyed to Area Drug and Therapeutics Committees (ADTCs) in the Health Boards, who ultimately decide upon the implementation of this advice.

SMC performs the difficult task of helping the NHS in Scotland to obtain value for money from those medicines which have recently obtained their marketing authorisation in the UK/Europe. For the last 12 years, it has fulfilled this challenging role by developing a fast, efficient, robust and independent process that has developed and adapted to changing needs and new circumstances. Its procedures are based firmly on the principles of evidence based medicine (EBM) and health economics, using rigorous and widely-accepted methodologies.

It is clear that the service which SMC provides is highly regarded and greatly appreciated by many health professionals working in the NHS in Scotland. Indeed SMC and its processes are held in high esteem internationally, and other HTA bodies worldwide have learned much from SMC when establishing their own systems. Others have compared their decision-making processes with those of SMC (Lexchin and Mintzes 2008, Bending et al 2012). The SMC process draws heavily on the expertise in evidence based medicine and health economics available in NHS Scotland and its two-stage process (assessment at New Drugs Committee [NDC] and then appraisal at SMC) adds further rigour and in-depth consideration. Examination of the documents made available to us and our face-to-face discussions with staff confirm the quality of the work leading up to preparation of the evidence for consideration at NDC and then SMC. NHS Scotland has developed a Patient Access Scheme (PAS) process which has further improved access to medicines by achieving greater value for money. This has been a result of the close engagement with the pharmaceutical industry from the inception of SMC.

It is vital that SMC maintains its well-earned international reputation for excellence, and continues to adapt to the expectations of the public, patients and those who submit their medicines for scrutiny. To do this, its processes should continue to evolve, as they already have over the last decade, and consideration should be given to the following recommendations:

Recommendation 1. SMC should meet in public so that members of the public, patients, patient group representatives, other health professionals and members of the pharmaceutical industry can attend to observe the appraisal process.

Recommendation 2. SMC should invite the manufacturer of the new medicine under consideration to give evidence at their main SMC appraisal meeting, in order to address any outstanding questions that SMC members have and highlight any outstanding issues of which they believe SMC should be aware prior to its advice being published.

Recommendation 3. SMC should be able to appraise any new medicines which the NHS in Scotland considers potentially of major importance to patient care, but which have not been submitted to SMC by the manufacturer within 12 weeks of launch. If necessary this appraisal may be conducted using such data as is already available in the public domain.

Recommendation 4. SMC should be able to have a temporary pause in the appraisal process at any stage in order to permit further dialogue with manufacturers on issues that would be likely to be central to the subsequent decision-making process.

Recommendation 5. SMC should develop a policy specifically relating to ultra-orphan medicines to guide the process of consideration of all available evidence relevant to its advice on these medicines.

Recommendation 6. SMC, with the appropriate resource and in partnership with other relevant bodies in Scotland, should be encouraged to set up an engagement process such as a "Citizen's Council" or "Citizen's Jury" to explore views around specific societal issues of importance to the people of Scotland in relation to the availability of new medicines and the impact of these views on the existing processes for ensuring access to medicines.

Recommendation 7. SMC should explore other innovative approaches to increasing patient and public awareness of its role in ensuring timely access to clinically effective and cost-effective medicines in Scotland. Consideration should also be given to expansion of its role to support other aspects of safe, effective and cost-effective prescribing. SMC should produce a publicly available annual report of progress in this regard detailing its important contributions to this objective.

Recommendation 8. NHS Scotland should explore ways in which the expertise available within SMC might be used to support the process of Value Based Pricing (VBP).

Recommendation 9. A register of IPTR decisions in all Health Boards, suitably anonymised to protect patient confidentiality should be kept, and supporting information related to IPTRs shared between Health Boards.

Recommendation 10. There should be regular sharing of experiences between the IPTR panels and members of IPTR panel members across Scotland should meet at least annually for induction, feedback and training.Background