Health and Social Care Committee
Access to medical technologies in Wales
Evidence from ABPI Cymru Wales – MT 39
Committee Clerk,
Health and Social Care Committee,
National Assembly for Wales,
Cardiff Bay, CF99 1NA
14th October 2013
Dear Llinos
Access
to medical technologies in Wales: Call for Evidence
Thank you for the opportunity to submit a response to your call for evidence around access to medical technologies in Wales. Our response is appended to this letter.
I would be very happy to further discuss any aspect of our response with the Committee and provide any supplementary evidence, as required.
If I can provide any further information, please don’t hesitate to contact me.
Regards
Dr Richard Greville
Director – ABPI Cymru Wales
1. Access to Medical Technologies in Wales
1.1 Thank you for the opportunity to respond to your inquiry into Access to Medical Technologies in Wales.
1.2 It is clear that access to medicines falls outside the scope and remit of this inquiry. We appreciate that the intention of doing so is to maintain focus during the inquiry. However, it is also critically important to recognise that many of the new technologies, as defined by the inquiry, which are now coming to market or will be available in the coming years, are “companion” products to new medicines.
2. Stratified Medicines
2.1 Stratified medicines (sometimes known as “personalised medicines” or “genomic medicines”) enable the pharmaceutical industry to target treatments specifically to the patient sub-populations most likely to respond. This is not creating medicines unique to a patient, but rather, about the ability to classify individuals into sub-populations, who differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those identified sub-populations who will benefit, sparing expense and side effects for those who will not. Critically for this inquiry, this new way of treating people also involves the development and use of companion diagnostics to identify the appropriate patient sub-populations and thereby achieve the best outcomes in the management of a patient’s disease.
2.2 We believe that the development and implementation of an integrated stakeholder approach to stratified medicine will bring benefits to patients. It will also benefit prescribers, payers, and regulators and will improve the efficiency and productivity of developing new treatments, and enhance UK competitiveness and attractiveness for pharmaceutical, diagnostic and devices research and development (R&D). Welsh Government needs to ensure that it is well connected and recognised as a partner in the UK stakeholder map, whilst being supportive of ensuring connectivity for and between Wales based stakeholders.
2.3 The Academy of Medical Sciences recently published their report ‘Realising the potential of stratified medicine’[1]. ABPI welcomed this report and were delighted to co-sponsor and work with colleagues at the Academy of Medical Sciences on it.
2.4
The ABPI has been intensively engaged on the development of an
integrated approach to stratified medicine over an extended period,
working closely with a range of partners such as:
· The diagnostics sector
· Research funders
· Regulators
· Healthcare providers and policymakers
· Health informatics programmes
· Health economists
2.5 As part of this engagement, ABPI recently hosted the second pharma-diagnostics stratified medicine networking event, where it was agreed that biomarker testing in order to ‘stratify medicines’ has an expanding role in clinical decision-making. A number of recommendations emerged from the event, these included:
· The new commissioning and innovation bodies (CCGs and AHSNs) in England should be engaged and shaped to ensure optimal and sustainable adoption of stratified medicine, and learn from barriers to adoption
· Biomarker test results should be adequately used to inform patient treatment
· A framework for molecular pathology that incorporates test laboratory service standards, patient pathway analysis to include tests, appropriate and evidence-based commissioning of services and education of healthcare professionals should be created
· Innovative alternatives to traditional business models should be developed within the pharmaceutical and diagnostics industries and healthcare sector to incorporate a stratified approach
2.6 These recommendations should be considered to be as relevant and pertinent to Wales and we would be happy to share further learns’ gained from this engagement if the Committee would find it useful.
3. Appraisal Processes
3.1 The Committee has specifically asked for comments on the current appraisal processes for innovative medical technologies and the decision-making process of NHS Wales for funding new medical technologies and treatments.
3.2 The Committee will be aware that all new medicines have to receive a positive recommendation from either the National Institute for Health and Clinical Excellence (NICE) or All Wales Medicines Strategy Group (AWMSG) to receive routine funding in NHS Wales.
3.3 NICE has a Medical Technologies Evaluation Programme, which was established in 2009. The independent Medical Technology Advisory Committee at NICE has two core remits:
· Selecting medical technologies for evaluation by NICE guidance programmes, and
· Developing medical technologies guidance
3.4 Its work programme focuses specifically on the evaluation of innovative medical technologies, including devices and diagnostics. Products evaluated include:
· Medical devices that deliver treatment, such as those implanted during surgical procedures,
· Technologies that give greater independence to patients, and
· Diagnostic devices or tests used to detect or monitor medical conditions
3.5 The Committee may wish to raise the role of the Medical Technologies Evaluation Programme in Wales with Welsh Government officials as part of the inquiry. Routine funding of all innovative medical technologies should be assessed with the same rigour for evidence of clinical and cost effectiveness as demanded for medicines.
3.6 It may also be useful for the Committee to consider speaking with CEDAR[2], an NHS evaluation centre and part of the Cardiff and Vale University Health Board, who have been commissioned to provide external assessments for NICE in this area.
4. Links to Economic Development
4.1 There is growing recognition of the importance of innovation and its adoption to both the health of the population and economic development. The Welsh Government is committed to providing ‘world class’ healthcare for its population as well as investing in life sciences as one of the 3 grand challenges in its Science Strategy and as one of the 7 priority sectors for economic development. Co-ordination and inter-linkages between organisations and Government departments involved in these ambitions is essential to ensure a successful, holistic and joined-up overarching strategy. The recently published Chief Medical Officer for Wales Annual Report dedicates a chapter to looking at the relationship between health and wealth and recommends that “NHS Wales and the Welsh Government should continue to drive economic development by supporting and sustaining a strong life science sector...”[3]
4.2 The Minister for Economy, Science and Transport and the Minister for Health and Social Services have jointly asked their officials to prepare a capital bid to build and support an infrastructure able to capture, store and analyse genomic information to meet clinical, research and economic development needs, which may lead to a Joint Ministerial statement of intent for genomic medicine in Wales.[4] Such an initiative could be very supportive of both the delivery of “world-class” healthcare and the broader medical technologies industry.
4.3 The development of an infrastructure for using e-health and genomics in research, alongside routine patient care, will enable more effective biomedical research across the entire R&D system – from the feasibility, recruitment and management of trials to observing patient outcomes over time. The quality and adoption of this new “Big Data” technology across Wales will be fundamental to its utility and usefulness.
4.4 This could provide the starting point for “Laboratory Wales” and further develop the country’s potential to become a fast-breeder for life sciences. However, capital funding needs to be linked to comparable investment in recurring revenue to support associated services, including the adoption of innovative practices.
Organisation: ABPI Cymru Wales
Contact (completed by): Dr. Richard Greville
Email: rgreville@abpi.org.uk
Telephone: 029 20 454297
We are happy for all information contained herein to be shared, as appropriate.