Mark Drakeford, Minister for Health and Social Services
On 30 April 2014, the Welsh Government launched a consultation following a review of the way patients access innovative and cost-effective medicines in Wales, including the Individual Patient Funding Request (IPFR) process.
This statement outlines the steps we will be taking to strengthen the IPFR process and additional funding we will be investing in the process of appraising orphan and ultra-orphan medicines by the All Wales Therapeutics and Toxicology Centre (AWTTC).
A total of 49 responses to the IPFR consultation were received from a wide range of organisations, health professionals and individuals. There was majority support for virtually all the recommendations outlined in the review. The responses provided thoughtful commentary on the IPFR process and the wider issue of access to new and innovative medicines in Wales. I would like to thank everyone who contributed.
The review group’s report is available online together with a summary of the consultation responses and the Welsh Government’s response.
Each of the review group’s 10 recommendations will strengthen the IPFR process – they have all been accepted. Work will start immediately to implement the recommendations and the process will be strengthened further by a new role for the All Wales Therapeutics and Toxicology Centre (AWTTC).
AWTTC will provide an expert, co-ordinating role, which will include the provision of advice about the availability of key evidence; it will undertake rapid reviews to produce evidence summaries for new medicines and it will support the training of panel members and clinicians. To help the centre provide this additional support, it will receive funding to recruit additional staff, including clinicians, pharmacists and scientists. When the enhanced service is fully operational it will receive funding of some £500,000 a year.
We want to have an expert view on whether each new and innovative medicine is cost-effective and whether it should routinely be available to patients in Wales.
At the moment, there is often a significant time lag between the launch of a new medicine and the appraisal undertaken by the National Institute for Health and Care Excellence (NICE) on behalf of the NHS in Wales and England. The All Wales Medicines Strategy Group (AWMSG) only appraises those new medicines where a decision from NICE is not expected for at least 12 months. As NICE timescales for appraisals can slip, health boards can be without authoritative advice about a particular medicine or treatment for a period of time. To ensure an appropriate evidence base is available to underpin decisions about access to treatments, AWMSG will now undertake interim appraisals ahead of NICE guidance.
Many respondents to the consultation commented on the difficulty of using the IPFR process to determine access to a new medicine or the use of off-label medicines for patient cohorts. The enhancement of the appraisal process will reduce the dependence on the IPFR process and AWMSG will provide expert advice on the use of off-label medicines. Health boards and the Welsh Health Specialised Services Committee have also been asked to coordinate their efforts and make a single, all-Wales decision for each patient cohort, supported by advice from AWTTC, based on the available evidence.
A key and equally important feature of the new process is a system to monitor and analyse the outcomes of IPFR decisions to improve transparency and confidence.
Some respondents to the consultation expressed disappointment that the review group did not recommend adopting a single panel to make IPFR decisions across NHS Wales. The review group explains its conclusions in the report and I have agreed that, for the time being, it is not a practical way forward given the frequency it would need to meet and that the logistics of bringing key staff and clinicians together will not best serve the interests of patients. However, I expect NHS Wales to re-examine this option once the new system has settled in.
It is not appropriate to routinely use the IPFR process to determine access to orphan or ultra-orphan medicines – those medicines developed specifically to treat very rare medical conditions.
AWTTC has been asked to develop a new appraisal process for this group of medicines and it will receive additional funding to support this. This will ensure those patients with rare diseases have fair and equitable access to appropriate, evidence-based treatments.
Taking all the new responsibilities together, the Welsh Government will invest some £1m in the new service to be provided by the AWTTC to improve the appraisal of and patients’ access to new and innovative medicines, including orphan and ultra-orphan drugs.
These investments will be met by using payments to Wales from the 2014 Pharmaceutical Price Regulation Scheme (PPRS) settlement. They will help NHS Wales more efficiently martial its expenditure of more than £198m on medicines in the hospital sector, the vast majority of which is spent on new and innovative medicines.
The new and expanded role of AWTTC will improve transparency and provide the comprehensive, authoritative, consistent and coherent approach required by clinicians and patients to ensure timely and evidence-based access to new treatments.