Although Wales has the power to make reimbursement decisions independently, its National Health Service (NHS) is closely aligned with England’s health service. Payer decision maker bodies in Wales represent a potential complementary, alternate route to reimbursement where a National Institute of Health and Care Excellence (NICE) decision may be delayed. As with the Scottish Medicines Group (SMC), Wales’s technology evaluation body is more flexible than NICE regarding timings, and the manufacturer plays a key role in setting appraisal timings and scope.
Wales’s Payer Stakeholders
NHS Wales covers health expenditures, including medicines, through seven Local Health Boards (LHBs) and three local NHS Trusts based on geography. The UK Parliament in Westminster sets the NHS Wales funding level annually.
Established in 2002, the All Wales Medicines Strategy Group (AWMSG) advises the Welsh Assembly Government (WAG) on medicines management and prescribing. It originally focused on high-cost treatments only (i.e. those costing above £2000 per patient per annum), filling the gap between launch and publication of NICE guidance. It has since expanded its remit, and now has capacity to conduct 32 appraisals a year.
Despite this, the AWMSG is not intended to be an alternative to NICE, and sponsors are first required to submit information about a product so that AWMSG can decide whether a full submission is necessary. In general, AWMSG is unlikely to appraise a product that is on the NICE technology-assessment work programme unless there is likely to be a large delay before publication of the NICE decision (more than 18 months). The AWMSG appraisal process takes around six months to publish a decision. In contrast to the NICE process, the AWMSG appraisal meeting is held in public.
For AWMSG recommendations, a medicine should be available no later than 60 calendar days after publication of the decision (following ratification of the recommendation by the Welsh Government). A three-month timescale for the introduction of a medicine for use is allowed for in exceptional circumstances, where the scale of service planning required will need longer than two months.
In general, AWMSG is intended to complement NICE decisions rather than replace them. Many new technologies will not require the sponsor to submit to AWMSG on their behalf, although this may change in the future as more high-cost treatments are introduced.
Important Points to Keep in Mind
AWMSG was designed to help “fill the gaps” around NICE decisions, and where NICE will review a medicine, a separate AWMSG review is unlikely unless a long delay in the NICE process is foreseen. It initially requires sponsors of a technology which may meet their criteria for a full submission, to provide more information so AWMSG can decide whether an appraisal is necessary. The AWMSG has neither the resources or remit of NICE (England) or the Scottish Medicines Consortium (SMC) and has only recently increased capacity to undertake up to 32 appraisals a year.
Implications for Industry
In most cases, AWMSG submissions are not required when new products are introduced. The role of AWMSG is increasing, and as more high-cost treatments are introduced it may play a greater role in providing quick advice to NHS Wales in advance of a NICE decision. GLOBALHealthPR can help you assess whether an AWMSG submission is necessary and take the required steps to do so.
Telling your value story early and often will smooth the pathway for access and maximum reimbursement for your product. The GLOBALHealthPR team has years of experience in Wales, all the other countries of the UK, and other EU markets and can offer valuable insights to your marketing and market access teams.
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