New system to ensure a more timely and consistent approach for new and innovative medicines to be introduced in Wales

A new system to ensure patients have fair and equitable access to new and innovative, evidence-based treatments will be introduced in Wales, Health and Social Services Minister Mark Drakeford announced today.

The new system will apply to so-called “orphan” and “ultra-orphan” medicines and treatments for patients with rare diseases.

The Minister has also announced the Individual Patient Funding Request (IPFR) process, which gives some patients access to innovative medicines not routinely available on the NHS, is to be strengthened.

The changes follow consultation on recommendations about the future of the IPFR process arising from a review commissioned by the Welsh Government in October 2013. It considered how the current IPFR process could be improved, with a particular emphasis on transparency and consistency of decision making between IPFR panels.

Currently, if a medicine or treatment has not been appraised or approved for use by the NHS in Wales, a clinician can apply for it to be made available under the IPFR process if there is clear evidence a patient will benefit because of some exceptional clinical circumstances. The review group recommended that the work of each IPFR panel should be centrally co-ordinated to ensure consistency. The Minister endorsed this recommendation.

The National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG) provide advice about whether a new medicine should be routinely available on the NHS in Wales based on the balance of clinical benefit to cost.

At the moment, AWMSG only appraises new medicines when a decision from NICE – which makes guidance about new medicines on an England and Wales basis – is not expected for more than 12 months. However, if a delay should occur when NICE is undertaking an appraisal this impacts on timely access to medicines for patients in Wales. To avoid this, AWMSG will undertake interim appraisals ahead of NICE advice on all key medicines to make sure advice is readily available to health boards.

Under the new arrangements announced today, orphan and ultra-orphan drugs – medicines developed specifically for very rare conditions – will be subject to an appraisal process specifically tailored to the novel challenges associated with those medicines. The new arrangements will also mean that patient groups and clinicians will have a stronger voice in the process.

Professor Drakeford said:

“In Wales, we have a proud record of making sure patients have access to proven and cost-effective treatments for all conditions.

“I’m very pleased to confirm the steps we are taking to strengthen the processes for accessing new medicines.

“The review of the IPFR process I commissioned supports rational, evidence-based decision-making to access medicines and non-medicine technologies, which are not routinely available in Wales.

“Ultimately, the desired position is to have a timely, consistent and expert view on whether a new medicine should be routinely available where clinically indicated.

“The measures I’m announcing today will ensure our evidence-based approach will be strengthened and informed by rigorous appraisal. This further opens up the opportunity for more new, cost-effective medicines to be routinely available in a timely manner across Wales.”