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One Wales Medicines process

When a group of patients might benefit from a medicine that isn’t routinely available, the All Wales Therapeutics and Toxicology Centre (AWTTC) co-ordinates the One Wales Medicines process. This involves an 'All Wales' consideration and, for positive recommendations, medicines will be made available across Wales.

One Wales can be used for medicines when:

  • the medicine’s licence holder commits to a future HTA of a licensed medicine;
  • the MHRA have not licensed a medicine;
  • the MHRA have licensed a medicine only to treat a different condition(s); or
  • a medicine isn’t included in current treatment guidelines and no other suitable medicine is licensed to treat the condition.

AWTTC regularly collects and analyses data from Individual Patient Funding Requests (IPFRs) across Wales to look for potential groups of patients for a particular medicine and condition. As well as finding groups of patients from IPFR requests, clinicians, chief pharmacists or medicines and therapeutics committees in Wales can ask AWTTC to consider medicines for One Wales. See our One Wales FAQs page for details on how to make a request. 

The One Wales Medicines Advisory Group (OWMAG) assesses the evidence collected by AWTTC and makes a recommendation on use of the medicine to the health board chief executives. If they endorse the recommendation, the decision applies across NHS Wales.

Health boards are responsible for implementing One Wales decisions and making sure that clinical outcomes are monitored. Clinicians who have requested access to use a medicine through One Wales must monitor and collect patient outcomes.

The duration of a One Wales decision is decided on a case-by-case basis. One Wales decisions will be reviewed by OWMAG after a minimum of 12 months (up to a maximum of three years) from the date of advice or earlier if new evidence becomes available.

For licensed medicines, One Wales advice is interim to HTA guidance from AWMSG or NICE.

View all current One Wales Medicines decisions

Frequently-asked questions about One Wales Medicines process

We welcome suggestions for medicines to be considered via the One Wales Medicines process from Individual Patient Funding Request (IPFR) panels, Welsh Health Specialised Services Committee (WHSSC), clinicians (ideally through clinical networks), chief pharmacists, formulary pharmacists or medicines and therapeutics committees.

The process is driven by identification of unmet clinical need by the service and therefore we cannot accept requests from pharmaceutical companies or from members of the public.

To submit a request for a medicine to be considered for the One Wales Medicines process please complete a medicine request form.

Yes, where a clearly defined cohort of potential patients has been described, the One Wales Medicines process may consider the following options:

  • the medicine is not licensed for any indication; OR
  • the medicine is not licensed for the indication of interest; OR
  • the requested use of the medicine is outside of accepted treatment pathway i.e. the specific sequence of treatment/s has not been approved by NICE/AWMSG,

However there must be no suitably licensed medicine available that will meet the patients’ needs.

A biosimilar medicine is a medicine developed to be similar to an existing biological medicine. Unlike generic medicines which are considered identical to their reference medicine, biologic medicines cannot be reproduced exactly due to the complex nature of the production methods and molecular structure.

To gain marketing authorisation biosimilar medicines have to demonstrate that they are as safe and as effective as the original reference medicine and are of the same quality.

One Wales interim decisions which refer to a biological medicine will also apply to relevant biosimilar products which may appear on the market subsequent to publication of the decision provided that the biosimilar has an equivalent or lower net price when compared to the reference product.

Due to the small differences between biosimilars and/or the reference products biologic medicines should be prescribed by brand name to avoid automatic substitution and therefore help with pharmacovigilance.

A committee, the One Wales Medicines Assessment Group (OWMAG) assesses the evidence and makes a recommendation to health board chief executives. This committee comprises representation from all IPFR panels, a lay member, industry representative, finance representative, a clinical pharmacologist and a health economist. Clinical experts and patient groups are invited to attend the OWMAG meeting to set the clinical and patient context.

One Wales decisions will be disseminated to the service following endorsement by health board chief executives.

OWMAG members list

Clinicians wishing to access a medicine not routinely available on the formulary, but available via a One Wales decision, will be obliged to collect/monitor patient outcomes. Evidence of clinical outcomes will be taken into consideration when reviewing the One Wales decision.

The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence.

Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. These risks may include: adverse reactions; product quality; or discrepant product information or labelling (e.g. absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet (PIL) is inconsistent with a medicine’s off-label use).

Health Boards will take responsibility for implementing One Wales decisions and ensuring that a process is in place for monitoring clinical outcomes.

The duration of a One Wales decision is decided on a case-by-case basis. For licensed medicines, it is unlikely to exceed 18 months and would normally be 12 months or until publication/ratification of NICE technology appraisal guidance/AWMSG recommendation. One Wales decisions will be reviewed by OWMAG a minimum of 12 months (maximum of three years) from the date of advice. AWTTC will conduct a literature search and may request outcome data annually for all medicines. 

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