Market Access, Funding and Rebates

New Treatment Fund

• The Welsh Government New Treatment Fund provides dedicated funding to enable Local Health Boards and Trusts to make newly recommended medicines available within 60 days of approval by NICE or AWMSG.
  
  
• In order to monitor compliance with the New Treatment Fund, Local Health Boards and Trusts report on how quickly they have added medicines recommended by NICE and AWMSG to their prescribing lists. These are compiled into formulary status reports by AWTTC.
  
  
• The most recent report (covering January-December 2025) showed a total of 76 medicines funded using the New Treatment Fund. The vast majority of these had been added to formularies within the required timescale.

Licensed Medicine Access

If NICE assess a medicine as being clinically effective and cost-effective then it will be provided to patients. However, for medicines that are deemed either too expensive or lack clinical evidence, patient access schemes and access agreements may be negotiated. Pharmaceutical companies with a medicine undergoing NICE evaluation that includes a commercial agreement should contact NHSWales.CA@wales.nhs.uk as early as possible. Separate engagement with NHS Wales is required to enable alignment of commercial agreements with those in NHS England. If no agreement is in place the NICE Technology Assessment cannot be implemented within NHS Wales

• Patient Access Scheme (PAS): a pricing agreement between the medicine’s licence holder and NHS England to help NHS patients receive high-cost medicines. The medicine’s licence holder may propose a PAS for a new medicine when NICE assesses that its value is unlikely to support the proposed list (full) price, based on the current evidence. Only the medicine’s licence holder can propose a PAS, which may be simple or complex. 

  • A PAS associated with a positive NICE recommendation will be accepted in Wales, however verification of the details of the scheme is expected to be shared by the licence holder with NHS Wales, via the National Procurement Lead Pharmacist for Wales and AWTTC.
    
    

• Commercial Access Agreement (CAA): proposed by a medicine’s licence holder to NHS England to manage the cost of a medicine to the NHS, such as where there are unusual or unique circumstances that mean launching a medicine is considered particularly challenging or not commercially viable.
  

  • If a CAA is signed with NHS England, the medicine's licence holder is responsible for sharing the details of the CAA with NHS Wales. On occasions, an alternative CAA may be agreed with NHS Wales, which offers equivalent value for the duration of the NICE recommendation.

• Managed Access Agreement (MAA): an agreement between NICE and NHS England, if at the time of appraisal, there is uncertainty about how well the medicine works or (and as a consequence) about whether it is cost-effective.

  • Details of an agreed MAA should be shared by the licence holder with NHS Wales via the Medicines Value Unit. Sometimes, an alternative MAA may need to be agreed with NHS Wales, which offers equivalent value for the period of the recommendation.

• More detail on NICE's approach to patient access can be found here.

• For medicines not appraised by NICE (or given a negative recommendation by NICE), then a Wales Patient Access Scheme (WPAS) may be proposed. A WPAS is a pricing agreement between the medicine’s licence holder and Welsh Government to help NHS patients in Wales receive high-cost medicines. The medicine’s licence holder may propose a WPAS within AWMSG’s HTA process. The Patient Access Scheme Wales Group advises Welsh Government on whether the proposed scheme is workable within NHS Wales.

Simple WPAS

• Simple WPAS: A simple WPAS offers a discount at the point of invoice. To qualify as a simple WPAS the applicant must offer a discount or price reduction:
  
  • from the list price, applied for all supplies of the product applicable to all current and future indications (within the duration of the WPAS). 
  • which applies to the original invoice, or the indicated price for the product.
  • which requires no additional administration to receive the price offered; ‘additional’ means over and above the administration required for procuring the medicine without a PAS (a single contract is allowed). 
  • which will remain in place until or after AWMSG review (3 years).
    
    
• The details of a simple scheme would routinely remain commercial in confidence. 

Complex WPAS

• The licence holder may consider a complex WPAS if their scheme doesn’t meet the criteria for a simple WPAS, and may include rebates, free stock, and outcome-based dose capping.
  
  
• Any proposed scheme for use in primary care would be considered complex. 
  
  
• The details of a complex scheme would not routinely remain commercial in confidence. The requirement for transparency is to ensure the administrative burden and cost to the service of implementing such schemes is minimised.
  
  
• If a complex agreement is being considered, companies should contact the Medicines Value Unit for early engagement to support the implementation and adaptability of the agreement within NHS Wales.

Commercial Access Agreements

• A CAA is a proposal from a medicine’s licence holder to the NHS to manage costs by offering enhanced value or addressing challenging commercial circumstances around launching a medicine. A CAA is usually used for a medicine that NICE’s budget impact test shows will have a high impact on the NHS in the first 3 years of funding.
  
  

• NHS England will offer to engage in commercial discussions with the licence holders of medicines that are expected to have a potential net budget impact over £40 million a year (previously £20 million) in any of the first three years of use. These discussions happen in parallel with the HTA process, and aim to reduce the impact of immediately funding the medicine on the NHS’s budget. If no agreement is reached, then NHS England may request a longer time to implement the statutory funding requirement for the medicine. NICE will consider these requests on a case-by-case basis.
  
  

• The Commercial Medicines Access Team (CMAT) is a collaborative multi-organisational team comprised of colleagues from AWTTC, NHS Wales Shared Services Partnership and the Medicines Value Unit. The role and responsibility of CMAT is to support and monitor the implementation of AWMSG and NICE recommended medicines associated with a commercial arrangement within NHS Wales, including both PAS and CAAs. CMAT is supported by the Commercial Arrangement Scheme Wales Group (CASWG), an AWMSG sub-committee which will provide increased stakeholder involvement, transparency and governance to the approval of commercial arrangements on behalf of NHS Wales. 

• CASWG will scrutinise, review and agree commercial arrangements associated with the medicines access processes of AWMSG, and will also scrutinise, review and agree commercial arrangements for NHS Wales that are offered as part of NICE submissions. CASWG considers the proposed commercial arrangements, and formulates advice for NHS Wales about the feasibility and implementation of a proposed scheme.

• Pharmaceutical companies with products undergoing an AWMSG evaluation should contact the CMAT Team at NHSWales.CA@wales.nhs.uk for early engagement to support the implementation and adaptability of the commercial agreement within NHS Wales.

• The difference between a CAA and complex PAS relates to the transparency of the agreement.

• Each CAA would be considered on a case-by-case basis. Examples of CAA formats include: 

• Outcomes-Based Agreements link drug reimbursement to patient health results and patient reported outcomes measures (PROMs), a key aspect of value-based healthcare.
   

• Project IDEATE (Innovation in Data to Evolve Agreements That Enhance patient health outcomes), a collaboration between NHS Wales, DHCW, Swansea University and Pfizer, developed a retrospective OBA model to generate a sustainable and scalable methodology to implement OBAs.

Managed Access Agreements

• MAA allows patients to access a new medicine while long-term data on it are still being collected. The medicine’s licence holder will provide the new medicine at a discounted cost, and before final funding decisions.
  
  

• MAAs are only considered if there is potential for a medicine to meet the criteria for routine prescribing, and uncertainty about the clinical data and the estimates of cost-effectiveness on which to recommend it.
  
  

• A highly specialised technology (HST) is a type of technology appraisal that covers one specialised medicine for treating one very rare, and often very severe, disease. NICE's method for appraising these technologies aligns to AWMSG's assessment of medicines developed to treat a very rare disease. MAAs are often used for HSTs, as they tend to combine high uncertainty with high cost.

• An MAA has two parts:
  

  • a data collection arrangement, stating what data to collect during the managed access period to resolve the most important areas of uncertainty.

  • a CAA or a PAS, determining how much the NHS will pay for the new medicine during the managed access period.
    
    

• In Wales, the medicine’s licence holder is encouraged to share the details of an agreed MAA through the CMAT team. Sometimes, the licence holder may need to agree an alternative MAA with NHS Wales, which offers equivalent value during the managed access period.

Blueteq High Cost Drug (HCD) System

• The Blueteq HCD system is a web-based software used to authorise use of National Institute for Health and Care Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG) approved high cost drugs across a whole range of healthcare conditions.
  
  

• The system provides a single process for recording and approving treatments that HBs wish to monitor. Approval of a HCD request is accomplished by the completion of a simple ‘form’ which lists the eligibility criteria for that medicine. A library of unique forms for HCDs is being developed with support from clinical teams across Wales. 
  
  

• Implementation of the Blueteq HCD system in Wales was developed in two phases.

  • Phase 1 (May 2021): Initially launched by the Welsh Health Specialised Services Committee (now the NHS Wales Joint Commissioning Committee)  to manage roughly 100 specialised medicines and Advanced Medicinal Therapeutic Products (AMTPs).

  • Phase 2 (April 2023-April 2025): The Welsh Government formally extended Blueteq's scope to secondary and primary care. The AWTTC achieved national rollout across all seven NHS Wales Health Boards by April 2025. This phase now covers roughly 600 high-costs medicines, with a final completion target of March 2027 for total systemic integration.

• To assist clinicians, a live centralised database of standardised NHS Wales Blueteq Medicine Forms is hosted on the AWTTC website, enabling full compliance with AWMSG and NICE criteria
  

• Health boards and Trusts identify their own priority areas for implementation and will continue with a phased approach until all eligible medicines are included. 

Access to Medicines Pre-License

Medicines can also be provided to Welsh patients pre-license through two main routes:

• Individual Patient Funding Requests: Allows clinicians to submit a request for funding the medicine on an individual basis, if evidence suggests significant, cost-effective clinical benefits.
  

• One Wales Medicines Process: a process coordinated by the AWTTC when a group of patients might benefit from a medicine that isn’t routinely available.

Free of Charge Medicines

• In the absence of, or whilst awaiting publication of health technology assessment advice, some pharmaceutical companies may wish to offer NHS Wales a free of charge medicine supply agreement to enable patients and clinicians access to a medicine at no cost.

• AWTTC guidance on free of charge medicine supply is currently being reviewed.

Individual Patient Funding Requests

• If a patient and their clinician agree that a medicine that isn’t routinely available would benefit the patient, their clinician can submit an Individual Patient Funding Request (IPFR) asking the health board, or NHS Wales Joint Commissioning Committee (NWJCC) to fund the medicine.
   
• Each health board and NWJCC has an IPFR panel of healthcare professionals and lay members who will meet to consider each application and decide whether to fund the medicine for that patient. 

One Wales Medicines Process

• The One Wales Medicines Process can be used for the consideration of using medicines that aren’t routinely available across all of Wales, including unlicensed or off-label medicine.
  
  
• One Wales can be used for medicines when: 
  
  • the medicine’s licence holder commits to a future HTA of a licensed medicine; 
  • the MHRA has not licensed a medicine; 
  • the MHRA has 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.
    
    
• The process results in a decision that applies to all of Wales. If a medicine gets a positive One Wales recommendation, if considered appropriate, it can then be prescribed for patients across Wales. 
  
  
• AWTTC regularly collects and analyses data from 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 panels, healthcare professionals through their clinical networks and committees in Wales can ask AWTTC to consider medicines for the One Wales Medicines process. 

One Wales Medicines Recommendations

• AWMSG’s Steering Committee decides whether a medicine will be assessed by the One Wales Medicines process.
  
  

• The One Wales Medicines Advisory Group (OWMAG) assesses the evidence and provides a recommendation on the use of the medicine to AWMSG. If AWMSG endorses the recommendation and it is subsequently ratified by Welsh Government, the decision applies across NHS Wales. 

• One Wales recommendations can only be prescribed when confirmation of ministerial ratification has been disseminated to the NHS, and the advice is published.
  
  

• 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.
  
  

• 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 the One Wales Medicines process must monitor and collect patient outcomes.

All Wales Drug Contracting Committee (AWDCC)

• The All Wales Drug Contracting Committee (AWDCC) awards all the hospital medicines contracts in Wales.
  
  
• The committee ensure that contracts meet all legal and governance requirements under the public procurement regulations, and also includes commercial agreements for new medicines, or medicines licensed for new indications, that NICE or AWMSG have assessed. The AWDCC Chair will agree any commercial agreements that are part of an HTA, including agreements under an MAA, and make sure the agreements meet all governance requirements.
  
  
• The AWDCC Chair also makes sure that all organisations in NHS Wales can obtain the medicine for their local population at the same time and at the same cost.

Primary Care Rebate Schemes

• Primary care rebate schemes are contractual arrangements offered by pharmaceutical companies, which offer financial rebates on GP prescribing expenditure for particular branded medicine(s). Individual schemes will be implemented by multiple Health Boards and so there are considerable opportunities to benefit from economies of scale by adopting an All Wales approach.
  

• The AWDCC advise Chief Pharmacists whether, or not, an individual proposal is suitable for adoption on a One Wales basis.
  

• Any rebate scheme must be compatible with the effective, efficient and economic use of NHS resources.

VPAG in Wales

• The Voluntary Scheme is an agreement between the UK government, the NHS and the pharmaceutical industry.

VPAG Health Technology Assessment Programme in Wales

• The AWTTC is leading the delivery of the VPAG Investment Programme’s Health Technology Assessment (HTA) programme in Wales. This national programme aims to ensure patients in Wales benefit from faster access to new and effective treatments, while supporting the NHS to make informed, sustainable decisions about medicines. The centre co-ordinates delivery through four projects:
  
  
  • Horizon scanning and financial forecasting: A once-for-Wales horizon scanning service providing early intelligence on emerging medicines to support timely access, financial planning and NHS service preparedness.
  • Medicines ecosystem: A redesigned, evidence-based medicines assessment system that modernises access decisions in Wales and aligns with UK innovation and appraisal pathways.
  • Implementation: A delivery-focused programme ensuring new medicines are adopted consistently and transparently across NHS Wales through strengthened governance and commercial arrangements.
  • Unlocking data: A data-driven initiative connecting and analysing medicines datasets to reduce unwarranted variation and improve planning, access and patient outcomes across Wales.
    
    
• Many of AWTTC’s objectives in it’s 2025-2028 plan are impacted by VPAG.