The Patient Access Schemes Liaison Unit (PASLU) works with companies who are considering a patient access scheme for their drug or treatment.
Patient access schemes are innovative pricing agreements proposed by pharmaceutical companies. They aim to improve cost-effectiveness and enable patients to gain access to high cost drugs and treatments.
Companies may submit a patient access scheme proposal for any technology going through the NICE appraisal process. We will look at the proposal to see if it is a scheme that would work in the NHS.
How we assess schemes
The Patient Access Schemes Liaison Unit is part of our Centre for Health Technology Evaluation. It was set up when the Department of Health asked NICE to advise on the feasibility of patient access scheme proposals from companies.
We coordinate the review and evaluation of patient access scheme proposals and issue advice to NHS England and NHS Improvement (NHSE&I). When assessing new drugs and treatments, we look at:
- what they cost
- how well they work, compared to the available alternatives
- whether they represent good value for the NHS.
Drugs or treatments that are expensive and do not have a significant benefit over existing treatments are unlikely to be approved for use in the NHS.
Patient access scheme proposals are assessed against the principles laid out in the 2014 Pharmaceutical Price Regulation Scheme (PPRS). This makes provisions for companies to submit proposals for patient access schemes to NHSE&I.
How to propose a scheme
Companies who want to propose a patient access scheme should:
- Contact us for an initial discussion about your intention to submit a scheme.
- Complete the proposal template, either for a complex scheme or simple discount scheme.
- Submit the completed proposal template and any supporting documents to NHSE&I, who will forward it to us for review.
The template helps us to collect the information required to assess whether the proposed scheme is feasible within the NHS in England and Wales.
Voluntary scheme for branded medicines pricing and access
The Voluntary Scheme for Branded Medicines Pricing and Access (VS) was introduced in January 2019. This will replace the 2014 Pharmaceutical Price Regulation Scheme (PPRS).
During the transition period, simple confidential and complex patient access schemes will continue to operate and be available for new products using existing processes. Please see paragraph 3.28 of the 2019 VS.
They will operate in accordance with the criteria and terms set out in the 2014 PPRS, and guidance on our website.
New commercial framework
Once NHSE&I establishes the commercial framework, any new commercial flexibilities similar to simple confidential and complex patient access schemes will operate in accordance with the new commercial framework. Please see paragraph 3.26 of the 2019 VS.
The proposal review process
For both types of scheme, companies submitting applications should read the procedure for the review of patient access scheme proposals (PDF).
The process guide describes:
- how the Patient Access Schemes Liaison Unit evaluates patient access scheme proposals
- when companies can provide clarification about the contents of the proposal and check for any factual errors in the advice to NHSE&I.
Complex schemes include:
- outcomes-based dose caps
- upfront free stock.
The complexity of these schemes means that the review involves a high level of consultation with the NHS.
The expert panel will meet a minimum of 8 weeks after our receipt of the application and will consider if the scheme is feasible to implement within the NHS in England and Wales.
We will usually submit our advice to NHSE&I within 4 weeks of the expert panel meeting, with a total review period of at least 12 weeks.
Simple discount schemes
Simple discount schemes can be either:
- a fixed pricing agreement that is lower than the list price of the treatment
- a percentage discount from the list price.
As these schemes are less complex and easier to implement than complex schemes, the review involves a lower level of consultation with the NHS.
As a result the review can be conducted rapidly, usually within 4 weeks.
Reviewing operational schemes
We are developing a process to review all operational patient access schemes currently used within the NHS.
This process started in April 2017 and a review of each scheme will occur approximately every 12 months.
We will contact pharmaceutical companies as their patient access scheme reviews are scheduled for each drug.