Patient access schemes and the NICE Patient Access Liaison Unit
When assessing new drugs and treatments, NICE looks at the cost of the treatment and the evidence on how well the treatment works in comparison with the available alternatives. NICE then decides 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 by NICE for use in the NHS.
Patient access schemes are pricing agreements proposed by pharmaceutical companies to enable patients to gain access to these high costs drugs.
The Patient Access Scheme Liaison Unit (PASLU) has been set up by NICE to work with companies who are considering a patient access scheme for their drug or treatment. PASLU looks at the proposal made by the company to see if it is a scheme that would work in the NHS.
Patient access schemes (PASs)
The Pharmaceutical Price Regulation Scheme 2014 (PPRS) makes provisions for companies to submit proposals for patient access schemes to NHS England. These schemes involve innovative pricing agreements designed to improve cost effectiveness and facilitate patient access to specific drugs or other technologies.
NICE was commissioned by the Department of Health to set up the PASLU to advise on the feasibility of patient access scheme proposals from companies.
Patient Access Scheme Liaison Unit (PASLU)
PASLU is the part of the NICE Centre for Health Technology Evaluation that coordinates the review and evaluation of patient access scheme proposals and issues advice to NHS England. Patient access scheme proposals are assessed against the principles laid out in the PPRS 2014.
Companies may submit a patient access scheme proposal for any technology going through the NICE appraisal process.
Patient access scheme application process
Companies wishing to put forward a patient access scheme must have an initial discussion about their intention to submit a scheme.
The company should then complete the patient access scheme proposal template - either for a complex scheme or a simple discount scheme. The template is the tool PASLU uses to collect the information required to assess whether the proposed patient access scheme is feasible within the NHS in England and Wales. The company completes the proposal template and then submits it to NHS England (with any supporting documents) who will then forward to PASLU for review.
PAS proposal review process
Simple discount schemes can be either a fixed pricing agreement that is lower than the list price of the treatment, or a percentage discount from the list price. As these schemes are of lower complexity and are easier to implement in the NHS (when compared with complex schemes), the review by PASLU can be taken forward with a lower level of consultation with the NHS. As a result the review can be conducted rapidly by PASLU usually within 4 weeks.
Complex schemes include outcomes based dose caps, rebates and upfront free stock. Due to the complexity of these schemes, the review by PASLU must be taken forward with a higher level of consultation with the NHS. The PASLU expert panel will meet a minimum of 8 weeks following receipt of the application to PASLU and will consider if the scheme is feasible to implement within the NHS in England and Wales. PASLU will submit its advice to NHS England usually within 4 weeks of the expert panel meeting, with a total review period of at least 12 weeks.
For both types of scheme, companies submitting applications should read the process guidance that describes how PASLU evaluates patient access scheme proposals and the points at which companies have opportunities to provide clarification with respect to the contents of the patient access scheme proposal and check for any factual errors within the advice to NHS England.
Reviewing operational PAS
PASLU is developing a process to review all operational PAS currently used within the NHS. This process started in April 2017 and a review of each scheme will occur approximately every 12 months going forward. PASLU will contact pharmaceutical companies as their PAS reviews are scheduled for each drug.
For more information on patient access schemes please contact the PASLU team.