Patient access schemes and the NICE Patient Access Liaison Unit
When assessing new drugs and treatments - to decide whether they represent good value for the NHS - NICE looks at evidence on how well the treatment works compared with available alternatives, and the cost of treatment.
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 special ways Pharmaceutical companies can propose to enable patients to gain access to high costs drugs.
The Patient Access Scheme Liaison Unit (PASLU) has been set up by NICE to work with manufacturers who are considering a patient access scheme for their drug or treatment. The Patient Access Scheme Liaison Unit (PASLU) looks at the proposal made by the manufacturer to see if it is a scheme that would work in the NHS.
Patient access schemes (PASs)
The Pharmaceutical Price Regulation Scheme 2014 makes provisions for manufacturers and sponsors to submit proposals for patient access schemes to the Department of Health. 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 manufacturers and sponsors.
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 schemes proposals and produces guidance to the Department of Health. Patient access scheme proposals are assessed against the principles laid out in the Pharmaceutical Price Regulation Scheme 2014.
Manufacturers and/or sponsors may submit a patient access scheme proposal for any technology going through the NICE single or multiple technology appraisal processes.
Patient access scheme application process
Manufacturers or sponsors of a technology wishing to put forward a patient access scheme must have an initial discussion about their intention to submit a patient access scheme proposal with the Department of Health.
The manufacturers or sponsors should then complete the patient access scheme proposal template. 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 manufacturer or sponsor completes the proposal template and then submits it to the Department of Health (with any supporting documents) who will then forward to PASLU for review.
- Template for the PASLU proposal template standard scheme
- Template for the PASLU proposal template simple scheme
PASLU review process
Manufacturers and sponsors submitting applications should read the process guidance process guidance that describes how PASLU evaluates patient access scheme proposals and the points at which manufacturers and sponsors have opportunities to:
- provide clarification with respect to the contents of the patient access schemes proposal and
- read and comment on the draft advice to the Department of Health
Patient access scheme proposals will be assessed by the Expert Panel at a scheduled monthly meeting. Applications will be considered at a meeting of the Panel a minimum of 8 weeks following their receipt by PASLU. PASLU will submit its advice to the Department of Health within 4 weeks of the Expert Panel meeting.
For more information on patient access schemes please contact the PASLU team.