A patient access scheme is a way to make expensive medicines more affordable for patients and the healthcare system.
We aim to improve cost-effectiveness and enable patients to gain access to high cost drugs and treatments.
What are patient access schemes?
If pharmaceutical company is unable to set an NHS list price that would be considered cost-effective, they can provide a simple confidential discount, via a Patient Access Scheme (PAS). This is the preferred way of providing a cost-effective price to the NHS.
Simple PAS is confidential, and gives a fixed or percentage discount off the list price applied at source. These are the preferred option as they need less monitoring, and are easier to manage for NHS organisations.
Complex PAS use detailed reimbursement proposals that are non-confidential. The requirement for transparency is to ensure the administrative burden and cost to the service of implementing such schemes is minimised. It helps ensure the value of the treatment, as determined by NICE, is achieved.
Unless companies are using the list price, they should include an approved PAS in their initial evidence submission. This allows enough time for full consideration in the committee meeting.
More information about using our evidence base tools
How to propose a patient access scheme
Companies who want to propose a patient access scheme should follow these steps:
- Review the procedure for the review of patient access scheme proposals (PDF), which explains:
- how we evaluate schemes
- when companies may provide clarification on proposal content
- how to check for factual errors in advice to NHSE.
- Contact us to discuss your intent to submit a scheme.
- Complete the appropriate proposal template, either for a complex scheme or a simple discount scheme:
- Submit the completed proposal template and any supporting documents to NHS England and send a copy to us. After conducting their own checks NHSE will formally refer it to us for review.
How to propose a change to an existing scheme
Companies who want to change an existing patient access scheme should:
- Complete the simple discount change request form (Word).
- Submit the completed form to NHSE and the commercial liaison team.
How we assess patient access schemes
We coordinate the review and evaluation of patient access scheme proposals, issuing advice to NHS England to determine suitability for the NHS.
The criteria and processes used for the assessment of simple confidential and complex published patient access schemes for new products are as outlined in:
The proposal review process
Complex schemes
Complex schemes include:
- outcomes-based dose caps
- rebates
- upfront free stock.
The complexity of these schemes means that the review involves a high level of consultation with the NHS. This includes a panel of experts from the NHS reviewing the proposals.
- A minimum of 8 weeks after we’ve received the application: the expert panel will meet to consider if the scheme is feasible to implement.
- Within 4 weeks of the expert panel meeting: we aim to submit our advice to NHSE.
- There is 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, the review involves a lower level of consultation with the NHS.
- Fast track proposals will be completed within 10 working days where companies meet the relevant requirements.
- Where companies do not meet these requirements, a simple discount proposal review will take a minimum of 4 weeks.
These timings are for formal referral from and issuance of our final advice to NHS England.
NHS England's review of our advice, and their final decision on the proposal have separate timings.
Other services
We can also support you in the following areas:
- identifying complex commercial challenges
- commercial briefings
- budget impact tests.
The team brings together pharmaceutical companies, NHS England and NICE to deliver streamlined evaluations, ensure cost-effective solutions, and maximise patient access to life-changing treatments.
This drives innovation and access.
Our goal
Our goal is to streamline the appraisal process and reduce delays. We do this by:
- encouraging the early submission of simple discount patient access schemes
- identifying topics early where simple patient access scheme options may be exhausted, prompting engagement between NHS England and companies
- supporting negotiations when NHS England offers them
- managing the budget impact test process.
We follow the principles outlined in the NHS commercial framework for new medicines.