Managed access

During managed access, more evidence is collected to address any uncertainties about a medicine using a managed access agreement. We then use this evidence to assess whether the medicine should be made available for routine use on the NHS.

Managed access also helps ensure value for money for taxpayers, and offers companies a route to NHS funding for medicines that are likely to be cost effective.

Suitability and feasibility for managed access

Every medicine being evaluated in our technology appraisals or highly specialised technologies guidance programmes is assessed on its suitability for managed access.

This determines whether uncertainties could be resolved through additional evidence generation over a defined period. If a company submits a managed access proposal, a feasibility assessment based on the proposal will be produced, which can provide guidance on:

• managed access eligibility

• whether data collection is feasible and could resolve key uncertainties

• whether data collection would add undue burden for patients or the health system

• potential barriers to managed access.

Making a managed access proposal

All companies have the option to submit a managed access proposal to NICE, which informs these feasibility assessments and subsequent appraisal decisions. For more information, read NICE's health technology evaluations manual on process and methods.

These services are independent of our guidance-producing programmes.

You can get more information and advice about managed access through our NICE Advice service or during the Innovative Licensing and Access Pathway.

What is a managed access agreement?

When we recommend a medicine with managed access, NHS England and the company responsible for the medicine develop a managed access agreement.

This is a time-limited agreement that sets out:

• the conditions under which people will be able to have NHS-funded medicine

• how data will be collected to address the uncertainties in the clinical- or cost-effectiveness data.

What does a managed access agreement consist of?

Managed access agreements consist of 2 elements:

A data collection agreement

We develop this agreement with stakeholders. It lasts for the shortest amount of time needed to collect enough data to address any uncertainties, up to a maximum of 5 years. It sets out:

• the roles and responsibilities of all stakeholders

• the patient population eligible for the medicine

• types of clinical assessments

• data to be collected and analysed.

A commercial access agreement

This agreement is between NHS England and the company. It lays out the commercial terms on which the NHS will fund the medicine. It also ensures that any identified uncertainties are mitigated against during managed access.

What happens during managed access?

As evidence is collected, managed access oversight groups meet regularly to check the quality and quantity of the data, and to discuss:

• the progress of data collection

• plans for analysis

• access or treatment service issues

• any issues that occur during clinical assessment

• any safety issues signalled by patients and health and care professionals.

Membership of these groups is decided on a case by case basis, depending on how much data needs to be collected in clinical practice, and might include:

• NICE and NHS England employees, clinicians and clinical experts

• representatives from patient organisations

• representatives from the company that manufactures the treatment

• members of NHS data custodians that collect and analyse data as part of the managed access agreement.

What happens at the end of managed access?

Evidence is collected on the medicine until the end date specified in the managed access agreement. After this, we update the guidance and decide whether to recommend the medicine for routine use in the NHS.

If the evidence shows that the medicine is not a cost-effective use of NHS resources, it will not be recommended.

How are medicines in managed access paid for?

There are 2 dedicated funding sources to pay for medicines in managed access, each has an annual budget of £340 million:

• NHS England's Cancer Drugs Fund

• NHS England's Innovative Medicines Fund.

Are medicines in managed access safe?

Yes, we publish guidance for medicines that have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA only licenses medicines that it has assessed as being safe.