Managed access gives people faster access to promising new treatments.
Otherwise, they might not be recommended because of uncertainties about their clinical or cost effectiveness.
It also helps ensure value for money for taxpayers, and offers companies a route to NHS funding for treatments that are likely to be cost effective.
During managed access, more evidence is collected to address any uncertainties about a treatment using a managed access agreement. We then use this evidence to assess whether the treatment should be made available for routine use on the NHS.
Treatments in managed access
Atezolizumab for adjuvant treatment of resected non-small-cell lung cancer
Autologous anti-CD19-transduced CD3+ cells for treating relapsed or refractory mantle cell lymphoma
Avelumab with axitinib for untreated advanced renal cell carcinoma
Cerliponase alfa for treating neuronal ceroid lipofuscinosis type 2
Crizanlizumab for preventing sickle cell crises in sickle cell disease
Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
Entrectinib for treating NTRK fusion-positive solid tumours
Fedratinib for treating disease-related splenomegaly or symptoms in myelofibrosis
Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
Larotrectinib for treating NTRK fusion-positive solid tumours
Nusinersen for treating spinal muscular atrophy
Pembrolizumab for treating relapsed or refractory classical Hodgkin's lymphoma
Risdiplam for treating spinal muscular atrophy
Selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer
Selpercatinib for untreated RET fusion-positive advanced non-small-cell lung cancer
Selpercatinib for treating advanced thyroid cancer with RET alterations
Sotorasib for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer
Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia
What is a managed access agreement?
When we recommend a treatment with managed access, NHS England and the company responsible for the treatment 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 treatment
- 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 treatment
- types of clinical assessments
- data to be collected and analysed.
For an example of a template data collection agreement, see NICE's technology appraisal guidance on fedratinib.
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 treatment. 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 clinicians.
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 treatment until the end date specified in the managed access agreement. After this, we update the guidance and decide whether to recommend the treatment for routine use in the NHS.
If the evidence shows that the treatment is not a cost-effective use of NHS resources, it will not be recommended.
How are treatments in managed access paid for?
There are 2 dedicated funding sources to pay for treatments in managed access, each has an annual budget of £340 million:
Are treatments in managed access safe?
Yes, we publish guidance for treatments that have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA only licenses treatments that it has assessed as being safe.
Making a managed access proposal
Companies can submit a proposal for managed access as part of its submission to NICE. For more information, see NICE's health technology evaluations manual on process and methods.
Companies can get information and advice about managed access through our NICE Advice service or during the Innovative Licensing and Access Pathway. NICE’s Scientific Advice can also provide input.
These services are independent of our guidance-producing programmes.