The Innovative Medicines Fund launched in June 2022 for any non-cancer medicine that NICE recommends with managed access.

Funding for medicines recommended with managed access via the Innovative Medicines Fund starts from the publication of NICE draft final guidance.

It is expected that managed access for non-cancer medicines will now be directed through the Innovative Medicines Fund.

Yes, any non-cancer medicine can be considered for managed access via the Innovative Medicines Fund. Companies should engage early with NICE to discuss whether their technology has the potential to be considered for a recommendation with managed access.

No. The ringfenced budget of £340m for the Cancer Drugs Fund will remain unchanged following the establishment of the Innovative Medicines Fund.

NICE will make recommendations for managed access for medicines that are evaluated via a Single Technology Appraisal, Highly Specialised Technology or a Multiple Technology Appraisal.

No, only the eligible patient population, as recommended by NICE, will receive treatments funded by the Innovative Medicines Fund.

No, an Innovation Passport is not be a pre-requisite for the Innovative Medicines Fund.

No. The primary function of the Innovative Medicines Fund is to operate as a managed access fund while evidential uncertainty is resolved in medicines that otherwise show significant clinical promise. Under these arrangements funding could be brought forward by up to five months, starting at the point NICE issues a draft positive final guidance.

Given the centrality of the NICE process to the Innovative Medicines Fund, it is highly unlikely that products that are not evaluated by NICE will gain entry into the Innovative Medicines Fund. NHSE retain the right to apply flexibility on a case-by-case basis.

As more topics are recommended for managed access, the complexity associated with new treatments becoming available will increase. Patients who have started on one treatment may want to switch to newer treatments – whether recommended for routine use or with managed access. NICE will work with all stakeholders (NHS England, company, patient organisations, clinicians and any other relevant parties) to consider what the clinical evidence says about the effectiveness of treatment switching and how it can be managed – e.g. by updating treatment eligibility criteria.

In all circumstances, guidance about treatment pathways and patient switching will be based on the clinical evidence to support clinical and patient decision-making about the most clinically appropriate treatment.

The NHS England commercial framework for new medicines sets out the engagement opportunities available for companies, including NICE Advice, the NHS England commercial surgery, and opportunity for direct discussions during the course of a NICE evaluation. This provides an opportunity for companies to consider the suitability and feasibility a recommendation with managed access.

Companies can engage with the Medicines and Healthcare Products Regulatory Agency (MHRA) and health technology agencies, including NICE, via the Innovative Licensing and Access Pathway.

NICE supports and facilitates activity at all stages of the managed access process:

• NICE can recommend, with managed access, any promising medicine, for a limited time, while further data is collected to resolve evidential uncertainty.
• During their evaluation, the NICE Managed Access Team will review the feasibility of data collection and whether it is likely to resolve evidential uncertainties. The NICE Committee will identify the uncertainties that prevent the medicine being routinely commissioned in the NHS and the data that could sufficiently resolve these uncertainties.
• During the managed access period, NICE facilitate arrangements that ensure the data collection and analytical outputs to be delivered by the analytical provider are on track.
• At the end of the data collection period, NICE start a new evaluation to update the guidance that determines whether the medicine can be recommended for routine use in the NHS.

This will vary, depending on the specific uncertainties identified by NICE. If there is an ongoing clinical trial, the data collection associated with that activity will continue.

For the purposes of the managed access data collection designed to resolve evidential uncertainty, additional data, over and above routine data collection, may be required.

To protect the identity of the patients involved, patient data is collected and stored within secure NHS databases, which are protected by NHS information governance approaches.

One of the benefits of early engagement between companies, NICE and NHS England is to enable options for data collection to be identified as soon as possible. This is especially important if there is no existing data collection, or if the existing data collection requires development.

Where there is no existing data collection, NICE will seek advice from clinicians, patient groups, academics and data custodians to facilitate the development of potential solutions for companies to consider.

NICE and NHS England horizon scanning will assist with the identification of potential data gaps ahead of a NICE evaluation.

Companies will be required to pay direct and associated managed access costs for:

• Database management – including data processing and quality assurance
• All costs related to the production of interim and final analyses and reports
• Costs associated with accessing and linking data to other sources (if applicable)
• Any other costs identified that are relevant to data collection and analysis associated with the uncertainties identified by the NICE committee

Considerations about the cost of data collection and analysis can be discussed during early conversations about the development of arrangements needed for the managed access agreement.

NICE and NHS England will continually assess the performance of managed access agreements delivered through the Innovative Medicines Fund. An interim review of a Data Collection Agreement may be conducted at a prescribed time point to confirm that the data collection is on track and delivering the analytical outputs required for the NICE guidance update. If the data required for the NICE guidance update is not being collected, the managed access agreement may be terminated early, if there is no way to address the issues with data collection.

The entire eligible patient population should have the opportunity to access medicines recommended for the Innovative Medicines Fund in the managed access period. Any eligible patient should have the option to receive therapy, if their clinician agrees this is an appropriate treatment choice. In all circumstances, NHS England and the manufacturer will jointly work together to ensure that eligible patients who wish to receive treatment can access it.

No, the Innovative Medicines Fund only funds the cost of the medicine.

Companies must provide an evidence submission to support a guidance update after a period of managed access. If the company does not make an evidence submission, NICE will withdraw the guidance. NICE will also host an engagement meeting with all stakeholders so the company can outline their reasons for not making a submission.

Any patients who have been prescribed the medicine during the time the medicine was in the Innovative Medicines Fund will continue to receive the medicine at the company’s cost until the patient and the treating clinician deems it appropriate to discontinue treatment and/or they meet a treatment stopping criteria (in line with NHS treatment continuation policies or company-sponsored free of charge schemes). Funding from the Innovative Medicines Fund will cease as soon as the guidance is terminated.