Varying the funding requirement for a health technology

After receiving submissions from the company and NHS England, NICE will assess the potential budget impact of the technology by estimating the net annual cost to the NHS (see NICE's assessing resource impact process manual ).

Where submissions have been received from both the company and NHS England, NICE will also share the initial company budget impact test submission with NHS England. Conversely NICE will share any budget impact test submission from NHS England with the company.

NICE will share a draft budget impact test with the company and NHS England, normally within 21 days after receiving the company submission.

NHS England and the company will have 14 days to comment on the draft budget impact test.

NICE will update and finalise the budget impact test within 14 days of receiving any additional information and re-issue a final budget impact test to NHS England and the company.

Within 7 days after receiving the final net budget impact estimate, NHS England must inform NICE whether it intends to have a commercial discussion with the company. This will allow NICE to plan for potential changes to the timelines of a technology evaluation.

If there remains a material difference of opinion between NHS England, the company and the NICE budget impact test, details will be submitted to the NICE executive team for resolution. NHS England and the company will be informed of progression to this step, and anticipated timelines for the decision.

NHS England and the company will be informed of the final decision within 7 days of NICE's executive team discussion. The budget impact test approved by NICE's executive team will be used for commercial negotiations and if NHS England requests any variation to the funding requirement.

Four weeks before the first committee meeting, NICE will ask NHS England if they anticipate a potential funding variation request for a full population recommendation. If NHS England indicate a funding variation may be needed, it should provide:

• The potential length of the funding variation.

• Justification for the potential funding variation, including if applicable:

  • the staff training required

  • the health service infrastructure changes required

  • the health service resources required

  • why the technology is not yet available in England.

• Any anticipated impact on patients who would be eligible for treatment under the guidance, but whose treatment would be delayed because of the potential funding variation, with consideration to NHS England's and NICE's responsibilities under equalities legislation.

At this stage, NICE will present the information provided to NICE's guidance executive and liaise with the relevant teams to prepare for a potential full funding variation submission.

If NHS England anticipates that a potential funding variation request would be 12 months or less, NICE's guidance executive will review the final funding variation submission, if submitted. If NHS England anticipates a potential funding variation request would be more than 12 months, NICE will notify the Funding Variation Advisory Group (FVAG). The FVAG will review the final funding variation request, if submitted, and provide a recommendation to NICE's guidance executive to support its decision making.

Any budget impact commercial discussion between the company and NHS England will be done in parallel with the evaluation timescales. NHS England must provide a progress update to NICE at least 14 days before the first committee meeting. Any budget impact commercial agreements confirmed at this point will be to specifically manage the net budget impact of the technology and will not be reviewed by the committee.

For a rapid review, cost-comparison and streamlined cost-utility, the time frame for the budget impact commercial discussion between the company and NHS England will be readjusted accordingly.

If the committee recommends the technology as an option or
for optimised use, NICE will update its assessment of the budget impact of the technology, when appropriate (see NICE's assessing resource impact process manual). NHS England and the company will be informed of the updated budget impact before the release of the final draft guidance and will have an opportunity for commercial engagement before final draft guidance is issued to stakeholders.

If the potential net budget impact is expected to significantly exceed £40 million per year in any of the first 3 financial years of a technology's use in the NHS, NICE may consider a request from NHS England to allow a pause after release of the final draft guidance to stakeholders before publication of the final guidance.

Requests will be considered on a case-by-case basis and must be received within 7 days of NHS England and the company being informed of the net budget impact.

If NHS England intends to apply for a variation to the funding requirement, it will submit a full request at the earliest opportunity, and no later than the end of the intention to appeal period. NICE will not usually accept a funding variation request that has not been signalled before the first committee meeting, as detailed in section 1.15.

If NICE receives both a funding variation request and an intention to appeal during the intention to appeal period (either from the same or different stakeholders), the appeals process will be paused while NICE considers the funding variation request.

NHS England can advise NICE that it may need to request a variation to the funding requirement. It can do this directly after receiving the estimate of the net budget impact at the evidence submission stage or at later stages in the evaluation. If NICE does not receive any correspondence regarding high-risk topics, it will contact NHS England 4 weeks before the committee meeting.

When requesting a variation to the funding requirement, NHS England should provide:

• The duration of, and the justification for, the proposed variation. This includes details of:

  • the staff training required, how it will be delivered and how long it will take

  • the health service infrastructure changes required, how the infrastructure will be changed and how long it will take

  • which health service resources are not in place, how they will be put in place and how long it will take

  • why the technology is not available in England and when it is expected to be available.

• The relevant provisions of any commercial arrangement reached with the company.

• In the case of a technology funded from the national specialised commissioning budgets, the amount and phasing of funding that will be made available and how this will be applied to patients eligible for treatment.

• In the case of technologies funded by integrated care boards, the direction NHS England intends to give about the phasing of funding during the deferred funding period.

• An assessment of the impact on patients who are eligible for treatment under the guidance, but whose treatment will be delayed because of the funding variation, with consideration to NHS England's and NICE's responsibilities under equalities legislation.

• Details of the interim commissioning policy that would be applied to phase in funding and to manage access to the technology during the extended funding variation period.

• Details of monitoring data that will be collected to demonstrate to NICE's guidance executive that the technology has moved into routine commissioning at the end of the funding variation period. This includes:

  • what data will be collected during the funding variation period and any restrictions on data sharing with NICE

  • how often the data will be reviewed and analysed

• how the data would inform adaptation to phased funding or an interim commissioning policy to ensure the technology moves into routine commissioning at the end of the funding variation period.

If the requested variation to the timescale for the funding requirement is 12 months or less, NICE will present the application for a variation to the funding requirement to NICE's guidance executive at the earliest opportunity.

If the requested variation to the timescale for the funding requirement is more than 12 months, NICE will present the application for a variation to the funding requirement to an FVAG at the earliest opportunity. The FVAG will provide a recommendation to NICE's guidance executive to support its decision making.

NICE's guidance executive (supported by the FVAG, as required) will decide whether it will vary the timescale for the funding requirement, taking into account whether:

• the budget impact test has been met

• all reasonable opportunities for reaching a commercial arrangement have been pursued

• the request is in proportion to the size of the budget impact

• the request takes account of the severity and acuity of the condition that the guidance relates to

• NHS England's and NICE's duties under equalities legislation have been considered

• an interim commissioning policy has been developed to provide phased funding for, and access to, the technology during the extended funding period

• implementation of the funding variation will be adequately monitored and data is being collected to ensure the technology moves into routine commissioning at the end of the funding variation period.

Regardless of the duration of the variation requested, all applications will need to contain proposals for a phased allocation of funding.

For technologies for which the budget impact test is met, NICE's guidance executive and the FVAG will consider applications to vary the funding requirement, normally for up to a maximum of 3 years.

Applications to vary the funding requirement are specific to each evaluation. But, NICE may consider new technologies for indications that already have recommended treatments with funding variations in place. In this circumstance, NICE will take into account the combined budget impact for both technologies when considering a funding variation for the second (and any subsequent) technology.

When NICE's guidance executive decides to vary the timescale for the funding requirement, NICE will share this decision with stakeholders, including NHS England and the Secretary of State for Health and Social Care. A 21-day consultation period will follow. The provisional decision will be published for information on the NICE website 7 days after the end of the consultation period.

Comments received during consultation from stakeholders will be presented to NICE's guidance executive and, if applicable, the FVAG to reach a final decision on the timescale for the funding requirement. NICE will publish the decision and comments received on the NICE website at the next appropriate step in the process.

The final draft guidance will be re-issued and will refer to the variation to the funding requirement (when appropriate) and be subject to an appeal period. Further information is available in NICE's guide to the technology appraisal and highly specialised technologies appeal process.

Annual reports (for funding variation periods more than 12 months) will be submitted by NHS England and presented to NICE's guidance executive. The report will be sent for information to the responsible Department of Health and Social Care team.

Annual reports are designed to be a standard method of reporting progress to NICE's guidance executive. It is not expected to place undue burden on the NHS. The annual reports should include (but are not limited to):

• status or percentage of sites up and running

• number of patients currently accessing the technology

• a timeline for national coverage or planned coverage in line with the request to vary the funding

• a brief updated financial analysis showing changes since the start of the funding variation period

• an clinical pathway updated with changes from the start of the funding variation period

• mitigation strategies and best practices for issues arising during treatment, learnt during the funding variation period.

The penultimate annual report should include a proposal for transition out of the funding variation period.

NICE's guidance executive will consider the following options for transition out of the funding variation period:

• The funding variation is formally stood down following a formal transition to routine commissioning, and the funding mandate now applies.

• NICE will consider if a review of the technology appraisal or an assessment via another mechanism (for example, Whole Lifecycle Approach or guideline update) is necessary. The re-review will not take place earlier than 3 years before the original technology appraisal publication date.