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  • Question on Consultation

    Is the proposed process for updating and withdrawing the TAs appropriate to achieve useful and usable guidance?

  • Question on Consultation

    Is the proposed process sufficiently clear? Are further details of the proposed process required by stakeholders?

  • Question on Consultation

    Should NICE consider adapting other elements of the proposed process to achieve more useful and usable guidance?

  • Question on Consultation

    Do you have any other comments on the proposed process for updating the TAs within the proportionate decision-making process?

  • Question on Consultation

    Would it be challenging to implement of any of the recommendations for the updated TAs? Please say why and for whom, and how these could be mitigated.

  • Question on Consultation

    Would implementation of any of the recommendations have significant cost implications?

Review proposal of TA388, TA679, TA773

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Proposed process statements and updates to the recommendations

We propose that an update of the technology appraisal guidance should be planned into the appraisal work programme. The update would be conducted through a new, proportionate decision-making process. NICE considers that it is appropriate to update the technology appraisals via a proportionate process because:

  1. NICE health technology evaluations: the manual states that "guidance can be updated…within another guidance-producing centre (for example in a NICE guideline)"

  2. The NICE Centre for Guidelines has recently updated recommendations on treating people with newly diagnosed and pre-existing heart failure with reduced ejection fraction and mildly reduced or preserved ejection fraction within NICE guideline 106 (NG106).

  3. The scope of the evaluation conducted to update NG106 is similar to the scope of the relevant technology appraisals. This includes a similar decision problem, reference case and evidence base. So, NICE considers that it is likely that the technology appraisal committee will be able to make a decision whether to update the technology appraisals on the basis of the evidence assessed by the guideline committee.

The proposed pilot decision-making process is designed to test this assumption, and to avoid duplication of the extensive work conducted by the guideline committee.

A summary of the new proposed process is:

  1. This draft surveillance review proposal will be used as the basis for a decision on whether the guidance should be amended, updated, withdrawn or not updated. This draft surveillance review proposal will outline. The proposed process statement for updating the technology appraisals.

  2. NICE has agreed to consult on this proposal. The consultation period will be 28 days and consultation will be open to consultees and commentators, as specified in the draft stakeholder list.

  3. This is a consultation on the proposed process for updating TA388, TA679 and TA773. It is not a consultation on the proposed updated recommendations for these appraisals.

  4. This proposed process for updating the technology appraisals is part of the Whole Lifecycle Approach work programme outlined in the NHS 10 year plan. The proposed process will only apply to the reviews of TA388, TA679 and TA773.

Proposed process statements for updating the technology appraisals

  1. Principle 13 of our principles that guide the development of NICE guidance and standards states that NICE should assess the need to update our recommendations in line with new evidence. NICE health technology evaluations: the manual states that:

    1. Guidance will be updated by the committee if there are changes to the evidence base, clinical pathway or economic case that are likely to have a material effect on the recommendations.

    2. Guidance can be updated within another guidance-producing centre (for example in a NICE guideline).

    3. Guidance will be permanently or temporarily withdrawn if the changes to the technology or the care pathway are such that the original guidance cannot be updated.

The pilot proportionate decision-making process is distinct from the surveillance decision options outlined in section 8.2 of NICE health technology evaluations: the manual. However, it is aligned with the principles stated in the manual of updating guidance based on work conducted within another guidance-producing centre.

  1. The NICE Centre for Guidelines has recently conducted a partial update of NICE guideline 106 (NG106) Chronic heart failure in adults: diagnosis and management. NICE updated recommendations on treating people with newly diagnosed and pre-existing heart failure with reduced ejection fraction and mildly reduced or preserved ejection fraction. The update published on 3rd September 2025.

  2. The final guideline for NG106 changes the clinical pathway for treating heart failure in adults based on an updated evidence base and earlier use of combinations of therapies.

  3. NICE proposes that the following technology appraisals should be updated:

  4. TA388: Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction

  5. TA773: Empagliflozin for treating chronic heart failure with reduced ejection fraction

The proposed draft recommendations will align with the recommendations made by the committee updating NG106.

  1. NICE will not charge the manufacturers of the products covered by the TAs for the proposed updates.

  2. NICE proposes withdrawing the TA for dapagliflozin (TA679) Generic dapagliflozin is now available in England because dapagliflozin is no longer under patent. NICE does not consider it appropriate to routinely update TAs for medicines that are no longer under patent. This is because the funding mandate is designed to drive uptake and adoption for medicines at the start of their guidance lifecycle. It is expected that well-established medicines will continue to be used in the NHS without the funding mandate. Therefore, considering the direction of the Whole Lifecycle Approach strategy, it would not be appropriate to update dapagliflozin in line with the other medicines in this review.

  3. Following consultation on this draft surveillance review proposal, the proposed updates to the TAs will be reviewed by a subset of committee members:

  4. NICE technology appraisal committee chair and vice chair

  5. NICE chronic heart failure in adults: diagnosis and management guideline committee chair and topic adviser

The committee decisions will be based on a consensus decision from the subset of committee members.

  1. For the proposed proportionate decision-making process, the subset of the committee will review the decision made by the guideline committee and the proposed updates to the recommendations. They will be able to make a recommendation outside of a full committee meeting and no stakeholders will be asked to attend a meeting. This is similar to the process set out in sections 5.8.23 to 5.8.27 of NICE health technology evaluations: the manual (Committee decisions outside of formal meetings).

  2. If the need arises, experts or other members of the NICE committees may be invited to contribute on a case-by-case basis. This will be if, in the opinion of the subset of committee or the NICE team, they are needed to address specific questions.

  3. The subset of committee will be asked to consider the following questions when considering whether they are able to make a recommendation to update the TAs (TA388 and TA773):

  4. Is the update to guideline NG106 a suitable basis on which to make the decision to update the TAs?

  5. Are there any uncertainties associated with updating the TAs to align with NG106? 

  6. If the subset of committee is able to make a recommendation to update the TAs (TA388 and TA773) in line with the updates to the NICE guideline, the recommendations will be updated and final draft guidance (subject to fact checking and appeal) will be published on the NICE website.

  7. The funding mandate will apply to the recommendation in the updated TA.

  8. The previous final guidance document and associated evidence will be archived.

  9. If the subset of committee considers that it is appropriate to withdraw the TA (TA679), this will be archived.

  10. If the subset of committee concludes that it cannot make a recommendation in line with the draft updates to the NICE guideline (NG106), as outlined in this draft surveillance review proposal, NICE will consider alternative approaches to updating the TAs. This may include making no changes to the TAs, withdrawing the TAs or rerouting to the standard process.

Marketing authorisation indication

The marketing authorisations for sacubitril valsartan, dapagliflozin and empagliflozin are reported in Table 2.

Table 2: Marketing authorisation indication

Treatment

Indication

Sacubitril valsartan

Adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction

Dapagliflozin

Adults for the treatment of symptomatic chronic heart failure

Empagliflozin

Adults for the treatment of symptomatic chronic heart failure

Questions for consultation

Is the proposed process for updating and withdrawing the TAs appropriate to achieve useful and usable guidance?

Is the proposed process sufficiently clear? Are further details of the proposed process required by stakeholders?

Should NICE consider adapting other elements of the proposed process to achieve more useful and usable guidance?

Do you have any other comments on the proposed process for updating the TAs within the proportionate decision-making process?

Would it be challenging to implement of any of the draft recommendations for the updated TAs? Please say why and for whom, and how these could be mitigated.

Would implementation of any of the draft recommendations have significant cost implications?

NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others.  Please let us know if you think that the proposal may need changing in order to meet these aims. In particular, please tell us if the proposed remit and scope: 

  • could exclude from full consideration any people protected by the equality legislation who fall within the patient population for which the treatments are licensed;

  • could lead to recommendations that have a different impact on people protected by the equality legislation than on the wider population, e.g. by making it more difficult in practice for a specific group to access the technology;

  • could have any adverse impact on people with a particular disability or disabilities. 

Please tell us what evidence should be obtained to enable the committee to identify and consider such impacts.