Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction

  • Technology appraisal guidance
  • TA388
  • Published: 
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5 How to implement the guidance

Clinicians' experiences have been used to develop practical suggestions on how to implement the NICE technology appraisal guidance on sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. Local organisations will need to assess the applicability of the learning from the examples of current practice, taking into consideration the time, resources, clinical factors and costs of an implementation programme.[4]

Project management

This technology can be best adopted using a project management approach. NICE has produced the into practice guide which includes a section on what organisations need to have in place to support the implementation of NICE guidance in this way.

Implementation group

The first step is to form an implementation group that will advise on the technology and manage any changes in practice. When establishing this group, consider:

  • establishing the geographical area of the working group

  • patient flows and pathways

  • whether the group may be specific to an individual NHS organisation or may work across a region, such as a cardiovascular network

  • making use of already established heart failure groups or prescribing liaison groups.

In order to implement this guidance in an effective and sustainable way, contributors to this resource suggested the following membership of the team:

  • Clinical champion(s): could be a senior clinician with an interest in heart failure (consultant cardiologist). They should have the relevant knowledge and understanding to be able to drive the project, answer any clinical queries and champion implementation at a senior level.

  • Commissioning lead(s): perhaps the chronic conditions lead and or local commissioning pharmacist. They will have the responsibility for assessing the cost impact on the drugs budget and existing heart failure services, liaising with the CCG board, raising awareness in primary care about the introduction of this new medication and agreeing reallocation or additional resource.

  • Other stakeholders or staff, which may include:

    • consultant cardiologists with an interest in heart failure from each of the prescribing centres (where the group is regional), including local hospitals

    • heart failure specialist nurses

    • GPs including those with a special interest in cardiology

    • cardiac pharmacists or community pharmacists representing the regional pharmacy committee, joint formulary group or local prescribing committee, or local medical committees

    • community providers of heart failure services

    • patient groups.

Direct membership from all stakeholders may not be needed, but contributors' experience suggests that clear communication, engagement and agreement between all stakeholders is important for successful implementation.

Early questions that the team may wish to consider are:

  • What will be the cost impact of implementing this guidance in our area?

  • Who within our area can prescribe this drug?

  • How will patients be referred for consideration of this drug?

  • How will we ensure patients started on this drug are titrated and monitored appropriately?

  • What communications systems do we need to set up to ensure that patients' GPs and other clinical staff are aware of patients having this drug and the potential side effects?

Care pathway mapping

Sites planning implementation of this guidance acknowledged that several factors would need to be considered and agreed locally between stakeholders:

  • Local referral pathways for patients who are not currently under the direct care of the specialist heart failure service.

  • Capacity of the heart failure team to manage a potential increase in referrals.

  • How consideration and initiation of the drug will fit in with current care pathways for people with heart failure.

  • Clarifying responsibilities, perhaps through shared care agreements for:

    • assessing and counselling people being considered for treatment

    • initiating treatment and informing relevant healthcare professionals that the patient is taking this drug

    • providing titration and associated monitoring

    • ongoing prescription and follow-up once the patient is established.

Several models of care are being considered by the sites that contributed to this resource.

Assessing, counselling and initiation

  • Develop patient information in line with the NICE guideline on medicines optimisation. Ensure that healthcare professionals can share information with patients about:

    • potential risks and benefits of changing (because this drug is recommended for people on a stable dose of ACE inhibitors or ARBs, some patients may be unsure or unhappy to change their current regimen)

    • what procedure to undertake for the washout period

    • provision of any relevant alert cards

    • reporting of side effects for the yellow card scheme.

  • Identify those responsible. This may be a consultant cardiologist or secondary care heart failure nurse specialists under the guidance of the consultant cardiologist. Consider planning for the heart failure nurse specialist with prescribing qualifications to take over initial prescribing once the team feels more experienced in prescribing the drug.

  • Develop systems for ensuring an appropriate washout period for ACE inhibitors. The electronic medicines compendium states that sacubitril valsartan must not be started until at least 36 hours after taking the last dose of ACE inhibitor therapy. After the prescription for sacubitril valsartan has been issued and collected, patients could return to clinic to take the initial dose under the supervision of the heart failure nurse specialist (or other heart failure specialist) who can confirm if the washout period has been adhered to. Experts considered a 48-hour washout period to be practical. ARB treatment should also be stopped, but a washout period is not stipulated.

  • See the complementary example checklist for details of factors to consider when commencing sacubitril valsartan.

Titration and associated monitoring

  • Establish responsibility for monitoring and drug titration. The guidance recommends this should be done by the most appropriate team member (of the specialist multidisciplinary heart failure team), as defined in NICE's guideline on chronic heart failure in adults: management. At the initial stage of implementation this is likely to be the specialist heart failure clinic. Review the patient 2 weeks after drug initiation at either a consultant or heart failure nurse clinic for assessment of renal function through blood results (which would have been taken before the appointment), blood pressure and patient-reported tolerance and, if appropriate, increase to maximum dose. Following the increase to maximum dose, review patients 2 weeks later to check blood results, blood pressure and patient-reported tolerance.

Ongoing prescription and follow-up

  • Establish a locally agreed period over which the specialist heart failure team will provide the prescription, and when the ongoing prescribing will be handed over to primary care. Agreements ranged from 1 month to 3 months after initiation. The agreement for ongoing prescribing in primary care was seen as essential for effective implementation.

  • Following stabilisation on a maximum tolerated dose, patients are monitored at least 6-monthly (if appropriate to clinical status). Depending upon current local pathways and patient suitability, this may be in primary care.

Patient selection

This guidance does not recommend sacubitril valsartan for all people with reduced ejection fraction. Before starting sacubitril valsartan it is anticipated that patients would be having care in line with current practice. See the complementary example checklist for details of factors to consider when starting sacubitril valsartan.

In order to ensure the use of the drug in a cost-effective manner, in line with the appraisal, NHS organisations may want to develop local protocols with locally agreed definitions of:

  • Whether previous assessments of ejection fraction can be used or if a new echo is needed. In defining this locally, sites will want to take the following into account in relation to the last measurement: timescales (no longer than 12 months since last measurement), the patient's condition; length of time on stable doses of optimal medical therapy; and other management since last measurement. For NYHA class assessment, it was felt that this could be done at the time of the prescribing decision.

  • A stable dose of ACE inhibitors or ARBs. In developing the guidance, the committee concluded that sacubitril valsartan should be started in people who are already having a stable, optimised dose of an ACE inhibitor or an ARB. In the main trial on which the guidance was based, a stable dose was taken to mean at least 4 weeks.

  • Appropriate patient and clinical factors which should be considered to account for the contraindications and considerations detailed by the company and in the electronic medicines compendium. These may include blood pressure, kidney function, potassium levels and history of angio-odema, and could be detailed in shared care protocols or initiation checklists.

Measuring success and monitoring implementation

The electronic medicines compendium states that 'This medicinal product is subject to additional monitoring'. Healthcare professionals are asked to report any suspected adverse reactions through the yellow card scheme.

In order to demonstrate that the guidance has been adopted in an effective way it may be helpful to take measurements before, during and after implementation. Some of these measures will not be routinely collected and sites must consider a data collection methodology that is appropriate to the service. Sites contributing to this resource considered this to be particularly important, because they plan to implement the guidance while considering the learning and experience of patients for whom sacubitril valsartan was prescribed.

Suggested measures include:

  • retrospective data collection of the number of patients for whom the drug would have been suitable (time period for data collection to be agreed locally depending upon aims)

  • prospective data collection about the number of patients started on the drug, an assessment of its suitability and whether they had appropriate follow-up

  • complications associated with abruptly stopping ACE inhibitors or ARBs during the washout period

  • adverse reactions

  • patients' blood pressure response to starting the drug.

Resource impact

This technology is commissioned by clinical commissioning groups. Providers are NHS hospital trusts and GP practices.

NICE has published a resource impact report and resource impact template that can be used by NHS commissioners and providers to understand better the local costs associated with adopting the guidance. The national assumptions used in the template can be altered to reflect local circumstances.

To help estimate the number of potentially suitable patients, organisations could consider counting the specialist heart failure service caseload and engaging with GPs to assess the proportion of patients who are in primary care.

Education and awareness raising

Once agreements for implementation have been established, sites that contributed to this resource suggest implementing an education and awareness-raising exercise with colleagues in primary care and healthcare professionals who are not specialised in heart failure but who may be prescribing drugs for the patient. This would include information about the drug, side effects, concomitant use with other drugs (in particular ACE inhibitors), patient suitability, the locally agreed protocols and side effect reporting for the yellow card scheme. The heart failure nurses who have close links with primary care were seen as an effective way of achieving this.

Consider a system for ensuring that GP letters are sent out on the same day that a patient started taking sacubitril valsartan, with initiation highlighted in bold.


[4] Section 5.1 of the technology appraisal guidance states that 'Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. Because sacubitril valsartan was made available in the NHS through the early access to medicines scheme, NHS England has indicated that this guidance will be implemented 30 days after final publication.'