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CCG Briefing on Sacubitril Valsartan (Entresto®) NICE Technology Appraisal Guidance TA388

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This briefing is designed to inform CCGs of the implications of NICE TAG 388 Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction.

Sacubitril valsartan is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people:

  • with New York Heart Association (NYHA) class II to IV symptoms and
  • with a left ventricular ejection fraction of 35% or less and
  • who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs).

Treatment with sacubitril valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team.

This technology is commissioned by clinical commissioning groups (CCGs). Providers are NHS hospital trusts and GPs in primary care.

Sacubitril valsartan for treating symptomatic chronic heart failure falls within the programme budgeting category 9: problems of circulation.

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, as opposed to the usual 90 days. Sacubitril valsartan is the first drug commissioned by CCGs to be approved under the early access to medicines scheme.

This therefore means that CCGs have been obliged to fund this treatment, where a clinician and patient feel it is the correct choice for them, from the end of May 2016.

This should therefore now be incorporated into local formularies, without further review of the evidence.

Sacubitril valsartan (Entresto®) – Heart failure

Sacubitril valsartan (Entresto®) is recommended by NICE as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people:

  • with New York Heart Association (NYHA) class II to IV symptoms and
  • with a left ventricular ejection fraction of 35% or less and
  • who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs).

Treatment with sacubitril valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be performed by the most appropriate team member. Guidance will be produced locally in relation to the implementation of the NICE TAG and the  management of patients who may be deemed suitable for treatment with this new agent but primary care clinicians may wish to familiarise themselves with the safety advice and cautions relating to this new agent before patients are discharged back to their care.

It is important to note that sacubitril / valsartan must not be co-administered with an ACE inhibitor or an ARB, and both ACE inhibitors and ARBs must have an appropriate wash out period before sacubitiril / valsartan is started.

Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) is also contraindicated.

Long term effects are still uncertain. Post marketing surveillance will therefore be important and clinicians are reminded of the importance of Yellow Card reporting.

Patients started on Sacubitril valsartan (Entresto®) with input from the heart failure nurses will be issued with a warning card.

For further cautions see: Entresto film-coated tablets – Summary of Product Characteristics (SPC) – (eMC)