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Sacubitril Valsartan (Entresto®) – Pathway for Treating Symptomatic Chronic Heart Failure with Reduced Ejection Fraction NICE TA 388 April 2016 (https://www.nice.org.uk/guidance/ta388) NICE recommendations Sacubitril valsartan is a combined neprilysin inhibitor +angiotensin II receptor inhibitor. It 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 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. Preparations Sacubitril 24mg + valsartan 26mg Sacubitril 49mg + valsartan 51mg Sacubitril 97mg + valsartan 103mg The valsartan in Entresto® is more bioavailable than in other formulations of valsartan: 26mg, 51mg and 103mg of valsartan in Entresto® is equivalent to 40mg, 80mg and 160mg of valsartan in other marketed formulations. Prescribing Monitoring of renal function, potassium and blood pressure will be undertaken by the team that initiated treatment until the patient is on the maximum tolerated dose and titration is complete. Adverse reactions The most common adverse reactions reported are low blood pressure, hyperkalaemia, and renal impairment, consistent with those associated with agents acting on the renin/aldosterone/angiotensin system. For full details of adverse effects see the SPC for Entresto®. Switching from current ACE or ARB Discontinue any ACE inhibitor for 2 days prior to initiating sacubitril valsartan (risk of angioedema if co-prescribed) Discontinue any ARB the day before starting sacubitril valsartan 1 Sacubitril Valsartan (Entresto®) Care pathway adapted for Western Hospitals NHS Foundation Trust Ratified: November 2016 APC Review date: November 2018 Dosing: sacubitril valsartan is given twice a day Sacubitril 24mg + valsartan 26mg Starting dose if on low dose ACE/ARB prior to initiation Sacubitril 49mg + valsartan 51mg Starting dose if on high dose ACE/ARB prior to initiation Sacubitril 97mg + valsartan 103mg Target dose Also consider this dose if any concerns about low blood pressure*, renal function* * or hyperkalaemia*** *Treatment should not be initiated if SBP < 100 mmHg **There is limited experience in patients with severe renal dysfunction (eGFR < 30ml/minute). Use is not recommended in end stage renal disease ***Treatment should not be initiated if potassium is > 5.4 mmol/l Dose titrations can be made at 2-4 week intervals (longer interval if starting on lowest dose) In the absence of contra-indications beta-blockers and mineralocorticoid receptor antagonists (MRAs) should be continued. Anticipated numbers of patients to be prescribed sacubitril/valsartan and anticipated cost Currently the population in Coastal West Sussex CCG is approx. 480,185 and there are 959 HF patients eligible for treatment derived from QOF, HES, and NHFA (Quality Outcomes Framework, Hospital Episode Statistics, National Heart Failure Audit). The NICE TAG suggests 12% of eligible patients should be initiated on Entresto® per annum.(This info from Novartis). Monthly cost of Entresto® = £91.60 (all tablet strengths). Therefore 115 patients per annum initiated on Entresto® – total drug cost = 115 x £91.60 x12 = £126,408 for first year. This figure would approximately double for the second year as a further 12% of eligible patients were initiated on Entresto®. Anticipated involvement of specialist nurses: Identify stable patients with heart failure not decompensating, but who have had a spell of breathlessness recently which resolved with diuretics. These patients would be on top tolerated dose of ACE inhibitor/ARB. Once identified, the heart failure nurses would stop the ACE inhibitor/ARB for at least 36 hours. Entresto® should not be coadministered with an ACE inhibitor due to the potential risk of angioedema. FULL PRESCRIBING INFORMATION AT http://www.medicines.org.uk/emc/medicine/31244 Adapted by C.Cornford from local implementation document prepared by A.Warren BSUH 2 Sacubitril Valsartan (Entresto®) Care pathway adapted for Western Hospitals NHS Foundation Trust Ratified: November 2016 APC Review date: November 2018 Care pathway map for Entresto® Adult with chronic heart failure due to left ventricular dysfunction First line treatment Optimised ACE/ARB and beta-blocker unless c/i NYHA class II to IV symptoms and a left ventricular ejection fraction of 35% or less Second line treatment Refer for specialist advice for options which include: aldosterone antagonist combination ACE/ARB hydralazine in combination with nitrate sacubitril valsartan As per NICE guidelines. Do not initiate sacubitril valsartan if serum K >5.4 or SBP < 100mmHg If SBP ≥ 100 -110 mmHg, consider starting dose of 24/26 mg bd Patient initiated on sacubitril valsartan by specialists (starting dose 49/51mg bd). Dose increased to 97/103 bd after 2 weeks subject to patient tolerance (BP and renal function). Stop ACE /ARB 36 hrs before starting sacubitril valsartan and ensure removed from repeat medication list Once patient stabilised on treatment prescribing can be transferred to primary care. Sacubitril is a black triangle drug and should be monitored for any side effects and these reported through the yellow card reporting system www.mhra.gov.uk/yellowcard 3 Sacubitril Valsartan (Entresto®) Care pathway adapted for Western Hospitals NHS Foundation Trust Ratified: November 2016 APC Review date: November 2018