Following publication of the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial,1 and being aware of the anticipated National Institute for Health and Care Excellence (NICE) approval of sacubitril/valsartan, this gave the impetus to ensure our patients could have access to this medication as soon as it was NICE approved.
Medway has a population of 280,000. The heart failure team at Medway Community Healthcare was established in 2003 and has grown and developed since then as part of the community cardiology team (also providing cardiac rehabilitation, arrhythmia and some diagnostics). The current team has seven clinicians working 3.9 WTE (whole time equivalent), incorporating a development structure with staff spanning from band 5 staff nurse to the cardiology clinical lead at band 8a, with a small admin team for support. Weekly multi-disciplinary team (MDT) meetings are attended by a consultant cardiologist from Medway Foundation Trust, which is invaluable in providing support and supervision for clinicians, and ensuring excellence is achieved in managing patients with heart failure.
The heart failure team active caseload is about 250 patients. The team have a very pro-active discharge policy, ensuring that new patients are seen in a timely manner with ongoing appointments for optimisation and symptom control. Patients can be referred on discharge from the local hospital, following consultant appointment or by GP, through a diagnostic pathway, which is coordinated by the clinical lead.
Setting up prescribing
The dedication and enthusiasm of the heart failure clinical team, who are open to change, facilitates providing patients with the opportunity to optimise their treatment. Since the team was familiar with the evidence from the PARADIGM-HF trial, they were aware of the patient benefits of being able to prescribe sacubitril/valsartan.
Once the NICE technology appraisal for sacubitrial/valsartan (TA388) was published in April 2016,2 I – as the cardiology clinical lead – was able to use this to produce local guidance on how the Medway Community team would be able to prescribe this agent. This also included guidance and responsibilities for GPs, which was vital to ensure that patients would not be prescribed an angiotensin-converting enzyme (ACE) inhibitor in addition to sacubitril/valsartan. This was an initial concern for the team, since most patients would be on an ACE inhibitor and, at the time of the switch to sacubitril/valsartan, it was necessary for patient safety, to ensure that the ACE inhibitor was removed from any repeat prescription.
Most of the clinicians in the team are non-medical independent prescribers, allowing them the autonomy to make treatment decisions at the time of the clinical review and then to provide the required prescription. If required, the cardiology consultant can provide a community prescription following a discussion at the MDT.
Local guidance on prescribing sacubitril/valsartan was agreed by the local medication management team and the quality team. This enabled us to apply for the medication to be added to the local formulary, which needed to be in place before clinicians could prescribe. Subsequently, guidance, flow chart and standard operating procedure, were approved by the drugs and therapeutic committee for Medway and Swale (Medway Clinical Commissioning Group, Swale Clinical Commissioning Group Medway NHS Foundation Trust and Medway Community Healthcare). A standard operating procedure was issued for local GPs, which provided all the information clinicians required to ensure that only appropriate patients were considered for the medication. Sacubitril/valsartan was listed on the formulary as specialist prescription only.
In the initial stages, heart failure nurses discussed at a clinical meeting patients that fulfilled the following criteria:
- those with New York Heart Association (NYHA) class II–IV symptoms
- those with left ventricular ejection fraction of ≤35%
- and those taking a stable dose of ACE inhibitor/angiotensin receptor blocker (ARB).
Clinicians quickly gained the confidence to prescribe sacubitril/valsartan without the need for discussion at the clinical meeting. Care was taken not to prescribe to any patient needing a dosette box. Clinicians had anticipated that patients might require additional appointments to start them on sacubitril/valsartan and then to titrate and monitor the patient. We discussed the options and terminology of ‘stable doses of ACE inhibitor/ARB’; it was agreed that this did not necessarily mean target dose but could be used for patients who were tolerating at least 50% of the target dose. By taking this approach, it meant that the majority of patients would not need additional appointments and blood tests.
Clinicians soon found that prescribing sacubitril/valsartan to patients was not a great deal different to prescribing the usual ACE inhibitors/ARBs, with which they were very familiar. Discussing options with some patients could be challenging, but most patients were keen to make the change in treatment. We made it clear that, at this stage, not all patients would note an improvement in symptoms but the medication may slow down any deterioration in their quality of life. When we began prescribing, we noted that several patients had developed significant muscle fatigue about four weeks after starting treatment, requiring sacubitril/valsartan to be stopped and a return to the previous dose of ACE inhibitor/ARB. As the numbers of patients prescribed sacubitril/valsartan have increased, this side effect has been less evident.
We have now established approximately 100 patients on sacubitril/valsartan. Once a patient’s heart failure medication is fully optimised and they have been considered for specialist treatments, they are discharged from the heart failure service. For patients taking sacubitril/valsartan, the clinician checks that a patient’s renal function and blood pressure are stable before they are discharged to the GP for ongoing care. All heart failure patients should have six-monthly monitoring of renal function, and a medication and clinical review at least every six months, as advised by the NICE heart failure guidance.3
Conflicts of interest
Cardiology Lead Nurse/Manager
Email: c/o email@example.com
Medway Community Healthcare, Unit 7–8 Ambley Green, Gillingham Business Park, Gillingham, Kent, ME8 0NJ
1. McMurray JJV, Packer M, Desai AS et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014;371:993–1004. https://doi.org/10.1056/NEJMoa1409077
2. National Institute for Health and Care Excellence. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. TA388. London: NICE, April 2016. Available from: https://www.nice.org.uk/guidance/ta388
3. The National Institute for Health and Care Excellence (NICE). Chronic heart failure in adults: management. CG108. London: NICE, 2010. Available from: http://www.nice.org.uk/guidance/cg108 [accessed 13 October 2017].
Articles in this supplement
1. Applying PARADIGM-HF to the use of sacubitril/valsartan in clinical practice
2. Early clinical experience with sacubitril/valsartan from a large UK tertiary centre
3. Initial experience of introducing sacubitril/valsartan in a UK heart failure service
5. Real-world experience and clinical data with sacubitril/valsartan: a Northern Ireland perspective
In clinical trials, sacubitril/ valsartan – initially known as the investigational agent LCZ696 – was used in 100 mg and 200 mg doses. These translate to the licensed doses of 49 mg sacubitril/51 mg valsartan and 97 mg sacubitril/103 mg of valsartan, respectively.
A smaller 50 mg dose, which equates to 24 mg sacubitril/26 mg valsartan, is also available.