Novartis announced that the Scottish Medicines Consortium (SMC) has accepted Entresto™ (sacubitril/valsartan) for use within NHS Scotland for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction.1 Sacubitril/valsartan represents a breakthrough therapeutic option for adult patients with symptomatic chronic heart failure with reduced ejection fraction. The SMC recognised that it may be used instead of angiotensin converting enzyme (ACE) inhibitors,1 the current gold standard treatment for the condition.
“Patients with heart failure can have a poor prognosis, with survival rates often being worse than certain types of cancer, such as breast and prostate.” said Dr Roy Gardner, Consultant Cardiologist, Scottish National Advanced Heart Failure Service, Golden Jubilee National Hospital. “The acceptance of sacubitril/valsartan is a step forward, offering a superior treatment option that will allow many heart failure patients in Scotland to benefit from a reduced risk of death and hospitalisation.”
The SMC carried out an evaluation of the clinical and cost effectiveness of sacubitril/valsartan and based its advice on data from the PARADIGM-HF study, the largest Phase III heart failure clinical trial conducted to date. The study compared the efficacy and safety of sacubitril/valsartan with enalapril, in 8399 patients with chronic heart failure with reduced ejection fraction. Results showed that sacubitril/valsartan, compared to enalapril, reduced the risk of death from heart-related causes or first hospitalisation for heart failure by 20% (absolute risk reduction: 4.7%).1 Based on this evidence, the SMC concluded that the introduction of sacubitril/valsartan would offer an alternative treatment to ACE inhibitors or angiotensin II receptor blockers (ARB) in patients with heart failure with reduced ejection fraction.1
“Today’s advice represents an important milestone for heart failure patients in Scotland.” said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. “The SMC conducts a robust evaluation of the clinical value and the cost effectiveness of new treatments, and we applaud the SMC for accepting the use of sacubitril/valsartan under its licensed indication with no restriction.”
Heart failure occurs when the heart muscle cannot pump a normal amount of oxygen-rich blood around the body, resulting in a substantial impact on patients’ daily lives. In Scotland, heart failure was responsible for 11,900 hospitalisations in 2013.3 It was estimated that 25% of patients needed emergency re-admissions within 30 days of hospital discharge4 and 23% of patients hospitalised with heart failure died within 30 days of being discharged from hospital.4
Sacubitril/valsartan received a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) with the Medicines and Healthcare Products Regulatory Agency on 1 September 2015. It is now available for use in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. Following publication of the SMC’s advice, NHS Boards in Scotland will now decide whether sacubitril/valsartan should be added to their formulary. Novartis is also working with NICE to ensure as many eligible patients as possible will be able to benefit from sacubitril/valsartan once it has been appraised.
- 1 SMC Detailed Advice Document sacubitril/valsartan 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets (Entresto®) SMC No. (1132/16).
- 2 ISD Scotland. Heart Disease Statistics Update, 2015. https://isdscotland.scot.nhs.uk/Health-Topics/Heart-Disease/Publications/2015-01-27/2015-01-27-Heart-Disease-Report.pdf. Last accessed on 26 February 2016.
- 3 ISD Scotland. Heart Disease Activity: Hospital Discharges. Table AC4: ISD Scotland, 2013. http://www.isdscotland.org/Health-Topics/Heart-Disease/Topic-Areas/Hospital-Activity/. Last accessed 26 February 2016.
- 4 ISD Scotland. Heart Disease Indicators: Information Services Division, 2015. https://isdscotland.scot.nhs.uk/Health-Topics/Heart-Disease/Publications/2015-09-22/2015-09-22-HeartDiseaseIndicators-Report.pdf. Last accessed 26 February 2016.