FORXIGA (DAPAGLIFLOZIN) ACCEPTED FOR USE WITHIN NHS SCOTLAND FOR THE TREATMENT OF SYMPTOMATIC CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN ADULTS[1]

FORXIGA (DAPAGLIFLOZIN) ACCEPTED FOR USE WITHIN NHS SCOTLAND FOR THE TREATMENT OF SYMPTOMATIC CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN ADULTS^[1]

• Dapagliflozin has been accepted for use within NHS Scotland for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), as an add-on to already optimised standard care.¹
• AstraZeneca estimates the number of patients eligible for treatment could be up to 24,701.^[2]

Luton, UK, Monday 12 April – AstraZeneca today announced that Forxiga (dapagliflozin) has been accepted for use within NHS Scotland by the Scottish Medicines Consortium (SMC) as an additional option for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (rEF) in adults, as an add-on to already optimised standard care.¹

John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “Today’s announcement is great news for people in Scotland living with [chronic] heart failure and a reduced ejection fraction. This decision means there will be a novel treatment option available that can make a difference to their lives, by improving symptoms, reducing their risk for hospitalisation for heart failure and cardiovascular death in this life-restricting and life-threatening condition.”

HF is a life-threatening, complex, chronic condition where a person’s heart is unable pump enough blood around their body.^[3] An estimated 46,000 people are living with HF in Scotland and the risk of death over five years associated with HF is worse than some of the most common cancers, such as prostate, bladder, colorectal, and breast cancer.^[4],[5],[6] HF is also the cause of over 17,000 hospital admissions per year in Scotland.^[7] With COVID-19 placing such a large burden on the health system, ^[8] it is critical that people living with heart failure have access to care options that can help reduce the risk of their symptoms worsening and need for admission to hospital.^[9]

Dapagliflozin is in a class of medicines called SGLT2-inhibitors and is the first medicine of this kind to be recommended for use in adults with symptomatic chronic HFrEF in Scotland. The acceptance by the SMC was based on the positive results from the DAPA-HF Phase III clinical trial. The trial showed that dapagliflozin, on top of standard of care, reduced the risk of the composite endpoint of: cardiovascular (CV) death, unplanned hospitalisation or an urgent visit to hospital requiring IV therapy for HF by 26% (relative risk reduction [RRR], absolute risk reduction [ARR] = 4.9%), when compared to placebo on top of standard care (hazard ratio [HR] = 0.74 [95% confidence interval {CI} 0.65-0.85]; p < 0.001) ([16.3% vs 21.2% patients with event, respectively]).^[10] The overall safety profile of dapagliflozin in patients with HF was consistent with the known safety profile of the medicine. The proportion of patients with volume depletion (7.5% versus 6.8%) and renal adverse events (6.5% vs 7.2%), which are commonly of concern when treating HF, were comparable to placebo. Major hypoglycaemic events were 0.2% in both treatment groups and occurred in patients with diabetes only.^[11]

Tom Keith-Roach, President, AstraZeneca UK, said: “We are thrilled with the SMC’s decision, which provides access to an additional treatment [option] for people living with [symptomatic chronic] heart failure [with reduced ejection fraction]. Now more than ever, it is vital that we find ways to reduce the strain on our health services. We are committed to collaborating with our NHS partners to eradicate unplanned admissions for heart failure in the UK and implement innovative approaches that help people live a better quality of life and stay out of hospital.”

[1] Scottish Medicines Consortium. Dapagliflozin for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction: Decision Advise Document (DAD) – Published 12 April 2021.

[2] AstraZeneca Data on File. REF-108702. April 2021

[3] Savarese G, Lund LH. Global public health burden of heart failure. Card Fail Rev. 2017;3:7-11.

[4] Scottish National Statistics. Scottish Heart Disease Statistics – Published 28 January 2020. Available at: https://beta.isdscotland.org/find-publications-and-data/conditions-and-diseases/heart-disease-and-blood-vessels/heart-disease-statistics/ Last accessed April 2021.

[5] National Records of Scotland. Population of Scotland. Available at: https://www.nrscotland.gov.uk/statistics-and-data/statistics/scotlands-facts/population-of-scotland Last accessed April 2021.

[6] Mamas MA, Sperrin M, Watson MC, et al. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017;19:1095-1104.

[7] Scottish National Statistics. Scottish Heart Disease Statistics – Published 28 January 2020 (Table AC1: CHD activity by health board). Available at: https://beta.isdscotland.org/media/3264/table-ac1-chd-activity-by-health-board.xlsx Last accessed April 2021.

[8] British Medical Association. The hidden impact of COVID-19 on patient care in the NHS in England. Available at: https://www.bma.org.uk/media/2841/the-hidden-impact-of-covid_web-pdf.pdf Last accessed April 2021.

[9] NHS. Guidance and standard operating procedures: General practice in the context of coronavirus (COVID-19). Available at https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/C1175-covid-19-primary-care-sop-gp-practice-v4.1-march-21.pdf Last accessed April 2021.

[10] McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381:1995-2008 (Supplementary appendix).

[11] McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381:1995-2008.