June 2023 • PharmaTimes Magazine • 6
// TREATMENTS //
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s dapagliflozin. The therapy, also known as Forxiga, is as an option among adults with symptomatic chronic heart failure with mildly reduced or preserved ejection fraction.
Currently, there are no disease-modifying treatments for this specific condition and, thus, dapagliflozin becomes the first NICE-recommended treatment for this population.
Meanwhile, evidence from a clinical trial demonstrated that adding dapagliflozin to standard care with diuretics effectively decreases the combined risk of dying from cardiovascular causes or the need attend hospital with heart failure. This was compared during the study with placebo in addition to standard care.
Helen Knight, director of medicines evaluation at NICE, reflected: “Until now there have been no treatments available to delay or slow the progression of this type of heart failure.
“The committee heard from patient and clinical experts who described how the lack of research and available treatments in this area led to a lack of hope and support that impacts the quality of life and mental health of people with the condition.”
She also reinforced NICE’s commitment to improving patient care and treatment access: “Today’s draft guidance means that for the first time there is an effective treatment available on the NHS for people with this type of heart failure. Not only does dapagliflozin have the potential to help them live well for longer, but it could also save the NHS money and free up space by reducing their risk of having to go to hospital for unplanned emergency treatment.”
Over 550,000 people in England have heart failure, with half having preserved or mildly reduced ejection fraction. Up to 150,000 of these individuals would be eligible for treatment with dapagliflozin.
AbbVie has announced that NICE has delivered a positive final draft guidance recommending its Rinvoq therapy for the treatment of moderately to severely active Crohn’s disease.
The therapy – also known as upadacitinib – will be used among patients whose condition has not responded well enough, or has lost response, to a previous biological treatment. It also involves individuals who have not tolerated a previous biological treatment.
The NICE recommendation is based on data emerging from three phase 3 studies, which have shown that many patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response. Clinical remission was measured by patient-reported symptoms of stool frequency and abdominal pain.
Dr Alexandra Kent, consultant gastroenterologist at King’s College Hospital NHS Trust, reflected: “As a progressive disease, it is imperative that we help people with Crohn’s disease to achieve disease control and improve their quality of life.”
She added: “There has been a lack of new advanced therapies made available on the NHS to treat Crohn’s disease for over half a decade. Being able to offer eligible people an additional treatment option that is available as a once daily pill is a positive step forward.”
Belinda Byrne, medical director at AbbVie UK, explained: “We are pleased that NICE has recommended upadacitinib for eligible people with Crohn’s disease on the NHS in England and Wales. This is another important milestone for the inflammatory bowel disease community, as it follows NICE’s recommendation for upadacitinib in ulcerative colitis last year.”
Around 155,000 adults are living with Crohn’s condition in the UK. It is a chronic, progressive condition of the digestive system, associated with inflammation and mucosal ulceration.