September 2023 • PharmaTimes Magazine • 7
// NHS //
Vazkepa, also known as icosapent ethyl, has been accepted by the Scottish Medicines Consortium (SMC) for restricted use within NHS Scotland.
The therapy is a secondary prevention among adult statin-treated patients at high cardiovascular risk who have elevated fasting triglycerides.
Patients involved will also have had established cardiovascular disease (CVD) and a history of acute coronary syndrome (ACS), coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or peripheral arterial disease.
Vazkepa was researched as part of the REDUCE-IT study and demonstrated the benefits of its use for optimising the outcomes of patients at high risk of CV events, in addition to standard of care with statins.
The trial, which randomised 8,179 statin-treated patients over an average of 4.9 years, further showed that treatment with icosapent ethyl, in contrast to the placebo, resulted in a 25% reduction in the risk of future adverse CV events.
Scott Curley, Amarin’s UK and Ireland general manager, reflected: “The introduction of icosapent ethyl to the Scottish healthcare system marks an important milestone in reducing CVD. As a Scotsman whose family has felt the suffering and pain caused by this devastating disease, I have been focused on ensuring eligible patients in Scotland have access to icosapent ethyl, as they do in England, Wales, and Northern Ireland.”
He added: “Scotland’s death rates from heart and circulatory disease are higher than in the rest of the UK. The SMC’s acceptance of icosapent ethyl will help to reduce the risk of CV events among a high proportion of patients across Scotland, and the impact this disease has on them and their families.”
CVD remains a considerable issue for individuals and healthcare professionals across Scotland. Existing drugs can help to reduce the risk of a first or recurrent CV event, however, there are still around 10,000 hospital admissions for heart attacks every year.
Celadon Pharmaceuticals, a company focused on the development of cannabis-based therapies, has announced that LVL Health, its private pain clinic, has been approved by the NHS Research Ethics Committee.
The approval involves the roll-out of its non-cancer chronic pain clinical trial for up to 5,000 patients.
Celadon has already received conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the commencement of the trial; however, the committee requested an initial feasibility study be undertaken over a three-month period.
Consequently, the results of the study were submitted for review in late 2022 and established positive outcomes for quality of life, pain and sleep, along with decreased opioid usage.
The research has been designed to create a data set that will support doctors’ prescriptions of cannabis-based medicines and, critically, potential reimbursement by the NHS and insurance companies.
Meanwhile, it will also allow GPs to prescribe the medicine to patients in addition to specialist doctors, and organisations, including charities, can advertise the trial in terms of recruitment.
Celadon believes these steps represent a significant advancement in enabling broader options for patients, leading to the widening of the UK cannabis-based medicine market.
James Short, chief executive officer at Celadon, was encouraged about the trial’s approval: “We are delighted that our clinical trial has received its approvals and we can now start the important work of getting our medicine to patients.
“Everything we do at Celadon starts with the patient, and the results from the first part of the study we have seen in terms of improvements in quality of life have been tremendous.”
He concluded: “Our longstanding aim remains to open up the UK market by giving doctors confidence in prescribing and creating the most robust data set to-date in the UK for cannabis-based medicines.”