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22 ETHICAL NEWS PRE-FILLED PEN ON PBS BOOSTS ACCESS TO ASTHMA DRUG GSK’s new pre-filled pen (autoinjector) for the self-administration of its biologic treatment for severe eosinophilic asthma, Nucala (mepolizumab), is now reimbursed by the PBS. The reimbursement gives healthcare professionals and patients greater choice around the administration of treatment, which can be received at home or in-clinic. GSK says access to alternative administration options will be important for the convenience of patients and their healthcare professionals during a period of uncertainty in the healthcare environment. Studies show that most patients find autoinjectors easy to use after appropriate training, and that at home administration is preferred to receiving treatment at a clinic by 96 per cent of patients.1,2 Nucala specifically targets IL-5, the main promoter of eosinophil growth, providing rapid and lasting reductions in blood eosinophil levels for up to 4.5 years without complete depletion.3,4 Nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over.3 Professor Peter Gibson, respiratory physician and clinical researcher at the Hunter Medical Research Institute, says affordable access to new self- administration options for severe eosinophilic asthma is timely and positive. “Ensuring effective, more convenient treatment options for severe eosinophilic asthma is an important step in reducing the burden of this disease for patients, their families and the healthcare system,” he said. “The option for at-home administration is especially significant at this time when Australians are self-isolating, spending more time at home and may be unable or prefer not to visit their healthcare professional. “Healthcare professionals should look forward to facilitating greater continuity of treatment and helping to protect patients who would prefer to receive their regular treatment at home.” Dr Andrew Weekes, Medical Director at GSK Australia, says PBS listing is therefore an important milestone for patients with severe eosinophilic asthma, enabling them to exercise more flexibility around how they receive their biologic treatment. “GSK is pleased that Australians with severe eosinophilic asthma can now access a self- administration option for Nucala via the PBS,” he said. “The availability of the pre-filled pen will give patients greater choice around how they receive their biologic treatment and consider the setting that best fits their needs, in consultation with their healthcare professional.” References available on request VERTIS-CV OUTCOMES TRIAL FOR STEGLATRO ‘IMPORTANT STEP’ A trial that evaluated the oral sodium- glucose cotransporter 2 (SGLT2) inhibitor, Steglatro (ertugliflozin), found it met the primary endpoint of non- inferiority in terms of cardiovascular (CV) outcomes versus placebo. MSD Australia announced the results, which were presented last month at the American Diabetes Association Virtual 80th Scientific Sessions, from the Phase 3 VERTIS-CV outcomes trial that evaluated Steglatro added to background standard of care treatment in more than 8,200 patients with type 2 diabetes mellitus (T2DM) and atherosclerotic CV disease across 531 centres in 34 countries, including Australia.1,2 This study met the primary endpoint of non-inferiority for Steglatro versus placebo on time to first major CV events (MACE) in patients with T2DM and atherosclerotic CV disease.1 MACE was defined as the composite of time to the first event of CV death, nonfatal myocardial infarction or nonfatal stroke.1 VERTIS-CV is the fourth major CV outcomes trial for SGLT2 inhibitors2,3,4,5 and contributes to the existing body of evidence for this class of medicines. MSD says it represents an important step for Steglatro and strengthens the overall evidence and understanding of its safety profile and role for patients with T2DM and atherosclerotic CV disease, within a clinical trial setting. Steglatro by MSD is available in Australia and PBS-listed for use in patients with T2DM as dual therapy (in combination with metformin or a sulphonylurea) or as triple therapy (in combination with metformin and a DPP-4 inhibitor).6,7 Key data highlights from VERTIS-CV include:1 • Steglatro achieved its primary endpoint of non-inferiority for MACE compared with placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease. » MACE was reported in 11.9 per cent (653/5494) of patients treated with Steglatro (5mg and 15mg doses), compared with 11.9 per cent (327/2745) of patients treated with placebo (HR=0.97; 95.6 per cent CI \\\[0.85-1.11\\\]; p<0.001 for non-inferiority). • The key secondary endpoints of superiority for Steglatro versus placebo for time to the first occurrence of the composite of CV death or hospitalisation for heart failure (HHF), time to CV death alone and time to the first occurrence of the composite of renal death, dialysis/ transplant or doubling of serum creatinine were not met. • The pre-specified endpoint of HHF, while not a part of the hierarchical testing sequence, showed a 30 per cent reduction in the risk of HHF for ertugliflozin versus placebo (2.5 per cent vs 3.6 per cent; HR=0.70; 95 per cent CI \\\[0.54-0.90\\\]. • The overall incidences of serious adverse events were similar for the Steglatro 5mg (34.9 per cent), Steglatro 15mg (34.1 per cent) and placebo (36.1 per cent) groups. » Urinary tract infection occurred in 12.2 per cent and 12.0 per cent of patients in the ertugliflozin 5mg and 15mg groups, respectively, and 10.2 per cent in the placebo group (p<0.05 for the comparison with placebo). Amputation occurred in 2.1 per cent and 2.0 per cent of patients in the ertugliflozin 5mg and 15mg groups, respectively, and 1.6 per cent in the placebo group. Diabetic ketoacidosis occurred in 0.3 per cent and 0.4 per cent of patients in the ertugliflozin 5mg and 15mg groups, respectively, and 0.1 per cent in the placebo group. References available on request. RETAIL PHARMACY • JUL 2020