Obese patients could potentially be given PBS-subsidised access to lifelong therapy with weekly injections of the GLP-1 agonist semaglutide in nurse-led or GP-led models of care, according to scenarios discussed by the Pharmaceutical Benefits Advisory Committee (PBAC).
The drug is currently available on the PBS for treatment of people with type 2 diabetes, but with the TGA now assessing an application for semaglutide to be used in weight management the PBAC recently convened a stakeholder meeting to help inform its consideration of an expected application for a PBS listing for semaglutide for this indication.
The meeting held on 26 August was attended by a Staff Specialist in Endocrinology from Sydney’s Royal North Shore Hospital as well as representatives from obesity patient groups, industry, GPs and allied health professional groups.
The meeting noted that there is currently a high unmet need for obesity treatments in the general population, with no pharmacotherapies listed on the PBS and access to bariatric surgery almost entirely limited to private hospitals, raising issue of inequity.
However while some stakeholders said that semaglutide would most likely have a role in people with more severe obesity, it was not envisaged as a replacement for bariatric surgery, but rather as an add-on therapy in addition to lifestyle change interventions.
According to the PBAC meeting outcome statement, the main goal of pharmacotherapy for obesity was likely to be sustained weight loss, “in order to reduce the likelihood of developing a range of comorbidities, such as micro/macrovascular disease complications from type 2 diabetes, cardiovascular disease, prevention of progression from pre-diabetes to diabetes, sleep apnoea and chronic kidney disease.”
This then raised the question of whether semaglutide and other pharmacotherapies would be potentially be a lifelong treatment, given that patients who achieve weight loss may put it back on due to metabolic adaptation if they stop treatment.
When evaluating a PBS listing, the PBAC would therefore have to set criteria for initiation and continuation of therapy, the meeting heard. This led to discussion around whether pharmacotherapy should be offered in settings such as primary care or in specialist and hospital-based weight loss and metabolic clinics, where obese patients are typically referred after having not responded to several attempts at weight loss.
The arguments in favour of a GP-led prescribing included their extensive experience in chronic disease management and regular patient access needed for review of therapy.
“Stakeholders were generally in agreement that restricting semaglutide prescribing to specialist services would result in … issues of inequity of access and prolonged waiting periods resulting in worsening of obesity and its associated health sequelae, and that positioning the therapy only in specialist settings would not allow it to reach all patients expected to benefit from treatment,” the outcome statement noted.
Conversely, concerns were raised about patients receiving weight management care from practitioners without specialist training or experience in the area.
“Some stakeholders noted that weight management services include nurse-led care models with holistic, multi-faceted approaches, and regular contact (e.g. fortnightly),” the PBAC noted.
“From a clinical perspective, it was noted that patients achieve optimal outcomes when they have an ongoing relationship with a health care professional. From a patient perspective, it was noted that patients value a continuing connection with a single health care provider who is adequately trained in weight management.”
There was concern around whether the requirement for weekly injections and potential gastrointestinal side effects would impair patient adherence to treatment, although this was already managed by patients with conditions such as diabetes and migraine.
“There was also some discussion around the degree of sustained weight loss required to achieve a reduction in the risk of developing long term complications, which was generally considered to be around 10%.
The PBAC chair said the discussion had provided useful context and feedback from stakeholders that would be used in any future consideration of PBS listing applications from the sponsor of semaglutide (Novo-Nordisk) and other potential pharmacotherapies for weight loss.