Biologic treatment for severe asthma listed on PBS

A new pre-filled autoinjector for at-home administration of mepolizumab will be reimbursed by the PBS from 1 June

Patients with severe refractory eosinophilic asthma can now choose to receive treatment with Nucala (mepolizumab) in clinic or to self-administer at home, with both options now subsidised by the government under the PBS.

In late 2016, mepolizumab was the first therapy to be approved in Australia as an add-on treatment for patients with severe refractory eosinophilic asthma.

At that time, it was heralded as the first new treatment for asthma in a decade. However it was designed to be delivered via subcutaneous injection every four weeks by a healthcare professional, and was expensive at a cost of over $20,000 per year.

This original form of mepolizumab was listed on the PBS from 1 December 2019.

Reimbursement for a new pre-filled autoinjector will provide further administration choice for the more than 1,400 patients currently accessing Nucala through the PBS.

“The Nucala pre-filled pen will be an important new treatment option for patients suffering from severe eosinophilic asthma, allowing them to self-administer their treatment at home avoiding the need to travel or attend a clinic to receive their monthly treatment,” Health Minister Greg Hunt said on Monday.

Consultant pharmacist Debbie Rigby told AJP that “the pre-filled pen will be an important option who may be unable to travel or attend hospitals to receive monthly treatments”.

“It provides greater flexibility for self-administration, especially in times of COVID-10 pandemic and social isolation and travel restrictions,” she said.

“These monoclonal antibodies are exciting add-on treatments for adults and adolescents with severe eosinophilic asthma and now there is the added convenience of self-administration.”

Research funded by manufacturer GSK found at-home administration of mepolizumab was preferred by 96% of patients surveyed in comparison to receiving treatment at a clinic.

The biologic drug targets pathways of inflammation that do not respond to usual steroid treatment, specifically IL-5, the main promoter of eosinophil growth, leading to reductions in blood eosinophil levels.

Results from placebo-controlled studies, published in the New England Journal of Medicine, The Lancet Respiratory Medicine, and the Journal of Allergy and Clinical Immunology, demonstrate clinically significant reductions in exacerbations with treatment of mepolizumab compared to placebo.

Research also shows a reduction in daily oral corticosteroid dose.

The most commonly reported adverse reactions (>3% incidence) in phase III clinical trials with mepolizumab were headache, injection site reaction, back pain and fatigue. The most common symptoms associated with subcutaneous injections included pain, erythema, swelling, itching and burning sensation.

Professor Peter Gibson, respiratory physician and clinical researcher at the Hunter Medical Research Institute (HMRI), said affordable access to new self-administration options for severe eosinophilic asthma is a timely and positive development.

“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. 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,” said Professor Gibson.

“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.”


Further listings

In addition to the listings of Nucala and Symbicort for mild asthma from 1 June, the Federal government has also expanded the listing of Revlimid (lenalidomide) on the PBS Highly Specialised Drugs Program to allow use in combination with Velcade (bortezomib) and dexamethasone for previously untreated multiple myeloma.

Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow.

It is estimated up to 2,300 patients may benefit from this listing each year, which might otherwise cost more than $64,000 per course of treatment, said Minister Hunt.

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