The red tape burden involved in prescribing evolocumab for hypercholesterolaemia looks set to ease a little, with the Pharmaceutical Benefits Advisory Committee backing a move to streamlined authority scripts.
If accepted by government, the revamp would reduce the current telephone/online authority PBS restriction for the PCSK9 inhibitor monoclonal antibody, in indications including homozygous familial hypercholesterolaemia, heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia.
Both the Rapatha branded evolocumab injection 140mg in 1mL single use pre-filled pen and injection 420mg in 3.5mL single use pre-filled cartridge would be impacted.
It comes after the PBAC considered a pair of proposals around the PBS listing for the agent at its March 2024 meeting.
The submission by Repatha importer Amgen Australia also requested in the clinical criteria to reduce the minimum treatment duration required with both a statin and ezetimibe prior to initiating evolocumab.
However, this was knocked back by the committee, which said there was “no evidence” provided to demonstrate a clinical benefit to patients with earlier initiation.
Beyond that, such a move would also entail an increase in costs to the PBS, which would also require an evidentiary justification, the committee said in an outcome statement (link here).
Nurse practitioners get PBAC nod to initiate SGLT2i
Meanwhile, the PBAC came out in favour of allowing Australia’s 2250 nurse practitioners to prescribe empagliflozin for heart failure, for eligible adults with symptomatic heart failure regardless of ejection fraction as an adjunct to standard of care therapy.
The recommendation will apply to both the Jardiance heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) PBS listings, as well as the 60-day dispensing PBS listing for HFrEF patients.
Australian College of Nurse Practitioners (ACNP) CEO Leanne Boase said the shift would be practice changing.
“Nurse practitioners are experts in complex disease management and ideally placed to initiate and oversee heart failure treatment,” she said.
“ACNP is actively supporting the removal of financial restrictions on medicines, allowing optimisation of nurse practitioner scope of practice within prescribing legislation, and equitable access to medicines. We hope to see these medicines become even more accessible for patients in the future.”
“Nurse practitioners can play a significant role in optimising the treatment and care of people with chronic illness.”
Icosapent ethyl gets PBAC backing
Separately, the PBAC recommended the listing of icosapent ethyl for the treatment of patients with atherosclerotic cardiovascular disease and elevated triglycerides.
The committee said it was satisfied the agent provided, for some patients, a significant improvement in efficacy over standard care of care consisting of dietary modification, lifestyle interventions, and concomitant optimisation of low-density lipoprotein cholesterol lowering using a statin-based therapeutic regimen.
Meanwhile, it supported a new pack size of tadalafil (60 tablets) 20 mg (Tadalis 20) on the PBS for the treatment of pulmonary arterial hypertension.