PBAC recommends novel HFrEF drug and GP prescribing of PCSK9 mAbs

Latest recommendations from the Pharmaceutical Benefits Advisory Committee include PBS listing for first-in-class heart failure drug vericiguat and widening access to PCSK9 mAbs to allow GP prescribing and expanded LDL-C criteria.

At its July 2022 meeting (linked here) the PBAC recommended listing of vericiguat for the treatment of symptomatic (NYHA class II, III or IV) chronic heart failure in patients with a reduced ejection fraction (LVEF less than 45%) and who are stabilised after a recent decompensation heart failure event requiring hospitalisation and/or intravenous diuretic therapy.

Marketed by Bayer as Verquvo, the drug is the first in a new class of medicines for heart failure known as soluble guanylate cyclase stimulators that target the cyclic GMP system.

In its decision summary, the PBAC said it was satisfied that vericiguat, with concomitant use of standard of care therapies, provides a modest improvement in efficacy over standard of care in high-risk patients in a late-line of therapy.

The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of vericiguat would be acceptable at the price proposed in the resubmission and using the intention-to-treat population in the VICTORIA trial.

Bayer Australia said it welcomed the recommendation to include vericiguat on the PBS, noting its inclusion in the new ‘Australian Consensus Statement on the Current Pharmacological Prevention and Management of Heart Failure’ for patients with recent hospitalisation and high risk of readmission.

“We are working with the Department of Health and Federal Government to have Verquvo made available on the PBS at the earliest opportunity for eligible patients with HFrEF following a recent decompensation event,” said a spokesperson.

At the July meeting the PBAC also recommended extending the existing PBS listings for the PCSK9 monoclonal antibody evolocumab for hypercholesterolaemia, to include patients who have a low density lipoprotein cholesterol (LDL-C) level between 1.8 and 2.6 mmol/L despite optimised treatment with statins and ezetimibe, and to allow initial prescribing by any medical practitioner in consultation with a specialist physician.

The PBAC said it was satisfied that evolocumab provides, for some patients, a significant improvement in efficacy over optimised background treatment, in the extended population.

“The PBAC advised that the expanded LDL-C criteria were consistent with current international clinical guidelines and the expanded prescriber criteria would reduce current equity and access issues associated with initiation only by specialists,” it said in a decision summary.

The PBAC noted that it had previously considered relevant clinical evidence with respect to alirocumab, and recommended that these changes flow on to alirocumab listings, at established pricing relativities with evolocumab.

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