A novel treatment for heart failure, vericiguat, has received its first listing on the PBS from 1 December and the government has also widened PBS access to the lipid-lowering therapy PCSK9 inhibitor evolocumab.
Vericiguat (Verquvo) is subsidised for use in addition to standard of care therapy for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) less than 45%, who are stabilised after a recent heart failure decompensation event requiring hospital admission and/or intravenous diuretic therapy.
The drug is first in a new class of soluble guanylate cyclase (sGC) stimulators, which improve both vascular and myocardial function by augmenting levels of intracellular cyclic guanosine monophosphate (cGMP), a signalling molecule that regulates cardiac contractility, vascular tone, and cardiac remodelling.
Federal minister for health Mark Butler said about 10,000 HFrEF patients would benefit from this listing annually, with the drug otherwise costing about $1,900 per course of treatment.
The listing was welcomed by cardiologist Professor Andrew Sindone, Director of the Heart Failure Unit and Department of Cardiac Rehabilitation at Concord Hospital, Sydney, who noted that international treatment guidelines now recommend vericiguat be considered for patients with worsening HFrEF despite optimal treatment.
“In addressing the deficient NO-sGC-cGMP pathway which drives heart failure progression, we have an entirely new mechanism of heart failure treatment with Verquvo,” he said.
“This medicine promises to make a significant difference in a disease area where symptoms are increasingly problematic, rates of hospitalisation remain high, and quality-of-life is often low,” he said.
Professor Sindone said a decompensation event indicated that a patient’s condition is worsening and that it’s time to reassess their treatment.
“All too often we see patients entering a downward spiral of hospitalisation after hospitalisation … One-in-five will be back in hospital within a month and most will be rehospitalised within 12 months,” he said.
He noted that results from the VICTORIA Study, in which he was a co-investigator, showed that compared to standard of care therapy, Verquvo showed a 10% relative risk reduction in the primary composite endpoint of death from cardiovascular causes or first hospitalisation for heart failure. In the high-risk HFrEF patient population, this translated to an Annualised Absolute Risk Reduction of 4.2% compared to standard of care.
“This means that for every 24 patients treated with Verquvo for one year, we can prevent one hospitalisation or death due to heart failure. This is on top of the benefit already delivered by standard or care therapy,” said Professor Sindone.
Another major PBS update for 1 December is an amended listing for evolocumab (Repatha) for hypercholesterolaemia to allow initial prescribing by a GP in consultation with a specialist physician
Mr Butler said the change would apply to about 10,000 patients per year who would otherwise be paying about $3,700 for every course of evolocumab, which is given by subcutaneous injection every two weeks or four weeks.
“Now that will have a huge impact particularly for people who are living in rural and regional Australia, or even in our outer suburbs in the cities who don’t have ready access to a specialist,” he said.