Positive PBAC recommendations announced in CVD, migraine, prostate cancer, IBD and fertility

Pharma News: The outcomes from the July 2022 Pharmaceutical Benefits Advisory Committee (PBAC) meeting are now available and indicate positive recommendations for Bayer, Lundbeck, Janssen, Gedeon Richter and Ferring therapies.

Bayer welcomes the recommendation to include Verquvo (vericiguat) on the PBS for use in addition to standard of care therapy for adults 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.

Ashraf Al-Ouf, General Manager of Pharmaceuticals for Bayer ANZ, said “Each day 179 Australians are hospitalised due to heart failure and more than a quarter of these patients will be re-hospitalised within one year. With an ageing population and hospitals under pandemic related strain, it is now more important than ever to prevent repeat hospitalisations for Australians with heart failure with reduced ejection fraction.”

This recommendation follows registration of the first-in-class therapy for heart failure in late 2021, as well as 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.

The PBAC recommended the listing of Lundbeck‘s IV administered Vyepti (eptinezumab) for the treatment of chronic migraine in patients who have experienced an inadequate response, intolerance or a contraindication to at least three (3) prophylactic migraine medications.

Eli Lilly’s Emgality (galcanezumab), subcut monthly injection, was first to be reimbursed in Australia in 2021 followed by Teva’s Ajovy (fremanezumab), subcut monthly/quarterly injection. Novartis withdrew Aimovig (erenumab) from the PBS process in 2019.

The PBAC recommended the listing of Janssen‘s Stelara (ustekinumab) for the treatment of moderate to severe ulcerative colitis (UC). The PBAC Committee considered the claim of non-inferior comparative effectiveness and safety to Takeda’s Entyvio (vedolizumab) and superior comparative effectiveness to AbbVie’s Humira (adalimumab) were reasonable. The cost of Stelara should be no greater than the cost of the alternative therapies (excluding Humira) over two years.

Janssen‘s Erlyand (apalutamide) has also been recommended for PBS listing in metastatic hormone sensitive prostate cancer (mHSPC), adding to its current indications in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic, castration-resistant prostate cancer (nmCRPC).

The Prostate Cancer Foundation of Australia (PCFA) said “This is the major first step toward convincing the new Health Minister to get this life-extending precision medicine listed. If we’re successful, eligible men and families will save around $40,000 a year in prescription costs. This outcome follows a lengthy advocacy campaign by PCFA, with thousands of men likely to benefit over time.”

Erlyand plus androgen deprivation therapy (ADT) provides a “moderate clinical benefit” for patients with mHSPC compared to ADT alone. While the resubmission proposed that Erlyand be used in patients with low volume (LV) disease and those with high volume (HV) disease who were unsuitable for treatment with docetaxel, the PBAC recommended Erlyand for use in patients with mHSPC regardless of disease volume or suitability for docetaxel.

In fertility, the PBAC recommended listings for Gedeon Richter and Ferring products.

Gedeon Richter’s Cyclogest (progesterone 400 mg pessary) was established as non-inferior to Merck’s Crinone (progesterone) gel and has been recommended for use under the PBS Section 100 – IVF Program for the treatment of infertile women who require luteal phase support as part of an Assisted Reproductive Technology (ART) treatment cycle.

Ferring’s Menopur, a combination of human follicle-stimulating hormone (FSH) and luteinising hormone (LH), is currently available as a powder and solvent for solution for injection. The new liquid formulation for administration with disposable pre-filled injection pen (600 I.U and 1200 I.U) has been recommended for PBS listing.

Menopur is a competitor to Merck’s Pergoveris (recombinant follicle stimulating hormone (FSH) and lutropin alfa) and Gonal-f (follitropin alfa) which have already had prefilled pens in the market for improved ease-of-use. Gedeon Richter’s Bemfola (Gonal-f biosimilar) also comes in a prefilled pen.