Latest PBAC meeting roundup – Novartis, Vertex, MSD, Kyowa Kirin

Pharma News: The recommendations from the March 2021 Pharmaceutical Benefits Advisory Committee (PBAC) meeting were published on Friday 23 April 2021 paving the way for potential drug listings for patients with advanced cancer, multiple sclerosis and macular degeneration.

Novartis

Novartis welcomes the PBAC’s positive recommendation of Kesimpta (ofatumumab) to be subsidised under the PBS which was approved by the Therapeutic Good Administration (TGA) last month for the treatment of relapsing forms of multiple sclerosis (MS).

According to MS Australia “A key distinction is that ofatumumab can be self-administered by monthly injection at home rather than requiring hospital infusion. Therefore, this treatment regime provides a potentially convenient option for people with relapsing MS, particularly to those located remotely.”

Another good news story for Novartis was in relation to its ophthalmic drug.

A Novartis spokesperson told Health Industry Hub “Novartis welcomes the decision of the PBAC to recommend the listing of Beovu (brolucizumab) on the PBS for the treatment of subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD) in patients who have persistent disease despite prior anti-VEGF treatment. Novartis will work closely with the Department of Health to allow Beovu to be accessible in a timely manner for eligible Australians.”

In a competitive market against Bayer’s Eylea, Novartis’ Beovu could help minimise treatment burden, with more than 50% of patients maintained on 12-weekly dosing intervals immediately after the loading phase to week 48.

MSD and Pierre Fabre

The PBAC recommended MSD’s Keytruda (pembrolizumab) for listing on the PBS as first line treatment of unresectable and metastatic deficient mismatch repair (dMMR) bowel cancer.

However, the PBAC deferred the listing of Pierre Fabre’s Braftovi (encorafenib) in bowel cancer until the Medical Services Advisory Committee (MSAC) lists the co-dependent BRAF V600 biomarker test on the Medicare Benefits Schedule (MBS).

Vertex

At its March meeting, the PBAC acknowledged the significant benefit that Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) can bring to Cystic Fibrosis (CF) patients but deferred a decision regarding PBS funding.

A Vertex spokesperson told Health Industry Hub “Along with the CF community, Vertex was hopeful for a first time PBAC recommendation, particularly given the company’s involvement in the Alignment Pilot being conducted by the Therapeutic Goods Administration (TGA) and the PBAC, which has the overall objective of aligning the regulation and reimbursement process to ensure patients have access to medicines as soon as possible.

“We understand how important it is to people living with CF, their families, and physicians to be able to rapidly access innovations in CF treatments and our mission is to secure the broadest sustainable access supported by the scientific evidence available.

“The Australian Cystic Fibrosis Disease Registry indicates that around 2,200 people aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene could potentially benefit from Trikafta.

“While Vertex acknowledges that this deferral was not the outcome people living with CF were hoping for, we are committed to continuing to work collaboratively with the PBAC to ensure all eligible patients who can benefit from treatment have government-funded access to Trikafta as quickly as possible.”

Kyowa Kirin

Kyowa Kirin Australia was disappointed by the PBAC decision to not recommend the reimbursement of the rare disease medicine Crysvita (burosumab) for the treatment of children with X-linked hypophosphataemia (XLH).

“It’s certainly not the outcome anyone in the XLH community was hoping for, but Kyowa Kirin remains committed to securing the reimbursement of Crysvita, and work is already underway on a new PBAC submission,” said General Manager of Kyowa Kirin Australia, Simon Dawson.

“Importantly, the PBAC has shown a genuine interest in better understanding the impact of XLH on the lives of patients. We will continue to work with the Committee through what has often been shown to be a challenging reimbursement process for rare disease medicines,” said Mr Dawson.

Other PBAC positive recommendations included:

• Eli Lilly Verzenio in HR+ HER2- locally advanced or metastatic breast cancer
• Takeda’s Adcetris for the treatment of patients with previously untreated CD30 positive peripheral T-cell lymphoma
• Seqirus’ Ikervis in severe keratitis with dry eye disease
• UCB’s Vimpat for the treatment of idiopathic generalised epilepsy
• Bristol-Myers Squibb’s Opdivo + Yervoy in malignant pleural mesothelioma (MPM)
• Roche’s Evrysdi in spinal muscular atrophy (SMA)
• Abbvie’s Rinvoq for the treatment of ankylosing spondylitis (AS)