Highlights from July PBAC meeting agenda

Pharma News: The agenda for the July 2024 Pharmaceutical Benefits Advisory Committee (PBAC) meeting is now accessible, with submissions in oncology, women’s health, vaccines, mental health, and migraine therapy, among others.

Oncology

With a focus on blood cancers, Pfizer aims to secure a PBS listing for Elrexfio (elranatamab), a BCMA-targeted bispecific drug currently undergoing multiple phase 3 trials. These trials encompass newly diagnosed patients, evaluating Elrexfio’s efficacy as both a post-transplant maintenance treatment and a viable option for transplant-ineligible patients.

Lilly has put forward a resubmission for Retevmo (selpercatini) for the treatment of advanced or metastatic, rearranged during transfection (RET) fusion-positive NSCLC. The phase 3 LIBRETTO-431 study demonstrated a significant reduction in the risk of progression or death by 53.5% when compared to the Keytruda-chemo combination in newly diagnosed patients. Retevmo exhibited impressive results, more than doubling the median progression-free survival time to 24.8 months, in contrast to 11.2 months for patients receiving Keytruda-chemo.

Takeda is pursuing reimbursement for the metastatic colorectal cancer (mCRC) drug Fruzaqla (fruquintinib), following its acquisition through a $1.1 billion deal with Hutchmed last year. Results from a global trial involving nearly 700 heavily pre-treated patients revealed a 34% reduction in the risk of death compared to placebo.

Women’s Health

Amidst the focus on improving endometriosis care, including the establishment of 20 Endometriosis and Pelvic Pain Clinics, the Endometriosis Management Plan, and the final year of the first National Action Plan for Endometriosis (NAPE), Bayer’s application for the PBS listing of Visanne (dienogest) comes at an opportune time.

Despite its efficacy, Visanne remains financially inaccessible for many women with endometriosis due to its price tag ranging from $70 to $120 per month. This cost burden exacerbates the challenges faced by individuals who may already be managing other chronic conditions. In line with its commitment to women’s health, the company is also seeking reimbursement for its long-term oral contraceptives Yaz and Yasmin.

Mental Health

Janssen has made a resubmission for Spravato (esketamine) in the treatment-resistant depression. Last year, during the re-evaluation process, the PBAC identified several uncertainties concerning the management of episodic treatment, the effects of treatment discontinuation in responders, and the potential extension of usage beyond the initially proposed 12-month period – topics not raised in prior submissions.

Professor Colleen Loo from the Black Dog Institute and UNSW Sydney has highlighted the potential off-label use of generic ketamine, citing a recent systematic review and meta-analysis of generic ketamine versus Spravato for the treatment of depression.

Vaccines

Sanofi and GSK are pursuing reimbursement for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease. Sanofi’s focus is on Beyfortus in neonates and infants born during or entering their first RSV season, extending to children up to 24 months of age. Conversely, GSK is targeting patients aged 60 years and over with Arexvy.

Drug Utilisation Sub Committee (DUSC) 

In response to persistent medicine shortages adversely affecting patient care and reports from the DUSC, the utilisation of PBS-listed chronic migraine treatments Emgality (Lilly) and Ajovy (Teva) will be under review. Furthermore, the assessment will extend to the utilisation of Novo Nordisk’s Ozempic (semaglutide) and other glucagon-like peptide 1 (GLP-1) analogues for treating type 2 diabetes mellitus (T2DM).

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