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Posted 11 March 2024 AM
Sixteen drugs are in line to secure government subsidy next month after entering the last stage before PBS listing occurs, exclusive Pharma in Focus analysis shows.
The analysis looked at drugs recommended over the past three years that have reached the 'government processes' stage.
On the list are four drugs which could make a PBS debut, including three hyped heart drugs - BMS' Camzyos, Novartis' Leqvio, and Pfizer's Vyndamax.
It took each company at least three submissions to secure a recommendation from the PBAC in 2023 for their innovative drugs, which have all previously been forecast to reach blockbuster status.
Novartis acquired Leqvio, a first-in-class RNAi-based PCSK9 inhibitor, when it bought The Medicines Company for US$9.7 billion in 2020.
It was recommended for the third-line treatment of heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia with atherosclerotic cardiovascular disease at the PBAC's May 2023 meeting.
Meanwhile, Camzyos is the centrepiece of BMS' US$13.1 billion acquisition of MyoKardia in 2020, targeting the underlying cause of obstructive hypertrophic cardiomyopathy (HCM).
It was recommended at the November 2023 meeting for adults with symptomatic obstructive HCM with the PBAC noting that it was "the first drug to have proven benefits over placebo in HCM".
Similarly, Pfizer bought Vyndamax from Akcea Therapeutics in a deal worth up to US$1.5 billion. It has been recommended by the PBAC for patients with transthyretin amyloid cardiomyopathy, with New York Heart Association class I-II.
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The fourth contender hoping to secure a PBS berth is ViiV Healthcare's long-acting HIV PrEP Apretude.
Other potential PBS listings
Meanwhile, Orion Pharma has two asthma and COPD inhalers nearing PBS listing - Bufomix Easyhaler targeting AstraZeneca's Symbicort Turbuhaler and Salfumix Easyhaler targeting GSK's Seretide Accuhaler.
The remaining listings cover expansions, including Eli Lilly's kinase inhibitor Verzenio in combination with standard adjuvant endocrine therapy for the treatment of HR+, HER-, lymph node positive, invasive, resected early breast cancer at high risk of disease recurrence.
The breast cancer treatment earned Lilly over $36.4 million in pre-rebate PBS benefits in 2023.
GSK is also looking to expand Zejula for maintenance therapy in patients with newly diagnosed HRD positive BRCA wild type advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
The PARP inhibitor, which was first listed in September 2022 for high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients with BRCA1/2 pathogenic gene variants earned GSK just over $1.3 million in pre-rebate PBS benefits last year.
Sanofi's application for Libtayo has also reached the government processes stage for adults with metastatic non-small cell lung cancer when used with a platinum doublet chemotherapy.
The company offloaded the PD-1 inhibitor to Regeneron in 2022, and receives an 11 per cent royalty on worldwide net sales of the drug.
AbbVie is also close to adding two new forms of its IL-23 inhibitor Skyrizi (150mg in 1 mL pre-filled syringe and 150 mg in 1 mL pre-filled pen) for chronic plaque psoriasis and changing the restriction level of its JAK inhibitor Rinvoq for the treatment of severe active rheumatoid arthritis.
Pfizer is seeking listing of a pre-filled syringe form of its injectable hormonal medication Depo-Provera while Gedeon Richter is looking to list a pre-filled pen form of its osteoporosis treatment Terrosa.
Meanwhile, Generic Health's Teriparatide Lupin is one step off becoming the first generic version of Terrosa listed on the PBS.
The maximum quantity of Merck Healthcare's Ovidrel could soon be increased for infertility indications other than that of assisted reproductive technology while MSD is still seeking the removal of a requirement from its scabies treatment Stromectol for patients who identify as Aboriginal or Torres Strait Islanders.
However, it's worth noting that the MSD application was recommended in November 2021 and has been sitting in the government processes stage for more than two years.
Tiffany Walker
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