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Posted 18 July 2023 AM
The Australian government has kicked off the first half of 2023 by listing 31 submissions recommended by the PBAC over the past two years, a Pharma in Focus analysis shows.
The analysis looked at submissions ranging from newcomers to additional indications for already subsidised drugs recommended by the PBAC from May 2021 to May 2023.
Apart from STADA's once-daily Parkinson's disease treatment Ongentys all the drugs listed over the past six months were recommended by the PBAC in 2022.
Roche's Vabysmo was listed for two indications - diabetic macular oedema and wet age-related macular degeneration - both recommended by the PBAC at its intracycle meeting in May 2022 the first-time around.
While the highly anticipated eye treatment had a reasonably slow start earning just $9.9 million for its first three months, it earned almost as much in May alone, pulling in $8.2 million.
Other PBS berths over the past six months include Biomarin's dwarfism drug Voxzogo, Sun Pharma's Cequa for chronic and severe dry eye with keratitis, and Novartis' Scemblix for Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase.
Novartis believes Scemblix is among eight drugs with billion-dollar-plus potential.
Meanwhile, Sun Pharma's Yonsa MPRED for prostate cancer also scored a listing, sparking competition with Janssen's Zytiga.
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Other new listings include Janssen's subcutaneous formulation Darzalex SC for amyloid light-chain amyloidosis, and Chiesi's asthma inhalers Fostair 200/6 and Trimbow 200.
Two eye drug generics - AFT Pharmaceuticals' VIZO-PF Dorzolatim and Petrus Pharmaceuticals' Optix - were also listed along with Celltrion Healthcare's adalimumab biosimilar Yuflyma, touted as a 'pain-free' option.
Expansions
The remaining 18 PBS listings for the first half of 2023 went to drugs previously subsidised in Australia.
MSD's Keytruda, which is forecast to become the world's top-selling drug this year, snagged two new indications covering endometrial cancer and renal cell carcinoma.
Meanwhile, BMS' Opdivo, another PD-1 inhibitor, was expanded in oesophageal carcinoma or gastroesophageal junction carcinoma. The drug scored an additional melanoma indication when used in combination with the company's Yervoy.
Notably, Janssen's Stelara, Celgene's Zeposia and AbbVie's Rinvoq all added ulcerative colitis indications.
Restrictions were also changed for two thrombopoietin-receptor agonists - Novartis' Revolade and Amgen's Nplate.
Novartis also secured two indications for Jakavi across graft versus host disease and expanded its ADHD drug Ritalin LA to include patients who are diagnosed after the age of 18.
The remaining expansions include Antengene's Xpovio in relapsed and/or refractory multiple myeloma, Janssen's Erlyand in prostate cancer, BioMarin's Kuvan in phenylketonuria, Chiesi's Epidyolex in Lennox-Gastaut syndrome, and GSK's Nucala in chronic rhinosinusitis with nasal polyps.
Vertex's cystic fibrosis triplet therapy Trikafta was also expanded for children aged six to 11 years old.
Tiffany Walker
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