Major Updates from the Pharmaceutical Benefits Advisory Committee
The Pharmaceutical Benefits Advisory Committee (PBAC) has made several recommendations for drug listings on the Australian Pharmaceutical Benefits Scheme (PBS) after July 2023 meeting. Some highlights include:
Recommended Drugs
Adalimumab (Ardalicip) has been recommended for listing in the form of 40 mg in 0.4 mL pre-filled syringe (PFS) and pre-filled pen (PFP) and 80 mg in 0.8 mL PFS as biosimilar brands of Humira. The PBAC advised the equi-effective doses to be 1 mg of Ardalicip = 1 mg of Humira and all other biosimilar brands and formulations of Adalimumab. The PBAC has also recommended extending the listing of Dapagliflozin for the treatment of patients with chronic heart failure. Enoxaparin (Exarane and Exarane Forte) as biosimilar has been recommended for listing on the General Schedule on a cost-minimisation basis. Lastly, Mirikizumab (MIRI) has been recommended for the treatment of moderate to severe ulcerative colitis (MSUC), and Tafamidis has been recommended for the treatment of transthyretin amyloid cardiomyopathy. The PBAC considered that the incremental cost-effectiveness ratio for Tafamidis was high, but would be acceptable at the lower price proposed in the pre-PBAC response, in the context of the high unmet need for this patient population.
Not Recommended Drugs
Despite the evident need for new treatments, the PBAC did not recommend the listing of several drugs. These include Olipudase alfa for the treatment of acid sphingomyelinase deficiency (ASMD) type A/B or type B, Patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy, Rimegepant for the acute treatment of adults with migraine, Selpercatinib for the treatment of RET fusion-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), and Tirzepatide for the treatment of adult patients with inadequately controlled type 2 diabetes (T2D). Tirzepatide for the treatment of adult patients with inadequately controlled T2D as dual therapy in combination with metformin was not recommended. The PBAC considered that Tirzepatide 10 mg once weekly and Tirzepatide 15 mg once weekly was superior in terms of effectiveness for glycaemic benefits and short-term weight loss compared to semaglutide 1 mg once weekly.
Withdrawn
The application for the listing of Foslevodopa with Foscarbidopa for the treatment of advanced Parkinson’s disease was withdrawn.
The PBAC plays a crucial role in the assessment of medicines in terms of their comparative effectiveness, safety and cost-effectiveness. These recommendations are an important step in ensuring that Australians have access to necessary and affordable medicines.