Ten new PBS listings mark access boost to treatments for rare and serious conditions

Ten new medicines will be added to the Pharmaceutical Benefits Scheme (PBS) from 1 July, expanding subsidised access to treatments for severe asthma, cancer, diabetes, growth hormone deficiency, autoimmune disease and anaphylaxis, Federal Health Minister Mark Butler has announced.

AstraZeneca’s first-in-class biologic monthly injection Tezspire (tezepelumab) will be listed on the PBS for the first time to treat patients aged 12 years and older with severe uncontrolled asthma (SUA) that is eosinophilic or allergic. The company’s Tagrisso (osimertinib) will also receive an expanded listing for the treatment of epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC) and unresectable Stage III NSCLC following chemoradiation.

Novo Nordisk’s Sogroya (somapacitan) will be listed for the first time to treat children with growth hormone deficiency (GHD). The long-acting growth hormone treatment is administered weekly and supports normal growth while removing the need for daily injections. More than 650 Australian children are expected to benefit from this listing each year. The company’s Tresiba Penfill (insulin degludec) will also be reimbursed to treat patients with Type 1 diabetes mellitus (T1DM).

UCB’s Rystiggo (rozanolixizumab) will be PBS listed for the first time to treat adults with generalised myasthenia gravis (gMG), a competitor to Alexion’s Ultomiris (ravulizumab rch) which was reimbursed in March. gMG is a rare, debilitating autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. Around 3,000 Australians are estimated to be living with the rare disease and approximately 80% are AChR Ab+.

Roche’s Alecensa (alectinib) will receive an expanded listing for the treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Around 440 Australians are expected to benefit from this listing each year. The company’s Perjeta (pertuzumab) will also be expanded for the treatment of high-risk human epidermal growth factor receptor 2-positive (HER2+) early breast cancer. More than 3,300 Australians are expected to benefit from this listing each year.

Reach Pharmaceuticals’ Romidepsin-Reach will be reimbursed for the first time to treat adult patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior drug therapy such as chemotherapy or radiotherapy. PTCL is a rare type of blood cancer and last year around 70 patients accessed a comparable treatment through the PBS.

Taiho Pharma Oceania’s Lytgobi (futibatinib) will be listed for the first time for the treatment of patients with previously-treated advanced or unresectable cholangiocarcinoma (CCA) with fibroblast growth factor receptor 2 (FGFR2) gene alterations. CCA is a rare and aggressive bile duct cancer with around 70 Australians expected to benefit from this listing each year.

CSL Seqirus’ Neffy nasal spray will be listed to treat children over 4 and adults at significant risk of anaphylaxis. The needle-free treatment is a new form of adrenaline (epinephrine) for the emergency treatment of acute severe allergic reactions in children over 4 years and 15 kg, and adults at significant risk of anaphylaxis.

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