20 August 2021 - Recommendations made by the PBAC in July 2021 relating to the listing of medicines on the PBS are now available.

In the end, the PBAC considered 48 submissions (35 initial, 13 resubmissions). Two submissions were withdrawn:

• Nivolumab (Opdivo) for gastric cancer/oesophageal cancer
• Inclisiran (Leqvio) for hypercholesterolaemia

The 48 submissions yield 76 outcomes. The following submissions yielded more than one outcome:

• Adalimumab (Abrilada) - new biosimilar medicine (multiple diseases)
• Bortezomib (Bortezomib Juno) - new formulation (multiple patient populations)
• Bortezomib (DBL Bortezomib) - new formulation (multiple patient populations)
• Cedazuridine with decitabine (Inqovi) - new combination product (multiple diseases)
• Etanercept (Enbrel) - new formulation (multiple diseases)
• Follitropin alfa (Ovaleap) - new biosimilar medicine (multiple patient populations)
• Secukinumab (Cosentyx) - restriction change (multiple diseases)
• Trabectedin (Yondelis) - new medicine (multiple patient populations)
• Zanubrutinib (Brukinsa) - new medicine (multiple patient populations - Waldenström's macroglobulinaemia)

The outcome for the submission for lumacaftor with ivacaftor (Orkambi) has been classified as a deferral.

The 76 outcomes are comprised of:

• 53 recommendations (70%)
• 16 rejections (21%)
• 7 deferrals (9%)

Insights:

• The PBAC rejected the submission for baricitinib (Olumiant) for adults with severe atopic dermatitis. The Committee is of the view that it is inferior to dupilumab and as such its clinical place is unclear. The PBAC deferred the submission for upadacitinib monohydrate (Rinvoq) for adults with severe atopic dermatitis. The Committee was of a mind to recommend 15 mg and 30 mg upadacitinib monohydrate on a cost minimisation basis compared to dupilumab, pending receipt of a positive TGA Delegate’s Overview.
• The PBAC recommended the PBS listing of budesonide with eformoterol fumarate dihydrate and glycopyrronium bromide (Breztri Aerosphere) for maintenance treatment of moderate to severe chronic obstructive pulmonary disease that is not adequately treated by a combination of an inhaled corticosteroid with long-acting beta2-agonist or a long-acting beta2-agonist with a long-acting muscarinic antagonist on the basis that it should be no greater than the lowest price combination of the PBS listed components of the triple therapy that are available for patients with chronic obstructive pulmonary disease.
• The PBAC recommended the PBS (Section 100) listing of elexacaftor with tezacaftor and ivacaftor (Triakfta) for the treatment of patients aged 12 years and older with cystic fibrosis who have one F508del mutation and one minimal function mutation in the CFTR gene (F/MF population). In March 2021, the PBAC deferred a submission from Vertex Pharmaceuticals for Trikafta for five patient populations.
• The PBAC recommended the PBS listing of hydrocortisone (Alkindi) for replacement therapy of adrenal insufficiency for patients aged six or younger. The Committee considered that the magnitude of the price requested by Chiesi was not adequately justified however, considered that Alkindi would be adequately cost effective if listed with a modest price advantage compared to the existing 4 mg tablets.
• The PBAC deferred the PBS listing of lorlatinib (Lorviqua) for the treatment of patients with locally advanced or metastatic anaplastic lymphoma kinase positive non-small-cell lung cancer. The Committee was of a mind to recommend the Authority Required line-agnostic listing of lorlatinib if it were cost minimised against the least costly alternative therapies (alectinib hydrochloride, brigatinib, ceritinib) but not crizotinib.
• The PBAC recommended the PBS (Section 100) listing of ravulizumab for the treatment of patients with paroxysmal nocturnal haemoglobinuria. The Committee noted that eculizumab is currently funded on the Life Saving Drugs Program. The PBAC considered the submission for ravulizumab provided an opportunity to reassess the cost effectiveness of eculizumab for listing on the PBS; the Committee concluded that eculizumab would be appropriate for inclusion on the PBS at a reduced price. The PBAC advised ravulizumab be listed on the basis of a cost minimisation to eculizumab.
  
• The PBAC did not recommend the listing of zanubrutinib (Brukinsa) for the treatment of adults with Waldenström's macroglobulinaemia who are treatment naïve and unsuitable for chemo-immunotherapy (first-line) and those with relapsed/refractory disease who have received at least one prior therapy (later-line). The Committee acknowledged the meaningful consumer support and engagement with regards to this submission, including a consumer hearing with patient group representatives held prior to the PBAC meeting.
  

Additional insights from the July 2021 PBAC meeting will be published in future issues of MAESTrO Daily.

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