PBS changes for sarilumab and febuxostat

Sarilumab, a monoclonal antibody targeting interleukin-6 receptor alpha (IL-6Rα), has been recommended for PBS listing for patients with rheumatoid arthritis.

The Pharmaceutical Benefits Advisory Committee (PBAC) has backed an application by Sanofi-Aventis for sarilumab injection 200 mg (Kevzara) to receive an Authority Required listing for the treatment of patients with severe active RA.

At its November meeting the PBAC recommended the listing of sarilumab on the basis that it was as cost effective as other biological disease modifying antirheumatic drugs (bDMARDs) such as tocilizumab in RA.

The PBAC also recommended that Pfizer’s tocilizumab 5mg tablets (Xeljanz) receive an Authority Required PBS listing for the treatment of patients with severe active psoriatic arthritis who have had an inadequate response to methotrexate and DMARDs.

Other recommendations made by the committee include easing of PBS restrictions on the gout drug febuxostat from Authority Required (telephone) to Authority Required (STREAMLINED).

The PBAC based the decision on a recent Drug Utilisation Sub-Committee (DUSC) review that found fewer patients had used febuxostat than predicted since it was first listed on the PBS in 2017.

A decision on an application by Merck Sharp & Dohme to ease restrictions on the PBS criteria for the etanercept biosimilar (Brenzys) was deferred.

MSD had requested changes to the current Initial 1, Initial 2 and First Continuing restrictions for Brenzys, including changing the restriction level to allow telephone authority listing for indications such as severe active RA, ankylosing spondylitis severe psoriatic arthritis and severe chronic plaque psoriasis.

The PBAC said it had deferred its consideration of the proposed biosimilar uptake drivers and requested the Department of Health to engage in broader biosimilar policy discussions “to determine the feasibility of the request for additional uptake drivers from a policy and implementation perspective regarding these requests.”

The committee also rejected an application for a PBS listing for the osteoporosis drug romosozumab (Evenity) by Amgen.

The PBAC stated it would not recommend the listing of romosozumab for the treatment of severe osteoporosis due to uncertainties in the clinical claims and the financial estimates compared to therapies such as teriparatide and alendronate.

In addition the PBAC “considered the risk of cardiac adverse events with romosozumab may be more manageable in a small population of patients with a higher level of fracture risk and more limited alternative treatment options.”

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