The biological DMARD baricitinib (Olumiant) has been recommended for listing on the PBS as an alternative option to currently PBS-listed bDMARDs for severe RA.
The drug overcame concerns raised about safety when its application was initially evaluated by the PBAC, which deferred its decision pending a TGA review.
“The PBAC was of a mind to reject baricitinib for treatment of severe RA based on uncertain clinical need and efficacy and concerns about the safety profile, particularly in relation to serious adverse events,” the committee stated in its report from its July 2017 meeting.
However at its March 2018 meeting the Eli Lilly drug won approval, albeit on the basis of cost minimisation against the least expensive bDMARD rather than against the requested comparator drug, tofacitanib.
At the March meeting a biosimilar etanercept product, Erelzi (Sandoz), was recommended for PBS listing as an alternative to the reference brand Enbrel for indications including RA, juvenile idiopathic arthritis (JIA) and juvenile plaque psoriasis (JPP).
The drug could be marked as equivalent (‘a’ flagged), and have biosimilar uptake drivers similar to those that apply to Merck’s Brenzys brand of etanercept for the adult indications (RA, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis), the committee recommended.
The biosimilar uptake drivers would include a streamlined authority listing for subsequent continuing prescribing and having a note in the restriction regarding biosimilar uptake.
The PBAC noted that Brenzys and other biosimilars are not listed for juvenile indications such as juvenile idiopathic arthritis (JIA) and paediatric plaque psoriasis. Since the Erelzi brand is TGA registered for these indications, the PBAC recommended that “similar to the adult indications, the restrictions for JIA and JPP be remodelled to facilitate the application of biosimilar uptake drivers to these Erelzi listings.”
The PBAC has also recommended the listing of the Sandoz biosimilar brand of rituximab (Riximyo) as an equivalent alternative to the IV infusion reference brand of rituximab (MabThera) marketed by Roche for rheumatoid arthritis.
The committee recommended that biosimilar uptake measures could apply, including a lowering of authority level for RA indications from written to streamlined authority at the subsequent continuing phase for RA. A note encouraging prescribing of the biosimilar brand to treatment naïve patients, would be appropriate for all indications, the PBAC advised.