Groundhog day for Evusheld’s PBS quest

4 minute read

Also in the latest PBAC outcomes, MTX recommendations to the paeds rheum inquiry get a tick.

The outcomes of the December 2022 PBAC intracycle meeting were released at the end of January, with some recommendations to potentially benefit the rheumatology community. 

SC MTX and ondansetron for kids 

In good news for paediatric rheumatology, a request to include children with juvenile idiopathic arthritis in the PBS listing for subcutaneous methotrexate in pre-filled syringes was recommended. PBAC acknowledged that oral and vial forms of methotrexate weren’t always suitable for children, and this provided another option.  

PBAC also recommended expanding the PBS listing of the antiemetic and antinauseant ondansetron to children taking methotrexate for rheumatic diseases. 

These were among the recommendations put forward by the Australian Paediatric Rheumatology Group in its submission to the parliamentary standing committee inquiry into childhood rheumatic diseases

Noting that some of the PBS restrictions on prescribing medicines to this patient group were “a barrier to international best practice”, the group’s recommendations included “[extending] PBS-approval to include subcutaneous methotrexate for JIA and other rheumatic disease and ondansetron for methotrexate-induced nausea in paediatric rheumatic disease” [4.1.4]. 

Evusheld PBS quest knocked back … again 

A resubmission from AstraZeneca to get tixagevimab + cilgavimab (Evusheld) listed on the PBS was unsuccessful, with the listing request for pre-exposure covid prophylaxis in immunocompromised people aged 12 and over with a 300-300mg dose not recommended. 

The request was first submitted at the September 2022 intracycle meeting where it was not recommended pending further consideration by the TGA regarding the efficacy and safety of the 300-300mg dose. Information since provided by AstraZeneca didn’t sway the committee.  

The PBAC also raised uncertainties about the future usefulness of Evusheld in the context of new and emerging variants. In the US, Evusheld is no longer authorised by the FDA as a pre-exposure prophylactic on the basis that it’s unlikely to be effective against more than 90% of currently circulating variants and the risks may outweigh the benefits. 

Increased HZ risk with JAKi over biologics 

A post-market review of herpes zoster infection in patients taking biologics and JAK inhibitors for conditions including rheumatoid conditions, psoriasis, inflammatory bowel disease and multiple sclerosis found increased risk for patients on JAKi. The PBAC noted that the findings were consistent with results of other studies. 

GCA diagnosis with ultrasound for tocilizumab prescription 

A request to extend the imaging diagnostic criteria for giant cell arteritis to include ultrasound was recommended. 

November PBAC outcomes 

Among the November PBAC outcomes, released at the end of 2022, the following are relevant to rheumatologists: 

Adalimumab (Humira – AbbVie) Request current authority listings for Humira be changed to align with those for adalimumab biosimilars for all indications except JIA – not recommended.  

Upadacitinib (Rinvoq – AbbVie) 

  • Request listing for subsequent continuing treatment change from written authority to streamlined authority for severe active RA – not recommended.  
  • Request written authority listing for non-radiographic axial spondyloarthritis – deferred pending TGA Delegate’s overview. 

Deucravacitinib (Sotyktu – BMS) Request PBS listing for treatment of severe chronic plaque psoriasis – deferred, pending further clinical advice.  

Etanercept (Nepexto – Alphapharm) Request new PBS listing under the same conditions as the reference biologic fpr RA, JIA, PsA, plaque psoriasis and ankylosing spondylitis – recommended.  

Infliximab (Remsima – Celltrion) Request change to PBS listing to include initial treatment of severe active rheumatoid arthritis – recommended. 

Risankizumab (Skyrizi – AbbVie) Request new written authority listing for treatment of Crohn disease – recommended.  

Upadacitinib (Rinvoq – AbbVie) Request written authority listing for treatment of moderate to severe ulcerative colitis in patients non-responsive to or unable to take conventional therapies.   

You can see the full November PBAC meeting outcomes here

March agenda 

  • Anifrolumab (Saphnelo, AstraZeneca) – written authority listing for severe systemic lupus erythematosus – resubmission (the initial submission in July 2022 was not recommended). 
  • Apremilast (Otezla, Amgen Australia) – streamlined listing for severe active psoriatic arthritis. 
  • Bimekizumab (Bimzelx, UCB) – written authority listing for chronic plaque psoriasis. 
  • Tildrakizumab (Ilumya, Sun Pharma) – request to allow eligible patients in clinical trials to transition to PBS-subsidised tildrakizumab for chronic plaque psoriasis. 
  • Tofacitinib (Xeljanz, Pfizer) – request written authority listing for ankylosing spondylitis and JIA. 
  • Varicella zoster virus recombinant vaccine (Shingrix, GSK) – request National Immunisation Program listing for adults 65 years and older and Aboriginal and Torres Straight Island adults aged 50 and older. 

PBAC will also be looking at the impact of regulatory reforms and PBS listing changes for opioid analgesics based on the drug utilisation sub-committee (DUSC) analysis. 

The full March PBAC meeting agenda is here

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