24 February 2022

Regulatory review – November 2021 PBAC recommendations

Medications PBAC

We go through public announcements from recommendations by PBAC to the PBS for funding listing that might be of interest to the rheumatology community, keeping you alert to what’s on the horizon.

Note, recommendation does not mean immediate listing.

Decisions – November 2021 meeting

Adalimumab (Hulio – Alphapharm): request listing for all adalimumab indications – recommended.

Etanercept (Rymti – Alphapharm): request listing for all etanercept indications with exclusion of children and adolescents weighing less than 62.5 kg – recommended.

Rituximab (Ruxience – Pfizer): request listing for all rituximab conditions under same conditions as currently listed biosimilars Riximyo and Truxima – recommended.

More players in the biosimilar adalimumab, etanercept, and rituximab market: will that bring more competition or more confusion?

Eculizumab (Soliris – Alexion): resubmission to request an authority listing for the treatment of patients with relapsing neuromyelitis optica spectrum disorder who are anti-aquaporin-4 (AQP4) antibody positive – not recommended.

Very expensive drugs clearly need good reasoning, and this application in an adjacent area was no go second time of asking.

Ixekizumab (Taltz – Eli Lilly): request written authority listing for the treatment of nr-axSpA, under the same circumstances as currently PBS-listed bDMARDs for this indication – recommended.

Another option for nr-axSpA – now just to find the patients?

Mepolizumab (Nucala – GlaxoSmithKline): request authority listing for the treatment of chronic rhinosinusitis with nasal polyps – not recommended.

A broad indication like rhinosinusitis knocked back – is it time for EGPA patients to get access to a vasculitis dosing for mepolizumab?

Pregabalin (Lyrica – Upjohn): request streamlined authority listing for controlled-release formulation for treatment of refractory neuropathic pain – deferred.

Pregabalin (Pregabalin-AFT – AFT Pharmaceuticals): request streamlined authority listing for oral solution formulation under same conditions as existing listings of capsules – deferred.

Different formulations of pregabalin might be useful in pain patients for whom small things can make a big difference.

Secukinumab (Cosentyx – Novartis): request written authority listing for treatment of paediatric patients with psoriasis – recommended.

Good data has led to access for kids.

See the full November recommendations here.

Intracycle meeting – December 2021

Hydroxychloroquine sulfate (multiple brands sponsors): To consider reverting the listing of hydroxychloroquine to an unrestricted listing – recommended.

No more provider numbers given the rush on hydroxychloroquine has passed and lupus patients can live in peace.

See the full December recommendations here.

Agenda for consideration – March 2022

Apremilast (Otezia – Amgen): request to allow dermatology registrars to initiate treatment in consultation with dermatologist; allow GPs to prescribe maintenance treatment.

Bimekizumab (Bimzelx – UCB): request written authority listing for adults with moderate to severe plaque psoriasis.

Infliximab (Remsima – Celltrion): request authority listing for the treatment of ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis and refractory fistulising Crohn’s Disease.

Risankizumab (Skyrizi – AbbVie): request to allow eligible clinical trial patients to transition to PBS-subsidised Risankizumab; plus new listing for psoriatic arthritis.

Secukinumab (Cosentyx – Novartis): request listings of new forms of secukinumab under same conditions as current listing.

See the full March agenda here.