Regulatory review – July 2021 PBAC recommendations

3 minute read

We review the recommendations by PBAC to the PBS that are relevant to the rheumatology community.

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 – July 2021 meeting

Adalimumab (Abrilada – Pfizer): request listing for all adalimumab indications – recommended.

Another meeting, another biosimilar – and Pfizer brings the game to adalimumab…

Baricitinib (Olumiant – Eli Lilly): request written authority listing for severe atopic dermatitis – not recommended.

Upadacitinib (Rinvoq – AbbVie): request authority listing for severe atopic dermatitis – deferred.

Baricitinib and upadacitinib are both multitalented drugs, clearly, but it’s interesting how safety was flagged in the reasons cited for not listing them for this newly proposed indication.

Etanercept (Enbrel – Pfizer): request listings of dose dispenser cartridges under same conditions as currently listed pre-filled syringes – recommended.

Nothing like the pressure from biosimilars to create innovation in delivery devices…

Melatonin (Slenyto – Aspen): resubmission to request phone authority listing for insomnia treatment in patients aged 2 to 18 with Smith-Magenis syndrome – deferred

While this listing was for a rare developmental disorder, it shows that the melatonin SR S3 product (available from a pharmacist without a prescription) will help to bring the price down to a level where it might even be considered for our patients in the future.

Secukinumab (Cosentyx – Novartis): request to supply two months’ worth per repeat – not recommended.

Nice to try and find a point of difference by reducing the number of scripts required (and therefore the co-pay for patients), but no bingo on this particular avenue.

Siltuximab (Sylvant – Eusa): request for new authority-required listing for treating idiopathic multicentric Castleman’s disease (iMCD) – not recommended.  

This application, for an IL-6 inhibitor for a rare disease, might highlight where challenges and opportunities are for similar treatments for rare rheumatological conditions.

See the full July recommendations here.

Agenda for consideration – November 2021

Rituximab (Ruxience – Pfizer): new biosimilar listing under same conditions as reference biologic.

Adalimumab (Hulio – Alphapharm): new listing of adalimumab biosimilar under the same conditions as its reference biologic.

Etanercept (Rymti – Alphapharm): new listing of etanercept biosimilar under the same conditions as its reference biologic (except children and adolescents weighing less than 62.5 kg).

Yep, that’s yet another biosimilar manufacturer ready to enter the scramble.

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.

It’s back again – we’ll see how it goes, as it might be useful for a handful of lupus patients.

Ixekizumab (Taltz – Eli Lilly): request authority listing for treatment of nr-axSpA under same conditions as currently listed bDMARDs for this indication.

A likely new entrant to the nr-axSpA space, following in the lead of Cosentyx.

Mepolizumab (Nucala – GlaxoSmithKline): request authority listing for the treatment of chronic rhinosinusitis with nasal polyps.

If this gets through, the restrictions will dictate how likely EGPA patients will be to access this through this indication (for those who can’t already on the basis of their asthma).

Pregabalin (Lyrica – Upjohn): request new streamlined listing for tablets and oral solution to treat neuropathic pain in adults refractory to other drugs.

An oral solution and controlled release formation would give more options for pregabalin.

Secukinumab (Cosentyx – Novartis): request new authority listing for paediatric patients with psoriasis.

Paediatric secukinumab is now on the table, after data was presented at EULAR 2021.

See the full November agenda here. Closing date for consumer comments is 22 September 2021.

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