PBAC has recommended expanded eligibility for free Shingrix, rheumatologist prescribing of apremilast and secukinumab for hidradenitis suppurativa.
Dermatology patients aged 18-64 years taking immunosuppressive medications are among the key beneficiaries of the November 2023 PBAC recommendations.
Many patients on medications including biologics, JAK inhibitors and other immunosuppressive medications missed out on free Shingrix when it was first listed on the National Immunisation Program in November last year, leaving them immunocompromised and at risk of herpes zoster infection.
PBAC has now expanded eligibility under the NIP to include people on a broad range of immunosuppressant medications.
Other outcomes of the November 2023 PBAC meeting include recommendations for rheumatologist and rheumatology registrar initial prescribing of apremilast for plaque psoriasis patients, although GPs did not get the nod.
Patients with hidradenitis suppurativa have the welcome addition of another biologic treatment in secukinumab, while patients with squamous cell carcinoma not responsive to surgical or radiotherapy treatment may now be able to access the melanoma treatment, pembrolizumab.
November 2023 PBAC meeting outcomes
Among the PBAC outcomes, the following are relevant to dermatologists. Note that recommendation does not mean immediate PBS listing.
Adalimumab (Hadlima – Organon): request a general schedule authority required (written) listing for two new doses of the biosimilar – 40mg in 0.4mL pre-filled syringe and 40mg in 0.4mL pre-filled pen – under the same conditions as the reference biologic Humira and for all indications for which Hadlima 40mg in 0.8mL pre-filled syringe and 40mg in 0.8mL pre-filled pen are currently listed on the PBS. Recommended.
For purposes of substitution, the Hadlima and Humira PFS are equivalent, as are the respective brands’ PFP. While the different doses (i.e. 40mg in 0.4mL and 40mg in 0.8mL) are considered equivalent when in the same form (i.e. PFP vs PFS), the Hadlima PFP is not equivalent with any adalimumab PFS for the purposes of substitution.
Apremilast (Otezia – Amgen):
- Request to allow rheumatologists and general physicians to initiate treatment in patients with chronic plaque psoriasis who have failed or unable to take methotrexate – recommended.
- Request to allow rheumatology registrars to initiate treatment in consultation with rheumatologists or general physicians – recommended.
- Request to allow GPs to initiate treatment – not recommended. GPs are able to prescribe continuing treatment in agreement with dermatologists or rheumatologists.
Dupilumab (Dupixent – Sanofi-Aventis) and upadacitinib (Rinvoq – AbbVie):
Request to consider cost effectiveness for severe atopic dermatitis in adults and adolescents. PBAC provided advice that at current levels of usage, which substantially exceed the anticipated usage, the drugs would not be considered cost effective at their current prices.
Pembrolizumab (Keytruda – Merck Sharp & Dohme): Request Section 100 (Efficient Funding of Chemotherapy Program) streamlined authority listing for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curative by surgery or radiation – recommended.
Risankizumab (Skyrizi – AbbVie): Request a general schedule authority required (written) to include two new forms of the drug – a 150mg pre-filled syringe and 150mg pre-filled pen – for treatment of severe chronic plaque psoriasis – recommended.
Secukinumab (Cosentyx – Novartis): request a written authority listing for the treatment of moderate to severe hidradenitis suppurativa (resubmission) – recommended.
Varicella zoster virus recombinant vaccine (Shingrix – GSK)
- B and T-cell targeted monoclonal antibody therapies
- some conventional immunosuppressive agents (including high dose methotrexate, mercaptopurine, azathioprine, mycophenolate, calcineurin inhibitors, mTOR inhibitors, cladribine)
- some biologic therapies (including TNF-a inhibitors, abatacept, dupilumab, mepolizumab, tocilizumab)
- immunomodulatory drugs (including sphingosine-1-phosphate inhibitors)
- some oral small molecule targeted therapies (including JAK inhibitors, BTK inhibitors, BCR-ABL inhibitors)
- cancer treatments, cellular therapies and anti-organ rejection therapy.
The full list of November 2023 PBAC outcomes can be found here.
