1 February 2024

Free Shingrix for rheum patients gets PBAC nod

PBAC Pharmaceuticals

Rheum patients aged 18-64 taking immunosuppressive medications are among the key beneficiaries of the November 2023 PBAC recommendations.

After rheum patients missed out on free Shingrix when it was first listed on the National Immunisation Program in November last year, the Australian Rheumatology Association approached PBAC proposing expanded eligibility for rheumatology patients taking medications likely to leave 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. The list includes many DMARDs, such as TNF inhibitors, rituximab, abatacept, mycophenolate and JAK inhibitors.

Other outcomes of the November 2023 PBAC meeting include recommendations for rheumatologist and rheumatology registrar initial prescribing of apremilast for plaque psoriasis patients.

In its December intracycle meeting, PBAC recommended that subsequent continuing prescriptions of upadacitinib change from written authority required to streamlined for severe rheumatoid arthritis, bringing it into line with other JAK inhibitors. Initial and first continuing prescriptions remain written authority required.

Meanwhile, in the upcoming March 2024 PBAC meeting, there will be another shot at PBS listing for avacopan for severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) and AstraZeneca is reattempting a PBS listing for anifrolumab for lupus.

Among other items on the March agenda is a request for PBS listing of Australia’s first ustekinumab biosimilar, Wezlana (Amgen), which was TGA approved on 18 January this year.

And bimekizumab, which was PBS listed last year for plaque psoriasis, is up for written authority listings for psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

November 2023 PBAC meeting outcomes

Among the PBAC outcomes, the following are relevant to rheumatologists. 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.

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.

Teriparatide

  • Teriparatide Lupin – Generic Health: Request a general schedule authority required (streamlined) listing for osteoporosis under the same conditions are the originator brand Terrosa – recommended.
  • Terrosa – Gedeon Richter: Request a general schedule authority required (streamlined) listing for a new form of drug delivery (pre-filled pen) for osteoporosis under the same conditions under the same conditions as the currently listed form (pre-filled cartridge) – recommended.

Teriparatide Lupin PFP and Terrosa in both PFP and PFC forms should be considered equivalent for the purposes of substitution.

Varicella zoster virus recombinant vaccine (Shingrix – GSK)

PBAC recommended an expanded eligibility for free Shingrix under the National Immunisation Program, including people likely to be immunocompromised due to the following treatments:

  • 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.

PBAC December 2023 intracycle meeting

Upadacitinib (Rinvoq, AbbVie): Request to change prescription for subsequent continuing treatment of severe rheumatoid arthritis from written authority to streamlined – recommended.

The full list of December 2023 outcomes can be found here.

PBAC March 2024 Agenda

The following are among the items on the March 2024 agenda. The full agenda can be found here.

  • Adalimumab (Humira, AbbVie): request streamlined authority listing for treatment of immune-mediated inflammatory disease in children.
  • Anifrolumab (Saphnelo, AstraZeneca): request Section 100 (Highly Specialised Drugs Program) written authority listing for severe systemic lupus erythematosus – resubmission.
  • Avacopan (Tavneos, Sequirus): request a streamlined authority listing for treatment of severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) – resubmission.
  • Bimekizumab (Bimzelx, UCB): Request written authority listings for psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
  • Tofacitinib (Xeljanz, Pfizer): Request new dose and form of tablet (11mg extended release) under the same conditions as existing listings for 5mg dose for severe rheumatoid arthritis and psoriatic arthritis.
  • Ustekinumab (Stelara, Janssen): Request written authority listing for new forms of delivery.
  • Ustekinumab (Wezlana, Amgen): Request general schedule and Section 100 (Highly Specialised Drugs Program) streamlined authority listings under the same conditions as its reference biologic.