Also among the recommendations was a new drug for ulcerative colitis. See the list.
The recently released March 2024 PBAC outcomes provide some new options for patients with Crohn’s disease and ulcerative colitis.
The latest biosimilar to be recommended for PBS listing is Amgen Australia’s Wezlana, which was approved by the TGA in January this year.
It’s the first ustekinumab biosimilar to hit the Australian market and was recommended for Crohn’s disease, ulcerative colitis, psoriatic arthritis and chronic plaque psoriasis.
New forms of the reference ustekinumab biologic Stelara (Janssen) were also approved for Crohn’s disease, fistulising Crohn’s disease, ulcerative colitis, psoriatic arthritis and chronic plaque psoriasis.
Adalimumab biosimilar Yuflyma (Celltrion), which is currently PBS-listed for various indications, including ulcerative colitis, Crohn’s disease and complex refractory fistulising Crohn’s disease, requested a written authority listing for an 80mg in 0.8mL pre-filled pen and pre-filled syringe under the same conditions as the reference biologic Humira.
PBAC recommended the listing, with written authority required for initial and first continuing treatment and streamlined authority for subsequent continuing treatment.
A request for listing of a new brand of budesonide for Crohn’s disease was recommended, with Budenofalk (Dr Falk Pharma) offering a 50-pack version of the 3mg enteric capsules with a maximum quantity of 100 able to be prescribed.
PBAC noted it provided another option for treatment of Crohn’s disease, and considered there may be less wastage over comparator Entocort (Chiesi), which comes in a pack of 90 3mg modified release capsules.
Also recommended for PBS listing was the selective sphingosine-1-phosphate (S1P) receptor modulator etrasimod (Velsipity, Pfizer) for people with moderate to severe ulcerative colitis.
In the ELEVATE UC trials, published in The Lancet last year, it demonstrated significant benefit over placebo, and the PBAC determined it was non-inferior to other biologic and targeted synthetic UC treatments. It was approved for UC by the FDA last year, and at time of writing was undergoing evaluation by the TGA.
March 2024 PBAC meeting outcomes
The following outcomes may be of interest to gastroenterologists. Note that recommendation does not mean immediate PBS listing.
Adalimumab (Yuflyma, Celltrion): requested a written authority listing for an 80mg in 0.8mL pre-filled pen and pre-filled syringe under the same conditions as the reference biologic Humira. Recommended.
Amino acid formula supplements with prebiotics, probiotics and long chain polyunsaturated fatty acids (Neocate Syneo, Nutricia): Request that a new formulation of Neocate Syneo continue to be listed on the PBS under the existing conditions for infants with cows’ milk enteropathy, proven combined immunoglobulin E (IgE) mediated allergy to cows’ milk protein and soy protein or combined intolerance to cows’ milk protein, soy protein and protein hydrolysate formulae. Recommended.
Budesonide (Budenofalk, Dr Falk Pharma): request streamlined authority listing for a new form of budesonide for mild to moderate Crohn’s disease. Recommended.
Etrasimod (Velsipity, Pfizer) Request a General Schedule written authority listing for the treatment of moderate to severe ulcerative colitis. Recommended.
Ustekinumab (Stelara, Janssen): Request written authority listing for new forms of delivery. Recommended.
Ustekinumab (Wezlana, Amgen): Request general schedule and Section 100 (Highly Specialised Drugs Program) streamlined authority listings under the same conditions as its reference biologic. Recommended.
Vedolizumab (Entyio, Takeda): Request change to allow additional dose of vedolizumab 300mg at week 10 for severe Crohn’s disease and request removal of the requirement to assess the risk of developing progressive multifocal leukoencephalopathy during this treatment. Recommended.
See the full list of outcomes from the March 2024 PBAC meeting for more.
