The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended Authority Required listings for two new forms and strengths of adalimumab – 20mg in 0.2ml prefilled syringe and 80mg in 0.8ml prefilled pen.

The change applies to a number of rheumatological and gastroenterological indications including severe Crohn’s disease, refractory fistulating Crohn’s disease and moderate to severe ulcerative colitis.

The PBAC has also recommended the listing of the biosimilar brand of adalimumab (Amgevita) for the same indication as the reference brand Humira.

Amgevita, Hadlima and Humira pre-filled syringes should be treated as equivalent to each other and Amgevita, Hadlima and Humira cartridges should be treated as equivalent to each other for their respective PBS-listed indications.

The PBAC also noted the clinical need for additional treatment options in patients with mild to moderate Crohn’s disease.

It recommended the listing of budesonide for mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon.

“The PBAC recommended the listing on cost minimisation basis against a weighted mixed comparator of mesalazine and prednisolone.”

New 1 g enteric-coated tablets of mesalazine were also recommended for an Authority Required (STREAMLINED) listing for the treatment of ulcerative colitis and Crohn’s disease.

The new strength mesalazine will have the same restriction as the currently PBS-listed forms of mesalazine.