The TNF inhibitor golimumab (Simponi) will be available on the PBS for the treatment of non-radiographic axial spondyloarthritis from 1 December.
The move, following a positive recommendation from the PBAC, will allow up to 4000 patients with spondyloarthritis to receive subsidised treatment with a biologic early in the course of the disease before it progresses and becomes evident on X-ray, rheumatologists told the limbic.
“It will give us the opportunity to help people with [SpA) in the early stages of what is an insidious disorder,” said Associate Professor Julian McNeil, a rheumatologist in Adelaide
“To date we have not been able to give TNF inhibitors unless we have evidence of radiological sacroiliitis. This change of indication allows us to use MRI criteria to determine if there is sacroiliitis, which will allow us to intervene much earlier, years earlier,” he said.
Professor McNeil said that if untreated, about 60% of people with nr-axSpA would progress to develop radiological signs of sponyloarthritis.
And while many would respond well to biologics, some would have treatment failure due to the development of anti-drug antibodies, he said. Treatment also came with a risk of infections including tuberculosis and shingles, he added.
While announcing the listing to start on 1 December, federal minister for health Greg Hunt said the government had also negotiated immediate compassionate access for patients, meaning those who need it most will have access to the medication without having to wait until it’s listed on the PBS
Accompanying him at the launch in Perth, rheumatologist Dr Andrew Taylor said the listing would be good news for patients with chronic back pain due to spondyloarthritis who until now had to rely for years on NSAIDs and exercise.
“They have a debilitating spinal pain and stiffness. Often they only have a window of a few hours in the middle of the day when they can get about their normal work activities and family activities. Often difficult for them to sleep at night, and they are facing seven to ten to twelve years of progressive disease and damage occurring before they could access treatment like Simponi. So for many patients, this is going to turn their life around and is really a wonderful day for those patients,” he said
According to the manufacturer, Janssen, golimumab will be available for patients with active non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria.
Eligible patients must have chronic lower back pain and stiffness for three or more months that is relieved by exercise but not rest; severe disease based on a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4; failed to achieve an adequate response following treatment with at least two NSAIDs, whilst completing an appropriate exercise program, for three months; elevated CRP level of greater than 10mg/L; sacroiliitis with active inflammation and/or oedema on MRI.
The MRI must be read by a radiologist with musculoskeletal expertise; no evidence on plain x-ray of bilateral Grade II sacroiliitis or unilateral Grade III or IV sacroiliitis; and experienced one or more of the following: (a) Enthesitis (heel); (b) Uveitis; (c) Dactylitis; (d)Psoriasis; (e) IBD; OR (f) positive HLA-B27.
The listing was supported by data from the Phase 3 GO-AHEAD trial.