- Today the Pharmaceutical Benefits Advisory Committee (PBAC) has announced their recommendations for two MS medications, siponimod (Mayzent) for secondary progressive MS, and ocrelizumab (Ocrevus) for primary progressive MS.
- The PBAC recommended siponimod for reimbursement under the Pharmaceutical Benefit Scheme (PBS) but did not recommend extending the listing of ocrelizumab to include people with early, MRI-active primary progressive MS.
- The positive recommendation for siponimod will now go before the Federal Government for final approval.
The Pharmaceutical Benefits Advisory Committee (PBAC) has announced on Friday, its position on two MS medications. It has recommended siponimod (Mayzent) be subsidised for patients with secondary progressive MS who are ambulant (with or without support), but did not recommend extending the listing of ocrelizumab (Ocrevus) to include people with early, MRI-active primary progressive MS. In 2018 ocrelizumab was listed on the Pharmaceutical Benefits Scheme (PBS) for people with relapsing remitting MS and this decision does not affect that.
Both of these medications were the first medications approved by the Therapeutic Goods Administration (TGA) for use in Australia for use in primary progressive MS (Ocrevus) or secondary progressive MS (Mayzent). This is the first time in Australia that a medication for secondary progressive MS has been recommended for subsidy.
The TGA approves the use of the medication in Australia but it is up to the Pharmaceutical Benefits Advisory Committee (PBAC) to recommend it to be listed on the Pharmaceutical Benefit Scheme (PBS). Once a medication receives a positive recommendation from the PBAC it is then submitted to the Federal Government for final approval.
Siponimod is an oral treatment in the same class as fingolimod (Gilenya), a medication already approved in Australia for the treatment of RRMS. It acts by targeting immune cells and preventing them from moving into the areas of inflammation in MS (the brain and spinal cord). Secondary Progressive MS clinical trials ofsiponimod showed a reduction in disability progression when compared to a mock treatment (placebo). People were treated for up to three years and disability progression was tracked every three months. The results showed that siponimod reduced disability progression, slowed brain tissue loss (atrophy), and reduced the number of new lesions. (see our article here)
Ocrelizumab on the other hand is given as two intravenous infusions once every six months. It is a monoclonal antibody (a type of antibody that recognises a single specific target) that blocks the activity of specific immune cells. These immune cells are called B cells and the antibody targets a molecule called CD20 which is found on the surface of these cells. Clinical trials with people with primary progressive MS showed that ocrelizumab significantly reduced the risk of disability progression by 24% compared to the placebo. It also decreased the volume of brain lesions. For more information about the effects of ocrelizumab read about the trial here .
The PBAC is required to considers a number of factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines and the cost to the government of a new listing. This decision is the first step in a process which will now see the decision go before the Federal Government for final approval. If approved, it will then allow people with MS across Australia access to this new treatment option.
MS Research Australia provided a written submission in support of both these medications to the PBAC. MS Research Australia supports and actively advocates for affordable access to all proven treatment options to increase the opportunity for people with MS and their doctors to find effective therapies suited to their individual circumstances and welcomes the addition of siponimod as an affordable treatment option for people with secondary progressive MS.
MS affects everyone differently and not everyone with MS responds to medications in the same way. It is important to discuss all medication options with your medical team to determine which medication is suited to your personal circumstances.