Two MS medications were considered at the July meeting of the Pharmaceutical Benefits Advisory Committee (PBAC). Ocrevus (ocrelizumab), received a positive recommendation for inclusion on the Pharmaceutical Benefits Scheme (PBS) for relapsing remitting MS. However, Copaxone was not recommended for listing for a possible precursor of MS, known as Clinically Isolated Syndrome (CIS).
The role of the PBAC is to make recommendations to the Federal Government as to whether medications should be subsidised on the Pharmaceutical Benefits Scheme. The PBAC is required to consider a number of factors when making recommendations, including the clinical efficacy and cost-effectiveness of a treatment relative to other medicines and the cost to the government of a new listing.
At the July meeting, Ocrevus was only considered for PBS listing for relapsing forms of MS. A submission to include Ocrevus on the PBS for primary progressive MS is expected to be made for the November PBAC meeting.
This decision is the first step in a process which will now see the recommendation go before the federal Government Cabinet for final approval. If approved, it will then allow people with relapsing MS across Australia to gain affordable access to this new treatment option.
Ocrevus has been registered for the treatment of relapsing and primary progressive forms of MS by the Therapeutic Goods Administration (TGA) to reduce the frequency of relapses and delay the progression of physical disability (please see our earlier article).
Ocrevus is given as an infusion every six months. The first infusion is given as two separate infusions, two weeks apart. 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.
During the same meeting, the PBAC considered listing Copaxone (glatiramer acetate) for the treatment of Clinically Isolated Syndrome (CIS). CIS is diagnosed when a person has had a single clinical attack similar to MS, and these people are at a high risk of developing MS. Whilst Copaxone is already subsidised for the treatment of RRMS, this would have been the first listing of a therapy on the PBS for the treatment of CIS. However, the PBAC did not recommended that Copaxone be listed on the PBS for the treatment of CIS citing concerns about the evidence for clinical benefit and cost-effectiveness. The sponsor of Copaxone, Teva Pharma Australia Pty Ltd, has replied that they will “continue to work with the department to resolve the identified issues”.
MS Research Australia looks forward to the final Government approval for Ocrevus for relapsing MS. The addition of a further affordable and effective treatment option for relapsing MS is a welcome development that will enable people with MS and their doctors to find effective therapies suited to their individual circumstances.
MS Research Australia will also continue to advocate for affordable access to Ocrevus for people with primary progressive MS and will keep the community updated regarding the opportunity for submissions to the PBAC as they consider this at their next meeting.
Individuals with MS should discuss any new treatment options with their neurologist.