Two MS medications knocked back by PBAC

In what comes as an extremely frustrating and disappointing blow for people with primary progressive MS and their families, the new MS medication, Ocrevus (ocrelizumab), has not been recommended for reimbursement on the Pharmaceutical Benefits Scheme. Additionally, they also did not recommend the inclusion of Mavenclad (cladribine tablets) for use in relapsing MS.

Earlier this year, Ocrevus was approved by the Australian Therapeutic Goods Administration (TGA) for use in both relapsing and primary progressive MS. Mavenclad, just recently received an updated approval as a 4 years treatment for RRMS with 2 years of active treatment followed by 2 years of observation.

The TGA grants approval for new medications after assessing the clinical evidence for their safety and efficacy.

However, it is the Pharmaceutical Benefits Advisory Committee (PBAC) that advises the Federal government on which medications should be listed for reimbursement on the Pharmaceutical Benefits Scheme (PBS).

Ocrevus for PPMS and Mavenclad for relapsing MS were considered at the November meeting of the PBAC. The outcome was published on their website on 15 December.

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.

The PBAC summary for Ocrevus states, “Although the PBAC noted the statistically significant results of ocrelizumab over placebo in the ORATORIO trial, the PBAC considered that the treatment effect was modest and that the clinical significance of the trial outcomes was uncertain.”

Essentially, the summary indicates that the PBAC felt that the potential benefits of Ocrevus in slowing disease progression for people with PPMS could only be expected to be moderate, and the benefits may be smaller in a broader, real world population than what was seen in the carefully controlled clinical trial. This means that the cost of the medication for the government relative to its expected benefits, based on the evidence supplied by the drug company to date, could not be justified by the PBAC at this time.

In July, the PBAC recommended that Ocrevus be included on the PBS for treating relapsing remitting MS (RRMS). However, this recommendation is still awaiting final sign off from the Federal Government.

For Mavenclad the PBAC’s consideration appears to centre on the comparison of Mavenclad with other relapsing MS medications, particularly Gilenya (fingolimod). The drug company had sought reimbursement based on evidence they presented that Mavenclad was ‘non-inferior’ to Gilenya, that is, that it would be expected to have at least a similar clinical benefit. At this stage, the PBAC appear to feel that the evidence presented so far for non-inferiority with Gilenya and the four year duration of its effect does not yet warrant a positive recommendation for PBS listing.

This is not the end of the line for either of these medications. The pharmaceutical companies have both indicated that they will continue to work with the government to ensure that the medications can be made available to Australians with MS as soon as possible.

MS Research Australia will also continue to strongly advocate for affordable access to both of these important treatment options, as with any medication that has been shown in clinical trials to provide a clinical benefit. In particular, for people with primary progressive MS there is a very great and urgent need for any proven medication that can safely slow down the progression of the disease.

For people with all forms of MS, the variability of the disease, the varying responses to treatments and every person’s individual life and health circumstances mean that a range of treatment options is crucial. Every person with MS and their healthcare team needs to be able to find the most appropriate and effective treatment option for them.