The Pharmaceutical Benefits Advisory Committee (PBAC) has announced on Friday that it will not recommend nabiximols (Sativex) to be reimbursed under the Pharmaceutical Benefits Scheme (PBS) for people with MS with moderate to severe muscle spasticity, and it has deferred making a recommendation for ozanimod (Zeposia) for people with relapsing remitting MS.
MS Research Australia provided submissions in support of both medications to the PBAC, as both have been shown in clinical trials to be safe and effective either in the treatment of MS or for the treatment of MS-related spasticity. The submissions can be viewed here. The PBAC is required to consider many 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.
The mouth spray, nabiximols, contains two chemical extracts derived from the cannabis plant – delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). For more information on medicinal cannabis and MS, see here. Nabiximols was registered for use for people with MS with muscle spasticity by the Therapeutic Goods Administration (TGA) in 2012, but was previously knocked back by the PBAC for inclusion on the PBS, see here. Muscle spasticity is a significant problem for many people living with MS, causing pain, disturbed sleep and reduced mobility. This has an impact on the quality of life and inclusion in employment and social activities. Unfortunately, therapeutic options for muscle spasticity are currently limited. Clinical trials have shown that nabiximols significantly reduced moderate to severe muscle spasticity in people with MS and was well-tolerated, with the most common side effects being vertigo, fatigue and dizziness. If nabiximols was included on the PBS, it would mean this medication would provide a choice for people with MS experiencing muscle spasticity for whom current medications are ineffective.
The PBAC summary for nabiximols states that “the key clinical trial (Markovà 2019) presented in the resubmission used an enriched population design in which non-responders to nabiximols were excluded from participation in the randomised phase of the study. The PBAC considered that, while the trial design was reasonable, it was likely to result in an overestimate of the clinical benefit and an underestimate of the adverse events for nabiximols”. Essentially, the summary states that the PBAC believed the main clinical trial results of nabiximols presented at the meeting potentially overestimated its safety and effectiveness.
Ozanimod, which is yet to be approved by the TGA for use in Australia, has had its consideration for reimbursement deferred. The PBAC summary for ozanimod states that “the PBAC recommendation cannot be made public until the TGA outcome is known”. Ozanimod is an oral treatment in the same class as fingolimod. Phase 3 clinical trials have shown that, compared to interferon beta-1a, ozanimod reduced the annualised relapse rate, reduced the number of new or active lesions and reduced brain volume changes. You can view the results from the clinical trials here. MS Research Australia is hoping for a positive outcome for ozanimod from the PBAC once the TGA outcome is known. While there is a number of medications already available for relapsing remitting MS, MS is a very varied disease and not everyone responds equally to each medication. Therefore, it is vital that there is a number of different options available for optimal treatment of everyone.
Siponimod (Mayzent), the first treatment option that has been approved by the TGA for people with secondary progressive MS, was previously considered at the November 2019 PBAC meeting, but was knocked back for inclusion on the PBS (see here for further information). It was to be reconsidered in the March meeting, but it has been recategorised as a major submission and will now be considered at a later date.
MS Research Australia is disappointed with the outcome for nabiximols but remains hopeful for ozanimod and siponimod. MS Research Australia supports affordable access to all proven treatment options allowing people of all ages with MS and their doctors to find effective therapies suited to their individual circumstances. Given that MS is a highly variable disease and that the responses to treatments varies between people, affordable access to 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.