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Multiple Sclerosis Research Australia (MSRA) 3Feb2020 Article "Three MS Treatments up for Consideration for PBS Inclusion" (one of which is ZEPOSIA/Ozanimod in RRMS)THREE MS TREATMENTS UP FOR CONSIDERATION FOR PBS INCLUSION03 February, 2020
In March, the Pharmaceutical Benefits Advisory Committee (PBAC) will meet to consider proposals to add nabiximols (Sativex), siponimod (Mayzent) and ozanimod (Zeposia) onto the Pharmaceutical Benefits Scheme (PBS) for people with MS. If added to the PBS, the cost of these medications can be subsidised by the Government, making them affordable. Nabiximols The mouth spray, 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. By being included on the PBS, this treatment would provide a choice for people with MS experiencing muscle spasticity for whom current medications are ineffective. Siponimod Siponimod will be considered by the PBAC for treatment of relapsing forms of MS. Relapsing forms of MS include relapsing remitting MS (RRMS) and secondary progressive MS (SPMS) with superimposed relapses. Siponimod is currently approved by the TGA for the treatment of SPMS and was considered at the November PBAC meeting for SPMS but was unfortunately knocked back. It 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). Clinical trials have shown that in addition to reducing disability progression, siponimod also reduced brain tissue loss (atrophy) and reduced the number of new or active lesions, so it would be suitable for treatment of relapsing forms of MS. The trial results can be viewed in more detail here. Ozanimod Ozanimod will also be considered by the PBAC for RRMS. Like siponimod, ozanimod is an oral treatment in the same class as fingolimod. Phase 3 clinical trials have shown that compared to interferon beta-1a, another treatment option for people with RRMS, people with RRMS who were treated with ozanimod had a reduced annualised relapse rate. They also had a lower number of new or active lesions and reduced brain atrophy compared to those treated with interferon beta-1a. There were only a few side effects of ozanimod, with the most common being nose and throat inflammation, headache, and upper respiratory tract infection. Results from the clinical trials can be found here. What does the PBAC consider in its decision making? The PBAC needs to consider a number of factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines, and the cost of a new listing for the government. The decision of the PBAC is the first step in a process where final approval is given by the Federal Government. Supporting affordable access to treatment 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. MS Research Australia will be making a submission to support the inclusion of nabiximols, siponimod and ozanimod on the PBS, as we welcome affordable access to all treatment options that have been shown in clinical trials to provide safe and effective treatment for MS. https://msra.org.au/news/ozanimod-shows-promise-in-rrms-clinical-trials/OZANIMOD SHOWS PROMISE IN RRMS CLINICAL TRIALS29 January, 2020
Two new international phase III clinical trials have just published very encouraging results of the drug ozanimod (Zeposia) in people with relapsing remitting MS (RRMS). A phase III clinical trial is the final phase before a treatment option is approved and on the market, and focuses on the safety and effectiveness of a treatment option compared to a standard intervention in a large group of participants. The first study called SUNBEAM, published in The Lancet Neurology, recruited 1,346 people across 20 countries and looked at the safety and effectiveness of ozanimod over at least a 12 month period. The second study called RADIANCE, also published in The Lancet Neurology, recruited 1,320 people across 21 countries and looked at this over a 24 month period. What is ozanimod? Ozanimod is an oral treatment in the same class as fingolimod (Gilenya), a treatment option currently available for people with RRMS. This means that ozanimod acts in a similar way to fingolimod, just with a slightly different mechanism. Drugs in this class act by keeping a type of immune cell called lymphocytes in the lymph nodes, preventing them from moving into the brain and spinal cord and causing the inflammation and damage seen in MS. How were the two trials carried out? Both clinical trials compared the safety and effectiveness of ozanimod with interferon beta-1a, a treatment option currently available for people with RRMS. Participants were split into three different treatment arms – one that took a lower dose of ozanimod (0.46mg) daily, one that took a higher dose of ozanimod (0.92mg) daily, and one that had weekly interferon beta-1a injections. To prevent any biases, this trial was double-blinded, meaning both researchers and participants weren’t aware of the treatment option they were giving or receiving. Because the treatment options differ (one being oral tablets and the other being an injection), the ozanimod groups received a weekly dummy injection and the interferon beta-1a group received daily dummy oral tablets. How were the results of the trials measured? At the end of each trial, the researchers compared the number of relapses over the course of a year in each treatment group. They also compared the number of new and active lesions, changes in brain volume, time taken for disability to progress using the expanded disability status scale (EDSS), changes in thinking and memory and quality of life. What did researchers discover? The number of relapses over the course of a year at the end of both clinical trials were significantly lower in people who received ozanimod at either dose. In both clinical trials, the number of new or active lesions as well as brain volume loss (atrophy) was significantly lower in people treated with ozanimod. Disability progression was not significantly different in those receiving ozanimod in either clinical trial. Measures of thinking and memory improved after treatment with either dose of ozanimod in the SUNBEAM trial, but only with treatment with the lower dose ozanimod in the RADIANCE trial. There were improvements in the physical component of quality of life after treatment with the higher dose of ozanimod in the SUNBEAM trial, and after treatment with the lower dose ozanimod in the RADIANCE trial. However, there were no improvements in the mental component of the quality of life in either clinical trial. Like any medication, there is a risk of side effects. Ozanimod was well-tolerated in both clinical trials, with the most common side effects being nose and throat inflammation, headache, and upper respiratory tract infection. The researchers reported that ozanimod was more effective than interferon beta-1a in reducing relapses and lesions in the brain and spinal cord, and that combined with the low side effects, could be an effective treatment option for people with RRMS. It is important to note that MS is a very varied condition and not everyone with MS responds to medications in the same way, so having more treatment options available will increase the opportunity for people with MS and their doctors to find effective therapies suited to their individual circumstances. |
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Msg # | Subject | Author | Recs | Date Posted |
1960 | Re: Multiple Sclerosis Research Australia (MSRA) 3Feb2020 Article "Three MS Treatments up for Consideration for PBS Inclusion" (one of which is ZEPOSIA/Ozanimod in RRMS) | JBWIN | 4 | 3/17/2020 5:17:43 PM |