Significant milestone for people with multiple sclerosis as people with relapsing-remitting form gain access to new first-in-class treatment with twice-yearly dosing
22 June 2018, Welwyn Garden City – The National Institute for Health and Care Excellence (NICE) today published a positive final appraisal determination (FAD) for OCREVUS® (ocrelizumab) to treat people living with relapsing-remitting multiple sclerosis (RRMS).[i]
NICE has recommended the use of ocrelizumab for treating RRMS in adults with active disease, defined by clinical or imaging features, when alemtuzumab is contraindicated or otherwise unsuitable.1 Ocrelizumab is a first-in-class treatment with twice-yearly dosing and has less burdensome monitoring requirements than currently available disease-modifying treatments.
The NICE announcement is a significant milestone for people with RRMS who gain access to a new treatment option. Ocrelizumab has been shown to reduce the number of relapses per year by nearly half and slow the risk of progression of the disease compared with current treatment, subcutaneous interferon beta-1a.[ii]
The majority of people with multiple sclerosis (MS) have a relapsing-remitting form at diagnosis with 100 people in the UK diagnosed with MS every week.[iii],[iv] MS affects approximately 100,000 people across the UK with 85 percent of those suffering from RRMS.4,[v]
There is significant unmet need in the treatment of MS, particularly for those with PPMS who currently have no disease-modifying treatment options. We welcome this positive NICE review for RRMS, and hope that it brings us closer to the treatment being made available to people with early PPMS too.
Jo Sopala, Director of Development, MS Trust.
NICE review is ongoing for ocrelizumab in early PPMS, for which there is currently no treatment available. Disability accumulates twice as fast in PPMS as in RRMS, meaning that people with PPMS may have to rely on mobility aids or become wheelchair bound, are unable to work, and need carers to look after them sooner.[vi] Ocrelizumab is the first and only licensed treatment for early PPMS which means the process for reimbursement is more complex and will take longer.
As of today, over 50,000 patients have received treatment with ocrelizumab worldwide and we are delighted that NICE has now recognised ocrelizumab as a cost-effective new treatment option for NHS patients with RRMS. It is important that we continue to work collaboratively with NICE to ensure people with early PPMS are also able to access ocrelizumab through the NHS as soon as possible.
Dr Marius Scholtz, Integrated Franchise Lead,
Neuroscience, Roche Products UK.
[i] National Institute for Health and Care Excellence (2018) Final Appraisal Determination: Ocrelizumab for treating relapsing multiple sclerosis. June 2018.
[ii] Ocrevus (Ocrelizumab) Summary of Product Characteristics 2018.
[iv] MS Trust website. Prevalence and Incidence of MS. Available at: https://www.mstrust.org.uk/a-z/prevalence-and-incidence-multiple-sclerosis. Last accessed June 2018.
[v] Multiple Sclerosis Society. Relapsing Remitting (RRMS). Available at: https://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms. Last accessed June 2018.
[vi] Raghavan K et al. (2015) Progression rates and samples size estimates for PPMS based on the CLIMB study population. Mult Scler J, 21(2) 180- 188.
[ix] National Multiple Sclerosis Society. Who Gets MS? Available at: https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Last accessed June 2018.
[x] Multiple Sclerosis Trust. Nerve damage caused by MS. Available at: https://www.mstrust.org.uk/a-z/nerve-damage-caused-ms. Last accessed June 2018.
[xi] National Multiple Sclerosis Society. MS symptoms. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms. Last accessed June 2018.
[xii] Ziemssen T, (2005). Modulating processes within the central nervous system is central to therapeutic control of multiple sclerosis. J Neurol, 252 (5), v38-v45.
[xiii] G. Giovannoni et al. (2016) Brain Health. Time Matters in Multiple Sclerosis. Multiple Sclerosis and Related Disorders (9) S5–S48 Available at: http://www.msard-journal.com/article/S2211-0348(16)30102-X/fulltext#s0010. Last accessed June 2018.
[xiv] National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Last accessed June 2018.
[xv] Multiple Sclerosis Society. Secondary Progressive MS (SPMS). Available at: https://www.mssociety.org.uk/what-is-ms/types-of-ms/secondary-progressive-spms. Last accessed: June 2018.
[xvi] Multiple Sclerosis Trust. Primary progressive MS. Available at: https://www.mstrust.org.uk/a-z/primary-progressive-ms#treatments. Last accessed June 2018.
[xvii] Multiple Sclerosis Society. Primary Progressive (PPMS). Available at: https://www.mssociety.org.uk/what-is-ms/types-of-ms/primary-progressive-ppms. Last accessed June 2018.
[xviii] Multiple Sclerosis Trust. Disease modifying drugs. Available at: https://www.mstrust.org.uk/understanding-ms/ms-symptoms-and-treatments/disease-modifying-drugs-ms-decisions/disease-modifying#work. Last accessed June 2018.
[xx] Hauser SL, et al. (2017). Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med, 376: 221-234.
[xxi] Montalban X, et al. (2017). Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med, 376: 209-220.
[xxii] Lehmann-Horn et al. (2013) Targeting B Cells in the treatment of multiple sclerosis: recent advances and remaining challenges. Ther Adv Neurol Disord. 6 (3) 161-173.
[xxiii] Dilillo DJ, et al. (2008). Maintenance of long-lived plasma cells and serological memory despite mature and memory B cell depletion during CD20 immunotherapy in mice. J Immunol, 180:361–71.