References

The UK will follow EMA regulatory decisions for 2 years after Brexit and it looks to speed up regulatory access in the longer term. 2020. https://remapconsulting.com/the-uk-will-follow-ema-regulatory-decisions-for-2-years-after-brexit-and-is-looking-to-speed-up-regulatory-access-in-the-longer-term/ (accessed 1 October 2020)

Time for a NICE change. 2021. https://deep-dive.pharmaphorum.com/magazine/market-access-2021/time-for-a-nice-change/ (accessed 10 January 2022)

Cohen JA, Comi G, Selmaj KW Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019; 18:(11)1021-1033 https://doi.org/10.1016/S1474-4422(19)30238-8

Comi G, Kappos L, Selmaj KW Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019; 18:(11)1009-1020 https://doi.org/10.1016/S1474-4422(19)30239-X

The UK's Post Brexit Medications Pathway Passports its first drug Baker. 2021. https://brexit.bakermckenzie.com/2021/03/16/the-uks-post-brexit-medicines-pathway-passports-its-first-drug/ (accessed 11 January 2022)

Gov.uk. How will Marketing Authorisation Applications reffered under Article 29 are handled Medicines and Healthcare Products Regulatory Agency. 2020. https://www.gov.uk/guidance/how-marketing-authorisation-applications-referred-under-article-29-are-handled (accessed 11 Janaury 2022)

Brexit and the end of the transition period: What it means for the health and social care system. 2021. https://www.kingsfund.org.uk/publications/articles/brexit-end-of-transition-period-impact-health-care-system (accessed 11 January 2022)

Melendez-Torres GJ, Armoiry X, Court R Comparative effectiveness of beta-interferons and glatiramer acetate for relapsing-remitting multiple sclerosis: systematic review and network meta-analysis of trials including recommended dosages. BMC Neurol. 2018; 18:(1) https://doi.org/10.1186/s12883-018-1162-9

Multiple Sclerosis Society. About MS. 2020. https://www.mssociety.org.uk/about-ms (accessed 11 January 2022)

National Institute for Health and Care Excellence. NICE and NHS England consultation on changes to the arrangements for evaluating and funding drugs and other health technologies assessed through NICE's technology appraisal and highly specialised technologies programmes. 2017. https://www.nice.org.uk/media/default/about/what-we-do/nice-guidance/nice-technology-appraisals/board-paper-ta-hst-consultation-mar-17-hst-only.pdf (accessed 11 January 2022)

National Institute for Health and Care Excellence. Ozanimod for treating relapsing–remitting multiple sclerosis. 2021. https://www.nice.org.uk/guidance/ta706/documents/final-appraisal-determination-document (accessed 11 January 2022)

Pickin M, Cooper CL, Chater T The Multiple Sclerosis Risk Sharing Scheme Monitoring Study – early results and lessons for the future. BMC Neurology. 2009; 9:(1) https://doi.org/10.1186/1471-2377-9-1

Polman CH, Reingold SC, Banwell B Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011; 69:(2)292-302 https://doi.org/10.1002/ana.22366

Scottish Medications Consortium. SMC2309 Ozanimod 0.23mg 0.46mg and 0.92mg hard capsules (Zeposia). 2021. https://www.scottishmedicines.org.uk/media/5755/ozanimod-zeposia-final-jan-2021-amended-2221-for-website.pdf (accessed 11 January 2022)

Surapaneni S, Yerramilli U, Bai A Absorption, Metabolism, and Excretion, In Vitro Pharmacology, and Clinical Pharmacokinetics of Ozanimod, a Novel Sphingosine 1-Phosphate Receptor Modulator. Drug Metab Dispos. 2021; 49:(5)405-419 https://doi.org/10.1124/dmd.120.000220

Euro Roundup:MHRA shares post Brexit assessment routes variations guidance Regulatory Focus Euro Regulatory Roundup Regulatory affairs professional society RAPS. 2020. https://www.raps.org/news-and-articles/news-articles/2020/10/euro-roundup-mhra-shares-post-brexit-assessment-ro (accessed 11 January 2022)

How will NICE fare in a post-Brexit world?. 2021. https://deep-dive.pharmaphorum.com/magazine/market-access-2021/nice-post-brexit-icon/ (accessed 11 Janaury 2022)

The history of NICE. 2004. https://indepth.nice.org.uk/20-years-of-NICE/index.html (accessed 25 January 2022)

Ozanimod for relapsing remitting multiple sclerosis and how Brexit changed the journey

02 February 2022
Volume 4 · Issue 2

Abstract

This article will focus on ozanimod, a medication that has been put forward for relapsing-remitting multiple sclerosis (RRMS). It will look at ozanimod's characteristics, including the pharmacokinetics and pharmacodynamics of the medication, and follow ozanimod's journey from clinical trials through the different licencing agencies, allowing ozanimod to be used as a treatment in multiple sclerosis (MS). Finally, this article will look at its journey through the National Institute for Clinical Excellence (NICE) to seek approval to be used as a medication to treat RRMS on the NHS. The article will also briefly reflect on the marketing authorisation changes in the UK since leaving the European Union (EU) and the impact of these changes.

Multiple sclerosis (MS) is an immune-mediated inflammatory condition that affects the central nervous system (CNS). The inflammatory process causes areas of demyelination, scarring and neuronal damage throughout the CNS, causing symptoms and accumulating progressive disability, which is dependent on the areas of the CNS that has been affected (MS Society, 2020).

In 1997, Beta-interferon 1a (Avonnex) was licenced in the European Union (EU) for RRMS to reduce the impact and disease process of MS. Today there is a mixture of tablets, injections and infusions available on the NHS for RRMS. It was hoped that Ozanimod would be added to this list and to be the first oral medication to be given after one relapse in 1 year (Comi et al, 2019).

Pharmacokinetics is a word that is used to describe how a medication passes through the body. This identifies the therapeutic effect of a medication and its safety profile by looking at the time and route the medication takes to be absorbed, distributed, metabolised and excreted (Surapaneni et al, 2021). This is important because certain factors can affect the absorption of a medication and therefore its effectiveness.

Register now to continue reading

Thank you for visiting Journal of Prescribing Practice and reading some of our peer-reviewed resources for prescribing professionals. To read more, please register today. You’ll enjoy the following great benefits:

What's included

  • Limited access to our clinical or professional articles

  • New content and clinical newsletter updates each month