Ocrelizumab, Primary Progressive Multiple Sclerosis (872)

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A guideline is intended to assist healthcare professionals in the choice of disease-specific treatments.

Clinical judgement should be exercised on the applicability of any guideline, influenced by individual patient characteristics. Clinicians should be mindful of the potential for harmful polypharmacy and increased susceptibility to adverse drug reactions in patients with multiple morbidities or frailty.

If, after discussion with the patient or carer, there are good reasons for not following a guideline, it is good practice to record these and communicate them to others involved in the care of the patient.

Background

Ocrelizumab (Ocrevus®) is accepted for use within NHS Scotland for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

Agent and route

Vial for intravenous infusion

Patient population applicable to

This can be defined as patients with PPMS who:

• have had symptoms 15 years or less and

• are able to walk 20 metres or more, with or without walking aids (up to EDSS 6.51) and

• have evidence of MS activity on MRI scans (see below)

1Expanded Disability Status Scale (EDSS) 6.5 - Requires two walking aids – pair of canes, crutches, etc. – to walk about 20m without resting

 

MRI evidence should be used to confirm inflammatory activity in all patients. Features characteristic of inflammatory activity are:

• T1-gadolinium enhancing lesions and/or

• Active (new or enlarging) T2 lesions2

2This can be defined as a significant change in lesion load between two MRI scans over up to a period of 2 years

There is limited experience of treating patients > 55 years but this would not necessarily preclude them from treatment. Risks and benefits of treatment would be carefully considered between patient and clinician.

Authorised and Designated Areas applicable to

Treatment will be administered in the Neurology Day Unit (ward 68) in the Institute of Neurological Sciences

Indication and place in therapy

Ocrelizumab is the first treatment to be approved for NHS treatment of primary progressive MS. Patients with this form of MS experience disability more rapidly than those with other types. Clinical trials have shown that ocrelizumab can slow the worsening of disability in early, inflammatory PPMS, with the potential to delay the need for a wheelchair by seven years.

Dose, duration and administration

Patients will receive an intravenous infusion of 300mg on days 1 and 15. A further dose of 600mg is administered every 6 months thereafter.

Patients will be followed up clinically (twice per year) and radiologically (once per year).

This will include an annual assessment of timed 25-foot walk, nine hole peg test, visual acuity and a cognitive assessment. An annual quality of life questionnaire will also be completed.

 

Ocrelizumab will be stopped if:

• Patient reaches a sustained EDSS of 8.03

• Patient becomes pregnant or is breast feeding

• Patient experiences an adverse drug reaction

• Patient develops co-morbid disease e.g. severe infections, malignancy

3EDSS 8.0 – Essentially restricted to bed or chair or pushed in wheelchair. May be out of bed itself much of the day. Retains many self-care functions. Generally has effective use of arms

Strength of preparation used

300mg

Licensed status

Licensed Medicine

Authorised prescribers

Dr Colin O’Leary, Consultant Neurologist, NHS GGC

Dr Stewart Webb, Consultant Neurologist, NHS GGC

Dr Pushkar Shah, Consultant Neurologist, NHS GGC

Dr Govind Chavada, Consultant Neurologist, NHS GGC

Dr Niall MacDougall, Consultant Neurologist, NHS GGC

Dr Paul Gallagher, Consultant Neurologist, NHS GGC

Designated non-medical prescribers (e.g. clinical nurse specialist, pharmacist)

Authorised for administration

Health professionals trained in the preparation and administration of intravenous infusions.

Authorised for preparation in clinical area

Yes

Authorised for storage in clinical areas

Yes. Store in a refrigerator

References

Last reviewed: 18 March 2020

Next review: 31 July 2023

Author(s): Lesley Murray, Pushkar Shah

Author Email(s): [email protected], [email protected]

Approved By: Medicines Utilsation Subcommittee of ADTC

Document Id: 872