THERAPY

 Québec:

Quebec:

PrKESIMPTA® (ofatumumab injection) is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS)evolutionary, defined by clinical features and imaging findings.

Reimbursement criteria for ofatumumab by the Régie de l'assurance maladie du Québec (RAMQ) (Code SN134):

For treatment of persons suffering from relapsing-remitting multiple sclerosis who have experienced 1 relapse in the last year and whose result on the EDSS scale is less than 7.

The authorization of the initial request is for a maximum period of one year. The same will apply to requests for further processing. However, in the latter cases, the doctor must provide proof of a beneficial effect by the absence of deterioration. The result on the EDSS scale must remain below 7. KESIMPTA® (ofatumumab injection) is indicated for the treatment of adult patients with progressive relapsing-remitting multiple sclerosis (RRMS), defined by clinical features and imaging findings. 

Ontario:

PrKESIMPTA® (ofatumumab injection) is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RMS)with active disease defined by clinical and imaging features.

Initiation criterial

For the treatment of RMS in patients who meet all thefollowing criteria:

1. 18 years of age or older; AND

2. Diagnosis of RMS is in accordance with the McDonald2017 criteria demonstrating dissemination of lesions in the central nervoussystem in space and time meeting the following;

• 2 or more attacks* and clinical evidence of 2 or more lesions

OR

• 2 or more attacks and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location

* If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below:

• Additional clinical attack

• Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)

• Presence of CSF-specific oligocional bands.

†if the patient has evidence of only one lesion thepatient must meet ONE of the additional criteria of dissemination in space in the list below:

• Additional clinical attack implicating different CNSsite

.1 or more MS-typical T2 lesions in 2 or more areas ofthe CNS: periventricular, cortical,

juxtacortical. infratentorial or spinal cord

 AND

3. An EDSS score of less than 6.0;

AND

4. Evidence of active disease defined as at least ONE of the following:

• One relapse during the previous year

• Two relapses during the previous 2 years

• A positive gadolinium (Gd)-enhancing MRI scan duringthe year before starting treatment with ofatumumab

AND

5. Ofatumumab is used as monotherapy;

AND

6. The drug request is from a neurologist experiencedin the management of RMS from one of the MS Society recognized

Ontario MS clinics‡ or includes a consult note from aneurologist from one of these clinics supporting the diagnosis.

1 MS Society recognized Ontario MS clinics:S

Hamilton MS Clinic HHS, McMaster University KingstonMS Clinic, Kingston General Hospital London MS Clinic, London Health SciencesCentre Ottawa MS Research clinic, Ottawa Hospital General Campus OttawaPediatric MS Clinic, CHEO

Toronto MS Clinic, St Michael's Hospital

Toronto Pediatric MS Clinic, The Hospital for SickChildren Sunnybrook Health Sciences Centre

Thunder Bay MS Clinic (35 Algoma Street North, ThunderBay, ON)

§ Note: Requests for patients who are under the careof a community neurologist working outside of one of the MS Society recognizedOntario MS clinics can be considered on a case-by-case basis.

Exclusion criteria:

1. Combination therapy with another disease modifyingtherapy for RMS will not be reimbursed.

2. Patients with an EDSS score equal to or greaterthan 7.0.

Renewal criteria

Ongoing funding will be provided for those whocontinue to benefit from treatment and who have an EDSS score less than 7.0.

When requesting renewal of funding, information thatshould be provided should include:

• Date and details of the most recent neurologicalexamination and EDSS scores to support ongoing benefit from therapy.

•Clinical details of the date and onset of clinicalattacks/relapses

• Information to support that the patient isstable/not demonstrating a sub-optimal response

Duration of approvals for initial and renewals: 12months

Renewal requests where patients have experienced morethan

1 attack in the past year will be externally reviewed.

Alberta:

- For the reduction of the frequency andseverity of clinical relapses and reduction of the number and volume of activebrain lesions, identified on MRI scans, in ambulatory adult patients (18 yearsof age or older) with relapsing remitting multiple sclerosis.
- Must be prescribed by a registered MSNeurologist. A current assessment must be completed by a registered MSNeurologist at every request. 

Initial Coverage 

1) The registered MS Neurologist mustconfirm a diagnosis of RRMS; 

2) The patient must have active diseasewhich is defined as at least two relapses* of MS during the previous two yearsor in the two years prior to starting an MS disease modifying therapy (DMT). 

3) The patient must be ambulatory withor without aid (The registered MS Neurologist must provide a current updatedExpanded Disability Status Scale (EDSS) score less than or equal to 6.5). 

Continued Coverage 

The patient must be assessed by aregistered MS Neurologist; 

The registered MS Neurologist mustconfirm a diagnosis of RRMS; 

The registered MS Neurologist mustprovide a current updated EDSS score. The patient must not have an EDSS scoreof 7.0 or above sustained for one year or more. 

Coverage of this drug may be consideredin a patient with a sustained EDSS score of 7.0 or above in exceptionalcircumstances

All requests (including renewalrequests) for Kesimpta must be completed using the same Special Authorization Form asOcrevus 

Saskatchewan:

Coverage will be considered for patientswho are assessed and meet the following criteria: 

have clinical definite RRMS, as definedby the 2017 McDonald diagnostic criteria; and 

have had a clinical relapse¹and/or new MRI activity² in the last two years; and 

are fully ambulatory for 100 meterswithout aids (canes, walkers, or wheelchairs) – EDSS of 5.5 or less; and 

are age 18 or older 

Applications for patients under 18 will be considered.

¹ A clinical relapse is defined as the appearance ofnew symptoms or worsening of old symptoms, lasting at least 24 hours in theabsence of fever, preceded by stability for at least one month. 

² MRI activity is defined as any new multiple sclerosislesion/s, expanding lesion/s, and/or enhancing lesion/s.

 Manitoba: 

Kesimpta will be covered for:

The treatment of adult patients with anestablished diagnosis of relapsing-remitting multiple sclerosis (RRMS), whenprescribed by a neurologist from the Manitoba Multiple Sclerosis (MS) Clinic. 

 New Brunswick:

For the treatmentof adult patients with relapsing-remitting multiple sclerosis (RRMS) who meetall of the following criteria: 

Confirmed diagnosis based on McDonaldcriteria 

Experienced one or more disablingrelapses or new MRI activity in the past two years 

Ambulatory with or without aid (i.e. hasa recent Expanded Disability Status Scale (EDSS) score of less than or equal to6.5)

Clinical Note:

Treatment should be discontinued forpatients with an EDSS score of greater than or equal to 7. 

Claim Notes: 

Must be prescribed by a neurologist.

Combined use with other diseasemodifying therapies to treat RRMS will not be reimbursed. 

Requests will be considered forindividuals enrolled in Plans ADEFGV. 

Approval Period: 2 years.

Nova Scotia:

For the treatment of adult patients withrelapsing remitting multiple sclerosis (RRMS) who meet all of the followingcriteria: 

An Expanded Disability Status Scale(EDSS) score of less than 6.0 

Evidence of active disease defined as atleast one of the following: 

One relapse during the previous year 

Two relapses during the previous 2 years 

A positive gadolinium (Gd)-enhancing MRIscan during the year before starting treatment with ofatumumab. 

Renewal Criteria: 

EDSS score less than 6.0. Date anddetails of the most recent neurological examination and EDSS score must beprovided (exam must have occurred within the last 90 days); 

AND 

Patients must be stable or haveexperienced no more than 1 disabling attack/relapse in the past year. 

Claims Notes: 

Approval: 1 year. 

Combined use with other diseasemodifying therapies to treat multiple sclerosis will not be reimbursed. 

Newfoundland-Labrador:

For the treatment ofadult patients with relapsing-remitting multiple sclerosis (RRMS) who meet allof the following criteria: 

Confirmed diagnosisbased on McDonald criteria; 

Has experienced oneor more disabling relapses or new MRI activity in the past two years; and 

Ambulatory with orwithout aid (i.e. has a recent Expanded Disability Status Scale (EDSS) score ofless than or equal to 6.5). 

Clinical Note: 

Treatment should bediscontinued for patients with an EDSS score of greater than or equal to 7. 

Claim Notes: 

Must be prescribed bya neurologist with experience in the treatment of multiple sclerosis. 

Combined use withother disease modifying therapies to treat MS will not be reimbursed. 

NIBH:

For the treatment of adult patients withan established diagnosis of relapsing-remitting multiple sclerosis (RRMS). 

Criteria for initial 12-months coverage: 

Coverage is provided for 1 year (initialdosing of 20 mg by subcutaneous injection at weeks 0, 1 and 2, followed bysubsequent monthly 20 mg subcutaneous injection, starting at week 4 for adultspatients who meet ALL the following criteria: 

For the treatment of adult patients withan established diagnosis of relapsing-remitting multiple sclerosis (RRMS); AND

Prescribed by a specialist withexperience in the treatment of multiple sclerosis; AND

Patient has an Expanded DisabilityStatus Scale (EDSS) score of less than 6.0; AND

Evidence of active disease defined as atleast 1 of the following: 

One relapse during the previous year

Two relapses during the previous 2 years 

A positive gadolinium (Gd)-enhancingmagnetic resonance imaging (MRI) scan during the year before starting treatmentwith ofatumumab 

Ofatumumab should not be used incombination with other disease-modifying treatments (DMTs) used to treatmultiple sclerosis (MS). 

Criteria for renewal coverage every 12months: 

Ofatumumab may only be renewed forpatients who do not exhibit evidence of disease progression since the previousassessment. The EDSS score must be provided (exam must have occurred withinthat last 90 days).

Patients must not have experienced morethan 1 relapse in the previous year. 

NWT:

For the treatment of adult patients withan established diagnosis of relapsing-remitting multiple sclerosis (RRMS). 

Criteria for initial 12-months coverage: 

Coverage is provided for 1 year (initialdosing of 20 mg by subcutaneous injection at weeks 0, 1 and 2, followed bysubsequent monthly 20 mg subcutaneous injection, starting at week 4 for adultspatients who meet ALL the following criteria: 

For the treatment of adult patients withan established diagnosis of relapsing-remitting multiple sclerosis (RRMS); AND

Prescribed by a specialist withexperience in the treatment of multiple sclerosis; AND

Patient has an Expanded DisabilityStatus Scale (EDSS) score of less than 6.0; AND

Evidence of active disease defined as atleast 1 of the following: 

One relapse during the previous year

Two relapses during the previous 2 years 

A positive gadolinium (Gd)-enhancingmagnetic resonance imaging (MRI) scan during the year before starting treatmentwith ofatumumab 

Ofatumumab should not be used incombination with other disease-modifying treatments (DMTs) used to treatmultiple sclerosis (MS). 

Criteria for renewal coverage every 12months: 

Ofatumumab may only be renewed forpatients who do not exhibit evidence of disease progression since the previousassessment. The EDSS score must be provided (exam must have occurred withinthat last 90 days).

Patients must not have experienced morethan 1 relapse in the previous year. 

VAC:

Open criteria – like Mayzent

British Columbia: 

PharmaCare has determined Kesimpta will not be covered 

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