Product information

KESIMPTA^® (ofatumumab injection) has provincial funding access with special authorization in Ontario.¹ You can find full coverage criteria below or online or you can schedule a call with a KESIMPTA^® sales representative. 
 

Initiation criteria¹  
 

For the treatment of RRMS in patients who meet all the following criteria: 

1. 18 years of age or older; AND  

2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system 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 oligoclonal bands.  

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

• Additional clinical attack implicating different CNS site

• 1 or more MS-typical T2 lesions in 2 or more areas of the 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 during the year before starting treatment with ofatumumab  

AND 
 

5. Ofatumumab is used as monotherapy;  

AND  
 

6. The drug request is from a neurologist experienced in the management of RRMS from one of the MS Society-recognized Ontario MS clinics‡ or includes a consult note from a neurologist from one of these clinics supporting the diagnosis.
    

^‡ MS Society recognized Ontario MS clinics:^§ 


• Hamilton MS Clinic HHS, McMaster University  

• Kingston MS Clinic, Kingston General Hospital  

• London MS Clinic, London Health Sciences Centre  

• Ottawa MS Research Clinic, Ottawa Hospital General Campus  

• Ottawa Pediatric MS Clinic, CHEO 

• Toronto MS Clinic, St Michael’s Hospital  

• Toronto Pediatric MS Clinic, The Hospital for Sick Children  

• Sunnybrook Health Sciences Centre  

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

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

Exclusion criteria
 

1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 

2. Patients with an EDSS score equal to or greater than 7.0.
    

Renewal criteria  
 

Ongoing funding will be provided for those who continue to benefit from treatment and who have an EDSS score less than 7.0.  
When requesting renewal of funding, information that should be provided should include:  

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

• Clinical details of the date and onset of clinical attacks/relapses  

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

Duration of approvals for initial and renewals: 12 months  
Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed. 

KESIMPTA^® (ofatumumab injection) is available on the formulary in Alberta (Special Authorization).² You can find full coverage criteria below or online or you can schedule a call with a KESIMPTA^® sales representative. 
 

Criteria²  

Special authorization coverage may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory adult patients (≥18 years of age) with RRMS. 

Coverage²
  

For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist, please complete the Registration for MS Neurologist Status Form (ABC 60002).
 

Initial coverage²
  

1. The registered MS Neurologist must confirm a diagnosis of RRMS; 

2. The patient must have active disease which is defined as ≥2 relapses* of MS during the previous 2 years or in the 2 years prior to starting an MS disease modifying therapy (DMT). 

3. The patient must be ambulatory with or without aid (the registered MS Neurologist must provide a current updated EDSS score ≤6.5.) 
    

Coverage may be approved for an initial dose of KESIMPTA^® 20 mg given by SC injection at Weeks 0, 1, 2, and 4, followed by monthly injections. Patients will be limited to receiving a 1 month's supply of KESIMPTA® per prescription at their pharmacy for the first 12 months of coverage.
 

Continued coverage² 
 

For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 

1. The patient must be assessed by a registered MS Neurologist; 

2. The registered MS Neurologist must confirm a diagnosis of RRMS; 

3. The registered MS Neurologist must provide a current, updated EDSS score. The patient must not have an EDSS score of ≥7.0, sustained for ≥1 year.
    

Coverage of this drug may be considered in a patient with a sustained EDSS score of ≥7.0 in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. 
 

Continued coverage may be approved for up to 24 months. Patients may receive up to 100 days' supply of KESIMPTA^® per prescription at their pharmacy. 

Restarting after an interruption in therapy greater than 24 months² 
 

In order to be eligible for coverage after an interruption in therapy greater than 24 months, the patient must meet the following criteria: 

1. At least 2 relapses* during the previous 24-month period;  
   OR 

All requests (including renewal requests) for KESIMPTA® must be completed using the Dimethyl Fumarate/Glatiramer Acetate/Interferon Beta-1b/Ocrelizumab/Ofatumumab/Peginterferon Beta-1a/Teriflunomide for RRMS/Interferon Beta-1a for SPMS or RRMS Special Authorization Request Form (ABC 60001). 
 
* A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting ≥48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of ≥1 month. At least 1 new T2 lesion or definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained ≥90 days after initiation of the DMT and ≥90 days before or after a relapse may substitute for 1 clinical relapse. 

KESIMPTA^® (ofatumumab injection) is available on the formulary in Saskatchewan (Exceptional Drug Status).³ You can find full coverage criteria below or online or you can schedule a call with a KESIMPTA^® sales representative. 
 

Criteria for KESIMPTA^® 20 mg/0.4 mL pre-filled pen³  
 

Approval for coverage will be given to patients who are assessed and meet the following criteria: 

• have clinical definite RRMS, as defined by the 2017 McDonald diagnostic criteria;  

AND 

• have had a clinical relapse* and/or new MRI activity^† in the last 2 years;  

AND 

• are fully ambulatory for 100 meters without aids (canes, walkers, or wheelchairs); EDSS score ≤5.5; 

AND 

• are age ≥18 years  
   

* A clinical relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting ≥24 hours in the absence of fever, preceded by stability for ≥1 month. 
^† MRI activity is defined as any new multiple sclerosis lesion/s, expanding lesion/s, and/or enhancing lesion/s. 

Physicians should also forward the following information:
· documentation of attacks, date of onset, date of diagnosis;
· neurological findings, EDSS;
· MRI reports or other significant information; and
· list of current medications.

For complete information, visit the Saskatchewan Formulary

KESIMPTA^® (ofatumumab injection) is available on the formulary in Manitoba (Exceptional Drug Status).⁴ You can find full coverage criteria below or online or you can schedule a call with a KESIMPTA^® sales representative.  
 

Criteria for KESIMPTA^® 20 mg/0.4 mL pre-filled pen⁴  

For the treatment of adult patients with an established diagnosis of RRMS, when prescribed by a neurologist from the Manitoba Multiple Sclerosis (MS) Clinic.