COSENTYX^® (secukinumab) is listed on the Manitoba formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative.

For treatment of adult patients with severe plaque psoriasis presently with one or more of the following:

• Psoriasis Area and the Severity Index (PASI) ≥ 10
• Body Surface Area (BSA) > 10%
• Significant involvement of the face, hands feet or genital region
• Dermatology Life Quality Index (DLQI) > 10 AND
• Failure to respond to, contraindications to, intolerant of or unable to access methotrexate, cyclosporine and/or phototherapy.

Coverage will be approved initially for a maximum of 3 months. For continued coverage the physician must confirm the patient’s response to treatment and demonstration of treatment clinical benefits:

• ≥ 50% reduction in the PASI score with ≥ 5 point improvement in the DLQI
• ≥ 75 % reduction in the PASI score
• ≥ 50% reduction in the BSA with significant improvement of the face, hands, feet or genital region.

Request for coverage must be made by a specialist in dermatology.

COSENTYX^® (secukinumab) is listed on the New Brunswick Drug Plans Formulary under special authorization criteria. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative.

For the treatment of patients with chronic moderate to severe plaque psoriasis who meet all of the following criteria:

• Psoriasis Area Severity Index (PASI) greater than 10 and Dermatology Life Quality Index (DLQI) greater than 10, or major involvement of visible areas, scalp, genitals, or nails
• Refractory, intolerant or unable to access phototherapy.
• Refractory, intolerant or have contraindications to methotrexate (oral or parenteral) at a dose of greater than or equal to 20 mg weekly (greater than or equal to 15 mg if patient is greater than or equal to 65 years of age) for a minimum of 12 weeks

Duration of coverage

Initial approval:

• Initial approval: 12 weeks
• Renewal approval: 1 year

Requests for renewal

• Confirmation of continued response is required.

Note:

• For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered.
• Refractory is defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.
• Must be prescribed by a dermatologist.
• Combined use of more than one biologic drug will not be reimbursed.
• Approval will be for 300 mg given at weeks 0, 1, 2, 3, and 4, then monthly.

Special Authorization Request Form

COSENTYX^® (secukinumab) is listed on the Newfoundland and Labrador prescription drug program as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative.

For the treatment of patients with moderate to severe plaque who meet all of the following criteria:

• Psoriasis Area Severity Index (PASI) > 10 AND Dermatology Life Quality Index (DLQI) >10 AND Body Surface Area (BSA) involvement of at least 10% OR involvement of the face, hands, feet or genital regions AND
• Refractory or intolerant to or unable to access phototherapy AND
• Refractory or intolerant or have contraindications to methotrexate (oral or parenteral) at a dose of greater than or equal to 20 mg weekly (greater than or equal to 15 mg if patient is 65 years of age or older) for a minimum of 12 weeks OR cyclosporine (6 weeks treatment).
• Response must be assessed after 16 weeks and therapy continued only in patients who have responded to therapy as defined below:

An adequate response defined below:

• Greater than or equal to 75% reduction in PASI score, OR
• Greater than ore equal to 50% reduction in PASI and greater than or equal to 5 points in the DLQI OR
• A quantitative reduction in BSA affected with qualitative consideration of specific regions such as face, hands, feet or genital region and situations such as itch and recalcitrant plaques

Claim Notes:

• Initial approval for a maximum of 12 weeks.
• Coverage may be approved as follows: initial dosing of 300 mg doses at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing of 300 mg doses starting at Week 4. If response criteria are met at 12 weeks, approval will be continued to a maximum dose of 300mg every month thereafter up to one year.
• Must be prescribed by a dermatologist or physician experienced in the treatment of moderate to severe plaque psoriasis.
• Combined use of more than one biologic drug will not be reimbursed.
• Refractory defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Intolerant defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.
• Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory.
• Patients will not be permitted to switch back to a previously trialed biologic agent if they had an unsatisfactory response to treatment.

COSENTYX^® (secukinumab) is listed on Nova Scotia Pharmacare as an Exception Status drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

• For patients with severe, debilitating chronic plaque psoriasis who meet all of the following
  • Body surface area (BSA) involvement of >10% and/or significant involvement of the face, hands, feet or genitals;
  • Failure to, contraindication to or intolerant of methotrexate and cyclosporine;
  • Failure to, intolerant of or unable to access phototherapy;
  • Written request of a dermatologist or prescriber with a specialty in dermatology.
• Continued coverage is dependent on evidence of improvement, specifically:
  • A >75% reduction in the Psoriasis Area and Severity Index (PASI) score; or
  • A >50% reduction in PASI with a > 5 point improvement in DLQI (Dermatology Life Quality Index); or
  • Significant reduction in BSA involved, with consideration of important regions such as the face, hands, feet or genitals.
• Concurrent use of biologics not approved.
• Initial approval for a maximum of 12 weeks.
• Coverage may be approved as follows: initial dosing of 300 mg doses at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing of 300 mg doses starting at Week 4.

COSENTYX^® (secukinumab) is listed on the Ontario Exception Access Program as a frequently requested drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). 

Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. 

The recommended dose for COSENTYX^® is 300mg subcutaneously at weeks 0, 1, 2 and 3, and then monthly starting at week 4. A maintenance dose of 300mg every 2 weeks may be considered for adult patients with a body weight of 90kg or higher. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved doses, higher doses are not recommended and the physician should consider switching to an alternative biologic agent.

Note 1: Definition of severe plaque psoriasis: 

• Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND
• Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND
• Dermatology Life Quality Index (DLQI) score of at least 10.

Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 

• 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND
• 12 week trial of phototherapy (unless not accessible), AND
• 6 month trial of at least 2 systemic, oral agents used alone or in combination
• Methotrexate 15-30mg per week
• Acitretin (could have been used with phototherapy)
• Cyclosporine

Maintenance/Renewal: 

After 3 months of therapy, patients who respond to therapy should have: 

• At least a 50% reduction in PASI, AND
• at least a 50% reduction in BSA involvement, AND
• at least a 5 point reduction in DLQI score

COSENTYX^® (secukinumab) is listed on the Prince Edward Island Pharmacare Formulary as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

For patients with severe, debilitating chronic plaque psoriasis who meet all of the following criteria:

• Body surface area (BSA) involvement of >10% and/or significant involvement of the face, hands, feet or genitals;
• Failure to, contraindication to or intolerant of methotrexate (oral or parenteral) at a dose of ≥20 mg weekly (≥15mg if patient is ≥65 years of age) for a minimum of 12 weeks or cyclosporine for a minimum of 6 weeks; AND
• Failure to, intolerant of or unable to access phototherapy.

Continued coverage is dependent on evidence of improvement, specifically:

• A >75% reduction (provide baseline and current score) in the Psoriasis Area and Severity Index (PASI) score; OR
• A >50% reduction (provide baseline and current score) in PASI with a > 5 point improvement in DLQI (Dermatology Life Quality Index); OR
• Significant reduction in BSA involved, with consideration of important regions such as the face, hands, feet or genitals.

Clinical Notes: 

• For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered
• Failure is defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Treatment should be discontinued if a response has not been demonstrated after 16 weeks.
• Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.

Claim Notes: 

• Approvals will be for a maximum adult dose of 300 mg at 0, 1, 2, and 3 weeks followed by monthly maintenance dosing starting at week 4, up to 12 weeks. If response criteria is met at 12 weeks, approval will be continued to a maximum dose of 300 mg.
• Maximum dosages as per existing criteria on the PEI Pharmacare Formulary
• Initial approval: 16 weeks. Renewal approval: 1 year.
• Concurrent use of biologics not approved.

Requests for Plaque Psoriasis Biologic Agents must be requested by a dermatologist using the Plaque Psoriasis Special Authorization form which is available from the Drug Programs office or on-line at https://www.princeedwardisland.ca/sites/default/files/forms/anti-tnf_agents_for_psoriasis_special_authorization_request_form.pdf.

Patients must also apply for coverage by the High-Cost Drug Program. The patient application is available from the Drug Program Office or online at https://www.princeedwardisland.ca/sites/default/files/forms/high_cost_drug_program_application.pdf.

COSENTYX^® (secukinumab) is listed on the Quebec RAMQ^† formulary as an Exception Drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

For persons suffering from a severe form of chronic plaque psoriasis: 

• in the presence of a score greater than or equal to 12 on the Psoriasis Area and Severity Index (PASI) and where at least 10% of the body surface area is affected, or in the presence of large plaques on the face, palms or soles or in the genital area;
  and
• where a phototherapy treatment of 30 sessions or more during three months has not made it possible to optimally control the disease, unless the treatment is contraindicated, not tolerated or not accessible or where a treatment of 12 sessions or more during one month has not provided significant improvement in the lesions;
  and
• where a treatment with two systemic agents, used concomitantly or not, each for at least three months, has not made it possible to optimally control the disease. Except in the case of serious intolerance or a contraindication, these two agents must be:
  • methotrexate at a dose of 15 mg or more per week;
    or
  • cyclosporine at a dose of 3 mg/kg or more per day; 
    or
  • acitretin at a dose of 25 mg or more per day.

The initial request is authorized for a maximum period of four months.

When requesting continuation of treatment, the physician must provide information making it possible to establish the beneficial effects of the treatment, specifically:

• an improvement of at least 75% in the PASI score compared to the baseline value; or
• an improvement of at least 50% in the PASI score of at least 50% in the body surface area affected, compared to the baseline values;
• a significant improvement in lesions on the face, palms or soles or in the genital area compared to the pretreatment assessment.

Requests for continuation of treatment are authorized for a maximum period of 12 months.

Authorizations for secukinumab are given for 300 mg on weeks 0, 1, 2, 3 and 4, then every month. However, for persons with a body weight of 90 kg or more, in the event of a sub-optimal response, the dose may be increased to 300 mg every two weeks from the 16th week of treatment. In this case, authorization will be given for a maximum period of six months, after which the physician will have to demonstrate the clinical benefits obtained at this dose in order to renew subsequent authorizations, which will be for a maximum period of 12 months.

^† Official mark of the Régie de l’assurance maladie du Québec. 

COSENTYX^® (secukinumab) is listed on the Saskatchewan formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

For the treatment of adult patients with severe debilitating plaque psoriasis who have failed, or are intolerant to methotrexate OR cyclosporine AND have failed, are intolerant to, or unable to access phototherapy. 

Coverage will be approved initially for the induction phase of up to 12 weeks.  

Coverage can be renewed in patients who have responded to therapy.  

Note: This product should be used in consultation with a specialist in this area.  

Coverage may be approved as follows: initial dosing of 300mg doses at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing of 300mg doses starting at week 4. 

COSENTYX^® (secukinumab) is listed on the Yukon formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Plaque Psoriasis

• On recommendation of a dermatologist. Consult to be provided. 
• For patients with body surface involvement (BSA) of >10% and a PASI of >10, OR significant involvement of the face, hands, feet or genitals. 
• For patients who are refractory or intolerant to a 12 week trial of parenteral methotrexate AND a 12 week trial of cyclosporine. 
• Maintenance therapy requires yearly dermatologist consult, showing that the patient has maintained at least 50% reduction both in PASI and BSA from baseline. 
• Coverage may be approved as follows: Initial dosing of 300mg doses at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing of 300mg doses starting at week 4. 

Approval for 1 year period.

Applications for Exception Drug Status should be sent to:

Chronic Disease Program
Health Services Branch (H—2)
Box 2703
Whitehorse, Yukon
Y1A 2C6
Phone: (867) 667-5092
Fax: (867) 393-6486

OR

Pharmacare Program
Box 2703
Whitehorse, Yukon
YlA 2C6
Phone: (867) 667-5403
Fax: (867) 393-6486

COSENTYX^® (secukinumab) is listed on the Non-Insured Health Benefits (NIHB) Program as a Limited Use benefit. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

For the treatment of moderate to severe psoriasis 

Coverage is provided for an initial period of 12 weeks at a dose of 300mg at Weeks 0, 1, 2 and 3, followed by 300mg per month starting at Week 4. 

• prescribed by a dermatologist 

For the treatment of patients with moderate to severe psoriasis who meet all of the following criteria:

• body surface area (BSA) involvement greater than 10% and/or significant involvement of the face, hands, feet or genital region; and
• intolerance or lack of response to phototherapy; or
• inability to access phototherapy; and
• intolerance or lack of response to methotrexate (MTX) weekly oral or parenteral at 20 mg or greater (15 mg or greater if patient is > 65 years of age) for more than 8 weeks; or
• a contraindication to methotrexate.

Coverage beyond 12 weeks will be based on a significant reduction in the Body Surface Area (BSA) involved and improvements in the Psoriasis Area Severity Index (PASI) score and the Dermatology Life Quality Index (DLQI): 

• a 75% reduction in Psoriasis Area Severity Index (PASI) score; or
• a ≥ 50% reduction in the Psoriasis Area Severity Index (PASI) score with a ≥ 5-point improvement in the Dermatology Life Quality Index (DLQI); or
• a significant reduction in Body Surface Area (BSA) involved, with consideration of important areas such as the face, hands, feet or genital regions.

COSENTYX^® (secukinumab) is listed on the Alberta Drug Benefit List (ADBL) formulary with special authorization. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• Use in combination with methotrexate (MTX) for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular PsA or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:
  • MTX at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO MTX or experience gastrointestinal intolerance to PO MTX must have a trial of parenteral MTX before being accepted as refractory; AND  
  • An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4-month trial).  

Duration of coverage 

• Initial coverage: 16 weeks
• Continued coverage: 12 months

Assessments

• For continued coverage beyond eight doses, the patient must meet the following criteria: 

1. The patient must be assessed by a specialist in rheumatology (RA Specialist) after the initial eight doses to determine response.
2. The RA Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria:
   • ACR 20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND
   • An improvement of 0.22 in HAQ score [reported to two (2) decimal places].

• Following this assessment, continued coverage may be considered for one 150 mg (or 300 mg for anti-TNF alpha inadequate responders) dose of secukinumab every month for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period: 

1. The patient has been assessed by a Specialist in Rheumatology (RA Specialist) to determine response;
2. The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:
   • Confirmation of maintenance of ACR20, or
   • Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.
3. A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.

Note 

• For coverage, this drug must be initiated by a Specialist in Rheumatology.
• Special authorization coverage of this agent may be provided for use as monotherapy in adult patients for whom MTX is contraindicated and/or for those patients who have experienced serious adverse effects.
• Initial coverage: Four weekly doses of 150 mg of secukinumab at weeks 0, 1, 2 and 3, followed by monthly dosing at weeks 4, 8, 12 and 16. A dose of 300 mg (given as 2 subcutaneous injections of 150 mg each) may be considered for anti-TNF alpha inadequate responders. Patients will be limited to receiving two doses of secukinumab per prescription at their pharmacy during the initial 3 weeks, then one dose per prescription thereafter.
• Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g., initial coverage period).
• Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.
• Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

* ‘Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above. 

^† ‘Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs. 

All requests (including renewal requests) for secukinumab for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC60029).

COSENTYX^® (secukinumab) is listed on the British Columbia formulary under special authorization criteria. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

Initial Coverage:

• Current status of cutaneous psoriasis
• Diagnosis of moderate to severe psoriatic arthritis, where patient currently exhibits at least two of the following:
  • ≥5 active joints s (if yes, complete homunculus);  
  • If oligoarticular (<5 joints), at least 1 active joint proximal to, or including, wrist or ankle(if yes, complete homunculus);  
  • >1 joint with erosion on imaging study;  
  • Dactylitis of ≥2 digits (indicate by arrow and “D” on homunculus);  
  • Tenosynovitis refractory to oral NSAIDs AND steroid injections (indicate by arrow and “TS” on homunculus);  
  • Enthesitis refractory to oral NSAIDs AND steroid injections (not required for Achilles tendon) (indicate by arrow and “E” on homunculus); 
  • Inflammatory spinal symptoms refractory to 2 NSAIDs (min 2-week trial each) and submit a BASDAI with a score >4;  
  • Daily use of corticosteroids to control active arthritis;  
  • Use of narcotics >12 hours /day for pain resulting from inflammation. 
• Functional assessment completed by patient and attached
  • Health Assessment Questionnaire (HAQ); AND/OR 
  • BASDAI (in spinal disease)  
• Patient has failed two or more DMARDs:
  • Sulfasalazine (if allergic, must have failed two of the medications listed below).Methotrexate: up to 25 mg (15 mg if over 65 years) parenteral weekly; Chloroquine and/or hydroxychloroquine; Leflunomide; Cyclosporine; Other (eg azathioprine, gold).

Duration of coverage 

• Initial approval: 1 year
• Renewal approval: 1 year

Assessments

• Status of cutaneous psoriasis
• Provide status for the criteria originally specified in the request for initial coverage
• Functional assessment completed by patient and attached
• Health Assessment Questionnaire (HAQ); AND/OR
• BASDAI (in spinal disease)

Note

• Must be prescribed by a rheumatologist

All requests (including renewal requests) for secukinumab for Psoriatic Arthritis must be completed using the Special Authority request forms; Initial/Switch or Renewal.

COSENTYX^® (secukinumab) is listed on the Manitoba formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of patients over 18 years of age who have active psoriatic arthritis who have failed treatment with at least 3 DMARD therapies, one of which is methotrexate and/or leflunomide unless intolerance or contraindications to these agents is documented. One combination therapy of DMARDs must also be tried.
• Initial application information should include information on disease activity such as the number of tender joints, swollen joints, erythrocyte sedimentation rate, C-reactive protein value.

Note 

• Request for coverage must be made by a specialist in rheumatology.

Exception Drug Status (EDS) Request Form

COSENTYX^® (secukinumab) is listed on the New Brunswick Drug Plans Formulary under special authorization criteria. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the treatment of patients with predominantly axial psoriatic arthritis who are refractory, intolerant or have contraindications to the sequential use of at least 2 NSAIDS at maximal tolerated dose for a minimum of two weeks each.
• For the treatment of patients with predominantly peripheral psoriatic arthritis who are refractory, intolerant or have contraindications to:
  • The sequential use of at least 2 NSAIDS at maximal tolerated dose for a minimum of two weeks each. AND 
  • Methotrexate (oral or parenteral) at dose ≥20mg weekly (≥15mg if patients is ≥65 years of age) for a minimum of 8 weeks AND 
  • Leflunomide for a minimum of 10 weeks or Sulfasalazine for a minimum of 3 months

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Assessments

• Confirmation of continued response is required 

Note 

• For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered.
• Refractory is defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.
• Most be prescribed by a rheumatologist
• Combined use with other biologic drugs or janus kinase inhibitors will not be reimbursed.
• Approvals will be for a maximum of 150 mg given at weeks 0, 1, 2, 3, and 4, then monthly.
• Requests for 300 mg given at weeks 0, 1, 2, 3, and 4 then will be considered for patients who have previously had an inadequate response to TNF-inhibitors.

Special Authorization Request Form

COSENTYX^® (secukinumab) is listed on the Newfoundland and Labrador prescription drug program as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For patients who have active PsA who meet ALL of the following criteria:
• Have ≥3 active and tender joints.
• Have not responded to an adequate trial of two DMARDs or have an intolerance or contraindication to DMARDs

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Assessments

• Achieving improvement in symptoms of at least 20% (20% improvement in the American College of Rheumatology response criteria (ACR 20) or response using the Psoriatic Arthritis Response criteria).

Note 

• Must be prescribed by a rheumatologist.
• Combined use of more than one biologic DMARD will not be reimbursed.
• Initial approval: the recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing.
• If a patient is an anti-TNF alpha inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg dose.
• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4).

Special Authorization Request Form

COSENTYX^® (secukinumab) is listed on Nova Scotia Pharmacare as an Exception Status drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the treatment of patients with predominantly axial psoriatic arthritis who are refractory, intolerant or have contraindications to the sequential use of at least two NSAIDs at maximal tolerated dose for a minimum of two weeks each.
• For the treatment of patients with predominantly peripheral psoriatic arthritis who are refractory, intolerant or have contraindications to:
  • The sequential use of at least 2 NSAIDS for a minimum of two weeks each. AND
  • Methotrexate (oral or parenteral) at dose ≥20 mg weekly (≥15 mg if patients is ≥65 years of age) for a minimum of 8 weeks AND
  • Leflunomide for a minimum of 10 weeks or Sulfasalazine for a minimum of 3 months.

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Renewal approval

• Confirmation of continued response is required. 

Note 

• The request for coverage must be made by a rheumatologist.
• For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered.
• Refractory is defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.
• Combined use of more than one biologic DMARD will not be reimbursed.
• Approvals will be for a maximum of 150 mg given at weeks 0, 1, 2, 3, and 4, then monthly. Requests for 300mg monthly will be considered for patients who have previously had an inadequate response to TNF-inhibitors.

Exception Drug Status Request Form

COSENTYX^® (secukinumab) is listed on the Ontario Exception Access Program as a frequently requested drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of psoriatic arthritis in patients who have:
• Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.
• If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided.

Duration of coverage  

• Initial approval: 1 year
• Renewal approval: 1 year
• Second and subsequent renewals: 5 years

Renewal approval 

• Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. 

Note 

• The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: Secukinumab 150mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. If a patient is an anti-TNFalpha inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg sc dose. 

Request Form

COSENTYX^® (secukinumab) is listed on the Prince Edward Island Pharmacare Formulary as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of predominantly axial arthritis who are refractory, intolerant or have contraindications to the sequential use of at least two NSAIDs for a minimum of two weeks each.
• For the treatment of patients with predominantly peripheral psoriatic arthritis who are refractory or intolerant to:
• The sequential use of at least 2 NSAIDS for a minimum of two weeks each. AND
• Methotrexate (oral or parenteral) at dose ≥ 20mg weekly (≥15mg if patients is ≥65 years of age) for a minimum of 8 weeks AND
• Leflunomide for a minimum of 10 weeks or Sulfasalazine for a minimum of 3 months

Duration of coverage  

• Initial approval: 16 weeks
• Renewal approval: 1 year

Renewal approval 

• Confirmation of continued response is required. 

Note 

• The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology.
• For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered.
• Refractory is defined as lack of effect at the recommended doses and for duration of treatments specified above.
• Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented.
• Combined use of more than one biologic DMARD will not be reimbursed.
• Approvals will be for a maximum adult dose of 150 mg at weeks 0, 1, 2 and 3 followed by monthly maintenance dosing of 150 mg starting at week 4.
• For patients who are anti-TNFα inadequate responders and continue to have active psoriatic arthritis, consider using the 300 mg dose.
• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4).

The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology, using the Psoriatic Arthritis Special Authorization form. 

Patients must also apply for coverage through the High-Cost Drug Program. The patient application, here. 

COSENTYX^® (secukinumab) is listed on the Quebec RAMQ formulary as an Exception Drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

PsA of rheumatoid type

Criteria 

• Prior to the beginning of treatment, the person must have eight or more joints with active synovitis and one of the following four elements must be present:
  • radiologically measured erosions; 
  • a score of more than 1 on the Health Assessment Questionnaire (HAQ); 
  • an elevated C-reactive protein level; 
  • an elevated sedimentation rate;  

AND

• The disease must still be active despite treatment with two disease-modifying anti-rheumatic drugs, used either concomitantly or not, for at least three months each. Unless there is a serious intolerance or a contraindication, one of the two drugs must be:
  • methotrexate at a dose of 20 mg or more per week;
    OR 
  • sulfasalazine at a dose of 2 000 mg per day 

Duration of coverage  

• Initial approval: maximum 5 months
• Renewal approval: 1 year

Renewal approval 

• When requesting continuation of treatment, the physician must provide information making it possible to establish the beneficial effects of the treatment, specifically:
  • A decrease of at least 20% in the number of joints with active synovitis and one of the following four elements:
    • a decrease of 20% or more in the C-reactive protein level; 
    • a decrease of 20% or more in the sedimentation rate; 
    • a decrease of 0.20 in the HAQ score; 
    • a return to work 

Note 

• Authorizations for secukinumab are given for 300 mg on weeks 0, 1, 2, 3 and 4, then every month. 

Secukinumab: Moderate or severe psoriatic arthritis of rheumatoid or non-rheumatoid form.

PsA of a type other than rheumatoid

Criteria 

• Prior to the beginning of treatment, the person must have at least three joints with active synovitis and a score of more than 1 on the Health Assessment Questionnaire (HAQ);
  AND 
• The disease must still be active despite treatment with two disease-modifying anti-rheumatic drugs, used either concomitantly or not, for at least three months each. Unless there is a serious intolerance or a contraindication, one of the two drugs must be:
  • Methotrexate at a dose of 20 mg or more per week;
    OR 
  • sulfasalazine at a dose of 2,000 mg per day 

Duration of coverage  

• Initial approval: maximum 5 months
• Renewal approval: 1 year

Renewal approval 

• When requesting continuation of treatment, the physician must provide information making it possible to establish the beneficial effects of the treatment, specifically:
• A decrease of at least 20% in the number of joints with active synovitis and one of the following four elements:
  • A decrease of 20% or more in the C-reactive protein level;
  • A decrease of 20% or more in the sedimentation rate;
  • A decrease of 0.20 in the HAQ score;
  • A return to work

Note

• Authorizations for secukinumab are given for 300 mg on weeks 0, 1, 2, 3 and 4, then every month. 

Secukinumab: Moderate or severe psoriatic arthritis of rheumatoid or non-rheumatoid form.

COSENTYX^® (secukinumab) is listed on the Saskatchewan formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of psoriatic arthritis in patients who have failed, or are intolerant to, methotrexate and one other non-biologic, disease-modifying anti-rheumatic drug (DMARD).

Note 

• This product should be used in consultation with a specialist in this area. 

Exception Drug Status form.

COSENTYX^® (secukinumab) is listed on the Yukon formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For psoriatic arthritis patients with moderate to severe disease who are refractory or intolerant to a 12-week trial of parenteral methotrexate AND an adequate trial (at least 4 months) of at least one other DMARD. 

Duration of coverage  

• Initial approval: 1 year
• Second approval: 24-month periods

Note 

• Coverage may be approved as follows: Up to 300 mg at weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. 

Applications for Exception Drug Status should be sent to:

Chronic Disease Program
Health Services Branch (H—2)
Box 2703
Whitehorse, Yukon
Y1A 2C6
Phone: (867) 667-5092
Fax: (867) 393-6486

OR

Pharmacare Program
Box 2703
Whitehorse, Yukon
YlA 2C6
Phone: (867) 667-5403
Fax: (867) 393-6486

COSENTYX^® (secukinumab) is listed on the Non-Insured Health Benefits (NIHB) Program as a Limited Use benefit. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• Coverage is provided for an initial period of one year at a dose of 150 mg at weeks 0, 1, 2 and 3, followed by 150 mg per month starting at week 4. If patient is an anti-TNF inadequate responder and continues to have active psoriatic arthritis or has co-existent severe plaque psoriasis, 300 mg per month will be considered
• For the treatment of moderate to severe psoriatic arthritis that meets at least 2 of the following criteria:
  • 5 or more swollen joints 
  • if less than 5 swollen joints, at least one joint proximal to, or including wrist or ankle 
  • more than one joint with erosion on imaging study 
  • dactylitis of two or more digits 
  • tenosynovitis refractory to oral NSAIDs and steroid injections 
  • enthesitis refractory to oral NSAIDs and steroid injections (not required for Achilles tendon) 
  • inflammatory spinal symptoms refractory to two NSAIDs (minimum four weeks trial each) and has a BASDAI greater than 4 
  • daily use of corticosteroids use of opioids > 12 hours per day for pain resulting from inflammation 
• AND Patient is refractory to:
  • a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks; PLUS a minimum of any two of the following:
    • methotrexate weekly (weekly oral or parenteral) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks; OR 
    • leflunomide: 20mg daily for 10 weeks; OR 
    • sulfasalazine at least 2g daily for 3 months; OR 
    • cyclosporine 
• Axial disease with both of the following:
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4; AND 
  • Patient is refractory to a trial of at least two different NSAIDs at maximum tolerated doses for a combined total duration of four weeks. 

Duration of coverage  

• Initial approval: 1 year 

Note 

• Coverage beyond one year will be based on improvement according to the Psoriatic Arthritis Response Criteria (PsARC).
• Improvement in at least two of the four PsARC criteria, one of which has to be joint tenderness or swelling score, with no worsening in any of the four criteria. A response in joint count is determined by a reduction of ≥ 30%. A response in the Physician or Patient Global Assessment scale is determined by a reduction of 1 point.

Pharmacy Claim form.

COSENTYX^® (secukinumab) is listed on the Alberta Drug Benefit List (ADBL) formulary with special authorization. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the reduction in the signs and symptoms of severely active AS as defined by the Modified New York criteria for AS, in adult patients (18 years of age or older) who have active disease as demonstrated by: 
  • A BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apart AND 
  • A Spinal Pain VAS of greater than or equal to 4 cm (on a 0–10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND
  • Who are refractory or intolerant to treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses. 

Duration of coverage 

• Initial coverage: 16 weeks
• Continued coverage: 12 months

Assessments

• For continued coverage beyond eight doses, the patient must meet the following criteria:

1. The patient must be assessed by a Specialist in Rheumatology (RA Specialist) after the initial eight doses to determine response.
2. The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:
   • Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND
   • Reduction of the Spinal Pain VAS by 2 cm or more.

• Following this assessment, continued coverage may be considered for one 150 mg dose of secukinumab every month for a period of 12 months. [Note: For patients who continue to have active Ankylosing Spondylitis, a monthly maintenance dosage of 300 mg may be considered.] Ongoing coverage may be considered if the patient is re-assessed by a RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above.

Note 

• For coverage, this drug must be initiated by a RA Specialist.
• Initial coverage: Four weekly doses of 150 mg of secukinumab at weeks 0, 1, 2 and 3, followed by monthly dosing at weeks 4, 8, 12 and 16. Patients will be limited to receiving two doses of secukinumab per prescription at their pharmacy during the initial 3 weeks, then one dose per prescription thereafter.
• Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g., initial coverage period).
• Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.
• Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.
• Continued coverage may be considered for one 150 mg dose of secukinumab every month for a period of 12 months. [Note: For patients who continue to have active Ankylosing Spondylitis, a monthly maintenance dosage of 300 mg may be considered.]

* ‘Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above. 

† ‘Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs. 

All requests (including renewal requests) for secukinumab for ankylosing spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028). 

COSENTYX^® (secukinumab) is listed on the British Columbia formulary under special authorization criteria. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

Initial Coverage:

• Diagnosis of moderate to severe ankylosing spondylitis (specifying all that apply): 
  • Extra-articular manifestations: 
    • Uveitis 
    • IBD 
    • Psoriasis 
    • Other 
  • Axial Disease 
    • Positive imaging finding of ankylosing spondylitis.
    • If no positive imaging, provide HLA B27 status and two additional spondyloarthropathy features: 
      • inflammatory back pain 
      • arthritis 
      • enthesitis 
      • uveitis 
      • dactylitis 
      • psoriasis 
      • IBD 
      • good response to NSAIDs 
      • family history for SpA 
      • elevated CRP 
    • Presence of spinal pain 
  • Peripheral Disease 
    • Active joints (complete homunculus; active joints, tenosynovitis and enthesitis) 
    • Active Tenosynovitis and/or Enthesitis (indicate by arrow and “TS” or “E” on homunculus as applicable) 
• Active ankylosing spondylitis with a BASDAI score ≥ 4 (Attach BASDAI and HAQ if predominantly peripheral disease) 
• For predominantly axial disease, treatment failure or intolerance to 2 NSAIDS for a minimum of 2 weeks each at accepted maximum dosage OR
• For predominantly peripheral disease, patient is refractory to minimum 3-month trials of each of the following: 
  • Methotrexate [up to 25 mg (15 mg over 65 years) parenteral weekly] 
  • Sulfasalazine [up to 3g daily]

Duration of coverage 

• Initial approval: 1 year
• Renewal approval: 1 year

Assessments

• Extra-articular manifestations
• Axial Disease (spinal pain)
• Peripheral Disease
  • Active joints (homunculus) 
  • Active tenosynovitis and/or enthesitis (homunculus) 
• Copy of BASDAI and HAQ (if predominantly peripheral disease)

Note 

• Must be prescribed by a rheumatologist

All requests (including renewal requests) for secukinumab for ankylosing spondylitis must be completed using the Special Authority request forms; Initial/Switch or Renewal.

COSENTYX^® (secukinumab) is listed on the Manitoba formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of patients with active ankylosing spondylitis who have failed to respond to an adequate trial of at least 3 different non-steroidal anti-inflammatory drugs (NSAIDs) and, in patients with peripheral joint involvement, have failed to respond to methotrexate or sulfasalazine.

Note 

• Request for coverage must be made by a specialist in rheumatology.

Exception Drug Status (EDS) Request Form

COSENTYX^® (secukinumab) is listed on the New Brunswick Drug Plans Formulary under special authorization criteria. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the treatment of patients with moderate to severe AS (e.g., Bath AS Disease Activity Index (BASDAI) score of ≥4 on 10-point scale who:
  • Have axial symptoms and who have failed to respond to the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks each or in whom NSAIDS are contraindicated OR
  • Have peripheral symptoms and have failed to respond, or have contraindications to, the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks each and have had an inadequate response to an optimal dose or maximal tolerated dose of a DMARD.

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Requests for renewal

• A decrease if at least 2 points on the BASDAI scale compared with the pre-treatment score OR
• Patient and expert opinion of an adequate clinical response as indicated by a significant functional improvement (measured by outcomes such as HAQ or “ability to return to work”)

Note 

• Must be prescribed by a rheumatologist or internist.
• Combined use of more than one biologic drug will not be reimbursed.
• Requests for 300 mg monthly will be considered for patients who continue to have active disease while on the recommended monthly maintenance dose of 150 mg.
• Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication to axial disease do not require a trial of NSAIDs.

Special Authorization Request Form

COSENTYX^® (secukinumab) is listed on the Newfoundland and Labrador prescription drug program as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the treatment of patients with moderate to severe active AS (e.g., BASDAI score of ≥4 on 10-point) scale who:
  • Have axial symptoms and who have failed to respond to the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks each or in whom NSAIDs are contraindicated, OR
  • Have peripheral symptoms and have failed to respond, or have contraindications to, the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks and have had an inadequate response to an optimal dose or maximal tolerated dose of a DMARD.

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Requests for renewal

• A decrease of at least 2 points on the BASDAI scale compared with the pre-treatment score OR
• An adequate clinical response as indicated by a significant functional improvement (measured by outcomes such as HAQ or “ability to return to work”).

Note 

• Must be prescribed by a rheumatologist or internist.
• Combined use of more than one biologic DMARD will not be reimbursed
• Approvals will be for 150 mg at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. If a patient continues to have active ankylosing spondylitis, consider a monthly maintenance dosage of 300 mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
• Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication to axial disease do not require a trial of NSAIDs alone.

Special Authorization Request Form

COSENTYX^® (secukinumab) is listed on Nova Scotia Pharmacare as an Exception Status drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For the treatment of patients with moderate to severe ankylosing spondylitis (e.g., Bath AS Disease Activity Index (BASDAI) score ≥4 on 10-point scale) who:
  • Have axial symptoms and who have failed to respond to the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks each, or in whom NSAIDs are contraindicated; OR
  • Have peripheral symptoms and who have failed to respond, or have contraindications to, the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 2 weeks each and have had an inadequate response to an optimal dose or maximal tolerated dose of a DMARD.

Duration of coverage 

• Initial approval: 6 months
• Renewal approval: 1 year

Renewal approval 

• Requests for renewal must include information demonstrating the beneficial effects of the treatment, specifically: 
• A decrease of at least 2 points on the BASDAI scale, compared with the pre-treatment score; OR 
• Patient and expert opinion of an adequate clinical response as indicated by a significant functional improvement (measured by outcomes such as HAQ or "ability to return to work").

Note 

• Must be prescribed by a rheumatologist or prescriber with a specialty in rheumatology.
• Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication to axial disease, do not require a trial of NSAIDs alone.
• Combined use of more than one biologic DMARD will not be reimbursed.
• Approvals will be for 150 mg given at weeks 0, 1, 2, 3, and 4, then monthly. If a patient continues to have active ankylosing spondylitis, a monthly maintenance dosage of 300 mg may be considered.
• Each 300 mg dose is given as two subcutaneous injections of 150 mg.

Exception Drug Status Request Form

COSENTYX^® (secukinumab) is listed on the Ontario Exception Access Program as a frequently requested drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with:
  • Age of disease onset 50 years of age or younger; AND 
  • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND
  • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND 
  • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND
• The information submitted with the request must include the following: 
  • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. 
  • Details of review of radiographic reports for severe active disease: 
    • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR 
    • MRI report stating the presence of “inflammation” or “edema” of the SI joint 
    • Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. 
• Additional information that should be provided if applicable: 
  • Schober measurement and chest expansion measurement 
  • Evidence of restricted spinal mobility 
  • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts 

Duration of coverage  

• Initial approval: 1 year
• Second and subsequent renewals: 5 years

Renewal approval 

• Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable).
• For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

Note 

• The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS are as follows:
  • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4 

Request Form

COSENTYX^® (secukinumab) is listed on the Prince Edward Island Pharmacare Formulary as a special authorization drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative.

Criteria 

• For the treatment of patients with moderate to severe AS (BASDAI score of ≥4 on 10-point scale) who:
  • Have axial symptoms* and have failed to respond to the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 3 months observation or in whom NSAIDS are contraindicated OR
  • Have peripheral symptoms and have failed to respond, or have contraindications to, the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 3 months and have had an inadequate response to an optimal dose or maximal tolerated dose of a DMARD.

* Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication to axial disease do not require a trial of NSAIDs alone.

Duration of coverage  

• Initial approval: 6 months
• Renewal approval: maximum 12 months

Renewal approval 

• Requests for renewal must include information showing the beneficial effects of the treatment, specifically:
  • A decrease of at least two points on the BASDAI scale, compared with pre-treatment score OR 
  • Patient and expert opinion of an adequate clinical response as indicated by a significant functional improvement (measured by outcomes such as Health Assessment Questionnaire (HAQ) or ability to return to work). 

Note 

• The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology.
• Combined use of more than one biologic DMARD will not be reimbursed.
• Approvals will be for 150 mg at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing of 150 mg doses starting at Week 4.

The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology, using the Ankylosing Spondylitis Special Authorization form. 

Patients must also apply for coverage through the High-Cost Drug Program. The patient application, here. 

COSENTYX^® (secukinumab) is listed on the Quebec RAMQ formulary as an Exception Drug. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative.  

Criteria 

For treatment of persons suffering from moderate or severe ankylosing spondylitis whose BASDAI score is ≥4 on a scale of 0 to 10 and in who the sequential use of two non-steroidal anti-inflammatories at the optimal dose for a period of four weeks each did not adequately control the disease, unless there is contraindication. 

• Upon the initial request, the physician must provide the following information:
  • The BASDAI score;
  • The degree of functional injury according to the BASFI (scale of 0 to 10).

The initial request will be authorized for a maximum of five months.

• When requesting a continuation of treatment, the physician must provide information making it possible to establish the beneficial effects of the treatment, specifically:
  • A decrease of 2.2 points or 50% on the BASDAI scale, compared with the pre-treatment score; OR
  • A decrease of 1.5 points or 43% on the BASFI scale; OR 
  • A return to work.

Requests for continuation of treatment will be authorized for maximum periods of one year.

Authorizations for secukinumab are given for a maximum of 150 mg on weeks 0, 1, 2, 3 and 4, then for a maximum of 300 mg every month.

COSENTYX^® (secukinumab) is listed on the Saskatchewan formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• For the treatment of ankylosing spondylitis (AS) according to the following criteria:
• Initial Application (for a 16-week medication trial):
• For patients who have already been treated conventionally with two or more non-steroidal anti-inflammatory drugs (NSAIDs) taken sequentially at maximum tolerated or recommended doses for four weeks without symptom control; AND
• Satisfy New York diagnostic criteria: a score ≥4 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) AND a score of ≥4 on the 0-10cm spinal pain visual analogue scale (VAS) on two occasions at least 12 weeks apart without any change of treatment.

Duration of coverage  

• Initial approval: 16 weeks
• Second application: 1 year

Assessments 

• Second Application (following the initial 16-week approval)
• Adequate response to treatment assessed at 16 weeks defined as at least 50% reduction in pre-treatment baseline BASDAI score OR by ≥ 2 units AND
• A reduction of ≥ 2cm in the spinal pain VAS.
• Subsequent Annual Renewal Applications (beyond the first 16 months, requests are to be submitted annually for consideration of ongoing approval on a yearly basis):
• The BASDAI score does not worsen (i.e., remains within two units of the second assessment) AND remains at least two units less than the initial application’s BASDAI score

Note 

• Requests for coverage for this indication must be made by a rheumatologist
• Applications for this indication must be submitted on the designated EDS Application – Ankylosing Spondylitis Drugs form found on the Formulary website

Exception Drug Status form.

COSENTYX^® (secukinumab) is listed on the Yukon formulary under the Exception Drug Status (EDS) Program. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria

• For ankylosing spondylitis patients with a BASDAI score greater than or equal to 4.
• For patients with predominantly axial disease who are refractory or intolerant to a minimum 4-week trial of 2 NSAIDs at maximal dosage. OR
• For predominantly peripheral disease, patients refractory to a 3 month trial of parenteral methotrexate or a 3 month trial of sulfasalazine.

Duration of coverage

• Initial approval: 1 year
• Second approval: 24-month periods

Note 

• Rheumatologist consult to be provided.
• Coverage may be approved as follows: 150 mg or 300 mg at weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing.
• For patients who continue to have active ankylosing spondylitis, a monthly maintenance dosage of 300 mg may be considered.

Applications for Exception Drug Status should be sent to:

Chronic Disease Program
Health Services Branch (H—2)
Box 2703
Whitehorse, Yukon
Y1A 2C6
Phone: (867) 667-5092
Fax: (867) 393-6486

OR

Pharmacare Program
Box 2703
Whitehorse, Yukon
YlA 2C6
Phone: (867) 667-5403
Fax: (867) 393-6486

COSENTYX^® (secukinumab) is listed on the Non-Insured Health Benefits (NIHB) Program as a Limited Use benefit. You can find full coverage criteria below, or here, or you can schedule a call with a COSENTYX^® sales representative. 

Criteria 

• Coverage is provided for an initial period of one year at a dose of 150mg at weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. If patient continues to have active as, 300mg per month may be considered. Prescribed by a rheumatologist  
• For the treatment of Ankylosing Spondylitis:
  • BASDAI >4; AND
  • Patient is refractory to a trial of two different NSAIDs at maximum tolerated doses for a combined total duration of at least 4 weeks; AND  
  • For peripheral joint involvement, patient is refractory:
    • Methotrexate (MTX) (weekly oral or parenteral) weekly at 20 mg or greater (15 mg or greater if patient is >65 years of age) for more than 8 weeks; AND 
    • Sulfasalazine 2 g/day for at least 3 months. 
  • Note: for axial involvement, patient does not need to be tried on methotrexate or sulfasalazine.

Duration of coverage  

• Initial approval: 1 year 

Note 

• Coverage beyond one year will be based on improvement in the BASDAI score.
  • Improvement of at least 50% or 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. 

Pharmacy Claim form.