Protopic® is covered on all provincial drug plans (exceptional status/special authorization)*

96%-97% of Canadians with private health insurance have coverage for Protopic®1

Alberta

Special authorization2

Protopic® 0.03% ointment
For use in patients:

  1. 2 to 15 years of age inclusive with atopic dermatitis who are unable to tolerate or
    have failed topical steroid therapy.
  2. 2 to 15 years of age inclusive with atopic dermatitis who require ongoing use of
    potent (Class 3 or higher) topical steroids.
  3. 16 years of age and older with atopic dermatitis affecting face and flexures who
    are unable to tolerate or have failed topical steroid therapy.
  4. 16 years of age and older with atopic dermatitis who require ongoing use of potent
    (Class 3 or higher) topical steroids over greater than 30% of body surface area.

Protopic® 0.1% ointment
For use in patients:

  1. 16 years of age and older with atopic dermatitis affecting face and flexures who
    are unable to tolerate or have failed topical steroid therapy.
  2. 16 years of age and older with atopic dermatitis who require ongoing use of potent
    (Class 3 or higher) topical steroids over greater than 30% of body surface area.

Special authorization for all criteria may be granted for 6 months. Information is required regarding the patient’s diagnosis, previous medications utilized (including specific topical steroids) and the patient’s response to therapy. In order to comply with the first criteria, information is also required regarding the area(s) affected. In order to comply with the second criteria, information is also required regarding the percentage body surface area affected.

British Columbia

Special authorization:3

All of the following criteria must be met:

  1. Diagnosis of eczema.
  2. Medication prescribed by a dermatologist.
  3. Patient is refractory to three months of specified potent topical corticosteroid therapy OR patient is intolerant to specified topical corticosteroid treatment.

Manitoba

Exception drug status4

Second-line therapy for short and long-term intermittent treatment of moderate to severe atopic dermatitis in non-immunocompromised patients, in whom the use of conventional topical corticosteroid therapies are deemed inadvisable because of potential risks, or who are not adequately responsive to or intolerant of conventional therapies.

Note: Both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years.

New Brunswick

Special authorization5

Protopic® 0.03% ointment
For children over 2 years of age with refractory atopic dermatitis. Approvals will be given for up to twelve months at a time.

Protopic® 0.1% ointment
For the treatment of adults with moderate to severe atopic dermatitis who have failed or are intolerant to a site appropriate strength of corticosteroid therapy (i.e. low potency for the face versus intermediate to high potency for the trunk and extremities).

Newfoundland and Labrador

Special authorization6

Protopic® 0.03% ointment
For children greater than 2 years of age with refractory atopic dermatitis for a 12-month period.

Protopic® 0.1% ointment
For the intermittent use for moderate to severe atopic dermatitis in adults who have failed OR are intolerant to a site appropriate strength of corticosteroid therapy (i.e., low potency on face versus intermediate to high potency for trunk and extremities).

†Failure to improve after adequate hydration of the skin and traditional topical corticosteroid therapy.

Nova Scotia

Exception status drug7

Protopic® 0.03% and 0.1% ointment
  1. For children greater than 2 years of age with refractory atopic dermatitis. Coverage will be renewed yearly.
  2. For the intermittent use for moderate to severe atopic dermatitis in adults who have failed OR are intolerant to a site appropriate strength of corticosteroid therapy (i.e., low potency on face versus intermediate to high potency for trunk and extremities).

Ontario

Limited use criteria8

Protopic® 0.03% and 0.1% ointment
For use in combination with moisturizers or oral antihistamines in patients with atopic dermatitis who have failed or are intolerant to an 8-week trial of an intermediate-potency topical steroid. Therapy should be reassessed at 6 months. Authorization period: 1 year.
LU Code 383

Prince Edward Island

Special authorization9

Protopic® 0.03% ointment
For use in children greater than 2 years of age with refractory atopic dermatitis for a period of up to 12 months.

Protopic® 0.1% ointment
For intermittent use in adults with moderate to severe atopic dermatitis who have failed or are intolerant to a site appropriate strength of corticosteroid therapy (i.e., low potency on face versus intermediate to high potency for trunk and extremities).

Quebec

Exceptional medication status10

  1. DE56:
    For treatment of atopic dermatitis in children, following failure of a treatment with a topical corticosteroid.
  2. DE57:
    For treatment of atopic dermatitis in adults, following failure of at least two treatments with a different topical corticosteroid of intermediate strength or greater, or following failure of at least two treatments on the face with a different low-strength topical corticosteroid.

Saskatchewan

Special authorizations11

For treatment:

  • Atopic dermatitis in patients unresponsive to topical steroids tried within the
    last 3 months.
  • Atopic dermatitis in patients intolerant to topical steroids tried within the last
    3 months.

Protopic Safety Information

Protopic@ is indicated for12:
Treatment: Protopic®, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years, is indicated as a second-line therapy for short- and long-term intermittent treatment of moderate to severe atopic dermatitis in non-immunocompromised patients, in whom the use of conventional therapies are deemed inadvisable because of potential risks, or who are not adequately responsive to or intolerant of conventional therapies.
Maintenance: Protopic® is also indicated for maintenance therapy to prevent flares and prolong flare-free intervals in patients with moderate to severe atopic dermatitis experiencing a high frequency of flares (i.e., occurring 5 or more times per year) who have had an initial response (i.e., lesions cleared, almost cleared or mildly affected) with up to 6 weeks of treatment with twice-daily Protopic®.

Most serious warning and precautions:
Risk of skin malignancy and lymphoma: Long-term safety of topical calcineurin inhibitors has not been established. Although causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Protopic® ointment 0.1% and 0.03%. Therefore:

● Continuous long-term use of Protopic® ointment should be avoided and application limited to areas of involvement with atopic dermatitis
● Protopic® ointment is not indicated in children less than 2 years of age. Only 0.03% Protopic® ointment is indicated for use in children 2-15 years of age

Other relevant warnings and precautions:
● Risk of skin burning (burning sensation, stinging, soreness) or pruritus
● Risk of infections
● Avoid use on pre-malignant and malignant skin conditions
● Do not use in immunocompromised adults and children
● Discontinue use in patients who do not improve within 6 weeks of twice-daily treatment
● 
Risk of lymphadenopathy
● 
Risk of acute renal failure
● 
Risk of varicella zoster virus infection (chickenpox or shingles), herpes simplex virus infection or eczema herpeticum
● 
Minimize or avoid natural or artificial sunlight exposure
● 
Risk of increased systemic absorption in patients with a skin barrier defect
● 
Use in pregnant and nursing women

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing/administration, which have not been discussed in this piece. The Product Monograph is also available by calling LEO Pharma Medical Information at 1-800-263-4218.

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References:
1. Mapol Inc. Protopic® Drug Reimbursement Monitor with Provincial Tables. June 6, 2016.
2. Alberta Health. Available at www.alberta.ca/drug-benefit-list-and-drug-review-process.aspx. Accessed April 2019.
3. British Columbia Ministry of Health Services. Limited Coverage Drugs – Special Authority Criteria. Available at: www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/limited-coverage-drug-program/limited-coverage-drugs-tacrolimus-ointment. Accessed May 2019.
4. Manitoba Drug Benefits and Interchangeability Formulary. Part 3 Exception Drug Status (EDS). Available at: www.gov.mb.ca/health/mdbif/index.html. Accessed April 2019.
5. New Brunswick Drug Plans Formulary. June 2019.
6. Newfoundland and Labrador Prescription Drug Program. Criteria for the Coverage of Special Authorization Drugs. October 2018.
7. Nova Scotia Formulary. June 2019. Available at: www.nspharmacare.ca.
8. Ontario Formulary. Available at www.ontario.ca/page/check-medication-coverage. Accessed April 2019.
9. P.E.I. Pharmacare Formulary. Available at: www.gov.pe.ca/photos/original/hpei_formulary.pdf. Accessed May 2019.
10. Régie de l’assurance maladie du Québec (RAMQ). Codes des medicaments d’exception. 2019.
11. Saskatchewan Online Formulary Database. Available at https://formulary.drugplan.ehealthsask.ca. Accessed April 2019.
12. Protopic® product monograph. LEO Pharma Inc. June 21, 2016.