OTEZLA® is available on the RxHelpTM ONE program. The program covers up to the difference in cost between OTEZLA® and its generic alternative(s)*
* Available in select provinces only. Refers to drug acquisition cost and reasonable markup. Dispensing fees not covered. Program can end at the manufacturer’s discretion.
an oral tablet for the
treatment of adult moderate-
to-severe plaque psoriasis
Demonstrated efficacy in psoriasis
clinical trials1,3
- PASI-75 response at week 16 with OTEZLA 30 mg
BID: 33.1% vs. placebo: 5.3%, p < 0.0001*
Simplicity of oral dosing1§
Proven safety profile1
- Most common adverse reactions (≥ 5%) during weeks 0–16 were diarrhea (17.8%), nausea (16.6%), upper respiratory tract infection (8.4%), tension headache (7.3%), and headache (5.8%), which were mostly mild in intensity.† Incidences of these adverse events were higher in females than in males‡
* OTEZLA 30 mg BID: n=562, baseline PASI score=18.7; placebo: n=282, baseline PASI score=19.4.
† Nearly half of the adverse reactions of diarrhea, nausea, tension headache, and headache resolved within 2 weeks of onset.
‡ The particular incidence rates were 29.7% for females experiencing nausea (vs. 9.9% for males), 24.0% for diarrhea (vs. 14.6% for males), 7.9% for vomiting (vs. 1.6% for males), and 11.5% for tension headache (vs. 5.2% for males).
§ OTEZLA is administered 30 mg BID after initial titration. Please consult the Product Monograph for complete dosage and administration instructions, including dose adjustments in patients with severe renal impairment (CrCl < 30 mL/min).
BID, twice daily; CrCl, creatinine clearance; PASI, Psoriasis Area and Severity Index.
OTEZLA IS COVERED BY RAMQ (EXCEPTIONAL MEDICATION)4
REIMBURSEMENT CRITERIA:
For treatment of persons suffering from a severe form of chronic plaque psoriasis, before using a biological agent listed to treat this disease:
- in the presence of a score ≥ 15 on the Psoriasis Area and Severity Index (PASI) or of large plaques on the face, palms, or soles or in the genital area; and
- in the presence of a score ≥ 15 on the Dermatology Quality of Life Index (DQLI) questionnaire; 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 a serious intolerance or 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; or
- an improvement of at least 50% in the PASI score and a decrease of at least five points on the DQLI questionnaire; or
- a significant improvement in lesions on the face, palms, or soles or in the genital area and a decrease of at least five points on the DQLI questionnaire.
Requests for continuation of treatment are authorized for a maximum period of six months. Authorizations for apremilast are given for 30 mg, twice a day. It must be noted that apremilast is not authorized if administered concomitantly with a standard or biological systemic treatment indicated for treatment of plaque psoriasis.
RAMQ, Régie de l'assurance maladie du Québec.