Limited Coverage Drugs – ustekinumab for plaque psoriasis

Last updated on September 17, 2024

Special Authority requests can now be submitted online. It's simple and quick!

Biosimilar transition initiative

PharmaCare is changing coverage of ustekinumab for plaque psoriasis (PsO).

To maintain PharmaCare coverage, patients currently covered for the originator biologic Stelara® must, in consultation with their prescriber, switch to an approved biosimilar product (Jamteki^™ , Wezlana^™ or Steqeyma^®)

May 30, 2024 – All new Special Authority (SA) requests, including renewals, for ustekinumab will only be approved for Jamteki. As of September 17, 2024, Wezlana and Steqeyma are also available as approved biosimilars.

May 30, 2024 to December 2, 2024 – During the six-month transition period, patients with PharmaCare coverage for the originator ustekinumab (Stelara) who wish to maintain their coverage must transition to an approved biosimilar ustekinumab product; a new SA request is not required for coverage of the biosimilar until the next scheduled renewal date. To maintain patients' coverage of ustekinumab, prescribers must write a new prescription for their patients on the originator ustekinumab (Stelara), indicating the transition to a specific biosimilar product.

December 3, 2024 – The originator ustekinumab (Stelara) is no longer an eligible PharmaCare benefit and only the approved biosimilar products are authorized for continued coverage.

SA requests for patients who are unable to transition to a ustekinumab biosimilar will be considered on an exceptional case-by-case basis.

Generic name:	ustekinumab
Brand name	Strength	Form
Jamteki^™	45 mg/0.5 mL	pre-filled syringe
	90 mg/1 mL
Wezlana^™	45 mg/0.5 mL	pre-filled syringe single-use vial
	90 mg/1 mL	pre-filled syringe
Steqeyma^®	45 mg/0.5 mL	pre-filled syringe
	90 mg/1 mL

Special Authority criteria	Approval period
Initial For the treatment of chronic moderate to severe plaque psoriasis in adult patients (18 years of age and older) who meet the following conditions: Patient has a body surface area (BSA) involvement of >10% and/or significant involvement of the face, hands, feet, or genital region AND Patient failed to respond, is intolerant, or is unable to access UV phototherapy AND Patient has a baseline pre-biologic psoriasis area severity index (PASI) of ≥ 12 AND Patient has had treatment failure¹, intolerance, or a contraindication to methotrexate AND cyclosporine AND Special Authority request submitted by a dermatologist	16 weeks
First renewal Patient has maintained a PASI of ≥ 75 from the baseline biologic naive PASI score AND Special Authority request submitted by a dermatologist	1 year
Second and subsequent renewals Patient has maintained a PASI of ≥ 50 from the baseline biologic naive PASI score AND Special Authority request submitted by a dermatologist	1 year

Special Authority criteria

Approval period

Initial

For the treatment of chronic moderate to severe plaque psoriasis in adult patients (18 years of age and older) who meet the following conditions:

Patient has a body surface area (BSA) involvement of >10% and/or significant involvement of the face, hands, feet, or genital region

AND

Patient failed to respond, is intolerant, or is unable to access UV phototherapy

AND

Patient has a baseline pre-biologic psoriasis area severity index (PASI) of ≥ 12

AND

Patient has had treatment failure¹, intolerance, or a contraindication to methotrexate AND cyclosporine

AND

Special Authority request submitted by a dermatologist

16 weeks

First renewal

Patient has maintained a PASI of ≥ 75 from the baseline biologic naive PASI score

AND

Special Authority request submitted by a dermatologist

1 year

Second and subsequent renewals

Patient has maintained a PASI of ≥ 50 from the baseline biologic naive PASI score

AND

Special Authority request submitted by a dermatologist

1 year

Practitioner exemptions

None

Special notes

¹For treatment failure, an adequate trial is considered to be a continuous 3-month trial of methotrexate at a dose of 20 mg weekly (15 mg weekly for ages >65), AND cyclosporine 4 mg/kg/day

PharmaCare coverage will not be provided for ustekinumab in combination with other biologic drugs for the treatment of PsO in adults
PharmaCare covers a maximum 84-day supply per fill of ustekinumab
Additional information expected to assist with processing of coverage requests is detailed on the forms linked below (and on the eForms published online)

Special Authority requests

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