Limited coverage criteria – tocilizumab for active systemic juvenile idiopathic arthritis

 

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Generic name		tocilizumab
Brand name		Strength	Form
Avtozma™		162 mg/0.9 mL	pre-filled syringe autoinjector1
		80 mg/ 4 mL 200 mg/10 mL 400 mg/20 mL	solution for intravenous infusion
Tyenne®		162 mg/0.9 mL	pre-filled syringe autoinjector1
		80 mg/ 4 mL 200 mg/10 mL 400 mg/20 mL	solution for intravenous infusion

Special Authority criteria	Approval period
For the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years and older who, due to intolerance or lack of efficacy, have not adequately responded to: Non-steroidal anti-inflammatory drugs (NSAIDs) AND Systemic corticosteroid drugs (with or without methotrexate)	1 year

Practitioner exemptions

• Special Authority requests must be submitted by a pediatric rheumatologist. A Collaborative Prescribing Agreement (CPA) is available to a limited number of pediatric rheumatology practitioners. Each CPA must be signed by the pediatric rheumatologist who is requesting coverage and not a delegate
• PharmaCare covers tocilizumab for patients who meet the limited coverage criteria and whose prescription has been written by a pediatric rheumatologist who has entered into a CPA
  • Practitioners who have not signed a CPA may submit a Special Authority request if the patient meets the criteria above; these prescriptions will not be covered automatically. Special Authority requests submitted by a rheumatologist who has not signed a CPA must include a Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) and a Visual Analogue Scale (VAS)

Special notes

• ¹The pre-filled syringe with needle safety device (PFS + NSD) can be used to treat pediatric patients of all approved ages. The autoinjector should not be used to treat pediatric patients <12 years of age
• Treatment should be 8 mg/kg (for patients ≥ 30 kg or 12 mg/kg (for patients < 30 kg) IV once every 2 weeks or 162 mg subcutaneously every 1 to 2 weeks
• PharmaCare covers a maximum of 28 days' supply per fill for the IV formulation, and up to 56 days' supply for the SC formulation when dosed at 14-day intervals

Special Authority request form(s)

• Log in to eForms
• HLTH 5328 – General Special Authority request (PDF, 656KB)