Product Details

Kineret

Anakinra
150 mg/mL
Solution for Injection
Single-Use 0.67-mL Prefilled Syringe (Preservative-Free)

DIN/PIN/NPN

02245913

Manufacturer

Swedish Orphan Biovitrum AB

Formulary Listing Date

2023-03-31  

Unit Price

54.6182

Amount MOH Pays

54.6182

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AC03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Rheumatoid Arthritis

Adalimumab – see Formulary for funded biosimilars

  • Brand(s): Humira and formulary listed biosimilars
  • Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Anakinra

  • Brand(s): Kineret
  • Dosage Form/Strength: 100 mg /0.67 mL subcutaneous injection

Certolizumab pegol

  • Brand(s): Cimzia
  • Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – see Formulary for funded biosimilars

  • Brand(s): Enbrel
  • Dosage Form/Strength: 25 mg and/or 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options

Golimumab

  • Brand(s): Simponi
  • Dosage Form/Strength: 50 mg/0.5 mL prefilled syringe and autoinjector

Infliximab – see Formulary for funded biosimilars

  • Brand(s): Remicade
  • Dosage Form/Strength: 100 mg/vial intravenous infusion

Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions.

It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval.

Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.

Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document)

For the treatment of rheumatoid arthritis in patients who have:

  1. Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease-modifying anti-rheumatic drugs (DMARDs)*.

    *Optimal use of DMARDs include:

  • Methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months in addition to an adequate trial (3 months) of at least one combination of DMARDs;

    OR

  • Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months.

    Note: If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale why other DMARDs cannot be considered.

    OR

  • Methotrexate (20mg/week), sulfasalazine (2 GM/day) and hydroxychloroquine (400mg/day)* for at least 3 months. If the patient could not receive an adequate trial of methotrexate, sulfasalazine and hydroxychloroquine due to intolerance, then the above DMARD trial criteria must be met.

    *Hydroxychloroquine is based by weight up to 400 mg per day

Duration of Approval: 1 Year

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.

The planned dosing regimen for the requested biologic should be provided.

The recommended doses for the treatment of rheumatoid arthritis are as follows:

  • Adalimumab 40mg every two weeks

  • Anakinra 100mg per day

  • Certolizumab pegol 400mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400mg every 4 weeks may be considered

  • Etanercept 25mg twice weekly or 50mg once weekly

  • Golimumab 50mg once a month

  • Infliximab 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year

Duration of Approval:
- First Renewal: 1 Year
- Subsequent Renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Systemic Juvenile Idiopathic Arthritis

Anakinra

  • Brand(s): Kineret
  • Dosage Form/Strength: 100mg/0.67mL pre-filled syringe

For the treatment of systemic juvenile idiopathic arthritis in patients who meet the following criteria:

  1. Patient must have a diagnosis of sJIA with fever (>38 degrees Celsius) for at least 2 weeks AND at least ONE of the following:
    •     rash of systemic JIA
    •     serositis (e.g., pericarditis, pleuritis, or peritonitis)
    •     lymphadenopathy (e.g., cervical, axillary, inguinal)
    •     hepatomegaly
    •     splenomegaly 

  1. The physician making the request has ruled out other potential etiologies (e.g., malignancies, serious clinical infections, and other inflammatory or connective tissue diseases); AND 

  1. Age of disease onset is younger than 16 years of age. (Note: the physician must specify age of disease onset in the request); AND 

  1. Systemic corticosteroids cannot be used for at least ONE of the following reasons (please specify name and current dose of corticosteroid, if applicable):
    •     The patient is unresponsive and/or refractory to systemic corticosteroids;
    OR
    •     The patient has experienced a systemic reaction (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly) while on tapering doses of systemic corticosteroids (i.e., the patient is corticosteroid dependent);
    OR
    •     The patient has experienced an adverse drug reaction to a systemic corticosteroid;
    OR
    •     The use of systemic corticosteroids is contraindicated in this patient.

Note: The following requests will undergo external review on a case-by-case basis: 

  1. Patients with Macrophage Activation Syndrome 

  2. Patients who meet initial sJIA criteria and are currently 16 years of age or older 

  3. Patients who meet initial sJIA criteria and are requesting higher dosing regimens (Please provide rationale for the higher dosing regimen with your request) 

Dosing: 1-2 mg/kg subcutaneously once daily. 

Duration of Approval: 1 Year 

Renewal will be considered for patients demonstrating at least a 50% reduction in corticosteroid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. 

The following renewal requests will undergo external review: 

  1. Evidence of active systemic disease

  2. Requests for higher dosing regimens (Please provide rationale for the higher dosing regimen with your request)

  3. Patient is currently 16 years of age or older 

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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