Exceptional Access Program (EAP)

Abatacept
Brand(s): Orencia
DOSAGE FORM/STRENGTH: 250 mg/15 mL intravenous injection, 125 mg/mL prefilled syringe for subcutaneous injection

For the treatment of adult patients with severe active rheumatoid arthritis who meet the following criteria:

The Patient has severe active disease as demonstrated by:
• ≥ 5 swollen joints; AND
• Rheumatoid factor positive; AND/OR
• Having radiographic evidence of rheumatoid arthritis
Despite the optimal* use of various disease-modifying anti-rheumatic drugs (“DMARDs”).

*For the purpose of the criteria, the optimal use of DMARDs is defined as:
• Use of methotrexate (dosed at 20 mg per week) for at least 3 months; AND
• Use of leflunomide (dosed at 20 mg per day) for at least 3 months; AND
• An adequate trial (3 months) of at least one combination of DMARDs;
OR
• Use of methotrexate (dosed at 20 mg per week) for at least 3 months; AND
• Leflunomide in combination with methotrexate for at least 3 months.

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

For patients who have failed treatment with an anti-TNF therapy due to lack of efficacy or toxicity, prescribers should consider use of a biologic with a different mechanism of action.

Approved Dosing:
IV use: The initial dose is administered at 0, 2, and 4 weeks then every 4 weeks thereafter. Note that funding for higher doses will not be considered.

SC use: 125 mg SC weekly. Note that an IV loading dose of 750 mg may be given prior to initiating the weekly SC dosing. (Please refer to the Orencia product monograph for further details.)

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

Renewals will be considered in patients with objective evidence of at least a twenty percent (20%) reduction in swollen joint count and a minimum of improvement in two (2) swollen joints over the previous year.

For renewals beyond the second year, objective evidence of the preservation of treatment effect must be provided by the requesting physician.

Adalimumab – see Formulary for funded biosimilars
Brand(s): Humira (Only for those approved for biosimilar exemption)
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 (Only for those approved for biosimilar exemption)
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 (Only for those approved for biosimilar exemption)
DOSAGE FORM/STRENGTH: 100 mg/vial intravenous infusion

For the treatment of rheumatoid arthritis in patients who have: • 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.
• 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 (20 mg/week), sulfasalazine (2 GM/day) and hydroxychloroquine (400 mg/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 40 mg every two weeks
• Anakinra 100 mg per day
• Certolizumab pegol 400 mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400 mg every 4 weeks may be considered
• Etanercept 25 mg twice weekly or 50 mg once weekly
• Golimumab 50 mg once a month
• Infliximab 3 mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3 mg/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

Rituximab – See Formulary for funded biosimilars
Brand(s): Riximyo, Ruxience, Truxima (Biosimilar); Rituxan (Only for those approved for biosimilar exemption)
DOSAGE FORM/STRENGTH: 10 mg/mL intravenous injection

First course of Rituximab for the treatment of rheumatoid arthritis in adult patients with:
• Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or radiographic evidence of rheumatoid arthritis); AND
• Failure to respond to optimal use of DMARDs or documented intolerance or contraindications to DMARDs (per current EAP reimbursement criteria for anti-TNF agents); AND
• Failure to respond to, or the patient has intolerance or contraindications to, an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol)

Initial approval: One year: One course of treatment is 1000 mg followed two weeks later by the second 1000 mg dose. Two courses will be approved each year (courses should be at least 6 months apart with the second course being given only AFTER loss of effect as noted in the re-treatment guidelines below). Second course is not approved for “maintenance” therapy.

Renewal criteria: A joint count at 3-4 months indicating at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints should be recorded to indicate a response, and then re-treatment can be given after an interval of at least 6 months AND after a loss of effect. Details of all courses given and the subsequent response should be provided in the renewal request.

Renewal approval: 1 year (2 courses). One course of treatment is 1000 mg followed two weeks later by the second 1000 mg dose. Repeated courses are not approved for maintenance therapy.

Note: Rituximab should not be used concomitantly with other anti-TNF agents.

Sarilumab
Brand(s): Kevzara
DOSAGE FORM/STRENGTH: 150 mg/1.14 mL, 200 mg/1.14 mL Pre-filled Pen and Pre-filled Syringe

For the treatment of rheumatoid arthritis in adult patients meeting the following criteria:

a) Sarilumab is being used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs); AND
b) Patient is 18 years of age or older; AND
c) Has 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); AND
d) Has one of the following:
i) Fails to respond to Optimal use¹ of DMARDs (e.g. hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds).

¹Optimal use of DMARDs is defined as one of the below:
a) 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;
b) Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months; or
c) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (based on weight and up to 400 mg/day) for at least 3 months.

ii) Has a documented intolerance or contraindication to DMARDs in which case the nature of the contraindication(s) or intolerance(s) must be provided with the request, along with details of trials of other DMARDs or clear rationale as to why other DMARDs cannot be considered.

Approval duration of Initials: 1 year

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.

Approval duration of first renewal: 1 year
For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

Subsequent Renewal Criteria: Approval duration 5 years

Recommended Dose:
The recommended dose of KEVZARA is 200 mg once every 2 weeks given as a subcutaneous injection.
A reduced dose of 150 mg once every two weeks is recommended for patients with neutropenia, thrombocytopenia, or with elevated liver enzymes.

Tocilizumab
Brand(s): Actemra
DOSAGE FORM/STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162 mg/0.9 mL Inj (Prefilled syringe), 162 mg/0.9 mL Auto Injector

For the treatment of rheumatoid arthritis in adult patients with:
• Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive and/or has radiographic evidence of rheumatoid arthritis); AND
• Failure to respond to optimal use¹ of DMARDs or with documented intolerance to DMARDs (per current EAP reimbursement criteria for anti-TNF agents).

Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as:
a) Methotrexate (20 mg/week) for at least 3 months AND
b) 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
c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR
d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)² 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.

²Hydroxychloroquine is based by weight up to 400 mg per day

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 the contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale as to why other DMARDs cannot be considered.

The requesting physician is required to provide the planned dosing regimen on the request.

Recommended Doses for Tocilizumab (Actemra) IV and SC for Rheumatoid Arthritis:

IV recommended dose:
Approval for 4 mg/kg/dose once every 4 weeks followed by an increase to 8 mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended.

SC recommended dose:
For patients < 100 kg weight: starting dose of 162 mg every other week, followed by an increase to every week based on clinical response.
For patients ≥100 kg weight: 162 mg every week.

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 joints over the previous year.

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

Duration of Approval of first Renewal: 1 Year
Duration of Second and Subsequent Renewals: 5 Years