Exceptional Access Program (EAP)

EAP forms are to be completed when applying for MOH funding for drugs for rheumatological diseases through Ontario’s Exceptional Access Program (EAP).

Systemic Lupus (SLE)

Documents Criteria

2.1 Initial Approval. The Executive Officer will approve a request to reimburse claims for Saphnelo under the EAP at the Approved Dose for up to one (1) year, starting from the date on which the first claim is made pursuant to said approval (“Initial Approval Period”), provided that:

(1) the request is submitted in respect of a Patient in accordance with section 16 of the ODBA by an Authorized Prescriber who has expertise in the diagnosis and management of systemic lupus erythematosus (SLE); and

(2) the Patient satisfies the following conditions:

(a) the Patient is at least 18 years old and has documented autoantibody positive SLE;

(b) the Patient’s SLE is moderate to severe having a score of at least 6 on the SLE Disease Activity Index 2000 (SLEDAI-2K); and

(c) attempts to control the Patient’s SLE have been inadequate despite:

(i) treatment with an oral dose of prednisone of at least 10 mg daily or an equivalent oral corticosteroid (OCS); and

(ii) standard of care therapy for SLE using one or more of the following drugs, with or without non-steroidal anti-inflammatory drugs:

(ii.1) an antimalarial drug such as hydroxychloroquine, which was discontinued upon developing toxicity; or

(ii.2) at least one immunosuppressive drug such as cyclophosphamide, azathioprine, methotrexate,                 cyclosporine, or mycophenolate.

2.2 Initial Renewal Period. The Executive Officer will extend a Patient’s coverage for Saphnelo under the EAP at the Approved Dose beyond the Initial Approval Period or an approval granted under section 2.4 of this Schedule, for an additional period of up to one (1) year (“Initial Renewal Period”), provided that:

(1) the Patient’s disease activity has been reduced demonstrated by either:

(a) a reduction of the SLEDAI-2K score to 5 or lower if the SLEDAI-2K was used for the baseline score; or

(b) if the British Isles Lupus Assessment (BILAG)-2004 index was used for the baseline score, improvement in involved organ systems from baseline demonstrated by a reduction in all baseline BILAG-2004 index scores and no new worsening; and

(2) the Patient has either:

(a) decreased the oral dose of prednisone to at least 7.5mg daily or, if an equivalent OCS is used, an equivalent reduction in the dose; or

(b) maintained an oral dose of prednisone that is higher than 7.5mg daily, or if an equivalent OCS is used maintained an equivalent dose, but has decreased the dose by at least 50% from the         baseline OCS dose.

2.3 Subsequent Approval Periods. The Executive Officer will extend a Patient’s coverage for Saphnelo under the EAP at the Approved Dose beyond the Initial Renewal Period for any number of additional periods of up to one (1) year (“First Subsequent Renewal Period”, “Second Subsequent Renewal Period”, etc.), provided that the Patient has maintained the initial response demonstrated after the first 12 months of therapy with Saphnelo.

2.4 Case-by-Case Consideration – Initial Approval Period. Despite section 2.1 of this Schedule, the Executive Officer may, on a case-by-case basis, approve a request to reimburse claims for Saphnelo under the EAP at the Approved Dose for up to one (1) year for a Patient who:     (a) does not use the SLEDAI-2K to measure disease activity as required in clause 2.1 (1) (b) of this Schedule due to its unavailability and rather uses the BILAG-2004 index; or     (b) is less than 18 years old and who satisfies the Reimbursement Criteria, except for the age requirement. In exercising this discretionary authority, the Executive Officer may rely on the advice and recommendations of external medical consultants.

2.5 Exclusion Criteria. The Executive Officer will not approve a request to reimburse claims for Saphnelo under the EAP if the Patient meets any of the following exclusion criteria:     (a) the Patient will be using Saphnelo in combination with other biologic treatments for SLE;     (b) the Patient has severe or unstable neuropsychiatric SLE; and     (c) the Patient has severe active SLE nephritis.

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