Abatacept (Orencia®)

Restricted Product(s):

• abatacept (Orencia® ) intravenous infusion and subcutaneous injection for administration by a healthcare professional 

FDA Approved Use:

• For adult patients with moderately to severely active rheumatoid arthritis
• For patients 2 years and older with active psoriatic arthritis (subcutaneous)
• For adult patients with active psoriatic arthritis (intravenous)
• For patients 2 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (subcutaneous)
• For patients 6 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (intravenous)
• For the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in patients 2 years and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a diagnosis of moderately to severely active rheumatoid arthritis (RA); AND
   1. The patient is 18 years of age or older; AND
   2. The patient has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months [medical record documentation required]; OR
   3. The patient has tried and had an inadequate response to another conventional agent (i.e., hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA for at least 3-months [medical record documentation required]; OR
   4. The patient has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA [medical record documentation required]; OR 
   5. The patient has an FDA labeled contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA [medical record documentation required]; AND
   6. ONE of the following: 
      1. The patient has tried and had an inadequate response to an infliximab product AND Simponi Aria® (golimumab) [medical record documentation required]; OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH an infliximab product and Simponi Aria® (golimumab) [medical record documentation required]; OR
      3. BOTH of the following:
         1. The prescriber has provided information indicating why ALL of the preferred agents (i.e., infliximab products, Simponi Aria) are not clinically appropriate for the patient [medical record documentation required]; AND
         2. The prescriber has provided a complete list of previously tried agents for the requested indication [medical record documentation required]; OR
2. . The patient has a diagnosis of active psoriatic arthritis (PsA); AND
   1. If the request is for subcutaneous administration, the patient is 2 years of age or older; OR
   2. If the request is for intravenous administration, the patient is 18 years of age or older; AND
   3. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months [medical record documentation required]; OR
   4. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA [medical record documentation required]; OR
   5. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA [medical record documentation required]; OR
   6. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) [medical record documentation required]; OR
   7. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) [medical record documentation required]; AND
   8. ONE of the following: 
      1. The patient is 2 to 17 years of age; AND
         1. The patient has tried and had an inadequate response to Simponi Aria® (golimumab) [medical record documentation required]; OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to Simponi Aria® (golimumab) [medical record documentation required]; OR
         3. BOTH of the following:
            1. The prescriber has provided information indicating why the preferred agent (i.e., Simponi Aria) is not clinically appropriate for the patient [medical record documentation required]; AND 
            2. The prescriber has provided a complete list of previously tried agents for the requested indication [medical record documentation required]; OR
      2. The patient is 18 years of age or older; AND
         1. The patient has tried and had an inadequate response to an infliximab product AND Simponi Aria® (golimumab) [medical record documentation required]; OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH an infliximab product and Simponi Aria® (golimumab) [medical record documentation required]; OR
         3. BOTH of the following: 
            1. The prescriber has provided information indicating why ALL of the preferred agents (i.e., infliximab products, Simponi Aria) are not clinically appropriate for the patient [medical record documentation required]; AND
            2. The prescriber has provided a complete list of previously tried agents for the requested indication [medical record documentation required]; OR
3. The patient has a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); AND
   1. If the request is for subcutaneous administration, the patient is 2 years of age or older; OR
   2. If the request is for intravenous administration, the patient is 6 years of age or older; AND
   3. The patient has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least 3-months [medical record documentation required]; OR
   4. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA [medical record documentation required]; OR
   5. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA [medical record documentation required]; OR
4. The patient will be using the requested agent for the prophylaxis of acute graft versus host disease (aGVHD); AND
   1. The patient is 2 years of age or older; AND
   2. The patient will be using the requested agent in combination with a calcineurin inhibitor and methotrexate; AND
   3. The patient is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor [medical record documentation required]; AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for RA, PsA, JIA) or has consulted with a specialist in the area of the patient’s diagnosis; AND
6. The patient will NOT be using abatacept (Orencia® ) in combination with another biologic immunomodulator agent or Otezla® ; AND
7. The patient does NOT have any FDA labeled contraindications to abatacept (Orencia® ); AND 
8. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
10. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 365 days (1 year)

*Maximum units allowed for duration of approval 

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
   4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
   5.  Requirement of a change in the requested restricted product formulation; AND
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References:

All information referenced is from FDA package insert unless otherwise noted below.

1. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care & Research. 2021;73(7):924-39.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually. 

November 2023: Criteria change: For PsA: Updated indication age requirements per label to allow for 2 years and older for subcutaneous formulation, and updated trial and failure requirements according to age for clarity. Updated FDA label reference table and dosing according to FDA label.

September 2023: Criteria change: For PJIA: Adjusted list of tried and failed conventional agents. Separated out intolerance/hypersensitivity criteria from FDA labeled contraindication criteria for clarity. Updated FDA label reference label for clarity according to FDA label.

February 2023: Criteria update: Added criteria to allow for the prescriber indicating the preferred agents (i.e., infliximab products, Simponi Aria) are not clinically appropriate for the patient for rheumatoid arthritis and psoriatic arthritis (PsA) indications. Adjusted list of tried and failed conventional agents for PsA indication. Updated references.

January 2023: Criteria change: Changed requirement for trial and failure of preferred agents for rheumatoid arthritis and psoriatic arthritis to include both an infliximab product AND Simponi Aria. Policy notification given 11/1/2022 for effective date 1/1/2023.

February 2022: Criteria change: Added new indication for prophylaxis of acute graft vs host disease with corresponding criteria and dosing table updates. Updated maximum units to 1500.

August 2021: Criteria change: Removed criteria points regarding medication history indicating use of another biologic immunomodulator agent FDA labeled for the treatment of the same condition. Policy notification given 6/1/2021 for effective date 8/1/2021.

June 2021: Criteria change: Medical record documentation required for all indications.

April 2021: Criteria change: Addition of criteria for history of use of another biologic immunomodulator agent (or Otezla) for the same indication; RA: added requirement for trial of methotrexate or another conventional agent; PsA: added requirement for trial of one conventional agent, added option for severe active PsA or concomitant severe psoriasis; PJIA: added requirement for trial of one conventional agent; added requirements to be prescribed by or in consultation with a specialist, that patient has no FDA labeled contraindications, and for TB testing; added maximum units; medical policy formatting change. Policy notification given 2/26/2021 for effective date 4/28/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy