Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Abatacept (Orencia) IV
Abatacept (Orencia) IV may be considered medically necessary and payable through the medical benefit when an individual meets the criteria for ANY ONE of the following:
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- The individual has a diagnosis of moderately to severely active PJIA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- BOTH of the following:
- ONE of the following:
- The individual is six (6) years of age or older; or
- The prescriber has provided information in support of using abatacept (Orencia) IV for the individual’s age; and
- ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least three (3)-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PJIA; and
- The prescriber is a specialist in the area of the individual’s diagnosis, or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using abatacept (Orencia) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using abatacept (Orencia) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for abatacept (Orencia) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Psoriatic Arthritis (PsA)
- The individual has a diagnosis of active PsA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- ALL of the following:
- ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of using abatacept (Orencia) IV for the individual’s age; and
- ONE of the following:
- The individual 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 three (3)-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA; or
- The individual 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); or
- The individual 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); or
- The individual’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PsA; and
- ONE of the following:
- BOTH of the following:
- ONE of the following:
- The individual has tried and had an inadequate response to ONE preferred infliximab agent (Inflectra or Renflexis) for the requested indication for at least 3-months; or
- The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE preferred infliximab agent (Inflectra or Renflexis) for the requested indication; or
- The individual has an FDA labeled contraindication to ALL preferred infliximab agents (Inflectra and Renflexis) for the requested indication; and
- ONE of the following:
- The individual has tried and had an inadequate response golimumab (Simponi Aria) for the requested indication for at least three (3)-months; or
- The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to golimumab (Simponi Aria) for the requested indication; or
- The individual has an FDA labeled contraindication to golimumab (Simponi Aria) for the requested indication; or
- BOTH of the following:
- The prescriber has provided information indicating why ALL of the preferred agents (Inflectra, Renflexis, and Simponi Aria) are not clinically appropriate for the individual; and
- The prescriber has provided a complete list of previously tried agents for the requested indication; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using abatacept (Orencia) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using abatacept (Orencia) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for abatacept (Orencia) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Rheumatoid Arthritis (RA)
- The individual has a diagnosis of moderately to severely active RA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with abatacept (Orencia) IV (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- ALL of the following:
- ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of using abatacept (Orencia) IV for the individual’s age; and
- ONE of the following:
- The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) used in the treatment of RA for at least three (3)-months; or
- The individual has tried and had an inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, or sulfasalazine) used in the treatment of RA for at least three (3)-months; or
- The individual has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
- The individual has an FDA labeled contraindication to ALL conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of RA; and
- ONE of the following:
- BOTH of the following:
- ONE of the following:
- The individual has tried and had an inadequate response to ONE preferred infliximab agent (Inflectra or Renflexis) for the requested indication for at least hree (3)-months; or
- The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE preferred infliximab agent (Inflectra or Renflexis) for the requested indication; or
- The individual has an FDA labeled contraindication to ALL preferred infliximab agents (Inflectra and Renflexis) for the requested indication; and
- ONE of the following:
- The individual has tried and had an inadequate response golimumab (Simponi Aria) for the requested indication for at least three (3)-months; or
- The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to golimumab (Simponi Aria) for the requested indication; or
- The individual has an FDA labeled contraindication to golimumab (Simponi Aria) for the requested indication; or
- BOTH of the following:
- The prescriber has provided information indicating why ALL of the preferred agents (Inflectra, Renflexis, Simponi Aria) are not clinically appropriate for the individual; and
- The prescriber has provided a complete list of previously tried agents for the requested indication; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using abatacept (Orencia) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using abatacept (Orencia) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for abatacept (Orencia) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
acute Graft versus Host Disease (aGVHD)
- The individual has a diagnosis aGVHD; and
- The individual will be using abatacept (Orencia) IV in combination with calcineurin inhibitor and methotrexate; and
- The individual will be undergoing hematopoietic stem cell transplantation from a matched or one (1) allele-mismatched unrelated-donor; and
- ONE of the following:
- The individual is two (2) years of age or older; or
- The prescriber has provided information in support of using abatacept (Orencia) IV for the individual’s age; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using abatacept (Orencia) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using abatacept (Orencia) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for abatacept (Orencia) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Compendia Sources
Abatacept (Orencia) IV may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
The use of abatacept (Orencia) IV for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
