Formulary Exception Inflammatory Conditions – Cimzia® (Certolizumab Pegol for Subcutaneous Injection [Lyophilized] and SC Injection [Solution])

Cigna National Formulary Coverage Policy Formulary Exception Inflammatory Conditions – Cimzia® (certolizumab pegol for subcutaneous injection [lyophilized] and SC injection [solution]) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 13288 Conditions Not Covered....................................... 5 References .......................................................... 6 Revision History ................................................... 6 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. National Formulary Medical Necessity Cigna covers certolizumab pegol (Cimzia®) for subcutaneous injection as medically necessary when the following criteria are met: Approval Duration: All approvals are provided for the duration noted below. In cases where the initial approval is authorized in months, 1 month is equal to 30 days. 1. Ankylosing Spondylitis. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months if the individual meets BOTH of the following conditions (i and ii): i. The medication is prescribed by or in consultation with a rheumatologist; AND ii. Individual has tried TWO of Enbrel, Humira, and Taltz [documentation required]. Note: If the individual has met criterion i but criterion ii is not met, offer to review for a Formulary product (Enbrel, Humira, or Taltz) using the appropriate standard Inflammatory Conditions criteria B) Individual is Currently Receiving Cimzia. Approve for 1 year if the individual meets BOTH of the following conditions (i and ii): i. Individual has had a response, as determined by the prescriber; AND Page 1 of 7 Cigna National Formulary Coverage Policy: FE Inflammatory Conditions – Cimzia Note: Examples of a response include decreased pain or stiffness, improved function or activities of daily living. The individual may not have a full response, but there should have been a recent or past response to Cimzia. ii. Individual meets ONE of the following conditions (a or b): a) Individual has been established on Cimzia for at least 90 days and prescription claims history indicates at least a 90-day supply of Cimzia was dispensed within the past 130 days [verification in prescription claims history required] or, if not available, [verification by prescribing physician required]; OR Note: In cases when 130 days of the individual’s prescription claim history file is unavailable to be verified, an exception to this requirement is allowed if the prescriber has verified that the individual has been receiving Cimzia for at least 90 days AND the individual has been receiving Cimzia via paid claims (e.g., individual has not been receiving samples or coupons or other types of waivers in order to obtain access to Cimzia). b) Individual has tried TWO of Enbrel, Humira, and Taltz [documentation required]. Note: If the individual has met criterion i but criterion ii is not met, offer to review for a Formulary product (Enbrel, Humira, or Taltz) using the appropriate standard Inflammatory Conditions criteria. 2. Crohn’s Disease. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months if the individual meets the following criteria (i, ii, iii, and iv): i. Individual is ≥ 18 years of age; AND ii. Individual meets ONE of the following conditions (a or b): a) Individual has tried or is currently taking corticosteroids, or corticosteroids are contraindicated in this individual; OR b) Individual has tried one other conventional systemic therapy for Crohn’s disease; AND Note: Examples of conventional systemic therapies for Crohn’s disease include azathioprine, 6- mercaptopurine, and methotrexate. A previous trial of a biologic also counts as a trial of one other agent for Crohn’s disease. Refer to Appendix for examples of biologics used for Crohn’s disease. A trial of mesalamine does not count as a systemic agent for Crohn’s disease. iii. Cimzia is prescribed by or in consultation with a gastroenterologist; AND iv. The individual has tried Humira. Note: If the individual has met criterion i and ii but criterion iii is not met, offer to review for a Formulary product (Humira or Stelara SC) using the appropriate standard Inflammatory Conditions criteria. B) Individual is Currently Receiving Cimzia. Approve for 1 year if the individual meets BOTH of the following conditions (i and ii): i. Individual has had a response, as determined by the prescriber; AND Note: Examples of a response include decrease in symptoms such as diarrhea, pain, bleeding; improvement in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), complete blood count, and/or fecal calprotectin (fCal). The individual may not have a full response, but there should have been a recent or past response to Cimzia. A individual with fistulizing Crohn’s disease or Crohn’s disease of the ileal pouch must meet the above criteria for Crohn’s disease in an adult. ii. Individual meets ONE of the following conditions (a or b): a) Individual has been established on Cimzia for at least 90 days and prescription claims history indicates at least a 90-day supply of Cimzia was dispensed within the past 130 days [verification in prescription claims history required] or, if not available, [verification by prescribing physician required]. Note: In cases when 130 days of the individual’s prescription claim history file is unavailable to be verified, an exception to this requirement is allowed if the prescriber has verified that the individual has been receiving Cimzia for at least 90 days AND the individual has been receiving Cimzia via paid claims (e.g., individual has not been receiving samples or coupons or other types of waivers in order to obtain access to Cimzia); OR b) Individual has tried Humira. Note: If the individual has met criterion i but criterion ii is not met, offer to review for the Formulary product (Humira or Stelara SC) using the appropriate standard Inflammatory Conditions criteria. 3. Plaque Psoriasis. Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months if the individual meets the following criteria (i, ii, iii, and iv): i. Individual is ≥ 18 years of age; AND Page 2 of 7 Cigna National Formulary Coverage Policy: FE Inflammatory Conditions – Cimzia ii. Individual meets ONE of the following conditions (a or b): a) Individual has tried at least one traditional systemic agent for psoriasis for at least 3 months, unless intolerant; OR Note: Examples of traditional systemic agents for psoriasis include methotrexate (MTX), cyclosporine, acitretin, or psoralen plus ultraviolet A light (PUVA). An exception to the requirement for a trial of one traditional systemic agent for psoriasis can be made if the individual has already has a 3-month trial or previous intolerance to at least one biologic. Refer to Appendix for examples of biologics used for psoriasis. A individual who has already tried a biologic for psoriasis is not required to “step back” and try a traditional systemic agent for psoriasis). b) Individual has a contraindication to methotrexate, as determined by the prescriber; AND iii. Cimzia is prescribed by or in consultation with a dermatologist; AND iv. Individual has tried TWO of Enbrel, Humira, Otezla, Skyrizi, Stelara subcutanous, Taltz, or Tremfya [documentation required]. Note: If the individual has met criterion i, ii, and iii but criterion iv is not met, offer to review for a Formulary product (Enbrel, Humira, Otezla, Skyrizi, Stelara subcutaneous, Taltz, or Tremfya) using the appropriate standard Inflammatory Conditions criteria B) Individual is Currently Receiving Cimzia. Approve for 1 year if the individual meets

Load more