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Cigna National Formulary Coverage Policy

Formulary Exception Inflammatory Conditions – Cimzia® ( 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. . 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 , 6- mercaptopurine, and . 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 BOTH of the following conditions (i and ii): i. Individual has had a response, as determined by the prescriber; AND Note: 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, Otezla, Skyrizi, Stelara SC, Taltz, or Tremfya [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, Otezla, Skyrizi, Stelara SC, Taltz, or Tremfya) using the appropriate standard Inflammatory Conditions criteria.

4. . Approve for the duration noted if the individual meets ONE of the following (A or B): A) Initial Therapy. Approve for 3 months if BOTH of the following conditions (i and ii): i. The medication is prescribed by or in consultation with a rheumatologist or a dermatologist; AND ii. Individual has tried TWO of Enbrel, Humira, Otezla, Stelara subcutaneous, Taltz, Tremfya, and Xeljanz/XR [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, Otezla, Stelara subcutaneous, Taltz, Tremfya, or Xeljanz/XR) 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 (e.g., less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths; improvements in acute phase reactants [for example, CRP]), as determined by the prescriber; AND Note: Examples of a response include less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths; improvements in acute phase reactants (for example, CRP). 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):

Page 3 of 7 Cigna National Formulary Coverage Policy: FE Inflammatory Conditions – Cimzia 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, Otezla, Stelara subcutaneous, Taltz, Tremfya, or Xeljanz/XR [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, Otezla, Stelara subcutaneous, Taltz, Tremfya, or Xeljanz/XR) using the appropriate standard Inflammatory Conditions criteria.

5. . 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, and iii): i. Individual has tried ONE conventional synthetic disease-modifying antirheumatic drug (DMARD) for at least 3 months; AND Note: Examples of conventional synthetic DMARDs include methotrexate (oral or injectable), leflunomide, , and . An exception to the requirement for a trial of one conventional synthetic DMARD can be made if the individual has already has a 3-month trial at least one biologic disease-modifying antirheumatic drug (DMARD). Refer to Appendix for examples of biologics used for RA. A individual who has already tried a biologic for RA is not required to “step back” and try a conventional synthetic DMARD. ii. Cimzia is prescribed by or in consultation with a rheumatologist; AND iii. Individual has tried TWO of Actemra subcutaneous, Enbrel, Humira, Rinvoq, and Xeljanz/XR [documentation required]. Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as a trial of ONE product. Note: If the individual has met criterion i and ii but criterion iii is not met, offer to review for a Formulary product (Actemra subcutaneous, Enbrel, Humira, Rinvoq, or Xeljanz/XR) 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 less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths; improved laboratory values; reduced dosage of corticosteroids. 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 Actemra subcutaneous, Enbrel, Humira, Rinvoq, and Xeljanz/XR [documentation required]. Note: Trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as a trial of ONE product.

Page 4 of 7 Cigna National Formulary Coverage Policy: FE Inflammatory Conditions – Cimzia Note: If the individual has met criterion i but criterion ii is not met, offer to review for a Formulary product (Actemra subcutaneous, Enbrel, Humira, Rinvoq, or Xeljanz/XR) using the appropriate standard Inflammatory Conditions criteria.

6. Non-Radiographic Axial Spondyloarthritis (nr-axSpA). 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 (i and ii): i. Individual has objective signs of inflammation, defined as at least one of the following (a or b): a) C-reactive protein (CRP) elevated beyond the upper limit of normal for the reporting laboratory; OR b) Sacroiliitis reported on magnetic resonance imaging (MRI); AND ii. The medication is prescribed by or in consultation with a rheumatologist. B) Individual is Currently Receiving Cimzia. Approve for 3 years if the individual has had a response, as determined by the prescriber. 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.

7. Spondyloarthritis, Other Subtypes. Approve for the duration noted if the individual meets ONE of the following conditions (A or B): Note: Examples of other subtypes include undifferentiated arthritis, reactive arthritis (Reiter’s disease). For ankylosing spondylitis, psoriatic arthritis, or non-radiographic axial spondyloarthrits, refer to the respective criteria under FDA-approved indications. A) Initial Therapy. Approve for 3 months if the individual meets ALL of the following conditions (i, ii, and iii): i. Individual has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet; AND ii. Individual has tried at least ONE conventional synthetic disease-modifying antirheumatic drug (DMARD). Note: Examples include methotrexate, leflunomide, and sulfasalazine; AND iii. Cimzia is prescribed by or in consultation with a rheumatologist. B) Individual is Currently Receiving Cimzia. Approve for 1 year if the individual has had a response, as determined by the prescriber. 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.

Documentation Required: The prescriber must provide written documentation supporting the trials of these other agents, noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts.

Conditions Not Covered

Certolizumab pegol (Cimzia®) is considered experimental, investigational or unproven for ANY other use including the following (this list may not be all inclusive):

A) Concurrent Use with a Biologic or with a Targeted Synthetic Disease-Modifying Antirheumatic Drug (DMARD). Note: This does NOT exclude the use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine) in combination with Cimzia; OR B) Other circumstances not listed in criterion 1 through 7 (above).

Page 5 of 7 Cigna National Formulary Coverage Policy: FE Inflammatory Conditions – Cimzia Appendix Mechanism of Action Examples of Inflammatory Indications for Products* Biologics SC Products (Humira®, Inhibition of TNF AS, CD, JIA, PsO, PsA, RA, UC biosimilars) Cimzia (certolizumab pegol SC injection) Inhibition of TNF AS, CD, nr-axSpA, PsO, PsA, RA SC Products (Enbrel, biosimilars) Inhibition of TNF AS, JIA, PsO, PsA IV Products (Remicade®, Inhibition of TNF AS, CD, PsO, PsA, RA, UC biosimilars) Simponi®, Simponi® Aria™ ( SC Inhibition of TNF SC formulation: AS, PsA, RA, injection, golimumab IV infusion) UC IV formulation: AS, PJIA, PsA, RA Actemra® ( IV infusion, tocilizumab Inhibition of IL-6 SC formulation: PJIA, RA, SJIA SC injection) IV formulation: PJIA, RA, SJIA Kevzara® (sarilumab SC injection) Inhibition of IL-6 RA Orencia® ( IV infusion, abatacept SC T-cell costimulation SC formulation: JIA, PSA, RA injection) modulator IV formulation: JIA, PsA, RA IV Products (Rituxan®, biosimilars) CD20-directed cytolytic RA Kineret® ( SC injection) Inhibition of IL-1 JIA^, RA Stelara® ( SC injection, Inhibition of IL-12/23 SC formulation: CD, PsO, PsA, ustekinumab IV infusion) UC IV formulation: CD, UC Siliq™ (brodalumab SC injection) Inhibition of IL-17 PsO Cosentyx™ ( SC injection) Inhibition of IL-17A AS, nr-axSpA, PsO, PsA Taltz® (ixekizumab SC injection) Inhibition of IL-17A AS, nr-axSpA, PsO, PsA Ilumya™ (tildrakizumab-asmn SC injection) Inhibition of IL-23 PsO Skyrizi™ (risankizumab-rzza SC injection) Inhibition of IL-23 PsO Tremfya™ (guselkumab SC injection) Inhibition of IL-23 PsO Entyvio™ ( IV infusion) receptor CD, UC antagonist Targeted Synthetic DMARDs Otezla® ( tablets) Inhibition of PDE4 PsO, PsA Olumiant® ( tablets) Inhibition of JAK pathways RA Rinvoq® (upadacitinib extended-release Inhibition of JAK pathways RA tablets) Xeljanz® ( tablets) Inhibition of JAK pathways RA, PJIA, PsA, UC Xeljanz® XR (tofacitinib extended-release Inhibition of JAK pathways RA, PsA, UC tablets) * Not an all-inclusive list of indication (e.g., oncology indications and rare inflammatory conditions are not listed). Refer to the prescribing information for the respective agent for FDA-approved indications; SC – Subcutaneous; TNF – Tumor necrosis factor; IV – Intravenous, IL – Interleukin; PDE4 – Phosphodiesterase 4; JAK – Janus kinase; AS – Ankylosing spondylitis; CD – Crohn’s disease; JIA – Juvenile idiopathic arthritis; PsO – Plaque psoriasis; PsA – Psoriatic arthritis; RA – Rheumatoid arthritis; UC – Ulcerative colitis; nr-axSpA – Non-radiographic axial spondyloarthritis; ^ Off-label use of Kineret in JIA supported in guidelines; DMARDs – Disease-modifying antirheumatic drug.

References

1. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Revision History

Type of Summary of Changes Approval Date Revision - - 02/24/2021

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“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.

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