Cigna National Formulary Coverage Policy

Prior Authorization Inflammatory Conditions – Olumiant® ( tablets)

Table of Contents Product Identifier(s)

National Formulary Medical Necessity ...... 1 58481 Conditions Not Covered...... 2 Background ...... 2 References ...... 2 Revision History ...... 3

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 baricitinib (Olumiant®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence:

Prior Authorization is recommended for prescription benefit coverage of Olumiant. Because of the specialized skills required for evaluation and diagnosis of individuals treated with Olumiant as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Olumiant to be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals are provided for the duration noted below. In cases where the approval is authorized in months, 1 month is equal to 30 days.

All reviews for use of Oluminat for COVID-19 and/or release syndrome associated with COVID-19 will be forwarded to the Medical Director.

FDA Indication(s)

1. . Approve for the duration noted if the individual meets ONE of the following criteria (A or B):

Page 1 of 4 Cigna National Formulary Coverage Policy: PA Inflammatory Conditions – Olumiant A) Initial Therapy. Approve for 3 months if the individual meets BOTH of the following (i and ii): i. Individual has had a 3-month trial of at least ONE inhibitor for this condition, unless intolerant; AND Note: Refer to Appendix for examples of tumor necrosis factor inhibitors used for rheumatoid arthritis. Conventional synthetic DMARDs such as , , hydroxychloroquine, and sulfasalazine do not count. ii. The medication is prescribed by or in consultation with a rheumatologist. B) Individual is Currently Receiving Olumiant. Approve for 3 years if the individual had a response as determined by the prescriber. Note: Examples of a response to therapy 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 Olumiant.

Conditions Not Covered

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

1. Concurrent Use with a Biologic or with a Targeted Synthetic DMARD. Olumiant should not be administered in combination with another biologic or with a targeted synthetic DMARD used for an inflammatory condition (see Appendix for examples).1 Combination therapy is generally not recommended due to a potential for a higher rate of adverse effects with combinations and lack of evidence for additive efficacy. Note: This does NOT exclude the use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine) in combination with Kevzara.

2. Concurrent use with Other Potent Immunosuppressants (e.g., , cyclosporine).1 Co- administration with other potent immunosuppressive drugs has the risk of added and has not been evaluated in rheumatoid arthritis. Note: This does NOT exclude use of Olumiant with methotrexate; Olumiant has been evaluated with background methotrexate or combinations of conventional synthetic DMARDs containing methotrexate.

3. COVID-19 (Coronavirus Disease 2019). Forward all requests to the Medical Director. Note: This includes requests for cytokine release syndrome associated with COVID-19.3-6

Background

Overview Olumiant, an inhibitor of the Janus kinases (JAK) pathways, is indicated for the treatment of rheumatoid arthritis in adults with moderate to severe active disease who have had an inadequate response to one or more tumor necrosis factor inhibitors.1 It is a targeted synthetic disease-modifying antirheumatic drug (DMARD) that may be used either as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs. Olumiant is not recommended for use in combination with other JAK inhibitors, or in combination with biologics or potent immunosuppressants such as azathioprine or cyclosporine.

Guidelines Guidelines from the American College of (2021) recommend addition of a biologic or a targeted synthetic DMARD for a patient taking the maximum tolerated dose of methotrexate who is not at target.2

References

1. Oluminat® tablets [prescribing information]. Indianapolis, IN: Lilly; July 2020. 2. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73(7):1108-1123.

Page 2 of 4 Cigna National Formulary Coverage Policy: PA Inflammatory Conditions – Olumiant 3. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Updated July 8, 2021. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed July 9, 2021. 4. US National Institutes of Health. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2021 July 9]. Available at: https://clinicaltrials.gov/. Search terms: coronavirus, baricitinib. 5. Rochwerg B, Siemieniuk R, Jacobs M, et al. Therapeutics and COVID-19: living guideline. Updated July 6, 2021. Available at: https://app.magicapp.org/#/guideline/nBkO1E. Accessed on July 9, 2021.

Revision History

Type of Summary of Changes Approval Date Revision Annual No criteria changes. 07/21/2021 Revision

Ap pendix Mechanism of Action Examples of Inflammatory Indications for Products* Biologics SC Products (Humira®, Inhibition of TNF AS, CD, PJIA, PsO, PsA, RA, SJIA, UC ) Cimzia ( SC injection) Inhibition of TNF AS, CD, nr-axSpA, PsO, PsA, RA SC Products (Enbrel, biosimilars) Inhibition of TNF AS, PJIA, PsO, PsA, RA, SJIA IV Products (Remicade®, Inhibition of TNF AS, CD, PJIA, PsO, PsA, RA, SJIA, UC biosimilars) Simponi®, Simponi® Aria™ ( SC Inhibition of TNF SC formulation: AS, PsA, RA, UC injection, golimumab IV infusion) IV formulation: AS, 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: PJIA, PSA, RA injection) modulator IV formulation: PJIA, PsA, RA IV Products (Rituxan®, biosimilars) CD20-directed cytolytic RA Ilaris (canakinumab SC injection) Inhibition of IL-1β SJIA Kineret® ( SC injection) Inhibition of IL-1 RA, SJIA^ Stelara® ( SC injection, Inhibition of IL-12/23 SC formulation: CD, PsO, PsA, UC ustekinumab IV infusion) IV formulation: CD, UC Siliq™ (brodalumab SC injection) Inhibition of IL-17 PsO Cosentyx™ ( SC injection) Inhibition of IL-17A AS, PsO, PsA Taltz® ( 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) CD, UC antagonist Targeted Synthetic DMARDs Otezla® ( tablets) Inhibition of PDE4 PsO, PsA Olumiant® (baricitinib tablets) Inhibition of the JAK RA pathways Rinvoq® ( extended-release Inhibition of the JAK RA tablets) pathways Xeljanz®, Xeljanz XR ( tablets, Inhibition of the JAK RA, PsA, UC tofacitinib extended-release tablets) pathways * 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 – ; AS – ; CD – Crohn’s disease; PJIA – Polyarticular juvenile idiopathic arthritis; PsO – Plaque ; PsA – Psoriatic

Page 3 of 4 Cigna National Formulary Coverage Policy: PA Inflammatory Conditions – Olumiant arthritis; RA – Rheumatoid arthritis; SJIA – Systemic juvenile idiopathic arthritis; UC – Ulcerative colitis; nr-axSpA – Non- radiographic axial spondyloarthritis; ^ Off-label use of SJIA supported in guidelines; DMARDs – Disease-modifying antirheumatic drugs.

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