Golimumab (Simponi Aria®)

Restricted Product(s)

• golimumab (Simponi Aria®) intravenous infusion for administration by a healthcare professional

FDA Approved Use

• For adult patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate 
• For patients 2 years and older with active psoriatic arthritis 
• For adult patients with active ankylosing spondylitis 
• For patients 2 years and older with active polyarticular juvenile idiopathic arthritis

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, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA [medical record documentation required]; OR 
   5. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled for the treatment of RA [medical record documentation required]; AND 
   6. The patient will be taking the requested agent in combination with methotrexate; OR 
   7. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate [medical record documentation required]; OR 
2. The patient has a diagnosis of active psoriatic arthritis (PsA); AND 
   1. The patient is 2 years of age or older; AND
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months [medical record documentation required]; OR 
   3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA [medical record documentation required]; OR 
   4. 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 
   5. 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]; OR 
   6. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled for the treatment of PsA [medical record documentation required]; OR 
3. The patient has a diagnosis of active ankylosing spondylitis (AS); AND
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial [medical record documentation required]; OR 
   3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of AS [medical record documentation required]; OR 
   4. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled for the treatment of AS [medical record documentation required]; OR 
4. The patient has a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); AND 
   1. The patient is 2 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., azathioprine, cyclosporine, intra-articular glucocorticoids, methotrexate, leflunomide, sulfasalazine, NSAIDs, COX-2 [celecoxib]) used in the treatment of PJIA for at least 3- months [medical record documentation required]; OR 
   3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide) used in the treatment of PJIA [medical record documentation required]; OR 
   4. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled for the treatment of PJIA [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, AS, JIA) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
6. The patient will NOT be using golimumab (Simponi Aria®) in combination with another biologic immunomodulator agent or Otezla; AND 
7. The patient does NOT have any FDA labeled contraindications to golimumab (Simponi Aria®); 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)

*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. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arth ritis. Arthritis Rheumatol. 2016;68(1):1-26.

Policy Implementation/Update Information

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 option for trial of another conventional agent, added requirement to be taken in combination with methotrexate; PsA: added requirement for trial of one conventional agent, added option for severe active PsA or concomitant severe psoriasis; AS: added requirement for trial of two different NSAIDs or intolerance/contraindication/hypersensitivity to all NSAIDs; 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.

Non-Discrimination and Accessibility Notice

Discrimination is Against the Law

• Blue Cross and Blue Shield of North Carolina (“Blue Cross NC”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. 
• Blue Cross NC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.
  Blue Cross NC: 
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified interpreters 
    • Written information in other formats (large print, audio, accessible electronic formats, other formats) 
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters 
    • Information written in other languages 
• If you need these services, contact Customer Service 1-888-206-4697, TTY and TDD, call 1-800-442-7028. 
• If you believe that Blue Cross NC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:
  • Blue Cross NC, PO Box 2291, Durham, NC 27702, Attention: Civil Rights Coordinator- Privacy, Ethics & Corporate Policy Office, Telephone 919-765-1663, Fax 919-287-5613, TTY 1-888-291-1783 civilrightscoordinator@bcbsnc.com 
• You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, Civil Rights Coordinator - Privacy, Ethics & Corporate Policy Office is available to help you. 
• • You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available here,  or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 1-800-368-1019, 800-537- 7697 (TDD). Complaint forms are available here
• This Notice and/or attachments may have important information about your application or coverage through Blue Cross NC. Look for key dates. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call Customer Service 1-888-206-4697.

ATTENTION: If you speak another language, language assistance services, free of charge, are available to you. Call 1-888-206-4697 (TTY: 1-800-442-7028).

ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al 1-888-206-4697 (TTY: 1-800-442-7028).

注意：如果您講廣東話或普通話，您可以免費獲得語言援助服務。請致電1-888-206-4697 (TTY：1-800-442-7028）。

CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợngôn ngữ miễn phí dành cho bạn. Gọi số 1-888-206-4697 (TTY: 1-800-442-7028).

주의: 한국어를사용하시는경우, 언어 지원 서비스를무료로이용하실수 있습니다. 1-888-206-4697 (TTY: 1- 800-442-7028)번으로전화해 주십시오.

ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposés gratuitement. Appelez le 1-888-206-4697 (ATS : 1-800-442-7028).

ملحوظة: إذا كنت تتحدث اللغة العربية، فإن خدمات المساعدة اللغوية تتوافر لك بالمجان. اتصل برقم .1-888-206-4697 المبرقة الكاتبة: .1-800-442-7028

LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hu rau 1-888-206-4697 (TTY: 1-800-442-7028).

ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните 1-888-206-4697 (телетайп: 1-800-442-7028).

PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa 1-888-206-4697 (TTY: 1- 800-442-7028).

સ ુચના: જો તમેગુજરાતી બોલતા હો, તો નન:સ ુલ્કુભાષા સહાય સેવાઓ તમારા માટેઉપલબ્ધ છે. ફોન કરો 1-888-206-4697 (TTY: 1-800-442-7028).

ចំណំ៖ ប្រសិនបរើបោកអ្នកនិយាយជាភាសាខ្មែរ បសវាកម្ែជំនួយខ្ននកភាសាមាននតល់ជូនសប្មារ់បោកអ្នកបោយម្ិនគិតថ្លៃ។ សូម្ទំនាក់ទំនងតាម្រយៈបលម៖ 1-888-206-4697 (TTY: 1-800-442-7028)។

ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: 1-888-206-4697 (TTY: 1-800-442- 7028).

ध्यान दें: यदद आप दिन्दी बोलतेिैंतो आपकेदलए मुफ्त मेंभाषा सिायता सेवाएंउपलब्ध िैं। 1-888-206-4697 (TTY: 1-800-442-7028) पर कॉल करें।

ໂປດຊາບ: ຖ້າວ່ າ ທ່ ານເວ ້ າພາສາ ລາວ, ການບໍ ລິ ການຊ່ ວຍເຫຼື ອດ້ານພາສາ, ໂດຍບໍ ່ ເສັ ຽຄ່ າ, ແມ່ ນມີພ້ ອມໃຫ້ທ່ ານ. ໂທຣ 1-888-206-4697 (TTY: 1-800-442-7028).

注意事項：日本語を話される場合、無料の言語支援をご利用いただけます。1-888-206-4697（TTY:1-800-442-7028）まで、お電話にてご連絡くださ い。