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Tocilizumab: Actemra®; Tofidence™; Tyenne®

Policy Number: PH-0002

Intravenous

​

Last Review Date: 08/01/2024

Date of Origin:  09/21/2010

Dates Reviewed: 12/2010, 03/2011, 05/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 09/2015, 12/0215, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 05/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019, 10/2020, 11/2020, 10/2021, 04/2022, 10/2022, 10/2023, 11/2023, 04/2024, 08/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization 1-3,19,31

Coverage will be provided as follows:

  • Castleman Disease: 4 months and may be renewed
  • Cytokine Release Syndrome: 4 doses only and may NOT be renewed
  • Immune Checkpoint Inhibitor Related Toxicities: 1 dose only* and may NOT be renewed
  • Giant Cell Arteritis: 1 year of therapy
  • All other indications: 6 months and may be renewed
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Actemra 80 mg/4 mL single-dose vial: 1 vial per 14 days
  • Actemra 200 mg/10 mL single-dose vial: 3 vials per 28 days
  • Actemra 400 mg/20 mL single-dose vial: 2 vials per 14 days
  • Tofidence 80 mg/4 mL single-dose vial: 1 vial per 14 days
  • Tofidence 200 mg/10 mL single-dose vial: 3 vials per 28 days
  • Tofidence 400 mg/20 mL single-dose vial: 2 vials per 14 days
  • Tyenne 80 mg/4 mL single-dose vial: 1 vial per 14 days
  • Tyenne 200 mg/10 mL single-dose vial: 3 vials per 28 days
  • Tyenne 400 mg/20 mL single-dose vial: 2 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

Diagnosis

Billable Units

Interval (days)

Giant Cell Arteritis

600

28

Rheumatoid Arthritis & Polyarticular Juvenile Idiopathic Arthritis, NMOSD

800

28

Systemic Juvenile Idiopathic Arthritis, Castleman’s Disease (B-Cell Lymphomas) & Acute Graft Versus Host Disease (aGVHD)

800

14

Cytokine Release Syndrome (CRS)

3200

1 course of therapy only

Immune Checkpoint Inhibitor Related Toxicities

800

1 course of therapy only
  1. Initial Approval Criteria 1-3

Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information.

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria 1-3

  • Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Patient will not receive live vaccines during therapy; AND
  • Patient is not on concurrent treatment with another IL-inhibitor, TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., abrocitinib, apremilast, tofacitinib, baricitinib, upadacitinib, deucravacitinib, etc.), unless otherwise specified; AND

Rheumatoid Arthritis † 1-3,21,29

  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Documented moderate to severe active disease; AND
  • Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; AND
  • May be used as a single agent or in combination with methotrexate or other non-biologic DMARDs (e.g., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine, etc.)

Giant Cell Arteritis (GCA) † 1-3,31-34

  • Patient has large vessel arteritis that has at some point been verified with biopsy or with imaging of the large vessels (color Doppler ultrasound [CDUS], MRI, PET-CT, or CT angiography); AND
  • Patient has active disease and an elevated c-reactive protein (CRP) and erythrocyte sedimentation rate (ESR); AND
  • Patient has had an inadequate response, contraindication, or intolerance to glucocorticoid therapy alone; AND
  • Used in combination with a tapering course of glucocorticoids (NOTE: tocilizumab can be used alone following discontinuation of glucocorticoids.)

Juvenile Idiopathic Arthritis (JIA) † Ф 1-3,7,20

  • Patient is at least 2 years of age; AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Patient has active systemic juvenile idiopathic arthritis (sJIA) OR polyarticular juvenile idiopathic arthritis (pJIA); AND
  • Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR an oral disease-modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); AND
  • May be used as a single agent or in combination with methotrexate

Castleman Disease (B-Cell Lymphomas) ‡ 4

  • Used as a single agent; AND
  • Patient has unicentric disease; AND
  • Patient is human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative; AND
  • Used as second-line therapy for relapsed or refractory disease; OR
  • Patient has multicentric disease; AND
  • Used as subsequent therapy for relapsed, refractory, or progressive disease

Cytokine Release Syndrome (CRS) † ‡ Ф 1,4

  • Patient is at least 2 years of age; AND
    • Patient has received or will be receiving chimeric antigen receptor (CAR) T cell therapy (e.g., axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, ciltacabtagene autoleucel, etc.); AND
      • Tocilizumab is being ordered to have on-hand, prior to the administration of CAR-T therapy, if needed for the treatment of CRS; OR
      • Used for management of one of the following:
        • Prolonged (>3 days) G1 CRS in patients with significant symptoms, comorbidities, and/or in elderly patients; OR
        • G1 CRS symptoms that persist >24 hours in patients who have been treated with axicabtagene ciloleucel or brexucabtagene autoleucel; OR
        • G1 CRS that develops <72 hours after infusion in patients who have been treated with lisocabtagene maraleucel; OR
        • G2-4 CRS; OR
        • G1-4 neurotoxicity as additional single-dose therapy if the patient has concurrent CRS; OR
    • Used as supportive care in patients with acute lymphoblastic leukemia (ALL) who have severe CRS related to blinatumomab therapy

Management of Immune Checkpoint Inhibitor Related Toxicities ‡ 4,19,28

  • Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, dostarlimab nivolumab/relatlimab-rmbw, retifanlimab, etc.); AND
    • Used as additional therapy for management of immunotherapy-related giant cell arteritis; OR
    • Used as additional disease modifying antirheumatic therapy (DMARD) for moderate or severe immunotherapy-related inflammatory arthritis; AND
      • Patient’s symptoms have not improved after holding immunotherapy; AND
        • Patient has not responded to oral corticosteroids; OR
        • Patient is unable to taper corticosteroids; OR
    • Patient has polymyalgia rheumatica and is unable to taper prednisone OR has no improvement in symptoms

Acute Graft Versus Host Disease (aGVHD) ‡ 4,22-24,30

  • Patient has received an allogeneic hematopoietic stem cell transplant; AND
  • Used for steroid-refractory acute GVHD; AND
  • Used in combination with systemic corticosteroids as additional therapy following no response to first-line therapies

Neuromyelitis Optica Spectrum Disorder (NMOSD) ‡ 25-27,35

  • Patient has a confirmed diagnosis based on the following:
    • Patient is seropositive for aquaporin-4 (AQP4) IgG antibodies; AND
      • Patient has at least one core clinical characteristic § (*Note: some core clinical characteristics require both clinical and typical MRI findings); AND
      • Alternative diagnoses have been excluded (e.g., myelin oligodendrocyte glycoprotein (MOG) antibody disease (MOGAD), multiple sclerosis, sarcoidosis, cancer, chronic infection, etc.); OR
    • Patient is seronegative for AQP-4 IgG antibodies OR has unknown AQP-4-IgG status; AND
      • Patient has at least two core clinical characteristics§ occurring as a result of one or more clinical attacks; AND
      • Patient experienced ALL of the following:
        • At least 1 core clinical characteristic must be acute optic neuritis, acute myelitis with LETM*, or area postrema syndrome; AND
        • Fulfillment of typical MRI finding requirements for each area affected ψ; AND
      • Alternative diagnoses have been excluded (e.g., myelin oligodendrocyte glycoprotein (MOG) antibody disease (MOGAD), multiple sclerosis, sarcoidosis, cancer, chronic infection, etc.); AND
  • Used as a single agent or in combination with immunosuppressive therapy (e.g., azathioprine, methotrexate, mycophenolate, etc.)

§ Core Clinical Characteristics of NMOSD 25,35
  • Acute optic neuritis
  • Acute myelitis
  • Acute area postrema syndrome (APS): episode of otherwise unexplained hiccups and/or nausea and vomiting (lasting for at least 48 hours or with MRI evidence of a dorsal brainstem lesion)
  • Acute brainstem syndrome other than APS
  • Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions ¥
  • Acute cerebral syndrome with NMOSD-typical brain lesions on MRI §

ψ Typical MRI findings in NMOSD related to clinical presentation (T2 unless noted otherwise) 35
  • Optic neuritis: Normal cerebral MRI (or only nonspecific white matter lesions) OR longitudinally extensive optic nerve lesion (≥ half of the length of the optic nerve or involving optic chiasm; T2 or T1/Gd)
  • Myelitis: Intramedullary lesion ≥ 3 contiguous VS (LETM) OR focal atrophy ≥ 3 contiguous VS in patients with a history of acute myelitis
  • Area postrema syndrome (APS): Lesion in the dorsal medulla oblongata/area postrema
  • Other brainstem syndrome: Periependymal brainstem lesion (4th ventricle)
  • ¥ Diencephalic syndrome: Periependymal lesion (3rd ventricle) OR hypothalamic/thalamic lesion
  • § Cerebral syndrome: Extensive periependymal lesion (lateral ventricle; often with Gd) OR long (> 1⁄2 length), diffuse, heterogeneous or edematous corpus callosum lesion OR long corticospinal tract lesion (unilateral or bilateral, contiguously involving internal capsule and cerebral peduncle) OR large, confluent (unilateral or bilateral) subcortical or deep white matter lesion

*LETM = longitudinally extensive transverse myelitis lesions

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1-3

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections, severe neutropenia, severe thrombocytopenia, severe hepatotoxicity, gastrointestinal perforation, immunosuppression, severe hypersensitivity reactions, demyelinating disorders, etc.; AND

Oncology Indications

Castleman Disease (B-Cell Lymphomas) 4

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

Acute Graft Versus Host Disease (aGVHD) 22-24,30

  • Response to therapy with an improvement in one or more of the following:
    • Clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score, etc.)
    • Patient-reported symptoms (e.g., Lee Symptom Scale, etc.)

Non-Oncology Indications

Rheumatoid arthritis (RA) 14-16

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g., an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria]

Giant Cell Arteritis 1-3,31-33

  • Disease response as indicated by improvement in signs and compared to baseline such as headache, temporal artery tenderness, visual symptoms, inflammatory parameters (e.g., erythrocyte sedimentation rate [ESR], C-reactive protein), etc.

Juvenile Idiopathic Arthritis (sJIA/pJIA) 17,18

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g., an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].

Cytokine Release Syndrome 1,4

  • May not be renewed

Management of Immune Checkpoint Inhibitor Related Toxicities 19

  • May not be renewed

NMOSD 25,26

  • Disease response as indicated by stabilization/improvement in any of the following:
    • Neurologic symptoms as evidenced by a decrease in acute relapses or improvement of stability
    • Reduced hospitalizations
    • Reduction/discontinuation in plasma exchange treatments
    • Reduction/discontinuation of corticosteroids without relapse
  1. Dosage/Administration 1-3,10,19,22-24,27,30

Doses exceeding 800 mg per infusion are not recommended (unless otherwise specified).

Indication

Dose

Adult Rheumatoid Arthritis

Administer 4 mg/kg intravenously every 4 weeks

  • May increase to 8 mg/kg every 4 weeks based on clinical response, up to a maximum of 800 mg per dose.

Polyarticular Juvenile Idiopathic Arthritis

Weight ≥ 30 kg

  • Administer 8 mg/kg intravenously every 4 weeks

Weight < 30 kg

  • Administer 10 mg/kg intravenously every 4 weeks

Systemic Juvenile Idiopathic Arthritis

Weight ≥ 30 kg

  • Administer 8 mg/kg intravenously every 2 weeks

Weight < 30 kg

  • Administer 12 mg/kg intravenously every 2 weeks

Castleman Disease (B-Cell Lymphomas)

Administer 8 mg/kg intravenously every 2 weeks for 16 weeks (8 doses total)

Cytokine Release Syndrome (CRS)

Weight ≥ 30 kg

  • Administer 8 mg/kg intravenously every 8 hours, if needed, up to a maximum of 4 total doses*

Weight < 30 kg

  • Administer 12 mg/kg intravenously every 8 hours, if needed, up to a maximum of 4 total doses*

*If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours. May be used with or without corticosteroids. Doses exceeding 800 mg per infusion are not recommended in CRS patients.

Immune-Checkpoint Inhibitor Related Toxicities

Administer 4 mg/kg intravenously one time only*

*Additional doses may be approved on a case by case basis

Acute GVHD

Administer 8 mg/kg intravenously, every 2-4 weeks until disease progression or unacceptable toxicity

NMOSD

Administer 8 mg/kg intravenously, every 4 weeks

Giant Cell Arteritis

Administer 6 mg/kg intravenously every 4 weeks in combination with a tapering course of glucocorticoids

  • Doses exceeding 600 mg per infusion are not recommended
  • Tocilizumab can be used alone following discontinuation of glucocorticoids.
  1. Billing Code/Availability Information

HCPCS Code:

  • J3262 – Injection, tocilizumab, 1 mg; 1 billable unit = 1 mg (Actemra IV Only)
  • J3590 – Unclassified biologics (Tyenne Only) (Discontinue use on 10/01/2024)
  • Q5133 – Injection, tocilizumab-bavi (tofidence), biosimilar, 1 mg; 1 billable unit = 1 mg
  • Q5135 – Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg; 1 billable unit = 1 mg (Effective 10/01/2024)

NDC(s):

  • Actemra 80 mg/4 mL single-dose vial: 50242-0135-xx
  • Actemra 200 mg/10 mL single-dose vial: 50242-0136-xx
  • Actemra 400 mg/20 mL single-dose vial: 50242-0137-xx
  • Tofidence 80 mg/4 mL single-dose vial: 64406-0024-xx
  • Tofidence 200 mg/10 mL single-dose vial: 64406-0022-xx
  • Tofidence 400 mg/20 mL single-dose vial: 64406-0023-xx
  • Tyenne 80 mg/4 mL single-dose vial: 65219-0590-xx
  • Tyenne 200 mg/10 mL single-dose vial: 65219-0592-xx
  • Tyenne 400 mg/20 mL single-dose vial 65219-0594-xx
  1. References
  1. Actemra [package insert]. South San Francisco, CA; Genentech, Inc.; December 2022. Accessed September 2023.
  2. Tofidence [package insert]. Cambridge, MA; Biogen MA Inc.; July 2024. Accessed July 2024.
  3. Tyenne [package insert]. Lake Zurich, IL; Fresenius Kabi USA, LLC. March 2024. Accessed March 2024.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tocilizumab. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.
  5. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
  6. Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res (Hoboken). 2011 Apr;63(4):465-82.
  7. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013 Oct;65(10):2499-512.
  8. Ringold, S, Angeles-Han, S, Beukelman, T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non‐Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res, 71: 717-734.
  9. DeWitt EM, Kimura Y, Beukelman T, et al. Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2012 Jul;64(7):1001-10.
  10. Nishimoto N, Kanakura Y, Aozasa K, et al. Humanized anti-interleukin-6 receptor antibody treatment of multicentric Castleman disease. Blood 2005;106:2627-2632
  11. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
  12. Fraser JA, Weyand CM, Newman NJ, Biousse V. The treatment of giant cell arteritis. Rev Neurol Dis. 2008 Summer;5(3):140-52.
  13. Dasgupta B, Borg FA, Hassan N, et al. BSR and BHPR guidelines for the management of giant cell arteritis. Rheumatology (Oxford). 2010 Aug;49(8):1594-7.
  14. National Institute for Health and Care Excellence. NICE 2018. Rheumatoid Arthritis in Adults: Management. Published 11 July 2018. Last updated 12 October 2020. NICE Guideline [NG100]. https://www.nice.org.uk/guidance/ng100. Accessed September 2023.
  15. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 25 August 2010. Technology appraisal guidance [TA195]. https://www.nice.org.uk/guidance/ta195. Accessed September 2023.
  16. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi:  10.1002/art.38705
  17. Ringold S, Bittner R, Neggi T, et al. Performance of rheumatoid arthritis disease activity measures and juvenile arthritis disease activity scores in polyarticular-course juvenile idiopathic arthritis: Analysis of their ability to classify the American College of Rheumatology pediatric measures of response and the preliminary criteria for flare and inactive disease. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1095-102.
  18. Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
  19. Stroud C, Hedge A, Cherry C, et al. Tocilizumab for the management of immune mediated adverse events secondary to PD-1 blockage. Journal of Oncology Pharmacy Practice. 2017 December. https://doi.org/10.1177/1078155217745144.
  20. Ringold S, Angeles‐Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care & Research, Vol. 71, No. 6, June 2019, pp 717–734 DOI 10.1002/acr.23870.
  21. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases 2020;79:685-699.
  22. Yucebay F, Matthews C, Puto M, et al. Tocilizumab as first-line therapy for steroid-refractory acute graft-versus-host-disease: analysis of a single-center experience, Leukemia & Lymphoma. 2019  60:9, 2223-2229, DOI: 10.1080/10428194.2019.1573996
  23. Ganetsky A, Frey NV, Hexner EO, et al. Tocilizumab for the treatment of severe steroid-refractory acute graft-versus-host disease of the lower gastrointestinal tract. Bone Marrow Transplant. 54, 212–217 (2019). https://doi.org/10.1038/s41409-018-0236-z
  24. Dobryski WR, Pasquini M, Kovatovic K, et al. Tocilizumab for the Treatment of Steroid Refractory Graft-versus-Host Disease. 17:12, 1862-1868 (2011). DOI:https://doi.org/10.1016/j.bbmt.2011.07.001
  25. Wingerchuk DM, Banwell B, Bennett JL, et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul;85(2):177-89. Epub 2015 Jun 19.
  26. Trebst C, Jarius S, Berthele A, et al. Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS). J Neurol 2014; 261:1.
  27. Zhang C, Zhang M, Qiu W, et al, TANGO Study Investigators. Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial. Lancet Neurol. 2020;19(5):391
  28. Stone J, Tuckwell K, Dimonaco S, et al. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med 2017; 377:317-328 doi: 10.1056/NEJMoa1613849
  29. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2021 Jul;73(7):1108-1123. doi: 10.1002/art.41752.
  30. Roddy JV, Haverkos BM, McBride A, et al. Tocilizumab for steroid refractory acute graft-versus-host disease. Leuk Lymphoma. 2016;57(1):81-5. doi: 10.3109/10428194.2015.1045896.
  31. Turesson C, Börjesson O, Larsson K, et al. (2019) Swedish Society of Rheumatology 2018 guidelines for investigation, treatment, and follow-up of giant cell arteritis, Scandinavian Journal of Rheumatology, 48:4, 259-265, doi: 10.1080/03009742.2019.1571223.
  32. Mackie SL, Dejaco C, Appenzeller S, et al. British Society for Rheumatology guideline on diagnosis and treatment of giant cell arteritis. Rheumatology (Oxford). 2020 Mar 1;59(3):e1-e23. doi: 10.1093/rheumatology/kez672.
  33. Ehlers L, Askling J, Bijlsma HW, et al. 2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis. Annals of the Rheumatic Diseases 2019;78:1160-1166.
  34. Maz M, Chung SA, Abril A, et. al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol. 2021 Aug;73(8):1349-1365. doi: 10.1002/art.41774. Epub 2021 Jul 8. PMID: 34235884.
  35. Jarius, S., Aktas, O., Ayzenberg, I. et al. Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) – revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part I: Diagnosis and differential diagnosis. J Neurol 270, 3341–3368 (2023). https://doi.org/10.1007/s00415-023-11634-0

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C83.50

Lymphoblastic (diffuse) lymphoma unspecified site

C83.51

Lymphoblastic (diffuse) lymphoma lymph nodes of head, face, and neck

C83.52

Lymphoblastic (diffuse) lymphoma intrathoracic lymph nodes

C83.53

Lymphoblastic (diffuse) lymphoma intra-abdominal lymph nodes

C83.54

Lymphoblastic (diffuse) lymphoma lymph nodes of axilla and upper limb

C83.55

Lymphoblastic (diffuse) lymphoma lymph nodes of inguinal region and lower limb

C83.56

Lymphoblastic (diffuse) lymphoma intrapelvic lymph nodes

C83.57

Lymphoblastic (diffuse) lymphoma spleen

C83.58

Lymphoblastic (diffuse) lymphoma lymph nodes of multiple sites

C83.59

Lymphoblastic (diffuse) lymphoma extranodal and solid organ sites

C91.00

Acute lymphoblastic leukemia not having achieved remission

C91.01

Acute lymphoblastic leukemia, in remission

C91.02

Acute lymphoblastic leukemia, in relapse

D47.Z2

Castleman disease

D89.810

Acute graft-versus-host disease

D89.812

Acute on chronic graft-versus-host disease

D89.813

Graft-versus-host disease, unspecified

D89.831

Cytokine release syndrome, grade 1

D89.832

Cytokine release syndrome, grade 2

D89.833

Cytokine release syndrome, grade 3

D89.834

Cytokine release syndrome, grade 4

D89.839

Cytokine release syndrome, grade unspecified

G36.0

Neuromyelitis optica [Devic]

G92.00

Immune effector cell-associated neurotoxicity syndrome, grade unspecified

G92.01

Immune effector cell-associated neurotoxicity syndrome, grade 1

G92.02

Immune effector cell-associated neurotoxicity syndrome, grade 2

G92.03

Immune effector cell-associated neurotoxicity syndrome, grade 3

G92.04

Immune effector cell-associated neurotoxicity syndrome, grade 4

M05.10

Rheumatoid lung disease with rheumatoid arthritis of unspecified site

M05.111

Rheumatoid lung disease with rheumatoid arthritis of right shoulder

M05.112

Rheumatoid lung disease with rheumatoid arthritis of left shoulder

M05.119

Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder

M05.121

Rheumatoid lung disease with rheumatoid arthritis of right elbow

M05.122

Rheumatoid lung disease with rheumatoid arthritis of left elbow

M05.129

Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow

M05.131

Rheumatoid lung disease with rheumatoid arthritis of right wrist

M05.132

Rheumatoid lung disease with rheumatoid arthritis of left wrist

M05.139

Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist

M05.141

Rheumatoid lung disease with rheumatoid arthritis of right hand

M05.142

Rheumatoid lung disease with rheumatoid arthritis of left hand

M05.149

Rheumatoid lung disease with rheumatoid arthritis of unspecified hand

M05.151

Rheumatoid lung disease with rheumatoid arthritis of right hip

M05.152

Rheumatoid lung disease with rheumatoid arthritis of left hip

M05.159

Rheumatoid lung disease with rheumatoid arthritis of unspecified hip

M05.161

Rheumatoid lung disease with rheumatoid arthritis of right knee

M05.162

Rheumatoid lung disease with rheumatoid arthritis of left knee

M05.169

Rheumatoid lung disease with rheumatoid arthritis of unspecified knee

M05.171

Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot

M05.172

Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot

M05.179

Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot

M05.19

Rheumatoid lung disease with rheumatoid arthritis of multiple sites

M05.20

Rheumatoid vasculitis with rheumatoid arthritis of unspecified site

M05.211

Rheumatoid vasculitis with rheumatoid arthritis of right shoulder

M05.212

Rheumatoid vasculitis with rheumatoid arthritis of left shoulder

M05.219

Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder

M05.221

Rheumatoid vasculitis with rheumatoid arthritis of right elbow

M05.222

Rheumatoid vasculitis with rheumatoid arthritis of left elbow

M05.229

Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow

M05.231

Rheumatoid vasculitis with rheumatoid arthritis of right wrist

M05.232

Rheumatoid vasculitis with rheumatoid arthritis of left wrist

M05.239

Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist

M05.241

Rheumatoid vasculitis with rheumatoid arthritis of right hand

M05.242

Rheumatoid vasculitis with rheumatoid arthritis of left hand

M05.249

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand

M05.251

Rheumatoid vasculitis with rheumatoid arthritis of right hip

M05.252

Rheumatoid vasculitis with rheumatoid arthritis of left hip

M05.259

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip

M05.261

Rheumatoid vasculitis with rheumatoid arthritis of right knee

M05.262

Rheumatoid vasculitis with rheumatoid arthritis of left knee

M05.269

Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee

M05.271

Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot

M05.272

Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot

M05.279

Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot

M05.29

Rheumatoid vasculitis with rheumatoid arthritis of multiple sites

M05.30

Rheumatoid heart disease with rheumatoid arthritis of unspecified site

M05.311

Rheumatoid heart disease with rheumatoid arthritis of right shoulder

M05.312

Rheumatoid heart disease with rheumatoid arthritis of left shoulder

M05.319

Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder

M05.321

Rheumatoid heart disease with rheumatoid arthritis of right elbow

M05.322

Rheumatoid heart disease with rheumatoid arthritis of left elbow

M05.329

Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow

M05.331

Rheumatoid heart disease with rheumatoid arthritis of right wrist

M05.332

Rheumatoid heart disease with rheumatoid arthritis of left wrist

M05.339

Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist

M05.341

Rheumatoid heart disease with rheumatoid arthritis of right hand

M05.342

Rheumatoid heart disease with rheumatoid arthritis of left hand

M05.349

Rheumatoid heart disease with rheumatoid arthritis of unspecified hand

M05.351

Rheumatoid heart disease with rheumatoid arthritis of right hip

M05.352

Rheumatoid heart disease with rheumatoid arthritis of left hip

M05.359

Rheumatoid heart disease with rheumatoid arthritis of unspecified hip

M05.361

Rheumatoid heart disease with rheumatoid arthritis of right knee

M05.362

Rheumatoid heart disease with rheumatoid arthritis of left knee

M05.369

Rheumatoid heart disease with rheumatoid arthritis of unspecified knee

M05.371

Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot

M05.372

Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot

M05.379

Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot

M05.39

Rheumatoid heart disease with rheumatoid arthritis of multiple sites

M05.40

Rheumatoid myopathy with rheumatoid arthritis of unspecified site

M05.411

Rheumatoid myopathy with rheumatoid arthritis of right shoulder

M05.412

Rheumatoid myopathy with rheumatoid arthritis of left shoulder

M05.419

Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder

M05.421

Rheumatoid myopathy with rheumatoid arthritis of right elbow

M05.422

Rheumatoid myopathy with rheumatoid arthritis of left elbow

M05.429

Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow

M05.431

Rheumatoid myopathy with rheumatoid arthritis of right wrist

M05.432

Rheumatoid myopathy with rheumatoid arthritis of left wrist

M05.439

Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist

M05.441

Rheumatoid myopathy with rheumatoid arthritis of right hand

M05.442

Rheumatoid myopathy with rheumatoid arthritis of left hand

M05.449

Rheumatoid myopathy with rheumatoid arthritis of unspecified hand

M05.451

Rheumatoid myopathy with rheumatoid arthritis of right hip

M05.452

Rheumatoid myopathy with rheumatoid arthritis of left hip

M05.459

Rheumatoid myopathy with rheumatoid arthritis of unspecified hip

M05.461

Rheumatoid myopathy with rheumatoid arthritis of right knee

M05.462

Rheumatoid myopathy with rheumatoid arthritis of left knee

M05.469

Rheumatoid myopathy with rheumatoid arthritis of unspecified knee

M05.471

Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot

M05.472

Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot

M05.479

Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot

M05.49

Rheumatoid myopathy with rheumatoid arthritis of multiple sites

M05.50

Rheumatoid myopathy with rheumatoid arthritis of unspecified sites

M05.511

Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder

M05.512

Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

M05.519

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder

M05.521

Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow

M05.522

Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow

M05.529

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow

M05.531

Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist

M05.532

Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist

M05.539

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist

M05.541

Rheumatoid polyneuropathy with rheumatoid arthritis of right hand

M05.542

Rheumatoid polyneuropathy with rheumatoid arthritis of left hand

M05.549

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand

M05.551

Rheumatoid polyneuropathy with rheumatoid arthritis of right hip

M05.552

Rheumatoid polyneuropathy with rheumatoid arthritis of left hip

M05.559

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip

M05.561

Rheumatoid polyneuropathy with rheumatoid arthritis of right knee

M05.562

Rheumatoid polyneuropathy with rheumatoid arthritis of left knee

M05.569

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee

M05.571

Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot

M05.572

Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot

M05.579

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot

M05.59

Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites

M05.60

Rheumatoid arthritis of unspecified site with involvement of other organs and systems

M05.611

Rheumatoid arthritis of right shoulder with involvement of other organs and systems

M05.612

Rheumatoid arthritis of left shoulder with involvement of other organs and systems

M05.619

Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems

M05.621

Rheumatoid arthritis of right elbow with involvement of other organs and systems

M05.622

Rheumatoid arthritis of left elbow with involvement of other organs and systems

M05.629

Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems

M05.631

Rheumatoid arthritis of right wrist with involvement of other organs and systems

M05.632

Rheumatoid arthritis of left wrist with involvement of other organs and systems

M05.639

Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems

M05.641

Rheumatoid arthritis of right hand with involvement of other organs and systems

M05.642

Rheumatoid arthritis of left hand with involvement of other organs and systems

M05.649

Rheumatoid arthritis of unspecified hand with involvement of other organs and systems

M05.651

Rheumatoid arthritis of right hip with involvement of other organs and systems

M05.652

Rheumatoid arthritis of left hip with involvement of other organs and systems

M05.659

Rheumatoid arthritis of unspecified hip with involvement of other organs and systems

M05.661

Rheumatoid arthritis of right knee with involvement of other organs and systems

M05.662

Rheumatoid arthritis of left knee with involvement of other organs and systems

M05.669

Rheumatoid arthritis of unspecified knee with involvement of other organs and systems

M05.671

Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems

M05.672

Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems

M05.679

Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems

M05.69

Rheumatoid arthritis of multiple sites with involvement of other organs and systems

M05.7A

Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement

M05.711

Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement

M05.712

Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement

M05.719

Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement

M05.721

Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement

M05.722

Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement

M05.729

Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement

M05.731

Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement

M05.732

Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement

M05.739

Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement

M05.741

Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement

M05.742

Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement

M05.749

Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement

M05.751

Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement

M05.752

Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement

M05.759

Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement

M05.761

Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement

M05.762

Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement

M05.769

Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement

M05.771

Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement

M05.772

Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement

M05.779

Rheumatoid arthritis with rheumatoid factor of unspecified ankle and wrist without organ or systems involvement

M05.79

Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement

M05.8A

Other rheumatoid arthritis with rheumatoid factor of other specified site

M05.811

Other rheumatoid arthritis with rheumatoid factor of right shoulder

M05.812

Other rheumatoid arthritis with rheumatoid factor of left shoulder

M05.819

Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder

M05.821

Other rheumatoid arthritis with rheumatoid factor of right elbow

M05.822

Other rheumatoid arthritis with rheumatoid factor of left elbow

M05.829

Other rheumatoid arthritis with rheumatoid factor of unspecified elbow

M05.831

Other rheumatoid arthritis with rheumatoid factor of right wrist

M05.832

Other rheumatoid arthritis with rheumatoid factor of left wrist

M05.839

Other rheumatoid arthritis with rheumatoid factor of unspecified wrist

M05.841

Other rheumatoid arthritis with rheumatoid factor of right hand

M05.842

Other rheumatoid arthritis with rheumatoid factor of left hand

M05.849

Other rheumatoid arthritis with rheumatoid factor of unspecified hand

M05.851

Other rheumatoid arthritis with rheumatoid factor of right hip

M05.852

Other rheumatoid arthritis with rheumatoid factor of left hip

M05.859

Other rheumatoid arthritis with rheumatoid factor of unspecified hip

M05.861

Other rheumatoid arthritis with rheumatoid factor of right knee

M05.862

Other rheumatoid arthritis with rheumatoid factor of left knee

M05.869

Other rheumatoid arthritis with rheumatoid factor of unspecified knee

M05.871

Other rheumatoid arthritis with rheumatoid factor of right ankle and foot

M05.872

Other rheumatoid arthritis with rheumatoid factor of left ankle and foot

M05.879

Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot

M05.89

Other rheumatoid arthritis with rheumatoid factor of multiple sites

M05.9

Rheumatoid arthritis with rheumatoid factor, unspecified

M06.0A

Rheumatoid arthritis without rheumatoid factor, other specified site

M06.019

Rheumatoid arthritis without rheumatoid factor, unspecified shoulder

M06.021

Rheumatoid arthritis without rheumatoid factor, right elbow

M06.022

Rheumatoid arthritis without rheumatoid factor, left elbow

M06.029

Rheumatoid arthritis without rheumatoid factor, unspecified elbow

M06.031

Rheumatoid arthritis without rheumatoid factor, right wrist

M06.032

Rheumatoid arthritis without rheumatoid factor, left wrist

M06.039

Rheumatoid arthritis without rheumatoid factor, unspecified wrist

M06.041

Rheumatoid arthritis without rheumatoid factor, right hand

M06.042

Rheumatoid arthritis without rheumatoid factor, left hand

M06.049

Rheumatoid arthritis without rheumatoid factor, unspecified hand

M06.051

Rheumatoid arthritis without rheumatoid factor, right hip

M06.052

Rheumatoid arthritis without rheumatoid factor, left hip

M06.059

Rheumatoid arthritis without rheumatoid factor, unspecified hip

M06.061

Rheumatoid arthritis without rheumatoid factor, right knee

M06.062

Rheumatoid arthritis without rheumatoid factor, left knee

M06.069

Rheumatoid arthritis without rheumatoid factor, unspecified knee

M06.071

Rheumatoid arthritis without rheumatoid factor, right ankle and foot

M06.072

Rheumatoid arthritis without rheumatoid factor, left ankle and foot

M06.079

Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot

M06.08

Rheumatoid arthritis without rheumatoid factor, vertebrae

M06.09

Rheumatoid arthritis without rheumatoid factor, multiple sites

M06.4

Inflammatory polyarthropathy

M06.8A

Other specified rheumatoid arthritis, other specified site

M06.811

Other specified rheumatoid arthritis, right shoulder

M06.812

Other specified rheumatoid arthritis, left shoulder

M06.819

Other specified rheumatoid arthritis, unspecified shoulder

M06.821

Other specified rheumatoid arthritis, right elbow

M06.822

Other specified rheumatoid arthritis, left elbow

M06.829

Other specified rheumatoid arthritis, unspecified elbow

M06.831

Other specified rheumatoid arthritis, right wrist

M06.832

Other specified rheumatoid arthritis, left wrist

M06.839

Other specified rheumatoid arthritis, unspecified wrist

M06.841

Other specified rheumatoid arthritis, right hand

M06.842

Other specified rheumatoid arthritis, left hand

M06.849

Other specified rheumatoid arthritis, unspecified hand

M06.851

Other specified rheumatoid arthritis, right hip

M06.852

Other specified rheumatoid arthritis, left hip

M06.859

Other specified rheumatoid arthritis, unspecified hip

M06.861

Other specified rheumatoid arthritis, right knee

M06.862

Other specified rheumatoid arthritis, left knee

M06.869

Other specified rheumatoid arthritis, unspecified knee

M06.871

Other specified rheumatoid arthritis, right ankle and foot

M06.872

Other specified rheumatoid arthritis, left ankle and foot

M06.879

Other specified rheumatoid arthritis, unspecified ankle and foot

M06.88

Other specified rheumatoid arthritis, vertebrae

M06.89

Other specified rheumatoid arthritis, multiple sites

M06.9

Rheumatoid arthritis, unspecified

M08.0A

Unspecified juvenile rheumatoid arthritis, other specified site

M08.011

Unspecified juvenile rheumatoid arthritis, right shoulder

M08.012

Unspecified juvenile rheumatoid arthritis, left shoulder

M08.019

Unspecified juvenile rheumatoid arthritis, unspecified shoulder

M08.021

Unspecified juvenile rheumatoid arthritis, right elbow

M08.022

Unspecified juvenile rheumatoid arthritis, left elbow

M08.029

Unspecified juvenile rheumatoid arthritis, unspecified elbow

M08.031

Unspecified juvenile rheumatoid arthritis, right wrist

M08.032

Unspecified juvenile rheumatoid arthritis, left wrist

M08.039

Unspecified juvenile rheumatoid arthritis, unspecified wrist

M08.041

Unspecified juvenile rheumatoid arthritis, right hand

M08.042

Unspecified juvenile rheumatoid arthritis, left hand

M08.049

Unspecified juvenile rheumatoid arthritis, unspecified hand

M08.051

Unspecified juvenile rheumatoid arthritis, right hip

M08.052

Unspecified juvenile rheumatoid arthritis, left hip

M08.059

Unspecified juvenile rheumatoid arthritis, unspecified hip

M08.061

Unspecified juvenile rheumatoid arthritis, right knee

M08.062

Unspecified juvenile rheumatoid arthritis, left knee

M08.069

Unspecified juvenile rheumatoid arthritis, unspecified knee

M08.071

Unspecified juvenile rheumatoid arthritis, right ankle and foot

M08.072

Unspecified juvenile rheumatoid arthritis, left ankle and foot

M08.079

Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot

M08.08

Unspecified juvenile rheumatoid arthritis, vertebrae

M08.09

Unspecified juvenile rheumatoid arthritis, multiple sites

M08.2A

Juvenile rheumatoid arthritis with systemic onset, other specified site

M08.211

Juvenile rheumatoid arthritis with systemic onset, right shoulder

M08.212

Juvenile rheumatoid arthritis with systemic onset, left shoulder

M08.219

Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder

M08.221

Juvenile rheumatoid arthritis with systemic onset, right elbow

M08.222

Juvenile rheumatoid arthritis with systemic onset, left elbow

M08.229

Juvenile rheumatoid arthritis with systemic onset, unspecified elbow

M08.231

Juvenile rheumatoid arthritis with systemic onset, right wrist

M08.232

Juvenile rheumatoid arthritis with systemic onset, left wrist

M08.239

Juvenile rheumatoid arthritis with systemic onset, unspecified wrist

M08.241

Juvenile rheumatoid arthritis with systemic onset, right hand

M08.242

Juvenile rheumatoid arthritis with systemic onset, left hand

M08.249

Juvenile rheumatoid arthritis with systemic onset, unspecified hand

M08.251

Juvenile rheumatoid arthritis with systemic onset, right hip

M08.252

Juvenile rheumatoid arthritis with systemic onset, left hip

M08.259

Juvenile rheumatoid arthritis with systemic onset, unspecified hip

M08.261

Juvenile rheumatoid arthritis with systemic onset, right knee

M08.262

Juvenile rheumatoid arthritis with systemic onset, left knee

M08.269

Juvenile rheumatoid arthritis with systemic onset, unspecified knee

M08.271

Juvenile rheumatoid arthritis with systemic onset, right ankle and foot

M08.272

Juvenile rheumatoid arthritis with systemic onset, left ankle and foot

M08.279

Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot

M08.28

Juvenile rheumatoid arthritis with systemic onset, vertebrae

M08.29

Juvenile rheumatoid arthritis with systemic onset, multiple sites

M08.3

Juvenile rheumatoid polyarthritis (seronegative)

M08.4A

Pauciarticular juvenile rheumatoid arthritis, other specified site

M08.411

Pauciarticular juvenile rheumatoid arthritis, right shoulder

M08.412

Pauciarticular juvenile rheumatoid arthritis, left shoulder

M08.419

Pauciarticular juvenile rheumatoid arthritis, unspecified shoulder

M08.421

Pauciarticular juvenile rheumatoid arthritis, right elbow

M08.422

Pauciarticular juvenile rheumatoid arthritis, left elbow

M08.429

Pauciarticular juvenile rheumatoid arthritis, unspecified elbow

M08.431

Pauciarticular juvenile rheumatoid arthritis, right wrist

M08.432

Pauciarticular juvenile rheumatoid arthritis, left wrist

M08.439

Pauciarticular juvenile rheumatoid arthritis, unspecified wrist

M08.441

Pauciarticular juvenile rheumatoid arthritis, right hand

M08.442

Pauciarticular juvenile rheumatoid arthritis, left hand

M08.449

Pauciarticular juvenile rheumatoid arthritis, unspecified hand

M08.451

Pauciarticular juvenile rheumatoid arthritis, right hip

M08.452

Pauciarticular juvenile rheumatoid arthritis, left hip

M08.459

Pauciarticular juvenile rheumatoid arthritis, unspecified hip

M08.461

Pauciarticular juvenile rheumatoid arthritis, right knee

M08.462

Pauciarticular juvenile rheumatoid arthritis, left knee

M08.469

Pauciarticular juvenile rheumatoid arthritis, unspecified knee

M08.471

Pauciarticular juvenile rheumatoid arthritis, right ankle and foot

M08.472

Pauciarticular juvenile rheumatoid arthritis, left ankle and foot

M08.479

Pauciarticular juvenile rheumatoid arthritis, unspecified ankle and foot

M08.48

Pauciarticular juvenile rheumatoid arthritis, vertebrae

M08.80

Other juvenile arthritis, unspecified site

M08.811

Other juvenile arthritis, right shoulder

M08.812

Other juvenile arthritis, left shoulder

M08.819

Other juvenile arthritis, unspecified shoulder

M08.821

Other juvenile arthritis, right elbow

M08.822

Other juvenile arthritis, left elbow

M08.829

Other juvenile arthritis, unspecified elbow

M08.831

Other juvenile arthritis, right wrist

M08.832

Other juvenile arthritis, left wrist

M08.839

Other juvenile arthritis, unspecified wrist

M08.841

Other juvenile arthritis, right hand

M08.842

Other juvenile arthritis, left hand

M08.849

Other juvenile arthritis, unspecified hand

M08.851

Other juvenile arthritis, right hip

M08.852

Other juvenile arthritis, left hip

M08.859

Other juvenile arthritis, unspecified hip

M08.861

Other juvenile arthritis, right knee

M08.862

Other juvenile arthritis, left knee

M08.869

Other juvenile arthritis, unspecified knee

M08.871

Other juvenile arthritis, right ankle and foot

M08.872

Other juvenile arthritis, left ankle and foot

M08.879

Other juvenile arthritis, unspecified ankle and foot

M08.88

Other juvenile arthritis, other specified site

M08.89

Other juvenile arthritis, multiple sites

M08.9A

Juvenile arthritis, unspecified, other specified site

M08.911

Juvenile arthritis, unspecified, right shoulder

M08.912

Juvenile arthritis, unspecified, left shoulder

M08.919

Juvenile arthritis, unspecified, unspecified shoulder

M08.921

Juvenile arthritis, unspecified, right elbow

M08.922

Juvenile arthritis, unspecified, left elbow

M08.929

Juvenile arthritis, unspecified, unspecified elbow

M08.931

Juvenile arthritis, unspecified, right wrist

M08.932

Juvenile arthritis, unspecified, left wrist

M08.939

Juvenile arthritis, unspecified, unspecified wrist

M08.941

Juvenile arthritis, unspecified, right hand

M08.942

Juvenile arthritis, unspecified, left hand

M08.949

Juvenile arthritis, unspecified, unspecified hand

M08.951

Juvenile arthritis, unspecified, right hip

M08.952

Juvenile arthritis, unspecified, left hip

M08.959

Juvenile arthritis, unspecified, unspecified hip

M08.961

Juvenile arthritis, unspecified, right knee

M08.962

Juvenile arthritis, unspecified, left knee

M08.969

Juvenile arthritis, unspecified, unspecified knee

M08.971

Juvenile arthritis, unspecified, right ankle and foot

M08.972

Juvenile arthritis, unspecified, left ankle and foot

M08.979

Juvenile arthritis, unspecified, unspecified ankle and foot

M08.98

Juvenile arthritis, unspecified, vertebrae

M08.99

Juvenile arthritis, unspecified, multiple sites

M31.5

Giant cell arteritis with polymyalgia rheumatica

M31.6

Other giant cell arteritis

M35.3

Polymyalgia rheumatica

T80.82XA

Complication of immune effector cellular therapy, initial encounter

T80.82XS

Complication of immune effector cellular therapy, sequela

T80.89XA

Other complications following infusion, transfusion and therapeutic injection, initial encounter

T80.89XS

Other complications following infusion, transfusion and therapeutic injection, sequela

T86.09

Other complications of bone marrow transplant

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan..

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC