State and School Employees' Health Insurance Plan - Giant Cell Arteritis

POLICY NUMBER

S.5.01.516

Actemra (tocilizumab)

Tofidence (tocilizumab-bavi)

Tyenne (tocilizumab-aazg)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Giant cell arteritis (GCA), also known as temporal arteritis, is categorized as a vasculitis affecting primarily large- and medium-sized vessels. Many clinical features result from vascular inflammation of the branches of the carotid arteries. Cranial manifestations include headaches, scalp tenderness, vision loss, and jaw claudication; however, patients with large vessel involvement may lack cranial manifestations. GCA most commonly occurs in patients over 50 years of age. Diagnosis is based on clinical presentation, temporal artery biopsy, and/or vascular imaging. Systemic glucocorticoid therapy is recommended for patients with newly diagnosed GCA and may be used with or without glucocorticoid-sparing agents. Tocilizumab, an interleukin-6 inhibitor, and upadacitinib, a Janus kinase inhibitor, are immunomodulators indicated for the treatment of adults with GCA.

Tocilizumab is indicated for the following:

• Treatment of giant cell arteritis (GCA) in adult patients;

• Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARD;

• Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease;

• Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older;

• Treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older;

• Treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older;

• Treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Related policies:

• State and School Employees’ Health Insurance Plan - Anti-Rheumatic Biologicals

• Treatment of Coronavirus Disease 2019 (COVID-19)

• Interstitial Lung Disease

• State and School Employees’ Health Insurance Plan - Biosimilar Medications

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

The following medications are not covered on the State Health Plan Medical Drug Formulary: 

• Actemra (tocilizumab)

• Tofidence (tocilizumab-bavi)

Initial Criteria

Tyenne (tocilizumab-aazg) may be considered medically necessary when ALL of the associated criteria are met:

1. The individual is ≥18 years of age;

2. The individual has a documented diagnosis of giant cell arteritis (GCA) and ALL of the following:

   1. Presence of cranial symptoms (i.e., new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth/jaw pain upon mastication), constitutional signs/symptoms (i.e., unexplained fever), OR signs/symptoms of vascular abnormalities (e.g., limb claudication, asymmetric blood pressures, vascular bruits);

   2. ONE of the following:

      1. ESR ≥30 mm/hr; OR

      2. CRP ≥1 mg/dL;

   3. Features of GCA and evidence of large-vessel vasculitis supported by temporal artery biopsy and/or imaging [e.g., color Doppler ultrasound (CDUS), high-resolution magnetic resonance imaging (MRI) with MR angiography (MRA)]; AND

   4. The individual is currently receiving systemic glucocorticoids;

3. The individual has been tested for latent TB prior to initiation of the requested agent;

4. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (i.e., rheumatologist, radiologist, etc.);

5. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, Otezla, etc.);

6. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

7. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval:12 months

Renewal Criteria

Tyenne (tocilizumab-aazg) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy with the requested agent through BCBSMS review process;

2. The individual has had a clinical response or stabilization from baseline in at least ONE of the following:

   1. Reduction of corticosteroid dose;

   2. Improvement in symptoms; OR

   3. Reduction in ESR or CRP;

3. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (i.e., rheumatologist, radiologist, etc.);

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, Otezla, etc.);

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): Self-administered drugs may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a self-administered drug are not covered under the medical benefit.

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "State and School Employees' Health Insurance Plan - Actemra (tocilizumab)" to "State and School Employees' Health Insurance Plan - Giant Cell Arteritis." Policy description updated regarding giant cell arteritis. Revised initial and renewal criteria for Actemra (tocilizumab). Policy Guidelines updated to remove language regarding medication failure. Sources updated.

11/01/2024: Effective 01/01/2025 - Policy description updated to remove Actemra. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statements updated to add "Tyenne (tocilizumab-aazg)" as medically necessary when the listed criteria are met. Added statement that Actemra (tocilizumab) and Tofidence (tocilizumab-bavi) are not covered. Sources updated. Code Reference section updated to add HCPCS code Q5135 to the Medically Necessary Codes table. Added HCPCS codes J3262 and Q5133 to the Not Covered/Non-Formulary Codes table. Policy update effective 01/01/2025.

07/22/2025: Policy description updated regarding systemic glucocorticoid therapy. Policy section updated to change initial length of approval from "6" to "12" months. Sources updated.

SOURCE(S)

1. Actemra prescribing information. Genentech, Inc. November 2024. Last accessed May 2025.

2. Maz, M., et al (2021). 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol, 73: 1349-1365. https://doi.org/10.1002/art.41774

3. Salvarani C, Muratore F. Treatment of giant cell arteritis. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Updated April 2025. (Accessed on May 14, 2025.)

4. Salvarani C, Muratore F. Diagnosis of giant cell arteritis. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Updated November 2024. (Accessed on May 14, 2025.)

5. Tofidence prescribing information. Biogen MA Inc. March 2025. Last accessed May 2025.

6. Tyenne prescribing information. Fresenius Kabi USA, LLC. December 2024. Last accessed May 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Covered/Non-Formulary Codes

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