State and School Employees' Health Insurance Plan - Anti-Rheumatic Biologicals

POLICY NUMBER

S.5.01.404

Actemra (tocilizumab)Avsola (infliximab-axxq)Cimzia (certolizumab)Cosentyx (secukinumab)Ilaris (canakinumab)Inflectra (infliximab-dyyb)InfliximabOrencia (abatacept)Remicade (infliximab)Renflexis (infliximab-abda)Simponi ARIA (golimumab)Skyrizi (risankizumab-rzaa)Stelara (ustekinumab)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

Medical Covered Agents (no step therapy requirement)

^{¹Cimzia –Reference is to the lyophilized powder for healthcare provider administration.}

 Indications Without Preferred Agents  

 Conventional Agent Prerequisites by Indication

*Table is not an all-inclusive listing of options for prerequisite therapies available. 

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• State and School Employees’ Health Insurance Plan - Crohn's Disease and Ulcerative Colitis

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• State and School Employees’ Health Insurance Plan - Giant Cell Arteritis

• State and School Employees’ Health Insurance Plan - Rituximab Non-Oncology

POLICY

The use of samples by an individual will not be considered current or stable therapy for purposes of Medical Policy review.

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

• Actemra (tocilizumab)

• Avsola (infliximab-axxq)

• Renflexis (infliximab-abda)

• Tofidence (tocilizumab-bavi)

Initial Criteria

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. The individual has a documented FDA-labeled indication for the requested agent;

2. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (e.g. rheumatologist);

3. ONE of the following:

4. 1. The individual has failed (see definition of Failure in the Policy Guidelines section) at least one conventional agent (including at least 3 consecutive months with one DMARD) as evidenced by medical records and/or pharmacy printout;

   2. The individual has an FDA-labeled contraindication or hypersensitivity to ALL conventional agents available;

   3. The individual's diagnosis is ankylosing spondylitis;

   4. There is documentation that the individual is currently being treated with the requested agent (use of samples or vouchers/coupons is not approvable);

   5. The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of RA, PsA, AS or nr-asXpA;

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

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

7. The individual has been tested for latent TB when required by the prescribing information for the requested agent AND if positive, the individual has begun therapy for active TB;

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

Length of Approval: 12 months

Renewal Criteria

The requested agent may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy through BCBSMS review process;

2. The individual has documented clinical improvement (i.e. slowing of disease progression or decrease in symptom severity and/or frequency);

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

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

5. 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.

Medication Failure

Medication failure is defined as disease progression despite maximally tolerated dose as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/01/2023: New policy added.

11/01/2024: Effective 01/01/2025 - Policy description updated to remove Actemra IV as a covered agent for rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (PJIA). Removed Avsola as a covered agent for psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Added Inflectra as a covered agent for RA, PsA, and AS, and Tyenne IV as a covered agent for RA and PJIA. Removed Actemra IV and added Tyenne as a formulary option for SJIA. Policy section updated to remove Inflectra from the not medically necessary policy statement. Revised statement to state that the following medications are not covered: Actemra (tocilizumab), Avsola (infliximab-axxq), Renflexis (infliximab-abda), and Tofidence (tocilizumab-bavi). Sources updated. Code Reference section updated to add HCPCS codes Q5103 and Q5135 to the Covered Codes table. Added HCPCS codes J3262, Q5121, and Q5133 to the Not Covered/Non-Formulary Codes table. Policy update effective 01/01/2025.

03/03/2025: Policy updated to add coverage for Cosentyx IV for psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis. Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS code J3247.

SOURCE(S)

1. Actemra prescribing information. Genentech, Inc. September 2024. Last accessed October 2024.

2. Avsola prescribing information. Amgen Inc. April 2023. Last accessed October 2024.

3. Cimzia prescribing information. UCB, Inc. September 2024. Last accessed October 2024.

4. Cosentyx prescribing information. Novartis Pharmaceuticals, Corp. October 2024. Last accessed December 2024.

5. Ilaris prescribing information. Novartis Pharmaceuticals, Corp. June 2024. Last accessed October 2024.

6. Inflectra prescribing information. Pfizer Laboratories Div Pfizer, Inc. August 2024. Last accessed October 2024.

7. Infliximab prescribing information. Janssen Biotech, Inc. October 2021. Last accessed October 2024.

8. Orencia prescribing information. E.R. Squibb & Sons, L.L.C. May 2024. Last accessed October 2024.

9. Remicade prescribing information. Janssen Biotech, Inc. April 2022. Last accessed October 2024.

10. Renflexis prescribing information. Merck Sharp & Dohme LLC. January 2023. Last accessed October 2024.

11. Simponi ARIA prescribing information. Janssen Biotech, Inc. July 2023. Last accessed October 2024.

12. Skyrizi prescribing information. AbbVie Inc. June 2024. Last accessed October 2024.

13. Stelara prescribing information. Janssen Biotech, Inc. March 2024. Last accessed October 2024.

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.

Covered Codes        

 Not Medically Necessary Codes

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