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

POLICY NUMBER

S.5.01.415

Avsola (infliximab-axxq)

Cimzia (certolizumab)

Entyvio (vedolizumab)

Imuldosa (ustekinumab-srlf)

Inflectra (infliximab-dyyb)

Infliximab

Otulfi (ustekinumab-aauz)

Pyzchiva (ustekinumab-ttwe)

Remicade (infliximab)

Renflexis (infliximab-abda)

Selarsdi (ustekinumab-aekn)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Steqeyma (ustekinumab-stba)

Tremfya (guselkumab)

Tysabri (natalizumab)

Wezlana (ustekinumab-auub)

Yesintek (ustekinumab-kfce)

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, Entyvio, Selarsdi, Skyrizi, Steqeyma, Tremfya, Yesintek – Placement in Medical Covered Agents Table is in reference to products requiring administration by a healthcare professional (e.g., Cimzia lyophilized powder; Entyvio, Selarsdi, Skyrizi, Steqeyma, Tremfya, and Yesintek for intravenous infusion).Conventional Agent Prerequisites

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

Related medical policies:

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

• State and School Employees’ Health Insurance Plan - Multiple Sclerosis

• State and School Employees’ Health Insurance Plan - Chronic Plaque Psoriasis

• 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.

Selarsdi, Steqeyma, and Yesintek are the ustekinumab formulary options effective 08/01/2025.

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

• Avsola (infliximab-axxq)

• Imuldosa (ustekinumab-srlf)

• Otulfi (ustekinumab-aauz)

• Pyzchiva (ustekinumab-ttwe)

• Renflexis (infliximab-abda)

• Stelara (ustekinumab)

• Wezlana (ustekinumab-auub)

Initial Evaluation

1. ONE of the following:

   1. The individual is 18 years of age or older;

      OR

   2. The individual is 6 years of age or older and request is for Inflectra, infliximab, or Remicade;

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

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

4. ONE of the following:

   1. The individual has moderate to severe disease and has failed (see definition of Failure in the Policy Guidelines section) at least ONE conventional agent (≥3 months use) as evidenced by medical records and/or pharmacy printout;

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

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

      OR

   4. The individual’s medication history documents prior use of another biologic immunomodulator for the treatment of ulcerative colitis;

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

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;

   AND

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

Length of Approval: 12 months

Renewal Evaluation

The requested agents will 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 shown 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.), Otezla, or Zeposia; AND

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.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response 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.

02/29/2024: Updated related medical policy link.

03/28/2024: Code Reference section updated to revise the code description for HCPCS code J3380, effective 04/01/2024.

10/18/2024: Policy description for step 1 preferred agents updated to change "Entyvio" to "Entyvio IV." Removed Inflectra from the medical covered agents table for ulcerative colitis. Added Skyrizi IV and Tremfya IV as step 1 preferred agents for ulcerative colitis. Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS code J1628.

11/01/2024: Policy description updated to remove Avsola as a covered agent and to add Inflectra as a covered agent. 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 statement criteria for those 6 years of age or older revised to remove Avsola and to add Inflectra. Revised renewal evaluation policy statement for clarity. Policy statement add Avsola (infliximab-axxq) as not covered. Code Reference section updated to add HCPCS code Q5103 to the Medically Necessary Codes table. Added HCPCS code Q5121 to the Not Covered/Non-Formulary Codes table. Effective 01/01/2025.

01/23/2025: Table for Medical Covered Agents updated to change "Stelara IV" to "Stelara." Policy statements unchanged.

04/28/2025: Table for Medical Covered Agents updated to add Tremfya as a Step 1 Preferred Agent for Crohn's Disease and remove "IV" from Entyvio, Skyrizi, and Tremfya. Added statement that for the medications listed, Placement in Medical Covered Agents Table is in reference to products requiring administration by a healthcare professional. Policy statements unchanged. Sources updated.

07/01/2025: Policy updated to add Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Steqeyma (ustekinumab-stba), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce). Policy description updated to add Selarsdi, Steqeyma, and Yesintek as Step 1 Preferred Agents for Crohn's Disease and Ulcerative Colitis. Revised foot note to add Selarsdi, Steqeyma, and Yesintek. Added note that Stelara will no longer be covered effective 8/1/25. Policy section updated to add the following medications as not covered on the State Health Plan Medical Drug Formulary: Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), and Wezlana (ustekinumab-auub). Sources updated. Code Reference section updated to add HCPCS code Q5099, Q5100, and Q9998 to the Medically Necessary Codes table. Added HCPCS codes Q5138, Q9997, and Q9999 to the Not Covered/Non-Formulary Codes table.

08/01/2025: Policy description updated to remove Stelara as a Step 1 preferred medical covered agent for Crohn's Disease and Ulcerative Colitis. Added statement that Selarsdi, Steqeyma, and Yesintek are the ustekinumab formulary options effective 08/01/2025. Added Imuldosa (ustekinumab-srlf) and Stelara (ustekinumab) to the list of medications not covered on the State Health Plan Medical Drug Formulary. Sources updated. Code Reference section updated to add HCPCS codes J3358 and Q5098 to the Not Covered/Non-Formulary Codes table.

SOURCE(S)

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

2. Cimzia prescribing information. UCB, Inc. January 2023. Last accessed October 2024.

3. Entyvio prescribing information. Takeda Pharmaceuticals America, Inc. June 2024. Last accessed October 2024.

4. Imuldosa prescribing information. Accord BioPharma Inc. July 2025. Last accessed July 2025.

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

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

7. Otulfi prescribing information. Fresenius Kabi USA, LLC. October 2024. Last accessed May 2025.

8. Pyzchiva prescribing information. SANDOZ INC. June 2025. Last accessed May 2025.

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. Selarsdi prescribing information. Teva Pharmaceuticals USA, Inc. February 2025. Last accessed May 2025.

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

13. Stelara prescribing information. Janssen Biotech, Inc. April 2025. Last accessed May 2025.

14. SteQeyma prescribing information. CELLTRION USA Inc. April 2025. Last accessed May 2025.

15. Tremfya prescribing information. Janssen Biotech, Inc. March 2025. Last accessed April 2025.

16. Tysabri prescribing information. Biogen Inc. October 2023. Last accessed October 2024.

17. Wezlana prescribing information. Optum Health Solutions (Ireland) Limited. April 2025. Last accessed May 2025.

18. Yesintek prescribing information. Biocon Biologics Inc. November 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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