Crohn's Disease and Ulcerative Colitis

POLICY NUMBER

L.5.01.415

Abrilada (adalimumab-afzb)

Amjevita (adalimumab-atto)

Avsola (infliximab-axxq)

Cimzia (certolizumab pegol)

Cyltezo (adalimumab-adbm)

Entyvio (vedolizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Imuldosa (ustekinumab-srlf)

Inflectra (infliximab-dyyb)

Infliximab

Omvoh (mirikizumab-mrkz)

Otulfi (ustekinumab-aauz)

Pyzchiva (ustekinumab-ttwe)

Remicade (infliximab)

Renflexis (infliximab-abda)

Rinvoq (upadacitimib)

Selarsdi (ustekinumab-aekn)

Simlandi (adalimumab-ryvk)

Simponi (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Steqeyma (ustekinumab-stba)

Tremfya (guselkumab)

Tysabri (natalizumab)

Velsipity (etrasimod)

Xeljanz/Xeljanz XR (tofacitinib)

Yesintek (ustekinumab-kfce)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Wezlana  (ustekinumab-auub)

Zeposia (ozanimod)

Zymfentra (infliximab-dyyb)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Table 1: Pharmacy Preferred / Non-Preferred Agents

^1aRequires failure of 2 (two) agents from Step 1 and/or Step 2.

^1bRequires failure of 3 (three) agents from Step 1 and/or Step 2.

²Requires failure or intolerance to one or more TNF inhibitors. If all TNF blockers are clinically inadvisable, see Policy criteria.

Table 2: Medical Covered Agents (no step therapy requirement)

¹Cimzia, Entyvio, Selarsdi, Skyrizi, Steqeyma, Tremfya, Yesintek – If the request is for the self-administered agent, please refer to Table 1. Placement in Table 2 is in reference to products requiring administration by a healthcare professional (e.g., Cimzia lyophilized powder; Entyvio, Selarsdi, Skyrizi, Steqeyma, Tremfya, Yesintek for intravenous infusion). 

Conventional Agent Prerequisites

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

Related medical policies:

• Anti-Rheumatic Biologicals

• Multiple Sclerosis

• Chronic Plaque Psoriasis

• Hidradenitis Suppurativa (HS)

• Uveitis

• Biosimilar Medications

POLICY

Prior authorization is required.

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

Hadlima and Simlandi are the adalimumab formulary options effective 01/01/2025. 

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

The following medications are not covered on any BCBSMS Formulary:

• Abrilada (adalimumab-afzb)

• Amjevita (adalimumab-atto)

• Avsola (infliximab-axxq)

• Cyltezo (adalimumab-adbm)

• Hulio (adalimumab-fkjp)

• Humira (adalimumab)

• Hyrimoz (adalimumab-adaz)

• Idacio (adalimumab-aacf)

• Imuldosa (ustekinumab-srlf)

• Omvoh (mirikizumab-mrkz)

• Otulfi (ustekinumab-aauz)

• Pyzchiva (ustekinumab-ttwe)

• Renflexis (infliximab-abda)

• Stelara (ustekinumab)

• Velsipity (etrasimod)

• Wezlana (ustekinumab-auub)

• Yuflyma (adalimumab-aaty)

• Yusimry (adalimumab-aqvh)

• Zymfentra (infliximab-dyyb)

Initial Criteria

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

1. ONE of the following:

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

   2. The individual is 6 years of age or older, is being treated for Crohn’s Disease, and request is for formulary adalimumab or formulary infliximab product; 

   3. The individual is 6 years of age or older, is being treated for ulcerative colitis, and request is for preferred infliximab product;

   4. The individual is 5 years of age or older, is being treated for ulcerative colitis, and request is for preferred adalimumab product; OR

   5. The individual weighs at least 15kg, is being treated for ulcerative colitis, and the request is for Simponi;

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);

   4. The individual has severe disease and/or risk factors for disease complications for which initial treatment with the requested agent is deemed clinically necessary - provider must include additional details regarding disease severity and/or risk factors (i.e., fistulizing disease, history of resection, extra-intestinal symptoms, corticosteroid-dependence, etc.); OR

   5. The individual's medication history documents prior use of another biologic immunomodulator for the treatment of Crohn's Disease or ulcerative colitis;

5.  If request is for a step 1b agent, then ONE of the following:

   1. The individual has tried and had an inadequate response to ONE Tumor Necrosis Factor (TNF) inhibitor for the requested indication after at least a 3-month duration of therapy (See Step 1a for preferred TNF inhibitors);

   2. The individual has a documented intolerance (see definition of Intolerance in the Policy Guidelines section) or hypersensitivity to ALL Step 1a TNF Inhibitors; OR

   3. ALL of the following:

      1. The requested agent is Rinvoq;

      2. TNF inhibitors are contraindicated or are not clinically appropriate for the individual; AND

      3. The individual has tried and had an inadequate response or intolerance to at least one approved systemic therapy for the requested indication;

6. If request is for a non-preferred agent, then ONE of the following:

   1. The individual's medication history indicates trial and failure of the required number of preferred biologic agents (See Preferred Agent table) unless there is an FDA-labeled contraindication or hypersensitivity to all of the required preferred agents; OR

   2. The request is for an FDA-labeled indication that is not covered by the preferred products;

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

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

9. 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 latent TB; AND

10. 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 PA 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 immunomodulatory agent (i.e., TNF-inhibitor, JAK inhibitor, IL-inhibitor, anti-IgE antibody, Otezla etc.); 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 which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 Member'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 Member'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 Member, his or her Provider; and

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

1999: Approved by Pharmacy & Therapeutics Committee.

12/23/1999: Rheumatoid Arthritis coverage added.

1/29/2001: Indications and usage added.

10/11/2001: Centocor Important Drug Warning added.

11/1/2001: Indications and Usage, "Off Label" uses, Boxed Warning moved to the "Policy" section. Centocor Drug Warning # 2 added to "Policy" section.

01/30/2002: Crohn's disease, moderate-severe added.

05/1/2002: Type of Service and Place of Service deleted.

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

10/21/2003: "Infliximab (Remicade®)" medical policy renamed "Infliximab (Remicade®) for Treatment of Crohn’s Disease", treatment of rheumatic arthritis merged with "Anti-Rheumatic Biologicals" medical policy, approved by the Pharmacy & Therapeutics Committee, ICD-9 diagnosis code range 555.0-555.9 listed separately.

01/15/2004: Recommended dosing added, Code Reference section updated, CPT code 90782 deleted, ICD-9 diagnosis code 99.29 deleted.

01/22/2004: Nova Factor new telephone and fax numbers added. Telephone # 1-866-591-9075 and fax # 1-866-591-9094 deleted.

02/13/2004: "and reducing and maintaining clinical remission" added to "Description" section.

8/15/2005: Recommended dosing deleted.

10/31/2005: Description section updated, FDA approved indications revised. Policy section updated: changed preferred provider to Accredo and changed the telephone # from 1-866-489-1899 to 1-866-240-3373.Sources updated; Remicade® added.

11/4/2005: Code reference section updated, ICD9 diagnosis codes 556.0 - 556.9 added; descriptors on ICD9 diagnosis codes 555.0 - 555.9 added and HCPCS code J1745 updated.

11/2005: Approved by Pharmacy & Therapeutics (P&T) Committee.

03/5/2007: Policy name changed from "Infliximab (Remicade®) for Treatment of Crohn's Disease and Ulcerative Colitis" to "Crohn's Disease and Ulcerative Colitis". Adalimumab (Humira®) description and indication added. HCPCS J0135 added. Removed boxed warning and package insert warning information for infliximab (Remicade®).

05/2/2007: Policy updated. Failure of Humira® is required before approval of Remicade® for anti-TNF naive patients with Crohn's disease added.

03/10/2008: Natalizumab (Tysabri®) prescribing information for use in Crohn's disease added. CuraScript and Accredo listed as preferred providers for Tysabri®. Code reference updated; J2323 added.

05/9/2008: Certolizumab pegol (Cimzia®) prescribing information for use in Crohn's disease added. Accredo is the preferred provider for Cimzia®.

01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.

03/31/2011: Policy statement for Cimzia updated to state that effective 04/01/11, new starts are only considered for Cimzia after failed treatment with Humira. Added "adult" to the Remicade policy statement.

11/27/2012: Policy description and statement updated regarding Humira®. Policy statement revised to state that effective 09/28/12, Humira® is also considered medically necessary for adults with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). (Six adalimumab (Humira®) injections for the first three weeks (Day 1 160mg and Day 15 80mg) and beginning Day 29, a maintenance dose of 40mg every other week will be covered). After 8 weeks of therapy, documentation of clinical remission must be submitted for continued therapy. Humira® is not medically necessary for patients who have lost response to or were intolerant to TNF blockers. 

01/09/2013: Added the following to the Policy Exceptions section: State Health Plan (State and School Employees): Prior authorization is not required for State Health Plan members. However, these biologic drugs will be reviewed for medical necessity based on medical policy guidelines.

11/15/2013: Policy reviewed; no changes to policy statement. Policy re-formatted for clarity purposes. Added J0718 to the Code Reference section.

01/01/2014: Policy description and statement updated regarding Simponi®. Policy statement revised to state that Simponi® is considered medically necessary in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Failure of Humira® is required before coverage of Simponi® will be approved. For new starts, Simponi will be approved at three Simponi® injections for the two weeks (Day 0 200mg and Day 15 100mg) and a maintenance dose of 100mg every month will be covered). Added HCPCS J1602 to the Code Reference section.

05/06/2014: Policy reviewed. Policy statement revised to state that Adalimumab (Humira®) is considered medically necessary for adults with moderate to severe Crohn's disease who are naïve to biologic therapy and have had an inadequate response to conventional therapy or adults who have lost response to or are intolerant to infliximab (Remicade®). (Six adalimumab (Humira®) injections for the first three weeks and beginning at Week 4, a maintenance dose of 40mg every other week will be covered).

11/06/2014: Policy description and statement updated regarding (Humira®). Added the following policy statement: Adalimumab (Humira®) is considered medically necessary for patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. (For patients less than 88 lbs, three adalimumab (Humira®) 40mg  injections for the first 3 weeks and beginning at Week 4, a maintenance dose of 20mg every other week will be covered. For patients 88 lbs or more, six 40mg injections for the first 3 weeks and beginning at Week 4, a maintenance dose of 40mg every other week will be covered.)

01/09/2015: Policy description and statement updated regarding Vedolizumab (Entyvio®). Added the following policy statement: Vedolizumab (Entyvio®) is considered medically necessary for adult patients with moderately to severely active ulcerative colitis and severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on cortiocsteroids. After 14 weeks of therapy, documentation of therapeutic benefit must be submitted for continued therapy of Entyvio®. Failure of Humira® is required before coverage of Entyvio® will be approved.

08/26/2015: Medical policy revised to add ICD-10 codes. Removed deleted HCPCS code J0718 from the Code Reference section. Added HCPCS code J0717.

05/26/2016: Policy number L.5.01.415 added. Policy Guidelines updated to add medically necessary definition.

08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

12/30/2016: Code Reference section updated to revise code description for HCPCS code J1745.

04/01/2017: Policy description updated to add information regarding Inflectra®. Policy statement revised to state that Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®) are considered medically necessary for "adult patients" with moderate to severe Crohn's Disease, fistulizing Crohn's disease, and moderate to severe ulcerative colitis. Added statement that Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®) are considered medically necessary for moderate to severe Crohn’s disease in pediatric patients 6 years of age and older who have had an inadequate response to conventional therapy. Failure of Humira® is required. Sources section updated.

07/07/2017: Policy updated to add indications for Ustekinumab (Stelara®). Effective 01/01/2017. Sources section updated.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

01/31/2018: Policy description and policy section updated to add indications for Infliximab-abda (Renflexis™). Sources updated.

03/05/2018: Policy description updated to add preferred/nonpreferred agents and conventional agent prerequisites for Crohn's disease and ulcerative colitis. Policy section updated to add prior authorization criteria for initial and renewal evaluations. Effective 04/01/2018.

03/29/2018: Code Reference section updated to add new HCPCS codes Q5103 and Q5104, effective 04/01/2018.

05/30/2018: Medical policy links updated in policy description.

12/20/2018: Code Reference section updated to add new HCPCS code Q5109, effective 01/01/2019.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated to add Xeljanz to the list of non-preferred agents. Policy section updated to state that for Xeljanz (ulcerative colitis), initial approval is 16 weeks and requires documentation of therapeutic benefit with a new request for continued treatment for 12 months. Sources updated. Effective 01/01/2019.

03/26/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Conventional agent prerequisites table updated. Added statement that the table is not an all-inclusive listing of options for prerequisite therapies available. Initial evaluation criteria updated to state the following: 1) the prescriber is a specialist or has consulted with a specialist in an area of the patient's diagnosis (e.g. gastroenterologist); 2) The patient has moderate to severe disease and has been unresponsive (>3 months use) to at least ONE conventional agent as evidenced by medical records. Sources updated.

08/16/2019: Added Tysabri (natalizumab) to the list of drugs at the top of the policy and made the following correction: "Entyvio (etanercept)" changed to "Entyvio (vedolizumab)."

04/01/2020: Policy description updated regarding subsequent trial/failure with Cimzia for Crohn's Disease. Preferred and Non-Preferred Agents updated for Crohn's Disease and Ulcerative Colitis. Updated policy statements for patients 6 years of age or older and for those with moderate to severe disease. Policy section updated to list examples of biologic immunomodulatory agents. Policy statement revised to state: The patient has an FDA-labeled contraindication or hypersensitivity to ALL conventional agents. Policy Guidelines updated to define medication failure. Sources updated. Added HCPCS code Q5102.

05/04/2020: Initial evaluation criteria updated to add "Length of Approval: 12 months."

06/29/2020: Code Reference section updated to add new HCPCS code Q5121, effective 07/01/2020.

07/27/2020: Code Reference section updated to add HCPCS code J3380.

10/19/2020: Policy description updated to remove Renflexis from the list of Non-Preferred agents. Added policy statement to state that renflexis is considered not medically necessary as other formulary options exist for the treatment of Crohn's Disease and Ulcerative Colitis. Code Reference section updated to change "Covered Codes" to "Medically Necessary Codes" and to remove HCPCS code Q5104.

01/01/2021: Added Renflexis (infliximab-abda) to the top of the policy. Policy description updated regarding Pharmacy Preferred/Non-Preferred Agents and Medical Covered Agents. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Code Reference section updated to add Not Medically Necessary Codes table for HCPCS code Q5104.

05/17/2021: Policy section updated to state that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Initial evaluation criteria updated to add the following requirement: Member is 5 years of age or older, is being treated for ulcerative colitis, and request is for Humira. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to define medication failure and to add information regarding BCBSMS request for records.

08/04/2021: Policy updated to add Zeposia (ozanimod). Policy description updated regarding Step 3 non-preferred agents. Policy statement updated with minor change to change "AND" to "OR." Sources updated.

06/14/2022: Policy description updated to add Rinvoq as a Step 2 Non-Preferred Agent for Ulcerative Colitis. Initial and renewal evaluation criteria updated to state: The member is not currently being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.), Otezla, or Zeposia.

06/15/2022: Table 1 in the Policy Description updated to indicate program requirements by disease state.

06/16/2022: Code Reference section updated to remove deleted HCPCS code Q5102 and to add HCPCS code J3358.

07/25/2022: Policy updated to add Infliximab. Sources updated.

09/14/2022: Policy updated to add Skyrizi (risankizumab-rzaa). Table 1 in policy description updated to add Skyrizi SC as a Step 1 preferred agent for Crohn's Disease. Table 2 updated to add preferred agents for Crohn's Disease and Ulcerative Colitis. Policy section for initial evaluation updated to add infliximab and update the length of approval. Sources updated. Code Reference section updated to revise code description for HCPCS code J1745.

01/12/2023: Table 1 in the policy description was updated to add Xeljanz/Xeljanz XR and Rinvoq as Step 1b preferred agents for ulcerative colitis. Added that Step 2 non-preferred agents require failure of Humira. Updated indication for Zeposia (Step 3 non-preferred agent). For the initial evaluation criteria, added policy statement that if the request is for a Step 1b preferred agent, the member’s medication history documents prior use of another biologic immunomodulator for the treatment of ulcerative colitis.

01/20/2023: Table 1 criteria updated regarding requirements for failure of Step agents. Medically necessary criteria updated to remove statement regarding Step 1b preferred agents. Added the following statement: The member’s medication history documents prior use of another biologic immunomodulator for the treatment of ulcerative colitis.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy 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 medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

02/16/2023: Code Reference section updated to add HCPCS code J2327.

06/01/2023: Policy description updated to add Rinvoq as a Step 1b pharmacy preferred agent for Crohn's Disease. Sources updated.

07/01/2023: Table 1 in policy description updated to add Step 1a preferred agents for Crohn's Disease and Ulcerative Colitis. Table 2 updated to remove Inflectra and Ixifi as Step 1 Preferred agents for Crohn's Disease and Ulcerative Colitis. Updated related medical policies. Policy section updated to revise initial evaluation criteria. Added policy statement that Abralida (adalimumab-afzb), Cyltezo (adalimumab-adbm), Hulia (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Yuflyma, Yusimry (adalimumab-aqvh), Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx), and Renflexis (infliximab-abda) are considered not medically necessary as other formulary options exist for the treatment of Crohn’s Disease and Ulcerative Colitis. Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants. Sources updated. Code Reference section updated to move HCPCS codes Q5103 and Q5109 from the Medically Necessary Codes table to the Not Medically Necessary Codes table.

01/16/2024: Policy description updated to add Entyvio as a Step 3 Non-Preferred Agent for Ulcerative Colitis. Policy statements unchanged. Sources updated.

03/08/2024: Policy description updated to remove Amjevita as a Step 1 Preferred Agent for Crohn's Disease and Ulcerative Colitis. Policy section updated to state that Amjevita (adalimumab-atto) is considered not medically necessary as other formulary options exist for the treatment of Crohn’s Disease and Ulcerative Colitis.

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

04/09/2024: Policy updated to state that Omvoh (mirikizumab-mrkz) and Velsipity (etrasimod arginine) are considered not medically necessary as other formulary options exist for the treatment of Crohn’s Disease and Ulcerative Colitis. Sources updated. Code Reference section updated to add HCPCS code C9168 to the Not Medically Necessary Codes table.

05/01/2024: Code Reference section updated to add HCPCS codes Q5131 and Q5132 to the Not Medically Necessary Codes table.

05/13/2024: Policy updated to add Simlandi (adalimumab-ryvk). Policy description updated to add Simlandi as a Step 1a Preferred Agent for Crohn's Disease and Ulcerative Colitis. Statements regarding failure of agents from Step 1 and/or Step 2 updated to include Hadlima and Simlandi as required Step agents. Length of Approval for Initial Evaluation updated to change "No more than 12 months" to "12 months." Sources updated.

05/31/2024: Policy updated to state that Hadlima or Simlanda are the adalimumab formulary options for new starts effective 07/01/2024.

06/27/2024: Code Reference section updated to make note of deleted HCPCS code C9168. Effective 06/30/2024.

08/02/2024: Policy description updated to add Skyrizi as a Step 1 Preferred Agent for ulcerative colitis. Policy statements unchanged. Sources updated.

10/18/2024: Policy updated to remove Ixifi (infliximab-qbtx). Corrected the spelling of Abrilada and Hulio. Policy description updated to add Tremfya SC as a Step 1a preferred agent for ulcerative colitis. Updated table for Step 2 non-preferred agents for Crohn's disease and ulcerative colitis to state that failure of adalimumab is required. Added Entyvio SC as a step 3 non-preferred agent for Crohn's disease and ulcerative colitis. Added Tremfya IV as a medical covered agent for ulcerative colitis. Policy statements updated to change "member" to "individual." Policy statement for initial evaluation updated to state: The individual's medication history documents prior use of another biologic immunomodulator for the treatment of Crohn's Disease or ulcerative colitis. It previously stated: The member’s medication history documents prior use of another biologic immunomodulator for the treatment of ulcerative colitis. Sources updated. Code Reference section updated to add HCPCS code J1628 to the Medically Necessary Codes table.

11/01/2024: Policy description updated to remove Humira as a Step 1a preferred agent for Crohn's disease and ulcerative colitis. Removed Avsola as a medical covered agent and added Inflectra. Revised policy statements to state the following: 1) The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 2) Hadlima and Simlandi are the adalimumab formulary options effective 01/01/2025. Added medically necessary statement for policy criteria. Policy statement revised to state that the following medications are not covered on any BCBSMS Formulary: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Avsola (infliximab-axxq), Cyltezo (adalimumab-adbm), Hulio (adalimumab-fkjp), Humira (adalimumab), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Omvoh (mirikizumab-mrkz), Renflexis (infliximab-abda), Velsipity (etrasimod arginine), Yuflyma (adalimumab-aaty), Yusimry (adalimumab-aqvh), and Zymfentra (infliximab-dyyb). Code Reference section updated to add HCPCS code Q5103 to the Medically Necessary Codes table. Added HCPCS codes J0135, J1748, and Q5121 to the Not Covered/Non-Formulary Codes table. Removed HCPCS code Q5109 for Ixifi as it is no longer on the market. Effective 01/01/2025.

01/01/2025: Code Reference section updated to add new HCPCS codes J0139, Q5140, Q5141, Q5142, Q5143, Q5144, and Q5145.

01/23/2025: Table 1 for Pharmacy Preferred/Non-Preferred Agents updated to change "Stelara SC" to "Stelara." Table 2 for Medical Covered Agents updated to change "Stelara IV" to "Stelara." Policy statements unchanged.

04/28/2025: Table 1 for Pharmacy Preferred/Non-Preferred Agents updated to add Tremfya as a Step 1a Preferred Agent for Crohn's Disease and remove "SC" from the following medications: Skyrizi, Entyvio, and Tremfya. Table 2 for Medical Covered Agents updated to add Tremfya as a Step 1 Preferred Agent for Crohn's Disease and remove "IV" from Skyrizi and Tremfya. Added information to refer to Table 1 if requests are for self-administered agents. Table 2 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). Table 1 in policy description updated to add Selarsdi, Steqeyma, and Yesintek as Step 1a Preferred Agents for Crohn's Disease and Ulcerative Colitis. Removed note listing required Step agents. Added note that Stelara will no longer be covered effective 8/1/25. Table 2 for Medical Covered Agents updated to add Selarsdi, Steqeyma, and Yesintek as Step 1 Preferred Agents for Crohn's Disease and Ulcerative Colitis. Revised footnote to include Selarsdi, Steqeyma, and Yesintek. Added the following medications as not covered on any BCBSMS Formulary: Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), and Wezlana (ustekinumab-auub). Sources updated. Code Reference section updated to add HCPCS codes J3357, Q5099, Q5100, and Q9998 to the Medically Necessary Codes table. Added HCPCS codes Q5137, Q5138, Q9996, Q9997, and Q9999 to the Not Covered/Non-Formulary Codes table.

08/01/2025: Policy description updated to remove Stelara as a pharmacy Step 1a preferred agent for Crohn's Disease and Ulcerative Colitis. Removed 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 any BCBSMS Formulary. Sources updated. Code Reference section updated to add HCPCS codes J2267, J3357, J3358, and Q5098 to the Not Covered/Non-Formulary Codes table. Removed deleted HCPCS code C9168.

11/15/2025: Policy updated to add Simponi pediatric indication for ulcerative colitis. Sources section updated. Updated last access dates for prescribing information.

02/06/2026: Policy description updated regarding Step 1b Preferred Agents and conventional agent prerequisites. Medically necessary statement criteria updated to change "preferred" to "formulary." Added criteria regarding individuals with severe disease and/or risk factors for disease complications. Moved criteria for step 1b agents from the description to the policy section. Updated criteria for Rinvoq where TNF inhibitors are contraindicated or not clinically appropriate. Added "JAK inhibitor" to the list of immunomodulatory agents and changed "active TB" to "latent TB."

SOURCE(S)

1. Abrilada prescribing information. Pfizer Laboratories Div Pfizer Inc. January 2025. Last accessed September 2025.

2. Amjevita prescribing information. Amgen, Inc. August 2024. Last accessed September 2025.

3. Avsola prescribing information. Amgen, Inc. September 2025. Last accessed September 2025.

4. Cimzia prescribing information. UCB, Inc. July 2025. Last accessed September 2025.

5. Cyltezo prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. August 2025. Last accessed September 2025.

6. Entyvio prescribing information. Takeda Pharmaceuticals America, Inc. June 2024. Last accessed September 2025.

7. Hadlima prescribing information. Organon LLC. June 2024. Last accessed September 2025.

8. Hulio prescribing information. Viatris Specialty LLC. August 2023. Last accessed September 2025.

9. Humira prescribing information. AbbVie Inc. July 2025. Last accessed September 2025.

10. Hyrimoz prescribing information. Sandoz Inc. July 2025. Last accessed September 2025.

11. Idacio prescribing information. Fresenius Kabi USA, LLC. October 2024. Last accessed September 2025.

12. Imuldosa prescribing information. Accord BioPharma Inc. September 2025. Last accessed September 2025.

13. Inflectra prescribing information. Pfizer Laboratories Div Pfizer Inc. September 2025. Last accessed September 2025.

14. Infliximab prescribing information. Janssen Biotech, Inc. June 2025. Accessed September 2025.

15. Omvoh prescribing information. Eli Lilly and Company. April 2025. Last accessed September 2025.

16. Otulfi prescribing information. Fresenius Kabi USA, LLC. October 2024. Last accessed September 2025.

17. Pyzchiva prescribing information. SANDOZ INC. July 2025. Last accessed September 2025.

18. Remicade prescribing information. Janssen Biotech, Inc. June 2025. Last accessed September 2025.

19. Renflexis prescribing information. Organon LLC. January 2024. Last accessed September 2025.

20. Rinvoq prescribing information. AbbVie Inc. October 2025. Last accessed November 2025.

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

22. Simlandi prescribing information. Teva Pharmaceuticals USA, Inc. February 2025. Last accessed September 2025.

23. Simponi prescribing information. Janssen Biotech, Inc. September 2025. Last accessed September 2025.

24. Skyrizi prescribing information. AbbVie Inc. September 2025. Last accessed September 2025.

25. Stelara prescribing information. Janssen Biotech, Inc. July 2025. Last accessed September 2025.

26. Steqeyma prescribing information. CELLTRION USA Inc. April 2025. Last accessed September 2025.

27. Tremfya prescribing information. Janssen Biotech, Inc. August 2025. Last accessed September 2025.

28. Tysabri prescribing information. Biogen Inc. March 2025. Last accessed September 2025.

29. Velsipity prescribing information. Pfizer Laboratories Div Pfizer Inc. August 2025. Last accessed September 2025.

30. Xeljanz prescribing information. Pfizer Laboratories Div Pfizer Inc. June 2025. Last accessed September 2025.

31. Wezlana prescribing information. Optum Health Solutions (Ireland) Limited. April 2025. Last accessed September 2025.

32. Yesintek prescribing information. Biocon Biologics Inc. November 2024. Last accessed September 2025.

33. Yuflyma prescribing information. Celltrion USA, Inc. March 2025. Last accessed September 2025.

34. Yusimry prescribing information. Coherus BioSciences, Inc. May 2025. Last accessed September 2025.

35. Zeposia prescribing information. Celgene Corporation. August 2024. Last accessed September 2025.

36. Zymfentra prescribing information. Celltrion USA, Inc. May 2025. Last accessed September 2025.

37. Singh, Siddharth et al. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology, Volume 167, Issue 7, 1307 - 1343 

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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