Anti-Rheumatic Biologicals

POLICY NUMBER

L.5.01.404

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Amjevita (adalimumab-atto)

Avsola (infliximab-axxq)

Cimzia (certolizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Enbrel (etanercept)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Imuldosa (ustekinumab-srlf)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Olumiant (baricitinib)

Otezla/Otezla XR (apremilast)

Orencia (abatacept)

Otulfi (ustekinumab-aauz)

Pyzchiva (ustekinumab-ttwe)

Remicade (infliximab)

Renflexis (infliximab-abda)

Rinvoq (upadacitimib)

Selarsdi (ustekinumab-aekn)

Simlandi (adalimumab-ryvk)

Simponi/Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Steqeyma (ustekinumab-stba)

Taltz (ixekizumab)

Tofidence (tocilizumab-bavi)

Tremfya (guselkumab)

Tyenne (tocilizumab-aazg)

Wezlana (ustekinumab-auub)

Xeljanz/Xeljanz XR (tofacitinib)

Yesintek (ustekinumab-kfce)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

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

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

^{¹Cimzia, Cosentyx, Orencia, Tyenne – 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; Cosentyx, Orencia, Tyenne for intravenous infusion).}

Indications Without Preferred Agents

Conventional Agent Prerequisites by Indication

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

Related policies -

• Biosimilar Medications

• Crohn's Disease and Ulcerative Colitis

• Chronic Plaque Psoriasis

• Giant Cell Arteritis

• Interstitial Lung Disease

• Otezla (apremilast)

• Hidradenitis Suppurativa (HS)

• Uveitis

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)

• Actemra (tocilizumab)

• Amjevita (adalimumab-atto)

• Avsola (infliximab-axxq)

• Cyltezo (adalimumab-adbm)

• Hulio (adalimumab-fkjp)

• Humira (adalimumab)

• Hyrimoz (adalimumab-adaz)

• Idacio (adalimumab-aacf)

• Imuldosa (ustekinumab-srlf)

• Otulfi (ustekinumab-aauz)

• Pyzchiva (ustekinumab-ttwe)

• Renflexis (infliximab-abda)

• Stelara (ustekinumab)

• Tofidence (tocilizumab-bavi)

• Wezlana (ustekinumab-auub)

• Yuflyma (adalimumab-aaty)

• Yusimry (adalimumab-aqvh)

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. The individual’s diagnosis is polymyalgia rheumatica and the individual has tried systemic corticosteroid therapy (at least 8 consecutive weeks) at a dose equivalent to at least 10 mg/day of prednisone and has had an inadequate response or cannot tolerate a corticosteroid taper;

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

   6. 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. If request is for formulary ustekinumab 90mg, the individual has a dual diagnosis of psoriasis AND psoriatic arthritis AND weighs >100kg;

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

7. 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;

8. The requested agent will not be used in combination with another immunomodulatory agent (i.e., TNF-inhibitor, JAK inhibitor, IL-inhibitor, anti IgE antibody, Otezla, etc);

   AND  

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

10. 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

11. 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 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 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 has 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.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of 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. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

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.

POLICY HISTORY

10/21/2003: "Etanercept (Enbrel)" medical policy merged with "Anti-Rheumatic Biologicals" medical policy, approved by the Pharmacy & Therapeutics Committee.

1/22/2004: Nova Factor new telephone and fax numbers added for Remicade, Enbrel, Humira and Kineret. Telephone # 1-866-591-9075 and fax # 1-866-591-9094 deleted for Remicade. Prior authorization requirement for Enbrel, Humira and Kineret added which is effective 2/2/04.

3/15/2004: Policy section second sentence; Once weekly dosing with Humira may only be considered with documentation of failed therapy using every other week dosing "of Humira and after failed treatment with Enbrel" deleted. The sentence now reads: "Once weekly dosing with Humira may only be considered with documentation of failed therapy using every other week dosing."

5/3/2004: Policy section; Infliximab coverage expanded for rheumatoid arthritis if failed treatment with Humira or Kineret. Coverage sentence now reads: "Infliximab (Remicade®) may be considered medically necessary for rheumatoid arthritis after failed treatment with Enbrel, Humira or Kineret."

6/3/2004: Policy section first paragraph "but not limited to" added, HCPCS J1745 added.

1/24/2005: New FDA approved indication - coverage expanded - Infliximab (Remicade) is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Sources updated.

10/28/2005: Description section updated. FDA approved indications revised; recommended dosing information deleted; link to Ulcerative Colitis and Chronic Plaque Psoriasis medical policy added; deleted Off-Label uses under identification. Policy section updated; changed preferred provider to Accredo and changed the telephone # from 1-866-489-1899 to 1-866-240-3373. Deleted statement "including, but not limited to, methotrexate;" changed two to one for number of DMARDs the patient must fail. Deleted statements about Infliximab and its use in the treatment of Crohn's disease and removed link to the Treatment of Crohn's Disease medical policy. Added statement about etanercept use in psoriasis and link to Chronic Plaque Psoriasis medical policy. Sources updated; Anakinra (Kineret®), Adalimumab (Humira®), and Infliximab (Remicade®) added.

11/04/2005: Code Reference section updated, HCPCS codes J1438, J1745, J3490 moved from the CPT section on the table to the HCPCS section, the drug Enbrel added to the description of code J1438, the drug Remicade added to the description of code J1745.

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

1/2006: Approved by Pharmacy & Therapeutics (P&T) Committee.

1/23/2006: Policy updated to add Abatacept (Orencia®). Prior authorization requirement added for Orencia. Policy section updated to distinguish Accredo as the preferred provider for Remicade, Enbrel, Humira and Kineret. Orencia telephone and fax numbers added. Code Reference section updated to add J7799 as a covered HCPCS code.

2/7/2006: Code reference table updated: code J0135 added, Adalimumab and Humira deleted from the description of code J3490.

3/14/2006: Policy updated to add Rituximab (Rituxan®). Prior authorization required added for Rituxan. Policy section updated to add Accredo and CuraScript as preferred providers for Rituxan. Policy section updated to add: contact Blue Cross Blue Shield of MS for Orencia. HCPCS J9310 code added to policy.

3/30/2006: Policy updated to state failure of DMARD therapy is not required for ankylosing spondylitis.

04/2006: Approved by Pharmacy & Therapeutics (P&T) Committee.

06/29/2006: CuraScript fax number changed from 877-462-6234 to 866-239-5502.

07/14/2006: Policy section updated; Accredo deleted as preferred provider for Rituximab (Rituxan®).

08/21/2006: FDA Approved Indications and Policy section updated to add ankylosing spondylitis for Humira.

12/27/2006: Code reference section updated per the 2007 HCPCS revisions.

01/2/2007: Code reference section updated; ICD-9 codes 714.81, 714.9, and 714.89 deleted.

04/27/2007: Updated policy section. Deleted information to contact Blue Cross & Blue Shield of Missisippi for Orencia. Added Orenica to CuraScript and Accredo as our preferred provider. Added Rituxan to Accredo as our preferred provider.

04/10/2008: Added juvenile idiopathic arthritis as an indication for Humira.

04/23/2008: Added juvenile idiopathic arthritis as an indication for Orenica.

07/29/2008: Updated FDA approved indication for Abatacept (Orenica®).

12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions.

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

05/11/2009: Policy section updated with addition of Golimumab (Simponi®) may be considered medically necessary in adults for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Prior authorization required.

05/18/2009: Policy section updated with addition of Certolizumab pegol (Cimzia®) may be considered medically necessary in adults with moderately to severely active rheumatoid arthritis. Prior authorization required.

02/22/2010: Policy section updated with addition of Tocilizumab (Actemra®). Tocilizumab (Actemra®) may be considered medically necessary in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least two of the following medications: Enbrel®, Humira®, Remicade®, Cimzia® and Simponi®. Prior authorization is required. Added HCPCS Code J3590 to Covered Codes Table for Actemra®.

02/28/2011: Added new HCPCS code J3262 for Actemra® to the Code Reference section.

03/31/2011: The first policy statement was updated to state that failure of DMARD therapy is not required for ankylosing spondlitis. The policy statements regarding Enbrel, Kineret, Simponi, and Cimzia were revised to state that effective 04/01/11, new starts are only considered after failed treatment with Humira.

01/17/2012: Policy description updated. Policy statement for Actemra® updated regarding coverage criteria for systemic juvenile idiopathic arthritis. "Failure of DMARD therapy is not required for ankylosing spondlitis" was deleted from the policy statement for Enbrel®. Also changed "rheumatoid" to "idiopathic in the Enbrel® statement. Replaced "with documentation of failed therapy" with "after failed therapy" in the policy statement for Humira®.

11/27/2012: Policy description and statement updated regarding Tocilizumab (Actemra®). Policy statement revised to state that effective 10/15/12, Tocilizumab (Actemra®) may be considered medically necessary for systemic juvenile idiopathic arthritis and in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least one of the following medications: Enbrel®, Humira®, Remicade®, Cimzia®, and Simponi®.

01/09/2013: Added the following to the Policy Exceptions section: State Health Plan (State and School Employees): The Anti-Rheumatic Biologicals listed in this policy do not require prior authorization. However, they will be reviewed for medical necessity based on medical policy guidelines.

03/06/2013: Policy updated to add coverage criteria for Tofacitinib (Xeljanz®), which may be considered medically necessary for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate and after failed treatment with at least one of the following medications: Enbrel®, Humira®, Simponi®, Kineret®, Cimzia®, Rituxan, Remicade®, or Orencia®. Dosage should not exceed 10mg/day (60 tablets/month). Prior authorization is required. Added J8499 to the Code Reference section.

09/01/2013: Policy reviewed. Policy description updated regarding Cimzia® to state that it may be used as a monotherapy or concomitantly with DMARDs. No changes to policy statement.

02/19/2014: Policy updated to add coverage criteria for Simponi ARIA®), which may be considered medically necessary in adult patients with moderately to severely active rheumatoid arthritis after failed treatment with Enbrel®, Humira®, Simponi®, or Kineret®.

03/14/2014: Policy updated to add Cimzia® indications for the treatment of adult patients with active psoriatic arthritis and ankylosing spondylitis. Added new HCPCS code J0717 to the Code Reference section.

06/25/2014: Policy description updated regarding Ustekinumab (Stelara®) and Rituxan® indication. Added "Prior authorization is required for Stelara®." Added the following policy statements: 1) Rituximab (Rituxan®) may be considered medically necessary for the treatment of patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids. 2) Ustekinumab (Stelara®) may be considered medically necessary for adults with active psoriatic arthritis alone or in combination with methotrexate after failed treatment with at least one of the following medications: Enbrel®, Humira®, Remicade®, Simponi®, or Cimzia®. Covered Stelara® dosage added. Added codes 446.0 and 446.4 to the Code Reference section.

09/02/2014: Policy description updated to include Apremilast (Otezla®). Policy statement updated to add the following: 1) Prior authorization is required for Otezla®. 2) Apremilast (Otezla®) may be considered medically necessary for adults with active psoriatic arthritis after failed treatment with Humira®. Dosage should not exceed 30mg/day (60 tablets/month). Sources section updated to add Otezla® Prescribing Information as a reference.

12/15/2014: Policy statement updated to correct dosage for Otezla®: Dosage should not exceed 30mg twice/daily (60 tablets/month).

08/18/2015: Medical policy revised to add ICD-10 codes.

02/25/2016: Policy description updated regarding Cosentyx® and Ilaris®. Prior authorization is required. Added the following policy statements: 1) Secukinumab (Cosentyx®) may be considered medically necessary for adults with active psoriatic arthritis or active ankylosing spondylitis after failed treatment with Humira®. Cosentyx® can be administered with or without a loading dosage. With a loading dosage, the dosage is 150mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dosage, the dosage is 150mg every 4 weeks. After documentation of failure with 150mg every 4 weeks, a dosage of 300mg every 4 weeks may be considered for patients who continue to have active psoriatic arthritis. 2) Canakinumab (Ilaris®) may be considered medically necessary for active systemic juvenile idiopathic arthritis in patients aged 2 years and older. Dosage should not exceed 300mg subcutaneously every 4 weeks. Policy guidelines updated to add medically necessary and investigative definitions. Sources section updated.

05/26/2016: Policy number L.5.01.404 added.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

01/01/2017: Policy updated to remove Otezla® information. Added link to new Otezla® medical policy in policy description. Revised code description for HCPCS code J1745.

04/01/2017: Policy evaluated and updated to add coverage guidelines for Inflectra®. Sources section updated.

06/26/2017: Code Reference section updated to add HCPCS codes J3357 and Q9989, effective 07/01/2017.

07/27/2017: Policy description updated to include Xeljanz XR® for rheumatoid arthritis. Medically necessary policy statement for Tofacitinib (Xeljanz®) (Xeljanz XR®) updated to add that dosage should not exceed 11 mg/day (30 tablets/month) for Xeljanz XR®.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

12/22/2017: Code Reference section updated to add new 2018 HCPCS code J3358.

01/31/2018: Policy description updated to add indications for Infliximab-abda (Renflexis™), Sarilumab (Kevzara®), Golimumab (Simponi ARIA®), Abatacept (Orencia®), Ixekizumab (Taltz®), and Tocilizumab (Actemra®). Policy section updated to add Infliximab-abda (Renflexis™) as medically necessary for rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis when meeting certain criteria. Policy statement updated to add that Tocilizumab (Actemra®) may also be considered medically necessary for polyarticular juvenile idiopathic arthritis. Added the following policy statements: 1) Ixekizumab (Taltz®) may be considered medically necessary for the treatment of adult patients with active psoriatic arthritis after failed treatment with Humira®. 2) Sarilumab (Kevzara®) may be considered medically necessary for the treatment of adult patients with moderately to severely active rheumatoid arthritis after failed treatment with Humira®. Sources updated.

03/05/2018: Policy description updated to list preferred/nonpreferred agents for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and systemic juvenile idiopathic arthritis. Added conventional agent prerequisites for FDA labeled indications. Policy section revised to add prior authorization criteria for initial and renewal evaluations. Sources updated. 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. Removed outdated sources from Sources section.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Sources section updated.

12/20/2018: Code Reference section updated to add new HCPCS codes J9312 and Q5109, effective 01/01/2019.

03/26/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding preferred agents and conventional agent prerequisites by indication. Added statement that the table is not an all-inclusive listing of options for prerequisite therapies available. Prior authorization criteria for initial evaluation 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. rheumatologist); 2) The patient has failed at least two conventional agents (including at least 3 months with one DMARD) as evidenced by medical records and/or pharmacy printout. Code Reference section updated to remove deleted HCPCS code Q9989.

02/25/2020: Policy description updated regarding preferred/non-preferred agents and program requirements by disease state. Code Reference section updated to remove deleted HCPCS code J9310.

03/02/2020: Added drug names to the top of the policy. Policy description updated regarding program requirement for rheumatoid arthritis. Updated the list of preferred and non-preferred agents for rheumatoid arthritis and the list of non-preferred agents for psoriatic arthritis. Policy statement for initial evaluation updated to change "The patient has an FDA-labeled contraindication or hypersensitivity to at least ONE conventional agent" to "The patient has an FDA-labeled contraindication or hypersensitivity to ALL conventional agents available." Policy Guidelines updated to define medication failure.

04/01/2020: Policy description updated to remove trial/failure with Actemra for rheumatoid arthritis and polyarticular juvenile idiopathic arthritis. Non-Preferred agents updated to add Avsola, Ixifi, Xeljanz XR, and Simponi ARIA for the disease state indicated. Policy section updated to list examples of biologic immunomodulatory agents.

04/13/2020: Policy description updated to add the following program requirement for polyarticular juvenile idiopathic arthritis: Trial/failure with two preferred agents then trial/failure with Actemra.

05/18/2020: Policy description updated to add NSAIDs as a conventional agent prerequisite for psoriatic arthritis. Policy statement criteria updated to change "The patient has failed at least two conventional agents" to "The patient has failed at least one conventional agent."

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

09/29/2020: Code Reference section updated to add new ICD-10 diagnosis codes M05.8A, M06.0A, and M08.9A, effective 10/01/2020.

01/01/2021: Added Tremfya to the top of the policy. Policy description updated regarding Pharmacy Preferred/Non-Preferred Agents, Medical Covered Agents, and Indications Without Preferred Agents. Policy section updated to add that Renflexis (infliximab-abda) is considered not medically necessary as other formulary options exist for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Revised policy statement for renewal evaluation to change "preferred and non-preferred agents" to "requested agents." Policy Guidelines updated to change "Nervous/Mental Conditions" to Mental Health Disorders." Sources updated. Code Reference section updated to move HCPCS code Q5104 from Covered to Not Medically Necessary.

01/11/2021: Code Reference section updated to remove HCPCS codes J9312 and J7799. Added HCPCS code J0638.

03/14/2022: Policy description updated to add Rinvoq and Skyrizi as preferred agents for psoriatic arthritis. Added indications for Enthesitis-Related Arthritis. Policy statement regarding patient failure of at least one conventional agent updated to change "3 months" to "3 consecutive months." Sources updated.

06/14/2022: Policy description updated to add Rinvoq as a Step 2 Non-Preferred Agent for Ankylosing Spondylitis. Updated the criteria for Ankylosing Spondylitis to include trial/failure with two Step 1 or Step 2 agents. Policy section updated to add statement that the requested agent may be considered medically necessary when all of the criteria are met. Policy statements updated to change "patient" to "member." For renewal criteria, policy statement updated to state that the member has "documented" clinical improvement. Sources updated.

06/20/2022: Code Reference section updated to add CPT codes J1602 and J1628.

07/19/2022: Added Infliximab to the top of the policy. Policy description updated to revise table 1 for Step 1 preferred agents. Table 2 updated to add Infliximab as a covered agent for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Policy statements unchanged. Sources updated.

09/14/2022: Policy description updated to include Cimzia as a covered agent for psoriatic arthritis and ankylosing spondylitis.

01/12/2023: Table 1 in the policy description was updated to add Rinvoq as a Step 1b preferred agent for nonradiographic axial spondyloarthritis (nr-asXpA). The medically necessary initial criteria was updated to add 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 RA, PsA, AS or nr-asXpA.

01/20/2023: Policy reviewed. The medically necessary initial criteria statement was updated to remove the previous statement regarding requests for Step 1b preferred agents. Added the following statement: The member’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.

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.

07/01/2023: Policy description updated regarding Pharmacy Step 1a Preferred Agents and Medical Covered Agents for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. Policy section updated to state 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 rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. 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 Covered to Not Medically Necessary.

03/08/2024: Table 1 in the Policy Description updated to remove Amjevita as a Step 1 Preferred Agent for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. Policy section updated to state that Amjevita (adalimumab-atto) is considered not medically necessary as other formulary options exist for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

05/13/2024: Policy updated to add Simlandi (adalimumab-ryvk). Policy description updated to add Simlandi as a Step 1a Preferred Agent for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. Policy statements unchanged. Sources updated. Code Reference section updated to add drug names to the code descriptions.

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

07/08/2024: Policy updated to add Rinvoq LQ as a Step 1 Preferred Agent for polyarticular juvenile idiopathic arthritis and psoriatic arthritis. Policy statements unchanged. Sources updated.

11/01/2024: Effective 01/01/2025 - Policy description updated to remove Humira as a Step 1a preferred agent for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Added Xeljanz and Xeljanz XR as a Step 1b preferred agent for ankylosing spondylitis. For Step 2 Non-Preferred Agents for RA and PJIA, removed Actemra SC, added Tyenne SC, and added "requires failure of adalimumab." Removed Actemra IV and Avsola as medical covered agents. Added Inflectra as a medical covered agent for RA, PsA, and AS. Added Tyenne IV as a covered agent for RA and PJIA. Removed Actemra and added Tyenne as a formulary option for SJIA. Added indication for polymyalgia rheumatica with Kevzara as a formulary option and oral glucocorticoids as a conventional agent prerequisite. Updated related policies. Policy section updated to add that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Revised policy statement to state that Hadlima and Simlandi are the adalimumab formulary options effective 01/01/2025. Added medically necessary indication for polymyalgia rheumatica. Policy statement revised to state that the following medications are not covered on any BCBSMS Formulary: Abrilada (adalimumab-afzb), Actemra (tocilizumab), Amjevita (adalimumab-atto), Avsola (infliximab-axxq), Cyltezo (adalimumab-adbm), Hulio (adalimumab-fkjp), Humira (adalimumab), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Renflexis (infliximab-abda), Tofidence (tocilizumab-bavi), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh). Sources updated. Code Reference section updated to add HCPCS codes Q5103, Q5135, and ICD-10 diagnosis code M35.3 to the Covered Codes table. Added HCPCS codes J0135, J3262, Q5121, Q5131, Q5132, and Q5133 to the Not Covered/Non-Formulary Codes table. Removed Ixifi (infliximab-qbtx) from the policy as it is no longer on the market. Policy update 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" for psoriatic arthritis. Policy statements unchanged.

03/03/2025: Table for pharmacy preferred agents updated to change "Cosentyx" to "Cosentyx SC" for psoriatic arthritis (PsA), ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis (nr-asXpA). Table for medical covered agents updated to add Cosentyx IV for PsA, AS, and nr-asXpA. Table for indications without preferred agents updated to change "Cosentyx" to "Cosentyx SC" for enthesitis-related arthritis. Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS code J3247.

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 for Pharmacy Preferred/Non-Preferred Agents updated to remove "SC" from the following medications: Tyenne, Orencia, and Cosentyx. Revised Step 1a Preferred Agents for psoriatic arthritis to add Selarsdi, Steqeyma, and Yesintek. Added note that Stelara will no longer be covered effective 8/1/25. Table 2 for Medical Covered Agents updated to remove "IV" from the following medications: Orencia, Tyenne, and Cosentyx. Revised note for Cimzia, Cosentyx, Orencia, and Tyenne to state the following: 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; Cosentyx, Orencia, Tyenne for intravenous infusion). For enthesitis-related arthritis, removed "SC" from "Cosentyx." Added the following medications as not covered on any BCBSMS Formulary: Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), and Wezlana (ustekinumab-auub). Medically necessary criteria updated to replace "Stelara" with "formulary ustekinumab." Sources updated. Code Reference section updated to add HCPCS codes Q5099, Q5100, and Q9998 to the Covered 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 from the list of Step 1a preferred agents for psoriatic arthritis. Policy section updated to state 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 J3357, J3358, and Q5098 to the Not Covered/Non-Formulary Codes table.

11/15/2025: Policy description updated to add Otezla XR to the list of Step 1a preferred agents for psoriatic arthritis. Sources section updated. Updated last access dates for prescribing information.

SOURCE(S)

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

2. Actemra prescribing information. Genentech, Inc. August 2025. Last accessed September 2025.

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

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

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

6. Cosentyx prescribing information. Novartis Pharmaceuticals Corporation. August 2025. Last accessed September 2025.

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

8. Enbrel prescribing information. Immunex Corp. June 2025. Last accessed September 2025

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

10. Hulio prescribing information. Biocon Biologics Inc. February 2025. Last accessed September 2025.

11. Humira

    prescribing information. AbbVie, Inc. July 2025. Last accessed September 2025.

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

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

14. Ilaris prescribing information. Novartis Pharmaceuticals Corporation. June 2025. Last accessed September 2025.

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

16. Inflectra prescribing information. Pfizer Laboratories Div Pfizer, Inc. August 2024. Last accessed September 2025.

17. Infliximab prescribing information. Janssen Biotech, Inc. June 2025. Last accessed September 2025.

18. Kevzara prescribing information. Sanofi-Aventis U.S., LLC. May 2025. Last accessed September 2025.

19. Kineret prescribing information. Swedish Orphan Biovitrum AB. July 2025. Last accessed September 2025.

20. Olumiant prescribing information. Eli Lilly and Company. November 2024. Last accessed September 2025.

21. Orencia prescribing information. E.R. Squibb & Sons, L.L.C. December 2024. Last accessed September 2025.

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

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

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

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

26. Rinvoq prescribing information. AbbVie Inc. April 2025. Last accessed September 2025.

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

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

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

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

31. Skyrizi prescribing information. AbbVie Inc. May 2025. Last accessed September 2025.

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

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

34. Taltz prescribing information. Eli Lilly and Company. November 2024. Last accessed September 2025.

35. Tofidence prescribing information. Biogen MA Inc. March 2025. Last accessed September 2025.

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

37. Tyenne prescribing information. Fresenius Kabi USA, LLC. December 2024. Last accessed September 2025.

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

39. Xeljanz/Xeljanz XR prescribing information. Pfizer Laboratories Div Pfizer Inc. June 2025. Last accessed September 2025.

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

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

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

43. Otezla prescribing information. Amgen Inc. July 2025. Last accessed September 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.

Covered Codes

Not Covered/Non-Formulary Codes

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