RXMP-09 Biologic & Immunologic Agents Form

Biologic & Immunologic Agents

Page 1 of 21 Updated on 12/23/2025 Policy Number RXMP-09 Line of Business Medicaid & Medicare Effective Date 10/11/2019 Revision Date 12/23/2025

Products: Actemra, Cosentyx, Entyvio, Orencia, Simponi Aria, Skyrizi, Stelara, and Tremfya

Override(s)
Approval Duration
MM Authorization
Initial Request: 6 months Renewal: 1 year

HCPCS Description Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered J3262 Actemra (tocilizumab) injection, 1mg Q5135 Tyenne (tocilizumab-aazg) injection, biosimilar, 1mg (preferred for Medicaid) Q5156 Avtozma (tocilizumab-anoh) injection, biosimilar, 1mg (preferred for Medicare) Q5133 Tofidence (tocilizumab-bavi) injection, biosimilar, 1mg (preferred for Medicare) J3247 Cosentyx (secukinumab) intravenous, 1mg
J3380 Entyvio (vedolizumab) intravenous, 1mg J0129 Orencia (abatacept) injection, 10mg J1602 Simponi Aria (golimumab) intravenous, 1mg J2327 Skyrizi (risankizumab-rzaa) intravenous injection, 1mg J3357 Stelara (ustekinumab) subcutaneous injection, 1mg
Q5098 Imuldosa (ustekinumab-srlf) injection, biosimilar, 1mg
Q9998 Selarsdi (ustekinumab-aekn) injection, biosimilar, 1mg
Q5099 Steqeyma (ustekinumab-stba) intravenous injection, biosimilar, 1mg (preferred for Medicare) J3590 Starjemza (ustekinumab-hmny) intravenous injection, biosimilar, 1mg (preferred for Medicaid) Q9999 Otulfi (ustekinumab-aauz) injection, biosimilar,1 mg
Q9997 Pyzchiva (ustekinuma-ttwe) intravenous, biosimilar, 1mg Q5137 Wezlana (ustekinumab-auub) subcutaneous injection, biosimilar, 1mg Q5100 Yesintek (ustekinumab-kfce) intravenous injection, biosimilar, 1mg
J1628 Tremfya (guselkumab) injection, 1mg Medicaid preferred agent: Tyenne or Starjemza; Medicare (new starts) preferred agents: Avtozma, Tofidence, or Steqeyma

Medicare Criteria
Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review the criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria

Actemra (and biosimilar products), Cosentyx, Entyvio, Orencia, Simponi Aria, Skyrizi, Stelara (and biosimilar products), Tremfya (New Starts): The member has an inadequate response to, intolerable adverse event to, or has a contraindication to:

Biologic & Immunologic Agents

Page 2 of 21 Updated on 12/23/2025 • Avsola or Inflectra OR • Preferred adalimumab products: adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi; OR
• Preferred ustekinumab products: Steqeyma; OR
• For Actemra: Avtozma or Tofidence are preferred Note: The above drugs apply FDA-approved indications only.

Abbreviations: Giant Cell Arteritis (GCA), Systemic Juvenile Idiopathic Arthritis (sJIA), Polyarticular Juvenile Idiopathic Arthritis (pJIA), Cytokine Release Syndrome (CRS), Non-Radiographic Axial Spondyloarthritis (nr-axSpA), Cryopyrin-Associated Periodic Syndrome (CAPS), Neonatal-Onset Multisystem Inflammatory Disease (NOMID), Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Polymyalgia Rheumatica (PMR)

Drug Name Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Plaque Psoriasis Crohn’s Disease Ulcerative Colitis Hidradenitis Suppurativa Other
(see FDA Indications & Dosing)
Actemra & biosimilars X

GCA, sJIA, pJIA, CRS, SSc-ILD, COVID-19 Cimzia X X X

X

nr-axSpA, pJIA Cosentyx

X X X

X nr-axSpA, ERA Enbrel
X X X X

pJIA Entyvio

X X

Humira & biosimilars X X X X X X X Uveitis, nr-axSpA Kevzara X

PMR, pJIA Kineret
X

CAPS, NOMID, sJIA Olumiant X

Alopecia Areata, COVID-19 Orencia X X

pJIA Otezla

X

X

Behçet’s Disease (oral ulcers) Remicade & biosimilars
X X X X X X

nr-axSpA Rinvoq X X X X X X

Atopic Dermatitis Siliq

X

Simponi X X X

X

Simponi Aria X X X

Skyrizi

X

X X X

Stelara & biosimilars

X

X X X

Taltz

X X X

Tremfya

X

X

Xeljanz/XR X X X

X

Biologic & Immunologic Agents

Page 3 of 21 Updated on 12/23/2025 Approval Criteria Products Actemra, Cosentyx, Entyvio, Orencia, Simponi Aria, Skyrizi, Stelara, Tremfya Diagnosis
All Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

1. The medication will not be used in combination with other JAK inhibitors [e.g., Xeljanz/XR (tofacitinib), Cibinqo (abrocitinib), Opzelura (topical ruxolitinib), Rinvoq (upadacitinib), Jakafi (ruxolitinib oral), Olumiant (baricitinib)], biologics [e.g., Humira (adalimumab), Enbrel (etanercept), Cosentyx (secukinumab), Stelara (ustekinumab), Dupixent (dupilumab), Adbry (tralokinumab-ldrm), Ebglyss (lebrikizumab-lbkz), Cimzia (certolizumab pegol), Orencia (abatacept), Kevzara (sarilumab), Simponi/Simponi Aria (golimumab), Skyrizi (risankizumab), Taltz (ixekizumab), Tremfya (guselkumab), Siliq (brodalumab)], or potent immunosuppressants [e.g., azathioprine, cyclosporine, tacrolimus, pimecrolimus, or 6-mercaptopurine]; AND

2. The request is for one of the following diagnoses: a. Ankylosing Spondylitis Initial | Renewal b. Crohn’s Disease Initial | Renewal c. Hidradenitis Suppurativa Initial | Renewal d. Non-Radiographic Axial Spondyloarthritis Initial | Renewal e. Plaque Psoriasis Initial | Renewal f. Polyarticular Juvenile Idiopathic Arthritis Initial | Renewal g. Psoriatic Arthritis Initial | Renewal h. Rheumatoid Arthritis Initial | Renewal i. Ulcerative Colitis Initial | Renewal j. Enthesitis-Related Arthritis Initial | Renewal k. Others Initial | Renewal

   Products Cosentyx (secukinumab), Simponi Aria (golimumab) Diagnosis
   Ankylosing Spondylitis
   Approval Length Initial Request: 6 months; Renewal: 1 year
   Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

3. Chart notes provided showing the diagnosis of ankylosing spondylitis; AND
4. Trial and failure, intolerance, or contraindication to one of the following non-steroidal anti-inflammatory drugs (NSAIDS): celecoxib, diclofenac ibuprofen, or indomethacin; AND
5. Trial and failure, intolerance, or contraindication to all the following: a. methotrexate, leflunomide, sulfasalazine, or cyclosporine; and b. infliximab products such as Avsola or Inflectra; and c. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit). Renewal Request
6. Diagnosis of active ankylosing spondylitis; AND
7. The requested medication led to significant improvement or stabilization in the member's clinical signs and symptoms such as: a. Disease activity (e.g., pain, fatigue, inflammation, stiffness); b. Lab values (erythrocyte sedimentation rate, C-reactive protein level); c. Function; d. Axial status (e.g., lumbar spine motion, chest expansion); or e. Total active (swollen and tender) joint count.

Biologic & Immunologic Agents

Page 4 of 21 Updated on 12/23/2025 Products Entyvio (vedolizumab), Skyrizi (risankizumab-rzaa), ustekinumab (Stelara) & biosimilar products Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis
Crohn’s Disease Approval Length Initial Request: 6 months; Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Request

1. Chart notes provided showing one of the following: a. Frequent diarrhea and abdominal pain; b. 10% weight loss; c. Complications such as obstruction, fever, or abdominal mass; d. Abnormal lab values [e.g., C-reactive protein (CRP)]; or e. CD Activity Index (CDAI) greater than 220. AND
2. Trial and failure, intolerance, or had a contraindication to one of the following conventional therapies [e.g., methotrexate, 6-mercaptopurine (6-MP, Purinethol), azathioprine (Imuran), corticosteroids (prednisone, prednisolone, or methylprednisolone), 5-Aminosalycylates (sulfasalazine, mesalamine)]; AND
3. All ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare, ok to approve Steqeyma (PA required);
   OR
4. For Skyrizi (Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required);
   b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi Rx Benefit) (PA required); or
5. Starjemza (no PA required)
   OR
6. For Skyrizi (Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit); or c. All other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma. OR
7. For Entyvio: Trial and failure, intolerance or contraindication to Skyrizi (refer to the requirements above). Renewal Request
8. Diagnosis of Crohn’s disease; AND
9. The requested medication led to significant improvement or stabilization in the member's clinical signs and symptoms such as: a. Intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline; or b. Reversal of high fecal output state
   AND
10. All ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare, ok to approve Steqeyma (PA required);
    OR
11. For Skyrizi (Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required);
    b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi Rx Benefit) (PA required); or c. Starjemza (no PA required)

Biologic & Immunologic Agents

Page 5 of 21 Updated on 12/23/2025 Products Entyvio (vedolizumab), Skyrizi (risankizumab-rzaa), ustekinumab (Stelara) & biosimilar products Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis
Crohn’s Disease Approval Length Initial Request: 6 months; Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. OR

5. For Skyrizi (Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit); or c. All other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma. OR

6. For Entyvio: Trial and failure, intolerance or contraindication to Skyrizi (refer to the requirements above).

   Products Cosentyx (secukinumab) Diagnosis Hidradenitis Suppurativa
   Approval Length Initial Request: 6 months; Renewal: 1 year
   Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

7. Chart notes provided showing the diagnosis of hidradenitis suppurative; AND
8. Trial and failure, intolerance, or contraindication to one of the following therapies such as topical clindamycin 1% or oral antibiotic (e.g., doxycycline or minocycline); AND
9. Trial and failure, intolerance, or contraindication to one of the following therapies such as: a. Corticosteroids (e.g., prednisone, prednisolone, or triamcinolone injection);
   b. Oral retinoids (e.g., acitretin or isotretinoin); c. Immunosuppressants (e.g., cyclosporine or methotrexate); or d. Hormone therapy (e.g., oral contraceptives, finasteride, or spironolactone). AND
10. Trial and failure, intolerance, or contraindication to a preferred adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit). Renewal Request
11. Diagnosis of moderate to severe hidradenitis suppurative; AND

12. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms such as: a. Reduction in Lesion Count; or b. Improvement in symptoms such as pain, inflammation, or drainage.

    Products Cosentyx (secukinumab) Diagnosis Non-Radiographic Axial Spondyloarthritis Approval Length Initial Request: 6 months; Renewal: 1 year
    Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

13. Chart notes provided showing the diagnosis of non-radiographic axial spondyloarthritis with objective signs of inflammation (e.g. C-reactive protein [CRP] levels above the upper limit of normal, Sacroiliitis on magnetic

Biologic & Immunologic Agents

Page 6 of 21 Updated on 12/23/2025 Products Cosentyx (secukinumab) Diagnosis Non-Radiographic Axial Spondyloarthritis Approval Length Initial Request: 6 months; Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. resonance imaging [MRI] indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); AND

2. Trial and failure, intolerance, or contraindication to one of the following non-steroidal anti-inflammatory drugs (NSAIDS) (e.g., celecoxib, diclofenac ibuprofen, indomethacin, meloxicam, nabumetone, piroxicam, or sulindac; AND
3. Trial and failure, intolerance, or contraindication to Cimzia (Rx Benefit). Renewal Request
4. Diagnosis of moderate to severe non-radiographic axial spondylarthritis; AND

5. The requested medication led to significant improvement or stabilization in the member's clinical signs and symptoms such as: a. Disease activity (e.g., pain, fatigue, inflammation, stiffness); b. Lab values (erythrocyte sedimentation rate, C-reactive protein level); c. Function; d. Axial status (e.g., lumbar spine motion, chest expansion); or e. Total active (swollen and tender) joint count.

   Products Cosentyx (secukinumab), Skyrizi (risankizumab), Tremfya (guselkumab); ustekinumab (Stelara) & biosimilar products Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred
   Diagnosis Plaque Psoriasis
   Approval Length Initial Request: 6 months; Renewal: 1 year
   Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

6. Chart notes provided showing the diagnosis of moderate to severe plaque psoriasis; AND

7. One of the following: a. Greater than or equal to 3% body surface area involvement; b. Severe scalp psoriasis; or c. Palmoplantar (e.g., pals, soles), facial or genital involvement. AND
8. Trial and failure, intolerance, or contraindication to one of the following topical therapies for minimum 4 weeks such as: a. High potency topical steroids (e.g., betamethasone cream 0.05%, clobetasol, desoximetasone);
   b. Vitamin D analogs (e.g., calcitriol, calcipotriene); or
   c. Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus). AND
9. Trial and failure, intolerance, or contraindication to one of the following therapies such as methotrexate, cyclosporine, acitretin, or phototherapy; AND
10. All ustekinumab products: For Medicaid: Starjemza (No PA required), for Medicare: okay to approve Steqeyma (PA required); OR
11. For Cosentyx: (Medicaid): Trial and failure, intolerance or contraindication to two of the following:
    a. infliximab products such as Avsola or Inflectra (PA required);

Biologic & Immunologic Agents

Page 7 of 21 Updated on 12/23/2025 Products Cosentyx (secukinumab), Skyrizi (risankizumab), Tremfya (guselkumab); ustekinumab (Stelara) & biosimilar products Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred
Diagnosis Plaque Psoriasis
Approval Length Initial Request: 6 months; Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required) OR

7. For Cosentyx (Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra) (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (PA required); or c. all other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma (PA required). OR
8. For Skyrizi and Tremfya: Trial and failure, intolerance, or contraindication to Cosentyx (refer to requirements above). Renewal Request
9. Diagnosis of moderate to severe plaque psoriasis; AND
10. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms such as: a. Reduction in the BSA involvement from baseline; or b. Improvement in symptoms (e.g., pruritus, inflammation) from baseline. AND
11. All ustekinumab products: For Medicaid: Starjemza (No PA required), for Medicare: okay to approve Steqeyma (PA required); OR
12. For Cosentyx: (Medicaid): Trial and failure, intolerance or contraindication to two of the following:
    a. infliximab products such as Avsola or Inflectra (PA required);
    b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required) OR
13. For Cosentyx (Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra) (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (PA required); or c. All other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma (PA required). OR

14. For Skyrizi and Tremfya: Trial and failure, intolerance, or contraindication to Cosentyx (refer to requirements above).

    Products Actemra (tocilizumab) & biosimilar products, Orencia (abatacept), or Simponi Aria (golimumab) Note: Medicaid: Tyenne is preferred; Medicare: Avtozma or Tofidence are preferred Diagnosis Juvenile Idiopathic Arthritis Approval Length Initial Request: 6 months; Renewal: 1 year
    Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

Biologic & Immunologic Agents

Page 8 of 21 Updated on 12/23/2025 Products Actemra (tocilizumab) & biosimilar products, Orencia (abatacept), or Simponi Aria (golimumab) Note: Medicaid: Tyenne is preferred; Medicare: Avtozma or Tofidence are preferred Diagnosis Juvenile Idiopathic Arthritis Approval Length Initial Request: 6 months; Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

1. Chart notes provided showing the diagnosis of juvenile idiopathic arthritis; AND
2. Trial and failure, intolerance, or contraindication to alll of the following: a. one systemic corticosteroid such as prednisone; and b. one of the following conventional therapies such as methotrexate or leflunomide; and c. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit). AND
3. For Simponi Aria: Trial and failure, intolerance, or contraindication to Cimzia (Rx Benefit); OR
4. For Orencia and tocilizumab and its biosimilars: Trial and failure, intolerance, or contraindication to Cimzia (Rx Benefit) and Simponi Aria; AND
5. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
   b. For Medicare: Avtozma or Tofidence
   Renewal Request
6. Diagnosis is for juvenile idiopathic arthritis; AND
7. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms from baseline such as: a. Number of joints with active arthritis; b. Number of joints with limitation of movement; c. Functional ability; or d. Systemic symptoms (e.g., fevers, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis. AND
8. For Simponi Aria: Trial and failure, intolerance, or contraindication to Cimzia (Rx Benefit); OR
9. For Orencia and tocilizumab and its biosimilars: Trial and failure, intolerance, or contraindication to Cimzia (Rx Benefit) and Simponi Aria; AND

10. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
    b. For Medicare: Avtozma or Tofidence

    Products Cosentyx (secukinumab), Orencia (abatacept), Simponi Aria (golimumab), Skyrizi (Risankizumab), Tremfya (guselkumab), ustekinumab (Stelara) & biosimilar products.
    Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis
    Psoriatic Arthritis
    Approval Length Initial Request: 6 months

    Renewal: 1 year
    Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

11. Chart notes provided showing the diagnosis of psoriatic arthritis; AND
12. One of the following is met: a. Actively inflamed joints; b. Dactylitis;

Biologic & Immunologic Agents

Page 9 of 21 Updated on 12/23/2025 Products Cosentyx (secukinumab), Orencia (abatacept), Simponi Aria (golimumab), Skyrizi (Risankizumab), Tremfya (guselkumab), ustekinumab (Stelara) & biosimilar products.
Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis
Psoriatic Arthritis
Approval Length Initial Request: 6 months

Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. c. Enthesitis; d. Axial disease; or e. Active skin and/or nail involvement. AND

3. One of the following: a. The member has peripheral arthritis (e.g., affecting the hands, wrists, elbows, knees, ankles and feet); AND trial and failure, intolerance, or contraindication to one of the following conventional therapies such as methotrexate, leflunomide, sulfasalazine, hydroxychloroquine. OR
   b. The member has axial arthritis affecting the spine, back and hips; AND trial and failure, intolerance, or contraindication to one of the following non-steroidal anti-inflammatory drugs (NSAIDS) (e.g., celecoxib, diclofenac ibuprofen, indomethacin, meloxicam, nabumetone, piroxicam, or sulindac. AND
4. For peripheral arthritis disease for ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare: ok to approve Steqeyma (PA required); OR
5. For peripheral arthritis disease for Cosentyx (Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required);
   OR
6. For peripheral arthritis disease for Cosentyx (Medicare): Trial and failure, intolerance, or contraindication to one of the following: a. infliximab products such as Avsola or Inflectra (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required); OR
7. For peripheral arthritis disease for Simponi Aria: Trial and failure, intolerance, or contraindication to Cosentyx
   (refer to requirements above); OR
8. For peripheral arthritis disease for Orencia, Skyrizi, and Tremfya: Trial and failure, intolerance, or contraindication to Simponi Aria (refer to requirements above).
   OR
9. For axial arthritis disease for Cosentyx (Medicaid/Medicare): Trial and failure, intolerance, or contraindication to both of the following:
   a. infliximab products such as Avsola or Inflectra (PA required); and
   b. adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required). OR
10. For axial arthritis disease for Simponi Aria (Medicaid/Medicare): Trial and failure, intolerance, or contraindication to Cosentyx.

Biologic & Immunologic Agents

Page 10 of 21 Updated on 12/23/2025 Products Cosentyx (secukinumab), Orencia (abatacept), Simponi Aria (golimumab), Skyrizi (Risankizumab), Tremfya (guselkumab), ustekinumab (Stelara) & biosimilar products.
Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis
Psoriatic Arthritis
Approval Length Initial Request: 6 months

Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Renewal Request

1. Diagnosis of moderate to severe psoriatic arthritis; AND
2. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms such as: a. Reduction in the BSA involvement from baseline; or
   b. Improvement in symptoms (e.g., pruritus, inflammation) from baseline. AND
3. For peripheral arthritis disease for ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare:
   ok to approve Steqeyma (PA required); OR
4. For peripheral arthritis disease for Cosentyx (Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required);
   OR
5. For peripheral arthritis disease for Cosentyx (Medicare):: Trial and failure, intolerance, or contraindication to one of the following: a. infliximab products such as Avsola or Inflectra (PA required); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required); or c. Starjemza (no PA required); OR
6. For peripheral arthritis disease for Simponi Aria: Trial and failure, intolerance, or contraindication to Cosentyx
   (refer to requirements above); OR
7. For peripheral arthritis disease for Orencia, Skyrizi, and Tremfya: Trial and failure, intolerance, or contraindication to Simponi Aria (refer to requirements above).
   OR
8. For axial arthritis disease for Cosentyx (Medicaid/Medicare): Trial and failure, intolerance, or contraindication to both of the following:
   a. infliximab products such as Avsola or Inflectra (PA required); and
   b. adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit) (PA required). OR
9. For axial arthritis disease for Simponi Aria (Medicaid/Medicare): Trial and failure, intolerance, or contraindication
   to Cosentyx.

Biologic & Immunologic Agents

Page 11 of 21 Updated on 12/23/2025 Products Actemra (tocilizumab) & biosimilar products, Orencia (abatacept), Simponi Aria (golimumab) Note: Medicaid: Tyenne is preferred; Medicare: Avtozma or Tofidence are preferred Diagnosis Rheumatoid Arthritis Approval Length Initial Request: 6 months, Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

1. Chart notes provided showing the diagnosis of rheumatoid arthritis with either of the following biomarkers and the test was positive: a. Rheumatoid factor (RF); or
   b. Anti-cyclic citrullinated peptide (anti-CCP). AND
2. Trial and failure, intolerance, or contraindication to all of the following: a. One conventional therapy such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine; and b. One of the preferred infliximab products such as Avsola or Inflectra; and c. One adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit). AND
3. For Simponi Aria – ok to approve; OR
4. For Orencia or tocilizumab biosimilars: Trial and failure, intolerance, or contraindication to Simponi Aria and Cimzia; AND
5. For Actemra: Trial and failure, intolerance, or contraindication to the following biosimilars: a. For Medicaid: Tyenne; or
   b. For Medicare: Avtozma or Tofidence. Renewal Request
6. Diagnosis of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis; AND
7. The requested medication led to significant improvement or stabilization in the member's clinical signs and symptoms such as: a. Reduction in the total active (swollen and tender) joint count from baseline; or
   b. Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline. AND
8. For Simponi Aria – ok to approve; OR
9. For Orencia or tocilizumab biosimilars: Trial and failure, intolerance, or contraindication to Simponi Aria and Cimzia. AND

10. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
    b. For Medicare: Avtozma or Tofidence

    Products Entyvio (vedolizumab), ustekinumab (Stelara) & biosimilar products, Skyrizi (risankizumab- rzaa) Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis Ulcerative Colitis
    Approval Length Initial Request: 6 months, Renewal: 1 year
    Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

11. Chart notes provided showing one of the following: a. Greater than 6 stools per day;

Biologic & Immunologic Agents

Page 12 of 21 Updated on 12/23/2025 Products Entyvio (vedolizumab), ustekinumab (Stelara) & biosimilar products, Skyrizi (risankizumab- rzaa) Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis Ulcerative Colitis
Approval Length Initial Request: 6 months, Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. b. Frequent blood in the stools; c. Frequent urgency; d. Presence of ulcers;
e. Abnormal lab values (e.g., hemoglobin, ESR, CRP); or f. Dependent on, or refractory to, corticosteroids. AND

2. Trial and failure, intolerance, or contraindication to one conventional therapies [e.g., methotrexate, 6- mercaptopurine (6-MP, Purinethol), azathioprine (Imuran), corticosteroids (prednisone, prednisolone, methylprednisolone), 5-Aminosalycylates (sulfasalazine, mesalamine)]; AND
3. All ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare, ok to approve Steqeyma (PA required); OR
4. For Skyrizi (for Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required);
   b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi Rx Benefit) (PA required); or c. Starjemza (no PA required). OR
5. For Skyrizi (for Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit); or All other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma. OR
6. For Entyvio: Trial and failure, intolerance or contraindication to Skyrizi (refer to the requirements above). Renewal Request
7. Diagnosis of moderate to severe ulcerative colitis; AND
8. The requested medication led to significant improvement or stabilization in the member's clinical signs and symptoms such as: a. Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline; or b. Reversal of high fecal output state;
   AND
9. All ustekinumab products: For Medicaid: Starjemza (no PA required), for Medicare, ok to approve Steqeyma (PA required); OR
10. For Skyrizi (for Medicaid): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra (PA required);
    b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi Rx Benefit) (PA required); or c. Starjemza (no PA required). OR
11. For Skyrizi (for Medicare): Trial and failure, intolerance, or contraindication to two of the following: a. infliximab products such as Avsola or Inflectra); b. adalimumab product such as adalimumab-aaty, adalimumab-fkjp, Hadlima, or Simlandi (Rx Benefit); or

Biologic & Immunologic Agents

Page 13 of 21 Updated on 12/23/2025 Products Entyvio (vedolizumab), ustekinumab (Stelara) & biosimilar products, Skyrizi (risankizumab- rzaa) Note: Medicaid: Starjemza is preferred; Medicare: Steqeyma is preferred Diagnosis Ulcerative Colitis
Approval Length Initial Request: 6 months, Renewal: 1 year
Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. c. All other ustekinumab products: Trial and failure, intolerance, or contraindication to Steqeyma. OR

6. For Entyvio: Trial and failure, intolerance or contraindication to Skyrizi (refer to the requirements above).

   Products Cosentyx (secukinumab)
   Diagnosis Enthesitis-Related Arthritis
   Approval Length Initial Request: 6 months, Renewal: 1 year
   Authorization Type MM auths only, use the Biologic criteria for Rx Important Note Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Criteria

7. Chart notes provided showing the diagnosis of Enthesitis-Related Arthritis; AND
8. The member is 4 years of age or older; AND
9. The member has tried and failed, intolerance, or contraindication to conventional therapy such as NSAIDs or non- biologic DMARDs methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine (approve for Cosentyx). Renewal Request
10. Diagnosis of moderate to severe psoriatic arthritis, plaque psoriasis or enthesitis-related arthritis; AND

11. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms such as: c. Reduction in the BSA involvement from baseline; or
    d. Improvement in symptoms (e.g., pruritus, inflammation) from baseline.

    Products Actemra (tocilizumab) & biosimilar products
    Diagnosis Giant Cell Arteritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome Line of Business MM auths only, use the Biologic criteria for Rx Approval Length Initial Request: 6 months

    Renewal: 1 year
    Override Type Authorization Required
    Initial Criteria For systemic juvenile idiopathic arthritis

12. Diagnosis of Systemic Juvenile Idiopathic Arthritis; AND
13. Chart notes confirming the presence of one active systemic feature such as fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis; AND

14. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
    b. For Medicare: Avtozma or Tofidence

    For Giant Cell Arteritis

15. Diagnosis of Giant Cell Arteritis is confirmed by one of the following:
    a. Temporal artery biopsy or cross-sectional imaging; or
    b. Acute-phase reactant elevation (e.g., high erythrocyte sedimentation rate [ESR] and/or high serum C-reactive protein [CRP]).

Biologic & Immunologic Agents

Page 14 of 21 Updated on 12/23/2025 Products Actemra (tocilizumab) & biosimilar products
Diagnosis Giant Cell Arteritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome Line of Business MM auths only, use the Biologic criteria for Rx Approval Length Initial Request: 6 months

Renewal: 1 year
Override Type Authorization Required
AND

2. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
   b. For Medicare: Avtozma or Tofidence

   For Cytokine Release Syndrome- indicated for Tyenne, Avtozma except Tofidence.

3. Chart notes confirming the diagnosis of cytokine release syndrome; AND
4. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
   b. For Medicare: Avtozma or Tofidence
   Renewal Request
   For Giant Cell Arteritis
5. Diagnosis is for Giant Cell Arteritis; AND
6. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms from baseline such as: a. Headaches; b. Scalp tenderness; c. Tenderness and/or thickening of superficial temporal arteries; d. Constitutional symptoms (e.g., weight loss, fever, fatigue, night sweats); e. Jaw and/or tongue claudication; f. Acute visual symptoms (e.g., amaurosis fugax, acute visual loss, diplopia);
   g. Symptoms of polymyalgia rheumatica (e.g., shoulder and/or hip girdle pain); or h. Limb claudication AND

7. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
   b. For Medicare: Avtozma or Tofidence

   For Cytokine Release Syndrome- indicated for all biosimilars except Tofidence

8. Diagnosis is for cytokine release syndrome; AND
9. Chart notes confirming that the use of the requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms; AND

10. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars: a. For Medicaid: Tyenne; or
    b. For Medicare: Avtozma or Tofidence

    For Systemic Sclerosis-Associated Interstitial Lung Disease

11. Diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease; AND
12. The requested medication led to significant improvement or stabilization in the member’s clinical signs and symptoms; AND
13. For Actemra: Trial and failure, intolerance, or contraindication to one of the following biosimilars
    a. For Medicaid: Tyenne; or
    b. For Medicare: Avtozma or Tofidence

Biologic & Immunologic Agents

Page 15 of 21 Updated on 12/23/2025 EXCLUSIONS:
• The use of two biological and immunologic agents.
• Requests for Orencia (abatacept) may not be approved for the following: In combination with topical or oral JAK inhibitors, ozanimod, apremilast, deucravacitinib, or any of the following biologic immunomodulators: TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, IL-1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR
• Tuberculosis or other active serious infections or a history of recurrent infections;
• If initiating therapy, individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC-) and Prevention - recommended equivalent test to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR
• Requests for Simponi (golimumab) and Simponi Aria (golimumab) may not be approved for the following:
a. In combination with oral or topical JAK inhibitors, ozanimod, apremilast, deucravacitinib, or any of the following biologic immunomodulators: Other TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, IL-6 inhibitors, IL-1 inhibitors, vedolizumab, ustekinumab, abatacept, rituximab, or natalizumab; OR
b. Tuberculosis, other active serious infections, or a history of recurrent infections; OR
b. If initiating therapy, individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Preventions -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors).

Table 1. Therapeutic Class
Therapeutic Class Drug Name Tumor Necrosis Factor Inhbitor Adalimumab Products; Cimzia (certolizumab pegol); Enbrel (etanercept); Simponi (golimumab); Zymfentra (infliximab-dyyb)
Interleukin – 6 Blockers Tocilizumab Products: Actemra (tocilizumab); Tyenne (tocilizumab-aazg), Tofidence (tocilizumab-bavi), Avtozma (tocilizumab-aazg); Kevzara (sarilumab)
Interleukin – 17 Blockers Bimzelx (bimekizumab); Cosentyx (secukinumab); Taltz (ixekizumab)
Interleukin – 23 Blockers
Ilumya (tildrakizumab-asmn); Omvoh (mirikizumab-mrkz); Skyrizi (risankizumab- rzaa); Tremfya (guselkumab)
Interleukin – 12/23 Blockers ustekinumab products
Interleukin – 1 Blocker Kineret (anakinra T-Cell Costimulation Modulator Orencia (abatacept)
Integrin Receptor Antagonist Entyvio (vedolizumab) Janus Kinase Inhibitor Olumiant (baricitinib), Rinvoq (upadacitinib), Rinvoq LQ (upadacitinib),

Xeljanz (tofacitinib), Xeljanz XR (tofacitinib ER)
Phosphodiesterase Type 4 Inhibitor Otezla (apremilast)
Spingosine 1 – Phosphate Receptor Modulator Velsipity (etrasimod), Zeposia (ozanimod) Tyrosine Kinase 2 Inhibitor Sotyktu (deucravacitinib)

FDA Indications & Dosing Drug Indication Dosing/Administration Actemra and biosimilars
Cytokine release syndrome, chimeric antigen receptor T- cell therapy- associated – indicated for all biosimilars except Tofidence 8mg/kg IV once; Max dose: 800mg/dose
If clinical improvement does not occur after the first dose, up to 3 additional doses may be administered (with at least 8 hour interval between consecutive doses.

Biologic & Immunologic Agents

Page 16 of 21 Updated on 12/23/2025 Drug Indication Dosing/Administration Giant cell arteritis (adjunctive agents)
IV: 6mg/kg once every 4 weeks in combination with glucocorticoids; some experts use 8mg/kg IV once every 4 weeks in combination with glucocorticoids (or as monotherapy following discontinuation of glucocorticoids)
Max dose: For 6mg/kg dosing, maximum dose is 600mg/dose. For 8mg/kg dosing, some experts do not exceed 800mg/dose (off-label dose)
SC: 162mg once every week; based on clinical considerations, may consider 162 mg every other week; to be administered in combination with glucocorticoids (or as monotherapy following discontinuation of glucocorticoids) Interstitial lung disease, systemic sclerosis (scleroderma) associated – Actemra Only
162 mg SC once every week
Rheumatoid arthritis
IV: 4mg/kg once every 4 weeks, may increase to 8mg/kg once every 4 weeks based on clinical response
Max: 800mg/dose
SC: Weighing ≥100 kg, 162mg once every week
Weighing <100kg: 162mg once every other week; may increase to 162mg once every week based on clinical response
Cosentyx (secukinumab)

Ankylosing spondylitis With loading dose:
• SC 150 mg SC once weekly at weeks 0, 1, 2, 3, and 4; then, 150 mg subcutaneously every 4 weeks • Dosage adjustment: If patient continues to have active ankylosing spondylitis, consider increasing dosage to 300 mg every 4 weeks • IV: 6 mg/kg IV at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks Without loading dose: • SC: 150 mg SC every 4 weeks. • Dosage adjustment: If patient continues to have active ankylosing spondylitis, consider increasing dosage to 300 mg every 4 weeks • IV: 1.75 mg/kg (do not exceed 300 mg) IV every 4 weeks Axial spondyloarthritis

With loading dose:
• SC: 150 mg SC once weekly at weeks 0, 1, 2, 3, and 4; then, 150 mg subcutaneously every 4 weeks • IV: 6 mg/kg IV at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks Without loading dose: • SC: 150 mg SC every 4 weeks • IV: 1.75 mg/kg (do not exceed 300 mg) IV every 4 weeks Hidradenitis suppurativa Initial dosage: 300 mg SC once weekly at weeks 0, 1, 2, 3, and 4. Maintenance dosage: 300 mg SC every 4 weeks Dosage adjustment: Increase to 300 mg SC every 2 weeks in patients who have an inadequate response Plaque psoriasis Initial dosage: 300 mg SC once weekly at weeks 0, 1, 2, 3, and 4. Maintenance dosage: 300 mg SC every 4 weeks

Biologic & Immunologic Agents

Page 17 of 21 Updated on 12/23/2025 Drug Indication Dosing/Administration Dosage adjustment: Some patients may only require 150 mg/dose Psoriatic arthritis With loading dose • SC: 150 mg SC once weekly at weeks 0, 1, 2, 3, and 4; then, 150 mg SC every 4 weeks • Dosage adjustment: If patient continues to have active psoriatic arthritis, consider increasing dosage to 300 mg every 4 weeks. • IV: 6 mg/kg IV at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks Without loading dose • SC: 150 mg SC every 4 weeks • Dosage adjustment: If patient continues to have active psoriatic arthritis, consider increasing dosage to 300 mg every 4 weeks • IV: 1.75 mg/kg (do not exceed 300 mg) IV every 4 weeks. Coexistent moderate to severe plaque psoriasis (SC): 300 mg SC once weekly at weeks 0, 1, 2, 3, and 4; then, 300 mg SC every 4 weeks; some patients may only require 150 mg/dose Enthesitis-related arthritis
Children ≥4 years of age and adolescents: • Weight 15 to <50 kg: 75 mg SC once weekly at weeks 0, 1, 2, 3, and 4, followed by 75 mg every 4 weeks • Weight ≥50 kg: 150 mg SC once weekly at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks Entyvio
Crohn disease IV: 300mg IV infusion at 0,2, and 6 weeks, and then every 8 weeks thereafter
SC: 108mg once every 2 weeks beginning after at least 2 IV infusions; administer in place of next scheduled IV dose and then every 2 weeks thereafter
Discontinuation of therapy: Discontinue therapy in patients who show no evidence of therapeutic benefit by week 14 Ulcerative colitis IV: 300mg infusion at 0,2, and 6 weeks, and then every 8 weeks thereafter
SC: 108mg once every 2 weeks beginning after at least 2 IV infusions; administer in place of next scheduled IV dose and then every 2 weeks thereafter
Discontinuation of therapy: Discontinue therapy in patients who show no evidence of therapeutic benefit by week 14 Orencia (abatacept)
Graft versus host disease, acute, prophylaxis 10mg/kg IV on the day prior to transplant (day -1), followed by 10mg/kg IV on days 5,14, and 29 post-transplant Max dose: 1g/dose
Psoriatic arthritis/Rheumatoid arthritis IV Dosing: Body weight
Dose
Number of vials <60kg
500mg
2 60 to 100kg 750mg 3

100kg
1g
4 Each vials provides 250mg for administration

SC Dosing: 125mg SC once weekly.

SC dosing may be initiated without an IV loading dose. If initiating with an IV

Biologic & Immunologic Agents

Page 18 of 21 Updated on 12/23/2025 Drug Indication Dosing/Administration loading dose, administer the initial IV infusion (using the weight-based dosing), then administer 125mg SC within 24 hours of the infusion, followed by 125mg SC once weekly. Simponi Aria (golimumab)
Ankylosing spondylitis (Simponi/Simponi Aria) Simponi: 50mg SC once per month Simponi Aria: 2mg/kg IV at weeks 0,4, then every 8 weeks thereafter
Polyarticular juvenile idiopathic arthritis (Simponi Aria)
Children ≥2 years of age and adolescents: Simponi Aria: 80mg/m2/dose IV at weeks 0,2, and then every 8 weeks thereafter
Ulcerative colitis (Simponi) Adult Dosing:
Initial dose: 200mg SC at weeks 0, followed by 100mg SC at week 2
Maintenance dose: 100mg SC every 4 weeks

[Off label] For children ≥6 years of age and adolescents ≤17 years of age Induction dose <45kg ≥45kg 90mg/m2 (max: 200mg/dose) SC at week 0 followed by 45mg/m2 (max: 100mg/dose) at week 2
200mg/dose SC at week 0 followed by 100mg at week 2

Maintenance dose (beginning at week 6) <45kg ≥45kg 45mg/m2/dose SC every 4 weeks; max dose: 100mg/dose
100mg SC every 4 weeks

Psoriatic arthritis, Rheumatoid arthritis
(Simponi/Simponi Aria) Adult Dosing:
Simponi: 50mg SC once per month Simponi Aria: 2mg/kg IV at weeks 0,4, then every 8 weeks thereafter

(May be given with or without methotrexate or other nonbiologic DMARDS, Corticosteroids, nonbiologic DMARDs, and/or NSAIDs may be continued during treatment)

Children dosing for Simponi Aria: 80 mg/m2/dose IV at weeks 0, 4, and then every 8 weeks thereafter. Stelara (Ustekinumab) and biosimilars
Ulcerative colitis, Crohn’s disease Induction ≤ 55kg

55kg to 85kg 85kg 260mg IV single dose 390mg IV single dose 520mg IV single dose • Maintenance dose: 90mg SC every 8 weeks; begin maintenance dosing 8 weeks after the IV induction dose • Off label- Incomplete response or non-response to induction therapy: If limited or no improvement in clinical symptoms and biomarkers of disease activity (e.g., C-reactive protein [CRP] and fecal calprotectin) 12 weeks after induction (4 weeks after first maintenance dose), decrease maintenance dosing interval to every 4 weeks. If inadequate response after an additional 8 to 12 weeks of every 4-week therapy, switch to

Biologic & Immunologic Agents

Page 19 of 21 Updated on 12/23/2025 Drug Indication Dosing/Administration alternative therapy. May switch to an alternative agent sooner than 8 to 12 weeks if disease activity is severe and symptom control is needed • Off label - Relapse while on maintenance therapy: For patients with initial response who have symptomatic relapse while on maintenance therapy, consider decreasing dosing interval to every 4 weeks. Plaque psoriasis Adult Dosing
≤100 kg

100kg 45mg SC initially and 4 weeks later, and then 45mg every 12 weeks thereafter 390mg IV single dose 90mg SC initially and 4 weeks later, and then 90mg every 12 weeks thereafter. Some patients may require maintenance dosing every 8 weeks.

Pediatric Dosing: Children ≥6 years of age and adolescents: <60 kg 60 to 100 kg 100 kg 0.75 mg/kg SC at 0 and 4 weeks, followed by maintenance dose of 0.75 mg/kg SC every 12 weeks 45 mg SC at 0 and 4 weeks, followed by maintenance dose of 45 mg SC every 12 weeks 90 mg SC at 0 and 4 weeks, followed by maintenance dose of 90 mg SC every 12 weeks Psoriatic arthritis Adult Dosing
• 45mg SC initially and 4 weeks later, and then 45mg every 12 weeks thereafter • Coexistent moderate to severe plaque psoriasis & weight >100 kg: 90mg SC at 0 and 4 weeks, then 90mg every 12 weeks thereafter. (Some patients may require maintenance dosing every 8 weeks.)

Pediatric dosing: Children ≥6 years of age and adolescents <60 kg ≥60 kg 100 kg 0.75 mg/kg SC at 0 and 4 weeks, followed by maintenance dose of 0.75 mg/kg SC every 12 weeks 45 mg SC at 0 and 4 weeks, followed by maintenance dose of 45 mg SC every 12 weeks 90 mg SC at 0 and 4 weeks, followed by maintenance dose of 90 mg SC every 12 weeks Crohn’s disease • 160mg SC on day 1 (four 40mg injections in 1 day or two 40mg injections per day for 2 consecutive days), followed by 80mg SC 2 weeks later (day 15), then at week 4 (day 29), 40mg SC every other week Pediatric dosing: Children ≥6 years of age and adolescents • Weight 17 to <40 kg: 80mg SC on day 1 (given on day 1), followed by 40mg SC 2 weeks later (day 15), then (beginning day 29): 20mg SC every other week • Weight ≥40kg: 160mg SC (administered on day 1 or split and given over 2 consecutive days), followed by 80mg SC 2 weeks later (day 15), then (beginning day 29): 40mg SC every other week

Biologic & Immunologic Agents

Page 20 of 21 Updated on 12/23/2025 Drug Indication Dosing/Administration Plaque psoriasis 80mg SC, then 40mg SC every other week starting 1 week after initial dose Ulcerative colitis • 160mg SC on day 1 (four 40mg injections in 1 day or two 40mg injections per day for 2 consecutive days), followed by 80mg SC 2 weeks later (day 15), then at week 4 (day 29), 40mg SC every other week Pediatric dosing: Children ≥5 years of age and adolescents • Weight 20 to <40 kg: 80mg SC on day 1, then 40mg SC QW for 2 weeks (a dose on day 8 and day 15), then (beginning day 29): 40mg SC QOW or 20mg QW • Weight ≥40kg: Initial dose of 160mg SC (administered on day 1 or split and given over 2 consecutive days), followed by 80mg SC weekly for 2 weeks (a dose on day 8 and day 15), then (beginning day 29): 40mg SC QOW
Psoriatic arthritis 40mg SC every other week Skyrizi (risankizumab)
Crohn’s disease
Induction: 600mg IV at weeks 0, 4, and 8
Maintenance dose: 180 to 360mg SC at week 12 and every 8 weeks thereafter, use lowest effect dosage to maintain therapeutic response
Plaque psoriasis,
Psoriatic arthritis
150mg SC at weeks 0,4, and then every 12 weeks thereafter
Note: For psoriatic arthritis, may be administered alone or in combination with non-biologic disease modifying antirheumatic drugs.
Ulcerative colitis
Induction: 1,200mg IV at weeks 0,4, and 8 Maintenance: 180 to 360mg SC at week 12 and every 8 weeks thereafter;
use lowest effective dosage to maintain therapeutic response
Tremfya (guselkumab) Crohn’s disease,
Ulcerative colitis
Induction: 200mg IV on weeks 0,4, and 8 OR SC induction regimen: 400mg SC (as 2 consecutive 200mg injections) on weeks 0, 4, and 8 Maintenance dose: 100mg SC every 8 weeks beginning at week 16 OR SC every 4 weeks beginning at week 12.
Note: Use lowest effective dosage to maintain therapeutic response
Plaque psoriasis,
Psoriatic arthritis 100 mg SC at weeks 0, 4, and then every 8 weeks thereafter

References

1. Alikhan A, Sayed C, Alavi A et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019; 81:91-101.
2. Centers for Disease Control and Prevention (CDC). Tuberculosis (TB). Available at: https://www.cdc.gov/tb/risk- factors/?CDCAArefVal=https://www.cdc.gov/tb/topic/basics/risk.htm. Last updated: March 12, 2024.
3. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: September 24, 2024.
4. DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated periodically.
5. Entyvio (vedolizumab) [prescribing information]. Cambridge, MA: Takeda Pharmaceuticals USA Inc; May 2024.
6. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology. 2020; 158(5):1450-61.

Biologic & Immunologic Agents

Page 21 of 21 Updated on 12/23/2025

7. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology. 2020; 158(5):1450-61.
8. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Psoriatic arthritis: Overview and guidelines of care for treatment with anemphasis on the biologics. J Am Acad Dermatol 2008;58(5):851-64.
9. Lexi-Comp ONLINE™ with AHFS™, Hudson, Ohio: Lexi-Comp, Inc.; 2024; Updated periodically.
10. Lichtenstein GR, Loftus EV, Isaacs KL, et al ACG clinical guideline: management of Crohn’s disease in adults. Am J
    Gastroenterol. 2018; 113:481-517.
11. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008; 58(5):826-50.
12. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009;60(4):643-59.
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17. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019; 80: 1029-72.
18. Orencia (abatacept) lyophilized powder for intravenous infusion [package insert]. Bristol-Myers Squibb Company;
20. Simponi (golimumab) [prescribing information]. Horsham, PA: Janssen Biotech Inc; September 2019.
21. Simponi Aria (golimumab) [prescribing information]. Horsham, PA: Janssen Biotech Inc; July 2023.
22. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2019; 71(1): 5-32.
23. Skyrizi (risankizumab-rzaa) [prescribing information]. North Chicago, IL: AbbVie Inc; May 2025.
24. Stelara [package insert]. Horsham, PA: Janssen Biotech Inc.; March 2024.
25. Tremfya (guselkumab) [prescribing information]. Horsham, PA: Janssen Biotech Inc; September 2025.

26. Ward MM. Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/ Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing

    Review History 12/7/2025 – Updated to include Starjema as the preferred Ustekinumab agent, AP/HB.