Amjevita (adalimumab-atto) - PA, NF - Standard Default
Indications for Prior Authorization
Amjevita (adalimumab-atto)
-
For diagnosis of Rheumatoid arthritis (RA)
Indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). -
For diagnosis of Polyarticular Juvenile idiopathic arthritis (PJIA)
Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Can be used alone or in combination with methotrexate. -
For diagnosis of Psoriatic arthritis (PsA)
Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Can be used alone or in combination with non-biologic DMARDs. -
For diagnosis of Plaque psoriasis (PsO)
Indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. -
For diagnosis of Ankylosing spondylitis (AS)
Indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. -
For diagnosis of Crohn’s disease (CD)
Indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. -
For diagnosis of Ulcerative Colitis (UC)
Indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers.
-
For diagnosis of Hidradenitis Suppurativa (HS)
Indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. -
For diagnosis of Uveitis (UV)
Indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Criteria
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately to severely active RA AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [2, 3]:
- methotrexate
- leflunomide
- sulfasalazine
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Diagnosis of moderate to severely active PJIA AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
- leflunomide
- methotrexate
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)
- Diagnosis of active PsA AND
- One of the following [5]:
- Actively inflamed joints
- Dactylitis
- Enthesitis
- Axial disease
- Active skin and/or nail involvement
- Prescribed by or in consultation with one of the following:
- Dermatologist
- Rheumatologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
- Reduction in the body surface area (BSA) involvement from baseline
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)
- Diagnosis of moderate to severe chronic plaque psoriasis AND
- One of the following [6]:
- Greater than or equal to 3% body surface area involvement
- Severe scalp psoriasis
- Palmoplantar (i.e., palms, soles), facial, or genital involvement
- Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies [7]:
- corticosteroids (e.g., betamethasone, clobetasol)
- vitamin D analogs (e.g., calcitriol, calcipotriene)
- tazarotene
- calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Prescribed by or in consultation with a dermatologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)
- Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1, 6]:
- Reduction in the body surface area (BSA) involvement from baseline
- Improvement in symptoms (e.g., pruritus, inflammation) from baseline
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)
- Diagnosis of active ankylosing spondylitis AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of a one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [8]
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)
- Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 8]:
- Disease activity (e.g., pain, fatigue, inflammation, stiffness)
- Lab values (erythrocyte sedimentation rate, C-reactive protein level)
- Function
- Axial status (e.g., lumbar spine motion, chest expansion)
- Total active (swollen and tender) joint count
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)
- Diagnosis of moderately to severely active Crohn’s disease AND
- One of the following [9, 10]:
- Frequent diarrhea and abdominal pain
- At least 10% weight loss
- Complications such as obstruction, fever, abdominal mass
- Abnormal lab values (e.g., C-reactive protein [CRP])
- CD Activity Index (CDAI) greater than 220
- Trial and failure, contraindication, or intolerance to one of the following conventional therapies: [9, 10]
- 6-mercaptopurine
- azathioprine
- corticosteroids (e.g., prednisone)
- methotrexate
- Prescribed by or in consultation with a gastroenterologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Crohn’s disease (CD)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 9, 10]:
- Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
- Reversal of high fecal output state
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 12 Week(s)
For diagnosis of Ulcerative Colitis (UC)
- Diagnosis of moderately to severely active ulcerative colitis AND
- One of the following [11, 12]:
- Greater than 6 stools per day
- Frequent blood in the stools
- Frequent urgency
- Presence of ulcers
- Abnormal lab values (e.g., hemoglobin, ESR, CRP)
- Dependent on, or refractory to, corticosteroids
- Trial and failure, contraindication, or intolerance to one of the following conventional therapies: [11, 12]
- 6-mercaptopurine
- Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
- Azathioprine
- Corticosteroids (e.g., prednisone)
- Prescribed by or in consultation with a gastroenterologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis (UC)
- One of the following:
- For patients who initiated Humira therapy within the past 12 weeks, patient demonstrates clinical remission or significant clinical benefit by eight weeks (Day 57) of therapy OR
- For patients who have been maintained on Humira therapy for longer than 12 weeks, patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 11, 12]:
- Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
- Reversal of high fecal output state
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)
- Diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley Stage II or III) AND
- Prescribed by or in consultation with a dermatologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)
- Patient demonstrates positive clinical response to therapy
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Uveitis (UV)
- Diagnosis of non-infectious uveitis AND
- Uveitis is classified as one of the following:
- intermediate
- posterior
- panuveitis
- Prescribed by or in consultation with one of the following:
- ophthalmologist
- rheumatologist
Amjevita*
*Approve at NDC list “2025DFADAL”.
Prior Authorization, Non-Formulary (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Uveitis (UV)
- Patient demonstrates positive clinical response to therapy
P & T Revisions
2024-11-27, 2024-11-15, 2024-09-30, 2024-09-16, 2024-06-18, 2024-04-19, 2024-03-06, 2024-03-06, 2024-02-12, 2023-11-02, 2023-10-10, 2023-07-21, 2023-05-03, 2023-02-09, 2023-02-02, 2022-10-23, 2021-11-04, 2021-09-27, 2021-05-19, 2021-04-08, 2020-11-17, 2020-01-09, 2019-12-10
References
- Amjevita Prescribing Information. Amgen Inc. Thousand Oaks, CA. August 2024.
- Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
- Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
- 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.
- Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.
- 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 spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
- 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.
- Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
- Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.
Revision History
- 2024-11-27: Update to only include Amjevita in the guideline as the preferred adalimumab product; background updates; no criteria changes
- 2024-11-15: Update to only include Amjevita in the guideline as the preferred adalimumab product; no criteria changes
- 2024-09-30: Addition of Hyrimoz psoriasis/uveitis pack; annual review - no criteria changes; background updates
- 2024-09-16: Removed anthralin and coal tar as topical step options for PsO
- 2024-06-18: Additional Cyltezo and adalimumab-adbm GPIs added; specified adalimumab-adbm manufactured by BI
- 2024-04-19: Updated guideline name to specify Standard Default; Addition of brand adalimumab-adbm and new Amjevita GPIs as preferred products; Updated Humira to specify tiers and manufacturers in headings and notes
- 2024-03-06: Addition of brand adalimumab-adbm and new Amjevita GPIs as preferred products
- 2024-03-06: Updated Humira to specify tiers and manufacturers in headings and notes
- 2024-02-12: Updated notes section to list Amjevita GPIs; no criteria changes
- 2023-11-02: Annual review - Updated standard reauth criteria verbiage to "Patient demonstrates..."
- 2023-10-10: Updated section headings and notes to account for the two manufacturers and tiers of the Hyrimoz products; no criteria changes; background updates
- 2023-07-21: Addition of Cyltezo, Hyrimoz, and Adalimumab-adaz
- 2023-05-03: Updated Amjevita indication for HS to remove off-label reference
- 2023-02-09: Addition of Amjevita
- 2023-02-02: Addition of Amjevita
- 2022-10-23: Further clinical detail and criteria added; annual review - background updates
- 2021-11-04: Annual review
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2021-04-08: Updated CD and UC indications per PI; removed prior failure to infliximab from CD criteria based on updated indication; UC indication now includes pediatric patients
- 2020-11-17: Annual review - Removed drug name from reauth criteria; Background and reference updates
- 2020-01-09: Updated Crohn's disease criterion to state, "Failure (i.e., lost response) or intolerance to infliximab" instead of "Remicade (infliximab)" in order to align with the prescribing information
- 2019-12-10: Added objective measures to the psoriasis reauthorization criteria
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