WHA

Nonpreferred Adalimumab – Premium Value Formulary UM – PA, NF

Indications for Prior Authorization

Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), Yusimry (adalimumab-aqvh)
  • 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.

Humira (adalimumab)
  • 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 severe active rheumatoid arthritis (RA). Humira can be used alone or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic 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 ages 2 years of age and older. Humira can be used alone or in combination with MTX.

  • 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. Humira 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. Humira 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 adults and pediatric patients 5 years of age and older. Limitations of use: The effectiveness of Humira 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 patients 12 years of age and older.

  • For diagnosis of Uveitis (UV)
    Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adults and pediatric patients 2 years of age and older.

Criteria

Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderately to severely active RA
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderately to severely active RA
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderate to severely active PJIA
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderate to severely active PJIA
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
      • OR
    • If the request is for Humira 10 mg/0.1 mL, submission of medical records (e.g., chart notes) documenting patient is unable to tolerate the Amjevita or Brand Adalimumab-adbm 10 mg/0.2 mL dosage form
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active PsA
    • AND
  • One of the following [5]:
    • Actively inflamed joints
    • Dactylitis
    • Enthesitis
    • Axial disease
    • Active skin and/or nail involvement
    AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Rheumatologist
    AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active PsA
    • AND
  • One of the following [5]:
    • Actively inflamed joints
    • Dactylitis
    • Enthesitis
    • Axial disease
    • Active skin and/or nail involvement
    AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Rheumatologist
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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)
    AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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)
    AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active ankylosing spondylitis
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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]
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active ankylosing spondylitis
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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]
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one of the following conventional therapies: [9, 10]
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone)
    • methotrexate
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one of the following conventional therapies: [9, 10]
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone)
    • methotrexate
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one of the following conventional therapies: [11, 12]
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone)
    • aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

  • Submission of medical records (e.g., chart notes) confirming a 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
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one of the following conventional therapies: [11, 12]
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone)
    • aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley Stage II or III)
    • AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley Stage II or III)
    • AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following**:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Uveitis (UV)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of non-infectious uveitis
    • AND
  • Uveitis is classified as one of the following:
    • intermediate
    • posterior
    • panuveitis
    AND
  • Prescribed by or in consultation with one of the following:
    • Ophthalmologist
    • Rheumatologist
    AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Uveitis (UV)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of non-infectious uveitis
    • AND
  • Uveitis is classified as one of the following:
    • intermediate
    • posterior
    • panuveitis
    AND
  • Prescribed by or in consultation with one of the following:
    • Ophthalmologist
    • Rheumatologist
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
      • OR
    • If the request is for Humira 10 mg/0.1 mL, submission of medical records (e.g., chart notes) documenting patient is unable to tolerate the Amjevita or Brand Adalimumab-adbm 10 mg/0.2 mL dosage form
Abrilada, Amjevita (Non-Preferred or NF), Cyltezo, Brand Adalimumab-adbm (Non-Preferred or NF, Quallent manufacturer), Hadlima, Hulio, Brand Adalimumab-fkjp, Hyrimoz, Brand Adalimumab-adaz, Idacio, Brand Adalimumab-aacf, Simlandi, Brand Adalimumab-ryvk, Yuflyma, Brand Adalimumab-aaty, Yusimry

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Off-Label Indications

  • Submission of medical records (e.g., chart notes) confirming the requested diagnosis
    • AND
  • One of the following:
    • Diagnosis is supported as a use in American Hospital Formulary Service Drug Information (AHFS DI)
      • OR
    • Diagnosis is supported in the FDA Uses/Non-FDA Uses section in DRUGDEX Evaluation with a Strength of Recommendation rating of IIb or better (see DRUGDEX Strength of Recommendation table in Background section)
      • OR
    • The use is supported by clinical research in two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal
    AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
Humira

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Off-Label Indications

  • Submission of medical records (e.g., chart notes) confirming the requested diagnosis
    • AND
  • One of the following:
    • Diagnosis is supported as a use in American Hospital Formulary Service Drug Information (AHFS DI)
      • OR
    • Diagnosis is supported in the FDA Uses/Non-FDA Uses section in DRUGDEX Evaluation with a Strength of Recommendation rating of IIb or better (see DRUGDEX Strength of Recommendation table in Background section)
      • OR
    • The use is supported by clinical research in two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming BOTH of the following:
      • For continuation of prior therapy if within the past 90 days
      • Patient demonstrates a positive clinical response to therapy
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial of BOTH of the following:
        • Amjevita (adalimumab-atto)
        • Brand Adalimumab-adbm
        AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Amjevita and Brand Adalimumab-adbm
      OR
    • Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Amjevita and Brand Adalimumab-adbm
      • OR
    • If the request is for Humira 10 mg/0.1 mL, submission of medical records (e.g., chart notes) documenting patient is unable to tolerate the Amjevita or Brand Adalimumab-adbm 10 mg/0.2 mL dosage form

  • Guideline ID
    GL-162061

  • Formulary
    EHB

  • Effective date
    Jan 1, 2025

  • P&T approval date
    Feb 16, 2023

P & T Revisions

2024-12-13, 2024-12-12, 2024-12-06, 2024-12-03, 2024-11-27, 2024-11-15, 2024-09-30, 2024-09-08, 2024-06-09, 2024-05-02, 2024-04-19, 2024-03-06, 2024-03-06, 2024-02-20, 2024-02-12, 2024-01-11, 2023-11-18, 2023-10-10, 2023-09-01, 2023-09-01, 2023-07-21, 2023-05-03, 2023-02-09, 2023-02-02

  1. Humira Prescribing Information. Abbvie Inc. North Chicago, IL. February 2021.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
  12. 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.
  13. Micromedex Healthcare Series. Recommendation, Evidence, and Efficacy Ratings. https://www.micromedexsolutions.com/micromedex2/librarian/CS/8F8397/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/136D2F/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=3198&contentSetId=50&title=Recommendation%2C+Evidence+and+Efficacy+Ratings&servicesTitle=Recommendation%2C+Evidence+and+Efficacy+Ratings. Accessed September 20, 2023.
  14. Abrilada Prescribing Information. Pfizer Inc. New York, NY. April 2024.
  15. Cyltezo Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. April 2024.
  16. Hadlima Prescribing Information. Samsung Bioepis Co, Ltd; Organon LLC. Jersey City, NJ. June 2024.
  17. Hulio Prescribing Information. Mylan Pharmaceuticals Inc. Morgantown, WV. August 2023.
  18. Hyrimoz Prescribing Information. Sandoz Inc. Princeton, NJ. April 2024.
  19. Idacio Prescribing Information. Fresenius Kabi. Lake Zurich, IL. October 2023.
  20. Simlandi Prescribing Information. Alvotech USA Inc. Leesburg, VA. February 2024.
  21. Yuflyma Prescribing Information. Celltrion Inc. Jersey City, NJ. December 2023.
  22. Yusimry Prescribing Information. Coherus BioSciences Inc. Redwood City, CA. September 2023.
  • 2024-12-13: New PVF guideline for nonpreferred adalimumab products
  • 2024-12-12: New PVF guideline for nonpreferred adalimumab products
  • 2024-12-06: New UM-Optimization guideline
  • 2024-12-03: Added separate sections and clinical criteria for each indication; updated the step to only include Amjevita and added a bypass for an allergic reaction to an excipient; separated Humira criteria to allow for continuation of therapy and a bypass for the 10 mg/0.1 mL strength for PJIA and uveitis; added a step through an additional adalimumab product for Humira.
  • 2024-11-27: Added separate sections and clinical criteria for each indication; updated the step to only include Amjevita and added a bypass for an allergic reaction to an excipient; separated Humira criteria to allow for continuation of therapy and a bypass for the 10 mg/0.1 mL strength for PJIA and uveitis; added a step through an additional adalimumab product for Humira.
  • 2024-11-15: Added separate sections and clinical criteria for each indication; updated the step to only include Amjevita and added a bypass for an allergic reaction to an excipient; separated Humira criteria to allow for continuation of therapy and a bypass for the 10 mg/0.1 mL strength for PJIA and uveitis; added a step through an additional adalimumab product for Humira.
  • 2024-09-30: Addition of new adalimumab-aacf products; annual review - no criteria changes; background updates
  • 2024-09-08: Addition of a new prefilled syringe formulation of adalimumab-ryvk
  • 2024-06-09: Added Adalimumab-adbm by Quallent
  • 2024-05-02: Addition of Simlandi, Brand Adalimumab-ryvk, and Brand Adalimumab-aaty products
  • 2024-04-19: April 2024 - Added new Yuflyma 20mg syringe; updated guideline name to specify Standard Default. March 2024 - Removed adalimumab-adbm and select Amjevita GPIs as nonpreferred targets; updated embedded step to include adalimumab-adbm as a preferred alternative; background updates
  • 2024-03-06: Removed adalimumab-adbm and select Amjevita GPIs as nonpreferred targets; updated embedded step to include adalimumab-adbm as a preferred alternative; background updates
  • 2024-03-06: Addition of Humira by Cordavis; update to specify tiers and manufacturers for Humira; background updates
  • 2024-02-20: Addition of new Amjevita GPIs
  • 2024-02-12: Addition of new Amjevita GPIs
  • 2024-01-11: Addition of new GPIs for Yuflyma, Adalimumab-aacf, and Hyrimoz by Cordavis; background updates
  • 2023-11-18: Annual review - added Abrilada GPIs; background updates
  • 2023-10-10: Addition of GPIs for brand adalimumab-adbm and Hyrimoz by Cordavis; updated background sections
  • 2023-09-01: Added Yuflyma 2-Syringe Kit formulation to clinical criteria
  • 2023-09-01: Added Yuflyma 2-Syringe Kit formulation to clinical criteria
  • 2023-07-21: Addition of Abrilada, Hadlima, Hulio, Brand Adalimumab-fkjp, Idacio, Yuflyma, and Yusimry; Tier 3 Amjevita added to criteria with other nonpreferred biosimilars; Separate tier 3 Amjevita criteria removed; Addition of EHB formulary
  • 2023-05-03: Updated Amjevita indication for HS to remove off-label reference
  • 2023-02-09: New guideline
  • 2023-02-02: New guideline

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