Humira and adalimumab biosimilar agents

Humira and adalimumab biosimilar agents 

WHA preferred adalimumab agents: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz [Sandoz manufacturer], Adalimumab-adaz

Non-preferred adalimumab agents: Hyrimoz [Cordavis manufacturer], Hadlima, Yuflyma, Abrilada, Yusimry, Hulio, Idacio, Adalimumab-adbm, Adalimumab-aacf, Humira [Cordavis manufacturer], Simlandi, Adalimumab-aaty, Adalimumab-ryvk, Adalimumab-fkjp

Self-Administration – subcutaneous (SC) injection may be given at home using the prefilled syringe or single dose pen

 

Indications for Prior Authorization:

 

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). 

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. 

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. 

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. 

Ankylosing spondylitis (AS): Indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 

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. 

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. 

Hidradenitis Suppurativa (HS): Indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 

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

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

• Documented 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine
  • hydroxychloroquine; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA):

• Documented diagnosis of 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of psoriatic arthritis (PsA):

• Documented diagnosis of active PsA; AND
• One of the following:
  • actively inflamed joints 
  • dactylitis 
  • enthesitis 
  • axial disease 
  • active skin and/or nail involvement; AND
• Prescribed by or in consultation with a dermatologist or rheumatologist; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of moderate to severe PsO; AND
• One of the following:
  • Greater than or equal to 3% body surface area involvement 
  • Severe scalp psoriasis 
  • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to ONE of the following topical therapies: 
  • corticosteroids (e.g., betamethasone, clobetasol) 
  • vitamin D analogs (e.g., calcitriol, calcipotriene) 
  • tazarotene 
  • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
  • anthralin 
  • coal tar; AND
• Prescribed by or in consultation with a dermatologist; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of ankylosing spondylitis (AS):

• Documented diagnosis of active AS; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of Crohn's disease (CD):

• Diagnosis of moderately to severely active CD; AND
• Prescribed by or in consultation with a gastroenterologist; AND
• One of the following:
  • 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
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
  • 6-mercaptopurine
  • azathioprine
  • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)
  • methotrexate; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of Ulcerative Colitis (UC):

• Diagnosis of moderately to severely active UC; AND
• Prescribed by or in consultation with a gastroenterologist; AND
• One of the following:
  • 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
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
  • 6-mercaptopurine
  • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
  • azathioprine
  • corticosteroids (e.g., prednisone, methylprednisolone, budesonide); AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of Hidradenitis Suppurativa (HS):

• Documented diagnosis of moderate to severe HS (i.e., Hurley Stage II or III); AND
• Prescribed by or in consultation with a dermatologist; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following preferred adalimumab agents cannot be used: Humira [Abbvie manufacturer], Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), and Brand Adalimumab-adaz.

 

For diagnosis of Uveitis (UV):

• Documented diagnosis of non-infectious uveitis (UV); AND
• Uveitis is classified as one of the following:
  • intermediate
  • posterior
  • panuveitis, AND
• Prescribed by or in consultation with an ophthalmologist or rheumatologist; AND
• (Request for nonpreferred biosimilars only): Medical reason why all of the following cannot be used: Humira [Abbvie manufacturer], Amjevita^¥, Cyltezo^¥, Hyrimoz (Sandoz manufacturer)^¥, and Brand Adalimumab-adaz^¥.

^¥ Off-label use

 

Reauthorization Criteria:

 

For diagnosis of RA, PJIA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following:
  • Reduction in the total active (swollen and tender) joint count from baseline
  • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

 

For diagnosis of PsA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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 

 

For diagnosis of PsO:

• Documentation of positive clinical response to therapy as evidenced by ONE of the following:
  • Reduction the body surface area (BSA) involvement from baseline 
  • Improvement in symptoms (e.g., pruritus, inflammation) from baseline 

 

For diagnosis of AS:

• Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • 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

 

For diagnosis of CD:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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

 

For diagnosis of UC:

• One of the following:
  • For patients who initiated Humira therapy within the past 12 weeks: Documentation of clinical remission or significant clinical benefit by eight weeks (Day 57) of therapy 
  • For patients who have been maintained on Humira therapy for longer than 12 weeks: Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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

 

For diagnosis of HS, UV: 

• Documentation of positive clinical response to therapy

 

Dosing:

 

RA, PsA, or AS (adults):

• 40 mg every other week.
• For rheumatoid arthritis only: Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

PJIA (2 years of age or older) or Pediatric UV (2 years of age or older):

• 10 kg (22 lbs) to less than 15 kg (33 lbs): 10 mg every other week
• 15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
• 30 kg (66 lbs) and greater: 40 mg every other week

PsO or UV (adults):

• 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

CD (adults and pediatrics 6 years of age or older):

• Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. 
• Pediatric patients (6 years of age or older):
  • 17 kg (37 lbs) to less than 40 kg (88 lbs): Day 1 give 80 mg. Day 15 give 40 mg. Starting on Day 29 give 20 mg every other week.
  • 40 kg (88 lbs) and greater: Day 1 give 160 mg (single dose or split over two consecutive days). Day 15 give 80 mg. Starting on Day 29 give 40 mg every week.

UC (adults and pediatrics 5 years of age or older):

• Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). 
• Pediatric patients (5 years of age or older):
  • 20 kg (44 lbs) to less than 40 kg (88 lbs): Day 1 give 80 mg. Day 8 give 40 mg. Day 15 give 40 mg. Starting on Day 29 give 40 mg every other week or 20 mg every week.
  • 40 kg (88 lbs) and greater: Day 1 give 160 mg (single dose or split over two consecutive days). Day 8 give 80 mg. Day 15 give 80 mg. Starting on Day 29 give 80 mg every other week or 40 mg every week.
    • Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen.

HS (adults and adolescents 12 years of age or older):

• Adults: Day 1 give 160 mg (single dose or split over two consecutive days). Day 15 give 80 mg. Starting on Day 29 give 80 mg every other week or 40 mg every week.
• Adolescents (12 years of age and older): 
  • 30 kg (66 lbs) to less than 60 kg (132 lbs): Day 1 give 80 mg. Day 8 and subsequent doses give 40 mg every other week.
  • 60 kg (132 lbs) and greater: Day 1 give 160 mg (single dose or split over two consecutive days). Day 15 give 80 mg. Starting on Day 29 give 80 mg every other week or 40 mg every week.

 

Coverage Duration:

 

UC:

• Initial: 6 months
  • Discontinue Humira in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. 
• Reauthorization: 1 year

CD:

• Initial: 6 months
• Reauthorization: 1 year

For all other indications (RA, PJIA, PsA, PsO, AS, CD, HS, UV):

• Initial: 1 year 
• Reauthorization: 1 year

 

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

 

Additional Information:

• Patients should be tested for latent Tuberculosis (TB) (e.g., TB skin test, QuantiFERON TB Gold test, or chest x-ray) before Humira use and during therapy. Treatment for latent infection should be initiated prior to Humira use.
• Humira should not be used in conjunction with another anti-TNF drug or interleukin-1 receptor antagonist
• Do not administer live vaccines or attenuated vaccines concurrently with Humira.

 

Policy Updates:

• 07/01/2020 – Original review
• 02/16/2021 – Annual review. Criteria and format updated; P&T Ad Hoc review of PA guidelines: removed reference to chart note requirement; updated oral DMARD examples for RA and PJIA; removed TB testing requirements; added medical necessity guidance for reauthorization requests
• 11/08/2021 – Updated dosing for rheumatoid arthritis
• 11/16/2021 – Updated JIA criteria for DMARDs
• 08/16/2022 – Updated for expanded indication for Crohn's Disease (CD).  Criteria not changed
• 01/01/2023 – Updated duration requirements for use of prerequisite drugs for RA, PJIA, AS; added symptom requirements for RA, PsA, PsO, CD, UC; removed prerequisite drugs for UV; updated requirements for reauthorization; updated initial coverage duration for UC and CD
• 09/01/2023 – Addition of Humira, Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options (P&T 08/15/2023)
• 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only. Add Adalimumab-adbm as a non-preferred adalimumab agent
• 03/07/2024 – Updated Humira [Abbvie] as preferred agent, Updated Humira [Cordavis] and adaliumab-accf as non-preferred agents
• 06/01/2024 – Addition of Simlandi, Adalimumab-aaty, and Adalimumab-ryvk to non-preferred (P&T 5/20/2024) (P&T Meeting May)
• 09/01/2024 – Addition of Adalimumab-fkjp to non-preferred (P&T 08/20/2024) (P&T Meeting August)

 

References:

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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. 
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