Medical Policy

Effective Date:01/01/2006 Title:Humira (Adalimumab)
Revision Date:01/01/2020 Document:BI153:00
CPT Code(s):J0135, 84999
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Pre-authorization is required.

2)    Humira is a specialty drug and must be obtained through the contracted specialty pharmacy.

3)    For the treatment of psoriasis, you must first try topical agents, phototherapy, and a non-biologic DMARD drug.

4)    The diseases for which Humira is used are:

a)    rheumatoid arthritis,

b)    psoriatic arthritis,

c)    plaque psoriasis, 

d)    Crohn’s Disease,

e)    Juvenile Rheumatoid Arthritis and

f)     Ankylosing Spondylitis.

g)    Ulcerative Colitis

h)    Hydradenitis suppurativa

i)     Non-infectious uveitis

Medical Statement

1)    Active Rheumatoid Arthritis (M05.00-M05.9, M06.80-M06.9)

    1.  Humira is considered medically necessary for members with moderate to severe active  adult rheumatoid arthritis, as indicated by all of the following:
      1. At least 6 swollen or painful joints; and
      2. morning stiffness more than 45 minutes;
      3. Elevated ESR or CRP unless member taking corticosteroids

AND

Member has failed to respond to at least one of the following disease-modifying anti-rheumatic drugs (DMARDs):

a.    Hydroxychloroquine

b.    Sulfasalazine

c.    Methotrexate

d.    Oral or injectable gold

e.    Azathioprine

f.     Penicillamine

2)    Juvenile Rheumatoid Arthritis (Juvenile Idiopathic Arthritis) (M08.00-M08.48)

a)    Age 4 years and older and;

b)    Moderate to severe active rheumatoid arthritis and;

c)    4 or more joints.

3)    Psoriatic Arthritis (L40.50-L40.59)

a)    For adults 18 years of age or older with moderate to severely active psoriatic arthritis (> 3 swollen and >3 tender joints) who have had an inadequate response to at least one (1) non-biologic DMARD (e.g. methotrexate, cyclosporine, sulfasalazine, leflunomide) or has a contraindication to DMARDs. According to the FDA-approved product labeling, adalimumab can be used alone or in combination with DMARDs.

4)    Ankylosing Spondylitis (M45.0-M45.9)

a)    Active disease not responsive to two or more NSAIDs.

5)    Psoriasis (L40.0, L40.8, L40.9)

Adults aged 18 and older with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy when the following selection criteria are met:

i)     Plaque psoriasis has been present for more than 1 year; and

ii)    Ten percent or more body surface area is affected by plaque psoriasis; and

iii)   Member has a history of failure for at least a 3 month trial of, contraindication, or intolerance to ALL of the following:

(1)  Topical therapy with corticosteroids, Vitamin D analogs (e.g. calcitriol, calcipotriene), calcineurin inhibitor (e.g. tacrolimus, pimecrolimus), or salicylic acid combination product.  AND

(2)  Phototherapy of at least 3 months duration with narrow-band UVB (in the office or at home) used alone or in combination with topical or systemic therapy (See BI 029 for additional information regarding UV light therapy) This requirement may be waived in any of the following situations: a) history or presence of melanoma or other skin cancer, lupus erythematosus, or xeroderma pigmentosum, b) psoriasis involving areas around the eye where eye protection may cause blockage of phototherapy to affected area, c) documented systemic disease involving the joints (meeting specific criteria for psoriatic arthritis), or 4) very severe plaque thickness or scaling (4 on a scale of 0 to 4) AND

(3)  Systemic therapy of at least 3 months duration with methotrexate or other non-biologic DMARD. This requirement may be waived in any of the following situations: a) member has chronic hepatic disease, b) member has acquired immunodeficiency syndrome (AIDS), c) member is pregnant or breast-feeding, or d) member has anemia, neutropenia, or thrombocytopenia.

6)    Crohn’s Disease (K50.0-K50.919) as manifested by any of the following:

a)    Diarrhea;

b)    Abdominal pain;

c)    Bleeding;

d)    Weight loss;

e)    Perianal disease;

f)     Internal fistulae;

g)    Intestinal obstruction;

h)    Megacolon; or

i)     Extra-intestinal manifestations: arthritis or spondylitis; and

j)     The disease has remained active despite use of the following:

(1)  Corticosteroids;

(2)  6-mercaptopurine/azathioprine;

7)    Ulcerative Colitis (K51.00-K51.319, K51.50-K51.919)

Members with moderate to severe active ulcerative colitis refractory to one or more of the following standard therapies:

a)    Corticosteroids (prednisone, methylprednisolone)

b)    5-aminosalicylic acid agents (sulfasalazine, mesalamine, balsalazide)

c)    Immunosuppressant’s (e.g., azathioprine, cyclosporine, 6-mercaptopurine)

 

8)    Hidradenitis suppurativa

Members with moderate to severe hidradnitis suppurativa.

 

9)    Non-infectious uveitis (including intermediate, posterior, and panuveitis)

Members with a diagnosis of non-infectious uveitis after failure of standard therapy (i.e. ophthalmic steroid drops).

Codes Used In This BI:

J0135             Adalimumab Injection, 20 mg

84999             Unlisted Chemistry Procedure (used for adalimumab antibodies)

Limits

Dosing Guidelines

Indication

Age/Weight

Dosing

Ankylosing spondylitis

Adults

40mg every other week

Rheumatoid Arthritis

Adults

40mg every other week w/ MTX

May use 40mg weekly if unable to take MTX concurrently

Juvenile Rheumatoid/Idiopathic Arthritis

>2 yrs of age 30kg+

>2 yrs of age 15-30kg

>2 yrs of age 10-15kg

40mg every other week

20mg every other week

10mg every other week

Psoriatic Arthritis

Adults

40mg every other week

Psoriasis

Adults

80mg day 1; 40mg every other week starting 1 week after initial dose

Crohn’s Disease

Adults

 

 

Children>6yrs;>40kg

 

 

Children >6yrs 17-40kg

160mg initial dose; then 80mg at week 2; then 40mg every other week starting week 4

160mg initial dose; then 80mg 2 weeks later; then 40mg every other week starting week 4

80mg initial dose; 40mg 2 weeks later; then 20mg every other week starting week 4

Ulcerative Colitis

Adults

160mg initial dose; then 80mg 2 weeks later; then 40mg weekly starting week 4

Hidradenitis suppurativa

Adults

160mg initial dose; then 80mg 2 weeks later; then 40mg weekly starting week 4

Non-infectious Uveitis

Adults

80mg subcutaneously initially; followed by 40mg every other week starting 1 week after initial dose

 

Adalimumab (Humira) is considered experimental and investigational for any of the following conditions because the safety and effectiveness of adalimumab for these conditions has not been established: Active infections

 

Performance of Anser ADA to measure adalimumab antibodies is considered experimental/investigational and is not covered.

Reference
  1. Abbott Laboratories. Humira (adalimumab) prescribing information. Ref. 03-5236-R2. North Chicago, IL: Abbott; revised January 2003. Available at: http://www.rxabbott.com/pdf/humira.pdf
  2. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum. 2003;48(1):35-45.
  3. Pincus T, Ferraccioli G, Sokka T, et al. Evidence from clinical trials and long-term observational studies that disease-modifying anti-rheumatic drugs slow radiographic progression in rheumatoid arthritis: Updating a 1983 review. Rheumatology (Oxford). 2002;41(12):1346-1356.
  4. Rau R. Adalimumab (a fully human anti-tumor necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: The initial results of five trials. Ann Rheum Dis. 2002;61 Suppl 2:ii70-ii73.
  5. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Adalimumab and rheumatoid arthritis. Ottawa, ON: CCOHTA; 2003.
  6. Scheinfeld N. Adalimumab (HUMIRA): A review. J Drugs Dermatol. 2003;2(4):375-377.
  7. Tobin AM, Kirby B. TNF alpha inhibitors in the treatment of psoriasis and psoriatic arthritis. BioDrugs. 2005;19(1):47-57.
  8. Winterfield LS, Menter A, Gordon K, Gottlieb A. Psoriasis treatment: Current and emerging directed therapies. Ann Rheum Dis. 2005;64 Suppl 2:ii87-ii90; discussion ii91-ii92.
  9. Hochberg MC, Tracy JK, Hawkins-Holt M, Flores RH. Comparison of the efficacy of the tumor necrosis factor alpha blocking agent’s adalimumab, Etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2003;62(Supplement 2):13-16.
  10. National Horizon Scanning Centre (NHSC). Adalimumab (Humira) for moderate to severe psoriatic arthritis - horizon scanning review. Birmingham, UK: NHSC; 2004.
  11. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279-3289.
  12. Hochberg MC, Lebwohl MG, Plevy SE, et al. The benefit/risk profile of TNF-blocking agents: Findings of a consensus panel. Semin Arthritis Rheum. 2005;34(6):819-836.
  13. Navarro-Sarabia F, Ariza-Ariza R, Hernandez Cruz B, Villaneuva I. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005;(3):CD005113.pub2.
  14. Singh JA, Furst DE, Bharat A, et al.  2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirehumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis.  Arthritis Care & research. 2012;64:625-639.
  15. Ringold S, Weiss PF, Beukelman T, et al.  2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. Arthritis & Rheumatism. 2013; 65:2499-2512.
  16. Clinical Pharmacology.  Accessed 03-23-17
  17. Menter A, Gottlieb A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2008; 58:826-50.
Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.