HMSA adalimumab Prior Auth Coverage

Coverage Criteria by Indication

General approval conditions

Coverage for non-preferred Humira/biosimilars is allowed when ALL of the following are met:

Preferred product trial or contraindication: Patient has documented inadequate response, intolerable adverse event, or contraindication to all preferred products listed for the specific indication (per the form) and supporting documentation is submitted.all preferred agents failed/intolerant/contraindicated

ACTION REQUIRED: submit supporting documentation

Continuation of therapy: For continuation requests, patient is currently receiving the requested drug (including samples or assistance program) and has achieved or maintained positive clinical response or improvement as specified in relevant indication section.demonstrated clinical benefit (examples provided by indication)

See indication-specific continuation questions

TB screening: TB test within 6 months or documentation of TB status; if positive/active TB, documentation of treatment initiation or completion is required.TB testing within 6 months

See exception and criteria question blocks

Rheumatoid arthritis

Rheumatoid arthritis (RA) covered when ALL of the following are met:

Diagnosis and prescriber: Patient has moderately to severely active RA and drug is prescribed by or in consultation with a rheumatologist.

Biomarker evidence or testing: Either RF or anti-CCP positive, or testing for RF, anti-CCP and CRP/ESR has been performed.

Methotrexate trial: Inadequate response after at least 3 months of methotrexate at a dose >=15 mg/week, or intolerance, or contraindication to methotrexate (specified contraindications listed on form).

Juvenile idiopathic arthritis

JIA covered when ALL of the following are met:

Age and prescriber: Diagnosis of moderately to severely active articular juvenile idiopathic arthritis and patient is >=2 years old; prescribed by or in consultation with a rheumatologist.

Prior conventional therapy: New starts require inadequate response to methotrexate or another conventional synthetic DMARD administered at adequate dose and duration; additional trials of scheduled NSAIDs and/or intra-articular glucocorticoids may be required as indicated.

Risk factors: Presence of risk factors for poor outcome (e.g., involvement of ankle/wrist/hip/SIJ/TMJ, erosive disease, elevated inflammatory markers, symmetric disease, positive RF/anti-CCP, pre-existing joint damage) may support approval.

Psoriatic arthritis

Psoriatic arthritis covered when ALL of the following are met:

Age/prescriber: Adult patient and drug is prescribed by or in consultation with a rheumatologist or dermatologist.

Prior csDMARD trial: For new starts, inadequate response to methotrexate, leflunomide, sulfasalazine, or another conventional synthetic DMARD at adequate dose/duration, or intolerance/contraindication to these agents.

Disease severity: Consideration of disease features (mild/moderate vs severe, enthesitis, axial disease) that influence pathway; certain presentations may permit alternative pathways per form.

Axial spondyloarthritis / Ankylosing spondylitis

Active ankylosing spondylitis or non-radiographic axial spondyloarthritis covered when:

Diagnosis/prescriber: Diagnosis of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis and prescribed by or in consultation with a rheumatologist.

NSAID trial: Inadequate response to at least two NSAIDs, or intolerance/contraindication to at least two NSAIDs (documented), for new starts.

Crohn's disease

Crohn's disease covered when ALL of the following are met:

Diagnosis/age/prescriber: Moderately to severely active or fistulizing Crohn's disease; patient is >=6 years old; drug prescribed by or in consultation with a gastroenterologist.

Continuation response: For continuation, patient has achieved or maintained remission or demonstrated clinical response (symptom or objective improvements or improvement on disease activity scoring tool such as CDAI).

Axial spondyloarthritis continuation and prior therapy

Covered when criteria below are met for continuation or new start

Continuation request handling: If continuation request, document whether patient is receiving samples/PAP and whether patient has achieved/maintained positive clinical response (low disease activity or symptom improvement). Improvement in functional status, spinal pain, inflammation, swollen/tender joints or CRP fulfills continuation questions.

See continuation questions

Prior therapy requirement for new starts: New starts must have inadequate response to at least two NSAIDs or have intolerance/contraindication to at least two NSAIDs.

See #408

Prior biologic exposure: Indicate prior receipt of biologic or targeted synthetic therapy for axial disease; prior biologic exposure influences review pathway.

See prior biologic question

Crohn's disease continuation and eligibility

Covered when criteria below are met for Crohn's disease (moderate-severe or fistulizing)

Age and prescriber: Patient age >=6 years and drug prescribed by or in consultation with a gastroenterologist.>=6 years

See Crohn's disease section

Continuation response: If continuation request, document samples/PAP status and whether patient achieved/maintained remission or positive clinical response; improvements such as abdominal pain, diarrhea, weight, abdominal mass, hematocrit, endoscopic appearance, or CDAI score satisfy continuation.

Ulcerative colitis continuation and eligibility

Covered when criteria below are met for moderately to severely active UC

Age and prescriber: Patient age >=5 years and drug is prescribed by or in consultation with a gastroenterologist.>=5 years

See UC section

Continuation response: For continuation, document samples/PAP status and maintained remission or positive clinical response; improvements may include stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic appearance, or improvement on scoring tools (UCEIS, Mayo).

Plaque psoriasis new starts and continuation

Covered when criteria below are met for moderate to severe plaque psoriasis

Adult and prescriber: Patient is an adult (>=18 years) and drug is prescribed by or in consultation with a dermatologist.>=18 years

Continuation response: If continuation, document samples/PAP status and maintained positive clinical response; reduction in body surface area (BSA) affected from baseline satisfies continuation.BSA reduction

Prior therapies for new starts: For new starts without prior biologic, document involvement of crucial body areas or percent BSA >=3% (or >=3% to <10% with prior inadequate response to phototherapy or methotrexate/cyclosporine/acitretin, or clinical reason to avoid these agents).BSA >=3% or crucial areas

Hidradenitis suppurativa continuation and eligibility

Covered when criteria below are met for moderate to severe HS

Age and prescriber: Patient age >=12 years and drug is prescribed by or in consultation with a rheumatologist or dermatologist.>=12 years

Continuation response: If continuation, document samples/PAP status and maintained positive clinical response; qualifying improvements include reduction in abscess/nodule count, decreased sinus tracts, reduced lesion frequency, decreased pain or suppuration, fewer relapses, improved quality of life, or improvement on a disease severity tool.

Prior therapy for new starts: New starts must have had inadequate response to at least 90 days of oral antibiotics, or have intolerance/contraindication to antibiotics, before approval if no prior biologic exposure.>=90 days

Behçet's disease criteria

Covered when criteria below are met for Behçet's disease

Prescriber involvement: Drug should be prescribed by or in consultation with a rheumatologist.

Prior therapy for new starts: New starts require inadequate response to at least one non-biologic medication for Behçet's disease (e.g., apremilast, colchicine, systemic glucocorticoids, azathioprine) or documentation if not applicable.

Non-infectious uveitis continuation and eligibility

Covered when criteria below are met for non-infectious intermediate, posterior, or panuveitis

Age and prescriber: Patient age >=2 years and drug is prescribed by or in consultation with an ophthalmologist or rheumatologist.>=2 years

Continuation response: If continuation, document samples/PAP status and maintained positive clinical response; qualifying improvements include reduced flare frequency, stability or improvement in anterior chamber cell grade, vitreous haze grade, visual acuity, reduced steroid use, or absence of new active lesions.

Prior therapy for new starts: New starts must have had inadequate response or intolerance to corticosteroids or immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate) or have contraindication to these agents.

Pyoderma gangrenosum criteria

Covered when criteria below are met for pyoderma gangrenosum

Prescriber: Drug should be prescribed by or in consultation with a dermatologist.

Continuation response: If continuation, document samples/PAP status and maintained positive clinical response.

Prior therapy: Patient must have had inadequate response to corticosteroids or immunosuppressive therapy (e.g., cyclosporine, mycophenolate mofetil) or have documented intolerance/contraindication to these agents.

Immunotherapy-related inflammatory arthritis criteria

Covered when criteria below are met for moderate to severe immunotherapy-related inflammatory arthritis

Prescriber: Drug should be prescribed by or in consultation with an oncologist, hematologist, or rheumatologist.

Disease severity and prior therapy: Patient must have moderate or severe immunotherapy-related inflammatory arthritis and have had inadequate response to corticosteroids or a conventional synthetic DMARD (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine), or documented intolerance/contraindication to these therapies.

If the patient can be switched to one of the plan's listed preferred products, the form requires the prescriber to obtain and submit the prior authorization form for that preferred product instead of requesting coverage for a non-preferred agent. Requests where a preferred alternative is appropriate should therefore be directed to obtain the preferred product form and submit the corresponding PA; failure to do so may lead to denial or redirection of the request.

For plaque psoriasis new-start assessments the form uses body surface area (BSA) to guide the pathway. If the affected BSA is less than 3% of BSA, the form routes to the 'No Further Questions' pathway, indicating the low BSA threshold that typically does not meet the criteria for biologic initiation under this policy.

Use of a non-preferred adalimumab product (including Humira or any listed non-preferred biosimilar) without documentation that the member has had an inadequate response, intolerable adverse event, or a contraindication to all listed preferred agents for the indication is not supported by the form's exception criteria and may be deemed not medically necessary.

Requested Codes, Products, and Key Coding Details

NDC / Drug ListNDC

Humira (adalimumab) - multiple NDCs

Humira and listed biosimilars: Abrilada, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz (Cordavis and non-Cordavis), Idacio, Simlandi, Yuflyma, Yusimry

ICD-10 Diagnosis CodesICD-10

(provider to supply)

ICD-10 code corresponding to the patient's diagnosis (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis) - provider must indicate the specific code on the form.

Prescriber and Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Humira and listed biosimilars. Prescribers must complete and fax the CVS Caremark Specialty Pharmacy prior authorization form to 1-866-237-5512. Provide accurate patient demographics (name, ID, DOB, weight/height, phone), ICD-10 diagnosis code, product requested, NPI, prescriber specialty, and site of administration on the faxed form. Approvals may be subject to dosing limits per FDA labeling, compendia, or evidence-based guidelines.

Send completed form to CVS Caremark Specialty Programs: Fax 1-866-237-5512
For questions call CVS Caremark: 1-808-254-4414 or Specialty Customer Care: CaremarkConnect 1-800-237-2767

Documentation Required

Prior Authorization Questionnaire — Complete Indication-Specific Items

The prior authorization request must include completion of the indication-specific questionnaire items on the fax form. The questionnaire captures: accurate diagnosis and ICD-10 code, patient age, prescriber specialty (when required by indication), whether this is a new start or continuation of therapy, whether drug is received via samples or manufacturer assistance, current clinical status and objective response measures (e.g., CRP, fecal calprotectin, endoscopic findings, BSA, lesion counts), and documentation of prior therapies tried and responses.

Background and Scope

This prior authorization form applies to requests for adalimumab products (Humira) and specified biosimilars across multiple immunologic specialties. It captures indication-specific eligibility and continuation criteria for rheumatologic, dermatologic, and gastroenterologic conditions and documents prior therapy history, response to therapy, and tuberculosis screening as required for coverage determinations.

Definitions and Key Concepts

TB testing — inv-37

Accepted TB testsTuberculosis skin test (PPD), interferon-gamma release assay (IGRA), or chest x-ray

Timing requirementTB test performed within 6 months of initiating therapy

Positive/latent TB handlingForm queries results and treatment status (latent TB initiated/completed or active TB) to inform decision-making

Continuation of therapy — inv-38

Current use assessmentForm asks whether the request is for continuation of therapy with the requested drug

Clinical response documentationForm requires documentation that the patient has achieved or maintained a positive clinical response since starting the drug

OpenPayer

Prior authorization criteria for adalimumab (Humira) and biosimilars

Coverage Criteria by Indication

Requested Codes, Products, and Key Coding Details

Prescriber and Administrative Requirements

Background and Scope

Definitions and Key Concepts