CurrentHawaii Medical Service Association (HMSA)Policy N/A

Humira (adalimumab) and Biosimilars — Prior Authorization Coverage Criteria

Prior authorization requirements and clinical criteria for coverage of Humira (adalimumab) and specified biosimilars for multiple inflammatory indications under the CVS Caremark-administered prescription benefit for HMSA members.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyHumira (adalimumab) and Biosimilars — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization to CVS Caremark Specialty Programs (fax 1-866-237-5512) with supporting documentation demonstrating inadequate response, intolerance, or contraindication to all listed preferred products when requesting non-preferred Humira or biosimilars.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleindications covered

manybiosimilars enumerated

detailedprior therapy rules

90 daysHS antibiotic requirement

2 yrsminimum age (uveitis)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Humira (adalimumab) and Biosimilars

Exception / Preferred-product failure

Coverage for non-preferred Humira or non‑preferred biosimilars is contingent on specified exception criteria and documented inadequate response, intolerance, or contraindication to preferred agents.

Adult and indication: Patient is an adult (>=18 years) and the requested product is for one of the listed indications (ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis).

See form's Exception Criteria Questions for indication list.

Can switch to preferred product: Provider indicates whether the patient's treatment can be switched to a preferred product; if yes, obtain and submit the corresponding preferred‑product PA form.

Form asks 'Can the patient's treatment be switched to a preferred product?'.

Failure/intolerance/contraindication to preferred products (by indication): For the requested indication, there must be documented inadequate response, intolerable adverse event, or contraindication to ALL listed preferred products for that indication (specific product lists depend on the diagnosis).

Action required: submit supporting documentation as requested on the form.

Continuation Therapy

Requests for continuation of therapy require demonstration of clinical benefit or maintained response on the requested drug.

Continuation confirmation: This is a request for continuation of therapy with the requested drug; confirm whether the patient is currently receiving the drug (including samples or manufacturer patient assistance program).

If not a continuation, evaluate under new‑start criteria.

Prescriber specialty: Requested drug is prescribed by or in consultation with the specialty appropriate for the indication (e.g., rheumatologist, dermatologist, gastroenterologist, ophthalmologist, oncologist/hematologist).

Form requires specialty confirmation for most indications.

Documented clinical response: Document that the patient has achieved or maintained a positive clinical response or low disease activity since starting the requested drug (improvement in signs/symptoms or disease‑specific measures).

Examples of acceptable measures are listed per indication (e.g., joint counts, CDAI, BSA, UCEIS, reduced abscess count).

New-start Indication Criteria

New‑start criteria require specialist involvement, age thresholds, prior conventional therapy trials, and specified trial durations or biomarker testing where applicable.

Rheumatoid arthritis (new start): Diagnosis of moderately to severely active RA; prescriber is or in consultation with a rheumatologist; patient meets biomarker testing requirements (RF/anti‑CCP and CRP/ESR per form) and has had an inadequate response to methotrexate given at >=15 mg per week for at least 3 months, unless intolerance/contraindication is documented.>= 3 months at >= 15 mg per week

See RA questions and prior‑therapy requirements.

Psoriatic arthritis (new start): Adult patient; prescriber is or in consultation with a rheumatologist or dermatologist; inadequate response or intolerance to conventional synthetic DMARD(s) (e.g., methotrexate, leflunomide, sulfasalazine) at adequate dose/duration is required unless contraindicated.

Form captures disease severity and prior‑therapy exceptions.

Ankylosing spondylitis (new start): Adult patient; prescriber is or in consultation with a rheumatologist; inadequate response or intolerance/contraindication to at least two NSAIDs is required prior to biologic initiation per the form.

Tuberculosis screening

TB risk assessment and testing.

TB testing and management: Determine prior use of biologic/targeted synthetic agents associated with increased TB risk; document TB testing (PPD/IGRA/chest X‑ray) within 6 months of initiating therapy and record the result; document latent TB treatment status or active TB management as applicable.6 months

Form asks whether TB testing occurred within 6 months and captures positive/negative/unknown results and latent/active TB treatment status.

General Continuation Criteria

Covered when ALL of the following are met for continuation of the requested biologic/targeted drug:

Prescriber specialty: Requested drug is prescribed by or in consultation with the specialty appropriate for the indication (examples specified by indication on the form).

Form lists required specialties per indication (e.g., dermatologist for psoriasis, ophthalmologist for uveitis).

Continuation request confirmation: This is a continuation request; verify whether the patient is currently receiving the requested drug including samples or manufacturer patient assistance program use.

If patient is not currently receiving the drug, new‑start criteria apply.

Demonstrated clinical response: Documentation that the patient has achieved or maintained a positive clinical response or low disease activity since starting therapy (improvement in signs/symptoms or disease‑specific measures).

Specific acceptable measures are listed per indication (e.g., reduction in BSA, decreased abscess/nodule count, stability/improvement in AC cell or vitreous haze, reduced glucocorticoid requirement).

The form routes certain diagnoses to a separate handling path: Systemic juvenile idiopathic arthritis and selections entered as Other lead to a “No Further Questions” result on the indication page, indicating these indications are managed outside the stepwise question flow captured for the listed conditions.

For plaque psoriasis the form uses body surface area (BSA) bands and crucial-area involvement to determine severity. If the patient has less than 3% BSA affected and does not involve listed crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas), the flow may not meet the severity thresholds and will continue alternate questioning or end with “No Further Questions” depending on responses.

Continued (renewal) therapy must show ongoing benefit: the form requires documentation that the patient has achieved or maintained a positive clinical response or low disease activity since starting the requested drug. Failure to provide evidence of clinical benefit or to meet indication-specific prior-therapy requirements (for example those listed for psoriasis, hidradenitis suppurativa, uveitis, or other conditions) will render continuation requests unsupported by the continuation criteria and may result in non-coverage.

inv-09: Body Surface Area (BSA) for psoriasis prior to treatment

BSA — >=3% to <10%Body surface area prior to treatment between greater than or equal to 3% and less than 10%

BSA — >=10%Body surface area prior to treatment greater than or equal to 10%

BSA — <3%Body surface area prior to treatment less than 3%

inv-10: Methotrexate trial duration and dose for RA

Methotrexate trial durationAt least 3 months of treatment

Methotrexate dose thresholdDose greater than or equal to 15 mg per week

ExceptionsIntolerance or contraindication to methotrexate may be documented instead of meeting the trial requirement

inv-11: Body Surface Area (BSA)

BSA category — <3%Less than 3% of body surface area affected

BSA category — 3% to <10%Greater than or equal to 3% to less than 10% of body surface area affected

BSA category — >=10%Greater than or equal to 10% of body surface area affected

inv-12: Oral antibiotic trial duration for HS

Oral antibiotic trial durationAt least 90 days of treatment with an oral antibiotic

Intolerance optionDocumented intolerance to oral antibiotics can be indicated instead of meeting the 90-day trial

Contraindication optionDocumented contraindication to oral antibiotics can be indicated instead of meeting the 90-day trial

inv-13: Minimum age for uveitis continuation

Minimum age for uveitis continuationPatient is 2 years of age or older to continue therapy

Prescriber specialtyRequested drug should be prescribed by or in consultation with an ophthalmologist or rheumatologist

Continuation evidenceContinuation requires documentation of clinical response or improvement in ocular measures since starting therapy

Initial (New-Start) Therapy Requirements

Initial therapy requirements

Initial therapy (new starts) criteria vary by indication and generally require specialist involvement, age thresholds, and prior trials of conventional therapies (or documented contraindication/intolerance).

Psoriasis initial: Patient diagnosed with moderate to severe plaque psoriasis; prescriber is or in consultation with a dermatologist; meet BSA/severity thresholds and have had inadequate response, intolerance, or contraindication to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless a clinical reason to avoid these therapies is documented.BSA thresholds as specified on form

Form captures BSA bands and prior‑therapy exceptions.

Crohn's disease initial: Patient age meets indication threshold (>=6 years for Crohn's); prescriber is or in consultation with a gastroenterologist; document disease activity and, where asked, prior therapy response or remission criteria as specified on the form.>=6 years

See Crohn's new‑start and continuation sections for required metrics.

Continuation Therapy Requirements

Continuation requests require evidence the member is benefitting from the current therapy and that the prescriber has attested to the accuracy of submitted information.

Required evidence of continued benefit varies by diagnosis but may include: tender/swollen joint count reduction (≥20% improvement), maintained low disease activity or remission, reduction in BSA (psoriasis), improvement in stool frequency/rectal bleeding (UC), improvement in CDAI or endoscopic mucosal appearance (Crohn's), reduction in abscess/nodule count (HS), improved visual acuity or reduced AC cell/vitreous haze (uveitis).

If the request lacks documentation of positive clinical response, maintained disease control, or verification of current therapy, it may be denied for failure to meet continuation criteria.

Provider must document prior required therapies and either inadequate response or intolerance/contraindication where applicable (examples in policy pathways).

Prescriber attestation statement must be included: "I attest that this information is accurate and true, and that documentation supporting this information is available for review if requested by the plan."

Step Therapy and Prior Treatment Requirements

Indication	Preferred products (examples listed on form)	Provider requirement / action
Rheumatoid arthritis
adalimumab-adaz, Enbrel, Hadlima, Hyrimoz (Cordavis brand), Inflectra, Rinvoq, Simponi Aria, unbranded infliximab, Xeljanz/Xeljanz XR
Provider must document failure/intolerance/contraindication to ALL listed preferred products before approval of non-preferred Humira/biosimilar; form asks if treatment can be switched to a preferred product.

Indication	Prior therapy required	Step requirement detail
Hidradenitis suppurativa
At least 90 days of treatment with an oral antibiotic
Prior oral antibiotic trial of at least 90 days required to establish inadequate response; if Yes, proceed to continuation questions; if No, additional questions follow (intolerance/contraindication options available).

Indication	Prior therapy failure/intolerance or contraindication required	Provider requirement / action
Uveitis (non-infectious intermediate, posterior, or panuveitis)
Inadequate response or intolerance to corticosteroids or immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate)
Document prior failure, intolerance, or contraindication to corticosteroids or immunosuppressives for new starts; prescriber specialty (ophthalmologist or rheumatologist) is required and supporting documentation should be submitted.

Indication group	Prior trial expectation	Provider requirement / action
Immunotherapy-related inflammatory arthritis
Prior trial of corticosteroids and/or conventional synthetic DMARDs (methotrexate, sulfasalazine, leflunomide, hydroxychloroquine) unless intolerance/contraindication
Prior trial required unless documented intolerance or contraindication; prescriber must attest to available supporting documentation of prior therapy failure or intolerance.

Step Therapy

Prior therapy required — document failure/intolerance/contraindication

Many indications require prior trials of specified therapies with documented inadequate response, intolerance, or contraindication before a non‑preferred Humira or biosimilar will be approved.

Psoriasis: inadequate response or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless a clinical reason to avoid them (chunk 19).
Hidradenitis suppurativa: inadequate response to oral antibiotics (see HS-specific requirements).
Uveitis/pyoderma/Behcet's: inadequate response or intolerance to corticosteroids or immunosuppressives (e.g., azathioprine, cyclosporine, methotrexate).

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required — submit form to CVS Caremark

Prior authorization is required for Humira and the adalimumab biosimilars listed on the form; complete the CVS Caremark Specialty Programs prior authorization form and fax it to 1-866-237-5512, or contact CVS Caremark for a PA determination.

For PA questions contact CVS Caremark at 1-808-254-4414.
Send completed form to: CVS Caremark Specialty Programs Fax: 1-866-237-5512.

Step Therapy

Preferred‑product switch — document and submit preferred PA if switchable

The form asks whether the patient can be switched to a preferred product and instructs providers to obtain and submit the preferred‑product form if switching is possible; if switch is possible, the preferred‑product step applies.

If “Yes” to switching, obtain the form for the preferred product and submit the corresponding PA.
If “No,” continue with exception documentation for non‑preferred product.

Key Clinical / Coding Parameters

inv-09: BSA thresholds used in psoriasis severity stratification (reference)

BSA thresholds — reference>=3% to <10% or >=10% or <3%

Clinical implicationBSA bands determine routing of form questions and whether prior systemic/phototherapy trials are required

Associated requirementsFor 3%–<10% BSA, inadequate response or intolerance to phototherapy or systemic agents is queried

inv-11: BSA categories

Category: <3%Less than 3% of BSA

Category: 3%–<10%Greater than or equal to 3% to less than 10% of BSA

Category: >=10%

Dispense and Administration Locations

Billing Rule

Specify site of care — indicate dispense and administration locations

The PA form captures both where the drug will be dispensed and where it will be administered; options include pharmacy, office, outpatient hospital, inpatient hospital, home, infusion center, and others.

Dispense location options include Pharmacy, Office, Outpatient Hospital, Inpatient Hospital, etc.
Administration location options include Home, Office, Outpatient Hospital, Inpatient Hospital, Ambulatory Surgical, and others.

Humira and Adalimumab Biosimilars

Note

Humira and adalimumab biosimilars — product list and exception requirement

The form lists multiple adalimumab biosimilars and branded products by indication; requests for non‑preferred Humira or non‑preferred biosimilars require exception documentation as specified on the form.

Listed products include Abrilada; adalimumab‑aacf; adalimumab‑aaty; adalimumab‑adaz; adalimumab‑adbm; adalimumab‑fkjp; Amjevita; Cyltezo; Hadlima; Hulio; Humira; Hyrimoz; Idacio; Simlandi; Yuflyma; Yusimry.
Exception logic in the form asks whether the product is Humira or a non‑preferred biosimilar and routes to exception criteria if so.

Background

Adalimumab (Humira) and its biosimilars are used to treat multiple immune-mediated inflammatory diseases including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and hidradenitis suppurativa. The prior authorization form captures indication-specific requirements such as specialist involvement, prior therapy trials, and continuation-response measures to support coverage decisions.

Definitions and Terms

inv-24: Continuation_of_Therapy — Definition reference for continuation of therapy

Definition — Continuation of therapyRequest to continue therapy with the currently prescribed biologic/targeted drug; requires documentation of maintained clinical benefit or low disease activity since starting therapy

Verification neededForm asks whether patient is currently receiving the requested drug (including samples or manufacturer assistance)

Evidence examplesImprovement in indication-specific measures (e.g., BSA, joint counts, CDAI, UCEIS) supports continuation

inv-25: TB testing — Definition: Testing and management of latent or active tuberculosis before/while on biologic therapy

Definition — TB testingTesting and management of latent or active tuberculosis prior to or while on biologic therapy (PPD/IGRA/chest X-ray within 6 months)

Result-based actions

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyHumira (adalimumab) and Biosimilars — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

See AS prior‑therapy item requiring >=2 NSAIDs.

Plaque psoriasis (new start): Adult patient; prescriber is or in consultation with a dermatologist; meet BSA/severity thresholds and have had an inadequate response, intolerance, or contraindication to phototherapy or systemic agents (e.g., methotrexate, cyclosporine, acitretin) unless a clinical reason to avoid these therapies is documented.BSA thresholds as specified on form

Form lists BSA bands and prior‑therapy requirements.

Indication‑specific response evidence: Examples of acceptable evidence include: for psoriasis, reduction in BSA or symptom improvement; for hidradenitis suppurativa, reduction in abscess/inflammatory nodules or improved QoL; for uveitis, reduced flares or improved/stable AC cell/VH/visual acuity; for immunotherapy‑related inflammatory arthritis, low disease activity or symptom improvement.

Any one of the listed indication‑specific improvements typically suffices per the form's flow.

Prior biologic exposure status: Form asks whether the patient has ever received a biologic/targeted synthetic for the same condition; prior exposure may alter the flow but is collected for continuation tracking.

Positive prior biologic use often leads to 'No Further Questions' on the form.

Prior/concomitant therapy failure or contraindication: Where applicable, there must be inadequate response, intolerance, or contraindication to listed prior therapies (examples: phototherapy, methotrexate, cyclosporine, acitretin for psoriasis; >=90 days oral antibiotics for HS; corticosteroids or immunosuppressives for uveitis/pyoderma/Behcet's; conventional synthetic DMARDs for immunotherapy‑related arthritis).

Some prior‑therapy items include minimum durations (e.g., 90 days for antibiotics in HS).

New-start Indication Criteria

New‑start criteria require specialist involvement, age thresholds, prior conventional therapy trials, and specified trial durations where applicable.

Rheumatoid arthritis (new start): Diagnosis of moderately to severely active RA; prescriber is or in consultation with a rheumatologist; required biomarker testing and inadequate response to methotrexate given at >=15 mg per week for at least 3 months, or documented intolerance/contraindication to methotrexate.>= 3 months at >= 15 mg per week

See RA questions for biomarker and methotrexate requirements.

Psoriatic arthritis (new start): Adult patient; prescriber is or in consultation with a rheumatologist or dermatologist; inadequate response to conventional synthetic DMARD(s) at adequate dose/duration is required unless contraindication or intolerance is documented.

Form captures prior‑therapy and disease severity items.

See AS prior‑therapy item.

Plaque psoriasis (new start): Adult patient; prescriber is or in consultation with a dermatologist; meet BSA/severity thresholds and have had inadequate response or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless a clinical reason to avoid these therapies is documented.BSA thresholds as specified on form

Form lists BSA bands and prior‑therapy requirements.

Indication	Preferred products (examples listed on form)	Provider requirement / action
Ankylosing spondylitis
Cosentyx SQ, Enbrel, Rinvoq, Taltz, adalimumab-adaz, Hyrimoz (Cordavis brand), Hadlima
Document inadequate response, intolerable adverse event, or contraindication to ALL listed preferred products; indicate whether patient can be switched to a preferred product and submit supporting documentation if requesting a non-preferred product.

Documentation Required

Continuation Therapy — Provider Verification and Required Attestation

Continuation requests must include explicit verification that the member is currently receiving the requested drug (including samples or manufacturer patient assistance) and that the drug has produced clinical benefit.

Document current receipt of therapy (date of last dose, route, and dose).
If using samples or a patient assistance program, indicate this and provide supporting documentation.
Provide objective evidence of maintained response or improvement in disease-specific measures (see criteria group).
If a formulary/biosimilar preferred product is available, include rationale for continuing the non-preferred product.
Include prior therapy history demonstrating trials of required conventional treatments or reasons for not using them (intolerance, contraindication).
Prescriber signature/attestation and date.

Denial Risk

Clinical Response Required

Requests lacking documentation of positive clinical response, maintained remission, or objective disease improvement are at high risk for denial.

Absence of evidence for ongoing benefit (no clinical notes, labs, imaging, or disease scores)
Failure to verify current receipt of the requested drug (including samples/assistance)
No documentation of required prior therapies or documented contraindication/intolerance when prior therapy is a policy requirement

Prior Authorization

Continuation Verification and Provider Responsibilities

Prior authorization/continuation approval depends on full documentation: diagnosis, start date of therapy, objective measures of response, prior therapy trials and outcomes, and prescriber attestation. Failure to provide these will delay or prevent approval.

Ensure medical record includes diagnosis, baseline measures, and follow-up assessments showing response or maintained disease control.
Document trials of required prior therapies (e.g., methotrexate, NSAIDs, corticosteroids/immunosuppressives) or state contraindication/intolerance.
If continuing a non-preferred product, include clinical rationale for not switching to a preferred/biosimilar product.
Verify and document current receipt of drug, including samples or patient assistance use.
Include prescriber attestation and signature on the request form.

Documentation Required

Submit supporting documentation of prior failures/intolerance

When requesting a non‑preferred Humira or biosimilar, submit supporting documentation demonstrating inadequate response, intolerable adverse event, or contraindication to all listed preferred products for the relevant indication as requested on the form.

The form's exception questions explicitly state: ACTION REQUIRED: Please submit supporting documentation where asked.
Provide documentation for each listed preferred agent for the indication as indicated on the form.

Documentation Required

Prescriber attestation — documentation must be available for review

The prescriber must attest that documentation supporting clinical response, prior therapies, contraindications, or intolerances is available for review by CVS Caremark or the sponsor; the attestation is required on the form.

The form contains an attestation: “I attest that this information is accurate and true, and that documentation supporting this information is available for review.”
Prescriber signature and date are required.

Denial Risk

Accurate diagnosis and required documentation — risk of denial if missing

Requests missing an accurate diagnosis or required supporting documentation (for example documentation of inadequate response, intolerance, or contraindication to preferred products) may be denied.

Provide the most accurate diagnosis for the prescribed medication on the PA form.
Failure to submit requested supporting documentation for exception criteria can lead to denial.

Step Therapy

Hidradenitis suppurativa — prior oral antibiotic trial (≥90 days) required

For hidradenitis suppurativa new starts, document at least 90 days of treatment with an oral antibiotic prior to initiating a biologic; lack of this prior antibiotic trial may result in non‑approval for new starts.

Question 808 asks whether the patient had an inadequate response after at least 90 days of oral antibiotic treatment.
If “No,” the form proceeds to further questions; absence of a 90‑day trial may trigger non-approval.

Documentation Required

Reiterate: document prior therapy failure/intolerance/contraindication

Document prior therapy failures, intolerances, or contraindications to listed preferred agents as required by the exception and step‑therapy questions; the form repeatedly requires evidence for prior therapies across indications.

The exception sections (G–L) ask whether the patient has inadequate response/intolerance/contraindication to ALL listed preferred products and state ACTION REQUIRED: Please submit supporting documentation.
Multiple indication sections require documentation of prior therapy failure/intolerance before progressing to biologic approval.

Greater than or equal to 10% of BSA

inv-10: Methotrexate trial details for RA

Required durationMinimum 3 months of methotrexate therapy

Required doseDose must be greater than or equal to 15 mg per week

Alternate pathDocumented intolerance or contraindication to methotrexate satisfies requirement in lieu of trial

inv-12: Minimum antibiotic trial duration for hidradenitis suppurativa

Minimum oral antibiotic durationAt least 90 days of oral antibiotic therapy required prior to biologic for HS

Intolerance or contraindicationDocumented intolerance or contraindication to oral antibiotics may be accepted instead of the 90-day trial

Continuation routingA 'Yes' to adequate antibiotic trial leads to 'No Further Questions' for HS continuation

inv-13: Minimum age for uveitis continuation

Minimum age2 years of age (patient must be 2 years or older)

Continuation flowIf age criterion met, form continues to specialty and response questions for uveitis

Response measuresImprovement in AC cell, vitreous haze, visual acuity, flare reduction, or reduced steroid requirement are used as continuation evidence

Positive, negative, or unknown TB test results direct subsequent questions about latent TB treatment or active TB status

DocumentationDocument latent TB treatment initiation or completion as applicable

inv-26: BSA — Definition: Body surface area percentage affected by psoriasis

Definition — BSABody surface area percentage affected by psoriasis used to stratify severity (e.g., <3%, 3–<10%, ≥10%)

Use in flowBSA category determines whether further systemic/phototherapy failure questions are asked

Crucial body areasInvolvement of hands, feet, face, neck, scalp, genitals/groin, intertriginous areas is separately queried and can affect coverage decisions