CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adalimumab (and biosimilars) medical necessity and coverage criteria

Defines clinical coverage, prior authorization criteria, continuation criteria, dosing, quantity limits and required documentation for adalimumab and its biosimilars for Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdalimumab (and biosimilars) medical necessity and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 15, 2020

Next Review DateN/A

Key ActionSubmit the member’s chart or medical record demonstrating medical necessity per the indication-specific criteria to support prior authorization (typically granted for 12 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTypical authorization period

365 daysLook-back period for prior biologic claim

1.6 ml / 3.2 mlExample product quantity limits per 28 days

Covered Indications and Medical Necessity

Covered Indications (FDA-approved and compendial)

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ALL of the following

- FDA-approved indications (examples listed)
  - Polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥2 years
  - Moderately to severely active rheumatoid arthritis (RA) in adults
  - Active psoriatic arthritis (PsA)
  - Active ankylosing spondylitis (AS) / axial spondyloarthritis
  - Moderately to severely active Crohn's disease (CD) in adults & pediatrics (age cutoffs included in dosing)
  - Moderately to severely active ulcerative colitis (UC) in adults & pediatrics (age cutoffs included in dosing)
  - Moderate to severe hidradenitis suppurativa (≥12 years)
  - Moderate to severe chronic plaque psoriasis (adults) when systemic therapy/phototherapy or other systemic agents are inappropriate
  - Non-infectious intermediate, posterior, and panuveitis (≥2 years)
- Compendial / other supported uses
  - Axial spondyloarthritis (non-radiographic)
  - Behcet's disease
  - Pyoderma gangrenosum
  - Oligoarticular juvenile idiopathic arthritis
- Submission of member chart/medical record documenting medical necessity for the applicable indication is required
- No concomitant use with another injectable biologic response modifier or listed targeted synthetic DMARDs
  Examples listed (etanercept, infliximab, secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, apremilast, tofacitinib, baricitinib, upadacitinib, etc.)
- Documented negative TB screen within 6 months prior to initiating therapy for biologic/tsDMARD-naive patients (PPD, IGRA, or chest X-ray)
  If positive, further testing to exclude active disease and start of TB treatment prior to adalimumab initiation required

Continuation of Therapy

Continuation (usually 12 months) requires documentation of positive clinical response or maintenance of response for the indication:

ALL of the following

Formulary adalimumab biosimilar will continue within quantity limit if there is at least one claim within the last 365 days for adalimumab or another biologic
Clinical response evidence (examples by indication)
- RA: ≥20% improvement from baseline in tender joint count, swollen joint count, pain, or disability
- PJIA: low disease activity or improvement in signs/symptoms (e.g., number of joints with limitation of movement, functional ability)
- PsA: improvement in swollen/tender joints, enthesitis, dactylitis, skin/nail involvement
- AS/axial SpA: improvement in functional status, total spinal pain, inflammation (morning stiffness)
- CD: remission or improvement in abdominal pain/tenderness, diarrhea, weight, abdominal mass, hematocrit, endoscopic mucosa, CDAI score
- UC: improvement in stool frequency, urgency, rectal bleeding, CRP, endoscopic mucosa, fecal calprotectin, UCEIS/Mayo score
- Psoriasis: reduction in BSA affected and improvement in signs/symptoms (itching, redness, scaling, etc.)
- HS: reduction in abscess/inflammatory nodule count, reduced new sinus tracts/scarring, pain reduction, decreased lesion frequency, reduced suppuration, QoL improvement, fewer relapses
- Uveitis: reduced frequency of flares, stability/improvement in anterior chamber cell grade, vitreous haze, visual acuity, reduced glucocorticoid requirement, no new active inflammatory retinal/chorioretinal lesions

Product-level Codes and Quantity Limits

NDC / product-level quantity limits (Hadlima, Hyrimoz, Hulio / examples)NDC|productCovered

Hadlima (adalimumab-bwwd) 40 mg/0.4 mL	Quantity Limit = 1.6 mL per 28 days; Daily Dose Quantity Limit = 0.06
Hadlima (adalimumab-bwwd) 40 mg/0.8 mL	Quantity Limit = 3.2 mL per 28 days; Daily Dose Quantity Limit = 0.12
Hyrimoz (adalimumab-adaz) 40 mg/0.4 mL	Quantity Limit = 1.6 mL per 28 days; Daily Dose Quantity Limit = 0.06
Hyrimoz (adalimumab-adaz) 80 mg/0.8 mL	Quantity Limit = 1.6 mL per 28 days (2 per 28 days); Daily Dose Quantity Limit = 0.06
Hulio (adalimumab-fkjp) 40 mg/0.4 mL	Quantity Limit = 2 per 28 days; Daily Dose Quantity Limit = 0.072
Hulio (adalimumab-fkjp) 40 mg/0.8 mL	Quantity Limit = 4 per 28 days; Daily Dose Quantity Limit = 0.15

Prior Authorization, Documentation, and Billing Rules

Prior Authorization

Prior authorization required with documentation

Submission of the member's chart/medical record demonstrating medical necessity per the indication‑specific criteria is required for approval. Authorizations are typically granted for 12 months.

Typical authorization period = 12 months

Documentation Required

Specialist involvement

Many indications require that adalimumab be prescribed by or in consultation with an appropriate specialist; examples include rheumatology, dermatology, gastroenterology, or ophthalmology as applicable.

Documentation Required

TB screening and management

Documented negative TB screening (PPD, IGRA, or chest X‑ray) within 6 months prior to initiating therapy is required for patients naive to biologic DMARDs or targeted synthetic DMARDs; if screening is positive, further evaluation to exclude active TB and initiation of TB treatment prior to starting adalimumab must be documented.

TB screening window: negative test within 6 months prior to biologic initiation

Step Therapy

Step requirements or prior therapy trials

For many indications providers must document inadequate response or intolerance to specified non‑biologic therapies (examples: ≥3 months of methotrexate at adequate dosing for RA; phototherapy or systemic agents for psoriasis; ≥90 days of oral antibiotics for hidradenitis suppurativa; corticosteroids or immunosuppressives for uveitis) prior to approval.

Billing Rule

Adhere to product-specific quantity limits

Dispensed quantity must adhere to the product‑specific quantity limits per 28 days for the specific adalimumab presentation; billing that exceeds these limits may be denied.

See NDC / product‑level quantity limits (examples include Hadlima, Hyrimoz, Hulio) in the policy's quantity limit table

Numeric/Clinical Thresholds and Defined Terms

Key clinical thresholds

TB screening windowNegative TB test within 6 months prior to biologic initiation (PPD, IGRA, or chest X-ray)

RA methotrexate trialAt least 3 months at adequate dosing (e.g., titrated to 20 mg/week) unless intolerance or contraindication

Psoriasis severityAt least 10% body surface area (BSA) affected or involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

HS antibiotic trialAt least 90 days of oral antibiotics without adequate response (or intolerance/contraindication to oral antibiotics)

Definitions (terms used in this policy)

BSABody surface area

DMARDDisease-modifying antirheumatic drug

tsDMARDTargeted synthetic DMARD (e.g., JAK inhibitors)

PPDTuberculin skin test (purified protein derivative)

IGRAInterferon-gamma release assay for TB

Clinical and Administrative Background

Adalimumab is a tumor necrosis factor-alpha (TNF-α) inhibitor approved for multiple inflammatory and autoimmune indications. This policy aligns coverage with FDA-approved labeling and compendial uses, and requires that prescribed dosing and quantities fall within FDA labeling or compendia-supported dosing guidelines.

Where applicable, the policy requires involvement of an appropriate specialist (for example, rheumatology, dermatology, gastroenterology, or ophthalmology) in prescribing or via documented consultation prior to authorization, and prior authorization requires submission of the member’s chart or medical record documenting medical necessity for the applicable indication.

Before initiating adalimumab or another biologic/targeted synthetic DMARD for members naive to those therapies, the policy enforces TB screening: documentation of a negative TB test (tuberculin skin test [PPD], an interferon-gamma release assay [IGRA], or a chest X-ray) within 6 months prior to starting therapy. If TB screening is positive, further testing to exclude active disease and initiation of TB treatment prior to starting the requested medication must be documented.

The policy also enforces product-level dispensing limits; examples of quantity limits per 28 days are provided for adalimumab biosimilars (e.g., Hadlima, Hyrimoz, Hulio) and billing that exceeds these limits may be denied.