CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rinvoq (upadacitinib) coverage and prior authorization criteria

Policy defines coverage, documentation, prescriber specialty, authorization durations, continuation criteria, contraindications, and dosing limit note for Rinvoq (upadacitinib) across FDA-approved indications (RA, PsA, AD, UC, AS, nr-axSpA, CD). It specifies required supporting documentation for initial and continuation requests and TB screening and concomitant therapy restrictions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRinvoq (upadacitinib) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFor initial requests submit chart notes, medical records, or claims history supporting prior medications tried and responses (indication-specific); for AD include affected body surface area and prior topical/systemic therapies or documentation why they are not advisable.

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

7Covered FDA indications

12 moTypical authorization duration (most indications)

4 moInitial authorization duration for atopic dermatitis

>=10%AD BSA threshold

Scope: This policy states Rinvoq (upadacitinib) is covered with criteria for the FDA‑approved indications: RA, PsA, atopic dermatitis (≥12 years), ulcerative colitis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, and Crohn's disease. Coverage is contingent on meeting indication‑specific approval criteria including prior therapy failures or intolerances (typically prior TNF inhibitor failure or other specified therapies), required safety screening for tuberculosis, prohibition on concomitant use with other biologic/targeted immunomodulators or certain potent immunosuppressants, and that the prescription be from or in consultation with the required specialist(s).

Initial Therapy Criteria

Covered Indications (general)

Covered when ANY of the following FDA-approved indications are present and all other approval criteria in this section are met:

Rheumatoid arthritis (RA)

Psoriatic arthritis (PsA)

Atopic dermatitis (AD)

Ulcerative colitis (UC)

Ankylosing spondylitis (AS)

Non-radiographic axial spondyloarthritis (nr-axSpA)

Crohn's disease (CD)

For all indications

For all indications, ALL of the following must be met:

ALL of the following

Documented negative tuberculosis (TB) screening test within the preceding 6 months if the member is biologic- or targeted-therapy naïve or if required per product labeling.
No concomitant use of another biologic therapy, another targeted synthetic immunomodulator, or other potent systemic immunosuppressant unless explicitly allowed by the prescribing information and payer policy.

Authorization durations and specific criteria by indication - Initial authorization

Initial authorization durations and indication-specific criteria:

Rheumatoid arthritis (RA)

Authorization of 12 months may be granted when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic DMARD for RA (e.g., tofacitinib, baricitinib).

Psoriatic arthritis (PsA)

Authorization of 12 months may be granted when the member has had an inadequate response or intolerance to at least one TNF inhibitor.
Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug indicated for PsA (e.g., tofacitinib, apremilast).

Prescriber specialty requirements

Prescriber specialty must be one of the following (ANY):

Rheumatologist (for RA, PsA, AS, nr-axSpA)

Dermatologist or allergist/immunologist (for atopic dermatitis; dermatologist may also manage PsA in consultation)

Gastroenterologist (for UC and CD)

Dosage and administration

ALL approvals are subject to adherence to dosing limits per FDA labeling, compendia, and payer clinical guidance:

Approvals may be subject to dose and quantity limits consistent with FDA-approved labeling, compendia, and clinical practice guidelines.

Continuation Therapy Criteria

Continuation (renewal) authorization criteria

Rheumatoid arthritis (RA): Authorization of 12 months may be granted when member achieves or maintains positive clinical response evidenced by >=20% improvement from baseline in tender joint count, swollen joint count, pain, or disability.>= 20% improvement

Psoriatic arthritis (PsA): Authorization of 12 months may be granted when member achieves or maintains positive clinical response evidenced by low disease activity or improvement in signs and symptoms (e.g., swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement).

Atopic dermatitis (AD): Authorization of 12 months may be granted for members >=12 years who achieve or maintain positive clinical response evidenced by low disease activity (clear or almost clear skin) or improvement in signs/symptoms (redness, itching, oozing/crusting).

Ulcerative colitis (UC): Authorization of 12 months may be granted when member achieves or maintains remission or positive clinical response evidenced by improvement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on imaging/endoscopy, or disease activity scoring tools (e.g., UCEIS, Mayo score).

Ankylosing spondylitis (AS) and nr-axSpA: Authorization of 12 months may be granted when member achieves or maintains positive clinical response evidenced by improvement in functional status, total spinal pain, or inflammation (e.g., morning stiffness).

Crohn's disease (CD): Authorization of 12 months may be granted when member achieves or maintains remission or positive clinical response evidenced by improvement in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on imaging/endoscopy, or improvement on disease activity tools (e.g., CDAI).

Contraindications and Concomitant Therapy Exclusions

Contraindications and exclusions: active tuberculosis is a contraindication until evaluated and treated — a documented negative TB test (PPD, IGRA, or chest x‑ray) within 6 months is required for biologic/targeted‑naïve members and positive tests require further evaluation and exclusion of active disease before initiation. The policy prohibits concurrent use of Rinvoq with other biologic drugs, targeted synthetic drugs, or potent immunosuppressants (e.g., azathioprine, cyclosporine), and claims may be denied if Rinvoq is used concomitantly with these agents.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Submit documentation for initial PA

Submit chart notes, medical records, or claims history that document prior medications tried and responses for the requested indication. For atopic dermatitis include documentation of affected body surface area and prior topical and systemic therapies or rationale why those therapies are not advisable.

Chart notes/medical records or claims history of prior medications and responses (indication-specific)
For atopic dermatitis: documentation of affected body surface area
For atopic dermatitis: documentation of prior topical therapies and systemic therapies or why they are not advisable

Documentation Required

Continuation documentation

For continuations, provide chart notes or medical record documentation showing a positive clinical response per the indication-specific measures (for example low disease activity or improvement in signs/symptoms for dermatologic or rheumatologic conditions, or remission/improvement on disease activity tools for inflammatory bowel disease).

RA/PsA/AS/nr-axSpA: documentation supporting positive clinical response
AD: documentation of low disease activity or improvement in signs/symptoms
UC/CD: documentation of remission or improvement (clinical, labs, endoscopy, or disease activity scores)

Prior Authorization

TB screening requirement

Obtain and document a negative TB screen (PPD, IGRA, or chest x-ray) within 6 months prior to initiating therapy for members naïve to biologic/targeted synthetic drugs. If screening is positive, confirm no active disease before starting Rinvoq; do not administer if active TB is present and latent TB must be treated prior to initiation.

Negative TB test (PPD, IGRA, or chest x-ray) within 6 months prior to initiation for biologic/targeted synthetic–naïve members
If TB test positive: further testing to exclude active disease before initiating therapy
If active TB: do not administer Rinvoq
If latent TB: start TB treatment before initiation

Denial Risk

Concomitant therapy prohibition

Claims may be denied if Rinvoq is used at the same time as another biologic, targeted synthetic agent, or a potent immunosuppressant. Confirm the member is not receiving prohibited concomitant therapies before submitting the request.

Examples of prohibited concomitant therapies: other biologic drugs, targeted synthetic drugs
Examples of potent immunosuppressants: azathioprine, cyclosporine

Billing Rule

Prescriber specialty requirement

The prescriber must be the appropriate specialist or consult with one as specified by indication to meet authorization requirements.

Rheumatoid arthritis, ankylosing spondylitis, nr-axSpA: rheumatologist
Psoriatic arthritis: rheumatologist or dermatologist
Atopic dermatitis: dermatologist or allergist/immunologist
Ulcerative colitis and Crohn's disease: gastroenterologist

Background

Background: Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor indicated for multiple inflammatory conditions. The policy aligns coverage to FDA‑approved indications and requires prior therapeutic failures/intolerances (commonly to TNF inhibitors or other specified therapies), tuberculosis screening prior to initiation, and restrictions on combining Rinvoq with other biologic/targeted or potent immunosuppressive agents to mitigate infection and safety risks.

Key thresholds

Atopic dermatitis BSA threshold>= 10% body surface area OR crucial body areas affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Atopic dermatitis initial authorization duration4 months when AD criteria met

Rheumatoid arthritis response threshold>= 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

Rheumatoid arthritis typical authorization duration12 months when response criterion met