Neighborhood Health Plan RI Humira Coverage

Coverage and Continuation Criteria

Ankylosing spondylitis / non-radiographic axial spondyloarthritis — Continuation criteria

Authorization of 12 months may be granted for adult members using the medication for ankylosing spondylitis or non-radiographic axial spondyloarthritis who achieve or maintain a positive clinical response as evidenced by improvement in any of the listed parameters:

AS/nr-axSpA response measures: Improvement from baseline in any of: functional status; total spinal pain; inflammation (e.g., morning stiffness); swollen joints; tender joints; C-reactive protein (CRP)improvement from baseline

Clinical response can be any listed improvement; authorization granted for 12 months if met.

Crohn's disease — Continuation criteria

Authorization of 12 months may be granted for members using the medication for moderately to severely active Crohn's disease who achieve or maintain remission or a positive clinical response as evidenced by improvement in any of the listed parameters:

Crohn's disease response measures: Remission OR improvement from baseline in any of: abdominal pain or tenderness; diarrhea; body weight; abdominal mass; hematocrit; appearance of the mucosa on endoscopy, CTE, MRE, or intestinal ultrasound; improvement on a disease activity scoring tool (e.g., CDAI)remission or improvement from baseline

Authorization for 12 months if remission or any listed improvement is documented.

Ulcerative colitis — Continuation criteria

Authorization of 12 months may be granted for members using the medication for moderately to severely active ulcerative colitis who achieve or maintain remission or a positive clinical response as evidenced by improvement in any of the listed parameters:

Ulcerative colitis response measures: Remission OR improvement from baseline in any of: stool frequency; rectal bleeding; urgency of defecation; C-reactive protein (CRP); fecal calprotectin (FC); appearance of the mucosa on endoscopy, CTE, MRE, or intestinal ultrasound; improvement on a disease activity scoring tool (e.g., UCEIS, Mayo score)remission or improvement from baseline

Authorization for 12 months if remission or any listed improvement is documented.

Plaque psoriasis — Continuation criteria

Authorization of 12 months may be granted for adult members using the medication for moderate to severe plaque psoriasis who achieve or maintain a positive clinical response as evidenced by either of the following:

Plaque psoriasis response measures: Reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)improvement from baseline

Either criterion suffices for 12-month authorization.

Hidradenitis suppurativa — Continuation criteria

Authorization of 12 months may be granted for members aged 12 years and older using the medication for moderate to severe hidradenitis suppurativa who achieve or maintain a positive clinical response as evidenced by any of the listed parameters:

Hidradenitis suppurativa response measures: Reduction in abscess and inflammatory nodule count from baseline; reduced formation of new sinus tracts and scarring; decrease in frequency of inflammatory lesions from baseline; reduction in pain from baseline; reduction in suppuration from baseline; improvement in frequency of relapses from baseline; improvement in quality of life from baseline; improvement on a disease severity assessment tool from baselineimprovement from baseline

Any listed improvement supports 12-month authorization.

Uveitis — Continuation criteria

Authorization of 12 months may be granted for members aged 2 years and older using the medication for non-infectious intermediate, posterior, or panuveitis who achieve or maintain a positive clinical response as evidenced by any of the listed parameters:

Uveitis response measures: Reduced frequency of disease flares compared to baseline; stability or improvement in anterior chamber (AC) cell grade compared to baseline; stability or improvement in vitreous haze (VH) grade compared to baseline; stability or improvement in visual acuity compared to baseline; reduction in glucocorticoid requirements from baseline; no new active inflammatory chorioretinal and/or inflammatory retinal vascular lesions relative to baselineimprovement or stability from baseline

Any listed improvement supports 12-month authorization.

Immune checkpoint inhibitor-related inflammatory arthritis — Continuation criteria

Authorization of 12 months may be granted for members using the medication for immunotherapy-related inflammatory arthritis who achieve or maintain a positive clinical response.

Immune checkpoint inhibitor-related toxicity response: Achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptomsclinical response

Supports 12-month authorization.

Other indications — Continuation criteria

Authorization of 12 months may be granted for other indications outlined in the coverage criteria section when the member achieves or maintains a positive clinical response.

Other covered indications: Member using the requested medication for an indicated condition who achieves or maintains low disease activity or improvement in signs and symptomsclinical response

12-month authorization possible.

Safety prerequisites

Universal conditions required for all indications

Universal safety prerequisites: Member must have a documented negative TB test within 12 months if biologic/targeted-synthetic-naïve; if screening is positive, further testing to exclude active TB (e.g., chest x-ray) and active TB must not be present; latent TB must be treated before initiation; member cannot use the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication.documented testing and treatment as applicable

Applies to all indications.

Do not administer the requested medication to members with active tuberculosis infection. The policy requires a documented negative TB test (TST or IGRA) within 12 months for members naïve to biologic or targeted-synthetic drugs; if screening is positive, further testing (for example, chest x-ray) must be done to exclude active disease and latent TB must be treated prior to initiation.

The reference sections included in the policy list supporting guideline and trial publications but do not state any additional explicit coverage exclusions beyond those noted in the main coverage criteria and safety prerequisites. Refer to the cited literature for clinical context and evidence supporting indications and management recommendations.

The reference material cited in the policy does not contain explicit statements labeling any uses of the medication as not medically necessary. The policy’s coverage stance and medical-necessity determinations are defined within the criteria sets and safety prerequisites rather than in the reference list.

Documentation, Authorization, and Safety Actions

Prior Authorization

12-month prior authorization for responders

Authorization of 12 months may be granted for members (including new members) who are using the requested medication for specified indications and who achieve or maintain a positive clinical response. For each indication, response should be documented from baseline and may include measures such as reduced disease activity, symptom improvement, or improvement on validated disease activity tools. Examples by indication include: ankylosing spondylitis and non-radiographic axial spondyloarthritis (functional status, spinal pain, inflammation, swollen/tender joints, CRP); Crohn's disease (abdominal pain/tenderness, diarrhea, weight, abdominal mass, hematocrit, mucosal appearance on imaging or endoscopy, CDAI); ulcerative colitis (stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on imaging or endoscopy, UCEIS/Mayo score); plaque psoriasis (reduction in BSA or improvement in signs/symptoms); hidradenitis suppurativa (reduced abscess/nodule count, reduced sinus tracts/scarring, decreased lesion frequency, pain, suppuration, relapses, QoL, disease severity tools); uveitis (reduced flare frequency, improved AC cell/vitreous haze/visual acuity, reduced steroid needs); immunotherapy-related inflammatory arthritis and other covered indications (low disease activity or symptom improvement).

12-month prior authorization may be granted for responders across covered indications
Documentation from baseline required to support clinical response for 12-month authorization

Clinical Background

Adalimumab and its biosimilars are indicated and used across a range of inflammatory and immune-mediated diseases including axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), inflammatory bowel disease (Crohn’s disease and ulcerative colitis), moderate to severe plaque psoriasis, hidradenitis suppurativa, non-infectious uveitis, and immunotherapy-related inflammatory arthritis. Continued authorization under this policy is tied to documented clinical benefit — typically an improvement from baseline or remission defined by indication-specific measures — and, when met, may support a 12-month authorization period. Universal safety prerequisites include documented TB screening within 12 months for biologic- or targeted-synthetic-naïve members and exclusion of active TB prior to administration.

Key Definitions and References

Remission (Crohn's disease)

DefinitionRemission in Crohn's disease: member is using the medication for moderately to severely active Crohn's disease and achieves or maintains remission.

Alternative response criterionAuthorization may also be granted for members who achieve or maintain a positive clinical response (i.e., low disease activity or improvement in signs/symptoms) rather than full remission.

Examples of supporting improvementsImprovement from baseline in any of: abdominal pain/tenderness; diarrhea; body weight; abdominal mass; hematocrit; mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound; disease activity score (e.g., CDAI).

Remission (ulcerative colitis)

DefinitionRemission in ulcerative colitis: member is using the medication for moderately to severely active ulcerative colitis and achieves or maintains remission.

Alternative response criterion

OpenPayer

Humira (adalimumab) and biosimilars — Coverage Criteria

Coverage and Continuation Criteria

Documentation, Authorization, and Safety Actions

Clinical Background

Key Definitions and References