CurrentUnitedHealthcarePolicy N/A

NC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Form and criteria for prior authorization of injectable biologic immunomodulator drugs for NC Medicaid beneficiaries with specified autoimmune conditions (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis). Applies to prescribers requesting PA for covered injectable biologics.

Policy Summary

PayerUnitedHealthcare

PolicyNC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the condition-specific prior authorization checklist documenting diagnosis, required prior therapy trials/failures, and infection screening (latent TB and Hepatitis B).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5disease-specific request sections on the form

3required infection screening items (TB, Hep B)

2TNF inhibitor prior-failure alternatives listed

NCapplicable state

Coverage Criteria for Injectable Biologic Immunomodulators

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Initial Therapy — Ankylosing Spondylitis

Ankylosing Spondylitis — covered when ALL of the following are met

Ankylosing Spondylitis PA criteria: 1) Diagnosis of Ankylosing Spondylitis; 2) Not currently on another injectable biologic immunomodulator; 3) Considered and screened for the presence of latent tuberculosis infection; 4) Tested with Hep B SAG and Core Ab; 5) Inadequate symptom relief from treatment with at least two NSAIDs OR 6) Unable to receive NSAIDs due to contraindications; 7) Clinical evidence of severe or rapidly progressing disease; 8) Trial and failure of Cosentyx, Enbrel, or Humira OR documented clinical reason the beneficiary cannot try these agents.

All items are presented as checkboxes on the form.

Initial Therapy — Psoriatic Arthritis

Psoriatic Arthritis — covered when ALL of the following are met

Psoriatic Arthritis PA criteria: 1) Documented definitive diagnosis of Psoriatic Arthritis; 2) Age ≥ 18 years; 3) Not currently on another injectable biologic immunomodulator; 4) Considered and screened for the presence of latent tuberculosis infection (note: latent TB screening not required for Otezla); 5) Tested with Hep B SAG and Core Ab; 6) Documented inadequate response to or inability to take methotrexate; 7) Trial and failure of Cosentyx, Enbrel, or Humira OR documented clinical reason the beneficiary cannot try these agents.

Otezla exception for TB screening is noted on the form.

Initial Therapy — Rheumatoid Arthritis

Rheumatoid Arthritis — covered when ALL of the following are met

Rheumatoid Arthritis PA criteria: 1) Diagnosis of Rheumatoid Arthritis; 2) Not currently on another injectable biologic immunomodulator; 3) Considered and screened for the presence of latent tuberculosis infection; 4) Tested with Hep B SAG and Core Ab; 5) Therapeutic failure/inadequate response with methotrexate or at least one disease-modifying antirheumatic drug (e.g., leflunomide, hydroxychloroquine, minocycline, sulfasalazine) OR 6) Unable to receive methotrexate/DMARD due to contraindication or intolerance; 7) Clinical evidence of severe or rapidly progressing disease; 8) Trial and failure of Enbrel or Humira OR documented clinical reason the beneficiary cannot try these agents.

Items appear across two form sections.

Initial Therapy — Ulcerative Colitis

Ulcerative Colitis (Adult) — covered when ALL of the following are met

Ulcerative Colitis PA criteria: 1) Diagnosis of ulcerative colitis; 2) Not currently on another injectable biologic immunomodulator; 3) Considered and screened for the presence of latent tuberculosis infection; 4) Tested with Hep B SAG and Core Ab; 5) Trial and failure of Humira OR documented clinical reason the beneficiary cannot try Humira.

Prescriber signature required on the form.

The Psoriatic Arthritis section of the PA form specifically notes an exception for Otezla (apremilast): latent tuberculosis screening is not required when Otezla is being considered. This is documented on the form where the latent TB screening item is annotated with the parenthetical note indicating the TB screening requirement does not apply to Otezla (apremilast).

The PA form requires condition-specific documentation and completion of checklist items. Requests that lack a documented diagnosis, missing required prior therapy trials or documented failures (or clinical justification for not trying listed agents), or absence of required infection screening (latent tuberculosis consideration/screening and Hepatitis B surface antigen and core antibody testing) do not meet the form’s stated coverage criteria and therefore risk denial or an incomplete request.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required: Complete Condition-Specific Checklist

Prior authorization requires completion of the condition-specific checklist demonstrating the documented diagnosis, screening, and that the beneficiary is not currently on another injectable biologic immunomodulator. Complete the checklist section that matches the beneficiary's condition (e.g., Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis) and ensure prescriber signature and date are provided.

Complete the condition-specific checklist in full
Confirm beneficiary is not on another injectable biologic immunomodulator
Include prescriber signature and date

Step Therapy

Step Therapy / Prior Trial Requirement

The form requires documentation of prior trials and failures of specific agents as applicable to the condition (examples on the checklist include Cosentyx, Enbrel, Humira, methotrexate, and other DMARDs). If the beneficiary cannot try a listed agent, a clinical rationale must be supplied.

Document prior trial(s) and failure(s) of required agents (e.g., Cosentyx, Enbrel, Humira)
Or provide clinical reason why an agent cannot be used
For RA/other indications, document trial/failure of methotrexate or other DMARDs if required

Documentation Required

Required Form Fields

Required form fields must be completed for submission: beneficiary and prescriber information, drug name/strength/quantity, requested length of therapy, and prescriber signature with date. Missing these fields will delay review.

Beneficiary name, ID#, DOB, gender
Prescribing provider NPI and requester contact info
Drug name, strength, quantity per 30 days, length of therapy
Prescriber signature and date

Denial Risk

Documentation Omissions Risking Denial

Failure to document required diagnosis-specific criteria (diagnosis, prior trials/failures, TB and Hep B screening, contraindications/intolerances, and clinical severity when requested) or omitting the prescriber signature/date may result in denial or processing delays. Provide explicit screening results (latent TB, Hep B SAG/Core Ab) and clinical rationale where exemptions are claimed.

Document TB and Hepatitis B screening results where requested
Record contraindications/intolerances if agent trials not completed
Provide clinical evidence for severe or rapidly progressing disease when requested
Omitted prescriber signature/date risks denial

Definitions

Prior trial/failure definition

DefinitionDocumented inadequate response, intolerance, contraindication, or inability to use listed prior therapies (e.g., NSAIDs, methotrexate/DMARDs, or specified biologics such as Cosentyx, Enbrel, Humira).

Examples of prior therapies referenced on formAt least two NSAIDs (Ankylosing Spondylitis) or methotrexate/DMARDs (Rheumatoid Arthritis) or specific biologics (Cosentyx, Enbrel, Humira).

How prior failure is demonstratedForm requires selection confirming prior trial and failure of named agents or documentation of a clinical reason the beneficiary cannot try those agents.

Exceptions/allowancesA documented clinical reason may be accepted in lieu of an attempted trial of the listed agents (e.g., contraindication or intolerance).

Where used in the formAppears across disease-specific sections: Ankylosing Spondylitis (trial of Cosentyx/Enbrel/Humira), Psoriatic Arthritis (same biologics), Rheumatoid Arthritis (Enbrel or Humira), Ulcerative Colitis (Humira).

Infection screening

DefinitionAssessment and documentation of latent tuberculosis screening and Hepatitis B surface antigen (SAG) and core antibody (Core Ab) testing prior to biologic initiation.

Required elements on formA checkbox confirming the beneficiary was considered and screened for latent tuberculosis and a checkbox confirming Hep B SAG and Core Ab testing have been performed.

Disease-specific notesTB screening is requested for Ankylosing Spondylitis, Psoriatic Arthritis (note: not required for Otezla), Rheumatoid Arthritis, and Ulcerative Colitis; Hep B testing is requested in all disease sections.

PurposeTo identify latent infections that could be reactivated by biologic immunomodulator therapy prior to approval of injectable biologics.

OpenPayer

NC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Coverage Criteria for Injectable Biologic Immunomodulators

Provider Actions and Prior Authorization Requirements

Background

Definitions