CurrentColorado Rocky Mountain Health PlansPolicy N/A

NC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Form and criteria checklist used by NC Medicaid for prior authorization of injectable biologic immunomodulator therapies for ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and adult ulcerative colitis; completed by prescribers for Colorado Rocky Mountain Health Plans members governed by NC Medicaid. Affects prescribing providers seeking PA for covered biologic injectables.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed condition-specific PA checklist including diagnosis, prior therapy trials/failures or contraindications, TB and Hep B screening, and prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5distinct indication-specific request sections

3common prior biologic comparators

3screening/lab checks required

Yescheckbox format used

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Initial therapy — Ankylosing Spondylitis

Covered when ALL of the following are met:

AS_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; 6) Unable to receive NSAIDs due to contraindications (if applicable); 7) Clinical evidence of severe or rapidly progressing disease; 8) Trial and failure of Cosentyx, Enbrel, or Humira OR a documented clinical reason the beneficiary cannot try Cosentyx, Enbrel, or Humira.

All checklist items are presented as yes/no checkboxes on the form.

Initial therapy — Psoriatic Arthritis

Covered when ALL of the following are met:

PsA_criteria: 1) Documented definitive diagnosis of psoriatic arthritis; 2) Age 18 years or older; 3) Not currently on another injectable biologic immunomodulator; 4) Considered and screened for the presence of latent tuberculosis infection (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 a documented clinical reason the beneficiary cannot try Cosentyx, Enbrel, or Humira.

Age restriction and Otezla exception noted on form.

Initial therapy — Rheumatoid Arthritis

Covered when ALL of the following are met:

RA_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 to 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 a documented clinical reason the beneficiary cannot try Enbrel or Humira.

Form lists DMARD examples and asks for prior trial/failure documentation.

Initial therapy — Ulcerative Colitis (Adult)

Covered when ALL of the following are met:

UC_criteria: 1) Diagnosis of ulcerative colitis (adult); 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 a documented clinical reason the beneficiary cannot try Humira.

Applies to adult patients per form heading.

Otezla (apremilast) is noted on the Psoriatic Arthritis checklist with an explicit exception: screening for latent tuberculosis is not required for Otezla. When completing a PA for Psoriatic Arthritis where Otezla is the agent requested, the latent TB checkbox need not be selected as a prerequisite for approval per the form language.

Prior authorization requests must include basic diagnostic confirmation and relevant screening results before injectable biologic immunomodulators will be considered. The form requires documentation of a definitive diagnosis, confirmation that the beneficiary is not already on another injectable biologic, and laboratory screening where applicable — specifically consideration/screening for latent tuberculosis and testing for Hepatitis B surface antigen (Hep B SAG) and core antibody (Core Ab). In addition, most indication sections require documented prior trials and failures (or documented contraindications/intolerance) of specified conventional therapies (e.g., methotrexate or other DMARDs) and/or specified comparator biologics such as Cosentyx, Enbrel, or Humira before the requested agent will meet criteria.

Prescriber Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization requires completion of the condition-specific checklist that corresponds to the patient’s diagnosis (e.g., Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis). The completed checklist must be submitted with the PA request and supporting clinical documentation (progress notes, prior treatment records, lab/test results).

Submit the checklist for the specific condition included with this policy.
Attach relevant clinical notes, prior therapy documentation, and lab results (e.g., TB screen, Hep B serology).

Documentation Required

Required Form Fields and Prescriber Signature

The PA form must include all required administrative fields and a prescriber signature. Missing fields or unsigned requests may delay review or result in denial.

Patient name, date of birth, and beneficiary ID
Prescribing provider name and NPI number
Requester contact name and phone number (with extension if applicable)
Drug name, strength, quantity per 30 days, and requested length of therapy
Prescriber signature and date (hand-signed or electronic signature as allowed)

Step Therapy

Step Therapy / Biologic Trial Requirement

Step therapy requirements apply: prior trials of specified biologics or alternative therapies must be documented, or a clear clinical rationale provided for bypassing step therapy (e.g., intolerance, contraindication, or prior meaningful adverse event).

Document trials and failures of the required biologics listed on the checklist (for example: Cosentyx, Enbrel, Humira where specified)
If step therapy is being bypassed, include detailed clinical justification and supporting records
Indicate dates, doses, and reasons for discontinuation of prior biologic or DMARD therapy

Denial Risk

Missing Required Checklist Documentation — Denial Risk

Failure to include the completed condition-specific checklist and required clinical documentation places the request at risk for denial. Common missing items include the documented diagnosis, prior therapy trials (with dates/reasons for failure), and TB/Hepatitis B screening results.

Checklist not submitted or incomplete — denial risk
No documentation of prior biologic/DMARD trials or reasons for failure — denial risk
Absent TB screening or Hep B serology documentation — denial risk

OpenPayer

NC Medicaid Pharmacy Prior Authorization Request — injectable biologic immunomodulators

Coverage Criteria — Initial Therapy

Prescriber Requirements and Prior Authorization Actions

Key Definitions

Policy Background