CurrentUnitedHealthcarePolicy N/A

Prior authorization checklist for injectable biologic immunomodulators

Form template governing prior authorization requests for injectable biologic immunomodulator therapy for multiple indications (ankylosing spondylitis, PJIA, pediatric and adult plaque psoriasis, psoriatic arthritis, rheumatoid arthritis) for North Carolina Medicaid beneficiaries.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization checklist for injectable biologic immunomodulators

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete the indication-specific checklist confirming diagnosis, TB and Hep B screening, and documentation of required prior therapy failures or contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7distinct indication-specific request sections on the form

screening itemscommon safety checks

requiredprior therapy requirements

NCapplicable state

Indication-specific Coverage Criteria

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Ankylosing Spondylitis

Covered when ALL of the following are met for Ankylosing Spondylitis

Ankylosing Spondylitis PA criteria: 1) Diagnosis of ankylosing spondylitis; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 4) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody; 5) Beneficiary experienced inadequate symptom relief from treatment with at least two NSAIDs or is unable to receive NSAIDs due to contraindication; 6) Clinical evidence of severe or rapidly progressing disease when applicable.

Items include alternatives for NSAID contraindication and disease severity checks.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Covered when ALL of the following are met for Polyarticular Juvenile Idiopathic Arthritis (PJIA)

PJIA PA criteria: 1) Diagnosis of polyarticular juvenile idiopathic arthritis; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 4) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody; 5) Beneficiary tried one systemic corticosteroid (e.g., prednisone, methylprednisolone) or methotrexate, leflunomide, or sulfasalazine with inadequate response, or is unable to take these therapies due to contraindications or intolerance; 6) Indicate if PJIA subtype is enthesitis-related arthritis when applicable.

Plaque Psoriasis (Pediatric)

Covered when ALL of the following are met for Pediatric Plaque Psoriasis (NC Medicaid prior authorization additions included)

Pediatric Plaque Psoriasis PA criteria: 1) Diagnosis of plaque psoriasis and candidate for systemic therapy or phototherapy; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 4) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody; 5) Therapeutic failure/inadequate response to or contraindication/intolerance to methotrexate; 6) Body surface area (BSA) involvement >= 3% OR involvement of palms/soles/head/neck/genitalia causing disruption in normal daily activities and/or employment.BSA >= 3%

NC Medicaid prior authorization requires methotrexate failure (or contraindication) and BSA/special-site involvement criteria.

Plaque Psoriasis (Adult)

Covered when ALL of the following are met for Adult Plaque Psoriasis

Adult Plaque Psoriasis PA criteria: 1) Documented definitive diagnosis of moderate-to-severe chronic plaque psoriasis; 2) Age >= 18 years; 3) Beneficiary is not currently on another injectable biologic immunomodulator; 4) Beneficiary has been considered and screened for the presence of latent tuberculosis infection (screening not required for Otezla); 5) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody (testing not required for Otezla); 6) Body surface area (BSA) involvement >= 3% OR 7) Involvement of the palms, soles, head and neck, or genitalia causing disruption in normal daily activities and/or employment; 8) Failed phototherapy AND one of (acitretin [Soriatane], methotrexate, or cyclosporine) or has contraindication/intolerance to these therapies; 9) Trial and failure of Cosentyx, Enbrel, or Humira OR a documented clinical reason the beneficiary cannot try these agents; 10) For Siliq, beneficiaries, providers, and pharmacies must be appropriately registered in the Siliq REMS program.BSA >= 3%

Step therapy includes required trial/failure of specified systemic and biologic therapies per the form.

Psoriatic Arthritis

Covered when ALL of the following are met for Psoriatic Arthritis

Psoriatic Arthritis PA criteria: 1) Documented definitive diagnosis of psoriatic arthritis; 2) Age >= 18 years (or >= 2 years for Simponi Aria where applicable); 3) Beneficiary is not currently on another injectable biologic immunomodulator; 4) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 5) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody (testing not required for Otezla); 6) Documented inadequate response to or inability to take methotrexate.

Rheumatoid Arthritis

Covered when ALL of the following are met for Rheumatoid Arthritis

Rheumatoid Arthritis PA criteria: 1) Diagnosis of rheumatoid arthritis; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 4) Beneficiary has been tested with Hepatitis B surface antigen (SAG) and core antibody; 5) Therapeutic failure/inadequate response to methotrexate or at least one disease-modifying antirheumatic drug (DMARD) (e.g., leflunomide, hydroxychloroquine, minocycline, sulfasalazine) OR beneficiary is unable to receive these therapies due to contraindication or intolerance; 6) Clinical evidence of severe or rapidly progressing disease when applicable.

NC Medicaid prior authorization notes include inability to receive methotrexate/DMARDs as an alternative pathway and requests prescriber signature certifying accuracy.

No specific exclusions are listed on the prior authorization form for injectable biologic immunomodulators. Note that the adult plaque psoriasis section explicitly states that latent tuberculosis screening and Hepatitis B surface antigen and core antibody testing are not required for Otezla, reflecting an Otezla-specific exception to those otherwise-common safety checks.

Requests that do not document completion of the indication-specific requirements on the form risk being considered not medically necessary. Specifically, prior authorization requires documentation of diagnosis, confirmation the beneficiary is not currently receiving another injectable biologic, completion of recommended screening for latent tuberculosis and Hepatitis B (unless the Otezla exception applies), and evidence of required prior therapy trials or documentation of contraindication/intolerance where applicable (for example, trials of two NSAIDs for ankylosing spondylitis; systemic steroid or methotrexate/leflunomide/sulfasalazine for PJIA; methotrexate failure for pediatric psoriasis; phototherapy plus one systemic agent for adult plaque psoriasis; or methotrexate/DMARD failure for rheumatoid arthritis).

Prior Authorization Requirements and Provider Responsibilities

Prior Authorization

Prior Authorization Checklist Requirements

Prior authorization requires completion of the indication-specific checklist on the prior authorization form. The checklist must affirm the documented diagnosis, confirm the beneficiary is not currently receiving another injectable biologic immunomodulator (unless otherwise specified), and verify screening for latent tuberculosis and Hepatitis B (HBsAg and core antibody) where required by indication or product labeling.

Complete the indication-specific checklist for the requested diagnosis (e.g., Ankylosing Spondylitis, PJIA, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis).
Confirm beneficiary is not on another injectable biologic immunomodulator (unless exception noted).
Document tuberculosis screening (TB) consideration and result where applicable.
Document Hepatitis B surface antigen (HBsAg) and core antibody testing where applicable (not required for certain agents per form notes).

Step Therapy

Required Prior Therapy / Step Therapy

Prior authorization will require documentation of prior therapy or step therapy trials as specified by indication. Provide evidence of failure, intolerance, contraindication, or inability to use specified prior agents.

Ankylosing Spondylitis: documentation of inadequate symptom relief from at least two NSAIDs.
Polyarticular Juvenile Idiopathic Arthritis (PJIA): trial and inadequate response to or contraindication to one systemic corticosteroid or methotrexate, leflunomide, or sulfasalazine.
Plaque Psoriasis (Adult): failure or intolerance to phototherapy and ONE of acitretin (Soriatane), methotrexate, or cyclosporine, and trial/failure of Cosentyx, Enbrel, or Humira (or clinical reason these cannot be used) where indicated.
Psoriatic Arthritis: documented inadequate response or inability to take methotrexate when required.
Rheumatoid Arthritis: therapeutic failure/inadequate response with methotrexate or at least one other disease-modifying antirheumatic drug (e.g., leflunomide, hydroxychloroquine, minocycline, sulfasalazine) or documentation of contraindication/intolerance.

Documentation Required

Required Documentation on the Form

Complete and submit the prior authorization form with all required beneficiary and prescriber identification and clinical documentation. The prescriber signature is mandatory and certifies accuracy of the information.

Beneficiary name, ID number, date of birth, and gender.
Prescribing provider name and NPI, requester contact name and phone number.
Drug name, strength, quantity per 30 days, and requested length of therapy.
Completed indication-specific checklist items (all questions answered as applicable).
Documentation of prior therapy trials, failures, contraindications, or intolerances (supporting clinical notes or medication history).
Evidence of TB and Hepatitis B screening where required by the indication/product labeling.
Prescriber signature and date (mandatory).

Denial Risk

Triggers for Potential Denial

The request may be denied if required information or supporting documentation is missing, incomplete, or does not meet the listed criteria. Ensure all checklist items and prior-therapy evidence are provided to avoid denial or delays.

Failure to document required prior therapy trials, failures, or contraindications for the specific indication.
Absence of documented screening for latent tuberculosis infection when required by the indication or product labeling.
Missing Hepatitis B surface antigen and core antibody testing results when required.
Incomplete beneficiary or prescriber identification, missing drug dosing/quantity/length of therapy, or lack of prescriber signature.
Checklist items left unanswered or contradictory responses on the indication-specific section.

OpenPayer

Prior authorization checklist for injectable biologic immunomodulators

Indication-specific Coverage Criteria

Prior Authorization Requirements and Provider Responsibilities

Policy Background

Definitions and Safety Programs