CurrentUnitedHealthcarePolicy N/A

Pharmacy prior authorization form for select biologic indications (NOMID, RA, DIRA)

This document is a pharmacy prior authorization request form governing coverage requests for biologic therapy for neonatal-onset multisystem inflammatory disease (NOMID), rheumatoid arthritis (RA), and deficiency of interleukin-1 receptor antagonist (DIRA) for UnitedHealthcare beneficiaries. It applies to providers submitting PA requests through the Pharmacy PA process.

Policy Summary

PayerUnitedHealthcare

PolicyPharmacy prior authorization form for select biologic indications (NOMID, RA, DIRA)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Pharmacy Prior Approval Request form with prescriber signature and indication‑specific checklist responses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3indications covered on form

6standard patient/prescriber/data fields

4common screening items asked for each indication (TB, Hep B)

Indication-specific Coverage Criteria

inv-01: NOMID

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NOMID criteria: (1) Diagnosis of neonatal-onset multisystem inflammatory disease (NOMID) is documented; (2) The beneficiary is not currently on another injectable biologic immunomodulator; (3) The beneficiary has been considered and screened for the presence of latent tuberculosis infection; (4) The beneficiary has been tested for Hepatitis B surface antigen (SAG) and core antibody (Core Ab).

All checklist items are requested on the PA form.

inv-02: Rheumatoid Arthritis

Covered when ALL of the following are met

RA criteria: (1) Diagnosis of rheumatoid arthritis is documented; (2) The beneficiary is not currently on another injectable biologic immunomodulator; (3) The beneficiary has been considered and screened for the presence of latent tuberculosis infection; (4) The beneficiary has been tested for Hepatitis B surface antigen (SAG) and core antibody (Core Ab); (5) The beneficiary has experienced therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug (DMARD) OR is unable to receive methotrexate/DMARD due to contraindication or intolerance; (6) There is clinical evidence of severe or rapidly progressing disease; (7) The beneficiary has had a trial and failure of Enbrel or Humira or there is a documented clinical reason the beneficiary cannot try Enbrel or Humira.

Form captures each item as a yes/no checklist.

inv-03: DIRA

Covered when ALL of the following are met

DIRA criteria: (1) Diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) is documented; (2) The beneficiary is not currently on another injectable biologic immunomodulator; (3) The beneficiary has been considered and screened for the presence of latent tuberculosis infection; (4) The beneficiary has been tested for Hepatitis B surface antigen (SAG) and core antibody (Core Ab).

All checklist items are requested on the PA form.

Initial Therapy Request Elements

inv-12: Initial therapy request elements

Initial therapy request elements

Initial request requirements: Prescriber must provide drug name, strength, quantity per 30 days, and requested length of therapy; the indication-specific checklist must be completed and the prescriber signature provided on the PA form.

Form lists standard lengths (up to 30–365 days) and requires prescriber signature.

Required Provider Actions and Documentation

Prior Authorization

Prior authorization required

A completed Pharmacy Prior Approval Request form with the prescriber signature and all indication‑specific questions must be submitted prior to approval. Include beneficiary demographics, prescriber NPI and contact information, and complete drug details (name, strength, quantity, length of therapy).

Prescriber signature is mandatory on the PA form.
Include beneficiary name, ID, DOB, and gender.
Provide prescribing provider NPI and requester contact phone/extension.

Step Therapy

Step therapy / RA prior treatment requirements

For rheumatoid arthritis requests, the form requires documentation of prior therapy trials or contraindications. The requester must indicate whether the beneficiary failed methotrexate or at least one other DMARD or is unable to receive them due to contraindication/intolerance. The form also asks whether the beneficiary had a trial and failure of Enbrel (etanercept) or Humira (adalimumab), or provide a clinical reason why these agents cannot be used.

Document therapeutic failure or intolerance to methotrexate or ≥1 DMARD (e.g., leflunomide, hydroxychloroquine, minocycline, sulfasalazine).
Document trial and failure of Enbrel or Humira, or provide clinical rationale for not using these agents.

Denial Risk

Potential triggers for denial

Requests may be denied if required diagnosis‑specific checklist items or screening tests are not documented. Ensure confirmation of the diagnosis and completion of recommended infection screening where applicable.

Failure to document diagnosis confirmation on the indication checklist (e.g., RA, NOMID, DIRA).
Missing documentation of prior biologic/immunomodulator status (whether currently on another injectable biologic).
Absence of latent tuberculosis screening documentation.
Absence of Hepatitis B surface antigen and core antibody testing results when requested.

Step Therapy / Trial Requirements

Step	Question (Rheumatoid Arthritis checklist)	Response
{"text":"1","status":""}\|{"text":"Does the beneficiary have a diagnosis of Rheumatoid Arthritis?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"2","status":""}\|{"text":"Is the beneficiary not on another injectable biologic immunomodulator?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"3","status":""}\|{"text":"Has the beneficiary been considered and screened for the presence of latent tuberculosis infection?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"4","status":""}\|{"text":"Has the beneficiary been tested with Hep B SAG and Core Ab?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"5","status":""}\|{"text":"Has the beneficiary experienced a therapeutic failure/inadequate response with methotrexate or at least one DMARD (e.g., leflunomide, hydroxychloroquine, minocycline, sulfasalazine)?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"6","status":""}\|{"text":"Is the beneficiary unable to receive methotrexate or a DMARD due to contraindications or intolerabilities?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"7","status":""}\|{"text":"Does the beneficiary have clinical evidence of severe or rapidly progressing disease?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}
{"text":"8","status":""}\|{"text":"Has the beneficiary had a trial and failure of Enbrel or Humira, or is there a clinical reason the beneficiary cannot try Enbrel or Humira?","status":""}\|{"text":"Yes / No (form prompts a selection)","status":""}

Condition Definitions

NOMID — Definition & required confirmations

TermNOMID (Neonatal-onset multisystem inflammatory disease)

DefinitionAn autoinflammatory condition characterized by systemic inflammation beginning in the neonatal period; listed as an indication on the PA form for biologic therapy.

Required form confirmationsDiagnosis of NOMID; not currently on another injectable biologic immunomodulator; considered and screened for latent tuberculosis; tested for Hepatitis B surface antigen (SAG) and core antibody (Core Ab).

DIRA — Definition & required confirmations

TermDIRA (Deficiency of interleukin-1 receptor antagonist)

DefinitionA rare autoinflammatory disorder caused by deficiency of the interleukin-1 receptor antagonist; listed as an indication on the PA form for biologic therapy.

Required form confirmationsDiagnosis of DIRA; not currently on another injectable biologic immunomodulator; considered and screened for latent tuberculosis; tested for Hepatitis B surface antigen (SAG) and core antibody (Core Ab).

RA — Definition, required confirmations, and step-therapy requirements

TermRA (Rheumatoid arthritis)

DefinitionChronic inflammatory arthritis; included on the PA form as an indication for biologic therapy with specific additional requirements.

Form-required clinical checkpointsDiagnosis of rheumatoid arthritis; not currently on another injectable biologic immunomodulator; considered and screened for latent tuberculosis; tested for Hepatitis B SAG and Core Ab; clinical evidence of severe or rapidly progressing disease.

Prior therapy / step therapyTherapeutic failure or inadequate response to methotrexate or at least one DMARD OR inability to receive those due to contraindication/intolerance; plus trial and failure of Enbrel or Humira or documented clinical reason they cannot be used.

Background and Scope

This Pharmacy Prior Approval Request form is used to request authorization for injectable biologic immunomodulators for specific indications: neonatal‑onset multisystem inflammatory disease (NOMID), rheumatoid arthritis (RA), and deficiency of interleukin‑1 receptor antagonist (DIRA). The form requires completion of standard beneficiary and prescriber information, drug details (name, strength, quantity per 30 days, and length of therapy), and the prescriber signature to validate the request.

For each indication the form captures a diagnosis confirmation and checks that the patient is not currently on another injectable biologic immunomodulator, documents screening for latent tuberculosis, and documents Hepatitis B testing (surface antigen and core antibody). Rheumatoid arthritis requests also require documentation of therapeutic failure or intolerance to methotrexate or at least one DMARD, clinical evidence of severe or rapidly progressing disease, and whether there has been a trial and failure of Enbrel or Humira or a clinical reason these agents cannot be used.

Providers should note that the prescriber’s signature is mandatory on the Pharmacy PA form and that incomplete documentation of the indication‑specific checklist items (diagnosis confirmation, prior biologic status, TB/Hepatitis B screening, prior DMARDs/biologic trials for RA, etc.) may delay or result in denial of the prior authorization request. For assistance, contact the Pharmacy PA Call Center at 1‑855‑258‑1593.