CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior authorization checklist for injectable biologic immunomodulators

A multi-indication prior approval request form used by Colorado Rocky Mountain Health Plans (NC Medicaid) to document clinical criteria for initiating or continuing injectable biologic immunomodulator therapy for select autoimmune conditions; completed by prescribers for beneficiaries.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior authorization checklist for injectable biologic immunomodulators

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including beneficiary/prescriber details, drug information, safety screening results, and documented prior TNF blocker trial or clinical rationale for not using TNF agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7form sections (AS, PsA, RA, UC, general)

At least 1required TNF trial

3safety screening items

Signatureprescriber attestation

Indication-specific Coverage Criteria

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Ankylosing Spondylitis

Covered when ALL of the following are met:

AS criteria: 1) Documented diagnosis of Ankylosing Spondylitis; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Individual risks and benefits have been considered for malignancy and/or major adverse cardiovascular events (MACE); 4) Beneficiary is not considered to be at high risk for thrombosis; 5) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 6) Beneficiary has been tested for Hepatitis B (SAG and Core Ab); 7) Beneficiary will not receive live vaccines during therapy; 8) Beneficiary has tried at least one Tumor Necrosis Factor (TNF) blocker with inadequate response or is unable to take TNF blockers due to intolerance or contraindications; 9) Beneficiary has had a trial and failure of Cosentyx, Enbrel, or Humira or there is a clinical reason the beneficiary cannot try Cosentyx, Enbrel, or Humira.

Psoriatic Arthritis

Covered when ALL of the following are met:

PsA criteria: 1) Documented definitive diagnosis of Psoriatic Arthritis; 2) Age ≥ 18 years; 3) Beneficiary is not currently on another injectable biologic immunomodulator; 4) Individual risks and benefits have been considered for malignancy and/or major adverse cardiovascular events (MACE); 5) Beneficiary is not considered to be at high risk for thrombosis; 6) Beneficiary has been considered and screened for the presence of latent tuberculosis infection; 7) Beneficiary has been tested for Hepatitis B (SAG and Core Ab); 8) Documented inadequate response, intolerance, or contraindication to at least one Tumor Necrosis Factor (TNF) blocker.

Rheumatoid Arthritis

Covered when ALL of the following are met:

RA criteria: 1) Documented diagnosis of Rheumatoid Arthritis; 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Individual risks and benefits have been considered for malignancy and/or major adverse cardiovascular events (MACE); 4) Beneficiary is not considered to be at high risk for thrombosis; 5) Beneficiary has been considered and screened for the presence of latent tuberculosis; 6) Beneficiary has been tested for Hepatitis B (SAG and Core Ab); 7) Beneficiary will not receive live vaccines during therapy; 8) Therapeutic failure or inadequate response to at least one Tumor Necrosis Factor (TNF) blocker OR inability to receive a TNF blocker due to contraindication or intolerance; 9) Trial and failure of Enbrel or Humira or a clinical reason the beneficiary cannot try Enbrel or Humira.

Ulcerative Colitis (Adult)

Covered when ALL of the following are met:

UC criteria: 1) Documented diagnosis of ulcerative colitis (adult); 2) Beneficiary is not currently on another injectable biologic immunomodulator; 3) Individual risks and benefits have been considered for malignancy and/or major adverse cardiovascular events (MACE); 4) Beneficiary is not considered to be at high risk for thrombosis; 5) Beneficiary has been considered and screened for the presence of latent tuberculosis; 6) Beneficiary has been tested for Hepatitis B (SAG and Core Ab); 7) Beneficiary will not receive live vaccines during therapy; 8) Trial and failure of Humira or a documented clinical reason the beneficiary cannot try Humira.

The prior authorization form does not list standalone exclusions beyond the checklist items for each indication. However, failure to complete required checklist confirmations — for example, documentation of diagnosis, safety screening (latent tuberculosis and Hepatitis B testing), confirmation that the beneficiary is not currently on another injectable biologic immunomodulator, or attestation regarding live vaccines and thrombosis/MACE risk — may result in denial. Providers should ensure every applicable checkbox and supporting documentation on the form is completed to avoid denial for administrative or clinical incompleteness.

Requests will be considered not medically necessary when the submission does not meet the required criteria for the selected indication. Examples include lack of a documented diagnosis, missing safety screening (latent TB or Hepatitis B SAG/Core Ab), absence of documentation that the beneficiary is not receiving another injectable biologic immunomodulator, or no documentation of required prior Tumor Necrosis Factor (TNF) blocker trial or a clinical reason why a TNF agent cannot be used (as specified per indication). Ensure the form demonstrates fulfillment of all listed items for the applicable condition to support medical necessity.

What the Prescriber Must Do

Prior Authorization

Prior authorization form completion

Prior authorization form must be fully completed and include beneficiary and prescriber details, drug-specific fields, clinical screening, prior therapy documentation, and the prescriber attestation/signature. Incomplete forms may result in denial or delayed review.

Beneficiary: name, Colorado Rocky Mountain Health Plans ID (or other beneficiary ID), date of birth, gender
Prescriber: name, prescribing provider NPI, requester contact name and phone (with ext.)
Drug: drug name, strength, quantity per 30 days, length of therapy (select duration)
Attach clinical documentation supporting diagnosis and prior therapy trials

Step Therapy

Step therapy / required trials

Step therapy and required prior trials must be documented on the form. For approval, evidence of prior trials and either inadequate response or a documented intolerance/contraindication is required where specified.

Document trials, dates, responses, and reasons for discontinuation or intolerance
If a required agent cannot be used, include clinical rationale (e.g., intolerance, contraindication, or safety concern)

Documentation Required

Required administrative data

Required administrative data must be provided on the request to allow processing and identification of the beneficiary and prescriber.

Beneficiary last name, first name, beneficiary ID number, date of birth, gender
Prescribing provider NPI and requester contact information (name, phone, ext.)
Drug-specific fields: drug name, strength, quantity per 30 days, length of therapy selected

Documentation Required

Clinical screening and prior therapy documentation

Clinical screening and prior therapy documentation must be completed for the relevant diagnosis. Screenings for latent tuberculosis and hepatitis B, assessment of vaccination plans, and evaluation of thrombotic and malignancy/MACE risk must be documented. Confirm the patient is not currently on another injectable biologic unless otherwise specified.

Diagnosis confirmation for the requested indication (Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, or Ulcerative Colitis)
Documentation that the beneficiary is not on another injectable biologic immunomodulator
Documentation of screening for latent tuberculosis and Hepatitis B (HBsAg and core Ab) and plan regarding live vaccines
Assessment that risks/benefits (including malignancy and MACE risks) were considered and that the beneficiary is not at high risk for thrombosis, or documentation otherwise

Step Therapy

AS TNF trial requirement

For Ankylosing Spondylitis, document a trial and inadequate response to at least one Tumor Necrosis Factor (TNF) blocker, or provide documentation of intolerance or contraindication to TNF blockers. Also document prior trial and failure of Cosentyx, Enbrel, or Humira or a clinical reason these cannot be used when required.

Confirm diagnosis of Ankylosing Spondylitis
Confirm not currently on another injectable biologic
Document TNF blocker trial with inadequate response OR intolerance/contraindication
Document trial and failure of Cosentyx, Enbrel, or Humira, or clinical rationale why these cannot be tried

Step Therapy

PsA TNF trial requirement

For Psoriatic Arthritis, document a definitive diagnosis and that the beneficiary had an inadequate response, intolerance, or contraindication to at least one TNF blocker. Include age confirmation (≥18) and the same clinical screenings noted above.

Documented diagnosis of Psoriatic Arthritis and beneficiary is ≥18 years
Documented inadequate response, intolerance, or contraindication to at least one TNF blocker
Confirm not currently on another injectable biologic and include TB and Hep B screening documentation

Step Therapy

RA TNF trial requirement

For Rheumatoid Arthritis, document therapeutic failure or inadequate response to at least one TNF blocker, or document contraindication/intolerance. Also document prior trial and failure of Enbrel or Humira or provide clinical reasons these cannot be used, and include required safety screenings.

Confirm diagnosis of Rheumatoid Arthritis
Document therapeutic failure/inadequate response to at least one TNF blocker OR contraindication/intolerance
Document trial and failure of Enbrel or Humira or clinical rationale for not trying them
Include TB and Hep B screening, vaccine plan, and risk assessment documentation

Step Therapy

UC TNF trial requirement

For Ulcerative Colitis (adult), document diagnosis and a trial and failure of Humira, or provide a clinical reason why Humira cannot be tried. Include TB and Hep B screening, vaccine plan, thrombosis risk assessment, and confirm the beneficiary is not on another injectable biologic.

Confirm diagnosis of ulcerative colitis
Document trial and failure of Humira OR clinical rationale why Humira cannot be tried
Confirm not currently on another injectable biologic
Include TB and Hep B screening, live vaccine plan, and thrombosis risk assessment
Prescriber signature and date required (see attestation)

Documentation Required

Prescriber attestation

Prescriber attestation and signature are mandatory. The prescriber must sign and date the form certifying the accuracy and completeness of the information; falsification or omission may have legal consequences.

Prescriber signature (mandatory) and date
Attestation: information is accurate and complete to the best of prescriber's knowledge; falsification or omission may lead to civil or criminal liability

Key Definitions and Safety Items

Tumor Necrosis Factor Blocker (TNF blocker) — prior therapy examples and trial requirement

Defined examples of prior TNF/biologic agentsForm lists Cosentyx, Enbrel, and Humira as prior therapy examples for consideration/step therapy.

Required trial before approval (most indications)Many indication sections require trial and inadequate response to at least one Tumor Necrosis Factor (TNF) blocker or documentation of intolerance/contraindication.

Indication-specific TNF trial wordingAnkylosing Spondylitis: 'tried at least one Tumor Necrosis Factor Blocker with inadequate response or unable to take these therapies due to intolerance or contraindications' (and trial/failure of Cosentyx, Enbrel or Humira).

Alternate/explicit agent trialsRheumatoid Arthritis section specifically asks for trial and failure of Enbrel or Humira (or clinical reason they cannot be tried).

Ulcerative Colitis Humira requirementUlcerative Colitis (Adult) section requires trial and failure of Humira or a documented clinical reason Humira cannot be tried.

Safety screening items

Latent tuberculosis screeningEach indication asks whether the beneficiary has been considered and screened for the presence of latent tuberculosis infection.

Hepatitis B testingEach indication asks whether the beneficiary has been tested with Hep B SAG and Core Ab.

MACE and thrombosis risk assessmentForm asks that individual risks/benefits for malignancy and major adverse cardiovascular events (MACE) be considered and that beneficiary is 'NOT considered to be at high risk for thrombosis.'

Vaccine guidanceSections include an item confirming the beneficiary will NOT receive live vaccines during therapy.

OpenPayer

Prior authorization checklist for injectable biologic immunomodulators

Indication-specific Coverage Criteria

What the Prescriber Must Do

Policy Scope and Context

Key Definitions and Safety Items