CurrentColorado Rocky Mountain Health PlansPolicy N/A

Alpha‑1 Proteinase Inhibitor (Human) — Washington Prior Authorization Form

This Washington-specific prior authorization request form is used by the payer for requests of alpha-1 proteinase inhibitor (human) augmentation and maintenance therapy for severe hereditary AAT deficiency; it affects prescribing providers and prior authorization reviewers.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAlpha‑1 Proteinase Inhibitor (Human) — Washington Prior Authorization Form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Washington-specific prior authorization form and fax to the number on the form; allow at least 24 hours for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1prior authorization form

FDA-approvedFDA-approved indication

≤65%FEV1 threshold

listedAAT lab cutoffs

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met

Initial therapy eligibility: 1) Request is for the FDA‑approved indication: augmentation and maintenance therapy for severe hereditary AAT deficiency with clinical evidence of emphysema; 2) Genetic confirmation of AATD (PiZZ, PiZ(null), or Pi(null,null) phenotype or other alleles increasing AATD risk); 3) One of the specified AAT laboratory thresholds is met: AAT < 11 µmol/L OR immunoturbidimetry ≤ 57 mg/dL OR nephelometry ≤ 57 mg/dL OR radial immunodiffusion ≤ 80 mg/dL (list measured level); 4) Documented emphysema with airflow obstruction; 5) FEV1 ≤ 65% predicted (list FEV1); 6) Patient is a non‑smoker or is initiating smoking cessation; 7) No anti‑IgA antibodies present; 8) Diagnosis established by or in consultation with a pulmonology specialist; 9) Recent patient weight provided to calculate dose per package labelingsee node text

All items are required as indicated on form

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy eligibility: 1) Prior approval or previous treatment with alpha1‑proteinase inhibitor for augmentation/maintenance therapy; 2) Documentation of a positive clinical response from pretreatment baseline to alpha1‑proteinase inhibitor therapy (describe positive response);positive clinical response documented

Provider signature and date required on form

Requests that do not meet the form’s listed requirements — including genetic confirmation of severe hereditary AAT deficiency, one of the specified AAT laboratory thresholds, documented emphysema with airflow obstruction, a recorded FEV1 ≤ 65% predicted, verification of non‑smoking status or an active smoking cessation plan, absence of anti‑IgA antibodies, specialist involvement, and provision of current weight for dosing — are not supported by this prior authorization form.

Use of alpha1‑proteinase inhibitor (human) without the required confirmatory data listed on the form will not meet the stated coverage criteria. Specifically, the form requires either genetic confirmation of PiZZ, PiZ(null), Pi(null,null) or other high‑risk alleles and at least one qualifying laboratory result (AAT < 11 µmol/L OR immunoturbidimetry ≤ 57 mg/dL OR nephelometry ≤ 57 mg/dL OR radial immunodiffusion ≤ 80 mg/dL). Absence of these findings, or failure to document emphysema with airflow obstruction and the FEV1 ≤ 65% predicted threshold, will render the request non‑covered per the form criteria.

Coding and Laboratory Thresholds

Diagnosis codes (requested)ICD-10

ICD-10 CODE

Requested on form — specific diagnosis code to be provided by prescriber

AAT laboratory thresholds

AAT (µmol/L)< 11 µmol/L

Immunoturbidimetry (mg/dL)≤ 57 mg/dL

Nephelometry (mg/dL)≤ 57 mg/dL

Radial immunodiffusion (mg/dL)≤ 80 mg/dL

FEV1 threshold

FEV1≤ 65% predicted

Submission, Documentation, and Provider Instructions

Prior Authorization

Prior Authorization Submission and Review

Prior authorization is required. Please complete the entire prior authorization request form and fax it to 866-940-7328. This form may contain multiple pages — complete all pages to avoid a delay. Allow at least 24 hours for review; if you have questions, call 800-310-6826.

Fax completed Washington-specific prior authorization form to 866-940-7328
Allow at least 24 hours for review
For questions, call 800-310-6826

Note

Preferred Product Rationale Required

Provide a clear explanation why preferred products on the plan's PDL are inappropriate for this patient. Reference the member's clinical circumstances and past medication trials when applicable, and include prior trial dates and reasons for failure.

Explain why preferred alternatives on the PDL would not meet the patient's needs
Include dates and reasons for failure or intolerance to preferred agents
Refer to the PDL at www.uhcprovider.com for preferred alternatives

Documentation Required

Required Documentation to Support Prior Authorization

Include the following documentation with the prior authorization request. Incomplete documentation may delay or result in denial.

Completed prior authorization form sections: Section A (Member Information), Section B (Provider Information), Section C (Medical Information), Section D (Previous Medication Trials), and Section E (Explanation why preferred medications are not appropriate)
Provider demographics, NPI number, specialty, and office contact/fax
Medication details: drug name, strength, directions, quantity, dates of therapy (for continuation requests provide start date)
Clinical information to support medical necessity: specific diagnosis and ICD-10 code, genetic confirmation of AATD genotype (e.g., PiZZ, PiZ(null), Pi(null,null)), and laboratory AAT level with test method and numeric result (e.g., <11 µmol/L, ≤57 mg/dL by immunoturbidimetry/nephelometry, or ≤80 mg/dL by radial immunodiffusion)
Documentation of emphysema with airflow obstruction and baseline/most recent FEV1 (list % predicted and value)
Smoking status verification and documentation of smoking cessation efforts if applicable
Confirmation the patient does not have IgA antibodies
Specialist involvement: documentation that diagnosis was established by or in consultation with a pulmonologist
Patient weight and date to calculate appropriate dosing per package labeling

Denial Risk

Denial Triggers for Incomplete Documentation

Requests lacking key elements may be denied. Ensure all required clinical, laboratory, and provider documentation are included.

Missing FDA‑approved indication for augmentation/maintenance therapy (clinical evidence of emphysema) risks denial
Absence of genetic confirmation of AATD genotype (e.g., PiZZ, PiZ(null), Pi(null,null)) or missing lab AAT levels/tests
No documentation of emphysema with airflow obstruction or missing/absent FEV1 % predicted
Failure to provide prior medication trial history or reason preferred agents are inappropriate
Missing provider NPI, specialty, or lack of specialist consultation when required
No patient weight or date to calculate dose as per labeling
For continuation requests, lack of documented positive clinical response from baseline

Definitions

Severe hereditary AAT deficiency (form definition)

DefinitionGenetic confirmation of PiZZ, PiZ(null), or Pi(null,null) phenotype alpha1-antitrypsin deficiency (AATD) or other alleles determined to increase risk, corroborated by low serum AAT level per specified laboratory thresholds

Genotype examplesPiZZ; PiZ(null); Pi(null,null)

Corroborating lab evidenceOne of the specified low AAT test results (AAT <11 µmol/L, immunoturbidimetry ≤57 mg/dL, nephelometry ≤57 mg/dL, or radial immunodiffusion ≤80 mg/dL)

Background

Alpha1‑antitrypsin deficiency (AATD) is an inherited disorder that in severe forms can produce clinical emphysema. Augmentation therapy with human alpha1‑proteinase inhibitor is indicated for patients meeting strict criteria: a severe hereditary AAT deficiency confirmed by genotype and corroborating low serum AAT levels, documented emphysema with airflow obstruction, and physiologic impairment as reflected by a reduced FEV1. The form captures these elements to determine eligibility for FDA‑approved augmentation and maintenance therapy.