Prior Authorization Request Letter (Severe Asthma Biologic Therapy)

A structured prior authorization request letter for severe asthma biologic therapy (omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, or reslizumab). Organized to present decision-driving clinical facts effi…

Document Type

letter / Prior Authorization Request Letter

Specialties

PulmonologyPediatric Pulmonology
Created by Augustun

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Header Block

Date: [Date of letter]

From: [Practice/Health System Name], [Street Address], [City, State ZIP], Phone: [Phone], Fax: [Fax]
Ordering Clinician: [Clinician Name], [Credentials], NPI: [NPI number]
Clinic Contact for PA Follow-up: [Name and role], Phone: [Phone], Fax: [Fax], Email: [Email]

To: [Payer/PBM Name], [Address] — Delivery Method: [fax / portal / mail]

Patient: [Full Name], DOB: [DOB], Member ID: [Member ID], Group #: [Group number if available], Plan Name: [Plan Name]

PA Reference: [PA Case # if assigned]

Subject Line

RE: Prior Authorization Request – [Biologic generic/brand] for Severe Asthma – [Patient Name], [DOB], [Member ID]

Executive Summary

[Summary paragraph of 5–8 lines covering: (1) Diagnosis and severity statement specifying asthma uncontrolled despite optimized high-dose ICS/LABA therapy; (2) Exacerbation count and healthcare utilization in past 12 months with specific dates; (3) Current controller regimen with doses and confirmation that adherence and inhaler technique were assessed; (4) Key objective findings: spirometry values and relevant biomarkers with dates and units; (5) Requested medication with dose/route/frequency and medical necessity statement]

Requested Medication

  • Medication: [Generic name], [Brand name], [Formulation] — [Dose], [Route], [Frequency], Planned Start: [Start date]
  • Administration: [office / infusion center / home]; Administered by: [clinician / nursing staff / patient or caregiver]
  • Benefit Channel: [Pharmacy benefit / Medical benefit]
  • Diagnosis Code(s): [ICD-10 code for severe persistent asthma]
  • Concomitant Therapy: [Statement that this is add-on maintenance therapy; list current controllers that will continue]

Asthma Diagnosis and Severity

  • Diagnostic basis: [Symptom pattern and variability] — Objective confirmation: [Spirometry with bronchodilator response and/or peak flow variability] on [Date]
  • Spirometry confirmation: [Date] Pre-BD FEV1: [L] ([% predicted]), FVC: [L] ([% predicted]), FEV1/FVC: [%]; Post-BD FEV1 change: [ΔL] ([Δ%]) (if available)
  • Current therapy step: [Step 4 / Step 5] intensity with [high-dose ICS/LABA ± LAMA/LTRA/OCS]

Current Symptom Control:

  • Daytime symptoms: [frequency]
  • Nighttime awakenings: [frequency]
  • Reliever use: [uses per week]
  • Activity limitation: [none / mild / moderate / severe]
  • Control score: [ACT / ACQ] = [score] on [Date]
  • High-risk features: [prior ICU admission / intubation / near-fatal event / none] (Include dates if present)

(Do not infer severity from medication list alone; explicitly link severity to exacerbation history, control score, lung function impairment, or OCS dependence.)

Exacerbations and Healthcare Utilization

(Document events in past 12 months; extend to 24 months if payer criteria require. Use exact dates. Do not estimate counts.)

Date Event Type Treatment Given Disposition
[Date] [OCS burst ≥3 days / Urgent visit / ED / Hospitalization] [Steroid dose/duration, other interventions] [Disposition]

Summary: OCS bursts: [#]; Urgent visits: [#]; ED visits: [#]; Hospitalizations: [#]
(If records incomplete, state limitation and sources used: EHR, patient report, external records.)

Controller Therapy Optimization

Current Regimen:

  • ICS/LABA (high-dose): [Product and strength] — [Dosing]
  • LAMA: [Product and strength] — [Dosing] (if applicable)
  • LTRA: [Product and strength] — [Dosing] (if applicable)
  • Maintenance OCS: [Prednisone equivalent mg/day] (if applicable)
  • Reliever strategy: [SABA PRN / SMART with ICS-formoterol]

Prior Therapy Trials:

Medication & Dose Dates of Use Reason Discontinued Clinical Response
[Medication/dose] [Date range] [Ineffective / Adverse effect / Contraindication / Formulary requirement] [Response summary]

Adherence Assessment: (Specify method; do not use generic phrasing)

  • Pharmacy refill data: PDC [%] over [date range]
  • Patient report/visit documentation: [Summary of adherence assessment]

Inhaler Technique Assessment: (Document direct observation using device-specific checklist)

  • Assessment date: [Date]; Device(s) reviewed: [Device names]
  • Errors identified: [Errors or none] — Education provided: [Description]

Modifiable Factors Addressed:

  • Tobacco/vaping/occupational exposures: [Status and actions]
  • Allergic rhinitis/sinusitis: [Assessment and therapy]
  • GERD/obesity/OSA/other comorbidities: [Assessment and management]
  • Allergen mitigation and immunotherapy: [Status] (if relevant)

(State "optimization in progress" if adherence, technique, or modifiable factors are not yet fully addressed.)

Objective Testing and Biomarkers

Spirometry/PFTs:

Date Pre-BD FEV1 (L, % predicted) Pre-BD FVC (L, % predicted) FEV1/FVC (%) Post-BD FEV1 Change
[Date] [L] ([%]) [L] ([%]) [%] [ΔL] ([Δ%])

Biomarkers: (Include only those relevant to the requested biologic)

  • Blood eosinophils: [Value] cells/µL on [Date] (Note if drawn while on systemic steroids)
  • Total IgE: [Value] IU/mL on [Date]
  • FeNO: [Value] ppb on [Date] (Note ICS status)
  • Allergy testing: [Perennial aeroallergen sensitization results] on [Date]
  • [Biomarker] pending — scheduled [Date] (if applicable)

Medical Necessity Rationale

Phenotype Alignment:

  • Asthma phenotype: [allergic/IgE-mediated / eosinophilic / OCS-dependent / severe asthma broadly] based on [Biomarkers, history, and control metrics supporting classification]
  • Requested biologic alignment: [Mapping of patient data to eligibility criteria] (Do not quote proprietary policy language)

Why This Biologic:

  • Biomarker/phenotype match: [Justification]
  • Exacerbation burden: [Number of events and impact despite optimized therapy]
  • OCS-sparing need: [Yes with rationale / Not applicable]
  • Prior biologic use: [None / Prior agent(s) with reason for switch]
  • Practical factors: [Dosing interval, route, administration site considerations] (if relevant to selection)

Expected Benefits:

  • Reduced exacerbations and urgent care utilization
  • Improved symptom control (ACT/ACQ) and quality of life
  • Improved lung function (FEV1 % predicted) (if expected for this agent)
  • Reduced OCS exposure and steroid-related complications (if applicable)

Safety Considerations:

  • Hypersensitivity monitoring with appropriate administration setting
  • Gradual corticosteroid taper planned; no abrupt discontinuation
  • Helminth screening if clinically indicated prior to initiation

Monitoring and Follow-up Plan

  • Response Assessment: Reassess at [4–6 months] after initiation
  • Outcomes to Track: Exacerbation count; ACT/ACQ; reliever use; spirometry/FEV1; OCS dose with taper protocol (if applicable)
  • Continuation Criteria: Continue if meaningful improvement in exacerbations, control score, lung function, or OCS reduction; discontinue or switch for inadequate response after adequate trial or intolerance/safety concerns
  • Follow-up Schedule: [Visit intervals and documentation plan for reauthorization]

Attachments

  • Spirometry/PFT report(s) with dates
  • CBC with differential (eosinophil count)
  • IgE and allergy testing results (if relevant)
  • FeNO report (if available)
  • ED/hospital discharge summaries
  • Medication fill history and adherence reports
  • Prior biologic authorization records (if applicable)

Closing

We respectfully request approval of [Biologic generic/brand] as add-on maintenance therapy for severe asthma as detailed above. We are available for peer-to-peer discussion if needed.

Signature Block

Clinician Signature: ________________________________ Date: [Date]
Name, Credentials: [Name, Credentials]
NPI: [NPI number]
Contact: Phone: [Phone] Fax: [Fax] Email: [Email]

Information above is accurate to the medical record. (Include only if true.)

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