Prior Authorization Request (Hepatitis C Direct-Acting Antiviral)

Date/Time Authored: [Date and time]

Author: [Name, credentials, role] (Include "prescriber-reviewed" when completed by support staff)

Request Status: [Draft / Submitted / Resubmission / Appeal Support]

Payer: [Payer name, plan, PBM if applicable] (If unknown, state: "To be updated prior to submission")

Member ID: [Member identifier] [RxBIN / RxPCN / RxGroup if known]

PA Reference Number: [Reference number] (Only include if resubmission or appeal)

Review Type: [Standard / Expedited]

Expedited Justification: [One-sentence clinical justification anchored to objective risk] (Only include if expedited; for Medicare Part D, state that delay may place health in serious jeopardy)

Executive Summary

(Provide 3–6 bullets for rapid reviewer orientation. If HCV RNA, fibrosis status, or regimen is missing, output: "Executive summary deferred—awaiting required data" and list pending items.)

• Diagnosis: [Confirmed chronic HCV infection with most recent HCV RNA value, units, and date]
• Fibrosis/Cirrhosis: [Fibrosis stage or cirrhosis status with assessment method and date]
• Requested Regimen: [Medication, dose, frequency, and duration in weeks]
• Safety Screens: [HBV screening results] [Pregnancy status if applicable]
• DDI Screen: [Date, tool used, and outcome summary]
• Medical Necessity: [Concise rationale for treatment timing]

Medication Requested

Medication: [Generic and brand name, strength, form, route, frequency]

Duration: [Number of weeks]

Quantity: [Total tablets requested] (Do not estimate if regimen not finalized)

Refills: [Number] (Typically none for finite DAA course; justify if otherwise)

Start Date: [Upon approval / Target date]

Pharmacy: [Dispensing pharmacy] (Only include if known)

Primary Diagnosis (ICD-10): [Chronic HCV code specifying with/without cirrhosis]

Secondary Diagnoses: [Comorbidities affecting regimen selection] (Only include if applicable)

Request Type: [Initial PA / Reauthorization / Non-formulary Exception / Appeal Support]

(If regimen is not finalized due to pending genotype or resistance testing, note explicitly and do not submit until complete.)

HCV Diagnosis and Virology

(HCV RNA is required to establish active infection; antibody alone is insufficient. If HCV RNA is pending, document order date and do not claim active infection.)

Test	Result	Date
HCV Antibody	[Reactive / Nonreactive / Not available]	[Date]
HCV RNA (quantitative)	[Value with units / Pending]	[Date]
HCV Genotype/Subtype	[Result / Not obtained]	[Date]

Infection Status: [Acute / Chronic] [Brief supporting clinical history]

(If pangenotypic regimen is planned and genotype not obtained, state: "Genotype not required for selected regimen per clinical pathway; payer requirements may differ.")

Fibrosis Assessment

Cirrhosis Status: [No cirrhosis / Compensated cirrhosis / Decompensated cirrhosis / Uncertain]

Fibrosis Stage: [F0 / F1 / F2 / F3 / F4] (If available)

Assessment Method: [FIB-4 / APRI / Transient elastography / Imaging / Biopsy] [Date]

• Serum score: [Score type and calculated value] [Component values: Age, AST, ALT, Platelets with dates] (Include if serum-based assessment used)
• Elastography: [kPa value and date] (Include if performed)
• Imaging findings: [Key findings and date] (Include if imaging used for staging)

(If cirrhosis is present or suspected, document compensation status below.)

Decompensation Assessment: Ascites [present / absent], Hepatic encephalopathy [present / absent], Variceal bleeding [yes / no], Jaundice/hyperbilirubinemia [present / absent]

Child-Pugh Score: [Score] Class [A / B / C] — Albumin [value, date], Bilirubin [value, date], INR [value, date], Ascites [none / mild / moderate-severe], Encephalopathy [none / grade 1-2 / grade 3-4]

Most Recent Liver Imaging: [Modality, date, key findings including HCC and ascites status] (Include if cirrhosis pathway; note if pending)

(Inference of "no cirrhosis" requires explicit objective basis such as serum score below threshold with normal platelets and no imaging stigmata.)

Pretreatment Safety Screening

(If HBV screening, renal function, or key liver labs are missing, document why submission is proceeding and what is being done to obtain them.)

Test	Result	Date
CBC	[Hgb, Hct, WBC, Platelets]	[Date]
INR	[Value]	[Date]
Hepatic function panel	[Albumin, Total bilirubin, ALT, AST]	[Date]
Renal function	[Creatinine and/or eGFR]	[Date]
Pregnancy test	[Result / Not applicable]	[Date]
HBsAg	[Positive / Negative / Pending]	[Date]
Total anti-HBc	[Positive / Negative / Pending]	[Date]
Anti-HBs	[Positive / Negative / Pending]	[Date]
HBV DNA	[Value / Not indicated]	[Date]
HIV Ag/Ab	[Negative / Positive with ART regimen / Pending]	[Date]

Relevant Comorbidities: [CKD stage or dialysis status, diabetes, anticoagulation, post-transplant status, active malignancy or suspected HCC, extrahepatic manifestations with objective evidence] (Include only those applicable)

Prior HCV Treatment History

Status: [Treatment-naïve / Treatment-experienced / Uncertain]

(Confirm from records, medication history, and patient report. If uncertain, document verification efforts.)

(Include the following only if treatment-experienced:)

• Prior regimen: [Regimen name] [Dates] [Outcome: SVR12 / relapse / nonresponse / early discontinuation] [Intolerance if any]
• RAS testing: [Performed / Not performed] [Results if available] (Include if prior DAA failure)

Drug-Drug Interaction Assessment

Current Medication List: [Prescription medications, OTCs, and herbal supplements with doses]

DDI Screening: [Tool/resource used], [Date performed], [Outcome: "No clinically significant interactions identified" or list interactions]

(For each clinically significant interaction, include:)

• [Interacting drug]: [Risk summary] — Action: [switch / hold / monitor / alternate DAA], [Responsible clinician], [Timing]

Protease Inhibitor Safety Check: [No moderate or severe hepatic impairment and no history of decompensation confirmed] (Include if glecaprevir/pibrentasvir or other PI-containing regimen planned)

Amiodarone Status: [No exposure / Current / Recently discontinued] [Management plan if current or recent] (Include if sofosbuvir-containing regimen planned)

(If medication list is incomplete, state DDI screen is pending completion and do not submit as interaction-checked.)

Treatment Plan

Selected Regimen: [Drug name(s), strength, dosing schedule]

Duration: [Number of weeks] — [Brief rationale based on cirrhosis status and treatment history]

Regimen Selection Rationale: [Cirrhosis/Child-Pugh class, renal function, genotype/RAS if applicable, DDI constraints, prior treatment history] (If non-preferred formulary agent, state why preferred agents are not appropriate)

Monitoring Plan: [Follow-up timing during therapy], [Safety monitoring as indicated], [SVR confirmation with HCV RNA ≥12 weeks post-treatment], [HCC surveillance plan if cirrhosis]

Medical Necessity Justification

Indication: [Statement that DAA treatment is indicated for this patient's chronic HCV infection]

Patient-Specific Risk Factors: [Fibrosis stage and progression risk, decompensation or HCC risk if advanced fibrosis/cirrhosis, extrahepatic manifestations if present]

Expedited Review Drivers: [Objective urgency factors with supporting data] (Only include if requesting expedited review)

Payer Criteria Checklist: [List each known criterion with location of supporting evidence] (If payer criteria unknown, state: "Standard clinical documentation included; specific payer criteria not available.")

Attachments

• HCV RNA lab report — [Attached / Not available: reason, date requested]
• HCV genotype report — [Attached / Not required for pangenotypic regimen / Not available]
• Fibrosis assessment documentation — [Attached / Not available] [Date]
• Hepatic function panel, CBC, INR, eGFR — [Attached / Not available] [Date]
• HBV serologies (± HBV DNA) — [Attached / Not available] [Date]
• Liver imaging report — [Attached / Not applicable / Not available] [Date]
• Medication list and DDI report — [Attached / Not available] [Date]
• Prior HCV treatment records — [Attached / Not applicable / Not available]
• Supporting clinic notes for extrahepatic manifestations — [Attached / Not applicable / Not available]

Prescriber Attestation

Prescriber: [Name, credentials, NPI, specialty]

Clinic: [Name, address]

Direct Phone: [Number] Fax: [Number]

"I have reviewed the above clinical information, selected regimen, and interaction screen."

Signature: [Electronic signature] Date: [Date]