Prior Authorization Request (Biologic Therapy)

Date of Submission: [date]

Request Type: [Initial / Renewal / Dose Escalation / Step-Therapy Exception / Non-Formulary Exception]

Urgency: [Standard / Expedited] — (If expedited, include brief clinical justification explaining why delay may seriously jeopardize the patient's health, life, or ability to regain maximum function.)

Patient: [name], [DOB], [Member ID], [Plan Name]

Prescriber: [name], [specialty], [NPI], [clinic address], [phone/fax]

(If any administrative identifier is unavailable, enter [pending] in that field. Do not use placeholders elsewhere in the document.)

Executive Summary

[Executive summary paragraph] (Single paragraph of 4–8 sentences covering: 1) Patient and confirmed diagnosis. 2) Requested biologic with dose, route, frequency, and intended duration. 3) Why now—current severity and most recent objective measures with dates. 4) Why this agent over alternatives—prior therapy failures, contraindications, or disease features favoring this choice. 5) Key supporting documents attached.)

Diagnosis and Clinical Problem

[Primary diagnosis with ICD-10 code and phenotype/subtype]. [Biologic-naïve / Biologic-experienced]. (Include only comorbidities that influence agent selection or represent contraindications to alternatives.)

Disease Severity and Objective Measures

(For initial requests, include disease onset/diagnosis date, course pattern, and major events such as hospitalizations, surgeries, or steroid dependence. For renewals, abbreviate history and focus on treatment response.)

[Current symptoms and functional impact, including work/school limitations and ADL impairment]

Instrument/Test	Baseline (date, value)	Most Recent (date, value)	Interpretation
[instrument name]	[baseline value, date]	[most recent value, date]	[brief interpretation]

(If a standard validated instrument was not obtained, explain why and provide alternative objective evidence such as exam findings, photographs, labs, or imaging.)

Prior Therapy Trials

(Document all relevant prior therapies including non-biologics required by step therapy and any prior biologics. Clearly distinguish clinical failure/intolerance from access-related discontinuations.)

Therapy (generic name, class)	Dates	Dose/Frequency	Outcome	Evidence of Failure
[therapy name and class]	[start–stop dates or duration]	[dose and frequency]	[inadequate response / loss of response / intolerance / contraindicated / access failure]	[objective measure, hospitalization, steroid escalation, or specific adverse event]

Contraindications to Alternatives

(Include only for step-therapy or non-formulary exceptions. Omit if not applicable.)

• [Alternative agent name]: [Reason inappropriate/contraindicated] — [Supporting clinical evidence]

Requested Therapy

• Drug: [generic name] ([brand name])
• Regimen: [loading dose if applicable]; [maintenance dose, route, frequency]
• Duration: [intended treatment period or renewal interval]
• Concomitant Therapy: [planned concurrent medications] (e.g., continue DMARD, steroid taper plan)
• Site of Care: [self-injection / infusion center / home infusion]
• Indication Status: [FDA-labeled / compendia-supported / off-label] (If off-label, include additional rationale.)

Medical Necessity Rationale

Medical necessity and urgency: [Current severity, risk of progression/complications, and impact on function/quality of life, referencing specific objective measures and recent clinical events]

Rationale for this biologic: [Why agent is expected to be effective for this patient's phenotype, including mechanism alignment, prior response patterns, and guideline-concordant sequencing]

Why covered alternatives are not appropriate: [Reference specific prior therapy failures and contraindications with drug names, doses, durations, and outcomes]

Risk–benefit and monitoring: [Key safety considerations for this agent, why benefits outweigh risks, and monitoring plan with follow-up interval]

Safety Screening

• TB screening: [test type, result, date]
• Hepatitis B/C screening: [status, results, dates]
• Baseline labs: [relevant labs with dates]
• Pregnancy status: [status] (Include only if applicable.)
• Vaccination status: [live vaccine considerations and updates completed] (Include only if relevant.)

Renewal Assessment

(Include only for renewal/continuation requests. Omit for initial requests.)

[Duration on therapy, adherence, dose adjustments]. [Clinical risk of discontinuation].

Measure	Baseline (date, value)	Current (date, value)	Change/Clinical Impact
[disease activity score, exacerbation rate, lab value, etc.]	[baseline value, date]	[current value, date]	[quantified improvement/stability and functional impact]

Supporting Documentation Attached

• [Relevant clinic notes]
• [Disease activity scores with dates]
• [Laboratory results]
• [Imaging or procedure reports]
• [Photographs] (if applicable)
• [Prior adverse event documentation]
• [Medication fill history or infusion records]

Attestation

Prescriber Signature: [electronic signature]

Date: [date]

Contact: [phone] / [fax]

(If expedited review is requested: I attest that delay may seriously jeopardize the patient's health, life, or ability to regain maximum function.)

(Omit any section that is not applicable. Include only information necessary to support medical necessity and safe use.)