Prior Authorization Request (IBD Biologic/Small-Molecule Therapy)

Prior Authorization Request: IBD Biologic/Small-Molecule Therapy

(This is a payer-facing utilization management document. Optimize for rapid adjudication. Use concise, objective language and only include information supported by the medical record. For any required field without data, enter "Unknown—pending" or "Records requested [date].")

Patient and Plan Information

Patient Name: [Patient full name]

DOB: [MM/DD/YYYY]

Member ID: [Member ID]

Plan Name / Group Number: [Plan / Group]

Request Details

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

Urgency: [Standard / Expedited] (If expedited, include brief clinical rationale demonstrating risk to health or function with delay.)

Submission Date: [MM/DD/YYYY]

Requested Start Date: [MM/DD/YYYY]

Ordering Clinician and Logistics

Ordering Clinician: [Name, credentials, NPI]

Practice Address: [Street, City, State, ZIP]

Contact: [Phone] | [Fax] | [Peer-to-peer availability]

Site of Care: [Office / Infusion Center / Home Infusion]

Specialty Pharmacy / Distribution: [Name, if known]

Medical Necessity Statement

[4–6 sentence summary integrating: (1) confirmed IBD diagnosis with extent/phenotype; (2) current disease activity with objective markers; (3) concise history of prior therapies failed, intolerant, or contraindicated; (4) rationale for the requested agent now; and (5) the explicit authorization request stating drug name, dose, route, frequency, and duration.] (This paragraph should stand alone as a skimmable summary for the reviewer. Avoid interpretive severity labels unless supported by data presented below.)

Diagnosis Confirmation

Diagnosis: [Crohn's disease / Ulcerative colitis / IBD-unclassified]

Date of Diagnosis: [MM/DD/YYYY or approximate]

Classification: [For CD: location, behavior (inflammatory / stricturing / penetrating), perianal involvement. For UC: extent (proctitis / left-sided / extensive).] (Include only elements documented in the record.)

Objective Confirmation:

• [Colonoscopy date] — [Key findings; reference attached report]
• [Pathology date] — [Key findings; reference attached report]
• [Imaging date/type] — [Key findings; reference attached report]

Relevant Comorbidities: [List only conditions affecting agent selection or safety: CHF, demyelinating disease, malignancy history, recurrent infections, liver disease] (State "None documented" if none are relevant.)

Extraintestinal Manifestations: [Arthritis, uveitis, PSC, erythema nodosum, pyoderma gangrenosum, if relevant to therapy choice] (Include only if documented; otherwise omit this line.)

(If confirmatory documents are unavailable, state why and what records have been requested.)

Current Disease Activity

Symptoms: [Stool frequency], [rectal bleeding], [urgency], [abdominal pain], [weight change], [fistula drainage if applicable], [functional impact: ER visits, hospitalizations, missed work/school], [current steroid use with dose and taper history]

Activity Index: [Mayo / partial Mayo score for UC; HBI / CDAI for CD] ([date]) (If not routinely captured, state why not available.)

Objective Markers:

• Fecal calprotectin: [value, unit] ([date])
• CRP: [value, unit] ([date])
• Albumin: [value, unit] ([date])
• Hemoglobin: [value, unit] ([date])
• Endoscopy: [Findings with ulceration severity, distribution; SES-CD or Mayo endoscopic subscore if documented] ([date])
• Imaging: [Modality and key findings] ([date])
• Recent complications (past 12 months): [Hospitalization / abscess / obstruction / surgery with dates, or none]

(List raw findings with dates. Do not apply interpretive severity labels without supporting data.)

Prior IBD Therapies

(Include only therapies documented in the medical record. For each therapy marked as "failed," document adequate trial: optimized dose, adherence addressed, sufficient duration. Include TDM results with dates when relevant. If exact dates unknown, note as estimates with source.)

Medication (generic/brand + class)	Dose/Route/Frequency	Dates (start–stop)	Response	Reason Stopped	Objective Support
[Medication 1]	[Dose/route/frequency]	[MM/YYYY – MM/YYYY or ongoing]	[Primary non-response / secondary loss of response / partial response / sustained response]	[Ineffective / intolerance / adverse event / contraindication]	[Biomarkers, endoscopy, TDM with dates]
[Medication 2]	[Dose/route/frequency]	[MM/YYYY – MM/YYYY]	[Response category]	[Reason stopped]	[Objective data]

(Add rows as needed for additional therapies.)

Current Concomitant Therapies: [Steroids with dose + taper plan], [immunomodulators], [antibiotics for perianal disease], [other relevant concomitants]

Step-Therapy Bypass Rationale: [Explicit rationale if requesting exception: contraindication, prior class failure, high-risk severity, urgent steroid dependence] (Include only if applicable; otherwise omit.)

Requested Therapy

Requested Agent: [Drug name] — Biosimilar substitution: [acceptable / not acceptable] (If not acceptable, provide rationale.)

Induction Regimen: [Dose, route, frequency, number of doses]

Maintenance Regimen: [Dose, route, frequency]

Route and Administration Setting: [IV / SC / PO] at [office / infusion center / home infusion]

Weight-Based Dosing: [Patient weight and date, with calculation basis] (Include only if applicable.)

Authorization Duration Requested: [Duration, e.g., 6 months for induction + early maintenance, 12 months for maintenance]

Diagnosis Codes (ICD-10): [Codes]

Drug Codes (HCPCS/J-code or NDC): [Codes as required by payer benefit type]

Indication Alignment: [On-label for specific IBD subtype / off-label with supporting evidence attached] (If non-preferred product requested, state whether preferred alternatives have been tried, are contraindicated, or are clinically inappropriate.)

Safety Screening

(Mark each item as "Complete" with date/result, "Ordered" with expected date, or "Not indicated" with rationale. Do not state a result as negative until confirmed.)

• TB Screening: [IGRA or TST: result, date]; [chest imaging if indicated]; [LTBI treatment plan if positive]
• Hepatitis B: [HBsAg, anti-HBc, anti-HBs: results, date]; [HBV DNA if indicated]; [prophylaxis plan if at risk]
• Hepatitis C / HIV: [Results per local policy and risk assessment, date]
• Vaccinations: [Up to date / needs updates with plan]; [live vaccine timing considerations]

Class-Specific Precautions: (Include only the subsection relevant to the requested agent; omit others.)

• Anti-TNF: [Demyelinating disease: present / absent], [moderate–severe CHF: present / absent], [prior serious infection history]
• JAK inhibitor: [VTE risk factors], [major CV risk factors], [malignancy history], [lipid monitoring plan]
• S1P modulator: [Baseline ECG: result, date], [cardiac history], [macular edema risk / ophthalmology clearance], [liver enzymes]

Baseline Labs: CBC ([date, result]), CMP/LFTs ([date, result]), CRP ([date, result]), pregnancy test ([date, result]) (Include pregnancy test only if applicable.)

Monitoring Plan

Effectiveness: [Clinical response assessment timeframe], [biomarker reassessment schedule], [planned endoscopic/imaging reassessment window], [criteria for continue/optimize/switch decisions]

Safety: [Lab monitoring cadence], [infection counseling completed: yes / no], [infusion/injection reaction protocol if applicable]

Steroid Taper: [Taper schedule and objective markers guiding pace] (Include only if currently on steroids.)

(For renewal requests: include objective evidence of treatment benefit—symptom improvement, biomarker trends, endoscopic findings—and adherence confirmation.)

Attachments

(List only documents actually included.)

• [Colonoscopy/pathology report, date]
• [Imaging report, date]
• [Key labs: CRP, fecal calprotectin, screening results, dates]
• [Therapeutic drug monitoring results, dates] (if relevant)
• [Prior authorization/denial letters] (if appealing)
• [Other supporting documentation]

Attestation and Signature

I attest that the information provided is accurate and supported by the medical record.

Prescriber Signature: [Signature]

Credentials: [Credentials]

Date: [MM/DD/YYYY]

Direct Contact for Peer-to-Peer: [Name, direct phone, availability]