Prior Authorization Request (IBD Biologic Therapy)

Patient: [Full name], DOB: [YYYY-MM-DD], Member ID: [Member ID], [Plan name]
Request Type: [prior authorization / formulary exception / step therapy override / continuation of therapy]
Requested Medication: [Generic name] ([Brand name]); [IV / SC]; [Dose]; [Frequency]; [Route]
Diagnosis: [Crohn's disease / Ulcerative colitis / Crohn's disease and ulcerative colitis]; ICD-10: [K50.__ / K51.__]
Prescriber: [Name], [Credentials], NPI: [NPI], [Specialty], Phone: [Phone], Fax: [Fax]
Urgency: [standard / expedited] (If expedited, state risk of delay such as hospitalization risk, steroid toxicity, or complication progression.)

Executive Summary

• [Confirmed diagnosis and phenotype] (State UC extent or Crohn's location/behavior; include perianal status for Crohn's if applicable.)
• [Current disease severity] (Anchor with at least two objective measures such as endoscopic score, CRP/ESR, fecal calprotectin, imaging, anemia/albumin; include values and dates.)
• [Complications or high-risk features] (Hospitalization, fistula, abscess, stricture, steroid dependence, extraintestinal manifestations; include dates. State "None" if not applicable.)
• [Prior therapies and outcomes] (List key agents with outcome: primary non-response, secondary loss of response, intolerance, or contraindication; reference TDM if available.)
• [Medical necessity for requested biologic] (Link phenotype/severity and prior outcomes to the agent's indication and guideline alignment.)
• [Proposed dosing] (Induction and maintenance dosing, interval, and site of care.)
• [Safety screening status] (TB and hepatitis B screening results or pending status; vaccination status.)
• [Monitoring plan] (Timeline for clinical reassessment, biomarkers, and objective restaging.)

Diagnosis and Disease Phenotype

[Diagnosis confirmation] (Brief paragraph confirming diagnosis with supporting evidence: endoscopy, histology, imaging, clinical course. Use absolute dates.)

Ulcerative Colitis (if applicable): Extent: [proctitis / left-sided / extensive]; Endoscopic severity: [Mayo endoscopic subscore] on [YYYY-MM-DD]; [Pathology summary]. (State "Not applicable" if UC not present.)

Crohn's Disease (if applicable): Location: [ileal / colonic / ileocolonic / upper GI]; Behavior: [inflammatory / stricturing / penetrating]; Perianal disease: [active / quiescent / none]; [Pathology summary]. (State "Not applicable" if Crohn's not present.)

Surgical history: [Relevant IBD surgeries with dates and current anatomy] (State "None" if no prior IBD surgery.)

Extraintestinal manifestations: [Arthritis / uveitis / PSC / dermatologic manifestations with dates] (Include only if relevant to biologic selection; otherwise state "None significant.")

Current Severity and Objective Evidence

[Current clinical status] (Brief narrative: predominant symptoms including stool frequency, bleeding, abdominal pain, urgency, nocturnal symptoms; systemic impact such as weight loss, fever, anemia; steroid exposure with current dose and taper history; functional impairment or recent hospitalizations with dates. State "Unknown/Not documented" where applicable.)

• Endoscopy: [YYYY-MM-DD]: [Distribution], [Key findings: ulceration, friability, strictures], [Mayo endoscopic subscore / SES-CD], [Pathology summary]. (Add additional entries if multiple scopes relevant. Do not infer results.)
• Imaging: [MRE / CTE] [YYYY-MM-DD]: [Findings: active inflammation, fistula, abscess, stricture], [Location and extent]. (State "Not applicable" if no recent cross-sectional imaging.)
• Biomarkers: CRP [value] on [YYYY-MM-DD]; ESR [value] on [YYYY-MM-DD]; Fecal calprotectin [value] on [YYYY-MM-DD]; Hemoglobin [value] on [YYYY-MM-DD]; Albumin [value] on [YYYY-MM-DD]. (State "Not available" for any not obtained.)
• Therapeutic drug monitoring: [Prior biologic] trough [value] on [YYYY-MM-DD]; Antibodies: [positive with titer / negative]; Interpretation: [subtherapeutic without antibodies / subtherapeutic with antibodies / therapeutic with antibodies]. (Include only if switching biologics. State "Pending [YYYY-MM-DD]; results will be forwarded" if scheduled.)

Prior Treatment History

Medication (Class)	Dose / Route	Dates (Start–Stop)	Outcome / Reason Stopped
[5-ASA agent]	[Dose / Route]	[YYYY-MM-DD] – [YYYY-MM-DD]	[primary non-response / secondary loss of response / intolerance: specify / not indicated for phenotype]
[Corticosteroid]	[Dose / Route]	[YYYY-MM-DD] – [YYYY-MM-DD]	[steroid dependence: unable to taper below X mg without relapse / steroid refractory / adverse effects: specify]
[Immunomodulator: thiopurine / methotrexate]	[Dose / Route]	[YYYY-MM-DD] – [YYYY-MM-DD]	[primary non-response / secondary loss of response / intolerance: specify / contraindication: specify]
[Biologic #1]	[Dose / Route]	[YYYY-MM-DD] – [YYYY-MM-DD]	[primary non-response / secondary loss of response / intolerance: specify]; [TDM: trough X, antibodies positive/negative]
[Biologic #2 / Small molecule]	[Dose / Route]	[YYYY-MM-DD] – [YYYY-MM-DD]	[Outcome with objective anchors]

(Include only therapies trialed. Add or remove rows as needed.)

Current IBD regimen: [Active medications including steroid dose if applicable]; [Steroid taper plan if applicable].

Rationale for Requested Therapy

[Medical necessity justification] (Explain why the requested biologic is appropriate: align agent's mechanism and indication with patient's diagnosis, phenotype, and risk features. Address why prior therapies are inadequate—primary non-response suggests mechanism switch; secondary loss of response with low trough and antibodies supports mechanism switch. Reference AGA guideline-concordant use for moderate-to-severe IBD. State treatment goals: steroid-free clinical remission with objective mucosal improvement.)

[Consequences of delay or denial] (Ongoing steroid toxicity, hospitalization risk, disease complications, need for surgery. Keep concise and objective.)

Alternatives not appropriate (if payer requires):

• [Alternative agent]: [Contraindicated due to: specify / Prior failure: reference treatment history / Not guideline-appropriate for this phenotype: explain]

(Include only if payer criteria require addressing specific alternatives.)

Dosing and Administration Plan

• Patient weight: [kg] (Include if weight-based dosing applies.)
• Induction: [Dose] at weeks [0, 2, 6 / 0, 4, 8 / other schedule]
• Maintenance: [Dose] every [interval] weeks
• Route and site of care: [IV at infusion center / IV home infusion / SC self-administered]
• Biosimilar: [Acceptable / Originator requested: specify reason if applicable]
• Duration and reassessment: Ongoing if effective; reassess response at [8–14 weeks post-induction] with [clinical assessment, biomarkers, consider endoscopy]

Safety Screening and Monitoring

• TB screening: [IGRA / TST] on [YYYY-MM-DD]: [Negative / Positive with management plan / Pending]
• Hepatitis B: HBsAg [negative / positive], anti-HBc [negative / positive], anti-HBs [negative / positive] on [YYYY-MM-DD]; [Immune / susceptible—vaccination planned / chronic infection—antiviral prophylaxis planned / resolved infection—monitor]
• Vaccinations: [Up to date / Live vaccines deferred until after initiation / Updates needed: specify]
• Baseline labs: CBC, CMP, CRP on [YYYY-MM-DD]: [Within normal limits / Abnormalities: specify]

Monitoring plan: Clinical reassessment at [8–14 weeks post-induction]; Biomarkers every [8–12 weeks initially]; Endoscopic reassessment at [6–12 months or as clinically indicated].

Attachments

1. [Colonoscopy/sigmoidoscopy report with pathology] ([YYYY-MM-DD])
2. [Imaging report: MRE/CTE] ([YYYY-MM-DD])
3. [Laboratory results] ([YYYY-MM-DD])
4. [Therapeutic drug monitoring report] ([YYYY-MM-DD])
5. [Hospital discharge summary] ([YYYY-MM-DD])
6. [Prior denial letter] (if appeal)

(Include only documents being submitted. Remove items not applicable.)

Closing Statement and Signature

[Authorization request] (Directly request authorization summarizing: confirmed diagnosis and phenotype, objective severity evidence, prior therapy inadequacy, and medical necessity of requested agent. If expedited, restate risk of delay. Attest that information is accurate to prescriber's knowledge.)

Prescriber: [Name], [Credentials]
NPI: [NPI]
Date: [YYYY-MM-DD]
Contact: Phone: [Phone], Fax: [Fax]