Prior Authorization Request (Biologic/Targeted DMARD)

Prior Authorization Request: Biologic or Targeted Synthetic DMARD

(Use absolute dates in YYYY-MM-DD format throughout; never use relative terms. Prefix data elements with source: "Patient reports," "On exam," or "Per outside records dated [date]." When required information is pending, document "Ordered on [date]; pending" and include safety gate statement. Do not infer diagnosis, medication failure, or adherence without explicit documentation.)

Patient & Coverage Information

Patient Name: [Patient full name]

Date of Birth: [Date of birth]

Payer/Plan: [Health plan name]

Member ID: [Member ID]

Request Type: [Initial / Renewal / Dose Escalation]

Urgency: [Standard / Expedited] (If expedited, include medical rationale.)

Requested Therapy

Medication: [Generic name] ([Brand name])

Dose/Route/Frequency: [Dose, route, frequency] (Include loading dose schedule if applicable.)

Requested Duration: [Authorization duration]

Quantity/Days Supply: [Quantity per fill] / [Days supply]

Planned Start Date: [Start date] (If safety prerequisites incomplete, state "Pending completion of safety screening.")

Prescriber Information

Prescriber Name and Specialty: [Prescriber name], [Specialty]

NPI: [NPI number]

Contact Phone/Fax: [Phone] / [Fax]

Clinical Contact for Questions: [Name, role, contact information]

Executive Summary

(Write 3–5 sentences that can stand alone for rapid reviewer decision. Follow this structure:)

[Diagnosis with subtype/phenotype] diagnosed [date of diagnosis] with current disease activity [standardized measure] = [value] on [date] ([interpretation category]). Prior therapy: [High-level summary of conventional DMARDs/biologics tried with outcomes]. The requested therapy is appropriate due to [patient-specific rationale: phenotype, extra-articular disease, prior response patterns, comorbidity considerations]. Safety screening: [TB/HBV/HCV/baseline labs status with dates]; vaccination review [complete / pending]. Monitoring plan established with [tests and timeline].

• Diagnosis supported by: [Key diagnostic features with sources and dates]
• Current severity: [Measure] = [value] ([interpretation]) on [date]
• Prior trials completed: [Classes/agents tried with documented outcomes]
• Contraindications to alternatives: [Contraindications with dates and evidence] (Omit if none.)
• Safety prerequisites: [TB/HBV/HCV/vaccination status with dates] (If pending: "Ordered on [date]; pending. Will not initiate therapy until prerequisites are completed/negative.")

Diagnosis & Diagnostic Support

Primary Diagnosis: [Diagnosis name] ([ICD-10 code]) — Diagnosed/onset: [date]. Subtype/phenotype: [seropositive/seronegative RA / axial/peripheral PsA / radiographic/non-radiographic axSpA / other].

Secondary Diagnoses: [Relevant secondary diagnoses with ICD-10 codes and dates] (Omit if none.)

Label Status: [On-label / Off-label] (If off-label, note supporting evidence or guideline rationale.)

• Clinical features: [Synovitis pattern, enthesitis, dactylitis, other findings with dates and sources]
• Laboratory support: [RF, anti-CCP, ESR, CRP, HLA-B27 results with dates and sources as applicable]
• Imaging support: [Radiograph, ultrasound, MRI findings with dates and sources]

Disease Activity & Severity

(Use standardized measures appropriate to diagnosis. If no standardized score performed, state explicitly and provide alternative objective anchors.)

• Standardized score: [CDAI / SDAI / DAS28 / DAPSA / MDA / ASDAS / BASDAI] = [value] on [date] ([remission / low / moderate / high disease activity]).
• Joint counts: TJC [value] / SJC [value] on [date]. (Omit if not applicable to diagnosis.)
• Inflammatory markers: CRP [value with units] on [date]; ESR [value with units] on [date].
• Imaging findings: [Active inflammation, structural damage, or progression with dates and sources]. (Omit if not applicable.)
• Extra-articular disease: [Uveitis, psoriasis severity, IBD activity with dates and sources]. (Omit if none.)
• Functional impact: [ADL limitations, work/school impact, assistive device use with dates].
• Glucocorticoid dependence: [Agent, dose, duration with start date]. (Omit if not on glucocorticoids.)

(If no standardized score:) No standardized disease activity score documented as of [date]; will implement [chosen measure] at follow-up on [date].

Prior & Current Treatment History

Current Regimen: [Current DMARDs with dose/route/frequency; current glucocorticoid dose and start date; relevant concomitant medications with sources and dates]

Prior Medication Trials: (Distinguish primary non-response vs secondary loss of response. If details incomplete from outside records, note what is known and whether additional records were requested.)

Drug Name	Dates (start–stop)	Max Dose	Duration at Therapeutic Dose	Response	Reason Stopped	Source
[Medication name]	[Start date] – [Stop date]	[Maximum dose achieved]	[Duration]	[Objective response or lack thereof]	[Ineffective / Intolerant / Contraindicated] — [specifics]	[Patient reports / On exam / Per outside records dated]

(Add rows as needed for each prior agent.)

Payer prerequisite confirmation: [Document required conventional DMARD trials completed at adequate dose/duration with dates; or document exception rationale with supporting evidence]

Contraindications & Exceptions

(Only include documented contraindications relevant to prerequisite agents or payer-preferred alternatives. Omit section if none apply.)

• [Contraindication]: [Supporting details with dates] (Examples: hepatotoxicity risk, cytopenias, pregnancy, serious infection history, demyelinating disease, heart failure NYHA III–IV, IBD history affecting IL-17 selection, recent malignancy.)
• Product selection rationale: [Medical reason if requesting reference product over biosimilar]. (Omit if not applicable.)
• Biosimilar substitution acceptable: [Yes / No] (If yes, list acceptable alternatives.)

Rationale for Requested Therapy

[Brief statement linking documented inadequate response or intolerance to prior therapy with guideline-consistent escalation to requested mechanism/agent. Include patient-specific factors: disease pattern, extra-articular manifestations, prior biologic exposure and response, class-switch rationale if applicable.]

Treatment target: [Remission / Low disease activity] assessed by [chosen measure] at [12–16] weeks. Continuation threshold: [target value or category].

Shared decision-making: Risks and benefits reviewed on [date]. Patient preferences: [route/frequency preferences, access considerations].

Safety Screening & Prerequisites

(If any prerequisite is pending or positive, include explicit safety gate: "Will not initiate therapy until [condition] is met.")

• TB Screening: [IGRA / TST]: [result] on [date]. CXR: [result] on [date]. (Omit CXR if not performed.)
• Hepatitis B: HBsAg [result], anti-HBs [result], anti-HBc [result] on [date]. [Management plan if positive/exposed].
• Hepatitis C: [Result] on [date]. [Referral plan if positive].
• Baseline Labs: CBC [date], CMP/LFTs [date], [lipids or therapy-specific labs with dates as indicated].
• Vaccination review: [Completed / Ordered; pending] on [date]. [Live vaccine timing/avoidance note if relevant].
• Therapy-specific screening: [VTE/MACE risk for JAK inhibitors; pregnancy/contraception; demyelinating disease; heart failure assessment with dates]. (Include only items applicable to requested therapy.)

(If prerequisites pending:) Ordered on [date]; pending. Will not initiate therapy until [screening] is completed/negative.

Dosing & Monitoring Plan

Dosing: [Dose] / [Route] / [Frequency]; [loading schedule if applicable]. Weight-based calculation: [weight] kg on [date]. (Omit weight if not applicable.) Concomitant DMARD: [plan]. Glucocorticoid taper: [plan and timeline].

Monitoring Schedule:

• CBC and LFTs: baseline, [4–8] weeks, then every [8–12] weeks.
• [Additional therapy-specific labs]: [timing/frequency].

Follow-up: Reassess [date] (~[12–16] weeks) with [disease activity measure]. Target for continuation: [threshold]. Patient counseled on infection precautions and when to hold therapy on [date].

Authorization Request

Requested approval duration: [Duration]

Quantity and refills: [Quantity] with [number] refills

Dose escalation anticipated: [Yes / No] (If yes, include criteria and rationale.)

If renewal: Prior PA reference: [number if known]. Response to date: [objective improvement with measures and dates]. Ongoing need: [brief justification].

Attachments

(Check all included with dates. Note if expected attachment is pending, requested, or not applicable.)

• [ ] Recent clinic note(s) dated [date]
• [ ] Disease activity score documentation dated [date]
• [ ] Lab results (TB, hepatitis, CBC/CMP, inflammatory markers) dated [date]
• [ ] Imaging reports dated [date]
• [ ] Prior medication records or pharmacy fill history dated [date]
• [ ] Specialist consultation letters dated [date] (if applicable)
• [ ] Other: [specify] dated [date]

Attestation

I attest that the information provided is accurate to the best of my knowledge and supported by the medical record.

Prescriber Signature: [Signature]

Date: [Date]