By Counterforce Health Team in Signifor / Signifor LAR (pasireotide) —

Getting Signifor LAR (Pasireotide) Covered by UnitedHealthcare in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Approval

UnitedHealthcare requires prior authorization for Signifor LAR (pasireotide) with specific criteria: confirmed endogenous Cushing's disease and documentation that pituitary surgery was non-curative or not viable. No step therapy required. Your board-certified endocrinologist must submit through OptumRx with biochemical proof (abnormal UFC or late-night salivary cortisol) and surgical documentation. If denied, North Carolina offers strong external review rights through Smart NC within 120 days. Start today: Gather your UFC/cortisol results, surgical notes, and have your endocrinologist complete the OptumRx prior authorization form.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Signifor LAR prescriptions UnitedHealthcare Provider Portal
Prescriber Board-certified endocrinologist only Medical license verification required
Diagnosis Confirmed endogenous Cushing's disease ICD-10 codes for Cushing's disease
Biochemical Proof Two abnormal results: UFC or late-night salivary cortisol Lab reports within last 6 months
Surgical Documentation Surgery non-curative or patient not a candidate Operative notes or specialist consultation
Quantity Limit 1 vial per 28 days for LAR formulation OptumRx Formulary
Appeal Deadline 180 days from final denial for internal appeals UnitedHealthcare member materials
External Review 120 days after final internal denial in NC Smart NC Program

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who: You and your endocrinologist
What: Gather two abnormal test results showing either elevated 24-hour urinary free cortisol (UFC) or late-night salivary cortisol levels
Timeline: Can be completed same day if recent labs available

2. Document Surgical History

Who: Your endocrinologist
What: Obtain operative notes showing surgery was non-curative, or specialist consultation confirming you're not a surgical candidate
Timeline: 1-3 business days if records need to be requested

3. Complete Prior Authorization Submission

Who: Your endocrinologist's office
What: Submit complete OptumRx prior authorization form through the specialty pharmacy portal
How: Online at OptumRx provider portal, fax to designated PA line, or phone submission
Timeline: Submit within 24-48 hours of gathering documentation

4. Track Your Request Status

Who: You or your clinic
What: Monitor PA status through UnitedHealthcare member portal or by calling OptumRx
Timeline: Check after 72 hours for urgent cases, 5-7 business days for standard requests

5. Receive Decision

What: Approval allows immediate prescription filling; denial triggers appeal rights
Timeline: Up to 15 business days for non-urgent, 72 hours for urgent cases

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing biochemical documentation Submit two abnormal UFC or salivary cortisol results Recent lab reports with abnormal values
Inadequate surgical history Provide operative notes or specialist assessment Surgical records or consultation notes
Non-specialist prescriber Have board-certified endocrinologist co-prescribe Medical license verification
Incomplete clinical justification Submit detailed medical necessity letter Comprehensive clinical documentation
Missing diagnosis codes Include specific ICD-10 codes for Cushing's disease Billing documentation with correct codes

Appeals Process in North Carolina

Internal Appeals with UnitedHealthcare

First-Level Internal Appeal:

  • Deadline: 180 days from denial letter date
  • Submission: UnitedHealthcare member portal, fax, or certified mail
  • Required: Complete appeal form, medical necessity letter, supporting clinical documentation
  • Timeline: 30 days for standard review, 72 hours for expedited

Peer-to-Peer Review: Your endocrinologist can request a direct discussion with UnitedHealthcare's medical director to explain clinical rationale and necessity for Signifor LAR specifically.

External Review Through Smart NC

If your internal appeals are exhausted, North Carolina provides robust external review rights:

Eligibility: State-regulated plans (not self-funded employer plans unless opted in)
Deadline: 120 days from final internal denial
Cost: Free to patients
Contact: Smart NC at 1-855-408-1212

How to File:

  1. Complete external review request form (available at NC Department of Insurance website)
  2. Include copy of final denial letter
  3. Submit all supporting medical records
  4. Provide physician statement of medical necessity

Timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent cases
  • Ultra-expedited: 24-72 hours for urgent non-formulary drug denials
Note: Smart NC staff can help you complete the external review request and gather supporting documentation. The Independent Review Organization's decision is binding on UnitedHealthcare.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Your Medical Necessity Letter

Patient Information:

  • Confirmed diagnosis of endogenous Cushing's disease with specific ICD-10 codes
  • Duration and severity of symptoms
  • Impact on daily functioning and quality of life

Biochemical Documentation:

  • Two abnormal test results (UFC levels >3x upper normal limit preferred)
  • Late-night salivary cortisol results if available
  • ACTH levels confirming ACTH-dependent disease

Surgical History:

  • Detailed explanation of why surgery was non-curative or patient is not a candidate
  • Operative notes if surgery was attempted
  • Specialist consultation notes if surgery is contraindicated

Treatment Rationale:

  • Why Signifor LAR is medically necessary for this specific patient
  • Expected clinical benefits and monitoring plan
  • Dosing rationale aligned with FDA labeling

Supporting Clinical Guidelines

Reference these authoritative sources in your documentation:

Cost Assistance and Patient Support

Manufacturer Support Programs

Recordati Rare Diseases Patient Assistance: Check eligibility for copay assistance or patient access programs through the manufacturer's patient support services.

North Carolina State Resources

Smart NC Consumer Assistance: Beyond external reviews, Smart NC provides free guidance on insurance appeals and can help you understand your rights under North Carolina insurance law.

NC Medicaid Expansion: With Medicaid expansion implemented in 2024, additional coverage options may be available for eligible North Carolina residents.

From our advocates: We've seen successful Signifor LAR appeals in North Carolina when families worked closely with Smart NC staff to compile comprehensive medical records. One key factor was having the endocrinologist clearly explain why the patient's specific type of Cushing's disease made surgery unsuitable, rather than just stating surgery "failed." This level of clinical detail often makes the difference in external review outcomes.

FAQ

How long does UnitedHealthcare prior authorization take in North Carolina? Standard requests take up to 15 business days; urgent cases are decided within 72 hours. OptumRx has streamlined many approvals to under 30 seconds for qualifying submissions.

What if Signifor LAR is non-formulary on my plan? Non-formulary status doesn't prevent coverage—it typically means higher copays and stricter prior authorization requirements. Focus your appeal on meeting medical necessity criteria rather than challenging formulary status.

Can I request expedited review if my condition is urgent? Yes. If delay would seriously jeopardize your health, request expedited internal appeal (72 hours) and expedited external review through Smart NC (also 72 hours maximum).

Does step therapy apply to Signifor LAR? No. UnitedHealthcare does not require step therapy for Signifor LAR, but you must meet the specific diagnostic and surgical history criteria.

What happens if Smart NC approves my external review? The decision is binding on UnitedHealthcare. They must provide coverage within 3 business days of the approval decision.

Can I appeal if I live in North Carolina but have an employer plan? Most employer plans are self-funded and not subject to state external review, unless your employer specifically opted into North Carolina's system. Contact Smart NC to verify eligibility.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address the specific reasons for denial. For complex cases like Signifor LAR, we help identify the exact documentation needed and draft point-by-point rebuttals aligned to each payer's requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official North Carolina insurance regulations and consumer rights, visit the NC Department of Insurance website.

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