How to Get Signifor LAR (Pasireotide) Covered by Cigna in Pennsylvania: Prior Authorization Requirements and Appeals Process
Quick Answer: Getting Cigna Coverage for Signifor LAR in Pennsylvania
Cigna requires prior authorization for Signifor/Signifor LAR (pasireotide) with strict medical necessity criteria. Your endocrinologist must document: confirmed acromegaly or Cushing's disease diagnosis, elevated IGF-1/UFC levels, failed surgery or ineligibility, and trial/failure of first-generation somatostatin analogs (octreotide/lanreotide) for acromegaly. If denied, Pennsylvania's new external review program overturns about 50% of denials. First step today: Have your endocrinologist submit a complete prior authorization with biochemical evidence and treatment history to Cigna's provider portal.
Table of Contents
- Coverage at a Glance
- Cigna's Policy Overview
- Medical Necessity Requirements
- Step Therapy and First-Line Treatment Failures
- Required Documentation and Lab Values
- Quantity Limits and Renewal Requirements
- Common Denial Reasons and How to Fix Them
- Appeals Process in Pennsylvania
- Cost and Financial Assistance
- FAQ
Coverage at a Glance
Requirement | Details | Documentation Needed | Source |
---|---|---|---|
Prior Authorization | Required for all plans | Complete PA form with clinical rationale | Cigna PA Policy |
Prescriber | Endocrinologist required | Specialist credentials verification | Cigna PA Policy |
Step Therapy | Must try octreotide/lanreotide first (acromegaly) | Documentation of failure/intolerance | Cigna PA Policy |
Lab Requirements | Elevated IGF-1 (acromegaly), UFC (Cushing's) | Recent lab results within 30 days | FDA Label |
Quantity Limits | 1 vial per 28 days | Dosing justification for higher amounts | Cigna Formulary |
Appeal Deadline | 180 days internal, 4 months external | Final denial letter required | PA Insurance Dept |
Cigna's Policy Overview
Cigna manages Signifor and Signifor LAR coverage through Express Scripts specialty pharmacy, requiring prior authorization for both the subcutaneous (Signifor) and long-acting release (Signifor LAR) formulations. The policy applies to all Cigna commercial plans, including HMO, PPO, and marketplace plans purchased through Pennie (Pennsylvania's state exchange).
Important: Self-funded employer plans (ERISA) may have different requirements. Check with your HR department to confirm whether your plan follows Cigna's standard medical policy or has custom criteria.
For Cushing's disease, Cigna provides initial approval for 4 months if all criteria are met, with subsequent approvals for 1 year if treatment response is documented. Acromegaly approvals typically follow a 6-month initial period with annual renewals based on biochemical improvement.
Medical Necessity Requirements
Acromegaly (Signifor LAR only)
Your endocrinologist must document:
- Confirmed diagnosis with elevated IGF-1 levels above upper limit of normal for age and gender
- Growth hormone >5 ng/mL on at least two separate occasions
- Surgical ineligibility or inadequate response to surgery/radiotherapy
- Trial and failure of octreotide LAR or lanreotide depot at maximum tolerated doses
- Age 18 or older (FDA-approved indication)
Cushing's Disease (Both formulations)
Required documentation includes:
- ACTH-dependent hypercortisolism confirmed by laboratory testing
- Elevated 24-hour urinary free cortisol (UFC) from at least two collections
- Pituitary source confirmed by MRI or inferior petrosal sinus sampling
- Surgical failure or ineligibility with clear documentation of why surgery isn't curative
- Prescription by endocrinologist or in consultation with specialist
Clinician Corner: The medical necessity letter should explicitly state why surgery failed or isn't an option. Vague statements like "patient prefers medical management" won't meet Cigna's criteria. Include specific surgical details, pathology results, or contraindications.
Step Therapy and First-Line Treatment Failures
Cigna requires documented trials of first-generation somatostatin analogs before approving Signifor LAR for acromegaly. This means patients must have tried and failed:
- Octreotide LAR (Sandostatin LAR) at doses up to 30-40 mg every 4 weeks for at least 3-6 months
- Lanreotide (Somatuline Depot) at doses up to 120 mg every 4 weeks for at least 3-6 months
Failure is defined as:
- Inability to normalize IGF-1 levels despite maximum tolerated doses
- Persistent growth hormone elevation >2.5 ng/mL after glucose suppression test
- Disease progression with continued symptoms
Intolerance documentation should include:
- Specific adverse effects (GI symptoms, gallstones, glucose dysregulation)
- Dose reductions attempted due to side effects
- Discontinuation due to hypersensitivity or severe reactions
For Cushing's disease, step therapy may include trials of other medical therapies like mifepristone or osilodrostat, depending on your specific Cigna plan.
From our advocates: We've seen approvals expedited when clinicians include a detailed timeline showing "Patient tried octreotide LAR 30mg monthly from [date] to [date], achieved only 15% IGF-1 reduction (still 2.8x upper normal), discontinued due to severe diarrhea requiring hospitalization." Specific numbers and dates strengthen the case significantly.
Required Documentation and Lab Values
Laboratory Requirements
For Acromegaly:
- IGF-1 levels >1.9 U/mL (males) or >2.2 U/mL (females), or above upper limit of normal for age/gender
- Growth hormone >5 ng/mL on random testing or >1 ng/mL after oral glucose tolerance test
- Recent labs within 30 days of PA submission showing persistent elevation despite prior treatment
For Cushing's Disease:
- 24-hour urinary free cortisol elevated above upper limit of normal from at least two separate collections
- Morning plasma ACTH levels confirming ACTH-dependent disease
- Dexamethasone suppression test results showing lack of appropriate suppression
Clinical Documentation
Your medical records must include:
- Detailed diagnosis with ICD-10 codes (E22.0 for acromegaly, E24.0 for Cushing's disease)
- Treatment history with specific medications, doses, durations, and outcomes
- Current symptoms and functional impairment
- Contraindications to surgery or reasons for surgical failure
- Monitoring plan for glucose levels and gallbladder function
Counterforce Health helps patients and clinicians compile this documentation by automatically pulling the right clinical evidence and formatting it according to each payer's specific requirements, significantly improving approval rates for complex cases like rare endocrine disorders.
Quantity Limits and Renewal Requirements
Cigna limits Signifor LAR to 1 vial per 28 days for both acromegaly and Cushing's disease. The approved doses are:
- Acromegaly: 40 mg every 4 weeks (starting dose), may increase to 60 mg
- Cushing's disease: 10-40 mg every 4 weeks based on response and tolerability
For doses above the standard quantity limit, your endocrinologist must provide additional justification including:
- Weight-based dosing calculations
- Body surface area considerations
- Previous dose escalation history
- Biochemical response data supporting higher doses
Renewal requirements include:
- Updated lab values showing treatment response
- Clinical notes documenting symptom improvement
- Monitoring results for glucose and gallbladder function
- Confirmation that treatment goals are being met
Common Denial Reasons and How to Fix Them
Denial Reason | How to Overturn | Required Documentation |
---|---|---|
"Not prescribed by specialist" | Submit endocrinologist credentials | Board certification, NPI verification |
"Inadequate trial of first-line therapy" | Provide detailed treatment timeline | Specific drugs, doses, durations, outcomes |
"Insufficient biochemical evidence" | Submit complete lab panel | IGF-1, GH, UFC with reference ranges |
"Surgery not attempted/documented" | Clarify surgical history | Operative reports, pathology, imaging |
"Experimental/investigational" | Cite FDA approval and guidelines | FDA label, Endocrine Society guidelines |
Appeals Process in Pennsylvania
If Cigna denies your Signifor LAR prior authorization, Pennsylvania offers a robust appeals process with high success rates.
Internal Appeals (Required First Step)
- File within 180 days of denial using Cigna's member portal or provider system
- Include new evidence such as additional lab results, peer-reviewed studies, or specialist letters
- Request peer-to-peer review where your endocrinologist can speak directly with Cigna's medical director
- Expect response within 30 days for standard appeals, 72 hours for urgent cases
Pennsylvania External Review
Pennsylvania's new external review program, launched in 2024, has overturned approximately 50% of appealed denials. Here's how it works:
Eligibility:
- Must have completed Cigna's internal appeal process
- Applies to commercial insurance (not self-funded ERISA plans)
- Covers medical necessity denials for FDA-approved treatments
Process:
- Submit request within 4 months of final internal denial
- Use online portal at pa.gov external review or mail forms to Pennsylvania Insurance Department
- Provide supporting evidence within 15 business days of case assignment
- Independent review by clinical experts within 45 days (72 hours for urgent cases)
- Binding decision that Cigna must follow if favorable
Contact Information:
- Pennsylvania Insurance Department Consumer Help Center: 1-877-881-6388
- Online external review portal
Cost and Financial Assistance
Signifor LAR costs approximately $20,000+ per vial, making financial assistance crucial for most patients.
Manufacturer Support:
- Recordati Rare Diseases patient assistance programs (verify current offerings)
- Copay assistance for commercially insured patients
- Free drug programs for uninsured/underinsured patients
Foundation Grants:
- Patient Advocate Foundation
- HealthWell Foundation
- National Organization for Rare Disorders (NORD)
State Resources:
- Pennsylvania pharmaceutical assistance programs
- Medicaid coverage for eligible patients
FAQ
How long does Cigna prior authorization take for Signifor LAR in Pennsylvania? Standard requests take 5-15 business days. Urgent requests (immediate health threat) are processed within 72 hours. Submit complete documentation to avoid delays.
What if Signifor LAR is non-formulary on my Cigna plan? You can request a formulary exception with medical justification. Document why formulary alternatives (octreotide, lanreotide) are inappropriate or have failed.
Can I request an expedited appeal if my condition is worsening? Yes, both Cigna internal appeals and Pennsylvania external reviews offer expedited pathways for urgent medical situations. Provide documentation of immediate health risks.
Does step therapy apply if I tried first-generation analogs in another state? Yes, treatment history from any provider counts toward step therapy requirements. Obtain complete medical records documenting previous trials and outcomes.
What happens if my employer plan is self-funded? Self-funded ERISA plans may not follow Cigna's standard policy and aren't eligible for Pennsylvania's external review. Contact your HR benefits administrator for plan-specific requirements.
How can I find out if my plan covers Signifor LAR? Check your Cigna formulary document or call member services. The drug may be listed under specialty pharmacy or require prior authorization regardless of formulary status.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently - verify current requirements with Cigna and your healthcare provider. For personalized assistance with complex prior authorization cases, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify specific approval pathways.
Sources & Further Reading
- Cigna Signifor Prior Authorization Policy (PDF)
- Pennsylvania External Review Program
- FDA Signifor LAR Prescribing Information
- Cigna Provider Precertification Portal
- Endocrine Society Clinical Practice Guidelines
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.