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

Blue Cross Blue Shield Ohio's Coverage Criteria for Signifor LAR (Pasireotide): What Counts as "Medically Necessary"?

Answer Box: Getting Signifor LAR Covered in Ohio

Blue Cross Blue Shield Ohio requires prior authorization for Signifor LAR (pasireotide). To qualify, you need: (1) endocrinologist prescription, (2) documented Cushing's disease with elevated UFC levels OR acromegaly with failed first-generation somatostatin analogs, and (3) evidence that surgery isn't an option or has failed. First step today: Contact your BCBS member services at the number on your insurance card to request the current prior authorization form and confirm your plan's specialty pharmacy network. Appeals must be filed within 180 days of denial.

Table of Contents

  1. Policy Overview: How BCBS Ohio Handles Specialty Drugs
  2. Indication Requirements: FDA Status and Medical Necessity
  3. Step Therapy & Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Lab Values
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in Ohio
  10. Common Denial Reasons & Solutions
  11. Cost Assistance Options
  12. FAQ

Policy Overview: How BCBS Ohio Handles Specialty Drugs

Blue Cross Blue Shield operates as 33 independent plans across the United States, with Ohio served primarily by Anthem Blue Cross Blue Shield. Each plan maintains its own formulary and prior authorization criteria, though they share common elements for specialty medications like Signifor LAR.

Plan Types and Coverage

  • Commercial Plans (PPO/HMO): Follow state-regulated prior authorization timelines (up to 14 business days standard, 72 hours expedited)
  • Federal Employee Program (FEP): Uses national formulary with exception request process available at 866-763-3608
  • Medicare Advantage: Subject to CMS guidelines with additional plan-specific requirements

All BCBS Ohio plans provide 180-day appeal windows for commercial lines and access to Ohio's external review process through the Ohio Department of Insurance.

Indication Requirements: FDA Status and Medical Necessity

Signifor LAR (pasireotide) has two FDA-approved indications that BCBS Ohio recognizes for coverage:

Cushing's Disease

  • Primary indication: When pituitary surgery is not an option or has not been curative
  • Required documentation: Confirmed endogenous Cushing's disease with biochemical evidence
  • ICD-10 codes: E24.0 (Pituitary-dependent Cushing's disease)

Acromegaly

  • Secondary indication: When inadequately controlled by surgery and/or first-generation somatostatin analogs
  • Required documentation: Elevated IGF-1 levels and failed prior therapy
  • ICD-10 codes: E22.0 (Acromegaly and pituitary gigantism)
Note: Off-label uses may require additional documentation and are subject to stricter review criteria.

Step Therapy & Exceptions

Cushing's Disease: No Step Therapy Required

Unlike many specialty medications, Signifor LAR does not have step therapy requirements for Cushing's disease. Approval depends on meeting diagnostic criteria and surgical history documentation.

Acromegaly: First-Generation SSA Trial Required

Patients must demonstrate:

  • Trial and failure of octreotide LAR or lanreotide
  • Documented intolerance to first-generation somatostatin analogs, OR
  • Contraindications to first-generation SSAs
  • Inadequate biochemical control after surgery

Medical Exception Pathways

Document contraindications or intolerance with:

  • Specific adverse events experienced
  • Dosing attempts and duration
  • Clinical notes from treating endocrinologist
  • Alternative therapy considerations

Quantity and Frequency Limits

Standard Dosing Parameters

  • Cushing's disease: 10-40 mg intramuscularly every 4 weeks
  • Acromegaly: Starting dose 40 mg every 4 weeks
  • Maximum supply: Typically 30-day supply (one vial per month)
  • Titration allowances: Dose adjustments based on biochemical response and tolerability

Renewal Requirements

Prior authorization typically requires renewal every 6-12 months with documentation of:

  • Continued medical necessity
  • Treatment response (biochemical markers)
  • Adverse event monitoring
  • Ongoing specialist oversight

Required Diagnostics and Lab Values

Cushing's Disease Documentation

Required within 3-6 months of PA request:

  • Two abnormal 24-hour urinary free cortisol (UFC) measurements, OR
  • Late-night salivary cortisol tests showing elevation
  • Dexamethasone suppression test results
  • Pituitary imaging (MRI) when available

Acromegaly Documentation

Required biochemical evidence:

  • Elevated serum insulin-like growth factor-1 (IGF-1)
  • Growth hormone levels >1 ng/mL two hours after oral glucose tolerance test
  • Documentation of inadequate surgical response or surgical contraindication

Timing and Recency Requirements

Lab values should be obtained within 3-6 months of the prior authorization request to ensure clinical relevance and current medical necessity.

Specialty Pharmacy Requirements

Mandatory Specialty Pharmacy Dispensing

Signifor LAR must be dispensed through an in-network specialty pharmacy for BCBS Ohio plans. Common specialty pharmacy networks include:

  • Anthem's InnovateRx: Primary specialty pharmacy network
  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Express Scripts Specialty
Important: Verify your specific plan's specialty pharmacy network before submitting your prior authorization to avoid coverage delays.

Site of Care Considerations

  • Administration: Must be given by healthcare provider (intramuscular injection)
  • Storage requirements: Refrigerated storage and handling protocols
  • Coordination: Specialty pharmacy coordinates with clinic for delivery timing

Evidence to Support Medical Necessity

Primary Guidelines and References

When submitting appeals or medical necessity letters, cite these authoritative sources:

  1. FDA Prescribing Information: Signifor LAR package insert for approved indications and dosing
  2. Endocrine Society Guidelines: Clinical practice guidelines for Cushing's syndrome treatment
  3. Pituitary Society Recommendations: Medical management protocols for pituitary disorders

Supporting Evidence Structure

For medical necessity letters, include:

  • Peer-reviewed studies demonstrating efficacy in your patient's specific condition
  • Comparative effectiveness data versus alternative therapies
  • Safety profile documentation for long-term use
  • Quality of life improvement evidence

Sample Medical Necessity Letter

Template Structure for Clinicians

Patient: [Name, DOB, Member ID]
Diagnosis: Cushing's disease (ICD-10: E24.0)
Requested medication: Signifor LAR (pasireotide) 20 mg IM every 4 weeks

Clinical rationale: This 45-year-old patient has biochemically confirmed Cushing's disease with two elevated 24-hour UFC measurements (150 mcg/24h and 162 mcg/24h; normal <50 mcg/24h) obtained in [dates]. Transsphenoidal surgery was attempted on [date] with incomplete resection due to cavernous sinus invasion, as documented in operative report. Post-surgical biochemical testing continues to show elevated cortisol production.

Medical necessity: Signifor LAR is FDA-approved specifically for Cushing's disease when surgery is not curative, which directly applies to this patient's clinical situation. Alternative medical therapies including ketoconazole were trialed with inadequate response and hepatotoxicity concerns.

Monitoring plan: Monthly clinic visits for first three months with UFC monitoring, quarterly thereafter with comprehensive metabolic panel and diabetes screening per FDA prescribing information.

Appeals Process in Ohio

Internal Appeal Timeline

  1. File within 180 days of initial denial
  2. Standard review: Up to 14 business days
  3. Expedited review: 72 hours for urgent medical situations
  4. Required documents: Complete medical records, denial letter, prescriber attestation

External Review Process

If internal appeals are unsuccessful:

  • File within 180 days of final internal denial
  • Submit to: Your BCBS plan (who forwards to Ohio Department of Insurance)
  • Cost: No charge to patient
  • Timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on insurer if overturned
Ohio-specific advantage: Even if your insurer claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility and order a review.

For assistance with appeals, contact the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526.

Common Denial Reasons & Solutions

Denial Reason Required Documentation How to Address
Lack of biochemical confirmation UFC or salivary cortisol results Submit recent lab results within 3-6 months
Surgery not attempted/documented Operative reports or consultation notes Provide surgical records or specialist note explaining contraindication
Non-specialist prescriber Endocrinologist involvement Obtain prescription or consultation from board-certified endocrinologist
Insufficient prior therapy trial (acromegaly) First-generation SSA documentation Document octreotide/lanreotide trial with response data
Dosing outside FDA parameters Clinical justification for dose Provide medical rationale with monitoring plan

Cost Assistance Options

Manufacturer Support Programs

Recordati R.A.R.E. Program provides:

  • Prior authorization assistance
  • Appeals support
  • Copay assistance for eligible patients
  • Patient access coordinators

Contact: R.A.R.E. Program website or through your specialty pharmacy

Financial Assistance

  • Income-based assistance: Available through manufacturer patient assistance program
  • Copay cards: May reduce out-of-pocket costs for commercially insured patients
  • Charitable foundations: Organizations like the HealthWell Foundation may provide grants

Counterforce Health helps patients navigate insurance denials and appeals for specialty medications like Signifor LAR. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that address specific payer criteria, improving approval rates for complex rare disease treatments. Learn more about their appeal assistance services.

FAQ

How long does BCBS Ohio prior authorization take for Signifor LAR?
Standard reviews take up to 14 business days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Signifor LAR is non-formulary on my plan?
You can request a formulary exception by demonstrating medical necessity and providing clinical documentation. The process follows the same prior authorization pathway.

Can I request an expedited appeal if my condition is worsening?
Yes, if a delay would seriously endanger your health, you can request expedited review at any appeal level. Document the urgency with your physician's clinical assessment.

Does step therapy apply if I failed similar medications outside Ohio?
Medical records from other states showing failed trials of first-generation somatostatin analogs (for acromegaly) should be accepted. Ensure complete documentation transfer.

What happens if BCBS denies my external review request?
The Ohio Department of Insurance can independently review eligibility even if your insurer initially claims you're not eligible for external review.

How much does Signifor LAR cost without insurance?
U.S. discount listings show costs often exceeding $20,000 per vial, though actual prices vary by pharmacy and patient assistance program eligibility.

From our advocates: "We've seen the strongest approval rates when patients submit comprehensive surgical records alongside recent biochemical testing. One common mistake is submitting outdated lab values - insurers want to see current medical necessity, typically within the last 3-6 months. The extra time spent gathering complete documentation upfront often prevents lengthy appeal processes later."

For patients facing complex insurance challenges, Counterforce Health specializes in turning denials into successful appeals by creating evidence-backed responses tailored to each payer's specific criteria and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by individual plan and may change. Always verify current requirements with your specific BCBS Ohio plan and consult with your healthcare provider for medical decisions. For official appeals assistance in Ohio, contact the Ohio Department of Insurance at 1-800-686-1526.

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