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

How to Get Signifor LAR (Pasireotide) Covered by Humana in Georgia: Prior Authorization Requirements and Appeals Guide

Answer Box: Getting Signifor LAR Covered by Humana in Georgia

Fastest path to approval: Have your endocrinologist submit prior authorization with documented failure/intolerance of first-generation somatostatin analogs (octreotide/lanreotide) and current IGF-1 or UFC levels. First step today: Call Humana at 1-800-448-6262 to confirm your plan's formulary status and PA requirements. If denied, you have four months to file an external review through Georgia's process after Humana's internal appeal.

Table of Contents

Policy Overview: How Humana Covers Specialty Drugs

Humana Medicare Advantage and commercial plans in Georgia require prior authorization for Signifor LAR (pasireotide), a high-cost specialty medication for Cushing's disease and acromegaly. This applies to all plan types—HMO, PPO, and Medicare Advantage.

Where to find official policies:

The prior authorization process ensures appropriate use of this expensive therapy, which can cost over $20,000 per monthly injection according to discount pharmacy listings.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage Humana PA List
Specialty Pharmacy Must use Humana's network Provider portal or member services
Endocrinologist Required Prescribed by or with consultation Most payer policies require specialist involvement
First-Gen SSA Trial 6+ months octreotide/lanreotide Clinical documentation in medical records
Biochemical Evidence Elevated IGF-1 or UFC levels Lab reports within 3-6 months
Appeal Deadline 4 months for external review Georgia external review process

Indication Requirements for Signifor LAR

Signifor LAR is FDA-approved for two specific conditions:

Cushing's Disease:

  • When pituitary surgery is not an option or has not been curative
  • Confirmed endogenous hypercortisolism (not from chronic steroid use)
  • Elevated 24-hour urinary free cortisol (UFC) levels

Acromegaly:

  • Inadequately controlled after surgery and/or first-generation somatostatin analog therapy
  • Elevated IGF-1 levels above age- and sex-adjusted normal ranges
  • Age 18 or older
Note: Off-label use may require additional justification and is less likely to be approved without compelling clinical evidence.

Step Therapy and Medical Exceptions

While Humana's current public lists don't explicitly require step therapy for pasireotide, most payers expect documentation of first-generation somatostatin analog failure or intolerance before approving this more expensive option.

Required First-Line Trials

For Acromegaly:

  • Octreotide LAR or lanreotide for at least 6 months
  • Optimal dosing attempted (up to maximum labeled doses)
  • Persistent IGF-1 elevation despite treatment

Medical Exception Pathways:

  • Documented intolerance to octreotide/lanreotide (GI effects, gallstones, severe hyperglycemia)
  • Contraindications to first-generation agents
  • Clinical deterioration requiring immediate alternative therapy

Documenting Treatment Failure

Your endocrinologist should include:

  • Exact medications tried, doses, and duration
  • Laboratory values before and after treatment
  • Specific adverse effects that led to discontinuation
  • Clinical rationale for pasireotide over other alternatives

Required Diagnostics and Documentation

Biochemical Evidence (within 3-6 months):

For Cushing's Disease:

  • 24-hour urinary free cortisol (UFC) levels
  • Dexamethasone suppression test results
  • Confirmation by endocrinologist of pituitary source

For Acromegaly:

  • IGF-1 levels (age and sex-adjusted reference ranges)
  • Growth hormone levels if available
  • MRI showing pituitary adenoma (if applicable)

Clinical Documentation:

  • Complete medical history and physical exam
  • Previous surgical reports (if applicable)
  • Treatment history with outcomes
  • Current symptoms and functional status
Tip: Use the same laboratory for follow-up testing to ensure consistent reference ranges and methodology.

Site of Care and Specialty Pharmacy Requirements

Administration Sites: Humana covers Signifor LAR administration in:

  • Physician offices
  • Hospital outpatient departments
  • Certified infusion centers
  • Home setting (with prior approval)

Specialty Pharmacy Network:

  • Must be dispensed through Humana's designated specialty pharmacy
  • Cannot be obtained through retail pharmacy
  • Requires coordination between prescriber and specialty pharmacy

Administration Details:

  • Intramuscular injection every 28 days (not IV infusion)
  • Must be administered by qualified healthcare provider
  • Proper storage and handling required

Evidence to Support Medical Necessity

Clinical Guidelines to Reference:

  • FDA prescribing information for approved indications
  • Endocrine Society Clinical Practice Guidelines for acromegaly and Cushing's disease
  • Pituitary Society recommendations for medical management

Key Evidence Points:

  • Biochemical control targets (IGF-1 normalization, UFC reduction)
  • Quality of life improvements with hormonal control
  • Risk of cardiovascular and metabolic complications if untreated
  • Superior SSTR5 receptor affinity compared to first-generation analogs

Sample Medical Necessity Paragraph

"Patient has confirmed acromegaly with persistently elevated IGF-1 levels (450 ng/mL, normal <220 for age/sex) despite 8 months of maximum-dose lanreotide 120mg monthly. Previous pituitary surgery achieved only partial biochemical control. Pasireotide LAR is indicated per FDA labeling for acromegaly inadequately controlled by surgery and first-generation somatostatin analogs, with superior SSTR5 affinity offering improved biochemical control in octreotide/lanreotide-resistant patients."

Appeals Process in Georgia

If Humana denies coverage for Signifor LAR, Georgia residents have robust appeal rights:

Step 1: Internal Appeal with Humana

  • Must be filed within 60 days of denial
  • Submit additional clinical documentation
  • Request peer-to-peer review with endocrinologist
  • Decision typically within 30 days (7 days if expedited)

Step 2: External Review in Georgia

  • Available after internal appeal denial
  • Must file within 4 months of final internal denial
  • Conducted by independent medical reviewers
  • Free to consumers
  • Decision within 45 days (72 hours if expedited)

How to File External Review:

  • Contact MAXIMUS Federal at 1-888-866-4662
  • Submit request online or by mail
  • Include all medical records and denial letters
  • Decision is binding on Humana
Georgia-Specific Advantage: Georgia's external review process has a strong track record of overturning inappropriate denials for specialty medications when medical necessity is clearly documented.

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Lack of specialist involvement Obtain endocrinologist consultation letter
Insufficient prior therapy documentation Provide detailed treatment history with lab values
Non-formulary status Request formulary exception with medical necessity letter
Dosing outside FDA label Provide clinical justification and literature support
Missing biochemical evidence Submit recent IGF-1 or UFC lab results
Alternative therapies available Document contraindications or failures of alternatives

Costs and Patient Support Programs

Manufacturer Support:

  • Recordati Rare Diseases offers patient assistance programs
  • Copay assistance may be available for commercial insurance
  • Check manufacturer website for current programs

Additional Resources:

  • Patient Advocate Foundation: 1-800-532-5274
  • NeedyMeds database for financial assistance programs
  • State pharmaceutical assistance programs (if available)

Medicare Considerations:

  • Medicare Part D coverage may apply
  • Extra Help program for low-income beneficiaries
  • Medicare Advantage may have different cost-sharing

At Counterforce Health, we help patients and clinicians navigate complex prior authorization requirements for specialty medications like Signifor LAR. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that address payer-specific criteria while incorporating the clinical documentation and regulatory requirements that lead to successful approvals.

FAQ: Your Top Questions Answered

Q: How long does Humana's prior authorization process take? A: Standard PA decisions are typically made within 1-2 business days for electronic submissions. Complex cases may take up to 14 days.

Q: What if Signifor LAR isn't on Humana's formulary? A: You can request a formulary exception with a medical necessity letter explaining why covered alternatives are inappropriate.

Q: Can I get an expedited appeal if my condition is urgent? A: Yes, if delay would seriously jeopardize your health, you can request expedited internal and external reviews with much faster timelines.

Q: Does step therapy apply if I tried octreotide outside of Georgia? A: Yes, treatment history from any state counts toward step therapy requirements. Provide documentation from your previous providers.

Q: What happens if the external review upholds the denial? A: For Medicare Advantage, you may appeal to the Medicare Appeals Council if the amount in controversy exceeds $1,840 (2024 threshold).

Q: Can my primary care doctor prescribe Signifor LAR? A: Most payers require endocrinologist involvement due to the complexity of pituitary disorders and monitoring requirements.

From Our Advocates: "We've seen Georgia patients successfully overturn Humana denials by providing detailed biochemical documentation showing inadequate response to first-generation somatostatin analogs. The key is submitting lab values before and after the initial treatment, along with a clear timeline of clinical deterioration. External review is particularly effective when the clinical picture strongly supports medical necessity."

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently—always verify current requirements with Humana directly. For personalized assistance with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298 or visit their website for additional resources.

Whether you're dealing with a prior authorization request or appealing a denial, Counterforce Health provides the tools and expertise to help you navigate the complex world of specialty drug coverage, turning insurance obstacles into successful approvals through targeted, evidence-based advocacy.

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