How to Get Signifor / Signifor LAR (pasireotide) Covered by Aetna (CVS Health) in Florida: Complete PA Forms and Appeals Guide
Quick Answer: Getting Signifor / Signifor LAR (pasireotide) Covered by Aetna (CVS Health) in Florida
Signifor / Signifor LAR (pasireotide) requires prior authorization from Aetna (CVS Health) in Florida. For acromegaly, you'll need documented failure of first-generation somatostatin analogs (octreotide, lanreotide) plus elevated IGF-1 levels. For Cushing's disease, provide elevated cortisol levels and evidence that pituitary surgery wasn't curative or feasible. Submit through CVS Specialty at 1-855-240-0535 or fax 1-888-267-3277. If denied, Florida law gives you 180 days to appeal internally, then external review through the state. Start today: gather your lab results, prior therapy records, and have your endocrinologist submit the PA request.
Table of Contents
- Understanding Florida's Prior Authorization Laws
- Aetna (CVS Health) Coverage Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Florida Step Therapy Override Rights
- Appeals Process in Florida
- When to Request Expedited Review
- External Review and Consumer Protection
- Cost Assistance Programs
- FAQ
Understanding Florida's Prior Authorization Laws
Florida's insurance laws provide strong protections for patients needing specialty medications like Signifor / Signifor LAR (pasireotide). Under Florida Statutes § 627.42395 and § 627.42397, insurers must approve step therapy override exceptions within 72 hours for expedited requests or 5 business days for standard requests when specific medical criteria are met.
These laws apply to all commercial fully insured plans in Florida, including Aetna (CVS Health) plans. Self-insured employer plans are exempt from state laws but may still honor override requests.
Note: Florida's external review process allows independent medical experts to overturn insurer denials, with decisions binding on the insurance company and free to consumers.
Aetna (CVS Health) Coverage Requirements
Coverage at a Glance
| Requirement | Details | Where to Find It |
|---|---|---|
| Prior Authorization | Required for both Signifor and Signifor LAR | Aetna PA policies |
| Formulary Status | Non-preferred (higher copay) | CVS Caremark formulary |
| Step Therapy | First-gen SSA required for acromegaly | PA form requirements |
| Prescriber | Endocrinologist preferred | Policy documentation |
| Lab Requirements | IGF-1 (acromegaly), UFC (Cushing's) | Medical necessity criteria |
| Authorization Duration | 12 months | Renewal required annually |
Medical Necessity Criteria
For Acromegaly:
- High pretreatment IGF-1 (above age/sex-adjusted upper normal limit)
- Inadequate response to surgery or surgery not an option
- Documented failure or intolerance of first-generation somatostatin analogs (octreotide LAR, lanreotide)
- Prescriber specialty in endocrinology preferred
For Cushing's Disease:
- Elevated pretreatment cortisol (24-hour urinary free cortisol, late-night salivary cortisol, or dexamethasone suppression test)
- Non-curative pituitary surgery or patient not a surgical candidate
- Specialist prescriber documentation
Step-by-Step: Fastest Path to Approval
- Gather Required Documentation (Patient + Clinic)
- Insurance card and member ID
- Lab results: IGF-1 levels (acromegaly) or cortisol studies (Cushing's)
- Records of prior therapy trials and failures
- Surgery reports (if applicable)
- Have Endocrinologist Submit PA Request (Clinic)
- Call CVS Specialty: 1-855-240-0535
- Fax completed forms: 1-888-267-3277
- Submit via CVS Specialty provider portal (verify current link)
- Timeline: 5 business days for standard, 72 hours for expedited
- Track Your Request (Patient)
- Use Aetna member portal or call member services
- Request expedited review if medically urgent
- Follow up if no response within stated timeframes
- If Approved (Patient + Clinic)
- Coordinate with CVS Specialty for delivery
- Set calendar reminder for reauthorization (11 months)
- Monitor for required lab work
- If Denied (Patient + Clinic)
- Request detailed denial reason
- Gather additional documentation
- File internal appeal within 180 days
- Consider peer-to-peer review
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documents |
|---|---|---|
| No prior SSA trial documented | Submit pharmacy records with dates, doses, outcomes | CVS Caremark records, physician notes |
| Non-specialist prescriber | Transfer to endocrinologist or get co-signature | Specialist consultation notes |
| Insufficient lab documentation | Provide complete biochemical workup | IGF-1, UFC, cortisol studies with dates |
| Alternative therapies available | Document contraindications or failures | Allergy records, trial failure notes |
| Not medically necessary | Submit peer-reviewed evidence and guidelines | FDA labeling, medical literature |
Florida Step Therapy Override Rights
Florida law provides powerful protections against inappropriate step therapy requirements. Under Florida Statutes § 627.42395, Aetna (CVS Health) must grant exceptions if any of these criteria apply:
Override Criteria (No Prior Failure Required)
- Prescriber attests preferred drug is ineffective, contraindicated, or likely to cause adverse reaction
- Patient has tried preferred drug(s) and failed (ineffective or intolerable side effects)
- Preferred drug is expected to be ineffective based on clinical characteristics
- Medical necessity is documented
How to Request Override
- Submit written request with prescriber attestation
- Use Florida step therapy override form (verify with source)
- Include clinical rationale and supporting documentation
- Timeline: 72 hours expedited, 5 business days standard
Tip: For Signifor / Signifor LAR, emphasize the drug's unique SSTR5 receptor affinity compared to first-generation analogs, making it clinically distinct rather than just "another option."
Appeals Process in Florida
Internal Appeal Timeline
- Deadline to file: 180 days from denial notice
- Aetna decision time: 30 calendar days (standard), 72 hours (expedited)
- Required documents: Denial letter, additional medical records, prescriber letter
How to File Internal Appeal
- Call Aetna Member Services: Number on your insurance card
- Submit in writing: Include member ID, denial details, new evidence
- Mark expedited if urgent: "EXPEDITED APPEAL REQUEST" on all documents
- Follow up: Track via member portal or phone
Clinician Corner: Medical Necessity Letter Checklist
When writing a medical necessity letter for Signifor / Signifor LAR appeal, include:
- Patient's specific diagnosis with ICD-10 codes
- Biochemical evidence: Exact IGF-1 or cortisol levels with dates
- Prior therapy details: Drug names, doses, duration, specific reasons for failure
- Clinical rationale: Why pasireotide is uniquely appropriate
- Guideline citations: FDA labeling, endocrine society recommendations
- Monitoring plan: Lab schedules, safety parameters
When to Request Expedited Review
Request expedited review (72-hour decision) when:
- Ongoing treatment interruption could worsen symptoms
- Severe, uncontrolled symptoms affecting daily function
- Risk of hospitalization without treatment
- Physician certifies urgency in writing
Expedited Review Process
- Mark all documents: "EXPEDITED APPEAL REQUEST"
- Call immediately: Aetna at 1-800-624-0756 (commercial) or 1-844-528-5815 (Medicaid)
- Fax physician letter: 860-607-7894 with urgency certification
- Follow up daily: Until decision received
External Review and Consumer Protection
If Aetna (CVS Health) denies your internal appeal, Florida provides independent external review at no cost to you.
External Review Process
- Deadline: 120 days after final internal denial
- Timeline: 45-60 days for decision (15 days if expedited)
- Cost: Free to consumers
- Decision: Binding on Aetna (CVS Health)
How to Request External Review
- Contact Florida Department of Financial Services: (877) 693-5236
- Submit complaint online: myfloridacfo.com
- Include all documents: Denial letters, medical records, appeal correspondence
- Independent physician review: Medical necessity determination
Important: External reviewers overturn approximately 40-45% of medical necessity denials, making this a valuable option for complex cases.
Cost Assistance Programs
Manufacturer Support
- Recordati Rare Diseases Patient Access Program: Contact manufacturer for eligibility
- Copay assistance: May reduce out-of-pocket costs significantly
- Free drug programs: For qualifying uninsured patients
Foundation Grants
- PAN Foundation: Rare disease medication assistance
- HealthWell Foundation: Specialty drug copay support
- Patient Advocate Foundation: Insurance navigation and copay relief
State Resources
- Florida Medicaid: AHCA for low-income coverage
- Insurance marketplace: Healthcare.gov for plan options
From Our Advocates
We've seen patients initially denied for Signifor LAR successfully obtain coverage after providing comprehensive documentation of octreotide failure, including specific side effects and biochemical non-response data. The key was working with their endocrinologist to submit a detailed timeline showing inadequate IGF-1 control despite maximum tolerated doses. While outcomes vary, thorough documentation significantly improves approval chances.
At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific basis for rejection, and drafts point-by-point rebuttals aligned with each insurer's own policies. For medications like Signifor / Signifor LAR, we pull the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals that meet procedural requirements while tracking deadlines and required documentation.
FAQ
Q: How long does Aetna (CVS Health) prior authorization take in Florida? A: Standard PA decisions take up to 30-45 days, while expedited requests are decided within 72 hours when urgency is documented.
Q: What if Signifor / Signifor LAR is non-formulary on my plan? A: You can request a formulary exception with medical necessity documentation. Florida law supports exceptions when alternatives are ineffective or contraindicated.
Q: Can I get expedited review if I'm already on treatment? A: Yes, if treatment interruption could seriously jeopardize your health. Your physician must certify the urgency in writing.
Q: Does Florida step therapy law apply to all Aetna plans? A: It applies to fully insured commercial plans but not self-funded employer plans (ERISA). Check with your HR department about your plan type.
Q: What happens if I miss the 180-day appeal deadline? A: You may lose your right to internal appeal, but you can still file a complaint with Florida DFS and request their assistance in resolving the coverage dispute.
Q: How much does Signifor / Signifor LAR cost without insurance? A: List prices often exceed $20,000 per vial, making insurance coverage or manufacturer assistance programs essential for most patients.
Q: Can my primary care doctor prescribe Signifor / Signifor LAR? A: While legally possible, Aetna (CVS Health) policies prefer endocrinologist prescribers and may deny requests from non-specialists.
Q: What should I do if Aetna doesn't respond within their timeframes? A: File a complaint with Florida DFS at (877) 693-5236, as insurers are required to meet response deadlines under state law.
Disclaimer: This information is for educational purposes and should not replace professional medical or legal advice. Insurance policies and state laws can change; verify current requirements with official sources. For personalized assistance with your specific situation, consult your healthcare provider and insurance plan directly.
Need help navigating your appeal? Counterforce Health specializes in turning insurance denials into successful approvals through evidence-based appeals that align with each payer's specific requirements.
Sources & Further Reading
- Aetna Signifor LAR Medical Policy
- Florida Step Therapy Laws
- Florida Department of Financial Services Consumer Assistance
- FDA Signifor / Signifor LAR Prescribing Information
- CVS Specialty Pharmacy
- Florida External Review Process
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