By Counterforce Health Team in Orfadin (nitisinone) —

Denied for Orfadin (Nitisinone) by Cigna in Washington? How to Appeal (Templates & Timelines)

Answer Box: Cigna requires prior authorization for Orfadin (nitisinone) with confirmed HT-1 diagnosis (elevated succinylacetone), genetic testing, dietary management plan, and metabolic specialist involvement. If denied, you have 180 days for internal appeals and can request external review through Washington's Independent Review Organization. First step today: Gather your denial letter, clinical notes, and lab results, then contact your prescriber to prepare a medical necessity letter addressing the specific denial reason.

Table of Contents

Read the Denial Letter

Your Cigna denial letter contains critical information that determines your next steps. Look for these key elements:

Denial Reason Codes:

  • PA001: Prior authorization required but not submitted
  • MED02: Not medically necessary per plan criteria
  • FORM: Non-formulary drug (requires formulary exception)
  • STEP: Step therapy requirements not met
  • QL: Quantity limit exceeded

Extract These Details:

  • Appeal deadline (typically 180 days from denial date)
  • Internal review levels available (usually 2 levels)
  • Required documentation for appeal
  • Specific clinical criteria not met
Note: Cigna processes Orfadin through Express Scripts/Accredo specialty pharmacy. Retail pharmacy requests are automatically denied.

Fixable Causes of Denial

Many Orfadin denials can be overturned by addressing documentation gaps:

Common Issue Solution Required Documentation
Missing HT-1 diagnosis Submit lab results Elevated succinylacetone levels, ICD-10 E70.29
No genetic confirmation Order FAH gene testing Pathogenic variant results
Inadequate dietary plan Metabolic dietitian consult Tyrosine/phenylalanine restriction protocol
Wrong prescriber type Specialist involvement Metabolic specialist consultation notes
Incomplete prior auth Resubmit full application All required forms and attachments

First-Level Appeal Process

Timeline: Submit within 180 days of denial date in Washington.

Required Components:

  1. Appeal request letter stating you're requesting internal review
  2. Medical necessity letter from prescriber (see template below)
  3. Supporting clinical documentation
  4. Copy of original denial letter

Medical Necessity Letter Checklist:

  • Confirmed HT-1 diagnosis with lab values
  • Statement: "Orfadin is the only FDA-approved treatment for HT-1"
  • Dietary management plan details
  • Risk of liver failure/death without treatment
  • Specialist credentials and experience

Submission Methods:

  • Online: Cigna member portal (fastest processing)
  • Fax: Use number provided in denial letter
  • Mail: Address specified in denial notice
Tip: Submit via multiple methods and request confirmation of receipt.

Peer-to-Peer Review Strategy

If your written appeal is denied, request a peer-to-peer review where your doctor speaks directly with Cigna's medical director.

Scheduling: Call Cigna provider services and request peer-to-peer within 30 days of written denial.

Prep Checklist for Your Doctor:

  • Patient's current succinylacetone levels
  • Progression of liver function tests
  • Dietary compliance documentation
  • Risk of hepatocellular carcinoma without treatment
  • Lack of alternative therapies

Key Talking Points:

  1. HT-1 is a life-threatening genetic disorder
  2. Orfadin prevents toxic metabolite accumulation
  3. Dietary restriction alone is insufficient
  4. Early treatment prevents irreversible liver damage
  5. No therapeutic alternatives exist

Second-Level & External Review in Washington

Internal Second-Level Appeal:

  • Available if first internal appeal denied
  • Same 180-day window from original denial
  • Include any new clinical evidence

External Review Process: Washington provides robust external review through Independent Review Organizations (IROs).

Eligibility: Available after completing internal appeals or if Cigna doesn't respond within required timeframes.

Timeline:

  • Request deadline: 180 days after final internal denial
  • IRO assignment: Within 5 business days
  • Decision: 30 days for standard review, 72 hours for expedited

How to Request:

  1. Contact Washington Office of Insurance Commissioner at 1-800-562-6900
  2. Submit external review request form
  3. Include all previous appeal documentation

Washington-Specific Advantages:

  • IROs include specialists familiar with rare diseases
  • State law requires consideration of latest clinical evidence
  • Decision is binding on Cigna
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements.

Appeal Templates & Scripts

Patient Phone Script for Cigna: "I'm calling about my Orfadin prior authorization denial dated [DATE]. My member ID is [ID]. I need to understand the specific clinical criteria not met and request information about filing an internal appeal."

Medical Necessity Letter Template:

[Date]

RE: Medical Necessity Appeal for Orfadin (nitisinone)
Member: [Name], ID: [Number]

Dear Medical Director,

I am writing to appeal the denial of Orfadin (nitisinone) for my patient with hereditary tyrosinemia type 1 (HT-1).

DIAGNOSIS: Confirmed HT-1 based on:
- Elevated succinylacetone: [VALUE] (normal <2 μmol/L)
- FAH gene mutation: [SPECIFIC VARIANT if available]
- ICD-10: E70.29

MEDICAL NECESSITY:
Orfadin is the only FDA-approved treatment for HT-1. Without treatment, patients develop progressive liver failure, hepatocellular carcinoma, and death. Dietary management alone is insufficient to prevent toxic metabolite accumulation.

TREATMENT PLAN:
- Orfadin [DOSE] twice daily
- Tyrosine/phenylalanine restricted diet (managed by metabolic dietitian)
- Regular monitoring of succinylacetone and liver function

This medication is essential for preventing irreversible organ damage and death. I request immediate approval.

Sincerely,
[Physician signature and credentials]

Tracking Your Appeal

Create an Appeal Log:

  • Date submitted
  • Method of submission
  • Confirmation numbers
  • Follow-up dates
  • Decision received
  • Next steps

Key Dates to Monitor:

  • 5 business days: Expected PA decision
  • 30 days: Internal appeal decision
  • 180 days: Deadline for external review request

Win-Rate Boosters

Strengthen Your Appeal With:

  1. Current Guidelines: Reference FDA labeling and metabolic disorder treatment protocols
  2. Functional Impact: Document how untreated HT-1 affects daily activities and development
  3. Contraindications: Note if generic alternatives cause adverse reactions
  4. Monitoring Plan: Detailed follow-up schedule showing responsible medication management

Evidence to Include:

  • Serial succinylacetone levels showing disease activity
  • Liver function trends
  • Growth and development assessments
  • Dietitian reports on dietary compliance

For complex cases requiring extensive clinical evidence compilation, Counterforce Health helps patients and clinicians identify the right citations and weave them into appeals with required clinical facts.

If Your Appeal Fails

Alternative Options:

  1. Formulary Exception: Request coverage of non-formulary Orfadin if generics available
  2. Manufacturer Support: Sobi Patient Access Program may provide financial assistance
  3. Foundation Grants: National Organization for Rare Disorders (NORD) offers medication assistance
  4. State Programs: Washington Apple Health (Medicaid) may have different coverage criteria

Regulatory Complaint: File with Washington Office of Insurance Commissioner if you believe Cigna violated state insurance laws or acted in bad faith.

FAQ

How long does Cigna prior authorization take for Orfadin in Washington? Standard review: 5 business days. Expedited review for urgent cases: 24-72 hours.

What if Orfadin is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. The process is similar to prior authorization appeals.

Can I request an expedited appeal? Yes, if delay risks serious health consequences. Your doctor must document the urgency and potential harm from treatment delay.

Does step therapy apply to Orfadin? No, Orfadin is the only FDA-approved treatment for HT-1. There are no required step-therapy alternatives.

What happens during external review in Washington? An independent medical expert reviews your case and makes a binding decision on Cigna. The process takes about 30 days for standard cases.

How much does Orfadin cost without insurance? Costs vary by strength and quantity. Contact Sobi for current pricing and patient assistance programs.

Sources & Further Reading

From Our Advocates: One family successfully overturned their Cigna denial by including a detailed timeline showing their child's liver function deterioration without treatment. The metabolic specialist's letter emphasized the irreversible nature of HT-1 complications, and the external review approved coverage within three weeks. This illustrates the importance of documenting disease progression and specialist involvement.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Consult with your healthcare provider and insurance company for guidance specific to your situation. For personalized assistance with complex appeals, consider consulting with organizations like Counterforce Health that specialize in insurance coverage advocacy.

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