By Counterforce Health Team in Orfadin (nitisinone) —

How Long Does It Take to Get Orfadin (nitisinone) Approved by Aetna (CVS Health) in Washington? Timeline & Appeals

Answer Box: Timeline Overview

Aetna (CVS Health) typically approves Orfadin (nitisinone) prior authorization requests within 72 hours for standard cases and 24 hours for expedited reviews in Washington. Over 95% of eligible requests are approved within 24 hours when complete documentation is submitted. Key requirements include confirmed hereditary tyrosinemia type 1 (HT-1) diagnosis with elevated succinylacetone levels (>2 μmol/L), genetic testing results, and an active dietary restriction plan. Submit via CVS Specialty Pharmacy at 1-866-814-5506 or through the Aetna provider portal. If denied, you have 180 days to appeal in Washington.

Table of Contents

What Affects Orfadin Approval Timing

Several factors influence how quickly Aetna (CVS Health) processes your Orfadin (nitisinone) prior authorization in Washington:

Benefit Type Impact: Commercial plans typically process faster than Medicare Advantage, which must follow CMS guidelines. Medicaid (Apple Health) plans may have additional state-specific requirements.

Documentation Completeness: The most significant factor affecting timeline is whether your initial submission includes all required evidence. Complete submissions with genetic testing, recent labs, and dietary plans move through review within the standard 72-hour window.

Clinical Complexity: Straightforward HT-1 cases with clear biochemical evidence process faster than complex presentations requiring additional specialist consultation.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization, gather these required documents:

Medical Evidence:

  • Recent succinylacetone levels (>2 μmol/L in blood or urine)
  • Genetic testing results showing FAH gene variants
  • Liver function tests (AST, ALT, GGT, albumin, bilirubin)
  • Metabolic specialist consultation notes

Treatment Plan:

  • Dietary restriction plan from registered dietitian
  • Weight-based dosing rationale (typically 1 mg/kg twice daily)
  • Monitoring schedule for succinylacetone and tyrosine levels

Insurance Information:

  • Current Aetna member ID card
  • Plan type verification (commercial, Medicare, Medicaid)
  • Previous denial letters (if applicable)
Tip: Call CVS Specialty at 1-866-814-5506 first to verify your benefits and receive the specific prior authorization packet for your plan.

Submission to Initial Review (1-5 Days)

Fastest Submission Methods

Primary Route - CVS Specialty: Call 1-866-814-5506 to initiate the prior authorization process. CVS Specialty handles all Orfadin dispensing for Aetna plans and can submit the PA directly.

Provider Portal: Healthcare providers can submit via Availity or the Aetna provider portal using the 2025 precertification form.

Fax Submission: Specialty medications can be faxed to 1-866-249-6155 with all supporting documentation.

Washington State Review Standards

Washington insurance regulations require Aetna to:

  • Acknowledge receipt within 1 business day
  • Complete standard reviews within 72 hours
  • Provide expedited decisions within 24 hours when medically urgent
  • Auto-approve if they miss decision deadlines

Additional Information Requests (1-7 Days)

If Aetna requests additional information, respond immediately to avoid delays:

Common Requests:

  • Updated succinylacetone levels if previous results are over 6 months old
  • Detailed dietary management plan from certified dietitian
  • Specialist letter explaining why generic nitisinone isn't appropriate
  • Prior therapy records if step therapy applies

Response Strategy: Submit additional documents within 24-48 hours via the same method used for initial submission. Include your case reference number on all correspondence.

Decision Window & Outcomes

Typical Decision Timeline

Review Type Timeline Approval Rate
Standard PA 72 hours 95%+ when complete
Expedited (urgent) 24 hours Similar rates
Step therapy exception 3-5 business days Variable
Non-formulary exception 5-7 business days Requires strong justification

Reading Your Approval: Approved authorizations will specify quantity limits, duration (typically 6-12 months), and any special requirements for renewal.

Partial Approvals: Aetna may approve a lower dose or shorter duration initially, requiring additional documentation for full coverage.

If Denied: Washington Appeal Timeline

Washington provides strong consumer protections for insurance appeals:

Internal Appeals (First Step)

  • Filing deadline: 180 days from denial notice
  • Decision timeline: 30 days for standard appeals, 72 hours for expedited
  • How to file: Use denial letter instructions or call member services

External Review (Final Step)

After exhausting internal appeals, Washington residents can request an independent external review:

  • Filing deadline: 30 days after final internal denial
  • Review timeline: 45 days for standard cases, 72 hours for urgent
  • Process: Submit request to Washington State Office of the Insurance Commissioner
  • Cost: Free for consumers
  • Decision: Binding on Aetna if approved
Note: Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900 for appeal assistance and forms.

Renewal Cycles

Orfadin authorizations typically require renewal every 6-12 months:

Renewal Requirements:

  • Updated succinylacetone and tyrosine levels
  • Adherence documentation (>85% compliance)
  • Continued dietary restriction confirmation
  • Growth/development assessment for pediatric patients

Timeline for Renewal: Submit renewal requests 30-45 days before expiration to ensure continuity of coverage.

Timeline Visual

Orfadin Approval Milestones

Day Milestone Action Required
0 Gather documentation Patient/provider collects labs, genetic testing, diet plan
1 Submit PA Call CVS Specialty or submit via provider portal
2-3 Initial review Aetna clinical team reviews against HT-1 criteria
3-5 Decision issued Approval letter sent; coverage begins immediately
30+ Appeal deadline If denied, file internal appeal within 180 days
60+ External review If internal appeal fails, request IRO review

Time-Saving Tips

Expedite Your Approval:

  1. Use CVS Specialty directly - They know Aetna's exact requirements and can submit complete applications
  2. Bundle all evidence - Include genetic testing, recent labs, and dietary plans in one submission
  3. Request expedited review if delay risks liver function or patient safety
  4. Follow up proactively - Call 48 hours after submission to confirm receipt and status

Provider Efficiency Tips:

  • Use template medical necessity letters that address Aetna's specific criteria
  • Submit via electronic portals rather than fax for faster processing
  • Include ICD-10 code E70.29 (Other disorders of tyrosine metabolism) for proper routing

Common Denial Reasons & Fixes

Denial Reason Solution Required Documentation
"No HT-1 diagnosis confirmed" Submit genetic testing results FAH gene analysis showing 2 pathogenic variants
"Missing biochemical evidence" Provide recent lab work Succinylacetone >2 μmol/L in blood or urine
"Step therapy not completed" Document generic nitisinone failure Records showing intolerance or inadequate response
"No dietary management plan" Include dietitian consultation Formal tyrosine/phenylalanine restriction plan

Appeals Playbook for Washington

Level 1: Internal Appeal

Timeline: File within 180 days of denial Process:

  1. Call Aetna member services number on your ID card
  2. Request internal appeal form
  3. Submit denial letter, medical records, and physician support letter
  4. Decision within 30 days (72 hours if expedited)

Level 2: External Review

Timeline: File within 30 days of final internal denial Process:

  1. Complete Washington State external review form
  2. Submit to Office of the Insurance Commissioner
  3. Include all previous correspondence and medical evidence
  4. Independent medical experts review case
  5. Decision within 45 days (binding on Aetna)

Contact: Washington Office of the Insurance Commissioner

For patients navigating complex insurance appeals, Counterforce Health helps turn denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

FAQ

Q: How long does Aetna (CVS Health) PA take in Washington? A: Standard prior authorizations are processed within 72 hours, with expedited reviews completed in 24 hours when medically urgent.

Q: What if Orfadin (nitisinone) is non-formulary on my plan? A: You can request a formulary exception by documenting medical necessity and why preferred alternatives aren't suitable.

Q: Can I request an expedited appeal in Washington? A: Yes, if delay would seriously jeopardize your health or ability to regain maximum function, you can request expedited internal and external reviews.

Q: Does step therapy apply if I've tried treatments outside Washington? A: Yes, document previous therapy attempts with generic nitisinone or other treatments, including reasons for discontinuation.

Q: What happens if Aetna misses their decision deadline? A: Under federal law, missed deadlines result in automatic approval of your request.

Q: Are there cost assistance programs for Orfadin? A: Sobi offers patient assistance programs, and Washington residents may qualify for state prescription assistance programs through the Department of Health.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. Counterforce Health provides tools to help patients and providers navigate insurance appeals but cannot guarantee coverage outcomes.

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