By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Approved by Cigna in Michigan: Complete Timeline and Appeal Guide

Answer Box: Fast Track to Orladeyo Approval

Getting Orladeyo (berotralstat) covered by Cigna in Michigan typically takes 15-30 days from prior authorization submission to final decision. The fastest path requires: (1) Complete HAE diagnosis documentation with C1-INH testing results, (2) Michigan PA form FIS 2288 submitted by your allergist/immunologist, and (3) attack frequency records showing ≥2 HAE episodes monthly. Start today: Contact a Michigan HAE specialist in Cigna's network, confirm your diagnosis labs are current, and begin documenting attack patterns. If denied, you have 127 days to file external review with Michigan DIFS.

Table of Contents

  1. What Affects Your Approval Timeline
  2. Pre-Submission Preparation (0-2 Days)
  3. Initial Review Process (1-15 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window and Outcomes
  6. If Denied: Michigan Appeal Process
  7. Renewal Cycles and Reauthorization
  8. Timeline Visual and Milestones
  9. Time-Saving Tips for Faster Approval

What Affects Your Approval Timeline

Several factors influence how quickly Cigna processes your Orladeyo (berotralstat) prior authorization in Michigan:

Benefit Type: Specialty drugs like Orladeyo typically require prior authorization regardless of your Cigna plan type. Commercial plans use Michigan's standardized PA process, while Medicare and Medicaid plans follow federal timelines.

Documentation Completeness: The most common cause of delays is incomplete clinical documentation. Cigna requires specific HAE diagnosis confirmation, attack frequency records, and specialist involvement—missing any element triggers requests for additional information.

Prescriber Network Status: In-network allergists and immunologists familiar with HAE can expedite the process by submitting complete, guideline-aligned requests. Out-of-network providers may face additional scrutiny.

Note: Michigan law mandates 15-day response times for standard PA requests and 72 hours for expedited reviews when health is at serious risk.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization, gather these required documents:

HAE Diagnosis Confirmation:

  • C1-INH quantitative and functional assay results
  • C4 complement levels (typically low in HAE)
  • Genetic testing results if applicable (SERPING1, F12, ANGPT1, PLG, or KNG1 genes)

Attack Frequency Documentation:

  • Medical records showing ≥2 HAE attacks per month
  • Patient diary or attack log with dates and severity
  • Emergency department or urgent care visit records for HAE episodes

Clinical Requirements:

  • Patient age ≥12 years
  • Prescription from or consultation with allergist/immunologist
  • Documentation that Orladeyo won't be used with other HAE prophylaxis drugs

Michigan-Specific Forms

Your prescriber must complete Michigan Prior Authorization Request Form FIS 2288 for commercial Cigna plans. This standardized form includes sections for:

  • Clinical rationale and medical necessity
  • Prior therapy trials and outcomes
  • Expedited review certification if urgent

Initial Review Process (1-15 Days)

Once submitted, Cigna's utilization management team conducts a systematic review:

Day 1-3: Administrative screening verifies form completeness, patient eligibility, and prescriber credentials.

Day 4-10: Clinical review against Cigna's berotralstat coverage criteria, including:

  • Confirmed HAE Type I or II diagnosis
  • Age and prescriber requirements
  • Attack frequency thresholds
  • Contraindications to alternative therapies

Day 11-15: Final determination and notification. Cigna must respond within 15 days per Michigan law, or the request is deemed approved.

What Reviewers Check First

Cigna's clinical pharmacists prioritize these verification points:

  1. Diagnosis codes: ICD-10 D84.1 (hereditary angioedema) with supporting lab values
  2. Prescriber specialty: Must be allergist/immunologist or in consultation
  3. Medical necessity: Attack frequency and impact on daily functioning
  4. Safety considerations: No concurrent prophylactic HAE treatments

Additional Information Requests (1-7 Days)

If Cigna requests additional documentation, respond within the specified timeframe to avoid voiding your request:

Standard requests: 21 days to provide additional information Expedited requests: 5 days to provide additional information

Common requests include:

  • Updated C1-INH laboratory results
  • Specialist consultation notes
  • Detailed attack frequency records
  • Documentation of contraindications to step therapy options
Tip: Submit additional information through the same channel as your original request (provider portal, fax, or mail) to maintain case continuity.

Decision Window and Outcomes

Cigna provides written notification of their determination, which falls into three categories:

Approved: Coverage authorized with specific quantity limits and renewal dates. Most approvals are for 12 months with reauthorization required.

Denied: Written explanation of denial reason with appeal rights information. Common denial reasons include:

  • Insufficient HAE diagnosis documentation
  • Age <12 years
  • Concurrent prophylactic therapy
  • Inadequate attack frequency records

Partial Approval: Coverage with modified quantity limits or step therapy requirements.

If Denied: Michigan Appeal Process

Michigan residents have robust appeal rights through multiple levels:

Internal Appeals with Cigna

Timeline: 180 days from denial date to file Process: Submit appeal through Cigna member portal or written request Response time: 30 days for standard appeals, 72 hours for expedited

External Review Through Michigan DIFS

After exhausting internal appeals, request external review within 127 days of Cigna's final denial:

Standard External Review:

  • Maximum 60 days for decision
  • Independent medical expert review
  • Binding decision if coverage approved

Expedited External Review:

  • 72-hour decision timeline
  • Requires physician letter certifying urgency
  • Available when delays could harm patient health

Contact: Michigan DIFS External Review or call 877-999-6442

Renewal Cycles and Reauthorization

Orladeyo approvals typically require annual reauthorization. Start the renewal process 30-60 days before expiration to ensure continuous coverage.

Renewal Documentation:

  • Updated attack frequency records showing therapeutic benefit
  • Continued specialist oversight
  • Current laboratory values if requested
  • Documentation of adherence and tolerability

Factors That Speed Renewals:

  • Demonstrated reduction in HAE attack frequency
  • Maintained specialist care
  • No safety concerns or adverse events
  • Complete submission of renewal paperwork

Timeline Visual and Milestones

Milestone Expected Timeline Key Actions
Pre-submission prep 0-2 days Gather documentation, complete forms
Initial submission Day 1 Submit via provider portal or fax
Administrative review Days 1-3 Verify completeness and eligibility
Clinical review Days 4-10 Medical necessity evaluation
Additional info request Days 5-12 Respond within 21 days (standard)
Final determination Days 11-15 Written notification of decision
Internal appeal (if denied) Within 180 days Submit appeal documentation
External review (if needed) Within 127 days File with Michigan DIFS

Time-Saving Tips for Faster Approval

Use Provider Portals: Electronic submission through Cigna's provider portal typically processes faster than fax or mail.

Bundle Evidence: Submit all required documentation together rather than piecemeal responses to avoid multiple review cycles.

Specialist Routing: Ensure your allergist/immunologist submits the PA request directly—referrals from primary care physicians often require additional review steps.

Track Status: Monitor your request through Express Scripts member portal under "Prior Authorizations" section.

Prepare for Appeals: If you have a complex case or previous denials, begin gathering appeal documentation while awaiting the initial decision.

Counterforce Health: Streamlining HAE Treatment Access

Getting specialty medications like Orladeyo approved shouldn't require navigating complex insurance processes alone. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies specific coverage criteria, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements—making the approval process more efficient for everyone involved.

From our advocates: "We've seen HAE patients succeed by maintaining detailed attack diaries from day one, even before starting the PA process. One patient's three-month log showing 2-3 attacks weekly, complete with dates and functional impact, helped overturn an initial denial within the first internal appeal. The key is specific, dated documentation that clearly demonstrates medical necessity."

Frequently Asked Questions

How long does Cigna PA take for Orladeyo in Michigan? Standard prior authorization takes up to 15 days. Expedited reviews are completed within 72 hours when medically urgent.

What if Orladeyo is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification from your prescriber.

Can I request an expedited appeal in Michigan? Yes, both Cigna internal appeals and Michigan DIFS external reviews offer expedited pathways when delays could harm patient health.

Does step therapy apply if I've tried other HAE treatments? Document any contraindications, intolerances, or inadequate responses to Takhzyro or other prophylactic therapies to support step therapy exceptions.

What happens if I miss the 127-day appeal deadline? Michigan's external review deadline is firm. Contact DIFS immediately if you're approaching the deadline—they may provide guidance on exceptional circumstances.

How much does Orladeyo cost without insurance? The wholesale acquisition cost is approximately $44,484 per 28-day supply as of 2025. Patient assistance programs may significantly reduce out-of-pocket costs.

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 benefits and medical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with insurance appeals and coverage issues, contact Counterforce Health or Michigan DIFS at 877-999-6442.

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