By Counterforce Health Team in Enhertu (fam-trastuzumab deruxtecan-nxki) —

How Long Does It Take to Get Enhertu Approved by UnitedHealthcare in Michigan? Timeline & Appeal Process

Answer Box: Getting Enhertu Covered by UnitedHealthcare in Michigan

Timeline: UnitedHealthcare's OptumRx system can approve Enhertu in under 30 seconds through automated prior authorization if all criteria are met, or up to 30 days for manual review. First step: Have your oncologist submit the prior authorization through the UnitedHealthcare Provider Portal with complete HER2 testing results, treatment history, and medical necessity documentation. If denied: You have 127 days to file for external review with Michigan DIFS after exhausting internal appeals.

Table of Contents

  1. What Affects Approval Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window & Outcomes
  6. If Denied: Appeal Timeline
  7. Renewal Cycles
  8. Timeline Visual & Milestones
  9. Time-Saving Tips

What Affects Approval Timing

Several factors determine how quickly UnitedHealthcare approves Enhertu (fam-trastuzumab deruxtecan-nxki) in Michigan:

Plan Type & Coverage Level

  • Commercial plans typically process faster than Medicare Advantage
  • Specialty drug tier placement affects review complexity
  • Buy-and-bill vs. specialty pharmacy routing impacts processing

Documentation Completeness Your approval speed depends heavily on having complete documentation upfront:

  • HER2 biomarker testing: IHC 3+ or ISH+ for HER2-positive; IHC 1+ or IHC 2+/ISH- for HER2-low breast cancer; confirmed HER2 (ERBB2) mutation via NGS for NSCLC
  • Prior therapy documentation: Detailed records of trastuzumab-based regimen failures
  • ILD monitoring plan: Baseline pulmonary assessment and ongoing surveillance protocol

Clinical Complexity

  • First-line requests may face additional scrutiny due to step therapy requirements
  • Rare indications or off-label use require more extensive review
  • Safety monitoring requirements for interstitial lung disease (ILD) add review layers
Tip: UnitedHealthcare's OptumRx PreCheck system can process eligible specialty drug requests in a median of 29 seconds when all criteria are automatically verified.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Patient Information

  • UnitedHealthcare member ID and policy details
  • Complete contact information and preferred pharmacy
  • Current weight for dosing calculations

Clinical Documentation

  • Original pathology reports with HER2 testing methodology and results
  • Complete treatment history with dates, outcomes, and reasons for discontinuation
  • Current staging and performance status
  • Baseline chest imaging and pulmonary function assessment

Provider Requirements

  • Medical necessity letter from oncologist
  • ICD-10 diagnosis codes (verify with the UnitedHealthcare provider portal)
  • Planned monitoring schedule for ILD surveillance

Step Therapy Documentation

UnitedHealthcare requires documented failure of specific prior treatments:

Cancer Type Required Prior Therapy Documentation Needed
HER2+ Breast Cancer Trastuzumab-based regimen ± pertuzumab Treatment dates, progression imaging, toxicity records
HER2+ Gastric Cancer Trastuzumab-containing regimen Prior therapy summary, current staging
HER2-mutant NSCLC Standard systemic therapy NGS results, prior treatment outcomes

Submission to Initial Review (1-5 Days)

Electronic Submission Process

Primary Method: Submit through the UnitedHealthcare Provider Portal

  1. Log in and select "Prior Authorizations"
  2. Choose "Specialty Pharmacy Transactions"
  3. Upload all required documentation
  4. Submit electronically for fastest processing

Alternative Methods:

  • Phone: 888-397-8129 for provider support
  • Medicaid plans: 1-800-310-6826

What Reviewers Check First

UnitedHealthcare's initial review focuses on:

  • FDA indication match: Confirming diagnosis aligns with approved uses
  • Biomarker requirements: Verifying appropriate HER2 testing
  • Step therapy compliance: Documenting required prior treatment failures
  • Safety protocols: Ensuring ILD monitoring plan is in place
Note: Michigan law requires acknowledgment of prior authorization requests within 5 calendar days, with determination within 30 days for standard reviews.

Additional Information Requests (1-7 Days)

If UnitedHealthcare needs more information, they'll typically request:

Common Requests

  • Updated HER2 testing if results are older than 6 months
  • More detailed prior therapy records
  • Clarification on dosing rationale
  • Enhanced ILD monitoring protocols

How to Respond Quickly

  • Check the provider portal daily for status updates
  • Respond to information requests within 24-48 hours
  • Use secure messaging through the portal when possible
  • Keep your office's fax number updated for urgent communications

Counterforce Health helps clinicians streamline this process by automatically identifying common information gaps and preparing comprehensive documentation packages that reduce back-and-forth requests with insurers.

Decision Window & Outcomes

Typical Timeline Ranges

Automated Approval: Under 30 seconds for eligible cases through OptumRx PreCheck Standard Manual Review: 7-14 business days Complex Cases: Up to 30 days maximum

Reading Your Approval Letter

Full Approval includes:

  • Approved indication and dosing
  • Quantity limits and refill authorization
  • Required monitoring parameters
  • Duration of approval (typically up to 12 months)

Conditional Approval may require:

  • Specific pharmacy network usage
  • Enhanced monitoring protocols
  • Periodic clinical updates

If Denied: Appeal Timeline

UnitedHealthcare Internal Appeals

First Level Internal Appeal

  • Deadline: 60 days from denial notice
  • Timeline: Decision within 30 days (72 hours for urgent cases)
  • How to file: Provider portal, phone, or written request

Second Level Internal Appeal

  • Deadline: 60 days from first-level denial
  • Timeline: 30 days for decision
  • Requirements: New clinical information or peer-to-peer review

Michigan External Review Process

After exhausting internal appeals, Michigan patients have strong external review rights:

Michigan DIFS External Review

  • Deadline: 127 days from final internal denial
  • Timeline: Decision within 60 days (72 hours for expedited)
  • How to file: Online form or mail/fax to DIFS
  • Cost: No fee to patient
  • Decision: Binding on UnitedHealthcare

Expedited External Review Available when delay would seriously jeopardize health:

  • Requires physician letter stating urgency
  • 72-hour decision timeline
  • Same 127-day filing deadline
Michigan Advantage: Michigan's 127-day external review deadline gives patients more time than the federal 120-day standard, providing additional flexibility for gathering documentation.

Appeal Success Strategies

Strengthen Your Case

  • Include updated clinical guidelines supporting Enhertu use
  • Provide peer-reviewed studies for your specific indication
  • Document why alternatives are inappropriate or have failed
  • Emphasize time-sensitive nature of cancer treatment

Professional Support Consider working with Counterforce Health to develop evidence-backed appeals that address UnitedHealthcare's specific denial reasons with targeted clinical documentation and policy-aligned arguments.

Renewal Cycles

Reauthorization Requirements

Standard Renewal: Every 12 months Documentation Needed:

  • Updated clinical status and imaging
  • Confirmation of treatment tolerance
  • Ongoing ILD monitoring results
  • Response to therapy assessment

Expedited Renewal: Available for stable patients with good response

  • Submit 30-60 days before expiration
  • Use previous approval letter as reference
  • Highlight continued medical necessity

Timeline Visual & Milestones

Phase Timeline Key Actions Expected Outcome
Pre-submission 0-2 days Gather documentation, verify HER2 status Complete PA package
Submission 1 day Submit via provider portal Acknowledgment within 5 days
Initial Review 1-14 days Automated or manual review Approval or info request
Additional Info 1-7 days Respond to requests Final review begins
Decision Up to 30 days Final determination Approval, denial, or conditions
Appeal (if needed) 60 days to file Internal appeal process Overturn or external review
External Review 127 days to file Michigan DIFS review Binding decision

Time-Saving Tips

Portal Optimization

  • Set up automated notifications for status changes
  • Upload documents in required formats (PDF preferred)
  • Use consistent naming conventions for easy tracking
  • Save templates for common documentation requests

Bundled Evidence Strategy

Submit comprehensive packages that anticipate reviewer questions:

  • Include both required and supporting documentation
  • Provide clinical rationale for dosing and monitoring
  • Reference specific UnitedHealthcare policy criteria
  • Attach relevant NCCN guideline excerpts

Direct Specialty Routing

  • Ensure requests go to oncology-specialized reviewers
  • Request peer-to-peer reviews with oncologists when denied
  • Use clinical terminology that demonstrates expertise
  • Highlight urgency appropriately for cancer treatment

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Enhertu in Michigan? Standard timeline is 7-14 business days, with automated approvals possible in under 30 seconds for complete submissions meeting all criteria.

What if Enhertu is non-formulary on my plan? Non-formulary drugs require medical exception requests with enhanced documentation showing medical necessity and failure of formulary alternatives.

Can I request an expedited review for cancer treatment? Yes, urgent cases qualify for 72-hour review timelines when delay would jeopardize health, requiring physician documentation of urgency.

Does step therapy apply if I failed treatments outside Michigan? Yes, documented treatment failures from any location count toward step therapy requirements when properly documented.

What happens if I miss the appeal deadline? Michigan allows 127 days for external review filing, but missing internal appeal deadlines may limit options - file as soon as possible.

From Our Advocates

"We've seen cases where patients received Enhertu approval in just 3 days when their oncologist submitted complete HER2 testing, detailed prior therapy records, and a comprehensive ILD monitoring plan upfront. The key is anticipating what reviewers need rather than waiting for information requests that can add weeks to the process."

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions.

For additional help with insurance appeals and coverage determination processes, Michigan residents can contact the Department of Insurance and Financial Services at 877-999-6442 or visit michigan.gov/difs.

Sources & Further Reading

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