By Counterforce Health Team in Cresemba (isavuconazole) —

How to Get Cresemba (Isavuconazole) Covered by UnitedHealthcare in Pennsylvania: Appeals, Alternatives & Success Strategies

Answer Box: Getting Cresemba Covered by UnitedHealthcare in Pennsylvania

Cresemba (isavuconazole) requires prior authorization from UnitedHealthcare and is typically Tier 3 with step therapy requirements. Your fastest path: 1) Try required alternatives (usually voriconazole, posaconazole, or fluconazole) first or document contraindications/failures, 2) Submit PA through OptumRx with infectious disease specialist documentation, 3) If denied, use Pennsylvania's external review program within 4 months—over 53% of appeals succeed. Start today by checking your specific formulary and gathering clinical documentation from your ID specialist.

Table of Contents

  1. When Formulary Alternatives Make Sense
  2. UnitedHealthcare's Typical Cresemba Alternatives
  3. Pros and Cons of Each Option
  4. Exception Strategy: When to Request Cresemba
  5. Switching Logistics and Coordination
  6. Re-Trying for Cresemba Later
  7. Appeals Playbook for Pennsylvania
  8. Coverage at a Glance
  9. FAQ

When Formulary Alternatives Make Sense

UnitedHealthcare places Cresemba (isavuconazole) as a Tier 3 specialty medication requiring prior authorization. The insurer typically requires you to try formulary-preferred alternatives first through step therapy protocols.

When alternatives are appropriate:

  • Invasive aspergillosis: Voriconazole remains first-line in many guidelines and is usually preferred by insurers
  • Mild-to-moderate infections: Lower-cost options like fluconazole may be tried first for susceptible organisms
  • Stable patients: Those without contraindications to standard antifungals can often start with preferred options

When to skip straight to Cresemba:

  • Renal impairment: Isavuconazole is preferred over amphotericin B formulations
  • Drug interactions: Fewer CYP450 interactions than voriconazole
  • Prior failures: Documented intolerance or resistance to formulary alternatives
  • Mucormycosis: Often requires immediate broad-spectrum coverage
Note: Pennsylvania's step therapy laws require insurers to provide clear exception pathways when alternatives are contraindicated or have failed.

UnitedHealthcare's Typical Cresemba Alternatives

Based on OptumRx formularies in Pennsylvania, these are the most common step therapy requirements before Cresemba approval:

First-Line Alternatives (Usually Required First)

Fluconazole (Tier 1, Generic)

  • Indication: Candida infections, some endemic mycoses
  • Limitations: No activity against Aspergillus or mucormycosis
  • Monitoring: Periodic liver function tests

Voriconazole (Tier 2-3, Generic Available)

  • Indication: First-line for invasive aspergillosis
  • Advantages: Extensive clinical data, oral/IV formulations
  • Disadvantages: Requires therapeutic drug monitoring, extensive drug interactions

Second-Line Options

Posaconazole (Tier 3)

  • Indication: Aspergillosis, mucormycosis prophylaxis/treatment
  • Forms: Delayed-release tablets, oral suspension, IV
  • Considerations: Food requirements for absorption (suspension)

Liposomal Amphotericin B (Tier 3)

  • Indication: First-line for mucormycosis, salvage for aspergillosis
  • Route: IV only
  • Monitoring: Intensive renal function, electrolyte monitoring required
Tip: Counterforce Health helps patients and providers navigate these complex formulary requirements by analyzing denial letters and crafting targeted appeals that address each payer's specific step therapy criteria.

Pros and Cons of Each Option

Medication Access Considerations Testing Requirements Monitoring Needs
Fluconazole Tier 1, usually covered Culture/susceptibility Basic LFTs
Voriconazole Generic available, may need PA Therapeutic drug monitoring Weekly levels, LFTs, vision
Posaconazole Tier 3, PA required Consider levels in some cases LFTs, drug interactions
Amphotericin B Hospital/infusion center Baseline labs Daily electrolytes, creatinine
Cresemba Tier 3, PA + step therapy Rarely needs levels LFTs, fewer interactions

Key advantages of Cresemba over alternatives:

  • No routine therapeutic drug monitoring needed (unlike voriconazole)
  • Lower hepatotoxicity rates compared to voriconazole
  • Fewer drug interactions than other azoles
  • Oral/IV bioequivalence allows seamless switching

Exception Strategy: When to Request Cresemba

Medical Necessity Criteria

UnitedHealthcare typically approves Cresemba exceptions when you can document:

  1. Confirmed invasive aspergillosis or mucormycosis with positive cultures, biopsy, or imaging
  2. Infectious disease specialist involvement (often required for complex cases)
  3. Failure, intolerance, or contraindication to formulary alternatives
  4. Clinical rationale supporting Cresemba over alternatives

Documentation That Helps

For the prescriber to include:

  • Diagnosis confirmation: Culture results, pathology reports, galactomannan/beta-D-glucan levels
  • Prior therapy details: Specific drugs tried, duration, reasons for discontinuation
  • Contraindications: Renal impairment, drug interactions, prior adverse reactions
  • Treatment goals: Expected duration, monitoring plan, endpoints

Supporting evidence to reference:

  • FDA prescribing information for approved indications
  • IDSA guidelines supporting isavuconazole for specific scenarios
  • Specialist consultation notes documenting medical necessity

Submission Process

  1. Use OptumRx provider portal for PA submissions
  2. Include all clinical documentation in initial request
  3. Request peer-to-peer review if initially denied
  4. Document submission date for appeal timeline tracking

Switching Logistics and Coordination

If Starting with Alternatives

Coordinate with your healthcare team:

  • Schedule follow-up within 2-4 weeks to assess response
  • Plan lab monitoring appropriate for the chosen alternative
  • Document any adverse effects or lack of efficacy for future appeals
  • Maintain infectious disease specialist involvement throughout

What to track during alternative therapy:

  • Clinical response (symptoms, imaging, biomarkers)
  • Adverse effects requiring discontinuation
  • Drug level results (if applicable)
  • Any hospitalizations or complications

Switching to Cresemba Later

No cross-taper needed when switching from other antifungals to isavuconazole. Follow standard loading dose protocol:

  • Loading: 372 mg every 8 hours × 6 doses (days 1-2)
  • Maintenance: 372 mg once daily starting day 3
  • IV to oral: Bioequivalent, can switch without re-loading

Re-Trying for Cresemba Later

Documenting Alternative Therapy Trials

Keep detailed records of:

  • Exact medications tried (generic name, dose, duration)
  • Reason for discontinuation (lack of efficacy, adverse effects, intolerance)
  • Clinical outcomes during each trial
  • Specialist recommendations for next steps

Timing your Cresemba request:

  • Submit new PA within 30 days of stopping alternative therapy
  • Include updated clinical notes showing current status
  • Reference previous trial documentation in your appeal

Strengthening Your Case

Each failed alternative strengthens your medical necessity argument. Counterforce Health specializes in turning these documented failures into compelling, evidence-backed appeals that address UnitedHealthcare's specific coverage criteria.

Appeals Playbook for Pennsylvania

Internal Appeals (UnitedHealthcare)

Level 1: Standard Internal Appeal

  • Timeline: Submit within 180 days of denial
  • Decision: Within 30 days (15 days for urgent)
  • How to submit: UnitedHealthcare member portal, phone, or mail
  • Required: Denial letter, medical records, prescriber statement

Level 2: Second Internal Appeal

  • Timeline: Within 60 days of Level 1 denial
  • Process: Similar to Level 1 with additional clinical evidence

Pennsylvania External Review

After exhausting internal appeals, Pennsylvania offers a state-supervised external review with impressive success rates.

Key Statistics:

  • Over 53% success rate in overturning denials
  • Over 100 successful appeals in the program's first six months
  • Free to consumers (insurers pay review costs)

Timeline:

  • Submit within 4 months of Final Adverse Benefit Determination
  • 5 business days: Eligibility determination
  • 45 days: Final decision (72 hours for urgent cases)

How to submit:

From our advocates: We've seen Pennsylvania's external review program particularly effective for specialty medications like Cresemba. One composite case involved a patient whose mucormycosis treatment was initially denied due to "insufficient documentation." After submitting infectious disease consultation notes and culture results through the state external review, the independent reviewer overturned the denial within 30 days, and UnitedHealthcare was required to provide immediate coverage.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must get approval before filling UnitedHealthcare PA requirements
Tier 3 Higher copay/coinsurance Your plan formulary document
Step Therapy Try alternatives first OptumRx formulary
Specialist Required ID consultation often needed PA criteria documentation
Appeals Deadline 180 days for internal Denial letter instructions
External Review 4 months after final denial PA Insurance Department

FAQ

How long does UnitedHealthcare PA take in Pennsylvania? Standard PA decisions are made within 72 hours for urgent requests, 15 days for non-urgent. Complex cases requiring peer-to-peer review may take longer.

What if Cresemba is non-formulary on my plan? Non-formulary medications require medical exception requests with stronger clinical justification. Document why all formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if your condition is urgent or could seriously jeopardize your health. Provide documentation of clinical urgency from your physician.

Does step therapy apply if I failed alternatives outside Pennsylvania? Yes, document previous therapy failures from any location. UnitedHealthcare should accept well-documented prior treatment history.

What counts as medical necessity for Cresemba? Confirmed invasive fungal infection with documented failure/contraindication to formulary alternatives, supported by infectious disease specialist consultation.

How much does Cresemba cost without insurance? WAC pricing: approximately $394 per IV vial or $1,620 per 14-capsule pack. Patient assistance programs may be available through Astellas.

Can I switch from IV to oral Cresemba? Yes, the formulations are bioequivalent. No re-loading dose is needed when switching between IV and oral forms.

What happens if Pennsylvania external review rules in my favor? UnitedHealthcare must provide immediate coverage, including retroactive payment if you paid out-of-pocket during the appeal process.

Disclaimer: This information is for educational purposes and is not medical advice. Always consult your healthcare provider about treatment decisions. For personalized help with UnitedHealthcare appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services or consider working with coverage advocates like Counterforce Health, who specialize in turning insurance denials into targeted, evidence-backed appeals.

Sources & Further Reading

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