By Counterforce Health Team in Elaprase (idursulfase) —

How to Get Elaprase (idursulfase) Covered by Aetna (CVS Health) in Pennsylvania: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Elaprase Covered by Aetna (CVS Health) in Pennsylvania

Yes, Aetna (CVS Health) covers Elaprase (idursulfase) for Hunter syndrome (MPS II), but prior authorization is required. Your fastest path: 1) Ensure you have enzymatic/genetic confirmation of MPS II deficiency, 2) Have your specialist complete Aetna's Elaprase Precertification Form (GR-69518), and 3) Submit at least 14 days before planned treatment. If denied, Pennsylvania's new external review program overturns 50% of appealed denials within 45 days.

Start today: Call Aetna member services to confirm your plan's formulary status and download the PA form.

Table of Contents

Coverage Basics: Is Elaprase Covered?

Aetna (CVS Health) covers Elaprase (idursulfase) as a specialty medication with prior authorization required for all commercial plans in 2024. The drug appears on Aetna's precertification list as "Elaprase (idursulfase, J1743) — precertification required."

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all plans Aetna Precert List 2024
Formulary Tier High-tier specialty Aetna Drug Guide
Site of Care Review Required for hospital outpatient Aetna Site of Care Policy
Diagnosis Required MPS II confirmed by enzyme/genetic test Aetna Clinical Policy
Prescriber Metabolic specialist preferred Aetna PA Form

Prior Authorization Process

Aetna requires submission of their Elaprase Medication Precertification Request form (GR-69518, 3-24) for all commercial non-Medicare requests. The form must include complete patient, prescriber, site of care, pharmacy, dose, diagnosis, and clinical information.

Required Documentation

All requests must include:

  • Confirmed MPS II diagnosis by iduronate-2-sulfatase enzyme assay deficiency OR genetic testing
  • ICD-10 diagnosis code for MPS II
  • Weight-based dosing calculation (0.5 mg/kg weekly)
  • Prescriber credentials (metabolic/lysosomal storage disorder specialist preferred)
  • Site of care justification if requesting hospital outpatient infusion
Note: Aetna's 2024 policy specifically requires "all sections" of the form to be completed, including clinical questions for initiation or continuation therapy.

Step-by-Step: Fastest Path to Approval

1. Gather Diagnostic Documentation

Who: Patient/family with clinic support
What: Enzyme assay report showing iduronate-2-sulfatase deficiency AND genetic test confirming IDS gene variant
Timeline: Before PA submission
Source: Mayo Clinic Labs MPS II Testing

2. Calculate Weight-Based Dose

Who: Prescribing physician
What: Current weight (kg) × 0.5 mg/kg = weekly dose
Tool: Elaprase Dosing Calculator
Timeline: Must be current within 30 days

3. Complete Aetna PA Form

Who: Healthcare provider
What: Form GR-69518
How: Availity provider portal or fax
Timeline: Submit ≥14 days before planned first infusion

4. Address Site of Care Requirements

Who: Prescribing physician
What: Document medical necessity for hospital outpatient if requested
Requirements: Prior severe reactions, antibodies, venous access issues, or medical instability
Source: Aetna Site of Care Policy

5. Monitor Application Status

Who: Patient or clinic staff
What: Check Availity portal or call Aetna provider services
Timeline: Expect decision within 30-45 days for standard review

Timing and Deadlines

Standard Prior Authorization

  • Submission deadline: At least 14 days before planned treatment start
  • Aetna decision timeline: 30-45 days for standard decisions
  • Expedited review: Available for urgent medical situations (≤72 hours)

Appeals Timeline (Pennsylvania)

  • Internal appeal deadline: 180 days from denial date
  • External review deadline: 4 months after final internal denial
  • External review decision: 45 days for standard, 72 hours for expedited

Clinical Criteria and Requirements

Initial Authorization Criteria

Based on Aetna's clinical policy, all of the following must be documented:

  1. Confirmed MPS II diagnosis by enzyme assay deficiency OR genetic testing
  2. ICD-10 diagnosis code for MPS II included on form
  3. Prescriber qualification as metabolic/lysosomal storage disorder specialist
  4. Weight-based dosing documented (mg/kg, frequency)
  5. Treatment status (initiation vs. continuation with dates)

Continuation Criteria

For renewal requests, documentation must show:

  • Clinically positive response defined as improvement, stabilization, or slowing of disease progression
  • Clinical notes showing functional assessments
  • Objective measures (organ size, pulmonary function, endurance) demonstrating benefit
Clinician Corner: Medical necessity letters should address the absence of FDA-approved alternatives for MPS II, multisystem disease involvement, and expected benefits of continued enzyme replacement therapy.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnostic proof Submit complete enzyme and genetic testing Lab reports with reference ranges
Incomplete specialist documentation Provide metabolic specialist consultation Specialist letter with credentials
Lack of hospital site justification Document medical necessity for hospital setting Prior reaction history, comorbidities
Missing weight-based calculations Include current weight and dose calculation Recent weight, dosing worksheet
Non-formulary status Request formulary exception No alternative FDA-approved ERT exists

Pennsylvania Appeals Process

Pennsylvania launched its Independent External Review Program in January 2024, giving residents a powerful new tool to fight insurance denials. The program has overturned 50% of appealed denials in its first year.

Internal Appeals (Required First Step)

  1. File with Aetna: Submit written appeal within 180 days of denial
  2. Include documentation: Denial letter, medical records, specialist letter
  3. Await final decision: Receive Final Adverse Benefit Determination Letter

Pennsylvania External Review

After completing Aetna's internal appeals:

  1. File with Pennsylvania Insurance Department within 4 months
  2. Submit online: PA.gov External Review Portal
  3. Timeline: 45 days for standard review, 72 hours for expedited
  4. Success rate: 50% overturn rate in 2024

Required Documents for External Review

  • Final Adverse Benefit Determination Letter from Aetna
  • Insurance card copy
  • Medical records supporting the need for Elaprase
  • Specialist letter of medical necessity
  • For expedited review: Physician Certification Form documenting urgent need

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by identifying denial basis and drafting point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and weaving them into appeals with required clinical facts.

Cost and Financial Assistance

Typical Costs

Elaprase costs approximately $3,230 per 6 mg vial (as of June 2025), with dosing based on patient weight requiring multiple vials per infusion.

Financial Assistance Options

  • Takeda Patient Assistance: Contact manufacturer for copay support programs
  • Foundation grants: National MPS Society and other rare disease foundations
  • State programs: Pennsylvania pharmaceutical assistance programs for eligible residents

Specialty Pharmacy Requirements

Aetna typically routes Elaprase through CVS Specialty Pharmacy for home infusion coordination. CVS Specialty provides:

Home Infusion Services

  • Specialized nursing for IV administration
  • Emergency medication supplies (epinephrine, antihistamines)
  • 24/7 clinical support line
  • Coordination with prescribing physician

Safety Requirements

Given Elaprase's boxed warning for anaphylaxis, home infusion requires:

  • Nurse trained in emergency response
  • Emergency medications readily available
  • Clear escalation plan for severe reactions
  • Patient/family education on reaction signs

For more information on navigating complex insurance requirements, Counterforce Health offers comprehensive support for getting specialty medications approved.

Frequently Asked Questions

How long does Aetna prior authorization take for Elaprase in Pennsylvania?

Standard PA decisions typically take 30-45 days. Submit at least 14 days before planned treatment start. Expedited review is available for urgent situations with ≤72 hour decisions.

What if Elaprase is non-formulary on my Aetna plan?

Request a formulary exception by documenting that no FDA-approved alternative exists for MPS II. Include specialist letter explaining medical necessity.

Can I request an expedited appeal in Pennsylvania?

Yes, if delay would seriously jeopardize life, health, or function. File an Expedited Independent External Review with Pennsylvania Insurance Department, which must be decided within 72 hours.

Does step therapy apply to Elaprase?

Typically no, as there are no FDA-approved alternative enzyme replacement therapies for MPS II. However, insurers may require documentation of supportive care attempts.

What happens if I'm denied during treatment?

Continue therapy if medically necessary while appealing. Document any clinical deterioration during coverage gaps to strengthen your appeal.

How do I find a metabolic specialist in Pennsylvania?

Contact the National MPS Society for specialist referrals or check with major academic medical centers like CHOP or UPMC.

What if my employer plan is self-funded?

Some self-funded ERISA plans may use federal rather than state external review. Confirm with HR or Aetna which appeals process applies to your specific plan.

Can I get help with the appeals process?

Yes, contact the Pennsylvania Insurance Department's Office of Consumer Services for guidance, or consider working with advocacy organizations specializing in rare disease coverage.

Sources & Further Reading

Disclaimer: This guide is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Aetna and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department's consumer services.

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