By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Aetna CVS Health in Ohio: Complete Prior Authorization Guide

Answer Box: Getting Onpattro (patisiran) Covered by Aetna CVS Health in Ohio

Aetna CVS Health requires prior authorization for Onpattro (patisiran) with strict medical necessity criteria. You need: (1) confirmed hATTR polyneuropathy with genetic testing showing a pathogenic TTR variant, (2) neurologist evaluation with baseline mNIS+7 and 6-minute walk test scores, and (3) documentation submitted through CVS Specialty Pharmacy. If denied, you have 180 days to appeal internally, then request external review through the Ohio Department of Insurance within 180 days of final denial. Start today: Contact your neurologist to ensure genetic testing and baseline assessments are complete, then have them submit the prior authorization request with all required documentation.

Table of Contents

Coverage Policy Overview

Aetna CVS Health covers Onpattro (patisiran) as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically classified as a preferred specialty agent on the formulary, but coverage isn't automatic.

Plan Coverage Specifics:

  • Commercial plans: Prior authorization required with 5-10 business day processing for complete submissions
  • Medicare Advantage: Follows Medicare Part B coverage guidelines with additional Aetna-specific requirements
  • Medicaid managed care: Subject to Ohio Medicaid's specialty drug protocols plus Aetna's clinical criteria

You can find your specific formulary status by logging into your Aetna member portal or calling member services at the number on your insurance card. The official prior authorization form is available through CVS Specialty Pharmacy or your provider's Aetna portal.

Note: Self-funded employer plans may have slightly different requirements, but generally follow the same clinical criteria outlined below.

Medical Necessity Requirements

Aetna CVS Health has specific criteria that must be met for Onpattro (patisiran) to be considered medically necessary:

Primary Requirements

Diagnosis Confirmation:

  • Confirmed hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN)
  • ICD-10 code: E85.1
  • Age 18 or older

Genetic Testing:

  • Documented pathogenic or likely pathogenic variant in the TTR gene
  • Laboratory report using HGVS nomenclature
  • Classification per ACMG guidelines required

Clinical Evaluation:

  • Evaluation by neurologist or amyloidosis specialist
  • Documented neurological examination findings
  • Baseline functional assessments (see Required Diagnostics section)

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before dispensing Aetna precertification list
Genetic Testing Pathogenic TTR variant required Lab report with ACMG classification
Specialist Evaluation Neurologist or amyloidosis expert Clinical notes with mNIS+7, 6MWT
Site of Care Home/office preferred over hospital Aetna site of care policy
Appeals Deadline 180 days for external review Ohio Department of Insurance

Step Therapy and Exceptions

While Onpattro is generally considered a preferred agent for hATTR-PN, some Aetna plans may require documentation of other treatment considerations:

Typical Requirements:

  • No concurrent use of other hATTR medications (Amvuttra, Tegsedi, Wainua, Vyndamax, Attruby)
  • Documentation if switching from another hATTR therapy
  • Justification for choosing Onpattro over other available options

Medical Exception Pathways: If step therapy applies to your plan, exceptions can be granted for:

  • Previous failure or intolerance to required medications
  • Contraindications to step therapy medications
  • Clinical reasons why Onpattro is more appropriate

Document any prior hATTR treatments, including dates, duration, response, and reasons for discontinuation. This information strengthens your prior authorization request.

Required Diagnostics and Documentation

Aetna CVS Health requires specific baseline assessments and ongoing monitoring documentation:

Baseline Assessments

mNIS+7 Score:

  • Modified Neuropathy Impairment Score plus 7 tests
  • Must be performed by qualified neurologist
  • Numeric score and detailed findings required
  • Establishes disease severity baseline

6-Minute Walk Test (6MWT):

  • Distance walked in meters
  • Assistance level (1-7 scale)
  • Use of assistive devices
  • Baseline vital signs and oxygen saturation
  • Must follow standardized protocol per American Thoracic Society guidelines

Additional Required Documentation:

  • Complete neurological examination notes
  • Medical history including symptom onset and progression
  • Family history if applicable
  • Laboratory results (liver function, vitamin A levels)
  • Imaging studies if performed (cardiac echo, nerve conduction studies)

Documentation Tips for Clinicians

Clinician Corner: When preparing the medical necessity letter, include: (1) clear problem statement with hATTR-PN diagnosis and genetic confirmation, (2) baseline functional assessments with numeric scores, (3) rationale for Onpattro selection, (4) treatment goals and monitoring plan, and (5) citations to FDA labeling and clinical guidelines. Ensure all documentation is recent (within 6 months) and clearly supports the diagnosis and treatment plan.

Site of Care and Specialty Pharmacy Requirements

Onpattro must be dispensed through CVS Specialty Pharmacy and administered according to Aetna's site of care policies:

Preferred Administration Sites

  • Home infusion services
  • Physician office with infusion capabilities
  • Independent (non-hospital) infusion centers

Hospital Outpatient Requirements

Hospital administration is only covered if:

  • First dose or re-initiation after ≥6 months
  • History of severe adverse events
  • Ongoing moderate to severe adverse events despite premedication
  • Clinical or physical instability requiring hospital-level monitoring

Infusion Protocol Requirements

  • Dedicated IV line with 1.2 micron PES filter
  • DEHP-free infusion sets
  • 80-minute infusion duration
  • Required premedication: acetaminophen, diphenhydramine, corticosteroids
  • Post-infusion monitoring per FDA labeling

Evidence to Support Medical Necessity

Strong evidence backing your request increases approval likelihood:

Clinical Guidelines and References

  • FDA labeling: Primary indication for hATTR-PN in adults
  • Clinical trial data: APOLLO study demonstrating efficacy
  • Professional society guidance: American Academy of Neurology recommendations
  • Drug compendia: Micromedex, Lexicomp entries supporting use

Key Clinical Evidence Points

  1. Genetic confirmation: Pathogenic TTR variant with clear clinical correlation
  2. Functional impairment: Documented neuropathy with measurable deficits
  3. Disease progression: Evidence of worsening symptoms or function
  4. Treatment rationale: Why Onpattro is appropriate choice for this patient
  5. Monitoring plan: How treatment response will be assessed

When citing evidence, use specific references with dates and page numbers when possible. This demonstrates thorough clinical evaluation and strengthens the medical necessity argument.

Appeals Process for Ohio Residents

If your Onpattro prior authorization is denied, Ohio residents have specific rights and timelines for appeals:

Step-by-Step Appeals Process

1. Internal Appeal (Required First Step)

  • File within 180 days of denial notice
  • Submit through Aetna member portal or by phone
  • Include additional clinical documentation
  • Standard review: 30 days; Expedited: 72 hours

2. External Review (Ohio Department of Insurance)

  • Request within 180 days of final internal denial
  • Submit request through Aetna (they forward to Ohio DOI)
  • Independent medical experts review case
  • Standard review: 30 days; Expedited: 72 hours
  • Decision is binding on Aetna

3. Contact Information for Help

Tip: Keep detailed records of all communications, including dates, times, and representative names. Ohio's external review process has strong consumer protections—even if Aetna claims your case isn't eligible, the Ohio Department of Insurance can independently determine eligibility.

Common Denial Reasons and Solutions

Understanding common denial reasons helps you prepare a stronger initial request:

Denial Reason Solution
"No genetic confirmation" Submit complete lab report with pathogenic TTR variant and ACMG classification
"Inadequate specialist evaluation" Ensure neurologist evaluation includes mNIS+7, 6MWT, and detailed clinical assessment
"Experimental/investigational" Cite FDA approval for hATTR-PN and include FDA labeling excerpts
"Step therapy required" Document contraindications or failures of other hATTR medications
"Site of care not justified" Provide clinical rationale for hospital administration if requested

Sample Appeal Language

When appealing a denial, be specific: "This denial is inappropriate because: (1) Patient has confirmed hATTR-PN with pathogenic TTR variant V30M documented by [Lab Name] on [Date], (2) Neurologist evaluation by Dr. [Name] on [Date] confirms stage II polyneuropathy with mNIS+7 score of [X] and 6MWT distance of [X] meters, (3) Onpattro is FDA-approved for this exact indication as documented in the prescribing information section [X]."

Costs and Patient Assistance

Even with insurance coverage, Onpattro can involve significant out-of-pocket costs:

Manufacturer Support

  • Alnylam Assist: Patient support program offering financial assistance
  • Eligibility based on income and insurance status
  • May cover copays, deductibles, or provide free drug
  • Contact: alnylamassist.com or 1-833-256-9526

Additional Resources

  • State pharmaceutical assistance programs: Ohio may have programs for rare diseases
  • Foundation grants: Organizations like HealthWell Foundation, Patient Access Network
  • Hospital financial assistance: If receiving infusions at hospital outpatient facility
From our advocates: We've seen cases where patients initially faced $2,000+ monthly copays for Onpattro, but after working with Alnylam Assist and their specialty pharmacy, they reduced their out-of-pocket costs to under $50 per month. The key is applying for assistance programs early in the process, as some have waiting lists or limited funding.

When to Get Help

Consider professional assistance if you encounter:

  • Multiple denials despite complete documentation
  • Confusion about Ohio's external review process
  • Complex insurance situations (multiple plans, ERISA coverage)
  • Urgent medical need requiring expedited appeals

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, identifies specific denial reasons, and drafts point-by-point rebuttals aligned to your plan's own rules, pulling the right clinical evidence and weaving it into appeals that meet procedural requirements while tracking deadlines.

FAQ

How long does Aetna CVS Health prior authorization take for Onpattro in Ohio? Complete submissions typically take 5-10 business days for standard review. Incomplete submissions may take longer due to requests for additional information.

What if Onpattro isn't on my Aetna formulary? You can request a formulary exception by providing clinical justification for why Onpattro is medically necessary compared to covered alternatives.

Can I request an expedited appeal in Ohio? Yes, if your doctor certifies that waiting for standard review could seriously jeopardize your health. Expedited appeals must be decided within 72 hours.

Does step therapy apply if I tried other medications outside Ohio? Yes, document any prior hATTR treatments regardless of where they were tried. Include medical records showing dates, duration, and reasons for discontinuation.

What happens if my employer plan is self-funded? Self-funded ERISA plans may not be subject to Ohio's external review process, but many voluntarily provide similar appeal rights. Check your plan documents or contact HR.

How much does Onpattro cost with Aetna coverage? Costs vary by plan, but specialty tier copays typically range from $100-500+ per infusion. Patient assistance programs can significantly reduce out-of-pocket expenses.

Can my family doctor submit the prior authorization? While possible, Aetna strongly prefers requests from neurologists or amyloidosis specialists who can provide the required clinical assessments.

What if I need to switch from another hATTR medication? Document the medical reason for switching (lack of efficacy, intolerance, contraindication) and include treatment history with the other medication.

This article provides educational information only and is not medical advice. For specific guidance about your situation, consult your healthcare provider and contact Aetna member services or the Ohio Department of Insurance at 800-686-1526. When working through complex insurance appeals, consider consulting with specialists like Counterforce Health who focus specifically on overturning coverage denials for specialty medications.

Sources & Further Reading

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