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Coverage criteria policies

Patisiran (Onpattroâ„¢)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Patisiran (Onpattro) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Onpattro is generally covered subject to the indications listed below and per your plan documents.

Initial Authorizations:
  1. Patient is an adult diagnosed with hereditary transthyretin-mediated amyloidosis (hATTR); and
  2. Prescribed by or in consultation with a neurologist; and
  3. Medical chart documentation of one of the following baseline scores and severities within the prior 3 months of request:
    1. Polyneuropathy disability score (PND) score <= IIIb (i.e., ambulatory)
    2. FAP Stage 1 or 2 (i.e., patients must be symptomatic and ambulatory); and
  4. Patient is experiencing clinical signs and symptoms of neuropathic disease activity (such as motor impairment, autonomic dysfunction, sensory neuropathy, etc.; and
  5. Patient has not had a liver transplant, and liver transplant status is documented in the medical record (ie, documentation of whether or not patient is on waiting list); and
  6. Onpattro will not be used in combination with Tegsedi; and
  7. Prescribed within the FDA approved regimen.

Initial authorization will be provided for 6 months.

Reauthorizations:
  1. Patient continues to have one of the following:
    1. Polyneuropathy disability score (PND) score <= IIIb, or
    2. FAP Stage 1 or 2; and
  2. Medical documentation demonstrating adherence to the medication; and
  3. Onpattro will not be used in combination with Tegsedi; and
  4. Prescribed within the FDA approved regimen; and
  5. Patient has been seen in the previous 12 months.

Re-authorization will be provided for 6 months

Definitions

ONPATTRO contains a transthyretin-directed small interfering RNA and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

C9036

Injection, patisiran, 0.1 mg (use before 10/1/2019)

J0222

Injection, Patisiran, 0.1 mg (effective 10/1/2019)

J3490

Unclassified biologics (use before 10/1/2019)

NDC Codes

Codes

Description

71336100001

Onpattro 10 MG/5ML SOLN

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. ONPATTRO package insert, Alynam Pharmaceuticals, Inc. 300 Third Street, Cambridge, MA 02142. August 2018.

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Policy activity

  • 02/04/2019 - Date of origin
  • 04/01/2019 - Effective date

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