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Coverage criteria policies

Edaravone (Radicava®) – Minnesota Health Care Programs

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

Edaravone (Radicava) requires prior authorization from HealthPartners Pharmacy Administration.

Approval criteria

Initial criteria:
  1. Patient must be at least 18 years old; and,
  2. Patient has a diagnosis of clinically definite or probable amyotrophic lateral sclerosis (ALS) based on El Escorial revised criteria or Awaji criteria; and,
  3. ALS disease duration is 2 years or less; and,
  4. Patient has a predicted forced vital capacity of ≥ 80%; and,
  5. Patient has retained functionality of most activities of daily living (scores ≥ 2 on each item of the ALS Functional Rating Scale – Revised [ALSFRS-R]); and,
  6. Trial and failure of Rilutek (riluzole) unless contraindicated; and,
  7. Patient has no history of hypersensitivity reactions to edaravone or product components.

Initial approval is for 6 months.

Renewal criteria:

  1. Patient has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (e.g., cumulative score on ALSFRS-R remains ≥ 4); and,
  2. Patient has not experienced hypersensitivity reactions (including sulfite allergy) or unacceptable toxicity (e.g., contusion, gait changes, respiratory adverse effects, dermatitis).

Renewal approval is for 6 months.

Dosage:

First month: 28 of the 30mg/100 mL injections per 28 days

Subsequent months: 20 of the 30 mg/100 mL injections per 28 days

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

Codes

Description

C9493

Injection, edaravone, 1 mg (Hospital outpatient use ONLY – use before 1/1/2019)

J1301

Injection, edaravone, 1 mg (effective 1/1/2019)

J3490

Unclassified drugs (use before 1/1/2019)

NDC Codes

Codes

Description

70510217101

Radicava 30 MG/100ML SOLN

70510217102

Radicava 30 MG/100ML 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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/radicava.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date
Review date
  • 11/2018

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