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HealthPartners

Coverage criteria policies

Edaravone (Radicava®)

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. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

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

Radicava is generally covered for amyotrophic lateral sclerosis (ALS) when all of the following criteria are met:

  1. Prescribed by a specialist; and,
  2. Diagnosis of definite or probable ALS per El Escorial/revised Airlie House criteria or Awaji-Shima criteria); and,
  3. Score of 2 or more points on each single item of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score; and,
  4. Onset of ALS has been less than 2 years; and,
  5. % forced vital capacity (%FVC) > or = 80% at baseline; and,
  6. Japan ALS severity classification grade less than 3; and,
  7. Dosing is in accordance with FDA approved dosing.
  8. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Approvals will be for six months.

Reauthorization will be provided for six months when patients continue to meet criteria 1, 2 and 7 above.

Indications that are not covered

Edaravone (Radicava) is not covered for any additional indication.

Definitions

Radicava is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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

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)

NDCs

Codes

Description

70510217101

Radicava 30 MG/100ML

70510217102

Radicava 30 MG/100ML

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. Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; August 2017

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Policy activity

  • 11/06/2017 - Date of origin
  • 01/01/2019 - Effective date
Review date
  • 11/2018
Revision date
  • 11/05/2018

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