Subject:
Edaravone (Radicava)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Radicava (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The efficacy of Radicava for the treatment of ALS was established in a 6-month, phase 3, randomized, placebo controlled, double-blind study conducted in 137 Japanese patients with ALS; 69 patients were enrolled in the Radicava arm and 68 in the placebo arm. Baseline characteristics were similar between these groups, with over 90% of patients in each group being treated with riluzole.
The primary efficacy endpoint was a comparison of the change between treatment arms in the ALS Functional Rating Scale – Revised (ALSFRS-R) total scores from baseline to Week 24. The ALSFRS-R scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of patients with ALS (speech, salivation, swallowing, handwriting, cutting food, dressing/hygiene, turning in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency). Each item is scored from 0-4, with higher scores representing greater functional ability. The decline in ALSFRS-R scores from baseline to week 24 was significantly less in the Radicava-treated patients as compared to placebo [-5.01+/- 0.64 vs. -7.50 +/- 0.66, 95% CI 2.49 (0.99, 3.98); p = 0.0013].
The most common adverse reactions that occurred in ≥10% of Radicava-treated patients were contusion, gait disturbance, and headache.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Edaravone (Radicava) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. Radicava (edaravone) is considered medically necessary for the treatment of members with amyotrophic lateral sclerosis (ALS) who have documentation of the following:
a. Member is 18 years of age or older, AND
b. Member has definite or probable ALS based on El Escorial and revised Airlie criteria confirmed by medical records, AND
c. Member has retained functionality of most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R]) confirmed by medical records, AND
d. Member has normal respiratory function (defined as percent predicted forced vital capacity (FVC) values of > 80%) confirmed by medical records, AND
e. Member has a disease duration of 2 years or less, AND
f. Member has received previous treatment with riluzole. Member may or may not continue to receive concomitant therapy with riluzole while on Radicava AND
g. The prescriber is a specialist in the area of the patient's diagnosis (e.g. neurologist) or has consulted with a specialist in the area of the patient's diagnosis
[INFORMATIONAL NOTE: The El Escorial revised criteria for the diagnosis of ALS requires:
(A) the presence of:
• (A: 1) evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological or neuropathologic examination,
• (A: 2) evidence of upper motor neuron (UMN) degeneration by clinical examination, and
• (A: 3) progressive spread of symptoms or signs within a region or to other regions, as determined by history or examination, together with:
(B) the absence of
• (B:1) electrophysiological or pathological evidence of other disease processes that might explain the signs of LMN and/or UMN degeneration, and
• (B:2) neuroimaging evidence of other disease processes that might explain the observed clinical and electrophysiological signs.
The ALS Functional Rating Scale – Revised (ALSFRS-R) scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of patients with ALS (speech, salivation, swallowing, handwriting, cutting food, dressing/hygiene, turning in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency). Each item is scored from 0-4, with higher scores representing greater functional ability.
The ALS Functional Rating Scale — Revised (ALSFRS-R):
1. Speech
• 4 Normal speech processes
• 3 Detectable speech disturbance
• 2 Intelligible with repeating
• 1 Speech combined with nonvocal communication
• 0 Loss of useful speech
2. Salivation
• 4 Normal
• 3 Slight but definite excess of saliva in mouth; may have nighttime drooling
• 2 Moderately excessive saliva; may have minimal drooling
• 1 Marked excess of saliva with some drooling
• 0 Marked drooling; requires constant tissue or handkerchief
3. Swallowing
• 4 Normal eating habits
• 3 Early eating problems — occasional choking
• 2 Dietary consistency changes
• 1 Needs supplemental tube feeding
• 0 NPO (exclusively parenteral or enteral feeding)
4. Handwriting
• 4 Normal
• 3 Slow or sloppy: all words are legible
• 2 Not all words are legible
• 1 Able to grip pen but unable to write
• 0 Unable to grip pen
5a. Cutting food and handling utensils (patients without gastrostomy)?
• 4 Normal
• 3 Somewhat slow and clumsy, but no help needed
• 2 Can cut most foods, although clumsy and slow; some help needed
• 1 Food must be cut by someone, but can still feed slowly
• 0 Needs to be fed
5b. Cutting food and handling utensils (alternate scale for patients with gastrostomy)?
• 4 Normal
• 3 Clumsy but able to perform all manipulations independently
• 2 Some help needed with closures and fasteners
• 1 Provides minimal assistance to caregiver
• 0 Unable to perform any aspect of task
6. Dressing and hygiene
• 4 Normal function
• 3 Independent and complete self-care with effort or decreased efficiency
• 2 Intermittent assistance or substitute methods
• 1 Needs attendant for self-care
• 0 Total dependence
7. Turning in bed and adjusting bed clothes
• 4 Normal
• 3 Somewhat slow and clumsy, but no help needed
• 2 Can turn alone or adjust sheets, but with great difficulty
• 1 Can initiate, but not turn or adjust sheets alone
• 0 Helpless
8. Walking
• 4 Normal
• 3 Early ambulation difficulties
• 2 Walks with assistance
• 1 Nonambulatory functional movement
• 0 No purposeful leg movement
9. Climbing stairs
• 4 Normal
• 3 Slow
• 2 Mild unsteadiness or fatigue
• 1 Needs assistance
• 0 Cannot do
10. Dyspnea (new)
• 4 None
• 3 Occurs when walking
• 2 Occurs with one or more of the following: eating, bathing, dressing (ADL)
• 1 Occurs at rest, difficulty breathing when either sitting or lying
• 0 Significant difficulty, considering using mechanical respiratory support
11. Orthopnea (new)
• 4 None
• 3 Some difficulty sleeping at night due to shortness of breath,
• does not routinely use more than two pillows
• 2 Needs extra pillows in order to sleep (more than two)
• 1 Can only sleep sitting up
• 0 Unable to sleep
12. Respiratory insufficiency (new)
• 4 None
• 3 Intermittent use of BiPAP
• 2 Continuous use of BiPAP during the night
• 1 Continuous use of BiPAP during the night and day
• 0 Invasive mechanical ventilation by intubation or tracheostomy
In the pivotal phase 3 study in which Radicava was studied, 91.3% of patients treated with edaravone had been receiving riluzole prior to study entry. Patients who had already been given riluzole could continue to receive riluzole provided that the regimen remained unchanged. According to the American Academy of Neurology Practice Parameter update on the care of the patient with amyotrophic lateral sclerosis, riluzole should be offered as a treatment to slow disease progression.]
2. When Radicava (edaravone) is considered medically necessary, initial therapy will be approved for 6 months at the following FDA-approved dose:
a. 60 mg intravenous infusion over 60 minutes as follows:
i. Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period in a 28-day cycle
ii. Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods (for a total of an 18-day drug-free period) in a 28-day cycle
3. Continuation of Radicava (edaravone) will be approved every 6 months at the FDA-approved dose when the member meets all of the following criteria:
a. There are no unacceptable toxicities (e.g. hypersensitivity reaction or sulfite allergic reactions)
b. Member has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (member has not experienced rapid disease progression while on therapy)
4. Other uses of Radicava (edaravone) are considered investigational, including but not limited acute ischemic stroke, myocardial infarction, and brain necrosis.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Edaravone (Radicava)
Radicava (Edaravone)
References:
1. Radicava™ (edaravone). [Prescribing Information]. MT Pharma America, Inc. Jersey City, NJ. August 2018.
2. Abe K, Aoki M, Tsuji S, et al. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 May 15.
3. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice Parameter update: The care of the patient with amyotrophic lateral sclerosis: Drug, nutritional, and respiratory therapies (an evidence-based review). Neurology. 2009 Oct 13;73(15):1227-33.
4. Brooks BR, Miller RG, Swash M, et al. El Escorial revisited: Revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9.
5. ALS Functional Rating Scale Revised (ALS-FRS-R). Version: May 2015.
6. ClinicalTrials.gov. Radicava. Available at https://clinicaltrials.gov/ct2/results?cond=&term=radicava&cntry=&state=&city=&dist=. Accessed February 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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