Category Filter
- Advanced Imaging
- Autism Spectrum Mandate
- Behavioral Health
- Blue Advantage Policies
- Chronic Condition Management
- Genetic Testing
- HelpScript Program
- Hemophilia Drugs
- Medical Policies
- Pre-Service Review (Predetermination/Precertification)
- Provider-Administered Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
Radicava (edaravone) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1183
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
01-01-2023 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Radicava ORS® (edaravone) Oral suspension Oral suspension starter kit |
Treatment of amyotrophic lateral sclerosis (ALS) |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Amyotrophic Lateral Sclerosis (ALS) |
Amyotrophic lateral sclerosis (ALS) is an idiopathic, fatal neurodegenerative disease.(2) It is characterized by loss of motor neurons in the spinal cord, brainstem, and motor cortex.(3) Age of onset is between 58-63 years for sporadic disease and 47-52 years for familial disease, with rapidly decreased incidence after 80 years. The clinical hallmark of ALS is the presence of upper and lower motor neuron (UMN and LMN) features involving the brainstem and multiple spinal cord regions of innervation.(2) ALS is a rapidly progressive disease with 50% of patients dying within 30 months of symptom onset, and about 20% of patients survive between 5 years and 10 years after symptom onset. Older age at symptom onset, early respiratory muscle dysfunction, and bulbar-onset disease are associated with reduced survival, whereas limb-onset disease, younger age at presentation, and longer diagnostic delay are independent predictors of prolonged survival. Dysphagia develops in most patients, with consequent weight loss and malnutrition. Respiratory compromise eventually develops in most cases, leading to exertional dyspnea, orthopnea, hypoventilation with resultant hypercapnia, and early morning headaches. Progressive weakening of the respiratory muscles leads to respiratory failure, often precipitated by pneumonia.(2) Respiratory function is a critical predictor of survival in ALS. International guidelines recommend the assessment of respiratory function in ALS patients at first visit and every 3 months thereafter.(7) Forced (FVC) and slow (SVC) vital capacities are non-invasive conventional tests used to estimate respiratory function in ALS. Their results depend on age, gender, height, and ethnicity, in addition to the functional integrity of the inspiratory and expiratory muscles. FVC is sensitive to detect hypoventilation in ALS and can be more sensitive in detecting diaphragmatic weakness when performed in the supine position.(8) However, the patient must expel air quickly and forcefully, which may cause fatigue and induce bronchospasm and result in an underestimation of actual lung capacity. SVC is easier for the patient with ALS to perform even in the presence of orofacial paresis because it involves exhalation of air in a slow, gentle manner after a maximal inspiration. FVC and SVC have been shown to be tightly correlated, can be used interchangeably, and decline similarly in ALS (about 2%/month).(8,9) Symptomatic treatments remain the cornerstone for management of patients with ALS. Disease modifying treatment options for ALS are limited. Riluzole is the only agent shown to have any impact on survival in ALS. The American Academy of Neurology (AAN) has recommended that riluzole be offered to slow disease progression in patients with ALS.(2) While edaravone has been shown to slow the decline of functional and quality of life ratings in patients with ALS, the short duration of trials did not allow for the assessment of an effect on survival.(6) According to CADTH Common Drug Review (CDR) of Radicava, Radicava should be considered for the majority of newly diagnosed ALS patients with preserved respiratory function and with functional independence. Patients with advanced ALS with severe disability, such as ventilator-dependence with very little limb function, are unlikely to benefit from therapy and should not be offered Radicava.(5) |
Efficacy |
The efficacy of edaravone was evaluated in a post-hoc analysis of a 6-month, phase III randomized, placebo-controlled, double-blind study, in patients aged 20 to 75 years with ALS. All study patients had to meet all of the following criteria at screening:
Patients who met the criteria above (n= 137) were randomized to receive either edaravone 60 mg intravenously (IV) or placebo for 6 cycles (4 weeks per cycle with 2 weeks on, 2 weeks off). 91% of patients in both the edaravone and placebo group were also receiving treatment with riluzole. The primary efficacy endpoint was change in the Revised ALS Functional Rating Scale (ALSFRS-R) score from baseline to 24 weeks or therapy discontinuation (if discontinuation occurred after the third cycle) after randomization. The change in ALSFRS-R score was -5.01 (SE 0.64) and -7.50 (0.66) in the edaravone and placebo group respectively. The trial authors concluded edaravone showed efficacy in a small subset of patients (i.e., those meeting the criteria noted above) and that “there is no indication that edaravone might be effective in a wider population of patients with ALS who do not meet the criteria”.(1,4) |
Safety |
Edaravone is contraindicated in patients with history of hypersensitivity to edaravone or any of its inactive ingredients.(1) |
REFERENCES
Number |
Reference |
1 |
Radicava prescribing information. Mitsubishi Tanabe Pharma Corporation. November 2022. |
2 |
Kiernan M. C., Vucic S., Cheah B. C., Turner M. R., Eisen A., Hardiman O., et al. (2011). Amyotrophic lateral sclerosis. Lancet 377 942–955. 10.1016/S0140-6736(10)61156-7. |
3 |
Miller R.G., Jackson C.E., Kasarskis E.J., England J.D., Forshew D., Johnston W., Kalra S., Katz J.S., Mitsumoto H., Rosenfeld J., et al. Practice parameter update: The care of the patient with amyotrophic lateral sclerosis: Multidisciplinary care, symptom management, and cognitive/behavioral impairment (an evidence-based review): Report of the Quality Standards Subcommittee of the American of Neurology. Neurology. 2009;73:1227–1233. |
4 |
Koji Abe, Mashashi Aoki, Shoji Tsuji, et al. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomized double-blind, placebo-controlled trial. Lancet Neurology. 2017 May 15, S1474-4422(17)30115-1. |
5 |
Clinical Review Report: Edaravone (Radicava): (Mitsubishi Tanabe Pharma Corporation): Indication: For the treatment of amyotrophic lateral sclerosis. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Apr. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542359/. |
6 |
Oskarsson B., Gendron T., Staff N. Amyotrophic Lateral Sclerosis: An Update for 2018. Mayo Clin Proc. 2018;93(11):1617-1628. |
7 |
EFNS Task Force on Diagnosis and Management of Amyotrophic Lateral Sclerosis. Andersen PM, Abrahams S, Borasio GD, de Carvalho M, Chio A, et al.. EFNS guidelines on the clinical management of amyotrophic lateral sclerosis (MALS)–revised report of an EFNS task force. Eur J Neurol. (2012) 19:360–75. |
8 |
Pinto S, de Carvalho M. SVC Is a Marker of Respiratory Decline Function, Similar to FVC, in Patients With ALS. Front Neurol. 2019 Feb 28;10:109. doi: 10.3389/fneur.2019.00109. |
9 |
Andrews JA, Meng L, Kulke SF, et al. Association Between Decline in Slow Vital Capacity and Respiratory Insufficiency, Use of Assisted Ventilation, Tracheostomy, or Death in Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. 2018;75(1):58–64. doi:10.1001/jamaneurol.2017.3339. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Radicava ors ; Radicava ors starter kit |
edaravone oral susp |
105 MG/5ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Radicava ors |
edaravone oral susp |
105 MG/5ML |
50 |
mLs |
28 |
DAYS |
|
|
70510232201 |
Radicava ors starter kit |
edaravone oral susp |
105 MG/5ML |
70 |
mLs |
180 |
DAYS |
|
|
70510232101 ; 70510232102 |
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Radicava ors ; Radicava ors starter kit |
edaravone oral susp |
105 MG/5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Radicava ors |
edaravone oral susp |
105 MG/5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Radicava ors starter kit |
edaravone oral susp |
105 MG/5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: For patients initiating therapy, approval will include 28 bags per 28 days (initial dose) for the first month and 20 bags per 28 days for the remainder of the 6 months. For patients initiating therapy with oral suspension, approval will include 70 mL starter kit per 180 days (initial dose) and 50 mL per 28 days for the remainder of the 6 months. NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: up to 6 months; Renewal: up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Radicava_PAQL _ProgSum_ 07-01-2024