PHARMACY POLICY – 5.01.599 Pharmacologic Treatment of Sleep Disorders Effective Date: May 1, 2020 Last Revised: July 13, 2020 Replaces: N/A

RELATED MEDICAL POLICIES: None

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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Excessive daytime sleepiness is a common complaint among those with sleep-related problems. Excessive daytime sleepiness itself is not a disorder. However, it can be a symptom caused by other medical problems. These are conditions like narcolepsy, obstructive sleep apnea, and Parkinson disease. People with daytime sleepiness describe feeling drowsy or sluggish most of the time. These symptoms can interfere with work or school. They also can increase the risk of accidents on the road or at work. The first step in treating daytime sleepiness is evaluating its underlying cause. In some cases, medication may be an appropriate treatment. This policy describes when medications may be medically necessary for specific types of sleep disorders and excessive daytime sleepiness.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria

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Drug Medical Necessity Xyrem® (sodium oxybate) Xyrem® (sodium oxybate) may be considered medically

necessary for the following labeled indications: • Treatment of cataplexy in narcolepsy patients 7 years and older

and when cataplexy is documented by: o Brief episodes of sudden bilateral loss of muscle tone with

maintained consciousness that are precipitated by laughter or joking

OR o In children or in individuals within 6 months of onset,

spontaneous grimaces or jaw-opening episodes with tongue thrusting or a global hypotonia, without any obvious emotional triggers

OR • Treatment of excessive daytime sleepiness (recurrent periods

within the same day of an irrepressible need to sleep, lapsing into sleep, or napping, that have been occurring at least 3 times per week over at least the previous 3 months) in narcolepsy patients, when ALL of the following conditions are met: o Diagnosis of narcolepsy* has been documented by a sleep

study AND

o Prior therapy with a stimulant medication (eg, methylphenidate) was ineffective, not tolerated or contraindicated

AND o Prior therapy with modafinil (Provigil®) or armodafinil

(Nuvigil®) was ineffective, not tolerated, or contraindicated AND • Dose prescribed is ≤ 9 grams per day AND • Xyrem® (sodium oxybate) is not used in combination with

Sunosi™ (solriamfetol) or Wakix® (pitolisant) *Diagnosis of narcolepsy is defined as recurrent periods of excessive daytime sleepiness (recurrent periods within the same day of an irrepressible need to sleep, lapsing into sleep,

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Drug Medical Necessity or napping, that have been occurring at least 3 times per week over at least the previous 3 months), and at least one of the following: • Episodes of cataplexy OR • Nocturnal sleep polysomnography (PSG) showing rapid eye

movement (REM) sleep latency ≤ 15 minutes OR • Multiple sleep latency (MSLT) showing a mean sleep latency ≤

8 minutes and 2 or more sleep onset REM periods Medical records showing diagnosis suggestive of narcolepsy is not considered diagnostic of narcolepsy. For patients unable to discontinue REM suppressing medications who do not meet the MSLT criteria, the diagnosis of narcolepsy will be determined on a case-by-case basis. Note: Requirement trial with a stimulant and modafinil/armodafinil may be waived if medical records show symptoms consistent with cataplexy.

Sunosi™ (solriamfetol) Sunosi™ (solriamfetol) may be considered medically necessary for the following labeled indications: • Treatment of excessive daytime sleepiness (recurrent periods

within the same day of an irrepressible need to sleep, lapsing into sleep, or napping, that have been occurring at least 3 times per week over at least the previous 3 months) in adult patients with narcolepsy or obstructive sleep apnea, when ALL of the following conditions are met: o Diagnosis of narcolepsy* or obstructive sleep apnea** has

been documented by a sleep study AND o Prior therapy with a stimulant medication (eg,

methylphenidate) was ineffective, not tolerated or contraindicated

AND o Prior therapy with modafinil (Provigil®) or armodafinil

(Nuvigil®) was ineffective, not tolerated or contraindicated

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Drug Medical Necessity AND o Dose prescribed is ≤ 150 mg once daily AND o Sunosi™ (solriamfetol) is not used in combination with

Wakix® (pitolisant) or Xyrem® (sodium oxybate) *Diagnosis of narcolepsy is defined as recurrent periods of excessive daytime sleepiness (recurrent periods within the same day of an irrepressible need to sleep, lapsing into sleep, or napping, that have been occurring at least 3 times per week over at least the previous 3 months), and at least one of the following: • Episodes of cataplexy OR • Nocturnal sleep polysomnography (PSG) showing rapid eye

movement (REM) sleep latency ≤ 15 minutes OR • Multiple sleep latency (MSLT) showing a mean sleep latency ≤

8 minutes and 2 or more sleep onset REM periods **Diagnosis of obstructive sleep apnea in adults is defined as: • The apneic/hypopneic index (AHI) is ≥ 15 events per hour,

including a minimum of 30 events documented per sleep study OR • The AHI is ≥ 5 events per hour and < 15 events per hour,

including a minimum of 10 events documented per sleep study, AND documentation of: o History of stroke; OR o Hypertension (systolic blood pressure > 140 mm Hg and/or

diastolic blood pressure > 90 mm Hg); OR o Ischemic heart disease; OR o Symptoms of impaired cognition, mood disorders, or

insomnia; OR o Excessive daytime sleepiness (documented by either

Epworth Sleepiness Scale > 10 or MSLT < 6); OR o Greater than 20 episodes of desaturation (ie, oxygen

saturation of less than 85%) during a full night sleep study,

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Drug Medical Necessity or any 1 episode of oxygen desaturation (ie, oxygen saturation of less than 70%); OR

o Obesity (BMI > 35) Medical records showing diagnosis suggestive of narcolepsy or obstructive sleep apnea are not considered diagnostic. For patients unable to discontinue REM suppressing medications who do not meet the MSLT criteria, the diagnosis of narcolepsy will be determined on a case-by-case basis.

Wakix® (pitolisant) Wakix® (pitolisant) may be considered medically necessary for the following labeled indications: • Treatment of excessive daytime sleepiness (recurrent periods

within the same day of an irrepressible need to sleep, lapsing into sleep, or napping, that have been occurring at least 3 times per week over at least the previous 3 months) in adult patients with narcolepsy when ALL of the following conditions are met: o Diagnosis of narcolepsy* has been documented by a sleep

study AND

o Prior therapy with modafinil (Provigil®) or armodafinil (Nuvigil®) was ineffective, not tolerated or contraindicated

AND o Patient does not have severe hepatic impairment (Child-

Pugh C) as documented by laboratory tests AND

o Dose prescribed is ≤ 35.6 mg once daily AND o Wakix® (pitolisant) is not used in combination with

Sunosi™ (solriamfetol) or Xyrem® (sodium oxybate) *Diagnosis of narcolepsy is defined as recurrent periods of excessive daytime sleepiness (recurrent periods within the same day of an irrepressible need to sleep, lapsing into sleep, or napping, that have been occurring at least 3 times per week over at least the previous 3 months), and at least one of the following:

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Drug Medical Necessity • Episodes of cataplexy OR • Nocturnal sleep polysomnography (PSG) showing rapid eye

movement (REM) sleep latency ≤ 15 minutes OR • Multiple sleep latency (MSLT) showing a mean sleep latency ≤

8 minutes and 2 or more sleep onset REM periods Medical records showing diagnosis suggestive of narcolepsy are not considered diagnostic. For patients unable to discontinue REM suppressing medications who do not meet the MSLT criteria, the diagnosis of narcolepsy will be determined on a case-by-case basis.

Drug Investigational Xyrem® (sodium oxybate), Sunosi™ (solriamfetol), Wakix® (pitolisant)

All other uses of Xyrem® (sodium oxybate), Sunosi™ (solriamfetol), or Wakix® (pitolisant) for conditions not outlined in this policy are considered investigational.

Length of Approval Approval Criteria Initial authorization Xyrem® (sodium oxybate), Sunosi™ (solriamfetol), or Wakix®

(pitolisant) may be approved up to 1 year. Re-authorization criteria Future re-authorization of Xyrem® (sodium oxybate) may be

approved up to 1 year in duration when documentation provided at the time of re-authorization show: • Diagnosis of narcolepsy has been documented by a sleep study

performed prior to starting Xyrem® o Note: This requirement only applies to patients started on

Xyrem® with a prior insurer or for patients who had grandfathering for Xyrem® removed

AND • Documentation of continued clinical response AND • Dose prescribed is ≤ 9 grams per day

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Length of Approval Approval Criteria

Future re-authorization of Sunosi™ (solriamfetol) may be approved up to 1 year in duration when documentation provided at the time of re-authorization show: • Diagnosis of narcolepsy or obstructive sleep apnea has been

documented by a sleep study performed prior to starting Sunosi™ o Note: This requirement only applies to patients started on

Sunosi™ with a prior insurer AND • Documentation of continued clinical response AND • Dose prescribed is ≤ 150 mg once daily Future re-authorization of Wakix® (pitolisant) may be approved up to 1 year in duration when documentation provided at the time of re-authorization show: • Diagnosis of narcolepsy has been documented by a sleep study

performed prior to starting Wakix® o Note: This requirement only applies to patients started on

Wakix® with a prior insurer AND • Documentation of continued clinical response AND • Dose prescribed is ≤ 35.6 mg once daily

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Drug Dosage and Quantity Limit Xyrem® (sodium oxybate) • Xyrem 0.5 g per mL, quantity limit of 270 grams (540 mL; 3

bottles) per 30 days • Doses greater than 9 grams per day are not supported by

clinical evidence and therefore are considered not medically necessary.

Sunosi™ (solriamfetol) • Sunosi™ 75 mg tablet, quantity limit of 60 tablets per 30 days • Sunosi™ 150 mg tablet, quantity limit of 30 tablets per 30 days • Doses greater than 150 mg once daily are not supported by

clinical evidence and therefore are considered not medically necessary.

Wakix® (pitolisant) • Wakix® 17.8 mg tablet, quantity limit of 60 tablets per 30 days • Doses greater than 35.6 mg once daily are not supported by

clinical evidence and therefore are considered not medically necessary.

Documentation Requirements The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following: • Office visit notes that contain the relevant history, diagnosis and medication history AND • Documented sleep study results when required

Child-Pugh Score Child Pugh Score is a scoring system used to measure the severity of chronic liver disease (including cirrhosis). The purpose of this scoring system is to allow clinicians to objectively describe liver function. The score is composed of the following components: • Total bilirubin (mg/dL):

o 50: 3 points

• Serum albumin (g/L):

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Child-Pugh Score o >35: 1 point o 28 to 35: 2 points o

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Consideration of Age

The ages noted in the policy statement for Xyrem® (sodium oxybate), Sunosi™ (solriamfetol), and Wakix® (pitolisant) are based on FDA approval.

Benefit Application

This policy is managed through the pharmacy benefit.

Evidence Review

Background

Excessive daytime sleepiness (EDS) is defined as the inability to stay awake and alert during usual waking hours that occurs almost daily and persists for at least three months. Among obstructive sleep apnea (OSA) patients, men are twice as likely as women to suffer from EDS. Approximately 7.5 million Americans suffer from EDS due to OSA or narcolepsy. EDS puts patients at increased risk of impaired cognitive functioning and accidental injuries, as well as decreased work productivity and quality of life. Tiredness, fatigue, and lack of energy are common complaints. The potential causes of EDS are numerous and fall under several general classifications: central disorders (eg, narcolepsy), breathing disorders (eg, OSA), circadian rhythm issues (eg, jet lag), movement disorders (eg, restless leg syndrome), psychiatric disorders, substance abuse, and various diseases (eg, Parkinson).

Summary of Evidence

Xyrem® (sodium oxybate)

Xyrem® (sodium oxybate) is a CNS depressant. The mechanism of action of Xyrem in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma and death. It is hypothesized that the therapeutic effects of Xyrem on cataplexy and excessive daytime sleepiness are mediated

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through GABA-B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. Xyrem is a Schedule III controlled substance. Because of its abuse/diversion potential, it is only available from a single pharmacy through a limited distribution scheme, the Xyrem Success Program. Both prescribers and patients must be registered in this program to obtain the drug. Serious side effects observed in patients taking Xyrem include hallucinations, agitation, severe confusion, abnormal thinking, sleep disturbances and depression.

The efficacy of Xyrem in the treatment of cataplexy was evaluated in two 4-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trials, n=136 and 55 respectively. The high percentages of concomitant stimulant use in these studies make it impossible to assess the efficacy and safety independent of stimulant use. Doses of 6-9 g per night resulted in statistically significant reductions in frequency of cataplexy attacks. The 3 g per night dose had little effect. Overall, the evidence supporting this indication is of low quality.

The efficacy of Xyrem in the treatment of excessive daytime sleepiness in patients with narcolepsy was evaluated in an 8-week randomized, double-blind, placebo-controlled trial, n=228. Most of these patients were also being treated with CNS stimulants. Statistically significant improvements in Epworth Sleepiness Scores (ESS) were seen with 6 and 9 g doses. A second multicenter randomized, double-blind, placebo-controlled, parallel-group trial evaluated 222 patients on modafinil at baseline, who were randomized to placebo, Xyrem, modafinil, or Xyrem plus modafinil. Xyrem dose was 6g per night for 4 weeks, followed by 9g per night for 4 weeks. Modafinil was continued in the modafinil groups at the patient’s prior dose. A statistically significant improvement in in the Maintenance of Wakefulness Test (MWT) score from baseline at Week 8 was seen in the Xyrem and Xyrem plus modafinil groups compared to placebo. The trial was not designed to compare Xyrem with modafinil.

Studies have been conducted to demonstrate the efficacy of Xyrem in fibromyalgia patients; however, all of these have been placebo-controlled. In 2010, FDA rejected an application for use in fibromyalgia. FDA panel members expressed serious concerns about the potential for abuse and diversion of sodium oxybate. This concern was felt to outweigh any benefits that might accrue and is supported by the lack of any head-to-head comparison with alternative treatments for fibromyalgia, none of which have the level of abuse potential seen with Xyrem.

Sunosi™ (solriamfetol)

The mechanism of action of Sunosi™ (solriamfetol) is unclear; however, it’s efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor. The

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published pivotal trials evaluating the efficacy and safety of Sunosi in excessive daytime sleepiness (EDS) are referred to as the TONES trials (Treatment of OSA and Narcolepsy Excessive Sleepiness). TONES 2 is a fair quality, unpublished, randomized controlled trial (RCT) that enrolled 239 adults with narcolepsy and EDS. Maintenance of Wakefulness Test (MWT) was improved in all Sunosi groups compared to placebo, but these differences were statistically significant in only the 300mg and 150mg groups (12.3 and 9.8 vs. 2.1, p

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placebo. Treatment lasted 8 weeks: 3 weeks of tapering dosing according to response (10 mg, 20mg, or 40 mg a day of pitolisant; 100 mg, 200 mg, or 400 mg a day of modafinil) followed by 5 weeks of stable dosing. There were two primary endpoints being difference in change in Epworth sleepiness scale (ESS) score between pitolisant and placebo group after 8-week treatment period (superiority test) and difference in change in (ESS) score between pitolisant and modafinil after 8-week treatment period (non-inferiority test). The mean difference in ESS score of -3.0 (95% CI -5.6 to -0.4 p=0.024) showed pitolisant to be superior to placebo, but not non-inferior to modafinil with an ESS score mean difference of 0.12 (95% CI -2.5 to 2.7 p=0.250). The non-inferiority margin was 2 ESS points. Maintenance of wakefulness test (MWT) values improved in pitolisant groups compared to placebo’s mean difference of 1.47 (1.01 to 2.14, p=0.044), but no statistically significant difference compared to modafinil with a mean difference of 0.77 (0.52 to 1.13, p=0.173). The total sustained attention to response task (SART) score showed no difference in changes from baseline between either pitolisant versus placebo or pitolisant versus modafinil. The proportion of patients who had improved in excessive daytime sleepiness (EDS) assessed with the clinical global impression of change (CGI-C) by the end of treatment was largest in modafinil group (86%), then pitolisant group (73%), and smallest in placebo group (56%). There was also little difference in severity of cataplexy assessed with CGI-C. European quality of life questionnaire (EQ-5D) values were much the same in the 3 groups, whereas the patients local impression on treatment improved only slightly more for pirolisant or modafinil than for placebo.

HARMONY CPT is a randomized, double-blind, placebo-controlled trial conducted in 9 countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia, Turkey, and Ukraine). Similar to HARMONY I, after 14 days of washout period, patients were randomized (1:1) to either receive pitolisant or placebo once per day. Treatment was 7 weeks: 3 weeks of tapering dosing based on efficacy and tolerance (5 mg, 10 mg, or 12 mg pitolisant), followed by 4 weeks of stable dosing (5 mg, 10 mg, 20 mg, or 40 mg). The primary endpoint was change in average weekly cataplexy rate (WCR). Pitolisant reduced cataplexy by 75% (WCR = 0.25), which is more than placebo did (38%, WCR=0.62).

The most common adverse reaction for pitolisant were headaches (35%), insomnia (10%), nausea (6%), and anxiety (5%). Pitolisant is contraindicated in patients with severe hepatic impairment and should be administered with caution in patients with moderate hepatic impairment or renal impairment. There is a risk of mild to moderate prolongation of QTc interval with supratherapeutic doses of pitolisant, therefore monitoring is required in patients with cardiac disease, those taking other QT-prolonging medication, and medications known to increase pitolisant levels (CYP2D6 inhibitors).

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Ongoing and Unpublished Clinical Trials

An unpublished meta-analysis of six randomized control trials involving subjects with obstructive sleep apnea (OSA) and excessive daytime sleepiness (EDS) showed there was no clinically meaningful difference in Epworth Sleepiness Score (ESS) outcomes between Sunosi 150mg daily and modafinil 200mg or 400mg daily [-1.7 (95% CI -3.3, -0.01) and -1.7 (-3.3, -0.04), respectively]. The forty-minute Maintenance of Wakefulness Test (MWT) results were not shown for modafinil, so could not be compared to Sunosi trial results.

2020 Update

Reviewed prescribing information for all drugs in policy and the diagnostic criteria for narcolepsy and obstructive sleep apnea. Added criteria that Xyrem® (sodium oxybate), Sunosi™ (solriamfetol), and Wakix® (pitolisant) are not to be used as combination therapy with each other as efficacy and safety has not been evaluated. No additional changes were identified for policy.

References

1. Xyrem® (sodium oxybate) prescribing information. Jazz Pharmaceuticals; Palo Alto, CA. October 2018.

2. Sunosi™ (solriamfetol) prescribing information. Jazz Pharmaceuticals; Palo Alto, CA. March 2019.

3. Wakix® (pitolisant) prescribing information. Harmony Biosciences; Plymouth Meeting, PA. November 2019.

4. FDA warning letter to Jazz Pharmaceuticals, October 11, 2011. Available at: https://wayback.archive-it.org/7993/20170114071237/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/index.htm?Page=10 Accessed April 2020.

5. Mc Millen M. FDA Panel Rejects Xyrem as Fibromyalgia Treatment. Advisory Panel Members Worry About Potential for Abuse of Drug That’s Similar to GHB. WebMD Health News, August 20, 2010. Available at http://www.webmd.com/fibromyalgia/news/20100820/fda-panel-rejects-xyrem-as-fibromyalgia-treatment%20 Accessed April 2020.

6. ClinicalTrials.gov. Available at http://clinicaltrials.gov/ct2/results?term=xyrem Accessed April 2020.

7. Schweitzer PK, Rosenberg R, Zammit GK, et al. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Dec 6. Doi: 10.1164/rccm.201806-1100C. [Epub ahead of print].

8. Strollo PJ, Hedner J. Collop N, et al. Solriamfetol for the treatment of excessive sleepiness in OSA: a placebo-controlled randomized withdrawal trial. Chest. 2018 Nov 22. Pii:S0012-3692(18)32732-6. Doi 10.1016/j.chest.2018.11.005. [Epub ahead of print].

https://wayback.archive-it.org/7993/20170114071237/http:/www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/index.htm?Page=10https://wayback.archive-it.org/7993/20170114071237/http:/www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/index.htm?Page=10https://wayback.archive-it.org/7993/20170114071237/http:/www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/index.htm?Page=10http://www.webmd.com/fibromyalgia/news/20100820/fda-panel-rejects-xyrem-as-fibromyalgia-treatmenthttp://clinicaltrials.gov/ct2/results?term=xyrem

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9. Thorpy MJ, Dauvillers Y, Shapiro C, et al. A randomized, placebo-controlled, Phase 3 study of solriamfetol (JZP-110) in patients with narcolepsy: effects on wakefulness, excessive sleepiness, and health-related quality-of-life. Sleep 2017;40(suppl):A250.

10. Chervin RD (2018). Approach to the patient with excessive daytime sleepiness. In TE Scammell (Ed.), UpToDate. Retrieved Jan 20, 2019 from www.uptodate.com Accessed April 2020.

11. Morgenthaler TI, Kapur VK, Brown TM, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep 2007;30(12):1705-11.

12. Veasey SC, Guilleminault C, Strohl KP, et al. Medical therapy for obstructive sleep apnea: a review by the medical therapy for sleep apnea task force of the standards of practice committee of the American Academy of Sleep Medicine. Sleep 2006;29(8):1036-44.

13. Franek BM, Ronnebaum S, Menno D, et al. Indirect treatment comparison of the efficacy of solriamfetol, modafinil, and armodafinil for the treatment of excessive sleepiness in obstructive sleep apnea. J Manag Care Spec Pharm. 2018 Oct;24(10-a):S56.

14. Carter LP, Henningfield JE, Wang YG, Lu Y, Kelsh D, Vince B, Sellers E. A randomized, double blind, placebo-controlled, crossover study to evaluate the human abuse liability of solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor. J Psychpharmacol. 2018 Dec;32(12):1351-61.

15. Arand D, Bonnet M, Hurwitz T, et al. The clinical use of the MSLT and MWT. Sleep 2005;28(1):123-44.

16. Crook S, Sievi NA, Bloch KE, et al. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomized controlled trials. Thorax 2018;0:1-7.

17. Scrima L, Emsellem HA, Becker PM, et al. Identifying clinically important difference on the Epworth Sleepiness Scale: result from a narcolepsy clinical trial of JZP-110. Sleep Medicine 38 (2017): 108-12.

18. Weaver TE, Crosby RD, Bron M, et al. Using multiple anchor-based and distribution-based estimates to determine the minimal important difference (MID) for the FOSQ-10. Sleep 2018;41(suppl 1): A227.

19. Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol 2013 Nov;12(11):1068-75.

20. Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC; HARMONY-CTP study group. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2017 Mar;16(3):200-207.

History

Date Comments 06/01/19 New policy, approved May 14, 2019. Xyrem (sodium oxybate) moved from policy

5.01.605. Criteria added for Sunosi (solriamfetol).

03/01/20 Interim Review, approved February 11, 2020. Updated Xyrem coverage criteria and added definition for cataplexy. Criteria added for Wakix (pitolisant).

04/01/20 Interim Review, approved March 3, 2020. Added under diagnosis of narcolepsy that for patients unable to discontinue REM suppressing medications who do not meet the MSLT criteria, the diagnosis of narcolepsy will be determined on a case-by-case basis.

http://www.uptodate.com/

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Date Comments 05/01/20 Annual Review, approved April 23, 2020. Added criteria that Xyrem (sodium oxybate),

Sunosi (solriamfetol), and Wakix (pitolisant) are not to be used as combination therapy with each other.

07/13/20 Correction made in policy section to read: Hypertension (systolic blood pressure > 140 mm Hg and (previously stated 140 mg Hg which was a typo). No other changes.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

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አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ።

( ةالعربي :(. امةھ ماتولعم اإلشعار ھذا يحوي

خالل من ھاعلي صولحلا تريد لتيا التغطيةلل أو ةصحيلاكطيتتغ لىع اظلحفل نةعيم يخراوت في إجراء خاذتال تحتاج وقد .اإلشعار ھذا في

تكلفة أية بدتك دون بلغتك مساعدةوال تاوملالمع ھذه على ولحصال لك يحق .800-722-1471 (TTY: 800-842-5357)

أو طلبك وصخصب مةمھ ماتوعلم عارشإلا ھذا ويحي قدةمھم يخراوت ھناك تكون قد .Premera Blue Cross

اعدةمس تصلايفكالتال دفع فيبـ

.

Arabic

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.

Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-722-1471 (TTY: 800-842-5357).

Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357).

Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357).

Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357).

Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).

Italiano ( ):Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

Italian

中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期

之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母

語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。

037338 (07-2016)

https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@Premera.com

日本語 (Japanese):この通知には重要な情報が含まれています。この通知には、 Premera Blue Crossの申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要な日付をご確認くだ

さい。健康保険や有料サポートを維持するには、特定の期日までに行動を

取らなければならない場合があります。ご希望の言語による情報とサポー

トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話ください。

한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 .

ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນີ້. ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົດ ເວລາສະເພາະເພື່ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລື່ອງ າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນີ້ ແລະ ຄວາມຊ່ວຍເຫຼື ອເປັ ນພາສາ ຂອງທ່ານໂດຍບ່ໍ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357).

ູຂໍ້

່

ສໍ ັ

ຈ

ໝ

ສິ

ັ

່

ວ

ຄ

ມ

ມູຮັ

ູມີ ມຂໍ້

ភាសាែខមរ ( ): ឹ

រងរបស់

Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

េសចកតជី ូ

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

កតាមរយៈ

ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

មប ឹ កការធានារា ខភាពរបស ជ

ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ ਖਾਸ

ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).

ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين. ميباشد ھمم اطالعات یوحا يهمالعا اين

در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا تان بيمهوشش حقظ

Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين جهتو يهمالعا اين

حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ زبان به را کمک و اطالعات اين که داريد را اين

استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش با اطالعات .اييدنم برقرار

้

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może

zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

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Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).