PHARMACY / MEDICAL POLICY – 5.01.593 Pharmacologic Treatment of -Mediated

BCBSA Ref. Policy: 5.01.30 Effective Date: Nov. 1, 2020 RELATED MEDICAL POLICIES: Last Revised: Oct. 22, 2020 None Replaces: N/A

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

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Introduction

Amyloid is an abnormal protein. There are many different reasons why the body makes amyloid. One cause is a change to the TTR gene. This gene provides instructions to the liver about how to make a ceratin protein. But changes to the TTR gene means this liver protein is faulty. These faulty liver proteins get deposited throughout the body and build up over time. This condition is known as hereditary transthyretin-mediated amyloidosis (hATTR). Symptoms like numbness, pain and weakness in the arms and legs, heart problems, and stomach and bowel problems develop as the condition progresses. One way to treat hATTR is to use certain drugs to reduce the amount of TTR protein the liver makes. This policy describes when these types of drugs may be considered medically necessary.

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

Drug Medical Necessity Onpattro™ (patisiran) Onpattro™ may be considered medically necessary for the treatment of polyneuropathy of hereditary transthyretin- mediated amyloidosis when: • Patient is 18 years of age or older AND • Documented transthyretin (TTR) mutation verified by genetic testing AND • Presence of symptoms consistent with polyneuropathy of hereditary transthyretin amyloidosis o Peripheral sensorimotor polyneuropathy (eg, tingling or increased pain in the hands or feet, loss of feeling or numbness in the hands or feet, carpal tunnel syndrome, loss of ability to sense temperature, difficulty with fine motor skills, weakness in the legs, difficulty walking) OR o Autonomic neuropathy (eg, postural hypotension, sexual dysfunction, recurrent urinary tract infection) AND • Polyneuropathy disability (PND) score IIIb or less or familial amyloid polyneuropathy (FAP) stage 2 or less AND • Not used in combination with the following: TTR stabilizers (eg, tafamidis, tafamidis , diflunisal) and Tegsedi™ () AND • Prescribed by or in consultation with a neurologist AND • Dose is based on actual body weight as follows: o For patients weighing less than 100 kg, the dosage is 0.3 mg/kg once every 3 weeks o For patients weighing 100 kg or more, the dosage is 30 mg once every 3 weeks

Note: Clinical description of PND score • Score 0 = No symptoms • Score I = Sensory disturbances but preserved walking capability

Page | 2 of 11 ∞ Drug Medical Necessity • Score II = Impaired walking capacity but ability to walk without a stick or crutches • Score IIIA = Walking with the help of one stick or crutch • Score IIIB = Walking with the help of two sticks or crutches • Score IV = Confined to a wheelchair or bedridden

Note: Clinical description of FAP stage • Stage 0 = No symptoms • Stage 1 = Unimpaired ambulation • Stage 2 = Assistance with ambulation required • Stage 3 = Wheelchair-bound or bedridden Tegsedi™ (inotersen) Tegsedi™ may be considered medically necessary for the treatment of polyneuropathy of hereditary transthyretin- mediated amyloidosis when: • Patient is 18 years of age or older AND • Documented transthyretin (TTR) mutation verified by genetic testing AND • Presence of symptoms consistent with polyneuropathy of hereditary transthyretin amyloidosis o Peripheral sensorimotor polyneuropathy (eg, tingling or increased pain in the hands or feet, loss of feeling or numbness in the hands or feet, carpal tunnel syndrome, loss of ability to sense temperature, difficulty with fine motor skills, weakness in the legs, difficulty walking) OR o Autonomic neuropathy (eg, postural hypotension, sexual dysfunction, recurrent urinary tract infection) AND • Polyneuropathy disability (PND) score IIIb or less or familial amyloid polyneuropathy (FAP) stage 2 or less AND • Not used in combination with the following: TTR stabilizers (eg, tafamidis, tafamidis meglumine, diflunisal) and Onpattro™ (patisiran) AND • Prescribed by or in consultation with a neurologist AND

Page | 3 of 11 ∞ Drug Medical Necessity • Dose prescribed is 284 mg injected subcutaneously once weekly

Note: Clinical description of PND score • Score 0 = No symptoms • Score I = Sensory disturbances but preserved walking capability • Score II = Impaired walking capacity but ability to walk without a stick or crutches • Score IIIA = Walking with the help of one stick or crutch • Score IIIB = Walking with the help of two sticks or crutches • Score IV = Confined to a wheelchair or bedridden

Note: Clinical description of FAP stage • Stage 0 = No symptoms • Stage 1 = Unimpaired ambulation • Stage 2 = Assistance with ambulation required • Stage 3 = Wheelchair-bound or bedridden Vyndamax™ (tafamidis), Vyndamax™ (tafamidis) and Vyndaqel® (tafamidis Vyndaqel® (tafamidis meglumine) may be considered medically necessary for the meglumine) treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) when: • Patient is 18 years of age or older AND • Documented wild type or hereditary transthyretin-mediated amyloidosis is confirmed with presence of amyloid deposits on biopsy specimens AND • Not used in combination with Onpattro™ (patisiran) or Tegsedi™ (inotersen) AND • Prescribed by or in consultation with a cardiologist

Drug Investigational Onpattro™ (patisiran), All other uses of Onpattro™, Tegsedi™, Vyndamax™ (tafamidis) Tegsedi™ (inotersen), and Vyndaqel® (tafamidis meglumine) for conditions not Vyndamax™ (tafamidis), outlined in this policy are considered investigational. Vyndaqel® (tafamidis meglumine)

Page | 4 of 11 ∞ Approval Criteria Initial authorization Onpattro™, Tegsedi™, Vyndamax™, and Vyndaqel® may be approved up to 12 months. Re-authorization criteria • Continued therapy with Onpattro™ or Tegsedi™ will be for Onpattro™ and approved for periods of one year if the above Onpattro™ or Tegsedi™ Tegsedi™ criteria are met and the patient has shown and continues to show efficacy documented in the medical record indicating positive clinical response (eg, improved or stable motor, neurologic, cardiac function, or serum TTR levels) AND • Improvement or stability in one of the following from baseline: PND score or FAP stage AND • Absence of treatment limiting toxicity Re-authorization criteria • Continued therapy with Vyndamax™ or Vyndaqel® will be for Vyndamax™ and approved for periods of one year if the above Vyndamax™ and Vyndaqel® Vyndaqel® criteria are met and the patient has shown and continues to show efficacy documented in the medical record indicating positive clinical response (eg, 6-Minute Walk Test [6MWT], Kansas City Cardiomyopathy Questionnaire-Overall Summary [KCCQ-OS] score)

Documentation Requirements For Onpattro™ or Tegsedi™ the patient’s medical records submitted for review should document that medical necessity criteria are met. The records should include the following: • Office visit notes that contain the relevant history and physical evaluation information AND • Documented TTR mutation verified by genetic testing AND • Results of the PND score or FAP stage AND • Dose and frequency of prescribed medication

For Vyndamax™ or Vyndaqel® the patient’s medical records submitted for review should document that medical necessity criteria are met. The records should include the following: • Office visit notes that contain the relevant history and physical evaluation information

Page | 5 of 11 ∞ Coding

Code Description HCPCS J0222 Injection, patisiran, (Onpattro™) 0.1 mg

J3590 Unclassified biologics (Tegsedi™)

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Consideration of Age

Age limits specified in this policy are determined according to FDA-approved indications, where applicable.

Benefit Application

The drugs in this policy that are administered orally (Vyndamax™ and Vyndaqel®) and subcutaneously (Tegsedi™) are managed through the Pharmacy benefit. Drugs administered via IV infusion (Onpattro™) are managed through the Medical benefit.

Evidence Review

Description

Hereditary transthyretin amyloidosis (hATTR), formerly known as familial amyloidotic polyneuropathy (FAP), is a rare, progressive disorder characterized by the extracellular deposition of TTR protein. hATTR can affect multiple organs and body systems, such as the heart, nervous system, gastrointestinal (GI) tract, and kidney. Symptoms may include autonomic

Page | 6 of 11 ∞ dysfunction, GI dysfunction, ocular manifestation, cardiac manifestation, compromised renal function, or carpal tunnel syndrome. The most common mutation associated with hATTR is Val30Met. Although some mutations are associated mainly with polyneuropathy or cardiomyopathy, most patients have mixed clinical phenotypes. If untreated, death occurs about 10 years after onset of hATTR.

The disease course begins with unimpaired ambulation (FAP stage 1), then requiring ambulation (FAP stage 2), which proceeds to wheel chair confinement (FAP stage 3), where patients experience life-impacting symptoms including burning neuropathic pain, loss of sensation in hands and feet, diarrhea/constipation, sexual impotence, and dizziness/fainting. The median survival for patients with hATTR with polyneuropathy is reported as 5-15 years. hATTR affects at least 10,000 people worldwide with about >120 TTR mutations being reported, with about 3,000-5,000 people in the U.S. However, symptoms of hATTR do not always start in one specific organ and the disease is often masked. As a result, these numbers may be underestimated due to under-diagnosis. Quantifying the disease burden in hATTR remains challenging since there is no single test that captures all the symptoms of the condition. Tests demonstrated that both mental and physical health in patients with hATTR were substantially lower than an age-match controlled group of patients not receiving treatment.

The protein TTR is synthesized and secreted by the liver, where it transports thyroxine and retinol. Mutations in TTR destabilize the protein, causing misfolding into a beta-pleated sheet configuration and forming insoluble amyloid fibrils. This mutation results in an autosomal dominant disorder primarily affecting the nerves and heart. With different mutations, symptomatic manifestations may vary even among family member.

Summary of Evidence

Onpattro™ (patisiran)

Fair quality evidence from the Phase 2 and APOLLO studies showed that patisiran 0.3 mg/kg intravenously (IV) every three weeks (Q3W) is effective in reducing transthyretin (TTR levels) and improving their modified neuropathy impairment scale+7 (mNIS+7) score, respectively, in adults diagnosed with hereditary transthyretin amyloidosis (hATTR) and neuropathy. The 0.3 mg/kg IV Q3W dosing regimen demonstrated the highest maximum TTR knockdown (KD) and TTR KD at nadir for both dose 1 (94.2% and 83.8%) and dose 2 (96.0% and 86.7%) compared to other dosing regimens (0.01, 0.05,0.15, and 0.3 mg/kg every four weeks [Q4W]). Patisiran showed significant improvement in patients’ change in mNIS+7 scores from baseline compared to

Page | 7 of 11 ∞ placebo (-6.03 vs. 27.96), suggesting improvement in autonomic function. This is further proven in the Phase 2 open-label extension (OLE) trial, where patients were on patisiran for 24 months and had a change in mNIS+7 from baseline of -7.0. Secondary endpoints in the APOLLO trial saw improved scores as well, most notably in assessing quality of life using the Norfolk quality of life-diabetic neuropathy (QoL-DN) scale (-6.7 vs. 14.4).

Mild to moderate adverse events (AEs) were common in patisiran. Most AEs were infused- related reactions (IRRs), which occurred in 10.3% of patients in the Phase 2 trial and 18.9% of subjects in the patisiran group from the APOLLO trial. The Phase 2 OLE trial demonstrated similar results as well with 22.2% of subjects experiencing IRRs. Researchers attempted to prevent IRRs by pre-medicating patients with dexamethasone, acetaminophen, an H1 blocker, and an H2 blocker. As a result, pill burden may play a role in adherence and managing AEs. Another common AE was peripheral edema (29.7% in patisiran vs. 22.1% in placebo) which decreased over time with no patient needing to discontinue treatment. The Phase 2 trial reported one patient experiencing a urinary tract infection (UTI), sepsis, nausea, and vomiting. Another patient reported cellulitis, nausea, and vomiting. Because one patient experienced these symptoms, it is difficult to associate patisiran with these serious adverse events (SAEs). The APOLLO study had 36.5% of the patisiran group experience a SAE. The most common SAE found was diarrhea in 5.4% of patients. No increase in observed frequency of events for patisiran compared to placebo group by SOC.

Tegsedi™ (inotersen)

In the Phase III trial NEURO-TTR trial, inotersen treatment slowed the progression of polyneuropathy relative to placebo and stabilized neuropathy-related quality of life (QOL). The statistically significant treatment difference in mNIS+7 reflected progression in the placebo group and delayed progression in the inotersen group, though many inotersen patients reported improved neuropathy scores. Open-label extension (OLE) data suggest sustained delay of progression of polyneuropathy, though neuropathy-related QOL gain may not be durable. Cardiac endpoints did not differ statistically between the inotersen group and placebo group after 15 months of intervention; however, the trial was not powered to detect differences in cardiac outcomes. A small single-arm open label study shows minimal worsening of left ventricular mass.

Five deaths were reported during the study, all of which occurred in the inotersen group, through 15 months of treatment. Four deaths were considered related to disease progression and one death was considered possibly inotersen-related. Safety data show two key concerns with inotersen treatment: thrombocytopenia and glomerulonephritis. Frequent platelet and renal

Page | 8 of 11 ∞ monitoring implemented during the Phase III NEURO-TTR trial suggests thrombocytopenia and decreased renal function may be manageable through enhanced monitoring. Adverse events considered related to treatment were more frequently reported by inotersen patients compared to placebo patients. Anti-inotersen antibodies were reported in 30.4% of NEURO-TTR patients. These antibodies typically develop after a median of 200 days of treatment and did not appear to affect drug efficacy, but patients with such antibodies reported more injection site reactions.

Vyndamax™ and Vyndaqel®

Tafamidis was studied in a large, multicenter, placebo-controlled, double-blind, 30-month, Phase 3 trial (ATTR-ACT trial) which randomized 441 patients with transthyretin amyloid cardiomyopathy (AATR-CM) to tafamidis 80 mg/day, tafamidis 20 mg/day, or placebo. The study included adults up to 90 years of age with confirmed amyloid transthyretin wild type (ATTRwt) or amyloid transthyretin due to a mutation (ATTRm) with amyloid cardiac involvement and heart failure (HF). The primary outcome measures were all-cause mortality and CV-related hospitalization which were assessed hierarchically. The study used the Finkelstein-Schoenfeld method to assess statistical significance. This method pairs each patient in a given strata with every other patient in that strata, assigning a +1 to the better patient and -1 to the worse patient based on all-cause mortality followed by cardiovascular (CV)-related hospitalization if both patients remain alive. These values are summed to create the test statistic. According to the Finkelstein-Schoenfeld method, pooled tafamidis was superior to placebo over 30 months (p<0.001) with a win ratio of 1.695 (95% CI 1.255-2.289). All-cause mortality was significantly decreased with pooled tafamidis compared to placebo with a 30% risk reduction (HR 0.7, 95% CI 0.51-0.96). The risk of CV-related hospitalization significantly decreased with pooled tafamidis compared to placebo (RR 0.68, 95% CI 0.56-0.81). The least squares (LS) mean change from baseline to month 30 in the 6-minute walk test (6MWT) and the Kansas City Cardiomyopathy Questionnaire – overall summary (KCCQ-OS) both significantly favored pooled tafamidis (6MWT: -55 vs -131 tafamidis vs placebo, p<0.001; KCCQ-OS -7 vs -21 respectively, p<0.001). All assessments met criteria for clinical as well as statistical significance. Subgroup assessment found results favored tafamidis in all-cause mortality and CV-hospitalization except for CV- related hospitalization in New York Heart Association (NYHA) Class III patients which significantly favored placebo. Of note, no difference in all-cause mortality was seen with the 20 mg dose of tafamidis compared to the 80 mg dose (26.1% vs 27.8%, respectively, statistical analysis not performed).

The prescribing information for tafamidis describes adverse events (AEs) seen with tafamidis as equivalent to placebo. In the ATTR-ACT trial, none of the AEs seen with tafamidis occurred with

Page | 9 of 11 ∞ an incidence ≥4% greater than the incidence seen with placebo. There are no contraindications or warnings. According to the prescribing information, in the 30-month placebo-controlled study, discontinuation due to AEs occurred in 7% of patients on Vyndaqel 80 mg, 6% on Vyndaqel 20 mg, and 6% on placebo. Of note, the published ATTR-ACT trial lists discontinuation rates due to treatment-emergent AEs (TEAEs) as 21.2% with tafamidis and 28.8% with placebo and temporary discontinuation due to TEAE as 20.1% and 26%, respectively.

2020 Update

A literature search from 12/1/2019 through 6/30/2020 did not identify new information requiring change to the medical policy criteria.

References

1. Onpattro™ (patisiran) prescribing information. Alnylam Pharmaceuticals, Inc.; Cambridge, MA. August 2018.

2. Tegsedi™ (inotersen) prescribing information. Akcea Therapeutics, Inc. September 2020.

3. What Is Hereditary ATTR Amyloidosis (hATTR)? hATTR Amyloidosis. https://www.hattrguide.com/about-hattr-amyloidosis/. Accessed October, 2020.

4. NIS-Neurological Impairment Scale. King's College London. https://www.kcl.ac.uk/nursing/departments/cicelysaunders/resources/tools/nis.aspx. Published April 2013. Accessed October, 2020.

5. Gertz M. Hereditary ATTR Amyloidosis: Burden of Illness and Diagnostic Challenges. American Journal of Managed Care. 2017;23.

6. ICER. Institute for Clinical and Economic Review. Inotersen and Patisiran for Hereditary Transthyretin Amyloidosis: Effectiveness and Value. Published October 4, 2018. Available at: https://icer-review.org/wp- content/uploads/2018/02/ICER_Amyloidosis_Final_Evidence_Report_101718.pdf Accessed October, 2020.

7. Vyndamax™ (tafamidis) and Vyndaqel® (tafamidis meglumine) prescribing information. Labs. April 2020.

8. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthy-retin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.

9. Data on File, Pfizer. AMCP Dossier for Vyndaqel® (tafamidis meglumine). Version date: May 24, 2019.

10. Maurer MS, Elliott P, Merlini G, et al. Design and rationale of the Phase 3 ATTR-ACT (tafamidis in transthyretin cardiomyopathy clinical trial). Circ Heart Fail. 2017;10:e003815.

History

Page | 10 of 11 ∞

Date Comments 04/01/19 New policy, approved March 12, 2019. Add to section. Onpattro (patisiran) and Tegsedi (inotersen) may be considered medically necessary when criteria are met. They are considered investigational for all other uses.

10/01/19 Coding update, added HCPCS code J0222 (new code effective 10/1/19).

12/01/19 Interim Review, approved November 12, 2019. Added coverage criteria for Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine).

11/01/20 Annual Review, approved October 22, 2020. No change to policy statements. Removed HCPCS J3490.

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.

Page | 11 of 11 ∞

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Benachrichtigung enthält unter Umständen wichtige Informationen You can also file a civil rights complaint with the U.S. Department of Health bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera and Human Services, Office for Civil Rights, electronically through the Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Office for Civil Rights Complaint Portal, available at Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten U.S. Department of Health and Human Services zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in 200 Independence Avenue SW, Room 509F, HHH Building Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) (TTY: 800-842-5357). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Hmoob (Hmong):

Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum Getting Help in Other Languages 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 This Notice has Important Information. This notice may have important Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv information about your application or coverage through Premera Blue no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub Cross. There may be key dates in this notice. You may need to take action dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj by certain deadlines to keep your health coverage or help with costs. You yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob have the right to get this information and help in your language at no cost. ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau Call 800-722-1471 (TTY: 800-842-5357). ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Iloko (Ilocano): Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion

ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti Arabic): partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti) العربية salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti يحوي ھذا اإلشعار معلومات ھامة . قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti التغطية التي تريد الحصول عليھا من خالل Premera Blue Cross. قد تكون ھناك تواريخ مھمة .(bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357 في ھذا اإلشعار . وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة في دفع التكاليف . يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة . اتصل :(Italiano (Italian بـ(TTY: 800-842-5357) 800-722-1471 Questo avviso contiene informazioni importanti. Questo avviso può contenere 中文 (Chinese): informazioni importanti sulla tua domanda o copertura attraverso Premera 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 Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe 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 essere necessario un tuo intervento entro una scadenza determinata per 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 consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. 語得到本訊息和幫助。請撥電話 。 800-722-1471 (TTY: 800-842-5357) Chiama 800-722-1471 (TTY: 800-842-5357).

037338 (07-2016) 日本語 (Japanese): Română (Romanian): 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 Prezenta notificare conține informații importante. Această notificare 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 poate conține informații importante privind cererea sau acoperirea asigurării 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 dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în aceast notificare. Este posibil s fie nevoie s ac iona i pân la anumite 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 ă ă ă ț ț ă termene limită pentru a vă menține acoperirea asigurării de sănătate sau 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 asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 ください。 (TTY: 800-842-5357).

한국어 (Korean): Pусский (Russian): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 Настоящее уведомление содержит важную информацию. Это 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 уведомление может содержать важную информацию о вашем Premera Blue Cross. 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 заявлении или страховом покрытии через В настоящем уведомлении могут быть указаны ключевые даты. Вам, 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 возможно, потребуется принять меры к определенным предельным 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . срокам для сохранения страхового покрытия или помощи с расходами. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 Вы имеете право на бесплатное получение этой информации и 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 . помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): Fa’asamoa (Samoan): ້ ້ ້ ້ ແຈ້ງການນີ ມີ ຂໍ ມູ ນສໍ າຄັ ນ. ແຈ້ງການນີ ອາດຈະມີ ຂໍ ມູ ນສໍ າຄັ ນກ່ ຽວກັບຄໍ າຮ້ອງສະ Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ໝັ ກ ຫືຼ ຄວາມຄຸ້ ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala ວັນທີ ສໍ າຄັ ນໃນແຈ້ງການນີ້ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົ ດ atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua ເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ ມຄອງປະກັນສຸ ຂະພາບ ຫືຼ ຄວາມຊ່ວຍເຫືຼ ອເລື່ ອງ 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 ້ ້ ຄ່ າໃຊ້ຈ່າຍຂອງທ່ານໄວ້ . ທ່ານມີ ສິ ດໄດ້ ຮັບຂໍ ມູ ນນີ ແລະ ຄວາມຊ່ວຍເຫືຼ ອເປັ ນພາສາ aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai ຂອງທ່ານໂດຍບໍ່ ເສຍຄ່ າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357). 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 徶羶ែខមរ (Khmer): ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). េសចកតជី ូនដណំ ឹងេនះ掶នព័ត៌掶ន架៉ ងស޶នំ។ ់ េសចកតីជូនដំណឹងេនះរបែហល ᾶ掶នព័ត៌掶ន架៉ ងសំ޶ន់អពំ ីទរមង់ ែបបបទ ឬζរ殶៉ បរង់ របសអ់ នក㾶មរយៈ Español (Spanish): Premera Blue Cross ។ របែហលᾶ掶ន ζលបរ េចិ ឆទសំ޶ន់េ俅កន ុងេសចកតជី ូន Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a ដណំ ងេនះ។ឹ អនករបែហលᾶរតវζរបេញូ ច ញសមត徶ពថ ដលក់ ណតំៃថ ់ ងᾶកច厶់ ស់ través de Premera Blue Cross. Es posible que haya fechas clave en este 侶侶 េដើមបីនងរកឹ 羶ទកζរ䮶侶ុ 殶៉ បរង់ សខ徶ពរបសុ ់អនក ឬរ厶កជ់ ំនួយេចញៃថល។ aviso. Es posible que deba tomar alguna medida antes de determinadas អនក掶នសទិ ធទទិ ួលព័ត掶នេ៌ នះ និងជំនួយេ俅កន ុង徶羶របស់អនកេ⮶យមនអសិ fechas para mantener su cobertura médica o ayuda con los costos. Usted លយេឡុ ើយ។ សូ មទូរស័ពទ 800-722-1471 (TTY: 800-842-5357)។ tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

ਪ ੰ ਜਾਬੀ (Punjabi): Tagalog (Tagalog): ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ƒ ਤੁਹਾਡੀ Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਕਵਰਜੇ ਅਤ ੇ ਅਰਜੀ ਬਾਰ ੇ ਮਹ ੱ ਤਵਪਰਨੂ ਜਾਣਕਾਰੀ ਹ ੋ ਸਕਦੀ ਹ ੈ . ਇਸ ਨ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ . tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue ਹੋ ਸਕਦੀਆਂ ਹਨ ਜੇਕਰ ਤਸੀੁ ਜਸਹਤ ਕਵਰਜੇ ਿਰੱ ਖਣੀ ਹਵੋ ੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring ਇਛ ੱ ੁਕ ਹ ੋ ਤ拓 ਤਹਾਨ ੁ ੰ ੂ ਅ ੰ ਤਮ ਤਾਰੀਖ਼ ਤ ƒ ਪਿਹਲ拓 ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੱ ਕਣ ੁ ਦੀ ਲੋੜ ਹ ੋ ਸਕਦੀ ਹ ੈ ,ਤੁਹਾਨੰ ੂ mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang ਮਫ਼ਤੁ ਿਵੱ ਚ ਤ ੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤ ੇ ਮਦਦ ਪਾਪਤ㘰 ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na 800-722-1471 (TTY: 800-842-5357). walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 .(Farsi): (TTY: 800-842-5357) فارسی اين اعالميه حاوی اطالعات مھم ميباشد .اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم :(ไทย (Thai تقاضا و يا پ وشش بيمه ای شما از طريق Premera Blue Cross باشد . به تاريخ ھای مھم در ั ประกาศนมข้ี ี ้อมลส ู ําคญ ั ประกาศนอาจม ้ี ีข ้อมลท ู ่ีส ําคญเก ั ่ียวกบการการสม ัครหร ั ือขอบเขตประกน اين اعالميه توجه نماييد .شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه . สขภาพของคุณผ ุาน ่ Premera Blue Cross และอาจมีก ําหนดการในประกาศนี ้ คณอาจจะต ุ ้อง ھای درمانی تان، به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد شما حق اين را داريد که اين اطالعات و ک مک را به زبان خود به طور رايگان دريافت نماييد . برای کسب ี่ ดําเน ินการภายในกาหนดระยะเวลาท ํ ่ีแนนอนเพ ่ ่ือจะร ักษาการประกนส ัขภาพของค ุณหร ุ ือการช ่วยเหล ือท اطالعات با شماره 1471-722-800 (کاربران TTY تماس باشماره 5357-842-800) تماس มคี่้่าใชจาย คณม ุีิิ่ี้ัู้สทธทจะไดรบขอมลและความชวยเหล ่ ื้ีอนในภาษาของคณโดยไม ุ่มค ี่้่าใชจาย โทร برقرار نماييد . 800-722-1471 (TTY: 800-842-5357) Polskie (Polish): To og oszenie mo e zawiera wa ne informacje. To og oszenie mo e ł ż ć ż ł ż Український (Ukrainian): zawiera wa ne informacje odno nie Pa stwa wniosku lub zakresu ć ż ś ń Це повідомлення містить важливу інформацію. Це повідомлення świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na може містити важливу інформацію про Ваше звернення щодо kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie страхувального покриття через Premera Blue Cross. Зверніть увагу на przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub ключові дати, які можуть бути вказані у цьому повідомленні. Існує pomocy zwi zanej z kosztami. Macie Pa stwo prawo do bezp atnej ą ń ł імовірність того, що Вам треба буде здійснити певні кроки у конкретні informacji we własnym języku. Zadzwońcie pod 800-722-1471 кінцеві строки для того, щоб зберегти Ваше медичне страхування або (TTY: 800-842-5357). отримати фінансову допомогу. У Вас є право на отримання цієї

інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за Português (Portuguese): номером телефону 800-722-1471 (TTY: 800-842-5357). Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio Tiếng Việt (Vietnamese): do Premera Blue Cross. Poderão existir datas importantes neste aviso. Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông Talvez seja necessário que você tome providências dentro de tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua determinados prazos para manter sua cobertura de saúde ou ajuda de chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông custos. Você tem o direito de obter esta informação e ajuda em seu idioma báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). 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).