PHARMACY / MEDICAL POLICY – 5.01.581 Hemlibra® (emicizumab-kxwh)

Effective Date: April 1, 2020 RELATED MEDICAL POLICIES: Last Revised: March 19, 2020 None Replaces: N/A

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Introduction

When a person bleeds, the body undertakes a series of steps to stop the bleeding. The first step is that blood platelets collect at the site of injury; this sets up a temporary plug. Next, several other proteins — known as clotting factors — work together to create a permanent plug in the damaged area. There are 13 types of clotting factors. Hemophilia is a condition in which clotting factors don’t work as they should. A person with hemophilia bleeds easily and the blood takes much longer to clot. Hemophilia A is the most common form, affects clotting factor VIII (factor 8), is usually inherited, and most often affects males. In some cases of hemophilia A, however, the person doesn’t inherit the condition. Rather, a genetic change occurs spontaneously which result in hemophilia A. Hemlibra® is a drug that can be used to prevent or reduce the number of bleeding episodes in children and adults with hemophilia A. It’s used in people who have developed an immune system response against factor VIII, which is known as factor VIII inhibitors. This policy describes when Hemlibra 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 Hemlibra® (emicizumab- Hemlibra® (emicizumab-kxwh) may be considered medically kxwh) necessary for adults and pediatric patients, when the following criteria are met: • Diagnosis of hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors AND • Hemlibra is not used concurrently with high dose aPCC o Note: High dose aPCC is defined as greater than 100 U/kg/day administered for greater than 24 hours

Drug Investigational Hemlibra® (emicizumab- All other uses of Hemlibra® (emicizumab-kxwh) for conditions kxwh) not outlined in this policy are considered investigational.

Approval Criteria Initial authorization Hemlibra® (emicizumab-kxwh) can be approved for 1 year. Re-authorization criteria Future re-authorization would depend on clinical benefit/response shown at the time of re-authorization where: • Chart notes documenting decreased incidence of bleeding episodes

Dosage and Quantity Limits Condition Dosage and Quantity Limit Hemophilia A • 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly.

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Coding

Code Description HCPCS J7170 Injection, emicizumab-kxwh (Hemlibra®), 0.5 mg

Related Information

Benefit Application

Hemlibra® (emicizumab-kxwh) may be managed through pharmacy or medical benefits.

Consideration of Age

The ages stated in this policy for which Hemlibra® (emicizumab-kxwh) is considered medically necessary is based on the FDA labeling for this drug.

Evidence Review

Description

Hemlibra® (emicizumab-kxwh) is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII.

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Background

Hemophilia is characterized as genetic mutations leading to deficiency in the factors necessary for coagulation. The most common types of hemophilia are hemophilia A, due to factor VIII deficiency, and hemophilia B, due to factor IX deficiency. The genes causing hemophilia are located on the X chromosome; therefore, most hemophiliacs are male while females are most commonly carriers. The liver produces both factor VIII and IX.

Summary of Evidence

Hemlibra® (emicizumab-kxwh) has been studied in two Phase 3 studies and a Phase 1 study with a trial extension.1-3 The trials were small and of moderate to fair quality overall. Emicizumab has been granted breakthrough therapy designation by the FDA in adults and adolescents with hemophilia A and inhibitors. An FDA decision is expected by February 18, 2018.

The Phase 1 study was a 12-week, multicenter, open-label, dose escalation trial conducted in Japan. Patients with severe hemophilia A, with or without inhibitors, and ages 12-59 were eligible for inclusion. Patients were enrolled into three cohorts with varying doses of emicizumab. No primary endpoint was specified. The study was limited by very small size (n=18), nonrandomized design, and a difference in baseline ABR between cohorts (baseline ABR 15.9- 37.9). Additionally, statistical comparisons were not performed. At Week 12, the median ABR decreased by 15.2-28.1 events from baseline across the cohorts. A total of 73% of patients with inhibitors and 72% of patients without inhibitors did not have a bleeding event during the trial. A trial extension with 27 months of follow-up in 16 patients found the range of change in median ABR from baseline was 15.2-31.1 events; eight patients did not experience any bleeding during the trial extension.3

The HAVEN 1 trial was a 24-week, multicenter, multinational, open-label, randomized, Phase 3 trial in 109 patients >12 years of age with hemophilia A and high FVIII inhibitor titers treated with BPAs.2 Patients receiving episodic BPAs prior to study enrollment were randomized to emicizumab prophylaxis or no prophylaxis (Groups A and B). Patients receiving prophylactic BPAs prior to enrollment were enrolled in Group C and received emicizumab prophylaxis. Group D received prophylactic emicizumab and consisted of all patients who did not enroll in the study before the closure of Groups A-C. Six or more bleeding events were required in the past 24 weeks for patients on episodic BPAs prior to enrollment while >2 events were required for patients on prophylactic BPAs. This difference may have led to selection bias. Controversy exists over the primary outcome measure for the HAVEN 1 trial. This was defined as the ABR for Groups A and B in clinicaltrials.gov while it was described as the rate of treated bleeding events

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in the same groups in the published NEJM article. At 24 weeks, the annualized rate of treated bleeding events significantly decreased with prophylactic emicizumab compared to no prophylaxis (episodic BPA treatment) (2.9 vs 23.3 events, 87% decrease, p<0.001 per NEJM, p<0.0001 per manufacturer and NEJM supplement). The ABR for all bleeding events significantly decreased with prophylactic emicizumab vs episodic BPA (5.5 vs 28.3 events, 80% decrease, p<0.0001). Overall, 62.9% of patients in Group A, 5.6% in Group B, and 69.4% in Group C had no bleeding events throughout the trial. Secondary endpoints including treated spontaneous bleeding events (1.3 vs 16.8 events, p<0.0001) and treated joint bleeds (0.8 vs 6.7, p=0.0005) significantly favored emicizumab prophylaxis over episodic BPA.3 Of patients in Group C who participated a previous nonintervention study (n=24), interindividual comparisons found bleeding events with prophylactic emicizumab were significantly less than BPA prophylaxis (3.3 vs 15.7 events, 79% decrease, p<0.001).2 Direct clinical trial evidence comparing emicizumab with prophylactic BPAs is lacking. Additionally, all quality of life (QoL) assessments in the trial overall significantly favored emicizumab prophylaxis compared to no prophylaxis.

Ongoing and Unpublished Clinical Trials

The HAVEN 2 trial is an ongoing, multicenter, open-label, single-arm, Phase 3 trial which enrolled children <12 years old (or 12-17 years old and <40 kg; <2 yo allowed following protocol-specified interim data review if criteria met) with hemophilia A and high FVIII inhibitor titers for a planned >52 week trial.3At the time of interim analysis, 20 enrolled patients had received treatment for >12 weeks. All patients were treated with emicizumab 3 mg/kg SQ for 4 weeks, then 1.5 mg/kg/week. A primary endpoint was not specified. At the time of interim analysis, the mean ABR was 0.4 for treated bleeds, 3.7 for all bleeds, 0.4 for treated spontaneous bleeds, and zero for joint bleeds. No comparison with baseline ABR was provided. A total of 94.7% of patients experienced zero treated bleeds and 63.2% had no bleeding events of any type at the time of interim analysis.

Additional ongoing trials include HAVEN 3 (R, OL, MC, Phase 3, 24-week trial in 145 patients with hemophilia A without inhibitors assessing ABR), HAVEN 4 (OL, MC, Phase 3 expansion trial in 46 patients), and the STASEY trial (2-year, OL, MC, Phase 3b trial in 200 patients with hemophilia A assessing AEs).3

Ref. Type Study Intervention Comparator Outcome Effect Population Size HAVEN 2 MC, OL, Hemophilia A, <12 Emicizumab SQ - Treated ABR 0.4 at >12 (interim) single- yo with high FVIII 3mg/kg/wk x4 wks, weeks arm, interim

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Ref. Type Study Intervention Comparator Outcome Effect Population Size phase 3 inhibitor titers then 1.5 mg/kg/wk analysis

* Abbreviations: ABR = annualized bleeding rate, BPA = bypass agent, FVIII = factor VIII, MC = multicenter, OL = open label, R = randomized, SQ = subcutaneous

Safety

The majority of adverse events (AEs) were described as mild to moderate. Common AEs were injection-site reactions (15%), headache (12%), nasopharyngitis or upper respiratory infection (URI) (9%-17%), fatigue (6%), and arthralgia (6%). Serious AEs occurred in 0%-8.7% of patients. Discontinuations due to AEs occurred in three patients across all clinical trials. Anti-emicizumab antibodies were detected five patients in Phase 1 trials and were suspected but not identified in two patients in the HAVEN 1 trial.

Thromboembolic (TE) events are of concern with emicizumab. The HAVEN 1 trial identified three events of thrombotic microangiopathy (TMA) and two TE events (cavernous sinus thrombosis and skin necrosis/superficial thrombophlebitis), all occurring following activated prothrombin complex concentrates (aPCC) administration (>100 U/kg/d) for >1 day. No events occurred with emicizumab alone, recombinant FVIIA (rFVIIa) alone, or aPCC x1 day. No anticoagulation was required for the TE events. The TMA events resolved in two patients and were considered to be resolving in the third at the time of death from rectal hemorrhage following treatment with aPCC for 4 days. Treatment was restarted in one TE and one TMA patient. Overall, the HAVEN 1 authors considered there to be a potential for substantial risk with the combination of aPCC and emicizumab. This is supported by in vitro and animal evidence showing increased thrombin formation with emicizumab plus aPCC and to a lesser degree with rFVIIa.

Practice Guidelines and Position Statements

The World Federation of Hemophilia (WFH) published hemophilia guidelines in 2013. The guidelines recommend use of viral-inactivated plasma-derived or recombinant concentrates rather than cryoprecipitate or fresh frozen plasma. The guidelines do not express a preference for plasma-derived or recombinant products. The WFH does recommend careful consideration of the purity of a product as well as viral inactivation/elimination.

The guidelines recommend screening for inhibitor development typically every 6-12 months along with quantification of the titer if present. Immune tolerance induction, frequent prolonged

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exposure to clotting factor with the goal of inducing tolerance, is recommended in patients with inhibitors, although the optimal treatment regimen is undefined. The WFH considers two doses of rFVIIa equivalent to one dose of aPCC for joint bleeding; however, some patients may respond better to one product over the other.

Medicare National Coverage

There is no national coverage determination.

2019 Update

A literature search from January 1, 2018, through February 28, 2019, did not identify any new evidence that would change the criteria in this policy.

2020 Update

Reviewed Hemlibra® prescribing information and conducted a literature search from March 1, 2019, through February 28, 2020. No new evidence was identified that would change the criteria in this policy.

References

1. Shima M, Hanabusa H, Taki M, et al. Factor VIII-mimetic function of humanized bispecific antibody in hemophilia A. New Engl J Med. 2016;374:2044-2053.

2. Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. New Engl J Med. 2017;377(9):809-818.

3. Data on File, Genentech, Inc. October, 2017.

4. Roche media release. Available at: https://www.roche.com/media/store/releases/med-cor-2017-08-24.htm Accessed March 2020.

5. Uchida N, Sambe T, Yoneyama K, et al. A first-in-human phase 1 study of ACE910, a novel factor VIII-mimetic bispecific antibody, in healthy subjects. Blood. 2016;127(13):1633-1641.

6. Adamkewicz J, Muto A, Soeda T, Suzuki S, Kitazawa T. In vitro thrombin generation testing and in vivo venous stasis model for assessing the pro-coagulant effects of FVIII, emicizumab, rFVIIa, and aPCC. Haemophilia. 2017; 23(Suppl S2):OR37 (abstract).

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7. ICER. Institute for Clinical and Economic Review posts draft scoping document to guide review of emicizumab for hemophilia A. Available at: https://icer-review.org/announcements/draft-scope-hemophilia Accessed March 2020.

8. Farrugia A, Cassar J, Kimber MC, et al. Treatment for life for severe haemophilia A – a cost-utility model for prophylaxis vs on- demand treatment. Hemophilia. 2013;19(4):e228-e238.

9. Mehta DA, Oladapo AO, Epstein JD, Novack AR, Neufeld EJ, Hay JW. A budget impact model of hemophilia bypassing agent prophylaxis relative to recombinant factor VIIA on-demand. J Manag Care Spec Pharm. 2016;22(2):149-157.

10. GoodRx. Coagulation factors. Available at: https://www.goodrx.com/coagulation-factors Accessed March 2020.

11. Clinicaltrials.gov. HAVEN 1 (NCT02622321). Available at: https://clinicaltrials.gov/ct2/show/NCT02622321 Accessed March 2020.

12. Bauer KA. Current challenges in the management of hemophilia. Am J Manag Care. 2015;21:S112-S122.

13. Kempton CL, Meeks SL. Toward optimal therapy for inhibitors in hemophilia. Blood. 2014;124(23):3365-3372.

14. FEIBA (anti-inhibitor coagulant complex) prescribing information. Baxalta US, Inc.; Westlake Village, CA. April 2017.

15. NovoSeven® RT (coagulation factor VIIa, recombinant) prescribing information. Novo Nordisk Inc.; Plainsboro, NJ. October 2017.

History

Date Comments 02/01/18 New policy, approved January 16, 2018. Add to Prescription Drug section. Considered medically necessary for pediatric and adults with hemophilia A (congenital factor VIII deficiency) when criteria are met.

04/01/18 Interim Review, approved March 20, 2018. Clarified criteria language for Hemlibra, addition of definition of high dose aPCC and added history of anti-FVIII titer. Also added benefit application information.

11/01/18 Interim Review, approved October 9, 2018. Updated per expanded indication approved by FDA 10/3/18 for hemophilia A with or without Anti-Factor VIII.

11/17/18 Coding update, added HCPCS code Q9995 to policy (effective 7/1/18), removed HCPCS code J3490.

01/01/19 Coding update, added new HCPCS code J7170 (new code effective 1/1/19), replacing Q9995.

04/01/19 Annual Review, approved March 19, 2019. Literature search from 1/1/18, No changes.

01/01/20 Coding update, removed HCPCS code Q9995 as it was terminated 1/1/19.

04/01/20 Annual Review, approved March 19, 2020. Reviewed prescribing information and conducted literature search from March 1, 2019, to February 28, 2020. No changes to coverage criteria.

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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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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).