Pharmacologic Treatment of Idiopathic Pulmonary Fibrosis

Transcription

1 PHARMACY POLICY Pharmacologic Treatment of Idiopathic Pulmonary Fibrosis Effective Date: Feb. 1, 2018 Last Revised: Jan. 30, 2018 Replaces: N/A RELATED MEDICAL POLICIES: Treatment of Pulmonary Hypertension Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Idiopathic means unknown cause. Idiopathic pulmonary fibrosis (IPF) is a lung (pulmonary) condition in which the lungs become scarred (fibrosis). Usually only one person in a family develops IPF. In a very small number of cases, IPF can develop in family members. When this happens, it s called familial pulmonary fibrosis. Because of the scar tissue, the lungs are not able to move oxygen into the bloodstream very well. The usual symptoms are a shortness of breath and a dry cough. It s a progressive condition, meaning it gets worse over time. IPF usually affects people between 50 and 70 years old. There is no cure for IPF but certain drugs can slow the progression to help maintain breathing capacity. This policy describes when medications for IPF 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

2 Drug Ofev (nintedanib)or Esbriet (pirfenidone) Medical Necessity Ofev (nintedanib) or Esbriet (Pirfenidone) may be considered medically necessary for the treatment of idiopathic pulmonary fibrosis (IPF)* when ALL the following conditions are met: IPF was diagnosed within the last five years, in accordance with the 2000 ATS/ERS criteria (see table below) AND Forced vital capacity (FVC) 50% of the predicted value AND DLCO between 30-79% of the predicted value AND HRCT performed within the last 12 months *Note: Patients must have a confirmed diagnosis of IPF. ATS/ERS/JRS/ALAT Criteria for the Diagnosis of Idiopathic Pulmonary Fibrosis 1. IPF is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of UIP (Usual Interstitial Pneumonia) 2. The diagnosis of IPF requires: a. Exclusion of other known causes of interstitial lung disease (ILD) (eg, domestic and occupational environmental exposures, connective tissue disease, and drug toxicity) b. The presence of a UIP pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy (Biopsy may not be feasible in certain patients due to their risk for the procedure) c. Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy 3. The accuracy of the diagnosis of IPF increases with multidisciplinary discussion between pulmonologists, radiologists, and pathologists experienced in the diagnosis of ILD (Published in Am J Respir Crit Care Med 201l;183: Available without membership or subscription at Accessed January 2018.) Page 2 of 10

3 Drugs Ofev (nintedanib) and Esbriet (pirfenidone) Investigational Combination therapy with Ofev (nintedanib) plus Esbriet (pirfenidone) is considered investigational. Use of these agents for any indication other than the above is considered investigational. Approval Initial authorization Re-authorization criteria Criteria Ofev (nintedanib) and Esbriet (pirfenidone) can be approved for 1 year. Future re-authorization would depend on clinical benefit/response shown at the time of re-authorization where: Chart notes documenting decrease in FVC not greater than 10% from previous year 22 Coding N/A Related Information Benefit Application This policy is managed by the Pharmacy benefit. Evidence Review Page 3 of 10

4 Comparison of Treatment Recommendations in the 2015 and 2011 ATS/ERS/JRS/ALAT Idiopathic Pulmonary Fibrosis Guidelines Treatment 2015 Guideline 2011 Guideline New and Revised Recommendations Multi-target tyrosine kinase inhibitor Conditional recommendation for Not addressed [nintedanib (OFEV) ] use* Antifibrotic agent [pirfenidone (ESBRIET)] Anticoagulation [warfarin (COUMADIN)] Combination corticosteroid (prednisone) + azathioprine + N- acetylcysteine Selective endothelin receptor antagonist [ambrisentan (LETAIRIS)] Single-target tyrosine kinase inhibitor [Imatinib (GLEEVEC)] Dual endothelin receptor antagonists [macitentan (OPSUMIT), bosentan (TRACLEER)] Phosphodiesterase-5 inhibitor [sildenafil (REVATIO)] Conditional recommendation for use* Strong recommendation against use* Strong recommendation against use Strong recommendation against use Strong recommendation against use* use use* use use use Not addressed Not addressed Strong recommendation against use* Not addressed Unchanged Recommendations Anti-acid therapy Conditional recommendation for use Conditional recommendation for use N-acetylcysteine monotherapy use use Antipulmonary hypertension therapy Recommendation deferred use Single vs. bilateral lung transplantation Recommendation deferred Not addressed * Moderate confidence in effect estimates Low confidence in effect estimates Very low confidence in effect estimates Page 4 of 10

5 Ofev (nintedanib) Ofev (nintedanib) is a tyrosine kinase receptor inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis (IPF). A recent Phase III replicate trial (INPULSIS-1 and INPULSIS-2) demonstrated the efficacy of nintedanib verses placebo in patients with idiopathic pulmonary fibrosis. The trial was conducted for 52 weeks and enrolled 1066 patients who were diagnosed with IPF within the previous five years. Criteria for eligibility included having a forced vital capacity (FVC) greater than 50% of the predicted value, a diffusion capacity of the lung for carbon monoxide (DLCO) between 30 79% of the predicted value, and a chest high resolution computed tomography (HRCT) within the last twelve months. The primary outcome for both trials was the annual rate of decline in FVC (milliliters/year). Secondary outcomes were the time to the first acute exacerbation and change from baseline score on the St. George s Respiratory Questionnaire (SGRQ) - a subjective measuring tool for quality of life. Patients receiving nintedanib 150mg BID as monotherapy achieved a significant decrease in annual FVC decline when compared to placebo at a reduction of 125.5ml/year (95% CI, , p< 0.001) in INPULSIS- 1 and 93.7ml/year (95% CI, , p< 0.001) in INPULSIS- 2. While IMPULSIS- 1 did not show significant reduction in the time until first exacerbation, IMPULSIS -2 did demonstrate some significant decrease with a hazard ratio of 0.38 (95%Ci, , p= 0.005). When comparing changes in SGRQ scores from baseline, there were decreases in both trials indicating an improvement in quality of life (QOL). However, once again only IMPULSIS- 2 demonstrated significance at (95% CI, to -0.43; p= 0.02). The TOMORROW Phase II trial was similar in design and primary outcomes. As opposed to the phase III trials that did demonstrate efficacy, the phase II trial did not show significance in regards to decreased annual FVC decline when compared to placebo. However, it was noted that with nintedanib 150mg twice daily, there was a trend towards a general reduction in annual FVC decline at 68.4% (p= 0.06). This prompted the current therapeutic dose recommended today of 150mg BID with a lower dose of 100mg showing some efficacy with less potential for adverse events. Secondary outcomes of this trial were incidences of acute exacerbations per 100 patient-years and difference in the mean SGRQ score from baseline. The number of acute exacerbations was significantly lower in the nintedanib group compared to placebo with a relative risk of 0.16 (95% CI, ; p= 0.02). Similar to phase III trials, there was a significant decrease in the SGRQ score from baseline of 0.66 (p= 0.007). The most common adverse events noted in the registrational clinical trials were gastrointestinal (GI) in nature. In the phase II trials, patients receiving nintedanib 150mg BID experienced at least one episode of diarrhea (55%), nausea (23%), and vomiting (13%) during the duration of the study and these events were responsible for most of the discontinuations in the treatment Page 5 of 10

6 group. Patients participating in IMPULSIS- 1 and -2 had similar adverse events, with diarrhea (61.5% and 63%) and nausea (23% and 26%) being the most prominent, and discontinuations of 4.5% and 4.3% in each trial, respectively. Nintedanib has also been associated with elevated liver enzymes in both phase II and III trials. Some patients experienced clinically significant increase (three times the upper limit of normal) in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Because nintedanib is metabolized partially by the liver, its use should be monitored for mild liver impairment and avoided in those with moderate to severe impairment. Liver enzymes should be monitored at baseline, prior to initiating nintedanib therapy and monitored periodically afterwards. Dose reduction and/or discontinuation of nintedanib resulted in a normalization of liver enzymes with no chronic liver impairment. Nintedanib has not been studied in patients with severe renal and moderate to severe hepatic impairment (Child Pugh score B or C). Currently there are no guidelines for the treatment of patients with severe renal impairment, but mild to moderate renal insufficiencies do not require any dose adjustments as less than 1% of the starting dose is excreted by the kidneys. Nintedanib should not be recommended for patients with moderate to severe hepatic impairment. Esbriet (pirfenidone) Esbriet (pirfenidone) is a novel antifibrotic agent that has been recently approved for the treatment of idiopathic pulmonary fibrosis (IPF) after being previously removed from the market a few years ago due to the lack of efficacy data. Since its removal, three more phase III trials were conducted: CAPACITY 004 & 006 and ASCEND. These were double blinded, randomized, placebo controlled, international and multi-center trials. Treatment consisted of pirfenidone 2403mg/daily compared to placebo. In the CAPACITY 004 trial, a lower 1197mg/day dose was used to examine any dose response relationship. Pirfenidone has shown mixed results in its efficacy, which is defined as a decrease in disease progression. The usual measurement is the change in forced vital capacity (FVC) over time. In the three studies, treatment duration either lasted between 52 and 72 weeks. Enrolled patients had either a clinical or radiographic diagnosis of IPF with other causes ruled out. Baseline characteristics were generally balanced amongst all groups. The population age was between years old with the mean age of 67 years. A majority of the patients were white males with some form of smoking history. The mean baseline FVC was 72% across all treatment groups. Both CAPACITY 004 and ASCEND showed significant results in regards to percent predicted FVC after the trial period from baseline. CAPACITY 004 had an absolute mean FVC difference of 4.4% Page 6 of 10

7 between pirfenidone 2403mg daily versus placebo after 72 weeks. ASCEND demonstrated an absolute mean FVC difference of 4.8% between pirfenidone 2403mg daily and placebo after 72 weeks. The impact of the 0.4% difference between the two trials is not known. CAPACITY 006 was the only trial out of the three that did not met its primary endpoint. There was no association between differences in predicted FVC and certain secondary outcomes. These include but are not limited to the University of California at San Diego Shortness of Breath Questionnaire (SOBQ) for dyspnea, World Health Organization Quality of Life score, and mortality. Secondary outcomes in all three trials were noted to be exploratory and not make a claim for efficacy in the prescribing information. The most common adverse effects noticed in all three trials were nausea (36%) and rash (30%). The mean exposure time to pirfenidone across all three trials was 62 weeks with the maximum duration being 118 weeks. Longer term safety risks have yet to be established. At the daily recommended dose of 2403mg, there were slightly higher discontinuations in treatment due to adverse effects than compared with placebo (15% vs. 10%). 1, 2 In three of the Phase III trials, there were higher incidences of photosensitivity reactions usually within the first 6 months of initiating treatment. Elevated liver enzymes have also been associated with pirfenidone. Across the three phase III trials, there were higher incidences of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations (3 times the upper limit of normal [ULN]) in pirfenidone treatment versus placebo (3.7% vs. 0.8%). These effects were reversible with dose reduction or discontinuation of the treatment. No further complications or liver failure were noted. In a trial comparing the pharmacokinetics of pirfenidone in patients with normal renal function to either mild, moderate, or severe renal impairment, there was an increase in overall systemic exposure of 1.4, 1.5, and 1.2 fold, respectively. Pirfenidone should be used with caution in patients that have mild, moderate, or severe renal impairment, and adverse effects should be monitored closely with therapeutic adjustments, if needed. Phase III data has shown that while the side effect profile of pirfenidone can vary to be gastrointestinal (GI) or dermatologic in nature, the symptoms can be treated with supportive therapy or avoidance of prolonged sun exposure and other concomitant photosensitive drugs. Page 7 of 10

8 2015 Update A primary literature search from 1/1/14 to 10/31/15 did not identify any new evidence requiring changes to this policy. This policy was reviewed by the Pharmacy and Therapeutics Committee November 19, Update Addition of new and revised recommendations, as well as annual policy maintenance. This policy was reviewed by the Pharmacy and Therapeutics Committee February 25, Update Recent data do not indicate a need for change to the above medical necessity criteria Update Primary literature search from 1/1/16 to 1/20/18 was conducted. Added initial approval duration and re-authorization criteria taken from a recent review article found. No other references were found that would impact this policy. References 1. Noble P, Albera C, Bradford W, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011; 377: King TE, Bradford W, Castro-Bernardini S, et al. A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The New England Journal of Medicine. 2014; 370 (22): Esbriet (pirfenidone) prescribing information. InterMune, Inc.; Brisbane, CA. October Archibald C, Guidotti T. Degree of objectively measured impairment and perceived shortness of breath with activities of daily living in patients with chronic obstructive pulmonary disease. Can J Rehab. 1987; 1: The University of California, San Diego Shortness of Breath Questionnaire (SOBQ). American Thoracic Society. Web. Accessed January Page 8 of 10

9 6. Selman M, King TE, Pardo A et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and implications for therapy. Annals of Internal Medicine. 2001; 134 (2): King TE, Schwartz M, Brown K, et al. Idiopathic pulmonary fibrosis: relationship between histopathologic features and mortality. American Journal of Respiratory and Critical Care Medicine. 2001; 164(6): Ley B, Collard H. Epidemiology of idiopathic pulmonary fibrosis. Clinical Epidemiology. 2013; 5: Yu T, Wu N, Chuang C, et al. Burden of hospital admissions and exacerbations among patients newly diagnosed with idiopathic pulmonary fibrosis. American Thoracic Society International Conference; May 16-21, 2014; San Diego, CA. 10. Collard H, Ward A, Lanes S, et al. Burden of illness in idiopathic pulmonary fibrosis. J Med Econ. 2012; 15(5): Raghu G, Collard H, Egan J, et al. An Official ATs/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. American Journal of Respiratory and Critical Care Medicine. 2011; 183: Cerri S, Spagnolo P, Luppi F, et al. Management of idiopathic pulmonary fibrosis. Clin Chest Med. 2012; 33(1): Dimitroulis I. Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Respir Care doi: /respcare Shi S, Wu J, Chen H, et al. Single- and Multiple- Dose Pharmacokinetics of Pirfenidone, an Antifibrotic Agent, in Healthy Chinese Volunteers. J Clin Pharmacol. 2007; 47: Richeldi L, du Bois R, Raghu G, et al. Efficacy and safety of Nintedanib in Idiopathic Pulmonary Fibrosis. The New England Journal of Medicine. 2014; 370 (22): Richeldi L, Costabel U, Selman M, et al. Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis. The New England Journal of Medicine. 2011; 365 (12): OFEV (nintedanib) prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT. October Paul W. Jones, Frances H. Quirk, Chloë M. Baveystock, and Peter Littlejohns "A Self-complete Measure of Health Status for Chronic Airflow Limitation: The St. George's Respiratory Questionnaire", American Review of Respiratory Disease, Vol. 145, No. 6 (1992), pp St. George s Respiratory Questionnaire. American Thoracic Society. Web. Accessed January Dimitroulis I. Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Respir Care doi: /respcare Wells AU, Kokosi M, Karagiannis K. Treatment Strategies for Interstitial Pneumonias. Curr Opin Pulm Med 2014;20(5): Shaw J, Marshall T, Morris H, et al. Idiopathic Pulmonary Fibrosis: A Holistic Approach to Disease Management in the Antifibrotic Age. Journal of Thoracic Disease. 2018; 9(11): History Date Comments 12/08/14 New policy, add to the Prescription Drug section. Considered medically necessary when criteria are met. 12/08/15 Annual Review. Policy updated with literature review; no change in policy statements. Page 9 of 10

10 Date Comments 04/01/16 Annual Review, approved March 8, Policy updated with new and revised recommendations. 07/07/17 Policy moved into new format, no changes to policy statement. 09/01/17 Annual Review, approved August 22, A literature search was conducted from 4/2/16 to 8/18/17. No new studies were found that would require changes to this policy. 02/01/18 Annual Review, approved January 30, Primary literature search from 1/1/16 to 1/20/18. Added initial approval duration and re-authorization criteria per new referenced found. 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) 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 10 of 10

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12 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 LifeWise Health Plan of Washington 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 (TTY: ) までお電話ください 한국어 (Korean): 본통지서에는중요한정보가들어있습니다. 즉이통지서는귀하의신청에관하여그리고 LifeWise Health Plan of Washington 를통한커버리지에관한정보를포함하고있을수있습니다. 본통지서에는핵심이되는날짜들이있을수있습니다. 귀하는귀하의건강커버리지를계속유지하거나비용을절감하기위해서일정한마감일까지조치를취해야할필요가있을수있습니다. 귀하는이러한정보와도움을귀하의언어로비용부담없이얻을수있는권리가있습니다 (TTY: ) 로전화하십시오. ລາວ (Lao): ແຈ ງການນ ມ ຂ ມ ນສ າຄ ນ. ແຈ ງການນ ອາດຈະມ ຂ ມ ນສ າຄ ນກ ຽວກ ບຄ າຮ ອງສະ ໝ ກ ຫ ຄວາມຄ ມຄອງປະກ ນໄພຂອງທ ານຜ ານ LifeWise Health Plan of Washington. ອາດຈະມ ວ ນທ ສ າຄ ນໃນແຈ ງການນ. ທ ານອາດຈະຈ າເປ ນຕ ອງດ າ ເນ ນການຕາມກ ານ ດເວລາສະເພາະເພ ອຮ ກສາຄວາມຄ ມຄອງປະກ ນສ ຂະພາບ ຫ ຄວາມຊ ວຍເຫ ອເລ ອງຄ າໃຊ ຈ າຍຂອງທ ານໄວ. ທ ານມ ສ ດໄດ ຮ ບຂ ມ ນນ ແລະ ຄວາມ ຊ ວຍເຫ ອເປ ນພາສາຂອງທ ານໂດຍບ ເສຍຄ າ. ໃຫ ໂທຫາ (TTY: ). ភ ស ខមរ (Khmer): សចកត ជ នដ ណ ង ន ម នព ត ម នយ ងស ខ ន សចកត ជ នដ ណ ង ន រប ហល ជ ម នព ត ម នយ ងស ខ ន អ ព ទរមង បបបទ ឬក ររ ប រងរបស អនកត មរយ LifeWise Health Plan of Washington រប ហលជ ម ន ក លបរ ចឆទស ខ ន ន កន ង សចកត ជ នដ ណ ង ន អនករប ហលជ រត វក រប ញច ញសមតថភ ព ដល ក ណត ថងជ ក ចប ស ន ន ដ មប ន ងរកស ទ កក រធ ន រ ប រងស ខភ ពរបស អនក ឬរប ក ជ ន យ ចញ ថល អនកម នស ទធ ទទ លព ត ម ន ន ន ងជ ន យ ន កន ងភ ស របស អនក ដ យម នអសល យ ឡ យ ស មទ រស ពទ (TTY: ) ਪ ਜ ਬ (Punjabi): ਇਸ ਨ ਟਸ ਵਚ ਖ ਸ ਜ ਣਕ ਰ ਹ. ਇਸ ਨ ਟਸ ਵਚ LifeWise Health Plan of Washington ਵਲ ਤ ਹ ਡ ਕਵਰ ਜ ਅਤ ਅਰਜ ਬ ਰ ਮਹ ਤਵਪ ਰਨ ਜ ਣਕ ਰ ਹ ਸਕਦ ਹ. ਇਸ ਨ ਜਸ ਜਵਚ ਖ ਸ ਤ ਰ ਖ ਹ ਸਕਦ ਆ ਹਨ. ਜ ਕਰ ਤ ਸ ਜਸਹਤ ਕਵਰ ਜ ਰ ਖਣ ਹ ਵ ਜ ਓਸ ਦ ਲ ਗਤ ਜ ਵ ਚ ਮਦਦ ਦ ਇਛ ਕ ਹ ਤ ਤ ਹ ਨ ਅ ਤਮ ਤ ਰ ਖ਼ ਤ ਪ ਹਲ ਕ ਝ ਖ ਸ ਕਦਮ ਚ ਕਣ ਦ ਲ ੜ ਹ ਸਕਦ ਹ,ਤ ਹ ਨ ਮ ਫ਼ਤ ਵ ਚ ਤ ਆਪਣ ਭ ਸ਼ ਵ ਚ ਜ ਣਕ ਰ ਅਤ ਮਦਦ ਪ ਰ ਪਤ ਕਰਨ ਦ ਅ ਧਕ ਰ ਹ,ਕ ਲ (TTY: ). 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Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do LifeWise Health Plan of Washington. 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 esta informação e ajuda em seu idioma e sem custos. Ligue para (TTY: ). Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin LifeWise Health Plan of Washington. 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 (TTY: ). Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Washington. 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 (TTY: ). 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, LifeWise Health Plan of Washington, 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 (TTY: ). Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al (TTY: ). 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 LifeWise Health Plan of Washington. 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 (TTY: ). ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน LifeWise Health Plan of Washington และอาจม ก าหนดการในประกาศ น ค ณอาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณ หร อการช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. 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 (TTY: ). 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 LifeWise Health Plan of Washington. 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 (TTY: ).