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PHARMACY / MEDICAL POLICY – 5.01.565 Pharmacotherapy of Multiple Sclerosis Effective Date: May. 1, 2017 RELATED MEDICAL POLICIES: Last Revised: Apr. 11, 2017 5.01.556 Replaces: Extracted from 11.01.523 Site of Service: Infusion Drugs and Biologic Agents Rituximab: Non-oncologic and Miscellaneous Uses 5.01.550 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 Multiple sclerosis is a disease that occurs when the body’s immune system reacts to and damages nerve cells. Damage occurs to nerves and their connections in the brain and spinal cord. Multiple sclerosis is also called MS. People with MS can have a variety of symptoms including vision problems, numbness and tingling, muscle weakness and other problems. Some people have only a few symptoms, and others may be severely disabled form the disease. There are several types of MS as well. This policy discusses the drugs used to treat MS and which of those drugs need to be pre-approved by the health plan. 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 providers about when a service may be covered. Policy Coverage Criteria Note: Quantity limits for individual agents can be found in the Dosage and Quantity Limits section below. Drug Investigational Rituximab (Rituxan®) The use of rituximab in the setting of multiple sclerosis is considered investigational. Relapsing Multiple Sclerosis (RMS) Drug Medical Necessity Anti-CD52 Alemtuzumab may be considered medically necessary for Alemtuzumab (Lemtrada®) the treatment of relapsing sclerosis when: The patient has had an inadequate response to two or more disease modifying drugs indicated for the treatment of multiple sclerosis (any two of the following: Binterferon(s), Glatiramer, Copaxone, teriflunomide, dimethyl fumerate, fingolimod, or natalizumab). Β-Interferons Interferon-β 1a or interferon-β 1b may be considered Interferon-β 1a (Avonex®, medically necessary as a first-line treat of relapsing forms Rebif®, Plegridy®) of multiple sclerosis, when BOTH of the following Interferon-β 1b (Betaseron®, Extavia®) conditions are met: The patient must have an Expended Disability Status Score (EDSS) of less than 6. AND β-interferons are not to be used concurrently with other MS disease modifying drugs. Copolymers Glatiramer 20 mg may be considered medically necessary Glatiramer 20 mg (generic) as a first-line agent for the treatment of relapsing forms Copaxone® 40 mg (not of multiple sclerosis when BOTH of the following available in generic) conditions are met: The patient must have an Expended Disability Status Score (EDSS) of less than 6. AND Glatiramer is not to be used concurrently with other MS disease modifying drugs. Copaxone® 40 mg (available as brand only) may be considered medically necessary as a first-line agent for the treatment of relapsing forms of multiple sclerosis when ALL of the following criteria are met: The patient must have an Expended Disability Status Score Page | 2 of 12 ∞ Relapsing Multiple Sclerosis (RMS) Drug Medical Necessity (EDSS) of less than 6. AND Copaxone® is not to be used concurrently with other MS disease modifying drugs. AND There has been documented inadequate response to or intolerance of generic glatiramer. Dihydroorotate Dehydrogenase Teriflunomide may be considered medically necessary as a Inhibitor first-line agent in the treatment of relapsing forms of Teriflunomide (Aubagio®) multiple sclerosis when BOTH of the following conditions are met: The patient must have an Expended Disability Status Score (EDSS) of less than 6. AND Teriflunomide is not to be used concurrently with other Multiple Sclerosis disease modifying drugs. Nrf2 Pathway Activator Dimethyl fumarate may be considered medically necessary Dimethyl Fumarate as a first-line agent in the treatment of relapsing forms of (Tecfidera®) multiple sclerosis when BOTH of the following conditions are met: The patient must have an Expended Disability Status Score (EDSS) of less than 6. AND Dimethyl fumarate is not to be used concurrently with other Multiple Sclerosis disease modifying drugs. Sphingosine 1-Phosphate Fingolimod may be considered medically necessary as a Receptor Modulator first-line agent in the treatment of relapsing forms of Fingolimod (Gilenya®) multiple sclerosis when BOTH of the following conditions are met: The patient must have an Expended Disability Status Score (EDSS) of less than 6. AND Fingolimod is not to be used concurrently with other Multiple Sclerosis disease modifying drugs. α4 Integrin Inhibitors Natalizumab may be considered medically necessary as a Natalizumab (Tysabri®) Page | 3 of 12 ∞ Relapsing Multiple Sclerosis (RMS) Drug Medical Necessity first-line agent in the treatment of relapsing forms of Note: Due to safety concerns, access multiple sclerosis when BOTH of the following conditions to Tysabri® requires enrollment are met: in the TOUCH registry maintained by the (EDSS) of less than 6. manufacturer. (See https://www.touchprogram.c om/TTP/) AND Natalizumab is not to be used concurrently with other Multiple Sclerosis disease modifying drugs. IL-2 receptor Inhibitor The patient must have an Expended Disability Status Score Daclizumab may be considered medically necessary as a second-line agent in the treatment of relapsing forms of Daclizumab (Zinbryta®) multiple sclerosis when: Patient has had an inadequate response to two or more first-line drugs indicated for the treatment of multiple sclerosis (any two of the following: B-interferon(s), Glatiramer, Copaxone, teriflunomide, dimethyl fumerate, fingolimod, or natalizumab). CD20-directed cytolytic Ocrelizumab may be considered medically necessary as a antibody second-line agent in the treatment of relapsing forms of Ocrelizumab (Ocrevus®) multiple sclerosis when: Patient has had an inadequate response to two or more first-line drugs indicated for the treatment of multiple sclerosis (any two of the following: B-interferon(s), Glatiramer, Copaxone, teriflunomide, dimethyl fumerate, fingolimod, or natalizumab). Primary Progressive Multiple Sclerosis (PPMS) Drug Medical Necessity CD20-directed cytolytic Ocrelizumab may be considered medically necessary as a antibody first-line agent in the treatment of primary progressive multiple sclerosis. Ocrelizumab (Ocrevus®) Dosage and Quantity Limits Drug Dosage and Quantity Limit alemtuzumab The first course is 12 mg / day on 5 consecutive days. (Lemtrada ®) The second course is 12 mg / day on 3 consecutive days 12 Page | 4 of 12 ∞ Dosage and Quantity Limits Drug Dosage and Quantity Limit months after the first treatment course. interferon-ẞ 1a (Avonex®) Dosing is 30 mcg once a week. This can be titrated starting with 7.5mcg for the first week, then increase by 7.5mcg each week for the next 3 weeks until recommended dose of 30mcg. interferon-ẞ 1a (Rebif®) Dosing is 22 mcg or 44 mcg three times per week. This can be titrated. interferon-ẞ 1a (Plegridy®) Dosing is 125 mcg every 14 days (titrate starting with 63 mcg on day 1; 94 mcg on day 15; and, 125 mcg (full dose) on day 29. interferon-ẞ 1b (Betaseron®) Dosing is 0.25 mg every other day (start at 0.065 mg (0.25mL) every other day, and increase over a six-week period to 0.25mg (1mL) every other day). interferon-ẞ 1b (Extavia®) Dosing 0.25 mg every other day (start at 0.065mg (0.25mL) every other day, and increase over a six-week period to 0.25mg (1mL) every other day). glatiramer (Glatopa®) Dosing is 20mg / mL per day (only available in this strength). Dosing is 20 mg / mL per day (if using 20 mg dose). Dosing is 40 mg / mL three times per week (if using 40mg 20mg (generic Copaxone) Copaxone® dose, not available in generic). teriflunomide (Aubagio®) Dosing is 7mg or 14mg once daily. dimethyl fumarate Initial dosing is 120mg twice a day for 7 days. (Tecfidera®) Maintenance dosing after 7 days is 240 mg twice a day. Quantity Limit o Quantity is limited to 14 of the 120 mg capsules, to achieve a dosage of one 120mg capsule twice daily for the first week. o Doses of 120 mg 2 or 3 times daily may be approved up to 90 days on a case by case basis for patients having difficulty tolerating the full dose. o After the first week of therapy, 240mg capsules should be dispensed except as noted above, with quantity limited to 60 capsules per 30 day supply, to achieve a dosage of 240 mg twice daily. o Doses in excess of 480 mg per day are considered not Page | 5 of 12 ∞ Dosage and Quantity Limits Drug Dosage and Quantity Limit medically necessary. fingolimod (Gilenya®) Dosing is 0.5mg once daily. Quantity Limit o Quantity is limited to achieve a dosage of 0.5 mg. per day. natalizumab (Tysabri®) Dosing is 300mg every 4 weeks daclizumab (Zinbryta®) Dosing is 150mg Sub-Q once monthly ocrelizumab (Ocrevus®) Start dose: 300mg intravenous infusion, followed two weeks later by a second 300mg intravenous infusion Subsequent doses: 600mg intravenous infusion every 6 months Coding HCPCS J0202 Injection, alemtuzumab, 1 mg J1595 Injection, glatiramer acetate, 20 mg J1826 Injection, interferon beta-1a, 30 mcg J1830 Injection interferon beta-1b, 0.25 mg J2323 Injection, natalizumab (Tysabri®), 1mg J3490 Unclassified drugs J3590 Unclassified biologics Q3027 Injection, interferon beta-1a (Avonex®), 1 mcg for intramuscular use Related Information N/A Evidence Review Page | 6 of 12 ∞ It is currently thought that multiple sclerosis (MS) is the result of a combination of factors including immune response, genetics, infection, and environmental issues. MS is characterized by the destruction of the myelin sheath that surrounds axons of the central nervous system (CNS) and eventual axonal damage. This is believed to be an autoimmune attack against myelin and the myelin-producing oligodendrocytes. There is an associated inflammatory response involving B-cells, T-cells, macrophages, antibodies, and complement. The myelin sheath is replaced by sclerotic plaques. The damage to the myelin sheath can delay or halt nerve impulses. Axonal damage leads to loss of nerve impulses. An estimated 250,000 to 400,000 cases exist in the United States. In 2000, the estimated prevalence was 191/100,000 Caucasians in the United States, with an incidence rate of 7.3/100,000 person-years at risk. Diagnosis usually occurs when patients are between 20 and 50 years of age. The disease is more prevalent: 1) further away from the equator; 2) in Caucasians; and 3) in women. Other risk factors include Epstein-Barr virus exposure, vitamin D deficiency, and smoking. MS usually follows one of the following four disease courses, but individual presentation can vary quite widely. 1. Relapsing-remitting MS (RRMS): clearly defined acute attacks followed by periods of partial or full recovery. This is the most common course of the disease describing approximately 85% of MS patients. 2. Primary-progressive MS (PPMS): the disease steadily progresses although there may be occasional plateaus or remissions. The patient does not experience acute attacks. Approximately 10% of MS patients have PPMS. 3. Secondary-progressive MS (SPMS): often follows RRMS. Patient experiences acute attacks similar to RRMS, but with progressively less recovery after acute attacks and progressively worsening function between attacks. As with PPMS, there may be occasional plateaus or remissions. Progressive-relapsing MS (PRMS): initially presents as PPMS with steady disease progression, but later experiences acute attacks with followed by partial recovery. This is only seen in approximately 5% of MS patients. New Oral Agents for Multiple Sclerosis Page | 7 of 12 ∞ Fingolimod is an oral modulator of sphingosine-1-phosphate receptor. After absorption, fingolimod is phosphorylated and fingolimod phosphate acts as agonist on the sphingosine-1phosphate-1 receptors of the lymphocyte and thymocytes. This interaction results in the internalization of the receptor and thus without signaling the lymphocytes become sequestered within the lymph nodes. It is hypothesized that the resulting decrease in circulating lymphocytes then leads to fewer lymphocytes entering the CNS. Additionally, it is also hypothesized that when fingolimod crosses the BBB the resulting binding down modulates the S1P in neural cells and thus there is a reduction in the astrogliosis that can lead to neurodegeneration. Fingolimod has not been shown to inhibit the effector functions of T and B cells, humoral immunity, or virusspecific cytotoxic T cells. The efficacy of fingolimod was demonstrated by two Phase III randomized placebo-controlled trials. Fingolimod was found to be significantly better than placebo at the strength of 0.5 mg at reducing the annualized relapse rate, MRI assessment measures, and disease progression measurements. The primary endpoint was reduction in annualized relapse rate over 24 months was 0.18 (0.15-0.22) for 0.5 mg fingolimod and 0.40 (0.34-0.47) for placebo with a p-value <0.001. This represents a 54% relative reduction in relapses as compared to placebo. Disease progression confirmed after 6 months had a probability of 12.5% for 0.5 mg fingolimod versus 19% for placebo. Fingolimod was compared to IM interferon beta-1a in one clinical trial. Fingolimod proved superior in the primary endpoint of annualized relapse rate. The ARR for fingolimod 0.5 mg was 0.16 (0.12-0.21) versus 0.31 (0.22-0.41) for interferon beta-1a with a p-value <0.001. Additionally, fingolimod was superior in the secondary endpoint of T1 lesion amount. For fingolimod 0.5 mg the mean volume was 22.61±111.59 versus 50.68±198.16 for interferon beta-1a with a p-value of <0.001. However, fingolimod did not prove superior at prevention of disease progression as compared to interferon beta-1a. Overall, fingolimod has a reasonable safety profile. There is a potential for bradycardia or AV block after administration of the first dose that may require monitoring. Additional concerns are potential increased susceptibility to infections, macular edema, and lymphopenia. The only deaths that occurred during the clinical trial were in the 1.25mg fingolimod arm and suffered a herpes zoster and herpes simplex encephalopathy infections respectively. Dimethyl fumarate, (Tecfidera) is a newly approved oral agent that is indicated for the treatment of relapsing forms of MS (RMS). The exact mechanism whereby it exerts its therapeutic effects is unknown. However, dimethyl fumarate and its metabolite, monomethyl fumarate (MMF), activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in cellular response to oxidative stress and implicated in regulation of myelin maintenance in the Page | 8 of 12 ∞ central nervous system. In vitro, MMF has also been identified as a nicotinic acid receptor agonist. Well designed and adequate evidence consistently supports the efficacy of dimethyl fumarate at approved dosing for reduction of relapse and improving neuroradiologic outcomes over 2 years in patients with relapsing-remitting MS. Whether the agent is “disease modifying” or delays disease progression is unclear because of the conflicting results for 12-week confirmed disability progression from the two registrational Phase III trials. After two years therapy in the placebo-controlled Phase III trials, the most common adverse events were mostly mild to moderate flushing and GI events (nausea, vomiting, and abdominal pain). Incidence of these events was highest in the first month of use and then generally decreased thereafter. Discontinuation due to AEs was similar to that for placebo. Excepting for relapse of MS, SAEs were reported very infrequently. Mean lymphocyte counts decreased approximately 30% during the first year of treatment with dimethyl fumarate then levels plateaued. However, incidence of infections and serious infections were similar between patients receiving the drug and those receiving placebo. Elevations in aminotransferase levels were also observed. In the Phase IIb study, transaminase elevations were considered dose related. Other Agents Daclizumab is a humanized monoclonal antibody that binds to the alpha subunit of the interleukin-2 receptor (IL-2Rα, CD25). The precise mechanism by which daclizumab exerts therapeutic effects in multiple sclerosis is unknown but is presumed to involve modulation of IL2 mediated activation of lymphocytes through binding to CD25, a subunit of the high-affinity IL2 receptor. The efficacy of ZINBRYTA was demonstrated in two randomized, double-blind, controlled studies (Study 1 and Study 2). Both studies evaluated 150 mg of subcutaneous ZINBRYTA taken once every four weeks in patients with relapsing multiple sclerosis (RMS). Study 1: ActiveControlled Trial in RMS Study 1 compared ZINBRYTA to 30 mcg weekly intramuscular doses of AVONEX in 1841 patients. The study included RMS patients who had either: 1) at least 2 relapses during the prior 3 years and at least one relapse in the year prior to randomization; or 2) one or more clinical relapses and one or more new T1 gadolinium (Gd)-enhancing or T2 hyperintense MRI lesions within the prior 2 years with at least one of these events in the prior 12 months. Patients with progressive forms of multiple sclerosis or an Expanded Disability Status Scale (EDSS) score greater than 5 were excluded. Treatment continued for up to 144 weeks until the last enrolled patient completed 96 weeks of treatment. Clinical assessments were to occur every Page | 9 of 12 ∞ 12 weeks and after relapse events. MRI scans were performed at Week 24 and Week 96. The primary outcome measure of Study 1 was the annualized relapse rate (ARR). Additional outcome measures included the proportion of patients relapsed, the proportion of patients who experienced confirmed disability progression, and the number of new or newly enlarging T2 hyperintense lesions. Confirmed disability progression was defined as at least a 1 point increase from baseline EDSS (1.5 point increase for patients with baseline EDSS of 0) sustained for 12 weeks. In Study 1, randomization assigned 919 patients to ZINBRYTA and 922 patients to AVONEX; 71% of ZINBRYTA- and 70% of AVONEX-treated patients completed at least 96 weeks of treatment with the assigned drug. At baseline, the mean age of patients was 36 years, the mean disease duration since diagnosis was 4.2 years, the mean EDSS score was 2.5, and the mean number of relapses in the prior year was 1.6. At baseline, 68% of patients were female, 46% of patients had MRI scans with T1 Gd-enhancing lesions and 41% of patients had previously taken one or more non-steroid treatments for MS. ZINBRYTA had a statistically significant effect on the annualized relapse rate and on the number of new or newly enlarging T2 hyperintense lesions. There was no statistically significant effect on 12-week confirmed disability progression. Ocrelizumab (Ocrevus) is second-generation humanized (murine) anti-CD20 monoclonal antibody that targets CD20+ B-lymphocytes; hence, it is an immunosuppressant. Rituximab (Rituxan) is another similar chimeric (murine/human) anti-CD20 monoclonal antibody that is used off-label for the treatment of MS. In vitro studies suggest ocrelizumab has greater antibody-dependent cell-mediated cytotoxicity and less complement-dependent cytotoxicity compared to rituximab. Whether this is of clinical relevance remains to be established. Development of rituximab for MS was discontinued by the manufacturer given its imminent patent expiration and development of ocrelizumab ensued. References 1. Kappos L, Radue EW, O’Connor P, et al, for the FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010a;362(5):1-15. 2. Cohen JA, Barkhof F, Comi G, et al, for the TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010a;362(5)402-415. 3. Comi G, O’Connor, Montalban X, et al. Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results. Mult Scler. 2010;16(2)197-207. 4. Kappos L, Antel J, Comi G, et al. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006;355:11241140. Page | 10 of 12 ∞ 5. O’Connor P, Comi G, Montalban X, et al. Oral fingolimod (FTY720) in multiple sclerosis: two-year results of a phase II extension study. Neurology. 2009;72:73-79. 6. Gilenya™ Prescribing Information. Novartis Pharmaceuticals, East Hanover, NJ. July 2011. 7. Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367(12):1087-1097. 8. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367(12):1098-1107. 9. Kappos L, Gold R, Miller DH, et al. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicenter randomized, double-blind, placebo-controlled phase IIb study. Lancet 2008;372:1463-1472. 10. Tefcidera™ (dimethyl fumarate) prescribing information. Biogen Idec Inc; Cambridge, MA. March 2013. 11. Miller AE, Rhoades RW. Treatment of relapsing-remitting multiple sclerosis: current approaches and unmet needs. Curr Opin Neurology 2012;25 Suppl:S4-10. 12. Zinbryta® (daclizumab) prescribing information. Biogen, Inc/AbbVie, Inc; Cambridge, MA/North Chicago, IL. May 2016. Accessed October, 2016. Available at: https://www.zinbryta.com/content/dam/commercial/multiplesclerosis/zinbryta/pat/en_us/pdfs/zinbryta-prescribing-information.pdf Accessed April 2017. 13. National Institute for Health and Clinical Excellence (NICE). Teriflunomide for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance 303. January 2014. Available at https://www.nice.org.uk/guidance/ta303 Accessed April 2017. 14. Lycke J. Monoclonal antibody therapies for the treatment of relapsing-remitting multiple sclerosis: differentiating mechanisms and clinical outcomes. Ther Adv Neurol Disord. 2015;8(6):274-93. History Date Comments 07/01/16 New policy, add to Prescription Drug section, approved June 14, 2016. This information was extracted from policy 5.01.550 and addresses medically necessary first and second line treatment options for multiple sclerosis. 11/01/16 Interim review, changes approved October 11, 2016. Inclusion of a new agent daclizumab (Zinbryta®), its criteria, and background. Also, included administration route for each of the agents listed in the “dosing” section. 01/01/17 Interim review, changes approved December 13, 2016. Types of the first-line drugs to be tried before Zinbryta can be approved have been added for clarity. 01/27/17 Coding update. HCPCS code J0202 added to policy; it was inadvertendly left off when the policy was extracted from 5.01.550 on 06/14/16. 05/01/17 Annual review, changes approved April 11, 2017. Criteria for newly approved agent ocrelizumab have been added. Page | 11 of 12 ∞ 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). ©2017 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 | 12 of 12 ∞ Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. Premera: • Provides free aids and services to people with disabilities to communicate effectively with us, such as: • Qualified sign language interpreters • Written information in other formats (large print, audio, accessible electronic formats, other formats) • Provides free language services to people whose primary language is not English, such as: • Qualified interpreters • Information written in other languages If you need these services, contact the Civil Rights Coordinator. 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Call 800-722-1471 (TTY: 800-842-5357). 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። ( العربيةArabic): قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو.يحوي ھذا اإلشعار معلومات ھامة قد تكون ھناك تواريخ مھمة.Premera Blue Cross التغطية التي تريد الحصول عليھا من خالل وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة.في ھذا اإلشعار اتصل. يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة.في دفع التكاليف 800-722-1471 (TTY: 800-842-5357)بـ 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) 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 (Italian): 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). 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。 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). 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. 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). ລາວ (Lao): ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357). ភាសាែខម រ (Khmer): េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់ នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។ អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។ ਪੰ ਜਾਬੀ (Punjabi): ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357). ( فارسیFarsi): اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم. اين اعالميه حاوی اطالعات مھم ميباشد به تاريخ ھای مھم در. باشدPremera Blue Cross تقاضا و يا پوشش بيمه ای شما از طريق شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه. اين اعالميه توجه نماييد شما حق. به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد،ھای درمانی تان برای کسب.اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد ( تماس800-842-5357 تماس باشمارهTTY )کاربران800-722-1471 اطالعات با شماره .برقرار نماييد 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 esta informação e ajuda em seu idioma e sem custos. Ligue para 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 (Spanish): 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 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 800-722-1471 (TTY: 800-842-5357). 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): ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่ มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร 800-722-1471 (TTY: 800-842-5357) 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).