Download 5.01.565 Pharmacotherapy of Multiple Sclerosis

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
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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
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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®)
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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
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∞
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
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∞
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
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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
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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
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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.
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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). ©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
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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).