Download 5.01.569 Pharmacotherapy of Type I and Type II Diabetes Mellitus

PHARMACY POLICY – 5.01.569
Pharmacotherapy of Type I and Type II Diabetes Mellitus
Effective Date: April 1, 2017
RELATED MEDICAL POLICIES:
Last Revised:
March 14, 2017
5.01.541
Replaces:
N/A
Medical Necessity Exception Criteria for Closed Formulary Benefits and
Dispense as Written (DAW) Exception Reviews
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
Metabolism refers to how the body converts the energy supplied by food into energy the body
can use. Diabetes is a disease of the metabolic system. Diabetes involves production of and
response to insulin. Insulin is a hormone produced by certain cells in the pancreas called beta
cells. These cells regulate the amount of glucose (sugar) in the blood. There are two types of
diabetes: type I and type II. In type I diabetes, the pancreas no longer makes insulin. The beta
cells of the pancreas have been destroyed. The body needs an external supply of insulin in order
to use glucose. Type I diabetes is usually diagnosed in children and young adults. In type II
diabetes, people can still make insulin, but their bodies don’t respond well to it. This is known as
insulin resistance. Type II diabetes can be diagnosed at any age and can be affected and
modified by a number of factors, such diet and exercise and other health conditions. It can also
be a side-effect of certain drugs. Type II diabetes can be treated with oral or injectable
noninsulin agents, as well as insulin injections.
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
Documentation in the form of clinical chart notes is required for a review of all nonpreferred agents.
Note: The following insulin products are NOT affected by this policy:

Levemir® (detemir)

Lantus® (glargine)

Tresiba® (degludec)

Ryzodeg® (degludec and aspart combination)

Humulin® R U-500 and Humulin R U-500 KwikPen
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∞
Toujeo® (glargine) U-300

For details on Toujeo (glargine U-300) for Closed Formulary Benefits, see Related
o
Policies.
Select the link below to view coverage criteria for non-preferred
products:
Insulin Products (Vials and Prefilled Pens)
Injectable Noninsulin Products
Oral Products
Note:
Documentation in the form of clinical chart notes is required for
a review of all below-mentioned agents.
Insulin Products (Vials and Prefilled Pens)
Coverage Criteria: Nonpreferred insulin products used for the treatment of type I and type II
diabetes mellitus may be considered medically necessary when patient has a contraindication
or intolerance to the preferred agent OR this insulin product was ineffective in reducing A1C to
goal after three months of therapy. For preferred and non-preferred products, see table below.
Preferred Insulin
Non-preferred Insulin
Rapid–Acting Insulin

aspart (Novolog®)

lispro (Humalog®)

glulisine (Apidra®)
Regular-Acting/Short-acting Insulin

Novolin R

Humulin® R
Intermediate-Acting NPH Insulin
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∞
Preferred Insulin

Non-preferred Insulin
Novolin N

Humulin® N
Mix of Intermediate-Acting NPH and Regular (Short-Acting) Insulin

Novolin Mix 70/30

Humulin® Mix 70/30
Mix of Intermediate Insulin Lispro Protamine + Rapid-acting Insulin Lispro
and
Mix of Intermediate-acting Insulin Aspart Protamine + Rapid-acting Insulin Aspart

Novolog® Mix 70/30

Humalog® Mix 75/25

Humalog® Mix 50/50
Insulin and Injectable Noninsulin Combination Products
Preferred Injectable
Non-preferred Injectable
Insulin and Glucagon-like Peptide-1 (GLP-1) Receptor Agonists

Insulin degludec+liraglutide

None at this time
(Xultophy®)*

Insulin glargine+lixisenatide (Soliqua®)*
*Note:
Currently, Xultophy is placed on a preferred formulary
(drug list) tier, while Soliqua is placed on a nonpreferred tier.
Coverage Criteria: For the above drugs to be
considered medically necessary, the patient
needs to have a diagnosis of type II diabetes,
and have an adequate trial of:

Metformin**
**If metformin is contraindicated, patient must try at least
one generic antidiabetic drug such as, glyburide, glipizide,
acarbose, or glimepiride, etc. If those agents are also
contraindicated or not tolerated, patient must try
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∞
Preferred Injectable
Non-preferred Injectable
appropriate insulin therapy.
If those agents are also contraindicated or not tolerated,
the patient must try the appropriate insulin therapy.
Injectable Noninsulin Products
Preferred Injectable
Non-preferred Injectable
Glucagon-like Peptide-1 (GLP-1) Receptor Agonists

exenatide (Bydureon® and Byetta®)

albiglutide (Tanzeum®)

liraglutide (Victoza®)

dulaglutide (Trulicity®)

lixisenatide (Adlyxin®)
Coverage Criteria: For the above drugs to be
considered medically necessary, patient needs
Coverage Criteria: For the above drugs to be
to have a diagnosis of type II diabetes, and have
considered medically necessary, the patient
an adequate trial of:
needs to have a diagnosis of type II diabetes,

and have an adequate trial of:
Metformin*

*If metformin is contraindicated, patient must try at least 1
generic antidiabetic drug such as, glyburide, glipizide,
Metformin*
AND

liraglutide (Victoza®)
acarbose, or glimepiride, etc. If those agents are also
AND
contraindicated or not tolerated, patient must try

appropriate insulin therapy.
*If metformin is contraindicated, patient must try at least

If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.
exenatide (Bydureon® or Byetta®)
one generic antidiabetic drug such as, glyburide, glipizide,
acarbose, or glimepiride, etc. If those agents are also
contraindicated or not tolerated, patient must try
appropriate insulin therapy.

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If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.
∞
Oral Products
Preferred Oral Drug
Non-preferred Oral Drug
Dipeptidyl Peptidase IV Inhibitors (DPP-4)

sitagliptin (Januvia®)

alogliptin (Nesina)

saxagliptin (Onglyza®)

alogliptin

alogliptin/pioglitazone (Oseni)

alogliptin/pioglitazone

linagliptin (Tradjenta®)
Coverage Criteria: For the above drugs to be
considered medically necessary, patient needs
to have an adequate trial of:

Coverage Criteria: For the above drugs to be
Metformin*
considered medically necessary, patient needs
to have an adequate trial of:
*If metformin is contraindicated, patient must try at least
one generic antidiabetic drug such as, glyburide, glipizide,
acarbose, or glimepiride, etc. If those agents are also
contraindicated or not tolerated, patient must try
appropriate insulin therapy.

If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.

Metformin*
AND

Onglyza® OR Kombiglyze®
AND

Januvia® OR Janumet®
*If metformin is contraindicated, patient must try at least
one generic antidiabetic drug such as, glyburide, glipizide,
acarbose, or glimepiride, etc. If those agents are also
contraindicated or not tolerated, patient must try
appropriate insulin therapy.

If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.
Biguanide and DPP-4 Combination

sitagliptin + metformin (Janumet®)

logliptin + metformin (Kazano)

sitagliptin +metformin extended release

linagliptin + metformin (Jentadueto)
(Janumet® XR)

linaglitpin + metformin extended release

saxagliptin +metformin (Kombiglyze®)

saxagliptin + metformin extended
(Jentadueto XR)

alogliptin/metformin
release (Kombiglyze® XR)
Coverage Criteria: For the above drugs to be
Coverage Criteria: No Prior Authorization
considered medically necessary, patient needs
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∞
Preferred Oral Drug
Non-preferred Oral Drug
Required.
to have an adequate trial of:

Onglyza® OR Kombiglyze®
AND

Januvia® OR Janumet®
Sodium-Glucose Cotransporter 2 Inhibitors (SGLT-2)

canagliflozin (Invokana®)

empagliflozin (Jardiance®)

dapagliflozin (Farxiga®)
N/A
Coverage Criteria: For the above drugs to be
considered medically necessary, patient needs
to have an adequate trial of:

Metformin*
*If metformin is contraindicated, patient must try at least one
generic antidiabetic drug such as, glyburide, glipizide, acarbose, or
glimepiride, etc. If those agents are also contraindicated or not
tolerated, patient must try appropriate insulin therapy.

If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.
Dipeptidyl Peptidase IV Inhibitor (DPP-4) and Sodium-Glucose Cotransporter 2
Inhibitor
N/A

empagliflozin and linagliptin
(Glyxambi®)
Coverage Criteria: For the above drugs to be
considered medically necessary, patient needs
to have an adequate trial of:

Metformin*
AND

Onglyza® OR Kombiglyze®
AND
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∞
Preferred Oral Drug
Non-preferred Oral Drug

Januvia® OR Janumet®
*If metformin is contraindicated, patient must try at least one
generic antidiabetic drug such as, glyburide, glipizide, acarbose, or
glimepiride, etc. If those agents are also contraindicated or not
tolerated, patient must try appropriate insulin therapy.

If those agents are also contraindicated or not
tolerated, the patient must try the appropriate
insulin therapy.
Coding
N/A – This benefit is managed through Pharmacy.
Related Information
None
Evidence Review
Insulin Agents
Types and Characteristics of Commonly Used Insulin Products
Insulin
Brand
Onset of
Peak Effect
Duration of
Name
Action
Lispro
Humalog
< 15 minutes
30 to 90 minutes
3 to 5 hours
Aspart
Novolog
< 15 minutes
30 to 90 minutes
3 to 5 hours
Action
Rapid-acting Insulin
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∞
Insulin
Glulisine
Brand
Onset of
Peak Effect
Duration of
Name
Action
Apidra
< 15 minutes
30 to 90 minutes
3 to 5 hours
Humulin R
0.5 to 1 hour
2 to 4 hours
4 to 8 hours
Novolin R
0.5 to 1 hour
2 to 4 hours
4 to 8 hours
Action
Short-acting Insulin
Regular
Intermediate-acting Insulin
NPH
Humulin N
1 to 2 hours
NovolinN
1 to 2 hours
4 to 10 hours
10 to 18 hours
Glargine
Lantus
1 to 2 hours
No peak
20 to 24 hours
Detemir
Levemir
1 to 2 hours
3 to 9 hours
6 to 24 hours *
0.5 to 1 hour
2 to 10 hours
10 to 18 hours
<15 minutes
1 to 2 hours
10 to 19 hours
Long-acting Insulins
Combination Insulins
Mix of intermediate insulin
lispro protamine and
rapid-acting insulin lispro
and
Humulin 70/30
and
Novolin 70/30
Mix of intermediate-acting
insulin aspart protamine
and rapid-acting insulin
aspart
Humalog 75/25
and
Novolog 70/30
*Duration of action for detemir is dose-dependent.
Insulin Interchangeability
As shown in the table above, two brands of insulin products have similar pharmacokinetic
profiles. Currently, there is no scientific literature or evidence to suggest that one insulin brand is
superior over the other. Switching between insulin brands should be done in consultation with a
physician and requires medical supervision (close monitoring of blood glucose) during the initial
phase.
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∞
Injectable Noninsulin Agents
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists
GLP-1 agonists are indicated as an adjunct to diet and exercise for glycemic control in adults
with T2DM. All are available as SQ injections with exenatide (Byetta) administered twice daily,
liraglutide (Victoza) once daily and all others administered once weekly. GLP-1 agonists act to
enhance glucose-dependent insulin secretion, suppress glucagon secretion, and slow gastric
emptying. GLP-1 agonists also decrease body weight and systolic blood pressure. GLP- 1
agonists are currently recommended as dual or triple therapy with metformin by the ADA.
Most significantly, a large, well-designed head-to-head trial with liraglutide and exenatide ER
found liraglutide significantly more effective in decreasing HbA1c. Additional data indicates
exenatide twice daily (Byetta) and albiglutide (Tanzeum) are associated with less reduction in
HbA1c than other GLP-1 agonists. Efficacy and safety data is now available to 5 years with
exenatide ER. Common AE include nausea, vomiting, and diarrhea as well as injection site
reactions with exenatide ER and albiglutide. The class carries a black box warning for use in
patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia
syndrome type 2.While cardiovascular outcomes studies are on-going, available data with shortterm trials does not indicate increased risk. Cost-effectiveness analyses have found GLP-1
agonists cost effective in comparison to other brand agents for T2DM and liraglutide cost
effective in comparison to exenatide ER. Cost effectiveness comparisons with generic agents are
not available.
A newer agent in this class is called lixisenatide is a GLP-1 receptor agonist that has been shown
to have significant effect on reducing HbA1c%, 2-h PPG, and modest weight loss benefit from 9
DB placebo-controlled RCTs and 5 meta-analysis. From the perspective of safety, it is considered
generally well tolerated. The most common side effect is GI disorders (N/V/D) and the
occurrence is more frequent than insulin and OADs. Of note, it has significantly less
hypoglycemia than insulin. Based on the results from four phase 3 or phase 4 active-controlled
RCTs, compared to other GLP-1 receptor agonists in the same drug class, lixisenatide does not
appear to be relatively more efficacious or safer. Currently, there is no cost-effectiveness analysis
conducted in a US setting.
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∞
Insulin and Injectable Noninsulin Combination Products
Insulin and Glucagon-Like Peptide-1 Receptor Agonists
Insulin degludeg and liraglutide (Xultophy®)
Insulin degludec/liraglutide (Xultophy®) combines two complementary mechanisms of
action into a once daily self-injection. Six trials have been published, all of which have shown
equal or improved efficacy to active comparators in patients above HbA1c goal. IDegLira has
received a narrow indication for patients inadequately controlled on liraglutide (less than 1.8
mg daily) or basal insulin (less than 50 units daily). This patient population can better reach
goal using the combination product without negatively affecting adherence rates. The
combination product offers benefits in terms of efficacy, safety and cost compared to
alternative strategies such as basal-bolus dosing, using the separate products in multiple
doses, and uptitrating a basal insulin. While the trials largely excluded those with a BMI
above 40 kg/m2, the consistent positive results in disparate treatment groups suggests strong
Phase III evidence for insulin degludec/liraglutide.
Insulin glargine and lixisenatide (Soliqua®)
Insulin glargine and lixisenatide (Soliqua®) like Xultophy® combines two complementary
mechanisms of action into a once daily self-injection. iGlarLixi was studied in two clinical trials: 1.
LixiLan-L: in patients uncontrolled on basal insulin, with or without previous exposure to
metformin, with insulin glargine alone as comparator; and 2. LixiLan-O: in patients uncontrolled
on 2 or more oral anti-diabetic drugs, with insulin glargine alone, and lixisenatide alone as
comparators. In study 1, Soliqua showed superiority to insulin glargine alone in terms of
hemoglobin A1C reduction, with no increase in hypoglycemia or weight. Fasting plasma glucose
(FPG) reduction with Soliqua was comparable to that of insulin glragine alone. Post prandial
glucose (PPG) reduction with Soliqua was greater than that of insulin glargine alone. In study 2,
Soliqua showed superiority to insulin glargine alone and lixisenatide alone with regard to
hemoglobin A1C reduction with no increases in hypoglycemia (as compared to glargine). FPG
reduction with Soliqua was comparable to that of insulin alone and great than that of
lixisenatide alone. Reduction in 2-h PPG with Soliqua was greater than that of insulin glargine
alone and lixisenatide alone. Study also showed that Soliqua resulted in significantly greater
weight loss compared with insulin glargine alone, but demonstrated less weight loss compared
with lixisenatide alone. For full description of the clinical trials, please refer to the package insert.
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∞
Oral Agents
Dipeptidyl Peptidase IV Inhibitors (DPP-4 inhibitors)
Comparisons with DPP-4 inhibitors and placebo have found the class decreases
HbA1capproximately -0.56% to -0.8%. Trials assessing these agents as add-on therapy have
found similar HbA1c decreases. No difference in efficacy has been found between DPP-4
inhibitors and other add-on therapy for diabetes including sulfonylureas and TZDs; however,
DPP-4 inhibitors are less effective than metformin. Head-to head-trials with saxagliptin and
sitagliptin have found no difference between agents; however, no comparative data is available
to date with newer agents (linagliptin and alogliptin). Long-term trial data is available for all
agents. The ADA guidelines recommend the class as an option along with sulfonylureas, TZDs,
SGLT2 inhibitors, GLP-1 receptor agonists, or basal insulin for add-on therapy with metformin.
The agents are generally well tolerated with little hypoglycemia unless given with insulin or
sulfonylureas. The DPP-4 inhibitors appear weight neutral. Reports of pancreatitis have led to an
FDA warning; however, trial data does not consistently support this and further study is needed.
Several recent randomized controlled trials have indicated that DPP-4 inhibitors did not increase
the risk of adverse cardiovascular outcomes. However, the SAVOR-TIMI 53 study found an
increase rate of heart failure hospitalization. Further study is ongoing.
Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors
SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) are oral agents indicated to
improve glycemic control in adults with T2DM as an adjunct to diet and exercise. SGLT2
inhibitors decrease glucose reabsorption in the proximal nephron and increase urinary glucose
excretion. The mechanism of action of SGLT2 inhibitors is not dependent on insulin.
Large, well-designed, long-term trials and meta-analyses have shown SGLT2 inhibitors decrease
HbA1c in comparison to placebo (-0.7 to -1.1%). SGLT2 inhibitors have been extensively studied
in dual and triple therapy regimens, typically as add-on agents to metformin, SUs, DPP4s, and
TZDs. Since the last review, new data has become available supporting the use of dapagliflozin
in triple therapy regimens. Additionally, longer duration trials to 104 weeks have been published
indicating continued effectiveness. Trials comparing SGLT2 inhibitors to other classes of agents
have found no difference in effectiveness in comparison with metformin. However, available
data conflicts about the efficacy of SGLT2 inhibitors in comparison to other classes (SU, TZDs,
and DPP4s) with some data indicating superiority and others non-inferiority. In addition, trials
with SGLT2 inhibitors are associated with decreased body weight and BP. Adverse events with
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∞
SGLT2 inhibitors include genital mycotic infections, UTIs, and, less commonly, volume depletion
and renal-related effects. The FDA has recently issued two safety warnings for the class,
concerning an increased risk of DKA across the class as well as increased incidence of upper
extremity, low- trauma fractures with canagliflozin. Further research is needed to fully define
these effects as well as the CV effects of the class. Cost effectiveness studies in the US setting
comparing SGLT2 inhibitors to other classes of agents for T2DM are not available and drug costs
remain high.
EMPA-REG: CV Outcomes Trial Summary
The goal of the trial was to examine the long-term effects of empagliflozin versus placebo, in
addition to standard of care (such as, lifestyle, risk reduction with antihypertensive treatment,
statins, aspirin, and metformin), on cardiovascular (CV) morbidity and mortality in patients with
T2DM and high risk of CV events. This was a randomized (1:1:1 to empagliflozin 10mg, 25mg,
and placebo), double-blind, placebo-controlled, international CV outcomes trial. Total number
of participants was 7,028. This was an industry-sponsored trial.
Key findings included:

The primary outcome, CV death, nonfatal MI, or stroke for empagliflozin vs. placebo: 10.5%
vs. 12.1%, hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.74 to 0.99, p<0.001 for noninferiority; p=0.04 for superiority.

o
For CV death: 3.7% vs. 5.9%, p<0.001
o
All MI: 4.8% vs. 5.4%, p=0.23
o
All stroke: 3.5% vs. 3.0, p=0.26
Reduced risk of composite cardiovascular events (NNT=63/3 years) and all cause death
(NNT=38/3years). The 10mg daily dose provided almost the same benefit as the 25mg dose.
Benefit realized despite A1C not reaching target (A1C=7.8%). Mean change was about
≤0.6%.

Increased risk of genital infections in both males (NNH=29/3 years) and females (NNH=14/3
years). Urosepsis, although rare, was also increased with empagliflozin (~0.4% vs. 0.1%).
Serious Adverse Events (SAE) were less with empagliflozin than placebo (NNT=24). A

Empagliflozin also lowered systolic blood pressure (SBP) by 3 to 4 mm Hg, and diastolic
blood pressure (DBP) by 1 to 2 mm Hg.
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∞

Weight was also noted to decrease by about 1 to 2 kg, which was more than in the placebo
group.

Average A1C achieved in the empagliflozin group was 7.8%.
For details on secondary outcomes (all-cause mortality, congestive heart failure (CHF)
hospitalization, CV death, all cause hospitalization, coronary revascularization, A1C at 12 weeks
for 10mg dose, A1C at 12 weeks for 25mg dose, confirmed hypoglycemic event, and urinary
tract infection rates), and for renal outcomes (incident or worsening nephropathy, doubling of
serum creatinine, progression to macroalbuminuria, and initiation of renal replacement therapy),
please refer to the American College of Cardiology article, Empagliflozin Cardiovascular
Outcome Event Trial in Type 2 Diabetes Mellitus Patients- EMPA-REG Outcome. Available at:
https://www.acc.org/latest-in-cardiology/clinical-trials/2015/09/17/10/11/empa-regoutcome.
The results of this trial demonstrate that empagliflozin is superior to placebo in improving
glycemic control, and reducing CV events in patients with type 2 diabetes and established
cardiovascular disease. The fact that CV safety is thought to be established in this trial is an
important factor in light of the prior serious safety concerns involving rosiglitazone. However,
the mechanism for this benefit is still unknown (and may be due to non-glucose related
mechanism).
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular
Outcomes Results (LEADER) Trial
The goal of this trial was to examine the long-term effects of liraglutide on cardiovascular
outcomes and other clinically important events. This was a multicenter, double-blind,
randomized (1:1), placebo-controlled trial at 410 sites in 32 countries, and included a total of
9,340 participants. Trial follow-up was about 3.8 years (+/- 3 months). Selected patients had
established cardiovascular disease, chronic kidney disease of stage 3 or greater, or both (in
addition to having diabetes). This trial was supported by Novo Nordisk and by grants from the
National Institutes of Health.
Key findings for the primary outcomes included:

The primary composite outcome (the first occurrence of death from CV causes, nonfatal MI,
or nonfatal stroke) occurred fewer in patients in the liraglutide group, 608 of 4668 (13.0%)
than in the placebo group, 694 of 4672 (14.9%); HR 0.87 with 95% CI; 0.78 to 0.97, p<0.001
for non-inferiority; p=0.01 for superiority.
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∞

Death from CV causes occurred in fewer patients in liraglutide group, 219 patients (4.7%)
than in the placebo group, 278 (6.0%); HR 0.78; with 95% CI, 0.66 to 0.93; p=0.007.

Rate of death from any cause was lower in liraglutide group, 981 patients (8.2%) than in the
placebo group, 447 (9.6%); HR 0.85; 95 CI, 0.74 to 0.97; p=0.02.

Nonfatal MIs were fewer in the liraglutide group than in the placebo group, but not
significant

Nonfatal stroke events were fewer in the liraglutide group than in the placebo group, but
not significant

Glycemic control analysis showed a mean difference in A1C between the liraglutide group
and placebo of -0.40 percentage points (95% CI, -0.45 to -0.34)

Weight loss was 2.3 kg (95%CI, 2.5 to 2.0) higher in the liraglutide group

Systolic blood pressure was 1.2 mm Hg (95% CI, 1.9 to 0.5) lower in the liraglutide group,
however, the diastolic blood pressure was 0.6 mm Hg (95% CI, 0.2 to 1.0) higher in liraglutide
group (and so was the heart rate at 3.0 beats per minute 95%CI, 2.5 to 3.4)
For details on the secondary outcomes (transient ischemic attack, coronary revascularization,
hospitalization for unstable angina pectoris, hospitalization for heart failure, microvascular
events, such as retinopathy and nephropathy, and safety and adverse events information, please
refer to The New England Journal of Medicine article available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa1603827.
The results of this trial suggest that liraglutide has lower rates of CV events and death form any
cause when compared to placebo, however, this study has a few limitations, such as relatively
short period of follow-up, and the fact that participants in the study already had high risk for CV
events, and had a mean baseline A1C of 8.7%, which makes it challenging to apply these
findings to patients with milder forms of the disease. It is important to recognize that the
findings of CV benefits in this trial are different from the ones described in EMPA-REG trial,
particularly the time to benefit was seen earlier in EMPA-REG than in the current study.
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Practice Guidelines and Position Statements
American Association of Clinical Endocrinologists and American College
of Endocrinologists (AACE/ACE) Comprehensive Diabetes Management
Algorithm (2016)
Goals for Glycemic Control of Type 1 and Type 2 Diabetes Mellitus
A1C
Goals are tailored to each person’s individual needs on the basis of age,
comorbidities (cardiovascular disease, hyperlipidemia, renal disease, etc.),
duration and extent of diabetes*
For patients without concurrent illness and at low hypoglycemic risk: ≤ 6.5%
For patient with concurrent illness and at risk for hypoglycemia: >6.5%
Fasting Plasma Glucose
<100 mg/dL
2-h Post-Prandial Glucose
<140 mg/dL
*Considerations should include residual life expectancy; duration of diabetes; presence or absence of microvascular (renal and
retinal) and macrovascular (CV) complications; CVD risk factors; comorbid conditions; risk for severe hypoglycemia (especially in
older adults); and psychological, social, and economic status (affordability of treatment choice can have impact on compliance).
Adapted from AACE Diabetes Resource Center.
Type 1 and Type 2 Diabetes Mellitus Management
Current and complete list of recommendations from AACE/ACE can be found at:

For Type 1: http://outpatient.aace.com/type1-diabetes/treatment

For Type 2: https://www.aace.com/publications/algorithm
U.S. Preventive Services Task Force Recommendations
Published recommendations include:

Abnormal Blood Glucose and Type 2 Diabetes Mellitus Screening for adults aged 40 to 70
years who are overweight or obese.
Page | 16 of 19
∞

Gestational Diabetes Mellitus Screening for asymptomatic pregnant women after 24 weeks
of gestation.
References
1.
The American Association of Clinical Endocrinologists and American College of Endocrinologists (AACE/ACE) Diabetes Resource
Center. [Online database]. Available at: http://outpatient.aace.com/type1-diabetes/treatment Accessed March 2017.
2.
Garber AJ, MD, PhD, FACE et. al. Consensus Statement by the American Association of Clinical Endocrinologists and American
College of Endocrinologists (AACE/ACE) On the Comprehensive Type 2 Diabetes Management Algorithm 2016- Executive
Summary. [Online database]. Available at: https://www.aace.com/publications/algorithm Accessed March 2017.
3.
American Diabetes Association. Living With Diabetes: Treatment and Care: Medication: Insulin and Other Injectables: Insulin
Basics. [Online database]. Updated July, 2015. Available at: http://www.diabetes.org/living-with-diabetes/treatment-andcare/medication/insulin/insulin-basics.html Accessed March 2017.
4.
U.S. Food and Drug Administration: Emergency Preparedness: Information Regarding Insulin Storage and Switching Between
Products in an Emergency. [Online database): Updated May, 2015. Available at:
http://www.fda.gov/Drugs/EmergencyPreparedness/ucm085213.htm Accessed March 2017.
5.
Detail-Document, Comparison of Insulins and Injectable Diabetes Meds. Pharmacist’s Letter/Prescriber’s Letter. [Online
database]: November 2012. Available at:
http://portal.mah.harvard.edu/cms/content/B7ACBE692D3340DD9CD308883BC9750B/48BE034147324F50A4FFD277C4
0B3DE1.pdf Accessed March 2017.
6.
Dowlat HA, Kuklmann MK, Khatami H, Ampudia-Blasco FJ. Diabetes Obes Metab 2016 Aug; 18(8):737-46 doi: 10.1111/dom.
12676. Epub May 2016. Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study
design and clinical implications. Available at: http://www.ncbi.nlm.nih.gov/pubmed/27097592 Accessed March 2017.
7.
McCulloch DK, MD, Nathan DM, MD, Mulder JE, MD. General Principles of Insulin therapy in Diabetes Mellitus. UpToDateOnline Database. Updated March, 2016. Available at: http://www.uptodate.com/contents/general-principles-of-insulintherapy-in-diabetes-mellitus Accessed March 2017.
8.
Plank J, Wutte A, Brunner G, et al. A Direct Comparison of Insulin Aspart and Insulin Lispro in Patients with Type I Diabetes.
Diabetes Care. 2002; 25:2053-2057. Available at: http://care.diabetesjournals.org/content/25/11/2053 Accessed March
2017.
9.
Hedman CA, Lindstrom T, Arnqvist HJ. Direct Comparison of Insulin Lispor and Aspart Shows Small Differences in Plasma Insulin
Profiles After Subcutaneous Injection in Type 1 Diabetes. Diabetes Care. 2001; 24:1120-1121. Available at:
http://care.diabetesjournals.org/content/24/6/1120 Accessed March 2017.
10. Von Mach MA, et al. Differences in Pharmacokinetics and Pharmacodynamics of Insulin Lispro and Aspart in Healthy Volunteers.
Exp Clin Endocrinol Diabetes. 2002; 110:416-419. Available at: http://www.ncbi.nlm.nih.gov/pubmed/12518253 Accessed
March 2017.
11. Marso SP, MD, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2016; 375: 311-322, July 28,
2016. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1603827 Accessed March 2017.
12. Package insert for Adlyxin® (lixisenatide). Sanofi-Aventis, LLC. Bridgewater, NJ. July, 2016. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf Accessed March 2017.
13. Package insert for Xultophy (insulin degludeg and liraglutide). Novo Nordisk, A/S. Bagsvaerd, Denmark. November, 2016.
Available at: http://www.novo-pi.com/xultophy10036.pdf Accessed March 2017.
Page | 17 of 19
∞
14. Package insert for Soliqua (insulin glargine and lixisenatide). Sanofi-Aventis, U.S. LLC. Bridgewater, NJ. November 2016.
Available at: http://products.sanofi.us/Soliqua100-33/Soliqua100-33.pdf Accessed March 2017.
15. Gough SCL, Bode B, Woo V, et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira)
compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in
insulin-naïve patients with type 2 diabets. DUAL I. Lancet Diabetes & Endocrinology. (2014). 2(11):885-893.
16. Lingvay I, Perez MF, Garcia-Hernandez P, et al. Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated
hemoglobin levels in patients with uncontrolled type 2 diabetes: The DUAL V Randomized Clinical Trial. JAMA 2016; 315(9):898907.
17. Buse JB, Vilsbøll T, Thurman J, et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide
(IDegLira). DUAL II. Diabetes Care. (2014). 37(11):2926-2933.
18. Rodbard HW, Bode BW, Harris SB, et al. Safety and efficacy of insulin degludec/liraglutide addedto sulphonylurea alone or to
sulphonylurea and metformin in insulin-naïve people with type 2 diabetes: the DUAL IV trial. Diabetic Medicine. (2016). doi:
10.1111/dme.13256
19. Hampp C, Borders-Hemphill V, Moeny DG, Wysowski DK. Use of antidiabetic drugs in the U.S., 2003-2012. Diabetes Care.
(2014). 37(5): 1367-1374. doi: 10.2337/dc13-2289
20. Aroda VR, Bailey TS, Carious B, et al. Effect of adding insulin degludec to treatment in patients with type 2 diabetes
inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1
study). Diabetes Obes Metab. (2016). 18(7):663-670. doi: 10.1111/dom.12661
History
Date
Comments
08/31/16
New policy, add to Prescription Drug section. Policy effective date is October 1, 2016.
11/08/16
Interim Review. New GLP-1 agent, called Adlyxin® (lixisenatide) was added to the nonpreferred GLP-1 agonist criteria.
01/10/17
Annual Review. Added new agents Xultophy and Soliqua to the policy. Updated
corresponding description and references sections.
03/14/17
Interim review. Updated formulary status for Xultophy and Soliqua, previously nonpreferred.
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.
Page | 18 of 19
∞
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 | 19 of 19
∞
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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.
If you believe that Premera has failed to provide these services or
discriminated in another way on the basis of race, color, national origin, age,
disability, or sex, you can file a grievance with:
Civil Rights Coordinator - Complaints and Appeals
PO Box 91102, Seattle, WA 98111
Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357
Email [email protected]
You can file a grievance in person or by mail, fax, or email. If you need help
filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health
and Human Services, Office for Civil Rights, electronically through the
Office for Civil Rights Complaint Portal, available at
https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue SW, Room 509F, HHH Building
Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at
http://www.hhs.gov/ocr/office/file/index.html.
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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).