prior authorization review panel mco policy …...acupuncture for weight loss body plethysmography...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 04/01/2019

Policy Number: 0039 Effective Date: Revision Date: 03/12/12018

Policy Name: Weight Reduction Medications and Programs

Type of Submission – Check all that apply: New Policy Revised Policy

Annual Review – No Revisions* *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0039 Weight Reduction Medications and Programs

Clinical content was last revised on 03/12/18 No additional non-clinical updates were made by Corporate since the last PARP submission.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

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Weight Reduction Medicationsand Programs

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History

Last Re

view

03/12/2018

Effective: 02/14/2000

Next

Review: 01/10/2019

Review

Histor

y

Definitions

Additional Information

Number: 0039

Policy

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Note: Many Aetna plan benefit descriptions specifically exclude services and

supplies for or related to treatment of obesity or for diet and weight control. Under

these plans, claims for weight reduction medications and for physician supervision

of weight reduction programs will be denied based on that exclusion. Please check

benefit plan descriptions for details.

Aetna considers the following medically necessary treatment of obesity when

criteria are met:

1. Weight reduction medications, and

2. Clinician supervision of weight reduction programs.

Weight Reduction Medications:

Note: Many Aetna benefit plans specifically exclude coverage of weight reduction

medications under the pharmacy benefit and/or under the health benefits plan. The

medical necessity criteria set forth below do not apply to health plans that

specifically exclude services and supplies for or related to treatment of obesity or

for diet or weight control. Under these plans, claims for weight loss drugs will be

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denied based on this exclusion. For members whose medical policies do not

exclude weight reduction medications or services and supplies for or related to

weight reduction programs, Aetna covers these drugs under the medical benefit,

not the pharmacy benefit. Please check benefit plan descriptions for details.

Weight reduction medications are considered medically necessary for members

who have failed to lose at least one pound per week after at least 6 months on a

weight loss regimen that includes a low-calorie diet, increased physical activity, and

behavioral therapy, and who meet either of the following selection criteria below:

I. Member has a body mass index * (BMI) greater than or equal to 30 kg/m²; or

II. Member has a BMI greater than or equal to 27 kg/m² with any of the

following obesity-related risk factors considered serious enough to warrant

pharmacotherapy:

A. Coronary heart disease

B. Dyslipidemia:

1. HDL cholesterol less than 35 mg/dL, or

2. LDL cholesterol greater than or equal to 160 mg/dL, or

3. Triglycerides greater than or equal to 400 mg/dL

C. Hypertension (systolic blood pressure [SBP] higher than 140 mm Hg or

diastolic blood pressure [DBP] higher than 90 mm Hg on more than one

occasion)

D. Obstructive sleep apnea

E. Type 2 diabetes mellitus.

Weight reduction medications are considered experimental and investigational

when these criteria are not met.

* Body Mass Index (BMI) = weight (kg) / [height (m)]²

Calculate Your Body Mass

Index (http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm)

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The following medications have been approved by the FDA for weight reduction:

▪ Benzphetamine [Didrex],

▪ Diethylpropion [Tenuate],

▪ Liraglutide [Saxenda],

▪ Lorcaserin [Belviq],

▪ Naltrexone and bupropion [Contrave]

▪ Orlistat [Xenical, Alli],

▪ Phendimetrazine [Bontril]

▪ Phentermine [Adipex-P], and

▪ Phentermine and topiramate [Qsymia].

For reauthorization criteria for weight reduction medications, see Aetna Pharmacy

CPB on Antiobesity Agents.

For Aetna’s clinical policy on surgical management of obesity,

see CPB 0157 - Obesity Surgery (../100_199/0157.html).

Clinician Supervision of Weight Reduction Programs:

Up to a combined limit of 26 individual or group visits by any recognized provider

per 12-month period are considered medically necessary for weight reduction

counseling in adults who are obese (as defined by BMI ≥ 30 kg/m2**). The number

of medically necessary visits for obese children are left to the discretion of the

member's physician.

** For a simple and rapid calculation of BMI, please click below and it will take you

to the Obesity Education Initiative:

BMI = weight (kg) ¸ [height (m)]

Calculate Your Body Mass Index

² (http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm)

The following services are considered medically necessary for the evaluation of

overweight or obese individuals:

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▪ Complete blood count

▪ Comprehensive history and physical examination

▪ Dexamethasone suppression test and 24-hour urinary free cortisol measures if

symptoms suggest Cushing's syndrome.

▪ Electrocardiogram (EKG) -- adult

▪ Glucose tolerance test (GTT)

▪ Hand x-ray for bone age -- child

▪ Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)

▪ Metabolic and chemistry profile (serum chemistries, liver tests, uric acid) (SMA

20)

▪ Thyroid function tests (T3, T4, TSH)

▪ Urinalysis

Very Low-Calorie Diets (VLCD):

For obese members who have been prescribed a very low-calorie diet (VLCD) (less

than 799 Kcal/day) (e.g., Optifast, Medifast), the following services are considered

medically necessary for up to 16 weeks after initiation of the VLCD:

1. EKG after 50 lbs of weight loss; and

2. Lipid profile at the beginning and end of the VLCD program; and

3. Serum chemistries and liver function tests (SMA 20) weekly during the rapid

weight loss phase of the VLCD, then every 2 weeks thereafter up to 16 weeks.

Note: VLCDs extending beyond 16 weeks are subject to medical review to

determine if additional services are medically necessary.

Notes: Prepackaged food supplements or substitutes and grocery items are

generally excluded from coverage under most benefit plans. Diagnostic tests

required by, for or as a result of non-covered weight loss programs (e.g., those not

requiring physician supervision) are not covered. Please check benefit plan

descriptions for details.

Excluded Services:

The following interventions/procedures are considered experimental and

investigational for weight reduction:

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▪ Acupuncture for weight loss

▪ Body plethysmography (diagnostic study)

▪ Low-level laser therapy

▪ Dual-energy X-ray (DEXA) body composition (diagnostic study)

▪ Fat mass and obesity-associated (FTO) genotyping

▪ FTO genotyping

▪ Gastric electrical stimulation (see

CPB 0678 - Gastric Pacing and Gastric Electrical

Stimulation (../600_699/0678.html) )

▪ Human chorionic gonadotropin (HCG) or vitamin injections for weight loss

▪ Indirect calorimetry (also known as oxygen uptake analysis; diagnostic study)

▪ Normobaric hypoxic conditioning.

Whole body calorimetry and composition and whole body bioimpedance analysis

are considered experimental and investigational for weight reduction and other

indications.

Hospital confinement is considered not medically necessary for a weight reduction

program.

Note: Under most benefit plans, the following services and supplies for weight

reduction are specifically excluded from coverage (please check benefit plan

descriptions for details)

▪ Exercise programs or use of exercise equipment

▪ Rice diet or other special diet supplements (e.g., amino acid supplements,

Optifast liquid protein meals, NutriSystem pre-packaged foods, Medifast foods,

or phytotherapy), see CPB 0061 - Nutritional Support (0061.html)

▪ Weight Watchers, Jenny Craig, Diet Center, Zone diet, or similar programs.

Background

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Weight reduction medications should be used as an adjunct to caloric restriction,

exercise, and behavioral modification, when these measures alone have not

resulted in adequate weight loss. Factors influencing successful weight loss are

weight loss during dieting alone, adherence to diet, eating habits, motivation and

personality.

Weight loss due to weight reduction medication use is generally temporary. In

addition, the potential for development of physical dependence and addiction is

high. Because of this, their use to aid in weight loss is not regarded as therapeutic,

but rather involves a risk/benefit ratio, which makes it medically inappropriate in

most cases.

Individuals who cannot maintain weight loss through behavioral weight loss therapy

and are at risk of medical complications of obesity are an exception to this; for

these persons, the risk of physical dependence or other adverse effects may

present less of a risk than continued obesity. For such individuals, use of weight

reduction medication may need to be chronic.

Tests with weight loss drugs have shown that initial responders tend to continue to

respond, while initial non-responders are less likely to respond even with an

increase in dosage. If a person does not lose 2 kg (4.4 lb) in the first four weeks

after initiating therapy, the likelihood of long-term response is very low. If weight is

lost in the initial 6 months of therapy or is maintained after the initial weight loss

phase, this should be considered a success and the drug may be continued.

Orlistat is a reversible inhibitor of gastric and pancreatic lipases. Binding of orlistat

to these enzymes forms inactive intermediates in the gut. This non‐systemic action

does not allow fat to be broken down and absorbed. Rather, an oil phase that

includes triglycerides and cholesterol is excreted in feces. This effect may lead to

weight loss.

Xenical (orlistat) is indicated for obesity management including weight loss and

weight maintenance when used in conjunction with a reduced‐calorie diet. It is also

indicated to reduce the risk for weight regain after prior weight loss.

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Orlistat is available as Xenical in 120mg capsules and as Alli in 60mg capsules. Alli

is available over‐the‐counter. Recommended dosage of Xenical is one 120-mg

capsule three times a day with each main meal containing fat (during or up to 1

hour after the meal).

Supplementation with fat‐soluble vitamins (A, D, E, K) and beta carotene is

recommended in some patients as these may not be adequately absorbed when

given orlistat therapy.

Comorbidities associated with obesity appear to be improved through weight loss in

orlistat treated patients. However, studies are limited in time span and comparison

with other pharmacologic agents is needed to determine place in therapy.

Dosage reductions of hypoglycemic agents may be necessary when glycemic

control is improved with weight loss.

Risk of cholelithiasis increases with substantial weight loss.

Pharmacologic treatment of exogenous obesity should be adjunctive to caloric

restriction, increased physical activity, and behavioral modification.

Other than orlistat (Xenical), which is approved for use in adolescents aged 12

years or older, weight reduction medications have not been proven to be safe and

effective for treatment of obesity in children and adolescents. Orlistat (Xenical) is

contraindicated in persons with chronic malabsorption syndromes and cholestasis.

Qsymia is contraindicated in pregnancy, glaucoma,

hyperthyroidism, hypersensitivity to sympathomimetic amines, and within 14 days

of taking monoamine oxidase inhibitors. Belviq is contraindicated in pregnancy.

Other drugs listed in this policy are contraindicated in the following conditions:

hypertension, atherosclerosis, coronary artery disease, and stroke.

Ioannides-Demos et al (2006) stated that there is limited safety and effectiveness

data for amfepramone (diethylpropion) and phentermine and their approvals for the

management of obesity are limited to short-term use. The authors stated that,

although the benefit-risk profiles of sibutramine and orlistat appear positive,

sibutramine continues to be monitored because of long-term safety concerns. The

safety and effectiveness of currently approved drug therapies have not been

evaluated in children and elderly patient populations.

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On October 8, 2010, Abbott Laboratories announced that that it was withdrawing its

diet drug Meridia (sibutramine) from the United States, Australian and Canadian

markets as a consequence of heightened concerns that the medication can trigger

heart attack or stroke, especially in patients with underlying cardiovascular disease.

Dual-energy X-ray (DEXA) was developed for the diagnosis of osteoporosis and

was employed originally to clinically significant locations of the forearm, femoral

neck, and lumbar spine. With body composition measurements by means of DEXA,

a controlled x-ray beam scans the entire body to ascertain bone mineral content,

body fat and lean tissue mass. The comprehensive view of body composition

provided by DEXA is thought to be the method of choice for evaluating body

composition by its advocates because of its speed, ease of application as well as

relatively low-dose of ionizing radiation. Its purported uses entail determining

appropriate nutritional support during disease progression and monitoring response

to therapeutic interventions.

Available evidence does not support the use of whole body DEXA for managing

obesity. There is a lack of reliable evidence demonstrating that whole body DEXA

measurement improves the management of persons with obesity over simpler

methods of measuring body composition (including BMI and anthropomorphic

measures), such that clinical outcomes are significantly improved. Published data

have focused on the level of agreement between whole body DEXA and various

other methods of measuring body composition, and on the use of DEXA as an

endpoint in research studies. Well-designed studies are needed to assess

the clinical value of whole body DEXA scanning (Ball and Altena, 2004; Williams et

al, 2006; Ritz et al, 2007; Pineau et al, 2007; Pineau et al, 2009).

There is currently no established role for whole body bioimpedance for weight

reduction or other indications. Current ACC/AHA guidelines on obesity mention no

role for bioimpedance analysis (Jensen, et al., 2013). Current NICE

obesity guidance (NICE, 2014) states: “Do not use bioimpedance as a substitute for

BMI as a measure of general adiposity.”

Balázs (2010) stated that the rapidly increasing prevalence of over-weight and

diabetes mellitus is a serious global threat to healthcare. Nowadays, medicinal plants

and natural treatments are becoming more and more popular. Diabetes has

historically been treated with plants or plant-derived formulations in different cultures,

mainly in China, Asia and India. Different mechanisms for the anti-diabetic

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effect of plants has been proposed: increased release of insulin, reduction of

intestinal glucose absorption, as well as enhancement of glycogen synthesis. The

scientific evidences for most of these plants are still incomplete. The large market

for plant remedies has resulted in an array of unauthorized products or marketed as

dietary supplements and, at the same time, no reliable pharmaceutical-grade

products are registered for this purpose.

Borel et al (2012) conducted a prospective intervention study in 104 viscerally

obese men classified according to their glucose tolerance status. They were

followed for one year while participating in a healthy eating-physician

activity/exercise lifestyle modification program while their insulin sensitivity was

tracked. The goals of the study were to evaluate glucose tolerance as well as to

evaluate the respective contribution so fo changes in body fat distribution versus

changes in cardiorespiratory fitness (CRF) to the improvements in indices of

plasma glucose/insulin homeostasis. The results showed insulin sensitivity

improved in assocication with decreases inboth visceral (VAT) and subcutaneous

adiposity (SAT) as well as improvement in CRF, regardless of baseline glucose

tolerance. The results of this study also showed that reduction in VAT was

associated with an improvement in homeostasis model assessment of insulin

resistance, whereas reduction in SAT was rather associated with improvement of

the insulin sensitivity index of Matsuda. The authors concluded that a one-year

lifestyle intervention improved plasma glucose/insulin homeostasis in viscerally

obese men, including those with normal glucose tolerance status at baseline.

Garvey et al (2012) conducted a placebo-controlled, double-blind, 52-week extension

study to evaluate the long-term efficacy and safety of controlled-release

phentermine/topiramate (PHEN/TPM CR) in overweight and obese subjects with

cardiometabolic disease. Subjects were randomly assigned to placebo, 7.5 mg

phentermine/46 mg controlled-release topiramete, or 15 mg phentermine/92 mg

controlled-release topiramate. Of the 676 extension study participants, 84%

completed the study. At week 108 PHEN/TPM-CR was associated with significant,

sustained weight loss. Significantly more PHEN/TPM CR-treated subjects at each

dose achieved ≥ 5%, ≥ 10%, ≥ 15%, and ≥ 20% weight loss compared with placebo

(P < 0.001). The authors therefore concluded that PHEN/TPM CR, in conjunction with

lifestyle modification, may provide a well-tolerated and effective option for the

sustained treatment of obesity complicated by cardiometabolic disease.

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Mulholland et al (2012) stated that evidence from the literature supports the safe

use of very-low-energy diets (VLED) for up to 3 months in supervised conditions for

patients who fail to meet a target weight loss using a standard low-fat, reduced-

energy approach. There is, however, a need for longer-term outcomes on obesity and

associated morbidities following a VLED. These researchers investigated longer-term

outcomes from studies using VLED, with a minimum duration of 12 months,

published between January 2000 and December 2010. Studies conducted in both

children and adults, with a mean/median BMI of greater than or equal to 28 kg/m2

were included. PubMed, Medline, Web of Science and Science Direct were searched.

Reference lists of studies and reviews were manually searched. Weight loss or

prevention of weight gain and morbidities were the main outcomes assessed. A

total of 32 out of 894 articles met the inclusion criteria. The duration of the studies

ranged from 12 months to 5 years. Periods of VLED ranged from 25 d to 9 months.

Several studies incorporated aspects of behavior therapy, exercise, low-fat diets, low-

carbohydrate diets or medication. Current evidence demonstrated significant weight

loss and improvements in blood pressure, waist circumference and lipid profile in the

longer term following a VLED. Interpretation of the results, however, was restricted

and conclusions with which to guide best practice were limited due to heterogeneity

between the studies. The authors concluded that the present review clearly identified

the need for more evidence and standardized studies to assess the longer-term

benefits from weight loss achieved using VLED.

Indirect calorimetry is designed to measure an individual’s oxygen consumption.

Using this measurement, the device calculates a person’s resting energy

expenditure (REE), also known as resting metabolic rate (RMR). Clinicians

supposedly can screen for abnormally low metabolic rates, teach energy balance,

and identify the precise caloric intake needed for weight loss. Clinical applications

of indirect calorimetry include obesity treatment, as well as treating obesity related

diseases such as diabetes, dysmetabolic syndrome X, hypothyroidism,

hyperthyroidism, hypertension, cardiovascular disease, as well as sleep apnea.

Under strict laboratory protocol, indirect calorimetry can also be used to measure

basal metabolic rate.

Published studies of indirect calorimetry in weight management have focused on its

accuracy (Frankenfeld, et al., 2010; Henes, et al., 2015; Wilms, et al., 2010). There

is a lack of reliable evidence that indirect calorimetry measurements result in

improved clinical outcomes in obesity management.

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McDoniel, et al., (2008) evaluated the efficacy of a weight management program

using indirect calorimetry to set energy goals. Fifty-four overweight, active duty adult

employees of the US Air Force (age 18-46 years, BMI 25.2–35.6 kg/m2)

participated in this quasi-experimental control design study. All participants were

enrolled in a four-session US Air Force ‘Sensible Weigh’ group weight control

program. Treatment participants received a personalized nutrition energy goal

message developed using measured resting metabolic rate (RMR) from a hand-

held indirect calorimeter (MedGem®). Usual care participants received a nutritional

message using a standard care equation (25 kcal/day × body weight) to set energy

intake goals. Investigators reported that treatment participants lost significantly more

weight than usual care participants (p ≤ 0.05). Ten of the 54 subjects dropped from

the study before completion. Difference in weight loss between the treatment and

usual care group were –4.3 kg ± 3.3 vs. –1.8 kg ± 3.2, respectively. The

investigators reported that were no significant differences in reported food intake or

energy expenditure between groups. The investigators posited that a possible

reason why experimental individuals experienced greater weight loss from

measured resting metabolic rate may be that the individualized nutrition message

influenced psychobehavioral constructs (i.e. motivation, self-efficacy, etc.) for

weight loss change. The investigators noted that study limitations include small

sample size, short duration, and small treatment effect. An additional issue is the

generalizability of the findings, given that, at the time of the study, the Air Force had

regulations that all personnel maintain a desired body weight and body fat

percentage, or these individuals could be discharged from service. The

investigators stated that future research is needed to determine the long-term

efficacy of using indirect calorimetry as part of a comprehensive weight control

program.

An UpToDate review on “Palliative care: Assessment and management of anorexia

and cachexia” (Bruera and Dev, 2013) states that “Handheld indirect calorimetry,

which is more accurate than equations at estimating basal energy needs but less

precise than traditional devices used in the research setting, may be useful in the

outpatient setting. Close to one-half of cancer patients being evaluated in an

outpatient cachexia clinic are noted to be hypermetabolic by indirect calorimetry.

These assessments are appropriate in the research setting but have little if any

utility in the clinic”.

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Whiting et al (2014) stated that capsaicinoids are a group of chemicals naturally

occurring in chilli peppers with bioactive properties that may help to support weight

management. These investigators conducted a meta-analysis investigating the

potential effects of capsaicinoids on energy intake, clarified previous observations

and formed evidence-based conclusions about possible weight management roles.

Medical databases (Medline, Web of Knowledge and Scopus) were systematically

searched for papers. Search terms were: 'capsaicin (*)' or 'red pepper' or 'chilli(*)' or

'chili(*)' with 'satiety' or 'energy intake'. Of the 74 clinical trials identified, 10 were

included, 8 of which provided results suitable to be combined in analysis (191

participants). From the studies, 19 effect sizes were extracted and analyzed using

MIX meta-analysis software. Data analysis showed that capsaicinoid ingestion prior

to a meal reduced ad libitum energy intake by 309.9kJ (74.0kcal) during the meal (p

< 0.001). However, results should be viewed with some caution as heterogeneity

was high (I(2) = 75.7 %). Study findings suggested a minimum dose of 2 mg of

capsaicinoids is needed to contribute to reductions in ad libitum energy intake,

which appears to be attributed to an altered preference for carbohydrate-rich foods

over foods with a higher fat content. The authors concluded that meta- analysis

findings suggested that daily consumption of capsaicinoids may contribute to weight

management through reductions in energy intake. Subsequently, there may be

potential for capsaicinoids to be used as long-term, natural weight-loss aids. They

stated that further long-term randomized trials are now needed to investigate these

effects.

In a systematic review, Onakpoya et al (2014a) evaluated the evidence for or

against the effectiveness of glucomannan, a soluble fiber, in body weight

reduction. Electronic searches were conducted in Medline, Embase, Amed, and

The Cochrane Library. Hand searches of bibliography were also conducted.

Outcomes of interest were body weight and BMI. Studies involving only over-

weight and/or obese participants were included. Two reviewers independently

determined the eligibility of studies and assessed the reporting quality of included

randomized controlled trials (RCTs), using the CONSORT and PRISMA guidelines.

A total of 18 trials were identified, and 9 were included. There was a variation in

the reporting quality of the included RCTs. A meta-analysis (random effect model)

of 8 RCTs revealed a non-statistically significant difference in weight loss between

glucomannan and placebo (mean difference [MD]: -0.22 kg; 95 % confidence

interval [CI]: -0.62, 0.19; I(2) = 65 %). Adverse events included abdominal

discomfort, diarrhea, and constipation. The authors concluded that the evidence

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from available RCTs does not show that glucomannan intake generates statistically

significant weight loss. They stated that future trials should be more rigorous and

better reported.

Onakpoya et al (2014b) noted that several slimming aids being sold as food

supplements are widely available. One of them is pyruvate. Its effectiveness in

causing weight reduction in humans has not been fully established. The objective of

this systematic review was to examine the effectiveness of pyruvate in reducing

body weight. Electronic and non-electronic searches were conducted to identify all

relevant human RCTs. The bibliographies of all located articles were also

searched. No restrictions in language or time were applied. Two independent

reviewers extracted the data according to predefined criteria. A fixed-effect model

was used to calculate MD and 95 % CI. A total of 9 trials were identified and 6

were included. All had methodological weaknesses. The meta-analysis revealed a

statistically significant difference in body weight with pyruvate compared to placebo

(MD: -0.72 kg; 95 % CI: -1.24 to -0.20). The magnitude of the effect is small, and

its clinical relevance is uncertain. Adverse events included gas, bloating, diarrhea,

and increase in low-density lipoprotein (LDL) cholesterol. The authors concluded

that the evidence from RCTs does not convincingly show that pyruvate is effective

in reducing body weight; limited evidence exists about the safety of pyruvate. They

stated that future trials involving the use of this supplement should be more

rigorous and better reported.

The FDA has approved liraglutide [rDNA origin] injection (Saxenda), a once-daily

injection of a glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight

management (Novo Nordisk, 2014). Liraglutide is indicated as an adjunct to a

reduced-calorie diet and increased physical activity for chronic weight management

in adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) in

the presence of at least one weight-related comorbid condition (e.g., hypertension,

type 2 diabetes mellitus, or dyslipidemia) (FDA, 2014).

The labeling of Saxenda states that liraglutide should not be used with insulin (FDA,

2014). It also states that the the effects of liraglutide on cardiovascular morbidity

and mortality have not been established. The labeling states that the safety and

efficacy of coadministration with other products for weight loss have not been

established. In addition, liraglutide has not been studied in patients with a history of

pancreatitis.

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Liraglutide for chronic weight management is contraindicated in the following

conditions: personal or family history of medullary thyroid carcinoma (MTC) or

multiple endocrine neoplasia syndrome type 2 (MEN 2); patients with a prior

serious hypersensitivity reaction to liraglutide or to any of the product components;

and pregnancy (FDA, 2014).

The FDA approval of liraglutide was based upon the SCALE (Satiety and Clinical

Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical

trial program, which included study participants who have obesity (BMI ≥30 kg/m2) or

who are overweight (BMI ≥27 kg/m2) with comorbidities (Novo Nordisk, 2014).

Trial data showed that liraglutide, in combination with a reduced-calorie diet and

increased physical activity, resulted in significantly greater weight loss than diet and

physical activity alone.

The SCALE phase 3 clinical trial program of the safety and effectiveness of

liraglutide for chronic weight management included three clinical trials that included

approximately 4,800 obese and overweight patients with and without significant

weight-related conditions (FDA, 2014). All patients received counseling regarding

lifestyle modifications that consisted of a reduced-calorie diet and regular physical

activity.

Results from a clinical trial that enrolled patients without diabetes showed that

patients had an average weight loss of 4.5 percent from baseline compared to

treatment with a placebo at one year (FDA, 2014). In this trial, 62 percent of

patients treated with liraglutide lost at least 5 percent of their body weight compared

with 34 percent of patients treated with placebo. Results from another clinical trial

that enrolled patients with type 2 diabetes showed that patients had an average

weight loss of 3.7 percent from baseline compared to treatment with placebo at one

year. In this trial, 49 percent of patients treated with liraglutide lost at least 5 percent

of their body weight compared with 16 percent of patients treated with placebo.

The FDA approved labeling states that patients using liraglutide should be

evaluated after 16 weeks to determine if the treatment is working (FDA, 2014). If a

patient has not lost at least 4 percent of baseline body weight, liraglutide should be

discontinued, as it is unlikely that the patient will achieve and sustain clinically

meaningful weight loss with continued treatment.

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Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be

used in combination with any other drug belonging to this class, including Victoza, a

treatment for type 2 diabetes (FDA, 2014). Saxenda and Victoza contain the same

active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively).

However, Saxenda is not indicated for the treatment of type 2 diabetes, as the

safety and efficacy of Saxenda for the treatment of diabetes has not been

established.

Saxenda has a boxed warning stating that thyroid C-cell tumors have been

observed in rodent studies with liraglutide but that it is unknown whether liraglutide

causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in

humans (FDA, 2014). Liraglutide causes dose-dependent and treatment-duration-

dependent thyroid C-cell tumors at clinically relevant exposures in both genders of

rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors,

including MTC, in humans, as the human relevance of liraglutide-induced rodent

thyroid C-cell tumors has not been determined.

The labeling states that liraglutide is contraindicated in patients with a personal or

family history of MTC or in patients with multiple endocrine neoplasia syndrome

type 2 (MEN 2) (FDA, 2014). The labeling states that patients should be counseled

regarding the risk of MTC with use of liraglutide and informed of symptoms of

thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent

hoarseness). The labeling states that routine monitoring of serum calcitonin or

using thyroid ultrasound is of uncertain value for early detection of MTC in patients

treated with liraglutide.

In clinical trials, the most common adverse reactions, reporting in ≥5%, were:

nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased

appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase (Novo

Nordisk, 2014).

Serious side effects reported in patients treated with liraglutide for chronic weight

management include pancreatitis, gallbladder disease, renal impairment, and

suicidal thoughts (FDA, 2014). Liraglutide can also increase heart rate and should

be discontinued in patients who experience a sustained increase in resting heart

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Based on spontaneous postmarketing reports, acute pancreatitis, including fatal

and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in

patients treated with liraglutide (Novo Nordisk, 2014). After initiation of liraglutide,

patients should be observed for signs and symptoms of pancreatitis (including

persistent severe abdominal pain, sometimes radiating to the back and which may

or may not be accompanied by vomiting). If pancreatitis is suspected, liraglutide

should promptly be discontinued and appropriate management should be initiated.

If pancreatitis is confirmed, liraglutide should not be restarted.

Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the

incidence of acute gallbladder disease was greater in liraglutide-treated patients

than in placebo-treated patients even after accounting for the degree of weight loss

(Novo Nordisk, 2014). If cholelithiasis is suspected, gallbladder studies and

appropriate clinical follow-up are indicated.

When liraglutide is used with an insulin secretagogue (e.g., a sulfonylurea) serious

hypoglycemia can occur (Novo Nordisk, 2014). The labeling recommends lowering

the dose of the insulin secretagogue to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with

nausea, vomiting, diarrhea, or dehydration, which may sometimes require

hemodialysis (Novo Nordisk, 2014). The labeling recommends using caution when

initiating or escalating doses of liraglutide in patients with renal impairment.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been

reported during postmarketing use of liraglutide (Novo Nordisk, 2014). The labeling

recommends that patients stop taking liraglutide and seek medical advice if

symptoms of hypersensitivity reactions occur.

The labeling states that patients treated with liraglutide should be monitored for the

emergence or worsening of depression, suicidal thoughts or behavior, and/or any

unusual changes in mood or behavior (Novo Nordisk, 2014). Liraglutide should be

discontinued in patients who experience suicidal thoughts or behaviors. Liraglutide

should be avoided in patients with a history of suicidal attempts or active suicidal

ideation.

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The labeling states that nursing mothers should either discontinue liraglutide for

chronic weight management or discontinue nursing (Novo Nordisk, 2014). The

labeling states that the safety and effectiveness of liraglutide have not been

established in pediatric patients and is not recommended for use in pediatric

patients.

The FDA is requiring the following post-marketing studies for liraglutide for chronic

weight management (FDA, 2014): clinical trials to evaluate dosing, safety, and

efficacy in pediatric patients; a study to assess potential effects on growth, sexual

maturation, and central nervous system development and function in immature rats;

an MTC case registry of at least 15 years duration to identify any increase in MTC

incidence related to liraglutide; and an evaluation of the potential risk of breast

cancer with liraglutide in ongoing clinical trials. In addition, the cardiovascular safety

of liraglutide is being investigated in an ongoing cardiovascular outcomes trial.

The FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy

(REMS), which consists of a communication plan to inform health care

professionals about the serious risks associated with Saxenda (FDA, 2014).

Lingwood (2013) stated that there is a critical need for improved technologies to

monitor fluid balance and body composition in neonates, particularly those

receiving intensive care. Bioelectrical impedance analysis (BIA) meets many of the

criteria required in this environment and appears to be effective for monitoring

physiological trends. These researchers reviewed the literature regarding the use

of bioelectrical impedance in neonates. It was found that prediction equations for

total body water, extracellular water and fat-free mass have been developed, but

many require further testing and validation in larger cohorts. Alternative

approaches based on Hanai mixture theory or vector analysis are in the early

stages of investigation in neonates. The authors concluded that further research is

needed into electrode positioning, bioimpedance spectroscopy and Cole analysis in

order to realize the full potential of this technology.

de Miguel-Etayo et al (2013) noted that nutrition, physical activity and behavior-

modifying techniques are widely applied components of interventions treating

obesity. These investigators reviewed available information on the short- and long-

term effects of intervention treatment on body fat composition of overweight and

obese children and adolescents and, to obtain a further understanding on how

different body composition techniques detect longitudinal changes. A total of 13

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papers were included; 7 included a multi-disciplinary intervention component, 5

applied a combined dietary and physical activity intervention and 1 a physical

activity intervention. Body composition techniques used included anthropometric

indices, BIA, and dual energy X-ray absorptiometry. Percentage of fat mass

change was calculated in when possible. Findings suggested, no changes were

observed in fat free mass after 16 weeks of nutritional intervention and the lowest

decrease on fat mass percentage was obtained. However, the highest fat mass

percentage with parallel increase in fat free mass, both assessed by DXA was

observed in a multi-component intervention applied for 20 weeks. The authors

concluded that more studies are needed to determine the best field body

composition method to monitor changes during overweight treatment in children

and adolescents.

Talma et al (2013) stated that BIA is a practical method to estimate percentage

body fat (% BF). In this systematic review, these researchers evaluated validity,

responsiveness, reliability and measurement error of BIA methods in estimating %

BF in children and adolescents. They searched for relevant studies in PubMed,

Embase and Cochrane through November 2012. Two reviewers independently

screened titles and abstracts for inclusion, extracted data and rated methodological

quality of the included studies. These investigators performed a best evidence

synthesis to synthesize the results, thereby excluding studies of poor quality. They

included 50 published studies. Mean differences between BIA and reference

methods (gold standard [criterion validity] and convergent measures of body

composition [convergent validity]) were considerable and ranged from negative to

positive values, resulting in conflicting evidence for criterion validity. These

investigators found strong evidence for a good reliability, i.e., (intra-class)

correlations greater than or equal to 0.82. However, test-retest mean differences

ranged from 7.5 % to 13.4 % of total % BF in the included study samples, indicating

considerable measurement error. The authors concluded that the findings of this

systematic review suggested that BIA is a practical method to estimate % BF in

children and adolescents. However, they stated that validity and measurement

error were not satisfactory.

Goldberg et al (2014) stated that the sensory and gastro-intestinal changes that

occur with aging affect older adults' food and liquid intake. Any decreased liquid

intake increases the risk for dehydration. This increased dehydration risk is

compounded in older adults with dysphagia. The availability of a non-invasive and

easily administered way to document hydration levels in older adults is critical,

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particularly for adults in residential care. This pilot study investigated the

contribution of BIA to measure hydration in 19 older women in residential care: 13

who viewed themselves as healthy and 6 with dysphagia. Mann-Whitney U

analyses documented no significant between-group differences for total body water

(TBW), fat free mass (FFM), Fat Mass (FM), and % BF. However, when compared

to previously published data for age-matched women, the TBW and FFM values of

the 2 participant groups were notably less, and FM and % BF values were notably

greater than expected. The authors concluded that if results are confirmed through

continued investigation, such findings may suggest that long-term care facilities are

unique environments in which all older residents can be considered at-risk for

dehydration and support the use of BIA as a non-invasive tool to assess and

monitor their hydration status.

Buffa et al (2014) defined the effectiveness of bioelectrical impedance vector

analysis (BIVA) for assessing 2-compartment body composition. These researchers

performed a systematic literature review using MEDLINE database up to February

12, 2014. The list of papers citing the first description of BIVA, obtained from

SCOPUS, and the reference lists of included studies were also searched. Selection

criteria included studies comparing the results of BIVA with those of other

techniques, and studies analyzing bioelectrical vectors of obese, athletic, cachectic

and lean individuals. A total of 30 articles met the inclusion criteria. The ability of

classic BIVA for assessing 2-compartment body composition has been mainly

evaluated by means of indirect techniques, such as anthropometry and BIA. Classic

BIVA showed a high agreement with body mass index, which can be interpreted in

relation to the greater body mass of obese and athletic individuals, whereas the

comparison with BIA showed less consistent results, especially in diseased

individuals. When a reference method was used, classic BIVA failed to accurately

recognize FM % variations, whereas specific BIVA furnished good results. The

authors concluded that specific BIVA is a promising alternative to classic BIVA for

assessing 2-compartment body composition, with potential application in nutritional,

sport and geriatric medicine.

Haverkort et al (2015) noted that BIA is a commonly used method for the evaluation

of body composition. However, BIA estimations are subject to uncertainties. These

researchers explored the variability of empirical prediction equations used in BIA

estimations and evaluated the validity of BIA estimations in adult surgical and

oncological patients. Studies developing new empirical prediction equations and

studies evaluating the validity of BIA estimations compared with a reference

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method was included. Only studies using BIA devices measuring the entire body

were included. Studies that included patients with altered body composition or a

disturbed fluid balance and studies written in languages other than English were

excluded. To illustrate variability between equations, fixed normal reference values

of resistance values were entered into the existing empirical prediction equations of

the included studies and the results were plotted in figures. The validity was

expressed by the difference in means between BIA estimates and the reference

method, and relative difference in %. Substantial variability between equations for

groups (including men and women) was found for TBW and FFM. The gender-

specific existing general equations assume less variability for TBW and FFM. BIA

mainly under-estimated TBW (range relative difference -18.8 % to +7.2 %) and

FFM (range relative differences -15.2 % to +3.8 %). Estimates of the FM

demonstrated large variability (range relative difference -15.7 % to +43.1 %). The

authors concluded that application of equations validated in healthy subjects to

predict body composition performs less well in oncologic and surgical patients.

They suggested that BIA estimations, irrespective of the device, can only be useful

when performed longitudinally and under the same standard conditions.

Ketogenic Diets for Weight Loss:

Gibson et al (2015) stated that VLEDs and ketogenic low-carbohydrate diets

(KLCDs) are 2 dietary strategies that have been associated with a suppression of

appetite. However, the results of clinical trials investigating the effect of ketogenic

diets on appetite are inconsistent. To evaluate quantitatively the effect of ketogenic

diets on subjective appetite ratings, these researchers conducted a systematic

literature search and meta-analysis of studies that assessed appetite with visual

analog scales (VAS) before (in energy balance) and during (while in ketosis)

adherence to VLED or KLCD. Individuals were less hungry and exhibited greater

fullness/satiety while adhering to VLED, and individuals adhering to KLCD were

less hungry and had a reduced desire to eat. Although these absolute changes in

appetite were small, they occurred within the context of energy restriction, which is

known to increase appetite in obese people. Thus, the clinical benefit of a

ketogenic diet is in preventing an increase in appetite, despite weight loss, although

individuals may indeed feel slightly less hungry (or more full or satisfied). Ketosis

appears to provide a plausible explanation for this suppression of appetite. The

authors concluded that future studies should investigate the minimum level of

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ketosis required to achieve appetite suppression during ketogenic weight loss diets,

as this could enable inclusion of a greater variety of healthy carbohydrate-

containing foods into the diet.

Medium-Chain Triglycerides for Weight Loss:

Bueno and colleagues (2015) examined the effect of replacing dietary long-chain

triacylglycerols (LCTs) with medium-chain triacylglycerols (MCTs) on body

composition in adults. These researchers conducted a meta-analysis of RCTs, to

examine if individuals assigned to replace at least 5 g of dietary LCTs with MCTs for

a minimum of 4 weeks show positive modifications on body composition. They

systematically searched, through July 2013, the CENTRAL, EMBASE, LILACS, and

MEDLINE databases for RCTs that investigated the effects of MCT intake on body

composition in adults. Two authors independently extracted data and assessed risk

of bias. Weighted mean differences (WMDs) were calculated for net changes in

the outcomes. These investigators assessed heterogeneity by the Cochran Q test

and I(2) statistic and publication bias with the Egger's test. Pre-specified sensitivity

analyses were performed. A total of 11 trials were included, from which 5

presented low risk of bias. In the overall analysis, including all studies, individuals

who replaced dietary LCT with MCT showed significantly reduced body weight

(WMD, -0.69 kg; 95 % CI: -1.1 to -0.28; p = 0.001); body fat (-0.89 kg; 95 % CI:

-1.27 to -0.51; p < 0.001), and WC (-1.78 cm; 95 % CI: -2.4 to -1.1; p < 0.001). The

overall quality of the evidence was low-to-moderate. Trials with a cross-over

design were responsible for the heterogeneity. The authors concluded that despite

statistically significant results, the recommendation to replace dietary LCTs with

MCTs must be cautiously taken, because the available evidence is not of the

highest quality.

Mumme and Stonehouse (2015) conducted a systematic review and meta-analysis

of RCTs comparing the effects of MCTs, specifically C8:0 and C10:0, to long-chain

triglycerides (LCTs) on weight loss and body composition in adults. Changes in

blood lipid levels were secondary outcomes. Randomized controlled trials of

greater than 3 weeks' duration conducted in healthy adults were identified

searching Web of Knowledge, Discover, PubMed, Scopus, New Zealand Science,

and Cochrane CENTRAL until March 2014 with no language restriction. Identified

trials were assessed for bias. Mean differences were pooled and analyzed using

inverse variance models with fixed effects. Heterogeneity between studies was

calculated using I(2) statistic. An I(2) > 50 % or p < 0.10 indicated heterogeneity. A

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total of 13 trials (n = 749) were identified. Compared with LCTs, MCTs decreased

body weight (-0.51 kg [95 % CI: -0.80 to -0.23 kg]; p < 0.001; I (2) = 35 %); waist

circumference (-1.46 cm [95 % CI: -2.04 to -0.87 cm]; p < 0.001; I (2) = 0%), hip

circumference (-0.79 cm [95 % CI: -1.27 to -0.30 cm]; p = 0.002; I (2) = 0 %), total

body fat (standard mean difference -0.39 [95 % CI: -0.57 to -0.22]; p < 0.001; I(2) =

0%), total subcutaneous fat (standard mean difference -0.46 [95 % CI: -0.64 to

-0.27]; p < 0.001; I(2) = 20 %), and visceral fat (standard mean difference -0.55 [95

% CI: -0.75 to -0.34]; p < 0.001; I(2) = 0 %). No differences were seen in blood lipid

levels. Many trials lacked sufficient information for a complete quality assessment,

and commercial bias was detected. Although heterogeneity was absent, study

designs varied with regard to duration, dose, and control of energy intake. The

authors concluded that replacement of LCTs with MCTs in the diet could potentially

induce modest reductions in body weight and composition without adversely

affecting lipid profiles. However, they stated that further research is needed by

independent research groups using large, well-designed studies to confirm the

effectiveness of MCT and to determine the dosage needed for the management of

a healthy body weight and composition.

FTO Genotyping:

Xiang and colleagues (2016) noted that studies have suggested that the fat mass and

obesity-associated (FTO) genotype is associated with individual variability in weight

loss in response to diet/lifestyle interventions, but results are inconsistent. These

investigators provided a summary of the literature evaluating the relation between the

FTO genotype and weight loss in response to diet/lifestyle interventions. They

performed a search of English-language articles in the PubMed and Embase

databases (through April 30, 2015). Eligible studies were diet/lifestyle weight-loss

intervention studies conducted in adults that reported changes in body weight or BMI

by the FTO variant rs9939609 (or its proxy). Differences in weight loss between FTO

genotypes across studies were pooled with the use of fixed- effect models. A meta-

analysis of 10 studies (comprising 6,951 participants) that reported the results of

additive genetic models showed that individuals with the FTO TA genotype and AA

genotype (those with the obesity-predisposing A allele) had 0.18-kg (95 % CI: -0.09

to 0.45-kg; p= 0.19; NS) and 0.44-kg (95 % CI: 0.09- to

0.79-kg; p = 0.015) greater weight loss, respectively, than those with the TT

genotype. A meta-analysis of 14 studies (comprising 7,700 participants) that

reported the results of dominant genetic models indicated a 0.20-kg (-0.43- to 0.04-

kg) greater weight loss in the TA/AA genotype than in the TT genotype (p = 0.10).

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In addition, differences in weight loss between the AA genotype and TT genotype

were significant in studies with a diet intervention only, adjustment for baseline BMI or

body weight, and several other subgroups. However, the relatively small number of

studies limited these stratified analyses, and there was no statistically significant

difference between subgroups. The authors concluded that the findings of this meta-

analysis suggested that individuals carrying the homozygous FTO obesity-

predisposing allele may lose more weight through diet/lifestyle interventions than non-

carriers; and clinical applications of these findings need further investigations. They

stated that these findings provided some support for considering genetic variability in

response to diet/lifestyle interventions in the development of more effective strategies

for weight loss; nevertheless, more studies are needed to explore which types of

diet/lifestyle interventions most powerfully facilitate the FTO genetic effect on weight

loss.

Normobaric Hypoxic Conditioning:

Hobbins and colleagues (2017) stated that normobaric hypoxic conditioning (HC) is

defined as exposure to systemic and/or local hypoxia at rest (passive) or combined

with exercise training (active). Hypoxic conditioning has been previously used by

healthy and athletic populations to enhance their physical capacity and improve

performance in the lead up to competition. Recently, HC has also been applied

acutely (single exposure) and chronically (repeated exposure over several weeks) to

over-weight and obese populations with the intention of managing and potentially

increasing cardio-metabolic health and weight loss. At present, it is unclear what the

cardio-metabolic health and weight loss responses of obese populations are in

response to passive and active HC. Exploration of potential benefits of exposure to

both passive and active HC may provide pivotal findings for improving health and

well-being in these individuals. These researchers carried out a systematic literature

search for articles published between 2000 and 2017. Studies investigating the

effects of normobaric HC as a novel therapeutic approach to elicit improvements in

the cardio-metabolic health and weight loss of obese populations were included.

Studies investigated passive (n = 7; 5 animals, 2 humans), active (n

= 4; all humans) and a combination of passive and active (n = 4; 3 animals, 1

human) HC to an inspired oxygen fraction between 4.8 and 15.0 %, ranging

between a single session and daily sessions per week, lasting from 5 days up to 8

months. Passive HC led to reduced insulin concentrations (-37 to -22 %) in obese

animals and increased energy expenditure (+12 to +16 %) in obese humans,

whereas active HC led to reductions in body weight (-4 to -2 %) in obese animals

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and humans, and blood pressure (BP; -8 to -3 %) in obese humans compared with

a matched workload in normoxic conditions. Inconclusive findings, however, exist

in determining the impact of acute and chronic HC on markers such as

triglycerides, cholesterol levels, and fitness capacity. More importantly, most of the

studies that included animal models involved exposure to severe levels of hypoxia

(= 5.0 %; simulated altitude greater than 10,000 m) that are not suitable for human

populations. The authors concluded that normobaric HC demonstrated observable

positive findings in relation to insulin and energy expenditure (passive), and body

weight and BP (active), which may improve the cardio-metabolic health and body

weight management of obese populations. However, they stated that further

evidence on responses of circulating biomarkers to both passive and active HC in

humans is needed.

Appendix

Ideal Weight Chart:

The following indicates maximum ideal weight in shoes with one-inch heels based

on body frame and height:

Ideal weights for adult men

Height Weight (lbs.)

Small Frame Medium Frame Large Frame

5'2" 134 141 150

5'3" 136 143 153

5'4" 138 145 156

5'5" 140 148 160

5'6" 142 151 164

5'7" 145 154 168

5'8" 148 157 172

5'9" 151 160 176

5'10" 154 163 180

5'11" 157 166 184


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6'0" 160 170 188

6'1" 164 174 192

6'2" 168 178 197

6'3" 172 182 202

6'4" 176 187 207

Ideal weights for adult women

Height Weight (lbs.)

Small Frame Medium Frame Large Frame

4'10" 111 121 131

4'11" 113 123 134

5'0" 115 126 137

5'1" 118 129 140

5'2" 121 132 143

5'3" 124 135 147

5'4" 127 138 151

5'5" 130 141 155

5'6" 133 144 159

5'7" 136 147 163

5'8" 139 150 167

5'9" 142 153 170

5'10" 145 156 173

5'11" 148 159 176

6'0" 151 162 179

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:

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Code Code Description

97802 Medical nutrition therapy; initial assessment and intervention, individual,

face-to-face with the patient, each 15 minutes

97803 re-assessment and intervention, individual, face-to-face with the

patient, each 15 minutes

97804 group (2 or more individual(s)), each 30 minutes

CPT codes not covered for indications listed in the CPB:

Fat mass and obesity-associated (FTO) genotyping, normobaric hypoxic conditioning – no specific code :

0358T Bioelectrical impedance analysis whole body composition assessment,

with interpretation and report

94690 Oxygen uptake, expired gas analysis; Rest, indirect (separate

procedure) [Indirect calorimetry]

94726 Plethysmography for determination of lung volumes and, when

performed, airway resistance

97810 Acupuncture, one or more needles without electrical stimulation; initial

15 minutes of personal one-on-one contact with patient

+ 97811 without electrical stimulation, each additional 15 minutes of personal

one-on-one contact with the patient, with re-insertion of needle(s) (List

separately in addition to code for primary procedure)

97813 Acupuncture, one or more needles with electrical stimulation; initial 15

minutes of personal one-on-one contact with thepatient

+ 97814 each additional 15 minutes of personal one-on-one contact with the

patient, with re-insertion of needle(s) (List separately in addition to code

for primary procedure)

Other CPT codes related to the CPB:

77072 Bone age studies

80048 Basic metabolic panel (Calcium, total)

80053 Comprehensive metabolic panel

80076 Hepatic function panel

80418 Combined rapid anterior pituitary evaluation panel

80420 Dexamethasone suppression panel, 48 hour

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Code Code Description

81000 Urinalysis, by dipstick or tablet reagent for bilirubin, glucose,

hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity,

urinobilogen, any number of these constituents; non-automated, with

microscopy

81001 automated, with microscopy

81050 Volume measurement for timed collection, each

82465 Cholesterol, serum or whole blood, total

82530 Cortisol, free

82533 total

82951 Glucose; tolerance test (GTT), three specimens (includes glucose)

82952 tolerance test, each additional beyond 3 specimens (list separately in

addition to code for primary procedure)

83718 Lipoprotein, direct measurement; high density cholesterol (HDL

cholesterol)

83719 direct measurement, VLDL cholesterol

83721 direct measurement; LDL cholesterol

84443 Thyroid stimulating hormone (TSH)

84478 Triglycerides

84479 Thyroid hormone (T3 or T4) uptake or thyroid hormone binding ratio

(THBR)

84550 Uric acid; blood

84560 other source

85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and

platelet count) and automated differential WBC count

85027 complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count)

and automated differential WBC count

93000 - 93010 Electrocardiogram, routine ECG with at least 12 leads

HCPCS codes covered if selection criteria are met:

G0270 Medical nutrition therapy; reassessment and subsequent intervention(s)

following second referral in same year for change in diagnosis, medical

condition or treatment regimen (including additional hours needed for

renal disease), individual, face to face with patient, each 15 minutes

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J0725

HCPCS codes not covered for indications listed in the CPB:

J7336

Other HCPCS Codes related to the CPB:

ICD-10 codes covered if selection criteria are met:

The above policy is based on the following references:

1. American Obesity Association, C. Everett Koop Foundation, and Shape Up

America! Guidance for treatment of adult obesity. Bethesda, MD: Shape Up

America! October 1996. Available at: http://www.shapeup.org/sua. Accessed

March 16, 2000.

2. Bra GA, Gray DS. Obesity. Part I. Pathogenesis. West J Med. 1988; 149:429-

441.

3. National Task Force on the Prevention and Treatment of Obesity, National

Institutes of Health. Very low-calorie diets. JAMA. 1993; 270:967-974.

4. National Task Force on the Prevention and Treatment of Obesity, National

Institutes of Health. Long-term pharmacotherapy in the management of

obesity.JAMA. 1996; 276:1907-1915.

5. Foster DW. Gain and loss in weight. In: Harrison’s Principles of Internal

Medicine. 14th ed. AS Fauci, E Braunwald, KJ Isselbacher, et al., eds. New

York, NY: McGraw-Hill; 1998:244-246.

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http://www.shapeup.org/sua

/data/1_99/0039.html

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http://www.aetna.com/cpb/medical

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6. U.S. Department of Agriculture and U.S. Department of Health and Human

Services. Nutrition and your health: Dietary guidelines for Americans. 3rd ed.

Home and Garden Bulletin. No. 232. Washington, DC: U.S. Government

Printing Office; 1990.

7. Goldstein DJ, Potvin JH. Long-term weight loss: The effect of pharmacologic

agents. Am J Clin Nutr. 1994;60(5):647-657.

8. Silverstone T. Appetite suppressants: A review. Drugs. 1992;43(6):820-836.

9. United States Pharmacopeial Convention, Inc. Appetite suppressants

(systemic). In: USP DI: Drug Information for the Health Care Professional.

19th ed. Rockville, MD: United States Pharmacopeial Convention; 1999: 452-

459.

10. No author listed. Weight control. In: Introductory Nutrition and Diet Therapy.

2nd ed. MM Eschleman, ed. Philadelphia, PA: J.B. Lippincott Co.

;1991;368.

11. No author listed. Metabolic drugs: Drugs used in obesity. In: AMA Drug

Evaluations Subscription. DR Bennett, ed. Chicago, IL: American Medical

Association (AMA); 1992: III/MET 6:7.

12. Scheen AJ, Desaive C, Lefebvre PJ. Therapy for obesity--today and

tomorrow. Baillieres Clin Endocrinol Metab. 1994;8(3):705-727.

13. Bjorntorp P. Treatment of obesity. Int J Obes Relat Metab Disord. 1992;16

(suppl 3):S81-S84.

14. Bray GA. Use and abuse of appetite-suppressant drugs in the treatment of

obesity. Ann Intern Med. 1993;119(7 pt 2):707-713.

15. Mosby-Year Book, Inc. Mosby’s GenRx: The Complete Reference for Generic

and Brand Drugs. 8th ed. St. Louis, MO: Mosby; 1998.

16. American Society of Health-System Pharmacists, Inc. American Hospital

Formulary Service Drug Information 98. Bethesda, MD: American Society of

Health-System Pharmacists; 1998.

17. U.S. Department of Health and Human Services, National Institutes of Health

(NIH). Clinical guidelines on the identification, evaluation, and treatment of

overweight and obesity in adults. National Heart, Lung, and Blood Institute and

National Institute of Diabetes and Digestive and Kidney Diseases. Bethesda,

MD: NIH; June 1998.

18. Jarvis M, McNaughton L, Seddon A, Thompson D. The acute 1-week effects

of the Zone diet on body composition, blood lipid levels, and performance in

recreational endurance athletes. J Strength Cond Res. 2002;16(1):50-57.

19. Haller C, Schwartz JB. Pharmacologic agents for weight reduction. J Gend

Specif Med. 2002;5(5):16-21.

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20. Shepherd TM. Effective management of obesity. J Fam Pract. 2003;52(1):34-

42.

21. Heshka S, Anderson JW, Atkinson RL, et al. Weight loss with self-help

compared with a structured commercial program: A randomized

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benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0039 Weight

Reduction Medications and Programs

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania annual 04/01/2019

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