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Weight Reduction Medications and Programs

Number: 0039

Policy

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 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:

  1. Member has a body mass index* (BMI) greater than or equal to 30 kg/m²; or
  2. 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:

    1. Coronary heart disease
    2. 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
         
    3. 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)
    4. Obstructive sleep apnea
    5. 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  http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm

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.

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)]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:

  • 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 are considered experimental and investigational for weight reduction:

  • Acupuncture for weight loss
  • Body plethysmography (diagnostic study)
  • Dual-energy X-ray (DEXA) body composition (diagnostic study)
  • Gastric electrical stimulation (see CPB 0678 - Gastric Pacing and Gastric Electrical Stimulation)
  • Human chorionic gonadotropin (HCG) or vitamin injections for weight loss
  • Indirect calorimetry (e.g., ReeVue Indirect Calorimeter) (diagnostic study)

Whole body calorimetry and composition is 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 
  • Weight Watchers, Jenny Craig, Diet Center, Zone diet, or similar programs.
Background

This policy is supported by NHLBI Guidelines on Diagnosis and Management of Obesity.

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.

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.

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).

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 effect of plants have 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 shoed 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.

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.

The ReeVue Indirect Calorimeter (KORR Medical Technologies, Salt Lake City, UT) was 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 the ReeVue Indirect Calorimeter 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, the ReeVue can also be used to measure basal metabolic rate.

Fioravante et al (2012) evaluated nutritional status, body composition, and (REE in patients with chronic hepatitis C before and during treatment with pegylated interferon and ribavirin.  This was a prospective study with the evaluation of patients with hepatitis C virus before and after 12 weeks of treatment with pegylated interferon and ribavirin.  The evaluation consisted of anthropometry (weight, height, BMI, and waist circumference), and body composition was determined by bioelectrical impedance analysis.  The REE of each individual was obtained by indirect calorimetry.  To compare the 2 phases of treatment, the Wilcoxon test was used.  The significance level was 5 %.  Subjects had significant weight loss during treatment with a consequent decrease in BMI.  This weight decrease was accompanied by a significant decrease in body fat and no decrease in fat-free mass.  There was a significant decrease in energy intake as assessed by 24-hour recall.  However, there was no change in REE and in REE corrected for fat-free mass.  The authors concluded that patients with hepatitis C treatment had significant weight loss and this was not associated with changes in energy expenditure.

Furthermore, 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”.

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 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. 

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. 

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 rate. 

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. 

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).

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
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-9 Codes
CPT codes covered if selection criteria are met:
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:
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 the patient
+ 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
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
G0271 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), group, (2 or more individuals), each 30 minutes
HCPCS codes not covered for indications listed in the CPB:
J7336 Capsaicin 8% patch, per sq cm
S9449 Weight management classes, non-physician provider, per session
Other HCPCS Codes related to the CPB:
S9451 Exercise classes, non-physician provider, per session
S9452 Nutrition classes, non-physician provider, per session
ICD-9 codes covered if selection criteria are met:
278.00 - 278.02 Overweight and obesity
V85.23 - V85.44 Body mass index 27.0-70 and over, adult
Other ICD-9 Codes related to the CPB:
250.00, 250.02, 250.10, 250.12, 250.20, 250.22, 250.30, 250.32, 250.40, 250.42, 250.50, 250.52, 250.60, 250.62, 250.70, 250.72, 250.80, 280.82, 250.90, 250.92 Diabetes
255.0 Cushing's syndrome
259.8 - 259.9 Other and unspecified endocrine disorders
272.0 Pure hypercholesterolemia
327.23 Obstructive sleep apnea (adult) (pediatric)
401.0 - 405.99 Hypertensive disease
414.00 - 414.9 Coronary atherosclerosis
783.1 Abnormal weight gain
783.6 Polyphagia
V85.0 - V85.22 Body mass index less than 19-26.9, adult


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