Asset Publisher
Weight Management Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-91228
This is an optional program that applies to Blue Partner, Commercial, GenPlus, NetResults A series, and SourceRx formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
10-01-2024 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Saxenda® (liraglutide) Subcutaneous injection solution |
Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
Limitations of Use:
|
|
1 |
Wegovy® (semaglutide) Subcutaneous injection solution |
In combination with a reduced calorie diet and increased physical activity:
Limitations of Use: Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended |
|
2 |
Zepbound™ (tirzepatide) Subcutaneous injection solution |
As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
Limitations of Use:
|
|
3 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Obesity |
Obesity rates have increased sharply over the last 30 years, creating a global public health crisis. The National Health and Nutrition Examination Surveys show that nearly 2 of 3 US adults are overweight or obese, and 1 of 3 adults are obese. Adults with body mass index (BMI) 25-29.9 kg/m^2 are considered overweight; those with BMI greater than or equal to 30 kg/m^2 are considered obese.(5) Weight loss is difficult for most people and weight loss medications help reinforce behavioral strategies to lose weight. Medications for weight loss do not work on their own. Numerous guidelines recommend the addition of weight loss medications only in conjunction with lifestyle and behavioral modifications.(4,5,6,11) GLP-1 is an endogenous incretin hormone produced by L cells within the intestinal mucosa in response to the intake of nutrients. GLP-1 receptors are expressed in multiple organs, including pancreas, gastrointestinal (GI) tract, heart, brain, kidney, lung, and thyroid. This ubiquitous expression of GLP-1 receptors could be the reason for its pleiotropic benefits for T2DM, weight loss, and cardio protection. GLP-1 has numerous metabolic effects, including but not limited to, glucose-dependent stimulation of insulin secretion, delayed gastric emptying, inhibition of food intake, and modulation of β-cell proliferation. Semaglutide was approved for the management of obesity in 2021. Having a dose–response effect on weight loss, semaglutide was approved at doses higher than indicated for T2DM. GLP-1 RAs do not have the same neuropsychiatric adverse effects as other FDA-approved drugs on the market. Other benefits include inherent glucoregulatory properties and cardio protection in select populations.(11) The American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity recommends the following:(5)
*Certain ethnicities (A BMI cutoff point value of greater than or equal to 23 kg/m^2 should be used in the screening and confirmation of excess adiposity in South Asian, Southeast Asian, and East Asian adults) The Endocrine Society clinical practice guidelines suggests medications approved for chronic weight management can be useful adjuncts to lifestyle change for patients who have been unsuccessful with diet and exercise alone. They recommend adherence to American Heart Association Guidelines (2013) [see below] which include advice for assessment and treatment with diet and exercise, as well as bariatric surgery for appropriate candidates.(4)
The American Heart Association/American College of Cardiology/Obesity Society Guideline (2013) suggests if weight and lifestyle history indicates the patient has never participated in a comprehensive lifestyle intervention program as defined in the guidelines (i.e., trained interventionist or nutritional professional supervision of diet, exercise, and behavior therapy), it is recommended that the patient undertake such a program before addition of adjunctive therapies (e.g., pharmacotherapy), since a substantial proportion of patients will lose sufficient weight to improve health with comprehensive lifestyle management alone. If a patient has been unable to lose weight or sustain weight loss with comprehensive lifestyle intervention and has BMI greater than or equal to 30 kg/m^2 or greater than or equal to 27 kg/m^2 with greater than or equal to 1 obesity-associated comorbid condition(s), adjunctive therapy may be considered. The expert panel did not review comprehensive evidence on pharmacotherapy for weight loss. Medications should be FDA approved and clinicians should be knowledgeable about the product label. The provider should weigh potential risks of the medication vs. potential benefits of successful weight loss for the individual patient. If the patient is currently taking an obesity medication but has not lost at least 5% of initial body weight after 12 weeks on a maximal dose of the medication, the provider should reassess the risk-to-benefit ratio of that medication for the patient and consider discontinuation of that drug.(6) The American Gastroenterological Association (AGA) clinical practice guidelines (2022) strongly recommended the use of pharmacotherapy in addition to lifestyle intervention in adults with overweight and obesity (body mass index 30 kg/m^2 or greater, or 27 kg/m^2 or greater with weight-related complications) who have an inadequate response to lifestyle interventions. The panel suggested the use of semaglutide 2.4 mg, liraglutide 3.0 mg, phentermine-topiramate ER, and naltrexone-bupropion ER (based on moderate certainty evidence), and phentermine and diethylpropion (based on low certainty evidence), for long-term management of overweight and obesity. The guideline panel suggested against the use of orlistat. The panel identified the use of Gelesis100 oral superabsorbent hydrogel as a knowledge gap.(11) |
Pediatric Obesity |
Pediatric obesity has become an epidemic and international problem. In the United States, the prevalence of obesity in children has risen from 5% in 1970 to 17% in 2004. Genetics and environment are the underlying causes of the increase in pediatric obesity. Obese children and adolescents are at risk of developing the same comorbid conditions as obese and overweight adults. Obesity and overweight in children are defined on percentages specific for age and gender defined BMI values. The American Academy of Pediatrics (AAP) define obesity as a BMI greater than or equal to 95th percentile or a BMI greater than or equal to 30 kg/m^2, whichever is lower, and overweight as a BMI within 85th to 94th percentile for children and adolescents 2 years of age and older.(9,10) The AAP recommends that clinicians should assess medical and behavioral risks in any child with a BMI above the 85th percentile before initiating any intervention.(9,10) The Endocrine Society Pediatric Obesity Treatment Guidelines also recommend that clinicians should evaluate for potential comorbidities in children and adolescents with a BMI greater than or equal to 85th percentile.(8) The 2023 AAP guidelines recommend the use of weight loss agents in conjunction with lifestyle and behavioral changes. Pediatricians and other primary healthcare providers should treat children and adolescents for overweight with comorbidities (BMI greater than or equal to 85th percentile; comorbidities such as dyslipidemia, prediabetes, Type 2 diabetes, fatty liver disease, hypertension) and obesity (BMI greater than or equal to 95th percentile).(10) The 2017 Endocrine Society guidelines only recommend the use of FDA approved pharmacotherapy in pediatric patients as adjunctive therapy to lifestyle modifications of the highest intensity available and only by clinicians that are experienced in the use of anti-obesity agents.(8)
|
Cardiovascular |
Wegovy (semaglutide) was studied to determine its effect relative to placebo on major adverse cardiovascular events (MACE) when added to current standard of care, which included management of cardiovascular risk factors and individualized healthy lifestyle counseling (including diet and physical activity), in patients who are overweight or with obesity, and without diabetes. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Inclusion requirements of the trial included: (12)
Guidelines recommend that patients work towards goal of tobacco cessation and avoiding tobacco exposure, managing hypertension to goal, and managing lipid levels to goal as risk reduction measures for CVD secondary prevention. (13,14,15) |
Efficacy |
SELECT Trial (Wegovy) Study 1 (NCT03574597) was a multi-national, multi-center, placebo-controlled, double-blind trial to determine the effect of Wegovy relative to placebo on major adverse cardiovascular events (MACE) when added to current standard of care, which included management of CV risk factors and individualized healthy lifestyle counseling (including diet and physical activity). The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. All patients were 45 years or older, with an initial BMI of 27 kg/m2 or greater and established cardiovascular disease (prior myocardial infarction, prior stroke, or peripheral arterial disease). Patients with a history of type 1 or type 2 diabetes were excluded.(2) In this trial, 17,604 patients were randomized to Wegovy or placebo. At baseline, the mean age was 62 years and 12,732 patients (72.3%) were male. The mean BMI was 33 kg/m^2, and 12,580 patients (71.5%) met the BMI criterion for obesity (≥30). The mean glycated hemoglobin level was 5.8%, and 11,696 patients (66.4%) met the glycated hemoglobin criterion for prediabetes (defined as a mean level of 5.7 to 6.4%). At baseline, prior myocardial infarction was reported in 76% of randomized individuals, prior stroke in 23%, and peripheral arterial disease in 9%. Heart failure was reported in 24% of patients. At baseline, cardiovascular disease and risk factors were managed with lipid lowering therapy (90%), platelet aggregation inhibitors (86%), angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (74%), and beta blockers (70%). A total of 10% had moderate renal impairment (eGFR 30 to <60 mL/min/1.73m2 ) and 0.4% had severe renal impairment eGFR <30 mL/min/1.73m2.(2,16) Patients were randomly assigned, with the use of a centralized system in a double-blind manner and in a 1:1 ratio without stratification, to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo. The starting dose of semaglutide was 0.24 mg once weekly, and the dose was increased every 4 weeks (to once weekly doses of 0.5, 1.0, 1.7, and 2.4 mg) until the target dose of 2.4 mg was reached after 16 weeks. If dose escalation led to unacceptable adverse effects, the dose-escalation intervals could be extended, treatment could be paused, or maintenance doses below the 2.4 mg per week target dose could be used.(16) Among the 17,604 patients with a BMI of 27 or greater and preexisting cardiovascular disease but without diabetes, treatment with once-weekly subcutaneous semaglutide at a dose of 2.4 mg for a mean duration of 33 months reduced the risk of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke by 20% (hazard ratio, 0.80; 95% CI, 0.72 to 0.90). |
Safety |
Liraglutide has the following:(1)
Semaglutide has the following:(2)
Tirzepatide has the following:(3)
Co-Administration None of the FDA approved weight loss agents have approval for co-administration with another weight loss agent. New guidelines do not support the use of co-administration of weight loss pharmacological agents.(4,5,10) Use of non-approved drug combinations for obesity treatment should be limited to clinical trials, and patients should be informed when drugs are being used off label alone or in combination.(6) |
REFERENCES
Number |
Reference |
1 |
Saxenda prescribing information. Novo Nordisk Inc. April 2023. |
2 |
Wegovy prescribing information. Novo Nordisk Inc. March 2024. |
3 |
Zepbound prescribing information. Lilly USA, LLC. March 2024. |
4 |
Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342–362. |
5 |
American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity. Endocr Pract. 2016 Jul:22(Suppl 3):1-203. |
6 |
Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014;129(25 Suppl 2):S102–S138. |
7 |
Yanovski SZ, Yanovski JA. Long-Term Drug Treatment for Obesity: A Systematic and Clinical Review. JAMA. 2014 Jan;311(1):74-86. |
8 |
Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity - Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Jan;102(3):709–757. |
9 |
Barlow SE, et al. Expert Committee Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity: Summary Report. Pediatrics. 2007 Dec;120(Suppl 4):S164-S192. |
10 |
American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity. Pediatrics. 2023 Jan;151(2):1-100. |
11 |
American Gastroenterological Association (AGA) Clinical Practice Guideline on Pharmacological Interventions for Adults with Obesity. Gastroenterology. 2022 Nov;163(5):1198-1225. |
12 |
Ryan DH, Lingvay I, Colhoun HM, et al. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design. American Heart Journal. 2020;229:61-69. doi:10.1016/j.ahj.2020.07.008. |
13 |
Smith SC, Benjamin EJ, Bonow RO, et al. AHA/ACCF Secondary Prevention and Risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update. Circulation. 2011;124(22):2458-2473. doi:10.1161/cir.0b013e318235eb4d. |
14 |
Kleindorfer D, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients with stroke and Transient Ischemic Attack: A Guideline from the American Heart Association/American Stroke Association. Stroke. 2021;52(7). doi:10.1161/str.0000000000000375. |
15 |
Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients with Chronic Coronary Disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023;148(9). doi:10.1161/cir.0000000000001168. |
16 |
Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389(24):2221-2232. doi:10.1056/NEJMoa2307563. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Saxenda |
liraglutide (weight mngmt) soln pen-inj |
18 MG/3ML |
M ; N ; O ; Y |
N |
|
|
Wegovy |
semaglutide (weight mngmt) soln auto-injector |
0.25 MG/0.5ML ; 0.5 MG/0.5ML ; 1 MG/0.5ML ; 1.7 MG/0.75ML ; 2.4 MG/0.75ML |
M ; N ; O ; Y |
N |
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
10 MG/0.5ML ; 12.5 MG/0.5ML ; 15 MG/0.5ML ; 2.5 MG/0.5ML ; 5 MG/0.5ML ; 7.5 MG/0.5ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Saxenda |
Liraglutide (Weight Mngmt) Soln Pen-Inj 18 MG/3ML (6 MG/ML) |
18 MG/3ML |
15 |
mLs |
30 |
DAYS |
|
|
|
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.25 MG/0.5ML |
8 |
Pens |
180 |
DAYS |
*This strength is not approvable for maintenance dosing |
|
|
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.5 MG/0.5ML |
8 |
Pens |
180 |
DAYS |
*This strength is not approvable for maintenance dosing for pediatric patients |
|
|
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
1 MG/0.5ML |
8 |
Pens |
180 |
DAYS |
*This strength is not approvable for maintenance dosing for pediatric patients |
|
|
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
1.7 MG/0.75ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
2.4 MG/0.75ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
2.5 MG/0.5ML |
4 |
Pens |
180 |
DAYS |
*This strength is not approvable for maintenance dosing |
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
5 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
7.5 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
10 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
12.5 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
15 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
ADDITIONAL QUANTITY LIMIT INFORMATION
Wildcard |
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Additional QL Information |
Targeted NDCs When Exclusions Exist |
Effective Date |
Term Date |
|
|||||||
6125207000D520 |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.25 MG/0.5ML |
*This strength is not approvable for maintenance dosing |
|
|
|
6125207000D525 |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.5 MG/0.5ML |
*This strength is not approvable for maintenance dosing for pediatric patients |
|
|
|
6125207000D530 |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
1 MG/0.5ML |
*This strength is not approvable for maintenance dosing for pediatric patients |
|
|
|
6125258000D520 |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
2.5 MG/0.5ML |
*This strength is not approvable for maintenance dosing |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Saxenda |
liraglutide (weight mngmt) soln pen-inj |
18 MG/3ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
semaglutide (weight mngmt) soln auto-injector |
0.25 MG/0.5ML ; 0.5 MG/0.5ML ; 1 MG/0.5ML ; 1.7 MG/0.75ML ; 2.4 MG/0.75ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
10 MG/0.5ML ; 12.5 MG/0.5ML ; 15 MG/0.5ML ; 2.5 MG/0.5ML ; 5 MG/0.5ML ; 7.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Saxenda |
Liraglutide (Weight Mngmt) Soln Pen-Inj 18 MG/3ML (6 MG/ML) |
18 MG/3ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
2.4 MG/0.75ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
1 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
0.25 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Wegovy |
Semaglutide (Weight Mngmt) Soln Auto-Injector |
1.7 MG/0.75ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
10 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
2.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
7.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
15 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
Zepbound |
tirzepatide (weight mngmt) soln auto-injector |
12.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL the following are met:
Length of Approval:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ PS_Weight_Management_PAQL _ProgSum_ 10-01-2024