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ModifiedPremera BluecrossPolicy N/A

Drugs for Weight Management — Coverage Criteria and Authorization

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Criteria for medical necessity, authorization lengths, and reauthorization requirements for prescription drugs used for chronic weight management and related indications; intended for providers and pharmacy reviewers.

Policy Summary

PayerPremera Bluecross

PolicyDrugs for Weight Management — Coverage Criteria and Authorization

Policy CodePolicy N/A

Change TypeMaterial updates: added Zepboundexpanded Wegovy indicationspediatric clarifications

Effective DateN/A

Last ReviewAug 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of baseline BMI, a 3-month behavioral modification trial, dose/tolerability, and drug-specific weight-loss response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated Wegovy (semaglutide) coverage criteria to include use in certain individuals with established cardiovascular disease.

Added Zepbound (tirzepatide) as an FDA-approved drug for chronic weight management to the policy.

Added Wegovy (semaglutide) to policy as an FDA-approved drug for chronic weight management.

Clarified pediatric coverage additions for Qsymia and brand orlistat and added pediatric re-authorization criteria.

Updated adult weight-related comorbid condition criteria to expand and rename the list of qualifying comorbidities (e.g., added asthma, COPD, coronary artery disease, dyslipidemia, knee osteoarthritis, MAFLD/NAFLD, PCOS; retained type 2 diabetes mellitus).

Added generic phentermine and generic extended-release phentermine/topiramate coverage criteria and required a trial of generic phentermine and phentermine/topiramate ER before branded Qsymia.

Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information.

≥5%required weight-loss response for reauthorization (adults for many agents)

2.4 mgWegovy dose limit

15 mgZepbound OSA dose limit

3×120 mgXenical dose limit

1 yeartypical reauth approval length

N=17,604Wegovy SELECT trial enrollment

Coverage Criteria Initial and Continuation

Contrave (naltrexone/bupropion) — Initial Therapy (Adults)

Contrave (naltrexone/bupropion) — Initial Therapy (Adults): Covered when ALL of the following are met:

ALL of the following

Individual is aged 18 years or older
Has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
Has a body mass index (BMI) ≥ 30 kg/m2 OR has a BMI ≥ 27 kg/m2 with one or more weight-related comorbid conditions (asthma; cardiovascular disease; chronic obstructive pulmonary disease; coronary artery disease; dyslipidemia; hypertension; knee osteoarthritis; metabolic-dysfunction associated steatotic liver disease/non-alcoholic fatty liver disease; obstructive sleep apnea; polycystic ovarian syndrome; type 2 diabetes mellitus)
Medication is being used as an adjunct to a reduced-calorie diet and increased physical activity

Qsymia (phentermine and topiramate ER) — Initial Therapy

Qsymia (phentermine and topiramate ER) — Initial Therapy (Adults and Pediatrics): Covered when ALL of the following are met (step requirement applies to adults and pediatric applicants):

ALL of the following

For adults: individual is aged 18 years or older
For pediatric individuals: aged 12 to 17 years
Has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
For adults: BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with one or more weight-related comorbid conditions (listed above)
For pediatric individuals: current BMI ≥ 95th percentile for age and sex
Medication is being used as an adjunct to a reduced-calorie diet and increased physical activity
Has tried and had an inadequate response or intolerance to generic phentermine and topiramate extended-release (step requirement)
Dose limited to one 15 mg/92 mg capsule daily
Medication is not being used concurrently with other medications intended for weight loss (see list under generic phentermine and topiramate)
Qsymia is contraindicated in pregnancy; topiramate component associated with increased risk of oral clefts with first-trimester exposure.

Wegovy (semaglutide) and Saxenda (liraglutide) — Initial Therapy

Wegovy (semaglutide) and Saxenda (liraglutide) — Initial Therapy (Adults and Pediatrics): Separate age-specific criteria apply:

ALL of the following

Wegovy — Adults
- Individual is aged 18 years or older
- Has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
- BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with one or more weight-related comorbid conditions (listed above)
- Medication is being used as an adjunct to a reduced-calorie diet and increased physical activity
- Dose limited to 2.4 mg once weekly
- Medication is not being used concurrently with other medications intended for weight loss (see list)
Wegovy — Pediatrics
- Individual aged 12 to 17 years
- Has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
- Current BMI ≥ 95th percentile for age and sex
- Medication is being used as an adjunct to a reduced-calorie diet and increased physical activity
- Dose limited to 2.4 mg once weekly (pediatric quantity note may apply)
Wegovy — MACE risk reduction (Adults with established CVD)
- Adult aged ≥ 45 years with BMI ≥ 27 kg/m2 and established cardiovascular disease
- Medication is used in combination with optimized drug therapy for established cardiovascular disease
- Dose limited to 2.4 mg once weekly
- Medication is not being used concurrently with other weight-loss medications
- SELECT trial evidence supports Wegovy for reduction of major adverse cardiovascular events in this population; confirm patient meets trial-aligned criteria (age, BMI, established CVD).
Saxenda — Adults and Pediatrics
- Follow agent-specific dosing: titrate to 3 mg daily for Saxenda; used as an adjunct to diet and activity
- Adult criteria: age ≥ 18 years; BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with one or more weight-related comorbid conditions
- Pediatric criteria: aged 12 to 17 years with BMI ≥ 95th percentile for age and sex
- Medication is not used concurrently with other weight-loss medications
- Saxenda has a boxed warning regarding rodent thyroid C-cell tumors and is contraindicated in individuals with personal or family history of MTC or MEN2.

Combined initial and reauthorization criteria (summary)

Combined initial and reauthorization criteria — Summary of reauthorization thresholds and duration:

ALL of the following

Non-formulary exception reviews and authorization durations may be approved up to 12 months where permitted by the benefit plan
Wegovy reauthorization (adults): clinical benefit/response demonstrated as weight loss ≥ 5% of baseline body weight after 7 months of treatment and patient able to tolerate maintenance dose
Wegovy reauthorization (pediatrics): follows agent-specific reauth standards and pediatric dosing notes
Saxenda reauthorization: weight loss ≥ 4% of baseline body weight after 16 weeks of treatment and patient tolerates maintenance dose (pediatric reauth criteria apply where relevant)
Qsymia reauthorization: weight loss ≥ 5% of baseline body weight after 26 weeks of treatment
Contrave reauthorization: weight loss ≥ 5% of baseline body weight after 15 weeks of treatment
Xenical reauthorization: weight loss ≥ 5% of baseline body weight after 6 months of treatment
Zepbound and other agents: reauthorization may follow documentation of clinical response (weight loss and tolerability) and may be approved up to 12 months when benefit allows
At reauthorization, continued adherence to reduced-calorie diet and increased physical activity must be documented; trials/thresholds mirror those used in pivotal studies.

Drugs for weight management are excluded under many benefit plans. Refer to the applicable benefit plan document to determine benefit availability and specific terms, conditions, and limitations of coverage.

Concurrent-use restrictions: The medications listed in this policy must not be used concurrently with other medications intended for weight loss (including but not limited to phentermine; phentermine and topiramate ER; benzphetamine; diethylpropion; phendimetrazine; Alli; Contrave; Qsymia; Saxenda; Wegovy; Xenical; Zepbound).

Pregnancy and teratogenicity: Qsymia (phentermine/topiramate) is contraindicated in pregnancy due to risk of fetal harm (oral clefts associated with topiramate). Pregnancy testing and appropriate counseling should be performed per product labeling.

MTC / MEN2 contraindication: GLP-1 receptor agonists and GLP-1/GIP agents (e.g., Saxenda, Wegovy, Zepbound) carry boxed warnings from rodent data for thyroid C-cell tumors and are contraindicated in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).

Off-label / outside-studied-context caution: Use of these agents outside the studied trial populations, doses, or indications (including combinations) should be approached cautiously and is considered investigational unless supported by evidence and benefit plan language.

Initial Therapy Criteria (Agent-Specific)

INITIAL THERAPY CRITERIA

Agent-specific initial coverage requires meeting age, behavioral trial, BMI (or pediatric percentile), adjunctive lifestyle use, dose limits, and no concurrent weight-loss drug use.

ALL of the following

age: Age criteria per agent (adult or pediatric as specified)see agent-specific nodes
behavioral_trial: 3-month trial of behavioral modification and dietary restriction>=3 months
bmi: BMI >=30 or >=27 with comorbidity for adults; BMI >=95th percentile for pediatricssee agent
adjunctive_use: Used as adjunct to reduced-calorie diet and increased physical activity
dose_limit: Agent-specific dose limits apply (see policy)see agent
concurrent_use: Not used concurrently with other weight-loss medications

Initial therapy notes

Initial therapy trial designs and titration schemes from pivotal trials.

Saxenda initiation: Titrated to 3 mg daily during a 4-week period; used with ~500 kcal/day deficit and exercise counselingtolerability to 3 mg

See trial descriptions

Qsymia initiation: 4-week titration period followed by up to 52 weeks of treatment; used with ~500 kcal/day deficit and lifestyle counselingstudy-specific

Pediatric study used 56-week duration

Contrave initiation: Three-week dose-escalation followed by approximately 1 year of continued therapy with instruction to take with food and lifestyle counselingstudy-specific

Multiple 56-week trials

Initial therapy

Initial therapy considerations reflect trial titration schedules and baseline eligibility.

Initial therapy: Initiation follows product-specific titration (e.g., Saxenda to 3 mg daily over 4 weeks; Wegovy to 2.4 mg weekly over 16 weeks; Zepbound titrated to 5/10/15 mg weekly over ~20 weeks; Xenical 120 mg three times daily) with documented reduced-calorie diet and physical activity counseling.product-specific dosing/titration

Trials required lifestyle intervention beginning at first dose.

Initial therapy (summary)

Initial authorization historically requires evidence of behavioral modification and dietary restriction; pediatric trial duration for behavioral modification was shortened from 4 to 3 months for certain drugs.

Initial therapy summary: Initial authorization typically requires documented trial of behavioral modification and dietary restriction, meeting BMI thresholds (adult and pediatric percentiles), and presence/absence of qualifying comorbidities as defined in the policy.see per-drug criteria

Updates in 2025 expanded qualifying comorbidities list.

Continuation / Re-authorization Criteria

CONTINUATION CRITERIA

Re-authorization is contingent on demonstrated clinical benefit/response and continued lifestyle adherence.

ALL of the following

weight_response_adult_contrave: Weight loss >=5% baseline body weight after 15 weeks of treatment (Contrave)>=5% at 15 weeks
weight_response_other_adults: Weight loss >=5% baseline body weight after 26 weeks of treatment (many other agents)>=5% at 26 weeks
pediatric_reauth: For pediatric patients (12–17) on phentermine/topiramate agents: weight loss >=5% baseline BMI after 26 weeks>=5% BMI at 26 weeks
ongoing_lifestyle: The individual continues to adhere to a reduced-calorie diet and increased physical activity

Continuation / Re-authorization

Continuation/re-authorization requires demonstration of clinical benefit at drug-specific timepoints and adherence to diet and activity; approvals frequently issued for 1 year.

General continuation: Demonstrate drug-specific weight-loss threshold and continued adherence to reduced-calorie diet and increased physical activitysee thresholds module

Typical approval length: 1 year

Continuation therapy

Continuation generally aligns with trial maintenance phases where clinically meaningful weight loss is achieved and adverse effects are tolerable.

Continuation: Member demonstrates benefit (e.g., percent weight loss milestones per product labeling) and tolerates therapy without contraindications; ongoing diet/exercise counseling continues.product-specific

Trials included maintenance dosing periods of 52+ weeks after titration.

Reauthorization (historical thresholds summary)

Reauthorization requirements exist and have been historically defined per drug (weight-loss response thresholds and tolerability).

Reauthorization summary: Reauthorization criteria historically include percent weight loss thresholds after specified treatment durations (examples: Contrave >=5% after 15 weeks; Qsymia >=5% after 26 weeks; Saxenda >=4% after 16 weeks; Wegovy >=5% after 7 months; Xenical >=5% after 6 months) and tolerance of maintenance dose for some agents.see history for exact drug thresholds

These thresholds were part of prior updates and retained unless superseded.

Coding, BMI Thresholds, and Key Values

BMI / Percentile thresholds — adults and pediatric

Adult BMI thresholdBMI ≥30 kg/m2, or BMI ≥27 kg/m2 with one or more specified weight‑related comorbidities

Pediatric (age 12–17) thresholdBMI ≥95th percentile for age and sex (see Appendix Table I)

Comorbidity examples that allow BMI ≥27 pathwayAsthma; cardiovascular disease; COPD; coronary artery disease; dyslipidemia; hypertension; knee osteoarthritis; MAFLD/NAFLD; obstructive sleep apnea; PCOS; type 2 diabetes mellitus

Re-authorization efficacy thresholds — drug-specific

General reauthorization ruleReauthorization requires demonstration of drug‑specific weight‑loss response and continued adherence to reduced‑calorie diet and increased physical activity; approvals commonly granted for 1 year

Saxenda (adults)≥4% baseline body weight at 16 weeks AND able to tolerate maintenance dose 3 mg once daily

Wegovy (adults)≥5% baseline body weight after 7 months of treatment AND able to tolerate maintenance dose 2.4 mg once weekly

Zepbound (adults)≥5% baseline body weight after 7 months AND able to tolerate up to 15 mg once weekly; for OSA indication: ≥10% after 12 months

BMI definitions — obesity and overweight cutoffs

Obesity (adult)BMI ≥30 kg/m2

Overweight with qualifying comorbidityBMI 27.0–29.9 kg/m2 when one or more specified weight‑related comorbidities are present

Pediatric definition (reference)Pediatric obesity defined by BMI percentiles per Appendix Table I (BMI ≥95th percentile qualifies)

HbA1c for T2DM trials — typical baseline ranges

Typical baseline HbA1c range in T2DM trial populationsHbA1c approximately 7–10% in trials enrolling individuals with type 2 diabetes mellitus

Saxenda T2DM studyStudy 2 enrolled individuals with HbA1c 7–10% receiving metformin, sulfonylurea, or glitazone or diet/exercise

Wegovy/Zepbound trials with T2DM cohortsTrials enrolling T2DM participants specified baseline HbA1c in the 7–10% range

Pediatric BMI percentiles — Appendix Table I

Pediatric obesity cutoff (summary)BMI ≥95th percentile for age and sex qualifies as obesity for pediatric coverage (age ≥12 years)

Appendix Table IProvides sex‑ and age‑specific BMI cutoffs (e.g., age 12 male 95th percentile = 24.2 kg/m2; female = 25.2 kg/m2) — see Appendix for full table

ApplicabilityUsed to determine pediatric eligibility for agents approved for ages 12–17 (e.g., Qsymia, Saxenda, Wegovy, Xenical)

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Authorization length limits

Initial authorization lengths vary by product. Non‑formulary exception reviews for any drug listed may be approved up to 12 months. Routine initial approvals by product: Contrave — as specified in product criteria; generic phentermine and phentermine/topiramate ER (including Qsymia) — up to 6 months; Saxenda — up to 4 months; Wegovy and Zepbound for chronic weight management — up to 7 months; Xenical and brand orlistat — up to 6 months. Follow the product's FDA dosing and administration prescribing information when requesting authorization.

Documentation Required

Re‑authorization requirements (drug‑specific)

Re‑authorization requires objective evidence of clinical benefit at drug‑specific timepoints. Examples: weight loss ≥5% of baseline body weight after 26 weeks for most adult agents (eg, Contrave, Qsymia, generic phentermine/topiramate ER); Saxenda—weight loss ≥4% after 16 weeks and ability to tolerate maintenance dose; Wegovy—weight loss ≥5% after ~7 months and ability to tolerate maintenance dose; Zepbound—weight loss ≥5% after 7 months and ability to tolerate up to 15 mg weekly. Pediatric re‑auth criteria use percent change in baseline BMI (not body weight) and include lower percent thresholds for some agents per product criteria.

Prior Authorization

Prior authorization requirement — documentation expectations

Prior authorization is required for the weight‑management drugs listed in this policy. Requests must include indication, baseline body weight and BMI, documentation of a trial of behavioral modification/dietary restriction (typically ≥3 months unless pediatric criteria specify otherwise), relevant weight‑related comorbidities, current medication dose and plan, and evidence of prior drug trials when the policy requires (for example, trial of generic phentermine and phentermine/topiramate ER is required prior to branded Qsymia).

Denial Risk

Concurrent weight‑loss medication exclusion (do not co‑prescribe)

These agents must not be used concurrently with other medications intended for weight loss. Concurrent use with other prescription or OTC weight‑loss agents (including generic phentermine, phentermine/topiramate ER, benzphetamine, diethylpropion, phendimetrazine, Contrave, Qsymia, Saxenda, Wegovy, Xenical/brand orlistat, and Zepbound) will result in denial of the request.

phentermine
phentermine and topiramate ER (generic and branded Qsymia)
benzphetamine
diethylpropion
phendimetrazine
Contrave (naltrexone/bupropion)
Qsymia (phentermine/topiramate ER)
Saxenda (liraglutide)
Wegovy (semaglutide)
Xenical / brand orlistat
Zepbound (tirzepatide)

Denial Risk

Contraindicated conditions for GLP‑1/GIP agents

Screen for contraindicated conditions for GLP‑1/GIP receptor agonists. These products (eg, Saxenda, Wegovy, Zepbound) carry boxed warnings regarding thyroid C‑cell tumors and are contraindicated in individuals with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). Document absence of these histories in the medical record prior to authorization.

Documentation Required

OSA diagnostic documentation for Zepbound

For Zepbound when requested for the OSA indication, include a sleep study (polysomnography) report performed within the prior 12 months documenting an apnea‑hypopnea index (AHI) ≥15 events/hour. Also document that central sleep apnea (≥50% central events) and Cheyne‑Stokes respiration are not present.

Documentation Required

Supporting clinical documentation

Support requests with prior clinical documentation: prior trials of indicated agents (including required step trials), prior lifestyle intervention attempts, baseline and on‑treatment weights/BMI, comorbidity history, and dose‑tolerance information. When policy requires a documented prior trial (for example, trial of generic phentermine and phentermine/topiramate ER before Qsymia), include treatment dates, doses, and reason for discontinuation if applicable.

Step Therapy

Step therapy requirement for Qsymia

Qsymia requires step therapy: trial and inadequate response or intolerance to generic phentermine and to generic phentermine/topiramate extended‑release (when available) are required prior to coverage of the branded product. Follow sequencing and coverage guidance in the policy when submitting requests.

Documentation Required

Adjunctive therapy and dosing notes

Adjunctive therapy: all drugs are approved only as adjuncts to a reduced‑calorie diet and increased physical activity — document the dietary/physical activity plan. Observe product dosing limits (for example, Saxenda titration to and maintenance at 3 mg daily; Wegovy maintenance at 2.4 mg weekly; Zepbound maintenance up to 15 mg weekly) and include dose‑tolerance evidence when required for re‑authorization.

Documentation Required

Pediatric step/re‑authorization notes

Pediatric‑specific requirements: where pediatric indications apply (eg, Qsymia, Saxenda, Wegovy, Xenical), ensure trials of behavioral modification are consistent with pediatric timing (often shortened to 3 months), document baseline BMI percentile (≥95th percentile for obesity), and apply pediatric re‑authorization thresholds based on percent change in baseline BMI. Include pediatric quantity limits or dose caps as noted in product guidance.

Step Therapy and Fail-First Requirements

Step	Requirement	Applies to
1	Trial of generic phentermine and topiramate extended‑release with inadequate response or intolerance prior to Qsymia; dose limit for generic formulation: one 15 mg/92 mg capsule daily	Adults (and pediatric where applicable per product labeling) — required before branded Qsymia

Topic	Policy note
Adjunctive use	Medications are required to be used as an adjunct to a reduced‑calorie diet and increased physical activity (policy reiterates diet/exercise counseling as part of therapy).
Dose limits	Dose limits are specified per product (examples: Wegovy maintenance dose limited to 2.4 mg once weekly; Saxenda maintenance dose limited to 3 mg once daily; generic phentermine/topiramate ER limited to one 15 mg/92 mg capsule daily).
Explicit sequencing	Policy operationalizes a required trial of generic phentermine and phentermine/topiramate ER prior to branded Qsymia (explicit step for Qsymia); other agents reference adjunctive lifestyle use and dose limits but do not specify additional multi‑step drug sequencing in the cited chunks.

Documentation element	Requirement
Behavioral modification trial	Medical record must document a trial of behavioral modification and dietary restriction (≥3 months) prior to initiating therapy or as required for re‑authorization evidence.
Baseline measures	Documentation should include baseline body weight and BMI (or baseline BMI percentile for pediatrics) to enable assessment of percent weight/BMI change at re‑authorization.
Re‑authorization response	Re‑authorization requires demonstration of drug‑specific clinical benefit (examples: ≥5% baseline body weight for many agents after specified treatment durations; Saxenda ≥4% at 16 weeks; Wegovy ≥5% at 7 months; Qsymia/Xenical/Zepbound thresholds as specified in policy).

Requirement	Least‑cost alternative required	Notes
Trial of least‑cost alternative prior to branded agent	Covered — trial of generic phentermine and phentermine/topiramate ER is required prior to coverage of branded Qsymia (explicit in 2025 update).	Policy update clarifies generic formulations and generic phentermine/topiramate ER must be tried first; concurrent use with listed policy agents is disallowed.

Quantity Limits and Dose Caps

Contrave quantity limit

Contrave quantity limitLimit to four Contrave 8 mg tablets per day (taken as two in the morning and two in the evening)

Phentermine / phentermine-topiramate ER quantity limits

Generic phentermine and phentermine/topiramate ER (including Qsymia) quantity limitLimit to one 15 mg/92 mg capsule per day

Note on step therapyQsymia requires prior trial and inadequate response or intolerance to generic phentermine and phentermine/topiramate ER in adults

Xenical (orlistat) quantity limit

Xenical (orlistat) quantity limitLimit to three 120 mg capsules daily (one capsule three times a day)

Wegovy (semaglutide) dose limit

Wegovy dose limit (adult maintenance)Limit to 2.4 mg once weekly (maintenance dose)

Pediatric maintenance dosing notePediatric maintenance doses referenced include 1.7 mg or 2.4 mg once weekly per reauthorization criteria

Saxenda (liraglutide) dose limit

Saxenda dose limitLimit to 3 mg once daily (maintenance dose)

Titration noteSaxenda is titrated to 3 mg daily during a 4‑week period in pivotal trials

Zepbound (tirzepatide) — OSA indication dose limit

Zepbound dose limit for OSA indicationLimit to 15 mg once weekly (maintenance) for the OSA pathway

General maintenance dosingZepbound maintenance dosing described up to 15 mg once weekly following titration to 5/10/15 mg

Wegovy pediatric quantity limit update

Wegovy pediatric quantity limit updateMinor correction made to the pediatric quantity limit for Wegovy in 2023 (see policy history and quantity limits section)

ImplicationPediatric quantity limit corrected but pediatric dosing/reauthorization criteria remain per Appendix and product labeling

Wegovy (semaglutide) pediatric quantity correction

Wegovy pediatric minor correction2023 update noted a minor correction to the pediatric quantity limit for Wegovy; pediatric maintenance doses referenced include 1.7 mg or 2.4 mg once weekly

ReferenceSee 2023 Update and Wegovy pediatric criteria in policy for exact pediatric quantity specification

Definitions and Appendix References

Behavioral modification trial — definition

Behavioral modification trial definitionA documented trial of behavioral modification and dietary restriction for at least 3 months prior to initiating drug therapy

PurposeRequired as part of initial authorization criteria for listed weight‑management medications

Age considerations — indications and pediatric applicability

Age considerations — FDA labelingAge indications for each listed drug follow FDA labeling (e.g., adults ≥18; certain agents have pediatric approval for ages 12–17)

Pediatric applicabilityPediatric coverage (age 12–17) applies where FDA‑approved and requires BMI percentile criteria per Appendix Table I

Run-in period — definition used in trials

Run‑in period definitionA pre‑randomization period in trials during which participants receive diet/exercise counseling and sometimes low‑calorie diets to assess initial weight loss; some trials randomized only those achieving predefined run‑in weight loss

Trial examplesSaxenda Study 3 used a 4–12 week diet run‑in with at least 5% weight loss for randomization; Wegovy Study 3 used an initial 8‑week low‑calorie diet run‑in prior to treatment

Pediatric BMI cut-offs — Appendix Table I reference

Pediatric BMI cut-offs referenceAppendix Table I provides BMI cut‑offs for obesity by sex and age for pediatric individuals aged 12 years and older (CDC criteria)

Example valuesAge 12 male 95th percentile = 24.2 kg/m2; female 95th percentile = 25.2 kg/m2; table contains detailed sex‑ and age‑specific cutoffs

Drugs for Weight Management — Coverage Criteria and Authorization

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Coverage Criteria Initial and Continuation

Initial Therapy Criteria (Agent-Specific)

Continuation / Re-authorization Criteria

Coding, BMI Thresholds, and Key Values

Provider Actions, Documentation, and Prior Authorization

Step Therapy and Fail-First Requirements

Quantity Limits and Dose Caps

Site of Care

Definitions and Appendix References

Background

Drugs for Weight Management — Coverage Criteria and Authorization

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Coverage Criteria  Initial and Continuation

Initial Therapy Criteria (Agent-Specific)

Continuation / Re-authorization Criteria

Coding, BMI Thresholds, and Key Values

Provider Actions, Documentation, and Prior Authorization

Step Therapy and Fail-First Requirements

Quantity Limits and Dose Caps

Site of Care

Definitions and Appendix References

Background

Coverage Criteria Initial and Continuation