Weight Loss - Appetite Suppressants and Orlistat Prior Authorization Policy - OpenPayer
CurrentCignaPolicy N/A
Weight Loss - Appetite Suppressants and Orlistat Prior Authorization Policy
Defines prior authorization requirements, approval durations, age and BMI thresholds, required behavioral modification trial, concomitant use requirement, continuing-therapy effectiveness thresholds, and non-covered uses for specified appetite suppressants and orlistat (Xenical) under Cigna-administered benefit plans. Part 1 of 2; covers policy overview, FDA indications, criteria for several products, and exclusions.
Policy Summary
PayerCigna
PolicyWeight Loss - Appetite Suppressants and Orlistat Prior Authorization Policy
Policy CodePolicy N/A
Change TypeAnnual revision with wording clarifications and header updates
Effective Date
Next Review Date
Key ActionDocument baseline BMI prior to the requested medication and ensure prior authorization is requested with required documentation (behavioral trial, comorbidities, and weight-loss response for continuation).
POLICY UPDATE CHANGES
Annual revision: no criteria changes; Regimax removed as obsolete; phendimetrazine tartrate extended-release capsules added to header.
Criteria language modified to reference 'at baseline' BMI rather than 'currently has' and behavioral modification wording simplified (removed 'failed to achieve desired weight loss').
Qsymia, orlistat, and others had similar wording updates clarifying baseline references and behavioral modification phrasing.
Removed previous language requiring failure to achieve weight loss after a 3-month behavioral trial; changed behavioral requirement to 'medication will be used concomitantly with behavioral modification and a reduced-calorie diet.'
Removed phrasing 'prior to initiation of Qsymia' in several places and standardized baseline language referencing orlistat 120 mg.
Phentermine/topiramate extended-release (generic to Qsymia) was added to the policy.
Examples of weight loss medications updated to reflect product availability.
9Drugs listed for PA coverage
1OTC product excluded (Alli)
>=3 moBehavioral modification trial minimum
>=5%Continuing therapy weight loss threshold
YesDistinct adult & pediatric rules
Coverage Summary
This policy defines prior authorization requirements for prescription appetite suppressants and prescription orlistat (Xenical/orlistat 120 mg) and supports coverage with specified clinical criteria. Coverage stance: covered_with_criteria — approvals are time-limited and require documentation of age, baseline BMI (or BMI percentile for pediatrics), behavioral modification/diet, and response for continuation. Prior Authorization is recommended for listed prescription products (e.g., phentermine formulations, benzphetamine, diethylpropion, phendimetrazine, phentermine/topiramate [Qsymia], Contrave, and Xenical/orlistat 120 mg) with product-specific approval durations; Alli (orlistat 60 mg OTC) is excluded from prior authorization/prescription benefit coverage.
The policy incorporates guideline and FDA context endorsing pharmacotherapy as an adjunct to lifestyle modification for patients who meet BMI thresholds or have weight-related comorbidities; pediatric guidance permits pharmacotherapy for selected agents in patients ≥ 12 years. Operational notes: Baseline refers to measurements prior to the requested medication (with explicit references to orlistat 120 mg baseline where specified), and continuing therapy generally requires ≥ 5% weight loss from baseline.
Prior Authorization is recommended for prescription benefit coverage of the listed products. Approvals are provided for the durations noted below. In months, 1 month = 30 days. Prior Authorization and coverage not recommended for Alli (orlistat 60 mg).
All approvals provided durations as noted per product-specific sections. Benefits determined by applicable benefit plan document and clinical judgment may apply.
Medical-Necessity Criteria (by product)
I. Diethylpropion, Lomaira, phendimetrazine, phentermine ODT - FDA-Approved Indication: Weight Loss
Approve when ONE of the following initial or continuing therapy criteria are met:
A) Initial Therapy (approve for 3 months)
Age and behavioral trial: Patient is ≥ 16 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity:
Not Covered / Contraindications
Conditions Not Covered / Contraindication
Not recommended when ANY of the following apply:
Concomitant use contraindication: Concomitant use with other medications FDA-approved for weight loss is not recommended
Examples listed in policy include phentermine, benzphetamine, diethylpropion, phendimetrazine, Contrave, Qsymia, orlistat 120 mg, Saxenda, Wegovy, Zepbound. Alli (orlistat 60 mg OTC) is available over-the-counter and PA/prescription benefit coverage is not recommended.
Coding
Products listed in policy header (drugs subject to prior authorization)mixedCovered
Adipex-P
phentermine hydrochloride capsules and tablets (Teva; brand obsolete 07/12/2023)
benzphetamine
benzphetamine tablets (generic only)
Contrave
naltrexone HCl/bupropion HCl ER tablets (Nalpropion/Currax)
diethylpropion
diethylpropion hydrochloride immediate-release and controlled-release tablets (generic only)
Lomaira
phentermine hydrochloride tablets (KVK-Tech)
phendimetrazine
phendimetrazine tartrate tablets and extended-release capsules (generic only)
Over-the-counter not recommended for PA (not covered via prescription benefit PA)mixedNot Covered
Alli
orlistat 60 mg capsules (OTC) - PA not recommended
DrugNDC
Orlistat 102 mg (Xenical, authorized generic)
Policy addresses orlistat 102 mg product (Xenical and authorized generic)
Provider Actions
Prior Authorization
Prior authorization required
Prior Authorization is recommended for the listed prescription products; approvals are time-limited per product (3 months, 4 months, 6 months, or 1 year for continuing therapy).
Adipex-P
benzphetamine
Contrave
diethylpropion
Lomaira
phendimetrazine
phentermine ODT
Qsymia
Xenical
Documentation Required
Background & Evidence
FDA-approved indications summarized in the policy: short-term adjunctive indications for benzphetamine, diethylpropion, phendimetrazine, and phentermine for management of exogenous obesity (initial BMI ≥ 30 kg/m2, or ≥ 27 kg/m2 with risk factors). Phentermine/topiramate extended-release (Qsymia) and Contrave are indicated as adjuncts to reduced-calorie diet and increased physical activity for adults (and for Qsymia, adults and pediatric patients ≥ 12 years with obesity), with evaluation and discontinuation thresholds referenced in product labeling.
Orlistat 120 mg (Xenical, authorized generic) is indicated for obesity management including weight loss and maintenance when used with a reduced-calorie diet in patients with initial BMI ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight-related comorbidity.
Guideline context: Endocrine Society (2015) and AACE/ACE (2016) recommend pharmacotherapy as an adjunct to behavioral modification for patients with BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with comorbidity and endorse continuation when response is adequate (e.g., weight loss ≥ 5%). AGA (2022) also supports adding pharmacologic agents for adults with obesity or overweight with weight-related complications after inadequate lifestyle response. Pediatric guidance from the American Academy of Pediatrics (2023) supports offering weight-loss pharmacotherapy to adolescents ≥ 12 years with obesity (BMI ≥ 95th percentile) per medication indications, risks, and benefits.
Evidence / sources
Guidelines citedEndocrine Society 2015; AACE/ACE 2016; AGA 2022; AAP 2023
Definitions & Thresholds
Baseline: measurements taken prior to initiation of the requested medication for weight loss (policy note repeated across product sections).
Operational note for orlistat 120 mg (Xenical, authorized generic): where specified, baseline refers explicitly to values prior to orlistat 120 mg and must be documented for adult and pediatric eligibility and for continuing therapy assessments (e.g., adult BMI thresholds or pediatric BMI ≥ 95th percentile).
Thresholds (quick reference)
Initial behavioral modification trial>= 3 months
Continuing therapy weight loss threshold>= 5% of baseline body weight
BMI - adult>= 30 kg/m2 OR >= 27 kg/m2 with >=1 qualifying comorbidity (at baseline)
BMI - pediatric>= 95th percentile for age and sex (>=12 and <18 years) (at baseline)
Qsymia - initial/continuing durations
Revision History
2025-05-28revisedLatest
Annual revision: no criteria changes; Regimax removed as obsolete; phendimetrazine tartrate extended‑release capsules added to the header; criteria apply to ER and IR formulations.
2025-01-15revised (policy wording clarified)
Criteria language modified to reference 'at baseline' BMI rather than 'currently has' and behavioral modification wording simplified to 'medication will be used concomitantly with behavioral modification and a reduced‑calorie diet' (removed requirement to have failed to achieve desired weight loss).
2025-01-15revised (baseline clarified)
Policy Summary
PayerCigna
PolicyWeight Loss - Appetite Suppressants and Orlistat Prior Authorization Policy
Policy CodePolicy N/A
Change TypeAnnual revision with wording clarifications and header updates
Effective Date
Next Review Date
Key ActionDocument baseline BMI prior to the requested medication and ensure prior authorization is requested with required documentation (behavioral trial, comorbidities, and weight-loss response for continuation).
On This Page
At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidity
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
B) Continuing Therapy (approve for 1 year)
Age: Patient is ≥ 16 years of age
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
Weight-related comorbidities list as above.
Effectiveness: Patient has lost ≥ 5% of baseline body weight≥ 5%
Baseline refers to baseline prior to the medication.
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
II. Contrave (naltrexone HCl/bupropion HCl ER) - FDA-Approved Indication: Weight Loss
Approve when ONE of the following initial or continuing therapy criteria are met:
A) Initial Therapy (approve for 4 months)
Age and behavioral trial: Patient is ≥ 18 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
B) Continuing Therapy (approve for 1 year)
Age: Patient is ≥ 18 years of age
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
Weight-related comorbidities list as above.
Effectiveness:
III. Qsymia (phentermine/topiramate ER) - FDA-Approved Indications
Separate adult and pediatric criteria. Approve when ONE of the following initial or continuing therapy criteria are met:
Age and behavioral trial: Patient is ≥ 18 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
Age and behavioral trial: Patient is ≥ 12 years and < 18 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
BMI percentile: At baseline, patient had a BMI ≥ 95th percentile for age and sex≥ 95th percentile
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
Age and behavioral trial: Patient is ≥ 18 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
Baseline BMI or BMI with comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
BMI >=30: At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
BMI >=27 with comorbidity: At baseline, patient had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidityBMI ≥27 + comorbidity
Age and behavioral trial: Patient is ≥ 12 years and < 18 years of age; Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
BMI percentile: At baseline, patient had a BMI ≥ 95th percentile for age and sex≥ 95th percentile
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
Baseline BMI percentile: At baseline, patient had a BMI ≥ 95th percentile for age and sex≥ 95th percentile
Effectiveness: Patient has had a reduction in BMI percentile for age and weight (taking into account height increase)BMI percentile improvement or ≥5% BMI reduction
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
Initial Therapy: At baseline, the patient had a BMI ≥ 30 kg/m2 OR at baseline had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidity; Patient will use medication concomitantly with behavioral modification and a reduced-calorie dietInitial approve 3 months (policy-level note)
Baseline refers to baseline prior to orlistat 120 mg (Xenical, authorized generic).
Continuing Therapy: At baseline, the patient had a BMI ≥ 30 kg/m2 OR at baseline had a BMI ≥ 27 kg/m2 AND at baseline had, or currently has, at least ONE weight-related comorbidity; Patient has lost ≥ 5% of baseline body weight; Medication will be used concomitantly with behavioral modification and a reduced-calorie dietContinuing approve 1 year
Baseline refers to baseline prior to orlistat 120 mg (Xenical, authorized generic).
Orlistat 102 mg - Weight Loss Pediatric Initial Therapy
Covered when ALL of the following are met:
Pediatric Initial Therapy: At baseline, the patient had a BMI ≥ 95th percentile for age and sex; Patient is ≥ 12 years and < 18 years of age; Medication will be used concomitantly with behavioral modification and a reduced-calorie dietInitial approve (policy-level) 3 months
Baseline refers to baseline prior to orlistat 120 mg (Xenical, authorized generic).
Orlistat 102 mg - Weight Loss Pediatric Continuing Therapy
Covered when ALL of the following are met:
Pediatric Continuing Therapy: At baseline, the patient had a BMI ≥ 95th percentile for age and sex; Patient has lost ≥ 5% of baseline body weight OR has had a reduction in BMI percentile for age and weight (accounting for height increase); Medication will be used concomitantly with behavioral modification and a reduced-calorie dietContinuing approve 1 year
Baseline refers to baseline prior to orlistat 120 mg (Xenical, authorized generic).
Document baseline BMI and comorbidities
Providers must document baseline BMI prior to the requested medication and, if BMI 27-<30, document at baseline the presence of at least one listed weight-related comorbidity.
Documentation Required
Document behavioral modification trial
Providers must document a trial of behavioral modification and dietary restriction for at least 3 months prior to initial therapy (except where plan indicates otherwise for specific products' age/indication).
Denial Risk
Effectiveness requirement for continuation
For continuing therapy approvals, providers must document weight-loss response or BMI/BMI-percentile response (as specified for pediatric Qsymia) or the request will not meet criteria for continued approval.
Continuing therapy requires ≥ 5% weight loss from baseline for most agents.
Pediatric Qsymia continuation requires ≥ 5% reduction in BMI from baseline or BMI-percentile improvement as specified.
Billing Rule
Duration conventions
When approval is authorized in months, 1 month equals 30 days.
Documentation Required
Baseline BMI documentation
Document baseline BMI prior to orlistat 120 mg (Xenical, authorized generic) to demonstrate eligibility (adult or pediatric thresholds as specified).
Documentation Required
Behavioral modification and diet
Document that the medication will be used concomitantly with behavioral modification and a reduced-calorie diet.
Denial Risk
Concomitant weight-loss medications
Claims may be denied or not recommended if patient is receiving concomitant FDA-approved weight-loss medications.
Concomitant use with other FDA‑approved weight‑loss medications is not recommended and may lead to denial.
Product prescribing informationReferences provided for each product (individual PIs cited in references: Benzphetamine 2024; Diethylpropion 2019; Phendimetrazine 2018; Adipex-P 2024; Lomaira 2023; Phentermine ODT 2023; Qsymia 2024; Contrave 2024; Xenical 2022)
Initial: 6 months; Continuing: 1 year
Contrave - initial/continuing durationsInitial: 4 months; Continuing: 1 year
Orlistat (Xenical) - initial/continuing durationsInitial: 3 months; Continuing: 1 year
Weight loss response (continuation)>= 5% reduction from baseline body weight (adults); pediatric Qsymia: >=5% BMI reduction or BMI percentile/BMI metric improvement per criteria
Notes added clarifying 'baseline' refers to measurements prior to the requested medication and baseline references were standardized across Qsymia, orlistat, and other agents.
2025-01-15revised (continuing therapy clarified)
Continuing therapy requirement clarified to require ≥ 5% weight loss from baseline, with baseline defined as prior to the specific medication (examples: prior to Qsymia or prior to orlistat 120 mg).
added
Phentermine/topiramate extended‑release (generic to Qsymia) was added to the policy (selected revision noted).
2025-05-28clarifiedLatest
Concomitant use with other medications FDA‑approved for weight loss is not recommended; examples of weight‑loss medications were updated to reflect product availability.
Patient has lost ≥ 5% of baseline body weight
≥ 5%
Baseline refers to baseline prior to Contrave.
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
Patient has lost ≥ 5% of baseline body weight
≥ 5%
Baseline refers to prior to Qsymia.
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet
Patient has lost ≥ 5% of baseline body weight
≥ 5%
Baseline refers to prior to orlistat 120 mg (Xenical, authorized generic).
Concomitant behavioral modification: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet