CurrentPacificSourcePolicy CLB1234_FETE_0524

2026 PacificSource Health Plans Formulary Exception and Tier Exception Criteria

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This policy governs PacificSource commercial member requests for formulary exceptions and lower-cost tier exceptions, including drug-specific criteria for Zepbound, Wegovy, and Nurtec.

Policy Summary

PayerPacificSource

PolicyFormulary Exception and Tier Exception Criteria

Policy CodePolicy CLB1234_FETE_0524

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument intolerance or treatment failure with formulary alternatives and confirm that the requested drug is prescribed within FDA-approved dosage and indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization duration

Tier 3 to Tier 2Tier exception direction

AHI ≥15Zepbound OSA threshold

≥27 or ≥30BMI thresholds

≥10%

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CurrentPacificSourcePolicy CLB1234_FETE_0524

2026 PacificSource Health Plans Formulary Exception and Tier Exception Criteria

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Sign up for pacificsource Policy CLB1234_FETE_0524 alerts

Get alerted when Policy CLB1234_FETE_0524 changes without checking for updates manually.

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This policy governs PacificSource commercial member requests for formulary exceptions and lower-cost tier exceptions, including drug-specific criteria for Zepbound, Wegovy, and Nurtec.

Policy Summary

PayerPacificSource

PolicyFormulary Exception and Tier Exception Criteria

Policy CodePolicy CLB1234_FETE_0524

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument intolerance or treatment failure with formulary alternatives and confirm that the requested drug is prescribed within FDA-approved dosage and indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization duration

Tier 3 to Tier 2Tier exception direction

AHI ≥15Zepbound OSA threshold

≥27 or ≥30BMI thresholds

≥10%

Zepbound reauthorization weight loss

8/30 daysNurtec acute limit

Formulary, Tier, and Drug-Specific Coverage

Commercial formulary exception

A formulary exception requires all of the following.

General formulary exception criteria

ALL of the following
- The member has documented intolerance or failure to formulary alternatives for the submitted diagnosis.
- The requested dosage and indication are within FDA-approved labeling.
- The requested drug will not be used experimentally, including experimental concomitant use with other drugs.
- The provider has demonstrated that no other medically reasonable formulary options exist.

Commercial tier exception

A tier exception must meet all applicable eligibility requirements.

ALL of the following

The request is to cover a Tier 3 drug at Tier 2.
The drug is not a Tier 1 or specialty drug.
All lower-tier options have been tried and found ineffective.
The medication is a high-risk anti-seizure treatment or transplant immunosuppressant.
The drug is on the member's current formulary.
Non-formulary drugs, including approved formulary exception authorizations, are not eligible for a tier exception.

Zepbound initial therapy

Zepbound is covered for moderate-to-severe obstructive sleep apnea in adults with obesity when all criteria are met.

ALL of the following

The member is at least 18 years old.
The member has moderate-to-severe obstructive sleep apnea with an apnea-hypopnea index (AHI) of at least 15 documented by polysomnography or a home sleep study performed within the past 5 years.AHI >= 15
The member has a body mass index of at least 30 kg/m2.BMI >= 30 kg/m2
The member has current OSA symptoms, such as excessive daytime sleepiness, loud snoring, choking, gasping, pauses in breathing, sleep arousals, or difficulty maintaining sleep.

Zepbound reauthorization

Zepbound reauthorization requires all treatment-success elements.

ALL of the following

There is improvement in the AHI score or OSA symptoms.
The member has achieved and maintained at least 10% weight loss after starting Zepbound.>= 10% maintained weight loss

Wegovy MACE risk reduction

Wegovy is covered for major adverse cardiovascular event (MACE) risk reduction when all criteria are met.

ALL of the following

The adult has established cardiovascular disease with a documented prior myocardial infarction, ischemic or hemorrhagic stroke, or symptomatic peripheral artery disease.
The member has a body mass index of at least 27 kg/m2.BMI >= 27 kg/m2
Treatment is used with caloric restriction, increased physical activity, and behavioral modification.
The member has documented intolerance or treatment failure with formulary cardiovascular alternatives, including lipid-lowering agents, antiplatelet or anticoagulant therapy, and antihypertensive agents.

Wegovy MASH

Wegovy is covered for MASH when all criteria are met.

ALL of the following

The adult has noncirrhotic MASH or NASH with moderate-to-advanced F2-F3 liver fibrosis.F2-F3 fibrosis
ONE of
- Fibrosis is confirmed by a conclusive result from a well-validated noninvasive test, such as FAST, MAST, or MEFIB.
- Fibrosis is confirmed by liver biopsy. Biopsy is also required when noninvasive testing is inconclusive or other causes of liver disease have not been ruled out.
Other causes of liver steatosis have been ruled out, such as alcohol-associated liver disease, chronic hepatitis C, Wilson disease, or drug-induced liver disease.

Drug-specific exclusions

The following uses are excluded.

Excluded uses

Zepbound is used for weight loss without OSA.
Zepbound is used for type 1 or type 2 diabetes, with or without OSA.
Zepbound is used for central or mixed sleep apnea.
Zepbound is used for obesity hypoventilation syndrome or daytime hypercapnia.
Zepbound is used with a history of ketoacidosis.
The member has a personal or family history of medullary thyroid carcinoma or MEN 2.

Nurtec coverage criteria

Nurtec formulary exception coverage requires all of the following.

ALL of the following

The member has documented intolerance or failure to formulary alternatives for the submitted diagnosis.
The requested dosage and indication are within FDA-approved labeling.
The provider has demonstrated that no other medically reasonable formulary options exist.

Zepbound is not covered for weight loss without obstructive sleep apnea (OSA), for type 1 or type 2 diabetes with or without OSA, or for central or mixed sleep apnea. Excluded uses also include obesity hypoventilation syndrome or daytime hypercapnia, a history of ketoacidosis, a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and concurrent use with another GLP-1 receptor agonist.

Wegovy is not covered for weight loss without a documented major adverse cardiovascular event (MACE) or metabolic dysfunction-associated steatohepatitis (MASH) diagnosis. Coverage is also excluded for type 1 or type 2 diabetes without MACE or MASH.

Combined use of Nurtec with Botox for migraine prevention is excluded from coverage.

Combined use of Nurtec with another calcitonin gene-related peptide (CGRP) inhibitor for acute or preventive treatment is excluded from coverage.

Clinical Thresholds and Operational Values

Zepbound OSA threshold

Apnea-hypopnea index (AHI)At least 15

Diagnostic sourcePolysomnography or home sleep study

Study timeframeWithin the past 5 years

Zepbound BMI threshold

Body mass index (BMI)30 kg/m2 or greater

Eligible populationAdults with obesity and moderate-to-severe obstructive sleep apnea

Required accompanying treatmentReduced-calorie diet, increased physical activity, and behavioral modification

Authorization, Documentation, and Denial Risks

Prior Authorization

Formulary Exception Authorization

Submit a formulary exception authorization request only when the member has documented intolerance or failure of formulary alternatives for the submitted diagnosis, the requested dosage and indication are FDA-approved, the use is not experimental, and no other medically reasonable formulary options exist.

Document the member’s response, intolerance, or failure with formulary alternatives.
Provide records supporting the FDA-labeled dosage and indication.
Address any potentially experimental concomitant drug use.
If approved, authorization is generally for 12 months; reauthorization requires treatment success and a clinically significant response.

Prior Authorization

Tier Exception Authorization

A tier exception may reduce cost sharing only from Tier 3 to Tier 2 and only for an eligible high-risk medication that is on the member’s current formulary.

Policy Purpose and Exception Pathways

This policy provides formulary exception and tier exception pathways when standard formulary placement or tier structure does not adequately support medically appropriate therapy. Requests are evaluated using clinical necessity, FDA-approved dosage and indication, documented intolerance or treatment failure with formulary alternatives, and the availability of other medically reasonable options. Drug-specific criteria apply to Zepbound for obesity-associated moderate-to-severe obstructive sleep apnea and to Wegovy for eligible adults requiring MASH treatment or reduction of major adverse cardiovascular event risk.

Key Terms

Tier exception

DefinitionCoverage of a drug at a lower cost-sharing tier

Eligible tier directionTier 3 to Tier 2 only

Formulary requirementThe drug must be on the member's current formulary

PAP treatment failure

DefinitionContinued obstructive sleep apnea symptoms despite qualifying PAP use

Qualifying PAP useAt least 4 hours per night on 70% or more of nights

Alternative eligibility pathwayA contraindication to PAP therapy

Initial Authorization Requirements

Zepbound initial therapy

Zepbound initial therapy requires all OSA, clinical, formulary, and PAP criteria.

ALL of the following

The member is at least 18 years old.
Moderate-to-severe OSA is documented by an AHI of at least 15 on polysomnography or a home sleep study within the past 5 years.AHI >= 15
BMI is at least 30 kg/m2.BMI >= 30 kg/m2
Current OSA symptoms are documented.

Reauthorization Requirements

Zepbound continuation

Zepbound reauthorization requires all of the following.

ALL of the following

There is improvement in the AHI score or OSA symptoms.
The member has achieved and maintained at least 10% weight loss after starting therapy.>= 10% maintained weight loss

Wegovy continuation

Wegovy reauthorization requires documented disease or treatment response.

ONE of

For MACE risk reduction, treatment success is documented.

Prior Treatment Requirements

Step	Prior therapy required	Duration	Requirement
1	Mounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus	At least 12 weeks	Documented treatment failure or intolerable adverse event for Wegovy MASH coverage

Nurtec Quantity Limits

Nurtec acute migraine quantity limit

MedicationNurtec

Acute migraine limit8 tablets per 30 days

PopulationAdults receiving acute treatment of migraine

Nurtec preventive migraine quantity limit

MedicationNurtec

Preventive migraine limit16 tablets per 30 days

PopulationAdults receiving preventive treatment of migraine

Cost-Effective Site-of-Care Requirements

Billing Rule

Use the most cost-effective site for Zepbound

All Zepbound approvals are subject to use of the most cost-effective site of care.

Billing Rule

Use the most cost-effective site for Wegovy

All Wegovy approvals are subject to use of the most cost-effective site of care.

Billing Rule

Use the most cost-effective site of care

All approvals are subject to utilization of the most cost-effective site of care. Confirm the approved treatment will be provided at the required site before submitting or billing.

Policy Summary

PayerPacificSource

PolicyFormulary Exception and Tier Exception Criteria

Policy CodePolicy CLB1234_FETE_0524

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument intolerance or treatment failure with formulary alternatives and confirm that the requested drug is prescribed within FDA-approved dosage and indication.

SourceLink

On This Page

Treatment is used with a physician-directed reduced-calorie diet, increased physical activity, and behavioral modification.

The member has documented intolerance or treatment failure with formulary alternatives for the submitted diagnosis.

ONE of

Treatment failure with positive airway pressure (PAP), defined as persistent OSA symptoms despite at least 4 hours of PAP use per night on at least 70% of nights.At least 4 hours per night on 70% or more of nights
A contraindication to PAP therapy.

Zepbound is prescribed concurrently with PAP therapy unless PAP is contraindicated or clinically significant adverse effects occur.

Baseline AST and ALT values are provided.

The member has documented treatment failure or an intolerable adverse event after at least 12 weeks of Mounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus.At least 12 weeks

The member abstains from alcohol.

Comprehensive comorbidity management is underway, including diet and exercise for weight management and medications for relevant comorbidities.

Zepbound is used concurrently with another GLP-1 receptor agonist.

Wegovy is used for weight loss without a MACE or MASH diagnosis.

Wegovy is used for type 1 or type 2 diabetes without MACE or MASH.

PAP treatment-failure threshold

PAP use thresholdAt least 4 hours per night on 70% or more of nights

Treatment-failure findingContinued symptoms of obstructive sleep apnea

Alternative to PAP failureA documented contraindication to PAP therapy may qualify

Zepbound reauthorization

Maintained weight loss10% or greater after starting Zepbound

Additional response requirementImprovement in AHI score or obstructive sleep apnea symptoms

Authorization stageReauthorization

Wegovy MACE risk reduction

Body mass index (BMI)27 kg/m2 or greater

Cardiovascular eligibilityEstablished cardiovascular disease with a prior myocardial infarction, stroke, or symptomatic peripheral artery disease

Required accompanying treatmentCaloric restriction, increased physical activity, and behavioral modification

Wegovy MASH fibrosis

Fibrosis stageF2 to F3

Disease definitionNoncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH)

Confirmation methodsA conclusive validated noninvasive test or liver biopsy

Wegovy MASH prior treatment

Prior-treatment durationAt least 12 weeks

Qualifying prior therapiesMounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus

Required treatment outcomeTreatment failure or an intolerable adverse event

Tier 1 and Specialty drugs are not eligible.

Non-formulary drugs, including drugs approved through a formulary exception, are not eligible.

All lower-tier options must have been tried and found ineffective.

Eligible high-risk categories include anti-seizure treatment and transplant immunosuppressants.

Approval is generally for 12 months.

Documentation Required

Nurtec Formulary Exception Documentation

For a Nurtec formulary exception, document intolerance or failure of formulary alternatives for the submitted diagnosis, confirm that the requested dosage and indication are within FDA-approved labeling, and show that no other medically reasonable formulary options exist.

Acute migraine treatment quantity limit: 8 tablets per 30 days.
Preventive migraine treatment quantity limit: 16 tablets per 30 days.
Initial authorization is generally 6 months; reauthorization is generally 12 months.

Prior Authorization

Specialist Prescriber Requirement

The prescriber must prescribe Wegovy or be in consultation with the appropriate specialist for the requested indication.

MACE risk reduction: cardiologist consultation is required.
MASH/NASH: gastroenterologist or hepatologist consultation is required.
Use the most cost-effective site of care.

Step Therapy

Lower-Tier Trial Requirement

Before requesting a tier exception, document that all available lower-tier formulary options were tried and were ineffective.

This requirement applies in addition to the Tier 3-to-Tier 2 eligibility and current-formulary requirements.

Step Therapy

Wegovy MASH Step Requirement

For Wegovy requested for MASH, document treatment failure or an intolerable adverse event after at least 12 weeks of an appropriate alternative regimen.

Qualifying alternatives include Mounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus.
Document alcohol abstinence and comprehensive comorbidity management, including diet and exercise and management of associated conditions.

Documentation Required

General Formulary Exception Documentation

For any formulary exception, submit documentation showing the member’s response or intolerance to formulary alternatives, that the requested treatment is being used for an FDA-labeled indication and dosage, and that no other medically reasonable formulary option is available.

Include relevant clinical records and supporting diagnostic information.
Reauthorization requires documentation of treatment success and clinically significant response.

Documentation Required

Zepbound OSA Documentation

For Zepbound coverage for obstructive sleep apnea, document moderate to severe OSA, qualifying sleep-study results, obesity, current symptoms, and use with a physician-directed weight-loss program.

Document an AHI of at least 15 on polysomnography or a home sleep study performed within the past 5 years.
Document BMI of at least 30 kg/m².
Include symptoms such as excessive daytime sleepiness, loud snoring, choking, gasping, pauses in breathing, sleep arousals, or difficulty maintaining sleep.
Document a reduced-calorie diet, increased physical activity, and behavioral modification.

Documentation Required

Zepbound PAP Documentation

For Zepbound OSA requests, document either PAP treatment failure or a contraindication to PAP therapy and address concurrent PAP use unless contraindicated or clinically significantly adverse.

PAP failure means continued OSA symptoms despite at least 4 hours of PAP use per night on 70% or more of nights.
Qualifying contraindications may include upper-airway anatomic abnormalities, pneumothorax, or invasive mechanical ventilation.
Document PAP adherence and ongoing symptoms or the applicable contraindication.
Zepbound should be prescribed concurrently with PAP unless contraindicated or clinically significant adverse effects occur.

Documentation Required

Wegovy MACE Documentation

For Wegovy MACE risk-reduction requests, submit evidence of an established qualifying cardiovascular event, BMI of at least 27 kg/m², and use with diet, physical activity, and behavioral modification.

Qualifying events include myocardial infarction, ischemic or hemorrhagic stroke, or symptomatic peripheral artery disease with intermittent claudication and ABI less than 0.85 at rest, or prior peripheral arterial revascularization.
Document the qualifying event and BMI.
Include the cardiovascular formulary alternative treatment failure or intolerance when required.

Documentation Required

Wegovy MASH Documentation

For Wegovy MASH coverage, document noncirrhotic MASH/NASH with moderate to advanced F2–F3 liver fibrosis and provide the required diagnostic evidence.

Provide a conclusive validated noninvasive test, such as FAST, MAST, or MEFIB, or a liver biopsy when noninvasive testing is inconclusive or other liver disease causes have not been excluded.
Document that other causes of hepatic steatosis have been ruled out.
Submit baseline AST and ALT values.

Step Therapy

Wegovy MASH Prior-Treatment Documentation

Before requesting Wegovy for MASH, document failure or intolerance after at least 12 weeks of one specified alternative therapy.

Acceptable alternatives are Mounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus.
Document the treatment duration and the failure or intolerable adverse event.

Documentation Required

Required Medical Information

Submit the medical information needed to establish formulary exception eligibility, including alternative treatment failure or intolerance, the FDA-approved use and dosage, and evidence supporting the applicable diagnosis-specific criteria.

Include clinical records and diagnostic test results relevant to the requested indication.
For Nurtec, document that no other medically reasonable formulary options exist.
For diagnosis-specific requests, provide all required supporting measurements, treatment history, and specialist information.

Denial Risk

General Formulary Exception Denial Conditions

A general formulary exception may be denied when the request lacks evidence of formulary alternative failure or intolerance, is for a non-FDA-approved dosage or indication, involves experimental use, or does not include sufficient supporting documentation.

Requests may also fail when medically reasonable formulary options remain available.
Reauthorization may be denied without treatment success and a clinically significant response.

Denial Risk

Tier Exception Eligibility Limits

A tier exception is ineligible when the request seeks a reduction other than Tier 3 to Tier 2, involves a Tier 1 or Specialty drug, concerns a non-formulary drug, or does not satisfy the lower-tier trial requirement.

Formulary exception approvals are not eligible for a tier exception.
All lower-tier options must have been tried and found ineffective.
The medication must be a qualifying high-risk medication on the member’s current formulary.

Unsupported block type: denial_riskول

Unsupported block type: denial_risk

MACE

MACEMajor adverse cardiovascular events

Cardiovascular deathIncluded

Non-fatal eventsNon-fatal myocardial infarction or non-fatal stroke

MASH

MASHMetabolic dysfunction-associated steatohepatitis

Disease classificationNoncirrhotic disease with moderate-to-advanced F2 to F3 liver fibrosis

Former terminologyFormerly called nonalcoholic steatohepatitis (NASH)

The member participates in a physician-directed reduced-calorie diet, increased physical activity, and behavioral modification program.

The member has documented intolerance or treatment failure with formulary alternatives for the submitted diagnosis.

ONE of

PAP treatment failure, defined as continued OSA symptoms despite at least 4 hours of PAP use per night on at least 70% of nights.At least 4 hours per night on 70% or more of nights
A contraindication to PAP therapy.

PAP therapy is used concurrently unless contraindicated or clinically significant adverse effects occur.

Wegovy MACE initial therapy

Wegovy MACE risk-reduction therapy requires all cardiovascular, BMI, lifestyle, and formulary criteria.

ALL of the following

The adult has established cardiovascular disease with a documented prior myocardial infarction, stroke, or symptomatic peripheral artery disease.
BMI is at least 27 kg/m2.BMI >= 27 kg/m2
Treatment is used with caloric restriction, increased physical activity, and behavioral modification.
The member has documented intolerance or treatment failure with appropriate formulary cardiovascular therapies, including lipid-lowering agents, antiplatelet or anticoagulant therapy, and antihypertensive agents.

Wegovy MASH initial therapy

Wegovy MASH therapy requires all diagnostic, laboratory, prior-treatment, lifestyle, and comorbidity criteria.

ALL of the following

The adult has noncirrhotic MASH or NASH with F2-F3 fibrosis.F2-F3 fibrosis
ONE of
- Fibrosis is confirmed by a conclusive validated noninvasive test, such as FAST, MAST, or MEFIB.
- Fibrosis is confirmed by liver biopsy.
Other causes of liver steatosis have been ruled out.
Baseline AST and ALT values are documented.
Treatment failure or an intolerable adverse event is documented after at least 12 weeks of Mounjaro, Ozempic, Trulicity, liraglutide, or Rybelsus.At least 12 weeks
The member abstains from alcohol.
Comprehensive comorbidity management is underway, including diet and exercise for weight management and medications for relevant comorbidities.

Nurtec initial authorization

Nurtec formulary exception requests are evaluated under all of the following requirements.

ALL of the following

Documented intolerance or failure to formulary alternatives for the submitted diagnosis.
The requested dosage and indication are within FDA-approved labeling.
The provider has demonstrated that no other medically reasonable formulary options exist.

For MASH, disease responsiveness is documented through improvement or stability in laboratory results such as ALT and AST, or in fibrosis assessed by a noninvasive test.