Prior Authorization : Services Requiring Prior Authorization

Anti-Obesity Drugs

PA requests for the following anti-obesity drugs must be submitted on the Prior Authorization Drug Attachment for Anti-Obesity Drugs form:

• Benzphetamine
• Diethylpropion
• Orlistat
• Phendimetrazine
• Phentermine
• Phentermine/topiramate
• Evekeo
• Saxenda
• Wegovy
• Xenical
• Zepbound

Anti-obesity drugs are covered for dual eligibles enrolled in a Medicare Part D PDP.

Submitting Prior Authorization Requests for Anti-Obesity Drugs

Prescribers, or their designees, are required to request PA for anti-obesity drugs using one of the following options:

• DAPO Center
• Portal
• Fax
• Mail

A prescriber, or their designee, should have all PA information completed before calling the DAPO Center to obtain PA.

Prescribers are required to retain a completed copy of the Prior Authorization Drug Attachment for Anti-Obesity Drugs form and any supporting documentation.

If a prescriber or their designee chooses to submit a paper PA request for anti-obesity drugs by fax or mail, the following must be completed and submitted to ForwardHealth:

• PA/RF
• Prior Authorization Drug Attachment for Anti-Obesity Drugs form
• Supporting documentation, as appropriate

The Prior Authorization Fax Cover Sheet is available on the Forms page of the Portal for prescribers or their designee submitting the forms and documentation by fax.

Prescribers are reminded that they are required to complete, sign, and date the PA/RF and the Prior Authorization Drug Attachment for Anti-Obesity Drugs form when submitting the PA request on paper.

Note: These anti-obesity drugs have separate PA submission requirements:

• Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease
• Wegovy to treat MASH
• Zepbound to treat moderate to severe OSA in adults with obesity

Information is available about general ForwardHealth policy for drugs that require PA approval. This includes what may not be considered criteria to support the need for a drug.

Clinical Criteria for Anti-Obesity Drugs

Clinical criteria for approval of a PA request for anti-obesity drugs require one of the following:

• The member is 18 years of age or older (or 12 years of age or older for Evekeo requests only) and has a BMI greater than or equal to 30.
• The member is 18 years of age or older (or 12 years of age or older for Evekeo requests only), has a BMI greater than or equal to 27 but less than 30 and has two or more of the following risk factors:
• The member is currently being treated for dyslipidemia.
• The member is currently being treated for hypertension.
• The member is currently being treated for sleep apnea.
• The member is currently being treated for type 2 diabetes mellitus.
• The member has cardiovascular disease, which is supported by a history of at least one of the following:
  • Myocardial infarction (heart attack)
  • Coronary revascularization
  • Angina pectoris
  • Stroke
  • Intermittent claudication with an ABI of less than or equal to 0.9
  Peripheral arterial revascularization due to atherosclerotic disease
  • Amputation due to atherosclerotic disease

For Saxenda PA requests for members 12–17 years of age, the member has a body weight above 132 pounds and a BMI corresponding to 30 or greater for adults by international cut-offs. (Note: BMI is determined using International Obesity Task Force BMI cut-offs for obesity by gender and age for pediatric patients aged 12 years and older [Cole Criteria]).

For orlistat, phentermine/topiramate, Wegovy, and Xenical PA requests for members 12–17 years of age, the member has a BMI greater than or equal to the 95th percentile standardized by age and gender.

In addition, all of the following must be true:

• The member is not pregnant or nursing.
• The member does not have a history of an eating disorder (for example, anorexia, bulimia, or binge eating disorder).
• The prescriber has evaluated and determined that the member does not have any medical or medication contraindications to treatment with the anti-obesity drug being requested.
• For controlled substance anti-obesity drugs, the member does not have a medical history of substance abuse or misuse.
• The member has participated in a weight loss treatment plan (for example, nutritional counseling, an exercise regimen, or a calorie-restricted diet) in the past six months and will continue to follow the treatment plan while taking an anti-obesity drug.

PA requests for anti-obesity drugs will not be renewed if a member's BMI is below 24.

PA requests for anti-obesity drugs will only be approved for one anti-obesity drug per member. ForwardHealth does not cover treatment with more than one anti-obesity drug.

ForwardHealth does not cover:

• Any brand name innovator single ingredient phentermine products or phentermine 8 mg tablets.
• OTC anti-obesity drugs.
• Anti-obesity drugs used for conditions not outlined in clinical PA criteria.

ForwardHealth will return PA requests for the previously listed drugs as noncovered services.

Initial and Renewal PA Requests for Benzphetamine, Diethylpropion, Phendimetrazine, and Phentermine

If clinical criteria for anti-obesity drugs are met, initial PA requests for benzphetamine, diethylpropion, phendimetrazine, and phentermine will be approved for up to 90 days. If the member meets a weight loss goal of at least 10 pounds of their weight from baseline during the initial 90-day approval, PA may be requested for an additional three months of treatment. The maximum length of continuous drug therapy for benzphetamine, diethylpropion, phendimetrazine, and phentermine is six months.

If the member does not meet a weight loss goal of at least 10 pounds of their weight from baseline during the initial 90-day approval or the member has completed six months of continuous benzphetamine, diethylpropion, phendimetrazine, or phentermine treatment, then the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with this group of drugs (benzphetamine, diethylpropion, phendimetrazine, and phentermine) during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Phentermine/Topiramate

If clinical criteria for anti-obesity drugs are met, initial PA requests for phentermine/topiramate will be approved for up to 183 days. If the member meets a weight loss goal of at least 5% of their weight from baseline, PA may be requested for an additional 183 days of treatment. PA requests for phentermine/topiramate may be approved for a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5% of their weight from baseline during the initial six-month approval or the member has completed 12 months of continuous phentermine/topiramate treatment, then the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with phentermine/topiramate during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Evekeo

If clinical criteria for anti-obesity drugs are met, initial PA requests for Evekeo will be approved for up to 30 days. The maximum length of continuous drug therapy for Evekeo is one month.

After the member has completed one month of Evekeo treatment, the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with Evekeo during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Saxenda

If clinical criteria for anti-obesity drugs are met, initial PA requests for Saxenda will be approved for up to 183 days. If the member meets a weight loss goal of at least 5% of their weight from baseline, PA may be requested for an additional 183 days of treatment. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Saxenda prescribing information. PA requests for Saxenda may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5% of their weight from baseline during the initial 183-day approval or the member has completed 12 months of continuous Saxenda treatment, then the member must wait six months before PA can be requested for Saxenda.

ForwardHealth allows only two weight loss attempts with Saxenda during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Wegovy

If clinical criteria for anti-obesity drugs are met, initial PA requests for Wegovy will be approved for up to 183 days. If the member meets a weight loss goal of at least 5% of their weight from baseline, PA may be requested for an additional 183 days of treatment. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Wegovy prescribing information. PA requests for Wegovy may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5% of their weight from baseline during the initial 183-day approval or the member has completed 12 months of continuous Wegovy treatment, then the member must wait six months before PA can be requested for Wegovy.

ForwardHealth allows only two weight loss attempts with Wegovy during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Xenical and Orlistat

If clinical criteria for anti-obesity drugs are met, initial PA requests for Xenical or orlistat will be approved for up to 183 days. If the member meets a weight loss goal of at least 10 pounds of their weight from baseline during the first six months of treatment, PA may be requested for an additional 183 days of treatment. If the member's weight remains below baseline, subsequent PA renewal periods for Xenical or orlistat are a maximum of 183 days. PA requests for Xenical or orlistat may be approved for a maximum treatment period of 24 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 10 pounds during the initial 183-day approval, the member's weight does not remain below baseline, or the member has completed 24 months of continuous Xenical or orlistat treatment, then the member must wait six months before PA can be requested for Xenical or orlistat.

ForwardHealth allows only two weight loss attempts with Xenical or orlistat during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Zepbound

If clinical criteria for anti-obesity drugs are met, initial PA requests for Zepbound will be approved for up to 183 days. If the member meets a weight loss goal of at least 5% of their weight from baseline, PA may be requested for an additional 183 days of treatment. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Zepbound prescribing information. PA requests for Zepbound may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5% of their weight from baseline during the initial 183-day approval or the member has completed 12 months of continuous Zepbound treatment, then the member must wait six months before PA can be requested for Zepbound.

ForwardHealth allows only two weight loss attempts with Zepbound during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Submitting PA Requests for Wegovy to Reduce the Risk of Major Adverse Cardiovascular Events in Overweight or Obese Adults With Established Cardiovascular Disease

PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease must be completed, signed, and dated by the prescriber. PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system). PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease may not be submitted to the DAPO Center.

Clinical Criteria for Wegovy to Reduce the Risk of Major Adverse Cardiovascular Events in Overweight or Obese Adults With Established Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease are all of the following:

• Wegovy must be prescribed in a dose and manner consistent with the FDA-approved product labeling.
• The member has established cardiovascular disease, as evidenced by one of the following:
  • Prior myocardial infarction (heart attack)
  • Prior stroke
  • Peripheral arterial disease as evidenced by one of the following:
    • Intermittent claudication with an ABI of less than or equal to 0.9
    • Peripheral arterial revascularization procedure or amputation that is due to atherosclerotic disease
• The member has a BMI greater than or equal to 27.
• The member has agreed to follow a reduced-calorie diet and increase their physical activity.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease. The supporting clinical information and medical records must document the following:

• Evidence that the member has established cardiovascular disease
• The member's current BMI
• The member's current treatment plan including the member's reduced-calorie diet and physical activity plan

If clinical criteria for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Request

Initial renewal PA requests require documentation to support the member continues to follow a reduced-calorie diet and maintains physical activity. A copy of the member's current medical records must be included with the PA request. Initial renewal PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease may be approved for up to 183 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Wegovy prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Subsequent Renewal PA Requests

Subsequent renewal PA requests require documentation to support the member continues to follow a reduced calorie diet and maintains physical activity. A copy of the member's current medical records must be included with the PA request. Subsequent renewal PA requests for Wegovy to reduce the risk of MACE in overweight or obese adults with established cardiovascular disease may be approved for up to 365 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Wegovy prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Submitting PA Requests for Wegovy to Treat Metabolic Dysfunction-Associated Steatohepatitis

PA requests for Wegovy to treat MASH must be completed, signed, and dated by the prescriber. PA requests for Wegovy to treat MASH must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Wegovy to treat MASH must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Wegovy to treat MASH may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system). PA requests for Wegovy to treat MASH may not be submitted to the DAPO Center.

Clinical Criteria for Wegovy to Treat Metabolic Dysfunction-Associated Steatohepatitis

Clinical criteria that must be documented for approval of a PA request for Wegovy to treat MASH are all of the following:

• Wegovy must be prescribed in a dose and manner consistent with FDA-approved product labeling.
• The member has been diagnosed with noncirrhotic MASH, formerly known as NASH, with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) by a biopsy or noninvasive tests (such as FibroScan MRE + MRI-PDFF).
• The member will use the medication in conjunction with diet and exercise.
• The prescriber has documented that the member has not had significant alcohol consumption within the past year.
• The prescription is written by a liver specialist physician such as a gastroenterologist or hepatologist.
• The prescriber will monitor for elevations in liver tests and development of liver-related adverse reactions.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Wegovy to treat MASH. The supporting clinical information and medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If the clinical criteria for Wegovy to treat MASH are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Request

Initial renewal PA requests require documentation to support that the member is responding adequately to treatment (as documented in laboratory tests). A copy of the member's current medical records must be included with the PA request. Initial renewal PA requests for Wegovy to treat MASH may be approved for up to 183 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Wegovy prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Subsequent Renewal PA Requests

Subsequent renewal PA requests require documentation to support that the member is responding adequately to treatment (as documented in laboratory tests and a biopsy or noninvasive tests [such as FibroScan or MRE + MRI-PDFF]) and has resolution of steatohepatitis without worsening of fibrosis or at least one stage improvement in fibrosis without worsening of steatohepatitis. A copy of the member's current medical records must be included with the PA request. Subsequent renewal PA requests for Wegovy to treat MASH may be approved for up to 365 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Wegovy prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Submitting PA Requests for Zepbound to Treat Moderate to Severe Obstructive Sleep Apnea in Adults With Obesity

PA requests for Zepbound to treat moderate to severe OSA in adults with obesity must be completed, signed, and dated by the prescriber. PA requests for Zepbound to treat moderate to severe OSA in adults with obesity must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Zepbound to treat moderate to severe OSA in adults with obesity must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Zepbound to treat moderate to severe OSA in adults with obesity may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system). PA requests for Zepbound to treat moderate to severe OSA in adults with obesity may not be submitted to the DAPO Center.

Clinical Criteria for Zepbound to Treat Moderate to Severe Obstructive Sleep Apnea in Adults With Obesity

Clinical criteria that must be documented for approval of a PA request for Zepbound to treat moderate to severe OSA in adults with obesity are all of the following:

• Zepbound must be prescribed in a dose and manner consistent with the FDA-approved product labeling.
• The member has moderate to severe OSA, evidenced by one of the following:
  • Results from an overnight PSG sleep study documenting an AHI or RDI greater than or equal to 15 events per hour must be submitted.
  • Results from an HSAT documenting an REI greater than or equal to 15 events per hour must be submitted.
• The member has attempted PAP treatment and will continue to use PAP treatment if tolerated.
• The member has a BMI greater than or equal to 30.
• The member has agreed to follow a reduced-calorie diet and increase their physical activity.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Zepbound to treat moderate to severe OSA in adults with obesity. The supporting clinical information and medical records must document the following:

• Evidence that the member has moderate to severe OSA
• The member's current BMI
• The member's current treatment plan, including their PAP usage, reduced-calorie diet, and physical activity plan

If clinical criteria for Zepbound to treat moderate to severe OSA in adults with obesity are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Request

Initial renewal PA requests require documentation to support the member is responding adequately to treatment (reduction in OSA symptoms) and is compliant with PAP treatment (if-tolerated). The member must continue to follow a reduced-calorie diet and maintain physical activity. A copy of the member's current medical records must be included with the PA request. Initial renewal PA requests for Zepbound to treat moderate to severe OSA in adults with obesity may be approved for up to 183 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Zepbound prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Subsequent Renewal PA Requests

Subsequent renewal PA requests require documentation to support the member is responding adequately to treatment (a reduction in the member's AHI, RDI, or REI compared to their baseline prior to the initiation of Zepbound). Repeat PSG results, HSAT results or PAP confirmation of AHI, RDI, or REI reduction must be submitted. The member must be compliant with PAP treatment (if-tolerated), continue to follow a reduced-calorie diet and maintain physical activity. A copy of the member's current medical records must be included with the PA request. Subsequent renewal PA requests for Zepbound to treat moderate to severe OSA in adults with obesity may be approved for up to 365 days. Renewal PA requests require the member to be taking an appropriate maintenance dose, as outlined in the Zepbound prescribing information.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.