Coverage Policies

Coverage for BELVIQ® and BELVIQ XR® is primarily through a patient’s pharmacy benefit. Coverage and reimbursement may vary significantly by payor, plan and patient. Payors can base coverage decisions on formal policies or make decisions on a case-by-case basis.

Part D Exclusion Category for Weight-Loss Drugs

Medicare, in its definition of a covered Part D drug, specifically addresses drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section 1927(d)(2) of the Social Security Act. Agents when used for anorexia, weight loss, or weight gain (even if used for a non-cosmetic purpose i.e., morbid obesity) are excluded from coverage.1 It is therefore highly unlikely that any weight-loss product, including BELVIQ® and BELVIQ XR®, will be reimbursable through the standard Part D prescription drug plan.

However, in addition to the standard Part D prescription drug plan, Medicare offers enrollees prescription drug coverage through enhanced Part D plans that may allow for weight-loss product coverage.2

Enhanced Alternative Prescription Drug Coverage

Enhanced alternative coverage includes both basic prescription drug coverage and supplemental benefits. Some Part D prescription drug plans may offer coverage for weight-loss drugs beyond the standard benefit. Enrollees may choose to pay extra to receive coverage under the optional supplemental benefit.

For more information on coverage for BELVIQ® and BELVIQ XR®, enrolled members will need to check their benefit plan descriptions for details. Providers can also contact the Eisai Assistance Program at 1-866-61-EISAI (1-866-613-4724) to research their patients’ benefits.

References

1. Centers for Medicare & Medicaid Services Website. Prescription Drug Benefit Manual, Chapter 6: Part D Drugs and Formulary Requirements, Information available at
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf.
Accessed March 17, 2016.

 2. Centers for Medicare & Medicaid Services Website. Prescription Drug Benefit Manual, Chapter 5: Benefits and Beneficiary Protections, Information available at
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/MemoPDBManualChapter5_093011.pdf
Accessed March 17, 2016.

Medicaid is a government insurance program that covers low-income parents and children, people who are elderly, and people with disabilities. State Medicaid programs and the federal government share the costs of covering most medical expenses for Medicaid beneficiaries. 

Weight-loss products are one of the classes of drugs that Medicaid programs may exclude from coverage or otherwise restrict under federal law.1 Coverage and reimbursement for BELVIQ® and BELVIQ XR® will vary from state to state, as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services. 

Reimbursement for BELVIQ® and BELVIQ XR® is expected to vary greatly from one state Medicaid program to another. State Medicaid programs are likely to apply coverage and utilization restrictions such as prior authorization or step therapy edits. Currently, less than half of all states offer coverage for weight-loss drugs. Additional payor review may be required to document the individual's weight loss, the patient's body mass index (BMI), or to verify the presence of risk factors/co-morbid conditions such as hypertension, dyslipidemia, and diabetes. 

For more information on Medicaid reimbursement for BELVIQ® and BELVIQ XR® contact your Medicaid program.  Providers can also contact the Eisai Assistance Program at 1-866-61-EISAI (1-866-613-4724) to research your patients’ benefits.

1. Social Security Law. Payment for covered outpatient drugs. Available at http://www.ssa.gov/OP_Home/ssact/title19/1927.htm. Accessed March 17, 2016.

Coverage for obesity related drugs is highly variable amongst plans offered by commercial payors. Payors generally implement "medical necessity" criteria for treatment of obesity or weight control. Weight reduction medications may be considered experimental and investigational when criteria are not met. For example, plans may reject a claim received that lists obesity as the sole diagnosis code. 
Most third-party payors, including Health Maintenance Organization (HMO) plans, managed care organizations, indemnity plans, and others, may initially deny coverage for BELVIQ® and BELVIQ XR® or limit coverage to patients suffering with co-morbid conditions such as diabetes. However, specific coverage requirements and restrictions will vary based on plan type. While some payors have established formal published policies, the lack of a published policy from a particular payor does not mean that BELVIQ® and BELVIQ XR® is not covered by that payor. 

Many Commercial Prescription Plans Have Developed a formulary, or List of Brand-Name Prescription Drugs that the Company Prefers.

Some plans only cover weight-loss drugs included on this list; others charge a higher copayment for drugs not on the formulary. Formularies are often organized into tiers. If a plan's pharmacy benefit involves tiers, members typically pay the smallest copayments for drugs in the lowest tier and the highest copayments for drugs in the highest tier. Some commercial plans may apply coverage and utilization restrictions such as prior authorization or quantity limit edits to BELVIQ® and BELVIQ XR®.

When BELVIQ® is Not Covered by a Health Plan, Coverage May Be Requested

Coverage of weight-loss drugs is determined by the member's pharmacy benefit. Providers or patients should contact the health plan directly to determine whether BELVIQ® and BELVIQ XR® is included on the formulary. If BELVIQ® and BELVIQ XR® is not covered by the plan, an exception may be requested by the prescriber. Determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements.

  • If you need additional assistance obtaining a payor's specific requirements for requesting coverage for BELVIQ® and BELVIQ XR®, please call The Eisai Assistance Program at 1-866-61-EISAI.

How to Request a Non-Formulary Coverage Determination

Health plans may grant various types of exceptions to members. Members may receive coverage for BELVIQ® and BELVIQ XR® even if it is not on the formulary, health plans may waive coverage restrictions or limits and make an exception to cover the drug.
When requesting an exception, a statement from their prescriber must be submitted via fax or mail. The statement must explain the medical reasons for requesting an exception. Once a request is submitted, a decision is generally made within 72 hours of receiving the prescriber's supporting statement. Members can request an expedited (fast) exception if the prescriber believes that a patient's health could be seriously harmed by waiting up to 72 hours for a decision.

  • If the request is expedited and granted, the health plan usually gives a decision no later than 24 hours after receiving prescriber's supporting statement.

  • If the decision is not in member's favor, the health plan will send a written statement with explanation and how to appeal the decision.

  • To download forms that may be used to request patient coverage when BELVIQ® and BELVIQ XR® is not on the formulary, please click here. Please note that some payors may not accept requests for coverage that are submitted on forms that have not been approved by their specific plan.

  • If you need additional assistance obtaining a payor's specific requirements for requesting coverage for BELVIQ® and BELVIQ XR®, please call the Eisai Assistance Program at 1-866-61-EISAI or click here to obtain an Insurance Verification Form. Once completed, please fax it to the Eisai Assistance Program. A representative will initiate research into the specific requirements of your patient's insurance to obtain coverage.

Appeal Request

An appeal is a request to change a previous adverse decision made by a health plan. A representative/prescriber or patient may appeal the adverse decision related to coverage. The prescriber will need to provide a reason why he/she believes the adverse coverage decision was incorrect and what the expected outcome should be. Along with the request form, supporting documentation may include previous medical necessity-related denials, the patient's medical records, and documentation from the healthcare professional or facility.

For more information on commercial payor-specific coverage of BELVIQ® and BELVIQ XR® providers can contact the member services department at their patients’ health plan. Providers can also contact the Eisai Assistance Program at 1-866-61-EISAI (1-866-613-4724) to research your patients’ benefits.

Need Help with NDC Codes?

NDC codes identify specific product package sizes for BELVIQ® and BELVIQ XR®.

Changes in Metabolic Parameters

See how BELVIQ® affected glycemic control, blood pressure, and lipid profiles.

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record

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Indication

BELVIQ® and BELVIQ XR® are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).

Limitations of Use

The safety and efficacy of coadministration of BELVIQ® and BELVIQ XR® with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations, have not been established. The effect of BELVIQ® and BELVIQ XR® on cardiovascular morbidity and mortality has not been established.

Important Safety Information

Contraindication

BELVIQ® and BELVIQ XR® should not be taken during pregnancy or by women who are planning to become pregnant.
Patients with prior hypersensitivity reactions to lorcaserin or to any of the product components should not take this medicine. Hypersensitivity reactions have been reported.

Warnings and Precautions

  • BELVIQ® and BELVIQ XR® are serotonergic drugs. The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John's Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination. Patients should be monitored for the emergence of serotonin syndrome symptoms or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea, and muscle rigidity. Treatment with BELVIQ® and BELVIQ XR® and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
  • Patients should not take BELVIQ® and BELVIQ XR® in combination with potent 5-HT2B receptor agonists that have been associated with regurgitant valvular heart disease (e.g., cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients were symptomatic. BELVIQ and BELVIQ XR should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur, should be evaluated and discontinuation of BELVIQ® and BELVIQ XR® should be considered.
  • Impairment in attention, memory, somnolence, confusion, and fatigue have been reported in patients taking BELVIQ®. Patients should not drive a car or operate heavy machinery until they know how BELVIQ® and BELVIQ XR® affects them.
  • The recommended daily dose should not be exceeded, as higher doses may cause euphoria, hallucination, and dissociation. Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. Discontinue BELVIQ® and BELVIQ XR® in patients who develop suicidal thoughts or behaviors.
  • Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ® and BELVIQ XR® is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
  • Men who experience priapism should immediately discontinue BELVIQ® and BELVIQ XR® and seek emergency medical attention. BELVIQ® and BELVIQ XR® should be used with caution with erectile dysfunction medications. BELVIQ® and BELVIQ XR® should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).
  • Because BELVIQ® and BELVIQ XR® may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree.
  • Consider monitoring for CBC changes, signs and symptoms of prolactin excess, and pulmonary hypertension.

Most Common Adverse Reactions for BELVIQ®

  • In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
  • In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).

Most Common Adverse Reactions for BELVIQ XR®

  • Common side effects in patients on BELVIQ XR® were similar to those seen in patients on BELVIQ®.

Nursing Mothers

  • BELVIQ® or BELVIQ XR® should not be taken by women who are nursing.
 
BELVIQ® and BELVIQ XR® are federally controlled substances that may lead to abuse or dependence.
 
For more information about BELVIQ® see full Prescribing Information
For more information about BELVIQ XR® see full Prescribing Information

This information is intended for use by healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.

BELVIQ® and BELVIQ XR® are registered trademarks of Arena Pharmaceuticals GmbH.