The information displayed below pertains specifically to the Pharmacy setting of care. Coverage and reimbursement may vary significantly by payor, plan and patient. See below.
Coverage refers to the circumstances under which products and services are eligible for payment. Payers can base coverage decisions on formal policies or make decisions on a case-by-case basis.
Payors cover products that are medically necessary, safe and effective, and not experimental or investigational. FDA-approved indications and scientific evidence will inform coverage criteria, and payers can make these decisions prospectively or retrospectively.
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® 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® 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, diabetes.
For more information on Medicaid reimbursement for BELVIQ®, contact your Medicaid program.
Pharmacy reimbursement for BELVIQ® varies by state Medicaid program. Most states base payment on Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC). Payments usually include a dispensing fee per fill that also varies by state.
1 Social Security Law. Payment for covered outpatient drugs. Available at http://www.ssa.gov/OP_Home/ssact/title19/1927.htm. Accessed August 23, 2012.
BELVIQ® is 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 (eg, hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use
- The safety and efficacy of coadministration of BELVIQ® with other products intended for weight loss, including prescription drugs (eg, phentermine), over-the-counter drugs, and herbal preparations, have not been established.
- The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established.
IMPORTANT SAFETY INFORMATION
- BELVIQ® should not be taken during pregnancy or by women who are planning to become pregnant.
Warnings and Precautions
- BELVIQ® is a serotonergic drug. 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 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® in combination with drugs that have been associated with valvular heart disease (eg, 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® 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® 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® affects them.
- The recommended dose of 10 mg twice daily 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® 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® 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 seek emergency medical attention. BELVIQ® should be used with caution with erectile dysfunction medications. BELVIQ® should be used with caution in men who have conditions that might predispose them to priapism (eg., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (eg., angulation, cavernosal fibrosis, or Peyronie's disease).
- Because BELVIQ® 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, prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions
- 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%).
- BELVIQ® should not be taken by women who are nursing.
For more information about BELVIQ® please see full Prescribing Information.