This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US health care professionals only.

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Understanding Health Care Payers

There are many different types of health care payers and plans, although all health insurance can be grouped under 2 major categories: private and public. Most Americans have some type of private (also known as commercial) health insurance coverage.1

Private Health Plans

Commercial plans are typically divided into 2 categories: fee-for-service (also known as indemnity plans) and managed care. Today, almost all health plans incorporate some form of a managed care component.2

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Health Maintenance Organization (HMO)

  • Provides care through a network of physicians and hospitals in particular geographic or service areas, who are either employed by or under contract with the HMO
  • Members receive all of their care through the HMO
  • Most HMOs ask members to choose a doctor or medical group to be their primary care physician (PCP)
  • In many HMOs, members must get authorization (also known as a referral) from their PCP to see other providers
  • Members generally have no coverage for services provided outside of the HMO network1

Preferred Provider Organization (PPO)

  • Offers a choice of getting care within or outside of a provider network with no referral necessary
  • Members may use out-of-network providers and facilities, but they will have to pay more than if they had used in-network ones1

Point-Of-Service (POS)

  • A combination of a PPO and an HMO plan
  • Members choose an in-network PCP and are encouraged to use in-network providers and facilities
  • Members can visit any in-network provider without a referral
  • If members go outside of the network, services are covered at a lower rate, unless they receive a referral from their PCP1

Consumer-Driven Health Plan (CDHP)

  • Has a high deductible and a tax-advantaged savings account
  • Contributions and withdrawals to the savings account may only be used for qualified health care expenses and remain tax free
  • Preventive care is covered without cost sharing3

Pharmacy Benefit Manager (PBM)

  • A third-party administrator of prescription drug programs
  • PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims
  • Examples of PBMs are CVS Caremark and Express Scripts, Inc.4

Catastrophic Plans

  • Does not cover any benefits other than 3 primary care visits per year before the plan's deductible is met
  • The monthly premium is generally lower than other plans, but the out-of-pocket costs for deductibles, co-pays, and co-insurance are higher5

Coverage through employers

Most health coverage is provided through employers or other organizations. Enrollment requirements and costs are determined by the company and vary depending on the plan type. The patient’s out-of-pocket costs (deductibles, co-pays, and co-insurance) can vary, based on differing plan restrictions, benefit levels, and other variables. Learning more about the types of health insurance may help you in making coverage decisions that affect your patients.9

Public Health Plans

Public plans are also known as government-funded plans and include Medicare, Medicaid, and CHIP.1

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Medicare

  • A federal program that provides health insurance coverage to eligible elderly and disabled individuals
  • Coverage benefits vary based on the site of service (e.g., doctor's office, hospital inpatient, hospital outpatient, or home health treatments)6

Medicaid

  • A state administered program designed to provide health insurance coverage to individuals who have a low income
  • Each state sets its own guidelines regarding eligibility and services7

Children’s Health Insurance Program (CHIP)

  • A state program designed to provide coverage to uninsured children whose families' income falls under a certain level, but is too high to qualify for Medicaid8

The information in this website relating to payers, insurance, and benefits is general information for educational purposes only. The information is not legal advice, is not to be acted or relied on as such, and may not be current. Check applicable law and individual health plan coverage, costs, and terms because they may change without notice. This information is based on public records.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
  • Warnings and Precautions
    • Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with Vyvanse for ADHD. Treatment may need to be interrupted in children not growing as expected.
    • CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
    • Increased risk of serotonin syndrome when co-administered with serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately and initiate supportive treatment.
  • Adverse Reactions
    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in ADHD clinical trials were:
    • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
    • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
    • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
    The most common adverse reactions (≥ 5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.
  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
  • Other Considerations
    • Safety and effectiveness in patients <18 years with B.E.D. have not been established.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

References

  1. Medical News Today. What Is Health Insurance? 2014. http://www.medicalnewstoday.com/info/health-insurance/. Accessed March 6, 2014.
  2. Pulmonary Hypertension Association. What Types of Health Insurance Are There? http://www.phassociation.org/Patients/Insurance/Types. Accessed March 6, 2014.
  3. Excellus BlueCross BlueShield. Consumer Driven Healthcare. 2014. https://www.excellusbcbs.com/wps/portal/xl/!ut/p/b0/04_Sj9CPykssy0xPLMnMz0vMAfGjzOINnTyNDEPNjYzcTIw8zbxMvY0tDCBAvyDbUREAPGZVLg!!/?menu=true. Accessed March 6, 2014.
  4. American Pharmacists Association. Pharmacy Benefit Management. 2007. http://www.pharmacist.com/sites/default/files/files/Profile_24_PBM_SDS_FINAL_090707.pdf. Accessed March 12, 2014.
  5. US Department of Health and Human Services. Catastrophic Health Plan - Healthcare Glossary. HealthCare.gov. 2014. https://www.healthcare.gov/glossary/catastrophic-health-plan/. Accessed March 11, 2014.
  6. Centers for Medicare & Medicaid Services. What is Medicare? http://www.medicare.gov/sign-up-change-plans/decide-how-to-get-medicare/whats-medicare/what-is-medicare.html. Accessed June 9, 2014.
  7. US Department of Health & Human Services. Do I qualify for Medicaid? https://www.healthcare.gov/do-i-qualify-for-medicaid/Centers for Medicare & Medicaid Services. Accessed June 9, 2014.
  8. Children’s Health Insurance Program. http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Childrens-Health-Insurance-Program-CHIP/Childrens-Health-Insurance-Program-CHIP.html. Accessed June 9, 2014.
  9. America’s Health Insurance Plans. Employer-Sponsored Coverage. http://www.ahip.org/Issues/Employer-Sponsored-Coverage.aspx. Accessed June 9, 2014.
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