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.

Shedding Light on the Affordable Care Act

The Affordable Care Act (ACA) includes some of the most sweeping changes to American health care since Medicare and Medicaid were established in 1965.1

As a result of the ACA, the number of uninsured individuals is expected to decrease. This is because more people will access coverage through the Health Insurance Marketplace or Medicaid.2 States are encouraged to expand Medicaid eligibility as of January 1, 2014. In states that choose to expand, the Medicaid eligibility threshold will increase to include individuals and families with incomes that are up to 138 percent of the federal poverty level.3 Still, it’s projected that most Americans will continue to have employer-sponsored health insurance.

As of 2014, 27 states, including the District of Columbia, have opted to expand Medicaid eligibility.3 Patients who are uninsured can visit healthcare.gov or call 1-800-318-2596 to find out if they are eligible for Medicaid, as well as explore other health insurance options.4

Frequently Asked Questions

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How can I help my patients access coverage?

The first step is to visit healthcare.gov or call 1-800-318-2596. This site will guide visitors through a series of questions based on their income and family status, and then direct them to the appropriate coverage and subsidy options based on their responses.5

Is everyone now required to have health insurance coverage?

Under the individual mandate provision, most Americans are required to purchase basic insurance or pay a penalty.6

What is the Health Insurance Exchange?

The Health Insurance Exchange (also known as the Health Insurance Marketplace) is a one-stop shop for health insurance. The Marketplace is available online, by phone, or in person. It provides a choice of health plans, common rules regarding the offerings, pricing of insurance, and helpful information about the plans. For small businesses, the Marketplace is called Small Business Health Options Program (SHOP).7

Will we see new insurance carriers?

While there may be new insurance carriers in the Marketplace, you will likely see many of the same health plans as before, both in and outside of the Marketplace. Insurers may choose which state Marketplaces they’d like to participate in. So far, there’s great variation in which insurers are offering Marketplace coverage in each state. Examples of some major national insurers that may be found in the Marketplace include WellPoint, Aetna, UnitedHealth Group, Cigna, and Humana.8-10

What new types of coverage will people have?

Most people will continue to have coverage under employer-sponsored plans. For those covered under the Health Insurance Marketplace (also known as exchange plans), there is a range of standard plan categories being offered by commercial carriers, including:

  • Bronze plans (cover 60% of expenses)
  • Silver plans (cover 70% of expenses)
  • Gold plans (cover 80% of expenses)
  • Platinum plans (cover 90% of expenses)7

In addition, the Marketplace also offers catastrophic plans for individuals who are under 30 or are facing a qualifying hardship. These members pay high out-of-pocket expenses in exchange for very low premiums.7

What services do plans have to cover?

Insurers that participate in Health Insurance Marketplaces must offer qualified health plans. In order for a plan to be considered a qualified health plan, it must:

  • Be certified by the Health Insurance Marketplace
  • Provide essential health benefits
  • Follow established limits on cost sharing (like deductibles, co-pays, and out-of-pocket maximum amounts)
  • Meet other requirements, such as state-specific regulations11

What are essential health benefits?

Essential health benefits include 10 essential services that qualified health plans must cover, including:

  • Ambulatory patient and emergency care
  • Behavioral health treatment
  • Hospitalization
  • Prescription drugs
  • Maternity and newborn care
  • Rehabilitative and habilitative services and devices
  • Care for patients with mental health and substance abuse disorders
  • Laboratory services
  • Preventive and wellness services, chronic disease management, and pediatric services, including oral and vision care7

What services are covered without cost sharing?

Plans cover a range of preventive services without cost sharing, as long as an in-network physician provides the services. These preventive services include many immunizations, screenings, well visit exams, well baby visits, prenatal care, behavioral assessments for children, and a number of other services.12

What financial assistance is available for those who are not eligible for Medicaid?

Most individuals and families who purchase plans through the Marketplace will be eligible for tax credits and subsidies to help pay for their insurance premiums and/or out-of-pocket costs. The Marketplace directs applicants to the appropriate program based on income.7

What is an Accountable Care Organization (ACO)?

An Accountable Care Organization is an entity comprised of physicians, hospitals, and other health care providers who are accountable for the cost and quality of care delivered to a specified group of patients.13

What insurance protections do people have under the ACA?

The ACA establishes a patient’s bill of rights to protect consumers in dealing with insurance companies and help them access health coverage regardless of their health status. These rules remove pre-existing conditions limitations, protect a patient's choice of doctors, prevent insurers from cancelling coverage except in cases of fraud, cover preventive care with no cost, end lifetime dollar limits on care, and more.14

How long can dependents stay on a parent or guardian’s health plan?

If a plan covers children, they can be added to or kept on a parent's health insurance policy until they turn 26 years old.7

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. National Conference of State Legislatures. The Affordable Care Act: A Brief Summary. 2011. http://www.ncsl.org/portals/1/documents/health/hraca.pdf. Accessed March 17, 2014.
  2. The Henry J. Kaiser Family Foundation. The Uninsured: A Primer – Key Facts about Health Insurance on the Eve of Coverage Expansions. 2013. http://kff.org/uninsured/report/the-uninsured-a-primer-key-facts-about-health-insurance-on-the-eve-of-coverage-expansions/. Accessed March 11, 2014.
  3. The Henry J. Kaiser Family Foundation. How Will the Uninsured Fare Under the Affordable Care Act? 2014. http://kff.org/health-reform/fact-sheet/how-will-the-uninsured-fare-under-the-affordable-care-act/. Accessed January 12, 2015.
  4. The Henry J. Kaiser Family Foundation. State Decisions on Health Insurance Marketplaces and the Medicaid Expansion, 2014. 2014. http://kff.org/health-reform/state-indicator/state-decisions-for-creating-health-insurance-exchanges-and-expanding-medicaid. Accessed June 9, 2014.
  5. US Department of Health and Human Services. A one-page guide to the Health Insurance Marketplace. HealthCare.gov. 2013. https://www.healthcare.gov/get-covered-a-1-page-guide-to-the-health-insurance-marketplace/. Accessed March 12, 2014.
  6. Internal Revenue Service. Questions and Answers on the Individual Shared Responsibility Provision. 2013. http://www.irs.gov/uac/Questions-and-Answers-on-the-Individual-Shared-Responsibility-Provision. Accessed March 12, 2014.
  7. Centers for Medicare & Medicaid Services. Health Insurance Marketplace 101. March 2014. http://amhp.us/wp-content/uploads/2014/02/March-Health-Insurance-Marketplace-101V3-slides.3.24.14.pdf. Accessed April 20, 2014.
  8. Doyle J. Health Insurers Face an Uncertain Future. Kaiser Health News. http://www.kaiserhealthnews.org/stories/2013/november/18/health-insurers-face-uncertainty.aspx. November 18, 2013.
  9. Humana. Welcome to Humana! 2013. https://www.humana.com/individual-and-family. Accessed November 18, 2013.
  10. Cigna. Our 2014 Marketplace Participation. 2013. http://www.cigna.com/assets/docs/about-cigna/informed-on-reform/cignaMarketplaceParticipation.pdf. Accessed March 19, 2014.
  11. US Department of Health and Human Services. Glossary: Qualified Health Plans. https://www.healthcare.gov/glossary/qualified-health-plan/. Accessed June 9, 2014.
  12. US Department of Health and Human Services. What are my preventive care benefits? https://www.healthcare.gov/what-are-my-preventive-care-benefits/. Accessed March 19, 2014.
  13. American Medical Association. New federal payment and delivery models 101. AMA. 2013. http://www.ama-assn.org/resources/doc/washington/new-federal-payment-delivery-models.pdf. Accessed December 10, 2013.
  14. Centers for Medicare & Medicaid Services. Patient’s Bill of Rights. 2013. http://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Patients-Bill-of-Rights.html. Accessed December 11, 2013.
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