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HETLIOZSolutions™

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Vanda Pharmaceuticals is committed to making HETLIOZ® (tasimelteon) accessible to people living with Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in SMS. HETLIOZSolutions™ was created to support people who have been diagnosed with Non-24 and nighttime sleep disturbances in SMS.

The program can assist with coordinating care to help answer insurance questions, as well as provide financial support and educational resources. And most importantly, by letting you know that you are not alone on this journey.

If you have questions about your insurance coverage, your prescription delivery or options for financial assistance, help is available through HETLIOZSolutions™ by calling 1-844-HETLIOZ. That's 1-844-438-5469, from 9:00AM to 8:00PM, Eastern Standard Time.

HETLIOZSolutions™ helps by:

  • Providing you and your doctor with personalized assistance with enrolling you in the HETLIOZSolutions™ program
  • Working with your insurance provider to determine your coverage
  • Offering a range of financial assistance programs for eligible patients
  • Providing educational resources
  • And coordinating HETLIOZ® delivery to your door from a specialty pharmacy*

*HETLIOZ® is only available through specialty pharmacies that distribute the medication directly to your door. Specialty prescriptions typically require special handling, administration or monitoring.

Step 1: Contact HETLIOZSolutions™

Call HETLIOZSolutions™ at 1-844-HETLIOZ. That's 1-844-438-5469. You or your doctor can make the first call. You'll be assigned a Patient Care Coordinator, who will explain how to enroll in the HETLIOZSolutions™ program and offer assistance with obtaining a prescription for HETLIOZ® (tasimelteon).

Step 2: Complete the HETLIOZSolutions™ Prescription and Service Request Form

Once you have been diagnosed, you and your physician will need to fill out and sign the HETLIOZSolutions™ Prescription and Service Request Form. Then fax it to 1-844-364-2424. Please note that your insurance company may require additional documentation to authorize coverage for HETLIOZ®. Download your copy of the HETLIOZSolutions™ Prescription and Service Request Form, or listen to the audio version.

Step 3: Determine Coverage

For every patient, HETLIOZSolutions™ will determine what type of insurance coverage is available for HETLIOZ®. Financial assistance programs are available to help cover costs of treatment. If you don't currently have any insurance coverage or you are underinsured, your Patient Care Coordinator will help you by seeking alternative coverage or financial support.

  • Financial assistance programs may be offered to patients with no insurance coverage or not enough insurance coverage to help make HETLIOZ® affordable
  • Eligibility is based on certain income and insurance criteria
  • Eligible patients may receive therapy with HETLIOZ® at little or no cost

Step 4: Receive a call from your Patient Care Coordinator

Together, you'll discuss your insurance coverage. A Patient Care Coordinator from HETLIOZSolutions™ will work with you one-on-one.

Your Patient Care Coordinator will help you understand your insurance benefits by:

  • Reviewing your insurance coverage
  • Determining whether any insurance copayments or deductibles may be required
  • Determining any limitations your insurance may have, such as a lifetime maximum
  • Checking to see if your insurance requires prior authorization for HETLIOZ®

Step 5: Coordinate with a Specialty Pharmacy

After reviewing your insurance benefits and discussing them with your doctor, your Patient Care Coordinator will forward your information to a specialty pharmacy. The specialty pharmacy partner will work with you to coordinate any final details regarding starting you on therapy with HETLIOZ® (tasimelteon).

Your Patient Care Coordinator will continue to follow your progress by:

  • Coordinating with your specialty pharmacy to help start you on therapy with HETLIOZ®
  • Making sure you are receiving therapy
  • Checking to see if you have any questions or concerns about receiving your therapy, and are getting refill reminders
  • Ensuring that you and your healthcare provider have all the necessary product information about HETLIOZ®
  • Identifying the reason for any rejected insurance claims

You will also receive ongoing follow-up calls from your Patient Care Coordinator.

  1. A welcome call to ask if you have any questions about starting HETLIOZ®, such as how to take HETLIOZ®, how HETLIOZ® works, what to expect, when to take HETLIOZ®, how much to take and how long before you may start feeling the benefits.
  2. A check-in call to find out if you have any questions or concerns about staying on HETLIOZ®, as directed by your doctor.
  3. Refill reminders, compliance and adherence assistance, as well as other ongoing support calls.

Here's Important Safety Information for
HETLIOZ® (tasimelteon).

Indications

HETLIOZ® (HeT-lee-ōz) [tasimelteon] capsules are indicated for the treatment of:

  • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
  • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients 16 years of age and older.

HETLIOZ LQ™ (HeT-lee-oz el-Cue) oral suspension is indicated for:

  • Nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

Important Safety Information

HETLIOZ® may cause drowsiness. After taking HETLIOZ®, limit your activity to preparing for bed. HETLIOZ® can potentially impair your ability to perform activities that require complete mental alertness.

The most common side effects associated with HETLIOZ® include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infection. These side effects may occur more frequently in patients 65 years of age or older. Adverse reactions were similar in patients treated for (Non-24) and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ™ oral suspension, and patients ≥16 years of age who received HETLIOZ® capsules.

Tell your healthcare provider about all of the medicines you're taking. HETLIOZ® should not be taken in combination with fluvoxamine or rifampin.

Tell your healthcare provider about all of your health conditions, including whether you are pregnant, are planning to become pregnant, or are breastfeeding. HETLIOZ® has not been studied in pregnant women.

The safety and effectiveness of HETLIOZ® for the treatment of Non-24-Hour in children have not been established. The safety and effectiveness of HETLIOZ LQ™ oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.

HETLIOZ® is not recommended for use in patients with severe liver problems.

Consumer Important Safety Information

You are encouraged to report side effects of prescription drugs to the FDA. To report side effects, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-0178 or www.fda.gov/medwatch.

For more information, ask your healthcare provider or call 1-844-HETLIOZ (1-844-438-5469).

This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.

Download an accessible PDF or listen to the full US Prescribing Information. You can also hear the full US Prescribing Information by calling 1-844-HETLIOZ (1-844-438-5469).