Frequently Asked Questions

HETLIOZAccess

Frequently Asked Questions about HETLIOZAccess

On September 15th, 2014, Vanda initiated an Expanded Access Program for HETLIOZ™ called HETLIOZAccess™. HETLIOZ™ is the only FDA-approved therapy for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Below are answers to questions Vanda has received about HETLIOZAccess

What is an Expanded Access Program?

An Expanded Access Program is designed to provide a patient with access to a medicine before it is approved by a national health authority and outside of the clinical trial setting. Expanded access programs are for patients who have a serious or immediately life-threatening disease or condition for which no comparable or satisfactory alternative therapy is available, and a physician has made an assessment that the potential benefits to the patient outweigh the risks to the patient.

Is this a clinical trial?

This is not a clinical trial; however similar to a clinical trial, the program has criteria for determining which patients are eligible to participate. Safety information will be collected and as required reported to the relevant regulatory authorities.

What about patients who are not eligible for this Expanded Access Program?

Vanda has established HETLIOZAccess™ for eligible patients with Non-24-Hour Sleep-Wake Disorder who are totally blind and who meet the program criteria. These criteria have been developed to help determine whether HETLIOZ™ is an appropriate treatment for a particular patient. Patients who do not meet these criteria will not be eligible to participate HETLIOZAccess™.

Does the program enroll like a clinical trial?

For enrollment in HETLIOZAccess™ patients must meet certain criteria in order to be eligible to participate. The entry criteria for HETLIOZAccess™ are broader than for the current or previous clinical trials and there are no required visits to a clinical research site. Prescribing physicians will determine how often patients should be evaluated while on therapy.

How long will it take to enroll/receive HETLIOZ™?

How long it might take to receive HETLIOZ™ through the program will be different for every patient. The timing can be affected by a number of factors, including:

  • when a physician submits the information on behalf of the patient;
  • whether any follow up is required to review that application;
  • how many other patients are enrolling; and,
  • local legal and regulatory authority approval process.

Due to these different factors the length of time can take a few weeks to a few months.

Can patients enroll themselves?

Patients cannot apply to HETLIOZAccess™ on their own. Patients must work through their physicians to apply.

What is the enrollment process?

Patients must work through their physicians to apply. iPatients cannot apply to HETLIOZAccess™ on their own.

  • Physicians outside of the U.S. who are interested in enrolling a patient in HETLIOZAccess™ should contact Idis via phone here or via email Non24@idispharma.com.

Which physicians will be eligible?

Physicians outside of the U.S. may contact Idis to learn more about the eligibility requirements of HETLIOZAccess™.

Is HETLIOZ™ drug approved by the U.S. Food and Drug Administration (FDA)?

Yes. HETLIOZ™ was approved by the U.S. FDA on January 31, 2014 for the treatment of Non-24.

How long can patients be enrolled in HETLIOZAccess™?

Patients may take HETLIOZ™ through this program until notified otherwise by Idis or Vanda, or if HETLIOZ™ becomes available in your country as a commercially approved medicine. If HETLIOZAccess™ is approved by the local regulatory body, then treatment through HETLIOZAccess™ will be discontinued and the product may be obtained with a prescription.

How to contact Vanda about the HETLIOZAcess

Patients should work through their physicians for HETLIOZAccess™ because only physicians can enroll patients in the program.

For HETLIOZAccess™, physicians outside of the U.S. should contact Idis by phone here or via email at Non24@idispharma.com.

Physicians within the U.S. or U.S. territories should visit www.HETLIOZ.com for more information on prescribing HETLIOZ™ to patients in the U.S.

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