Business Associate Agreement Terms and Conditions of Use

I am providing information about my patient to Vanda Pharmaceuticals Inc. (“Vanda”), including Vanda’s HETLIOZSolutions™ Program operated by RxC Acquisition Company d/b/a RxCrossroads, and/or any other entity that subsequently operates the HETLIOZSolutions™ Program on behalf of Vanda (collectively “the Entities”) on the HETLIOZSolutions™ Prescription & Service Request Form for the purposes set forth on that form with the understanding that, with respect to any protected health information of my patient, the Entities agree to do the following, in compliance with the requirements imposed on business associates in 45 CFR Parts 160 and 164:

(a) Not use or disclose protected health information other than as permitted or required in the HETLIOZSolutions™ Prescription & Service Request Form or as required by law;
(b) Use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided herein;
(c) Report to me any use or disclosure of protected health information not provided for herein of which the Entities becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which the Entities becomes aware;
(d) In accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the Entities agree to the same restrictions, conditions, and requirements that apply to the Entities with respect to such information;
(e) Make available protected health information in a designated record set to me as necessary to satisfy my obligations under 45 CFR 164.524;
(f) Make any amendment(s) to protected health information in a designated record set as directed or agreed to by me pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy my obligations under 45 CFR 164.526;
(g) Maintain and make available to me the information required to provide an accounting of disclosures as necessary to satisfy my obligations under 45 CFR 164.528;
(h) To the extent the Entities are to carry out one or more of my obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to me in the performance of such obligation(s); and
(i) Make their internal practices, books, and records available to the Secretary of the Department of Health and Human Services for purposes of determining compliance with the HIPAA Rules.
(j) Use or disclose protected health information only as set forth in the HETLIOZSolutions™ Prescription & Service Request Form and only to the extent of the minimum information necessary to accomplish the purpose of the use or disclosure or to de-identify the information in accordance with 45 CFR 164.514(a)-(c).
(k) In the event I elect to terminate my participation in the HETLIOZSolutions™ Program (which I may do at any time by notifying the Entities in writing), return or destroy all protected health information they received from me, provided such return or destruction is feasible. If return or destruction is infeasible, the Entities will extend the protections of this agreement to the information for as long as the Entities hold the information.
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Healthcare Provider Important Safety Information

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.

Indication

HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQ® oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.

Important Safety Information

  • HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
  • The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.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
  • Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
  • There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
  • HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
  • The safety and effectiveness of HETLIOZ® for the treatment of Non-24 in pediatric patients 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information.