Supplemental Information for JYNARQUE® (tolvaptan)

Preparing the JYNARQUE^® (tolvaptan) folder: Resources for you and your patients.

For You: Professional Materials

REMS Patient Enrollment

Enroll patients on the REMS portal at www.TolvaptanADPKDSharedREMS.com or by downloading and returning this form.

English

Prescription Referral Form

Download the prescription referral form and send to your selected pharmacy.

English

Patient Experience Program Enrollment

Download the patient enrollment form or direct patients to enroll online at PatientExperienceProgram.com.

English Español

JYNARQUE Patient Enrollment Checklist

Navigate the treatment initiation and patient management with this downloadable guide.

English Español

For Your Patients: Educational Materials

REMS Patient Guide

Help patients understand the REMS Program, including how it works and its enrollment requirements.

English

Tips for Side Effect Management While on Treatment

Provide patients with practical strategies for managing JYNARQUE treatment and side effects.

English Español

Patient Experience Program Flashcard

Give patients information on the Otsuka Patient Experience Program.

English Español

Getting Ready to Start Treatment With JYNARQUE Patient Brochure

Give patients this guide to treatment resources and support to help them start and stay on JYNARQUE.

English Español

Details and Eligibility

For patients:

In order to redeem this offer you must have a valid prescription for ABILIFY MAINTENA^® (aripiprazole). This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria (not a member of a federal, state, or government insurance program) and will comply with the terms and conditions described in the Restrictions section below. Patients with questions about the offer should call 1-888-591-9812.

Pharmacist:

When you use this card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs for this prescription. As a condition of payment, you certify that you are in compliance with all program rules, terms, and conditions, as well as with any obligations to provide notice of your participation in this program to third-party payers as required by law, contract, or otherwise.

Submit the claim to the primary Third Party Payer first, then submit the balance due to Therapy First Plus as a Secondary Payer COB [coordination of benefits] with patient responsibility amount and a valid Other Coverage Code (eg, 8). Eligible patients are responsible for as little as $10, with up to $8,000 in annual savings. A valid Prescriber ID# is required on the prescription. Reimbursement will be received from Therapy First Plus. For any questions regarding Therapy First Plus online processing, please call the Help Desk at 1-800-422-5604.

For Healthcare Professionals:

When you apply for this offer, you are certifying that you have not submitted a claim for reimbursement under any federal, state, or other governmental programs for this prescription. Participation in this program must comply with all applicable laws and regulations as a pharmacy provider. By participating in this program, you are certifying that you will comply with the terms and conditions described in the Restrictions section below.

Restrictions:

This offer is only valid in the United States and Puerto Rico and is not transferable. Patients are not eligible if they are under 18 years of age or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE. Offer void where prohibited by law, taxed, or restricted. Other restrictions may apply. This program is not health insurance. Otsuka America Pharmaceutical, Inc. has the right to rescind, revoke, or amend this program at any time without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage and that you will report the value received if required by your insurance provider. When you use this card, you are certifying that you understand and will comply with the program rules, terms, and conditions. Program managed by PSKW, LLC on behalf of Otsuka America Pharmaceutical, Inc. Offer not valid for cash-paying patients OR where drug is not covered by the primary insurance.

Please see U.S. FULL PRESCRIBING INFORMATION, including BOXED WARNING, AND MEDICATION GUIDE for ABILIFY MAINTENA.

Details and Eligibility

For patients:

In order to redeem this offer you must have a valid prescription for ABILIFY ASIMTUFII^® (aripiprazole) and commercial insurance. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria (not a member of a federal, state, or government insurance program) and will comply with the terms and conditions described in the Restrictions section below. Patients with questions about the offer should call 833-742-0816. Patients may pay as little as $5 per fill with an annual maximum benefit of $8,000 and monthly maximum benefit of wholesale acquisition cost plus usual and customary pharmacy charges. Presumes only 1 prescription filled per two calendar months.

Pharmacist:

Pharmacist Instructions for a Patient with an Eligible Third Party:

Submit the claim to the primary Third-Party Payer first, then submit the balance due to PDMI as a Secondary Payer coordination of benefits with patient responsibility amount and a valid Other Coverage Code (e.g., 8). For ABILIFY ASIMTUFII prescription, patient may pay as little as $5 per fill with an annual maximum benefit of $8,000 and monthly maximum benefit of wholesale acquisition cost plus usual and customary pharmacy charges; limits apply. Reimbursement will be received from PDMI. Valid Other Coverage Code Required. For any questions regarding PDMI online processing, please call the Help Desk at 833-742-0816.

For Healthcare Professionals:

Restrictions:

This offer is only valid in the United States and Puerto Rico, and is not transferable. Patients are not eligible if they are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE. Offer void where prohibited by law, taxed, or restricted. Other restrictions may apply. This program is not health insurance. Otsuka America Pharmaceutical, Inc. has the right to rescind, revoke, or amend this program at any time without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage and that you will report the value received if required by your insurance provider. When you use this card, you are certifying that you understand and will comply with the program rules, terms, and conditions. Program managed by TrialCard on behalf of Otsuka America Pharmaceutical, Inc.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, AND MEDICATION GUIDE.

Otsuka Patient Support™ Health Information Use and
Disclosure Authorization (“Authorization”)

Permission to Use and Disclose Health Information: This Authorization relates to the Otsuka Patient Experience Program and patient experience team. The Program provides services relating to drugs and devices ("Products") of OPH Inc. and its affiliates and successors ("Otsuka"). Your "Providers," for purposes of this Authorization, include any physician, pharmacy, care center, clinic, or other healthcare facilities and professionals, as well as any discount plan, health plan, or other payors that may have information related to the Products you use. By signing this Authorization, you (or your personal representative on your behalf) allow your Providers and Otsuka, along with the Recipients defined below, to use and disclose some of your Protected Health Information as defined below ("PHI") and as described in this Authorization.

PHI Recipients: Your Providers may give your PHI to Otsuka and any Program operators, manufacturers and distributors of the Product, and contractors ("Recipients"). The Recipients can also re-disclose your information to their contractors, vendors, and third parties that may take over the Program in the future. For example, Otsuka may give your information to vendors, advocacy organizations, patient assistance programs, patient access centers, data aggregators, laboratories, safety program administrators, Otsuka Digital Health, other business partners, website tracking tool vendors, and personnel of these third parties. For purposes of this Authorization, “Recipients” include Otsuka and all of these other third parties. “Recipients” also include any legal representatives, caregivers or other contacts listed in this Authorization.

PHI to be Used and Disclosed: PHI includes any and all health information related to the following:

Your name, address, patient ID number, and other demographic data, date of birth, and information you provide on any forms related to the Products
Healthcare records related to your eligibility for and use of the Products, such as dates of treatment, dosage, and dispensing
The healthcare condition for which the Products were or may be prescribed, or your condition while taking or after stopping the Products. You understand that this may include sensitive PHI
Your experience with the Products, including whether you take them as prescribed
Health coverage, financial, payment, and claim information related to the Product or your ability to pay
Information to help support your transition of care, such as getting discharged from a hospital

Purposes: The Recipients may use, share, and re-disclose your PHI, in electronic or any other form or format, for the following purposes:

Determining if you qualify for and contacting you about the Program and Product-related services
Providing assistance to you regarding the Product, facilitating access to the Product, determining health plan coverage requirements, and communicating with you and the Providers regarding the Product, your treatment, or payment for the Product
Internal data collection, research, and reporting, including reviewing utilization, trends, and future needs of patients and providers
Data analysis including de-identifying the PHI, creating limited data sets, or combining it with other information, and monetizing de-identified data as permitted by law
Establishing your treatment profile, tracking coverage, and determining cost sharing
Examining the effectiveness and operation of the Program
Analysis to help evaluate and improve the Program and create new programs
Consistent with applicable law and any applicable standards of ethical conduct, contacting your healthcare provider(s), law enforcement, emergency services, a family member, or any other person reasonably able to assist if a Recipient has a good faith belief that such action is necessary to prevent or lessen a threat to your health or safety, or to the health and safety of others
Fulfilling the Recipients' legal obligations
Using tracking tools on websites and applications to examine your interaction and experience with Program-related or Product-related platforms and to help the websites and applications function
Proper management and administration of the Recipients and the Program, including re-disclosures to other Recipients, Providers, payors, and service providers as needed to operate the Program

Revocation: You may revoke and cancel this Authorization by calling 1-833-468-7852 emailing [email protected], or sending a written notice to Otsuka Patient Support™, 508 Carnegie Center Drive, Princeton, NJ 08540. If you have questions about the Program, you can talk to your Provider and/or call Otsuka Patient Support™ at that number. If a Provider is disclosing PHI for the Program on an ongoing basis, your revocation will take effect with respect to such Provider when they receive notice of your revocation. Revocation will not affect any uses or disclosures of PHI that took place before such cancellation was received. For example, if your PHI has already been shared with third parties, it will not be able to be deleted. If you revoke this Authorization you will no longer be eligible to receive Program services, but this will not affect your ability to receive the Product.

Voluntary Authorization: You do not have to sign this Authorization. Refusal to sign will not affect the start, continuation, or quality of your treatment or any other treatment, payment, enrollment in health plans, or eligibility for benefits for which you qualify. Your Providers may not condition treatment, payment, enrollment, or eligibility for benefits on whether you sign this Authorization.

Re-Disclosure: Once your PHI is disclosed as allowed in this Authorization, it may be re-disclosed by the Recipients and will no longer be protected by the Health Insurance Portability and Accountability Act (HIPAA). Additionally, it may no longer be protected by certain other state and federal privacy and security laws.

Expiration: This Authorization will remain in effect for one (1) year from the date of the signature(s) below or until it is revoked, whichever is earlier.

Copy of Authorization: You have a right to receive a copy of this authorization.

By signing this Authorization, you acknowledge that you have read and understand this Authorization and expressly authorize the uses and disclosures of PHI referenced in this Authorization.

Consent: By signing this Authorization, I acknowledge and confirm that I have read, understand, and agree to this Authorization and expressly authorize the uses and disclosures of PHI referenced in this Authorization.

Individuals signing electronically: By signing this Authorization electronically, you understand that you will receive a copy of your completed Authorization to the email address that you provide. You must let us know if your email or other contact information changes. You understand that your email system may not be a completely secure form of transmission and is not always encrypted. You understand that you may sign a hard copy of this form if you prefer not to sign electronically.

JYNARQUE®

(tolvaptan) tablets

Preparing the JYNARQUE® (tolvaptan) folder: Resources for you and your patients.

For You: Professional Materials

REMS Patient Enrollment

Prescription Referral Form

Patient Experience Program Enrollment

JYNARQUE Patient Enrollment Checklist

For Your Patients: Educational Materials

REMS Patient Guide

Tips for Side Effect Management While on Treatment

Patient Experience Program Flashcard

Getting Ready to Start Treatment With JYNARQUE Patient Brochure

Details and Eligibility

For patients:

Pharmacist:

For Healthcare Professionals:

Restrictions:

Details and Eligibility

For patients:

Pharmacist:

Pharmacist Instructions for a Patient with an Eligible Third Party:

For Healthcare Professionals:

Restrictions:

Otsuka Patient Support™ Health Information Use and Disclosure Authorization (“Authorization”)

PHI to be Used and Disclosed: PHI includes any and all health information related to the following:

Purposes: The Recipients may use, share, and re-disclose your PHI, in electronic or any other form or format, for the following purposes:

JYNARQUE^®

Preparing the JYNARQUE^® (tolvaptan) folder: Resources for you and your patients.

Otsuka Patient Support™ Health Information Use and
Disclosure Authorization (“Authorization”)