Patient Support Program Privacy Policy

This Privacy Policy describes how North 53, LLC and its subsidiary and affiliated companies (“we,” “our,” or “us”) collects Personal Information from and about you, including through your interactions with us https://portal.trialcard.com/cordavis/pyzchiva (the “Site”). We refer to these collectively as the “Services.” It also describes the types of Personal Information we collect, how we may use and disclose such information, and your choices and legal rights with respect to such information.

By using our Services, you agree to the collection, use, and disclosure of your information as described in this Privacy Policy. If you do not agree, please do not use our Services.

Contents:

1. Personal Information We Collect

There are several ways we may collect Personal Information about you, including through information you provide to us; information we collect through your use of the Services and interactions with us; information we receive from third parties; and by combining information from different sources. This includes data that identifies you personally, whether directly or indirectly. For purposes of this Privacy Policy, “Personal Information” refers to information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, to you, and includes “personal data” or similar terms as defined in applicable law.

a) Categories of Information We May Collect
We may collect certain categories of Personal Information, such as:

  • Identifiers/demographic information, such as name, age, date of birth, sex, gender, postal and email address, phone number, and online identifiers, Internet Protocol (“IP”) address, and other similar identifiers.
  • Commercial information, such as products or services purchased, obtained, or considered and other purchasing or consuming histories or tendencies.
  • Internet or other electronic network activity information.
  • Geolocation data (non-precise).
  • Sensitive Personal Information as defined by applicable laws, including Personal Information collected and analyzed concerning a consumer’s health.

b) Information You May Provide
When you use our Services, we may collect Personal Information from you, such as when you enroll in a patient support program or call into the medical information center.

c) Information We May Automatically Collect
When you visit and interact with our Services, we or our service providers do not use first or third-party cookies or any tracking technologies on our website.

d) Information We May Receive from Third Parties
We may receive Personal Information from other sources. Our third-party sources may include:

  • Providers, such as a prescriber of your medication.

e) Combination of Information
We may combine Personal Information that we receive from various sources. For example, we may combine Personal Information that we receive from third parties with Personal Information we already have about you. We use, disclose, and protect combined Personal Information as described in this Privacy Policy.

f) Retention
We will retain your Personal Information for as long as reasonably necessary to provide you with our Services that you request or otherwise where permitted or required in accordance with applicable law. We will retain and use your Personal Information as necessary to comply with our legal obligations, resolve disputes, and enforce our agreements. What this means in practice will vary between different types of information, and when we consider our approach, we take into account ongoing business or legal needs for the information, for example in relation to tax, health and safety, and potential or actual disputes or investigations.

2. Purposes for Processing Your Personal Information

We may use the Personal Information we collect about you for the purposes listed below:

  • To provide you with our Services, including to enroll you in a patient support program.
  • To communicate with you, including to respond to your inquiries/requests and request feedback from you, and to send you important updates and messages about changes to our Services, our Privacy Policy, and/or other applicable terms and conditions.
  • To review the usage and maintain the operation of our Services.
  • To conduct analysis and develop and/or improve our Services.
  • To monitor, protect, and maintain the security and integrity of our Services and our business, such as protecting against and preventing fraud, unauthorized transactions, claims and other liabilities.
  • To comply with applicable laws and regulations and respond to lawful requests and communications from law enforcement and other government officials.
  • To carry out sales and business transactions in which information held by us is among the assets transferred or is otherwise relevant to the evaluation, negotiation, or completion of the transaction.
  • To protect our rights, privacy, safety, property and/or those of others.
  • To fulfill any other purpose for which you provide your Personal Information or as explained to you at the point of information collection.

3. How We May Disclose Your Personal Information

We may disclose Personal Information that we collect to the following categories of recipients:

  • Our Service Providers. We disclose your Personal Information to our service providers that provide business, professional, or technical support services to us, help us operate our business and the Services, or administer activities on our behalf. We require our service providers to only use your Personal Information in connection with providing services to us.
  • Commercial information, such as products or services purchased, obtained, or considered and other purchasing or consuming histories or tendencies.

In certain circumstances, we may disclose each category of your Personal Information to:

  • Competent Governmental, Regulatory, and Public Authorities. We may disclose your Personal Information only as permitted or if required to do so by government and law enforcement authorities. We disclose Personal Information in matters involving claims of personal or public safety, or in litigation. This may include disclosure of your Personal Information to allow us to pursue remedies or to limit the damages we may sustain. We may also use or disclose your information to enforce our terms and conditions, to protect our operations or those of any of our affiliates, to prevent misuse of our Services, or to protect our rights, privacy, safety or property and/or that of our affiliates, you, or others.
  • Relevant Third Parties as Part of a Corporate Transaction. In the event of a reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with a bankruptcy or similar proceeding), we may disclose or transfer your Personal Information to certain third parties, such as the acquiring entity and its advisers.
  • Other Third Parties. We will disclose your Personal Information to other third parties at your direction or with your consent. Additionally, we will disclose your Personal Information as we believe necessary or appropriate to: (a) comply with applicable law; (b) enforce our terms and conditions; (c) protect our operations; (d) protect our rights, privacy, safety, or property, and/or those of you or others; and (e) allow us to pursue available remedies or limit damages that we may sustain.

We may disclose Personal Information for other reasons that we will describe at the time of information collection or prior to disclosing your information.

Please note that we may de-identify or aggregate Personal Information so that it will no longer be considered Personal Information and disclose such information to other parties for purposes consistent with those described in this Privacy Policy. Unless you take action to re-identify your de-identified information, we will not attempt to re-identify this information so that it may be associated with you.

4. Your Privacy Choices and Rights

You have the ability to make certain choices about how we use your Personal Information, as follows:

a) Privacy Rights and Requests

Depending on your U.S. state of residence, including California, Colorado, Connecticut, Delaware, Iowa, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Tennessee, Texas, Utah, Virginia, and such other states with privacy laws that are enacted, you may have certain rights in relation to your Personal Information, including:

  • Right to Know: You may have the right to know what Personal Information we have collected about you, including the categories of sources from which the Personal Information is collected, the business or commercial purpose for collecting, selling, or sharing Personal Information, the categories of third parties to whom we disclose Personal Information, the categories of Personal Information disclosed to third parties, and the specific pieces of Personal Information we have collected about you. Please note that we may not be required to respond to your requests “to know” or access specific pieces of Personal Information more than twice in any 12-month period.
  • Right to Request Specific List of Third Parties: We do not share or sell personal information to third parties, so we do not offer a method to request this information.
  • Right to Request a List of Categories of Third Parties: You may have the right to request a list of the categories of third parties to which we have disclosed Personal Information.
  • Right to Data Portability: You may have the right to access your information in a portable format.
  • Right to Delete: You may have the right to request that we delete Personal Information that we have collected from or about you, subject to certain exceptions.
  • Right to Correct: You may have the right to correct inaccurate Personal Information that we may maintain about you, subject to appropriate verification.
  • Right to Opt Out of Certain Types of Personal Information Uses and Disclosures: We do not use and disclose to third parties Personal Information for analytics and advertising purposes. Therefore, we do not offer an opt out of the “sale” or "sharing” of your Personal Information, or the use and disclosure of your Personal Information for “targeted advertising” (as these terms are defined under applicable law).

Please note that, where permitted under applicable law, we may decline a request if we are unable to verify your identity (or an agent’s authority to make the request) and confirm the Personal Information we maintain relates to you.

If you are interested in exercising one or more of the rights outlined above, please email us at ConsumerPrivacy@CVSHealth.com or call us at 1-833-533-0768. We may take steps to verify your identity before responding to your request by asking you a series of questions about you or your previous interactions with us. Submitting a privacy rights request does not require you to create an account with us.

We will not discriminate against you if you decide to exercise your privacy rights.

b) Agent Requests

Only you, or someone legally authorized to act on your behalf, may submit a request related to your Personal Information.

Depending on your U.S. state of residence, you may authorize someone to make a privacy rights request on your behalf (an authorized agent). Authorized agents will need to demonstrate that you’ve authorized them to act on your behalf. We retain the right to request confirmation directly from you confirming that the agent is authorized to make such a request, or to request additional information to confirm the agent’s identity.

c) Right to Appeal

Depending on your U.S. state of residence, you may have the right to appeal a decision we have made in connection with your privacy rights request. To appeal a decision, please contact us at ConsumerPrivacy@CVSHealth.com.

d) Notice of Financial Incentive

We do not offer financial incentives to promote our products and services.

5. External Links

Our Services may have links to third-party services, which may have privacy policies that differ from our own. We are not responsible for the practices of third-party services.

6. Children’s Privacy

Our Services are intended for a general audience. We do not direct our Services to individuals under eighteen (18), nor do we knowingly solicit or collect any Personal Information from individuals under eighteen (18).

7. Data Security

We have implemented physical, administrative, and technical safeguards to maintain the security, confidentiality, and integrity of your information. However, as no transmission of information over the internet is absolutely secure, we cannot guarantee the safety of your information.

8. Revisions To This Privacy Policy

We reserve the right, in our sole discretion, to change, modify, add, remove, or otherwise revise portions of this Privacy Policy at any time. When we do, we will post the change(s) to our Services. Your continued use of our Services following the posting of changes to these terms means you accept these changes. If we change the Privacy Policy in a material way, we will provide appropriate notice to you and seek your consent where required by applicable privacy laws. Notice may be provided via a temporary banner on our Site, an email sent to users for whom we have an email address, or by temporarily noting “UPDATED” next to the Privacy Policy link on the footer of our Site.

9. How To Contact Us

If you have any questions or concerns about this Privacy Policy or the practices described herein, you may contact us by email at ConsumerPrivacy@CVSHealth.com, by mail to 1 CVS Drive, Woonsocket, RI 02895, or by phone at 1-833-533-0768.

Indications and Important Safety Information

What is PYZCHIVA® (ustekinumab-ttwe)?

PYZCHIVA® is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of:

Adult patients with:

  • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
  • active psoriatic arthritis (PsA)
  • moderately to severely active Crohn’s disease (CD)
  • moderately to severely active ulcerative colitis

Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
  • active psoriatic arthritis

IMPORTANT SAFETY INFORMATION

PYZCHIVA® is a prescription medicine that affects your immune system. PYZCHIVA® can increase your risk of having serious side effects, including:

Serious infections: PYZCHIVA® may lower your ability to fight infections. Some people have serious infections while taking PYZCHIVA®, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Therefore, your doctor should check you for TB before starting PYZCHIVA® and watch you closely for signs and symptoms of TB during treatment with PYZCHIVA®. If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with PYZCHIVA®. You should not start taking PYZCHIVA® if you have any kind of infection unless your doctor says it is okay.

Before starting PYZCHIVA®, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweat, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feel very tired
  • are being treated for an infection or have any open cuts
  • get a lot of infections or have infections that keep coming back
  • have TB or have been in close contact with someone with TB

After starting PYZCHIVA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. PYZCHIVA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins IL-12 and IL-23 are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take PYZCHIVA® may also be more likely to get these infections.

Cancers: PYZCHIVA® is an immunosuppressant and may increase your risk of certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving PYZCHIVA® and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with PYZCHIVA®, tell your doctor if you develop any new skin growths.

Posterior Reversible Encephalopathy Syndrome (PRES): PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:

  • headache
  • seizures
  • confusion
  • vision problems

Serious Allergic Reactions: Serious allergic reactions can occur with PYZCHIVA®. Stop using PYZCHIVA® and get medical help right away if you have any of the following symptoms of a serious allergic reaction:

  • feeling faint
  • chest tightness
  • swelling of your face, eyelids, tongue, or throat
  • skin rash

Lung Inflammation: Cases of lung inflammation have happened in some people who receive PYZCHIVA®, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with PYZCHIVA®.

Before you receive PYZCHIVA®, tell your doctor about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed above for serious infections, cancers, or PRES
  • ever had an allergic reaction to PYZCHIVA® or other ustekinumab products. Ask your doctor if you are not sure
  • have recently received or are scheduled to receive an immunization (vaccine). People who take PYZCHIVA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving PYZCHIVA® or one year after you stop receiving PYZCHIVA®
  • have any new or changing lesions within psoriasis areas or on normal skin
  • are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with PYZCHIVA®. PYZCHIVA® may also increase your risk of having an allergic reaction to an allergy shot.
  • receive or have received phototherapy for your psoriasis
  • are pregnant or plan to become pregnant. It is not known if PYZCHIVA® can harm your unborn baby. You and your doctor should decide if you will receive PYZCHIVA®
  • received PYZCHIVA® while you were pregnant. It is important that you tell your baby’s doctor before any vaccinations are given to your baby
  • are breastfeeding or plan to breastfeed. PYZCHIVA® can pass into your breast milk
  • Talk to your doctor about the best way to feed your baby if you receive PYZCHIVA®

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed PYZCHIVA®:

  • use PYZCHIVA® exactly as your doctor tells you to
  • PYZCHIVA® is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that PYZCHIVA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of PYZCHIVA® at home, you should receive training on the right way to prepare and inject PYZCHIVA®. Your doctor will determine the right dose of PYZCHIVA® for you, the amount for each injection, and how often you should receive it. Do not try to inject PYZCHIVA® yourself until you or your caregiver have been shown how to inject PYZCHIVA® by your doctor or nurse

Keep PYZCHIVA® and all medicines out of the reach of children.

Common side effects for PYZCHIVA® include nasal congestion, sore throat, and runny nose; upper respiratory infections; fever; headache; tiredness; itching; nausea and vomiting; redness at the injection site; vaginal yeast infections; urinary tract infections; sinus infection; bronchitis; diarrhea; and stomach pain. These are not all of the possible side effects with PYZCHIVA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please see your doctor to discuss any questions you may have.

Please see full Prescribing Information, including Medication Guide, for PYZCHIVA®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications & Important Safety Information

What is PYZCHIVA® (ustekinumab-ttwe)?

PYZCHIVA® is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of:

Adult patients with:

  • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
  • active psoriatic arthritis (PsA)
  • moderately to severely active Crohn’s disease (CD)
  • moderately to severely active ulcerative colitis

Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
  • active psoriatic arthritis

IMPORTANT SAFETY INFORMATION

PYZCHIVA® is a prescription medicine that affects your immune system. PYZCHIVA® can increase your risk of having serious side effects, including:

Serious infections: PYZCHIVA® may lower your ability to fight infections. Some people have serious infections while taking PYZCHIVA®, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Therefore, your doctor should check you for TB before starting PYZCHIVA® and watch you closely for signs and symptoms of TB during treatment with PYZCHIVA®. If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with PYZCHIVA®. You should not start taking PYZCHIVA® if you have any kind of infection unless your doctor says it is okay.

Before starting PYZCHIVA®, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweat, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feel very tired
  • are being treated for an infection or have any open cuts
  • get a lot of infections or have infections that keep coming back
  • have TB or have been in close contact with someone with TB

After starting PYZCHIVA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. PYZCHIVA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins IL-12 and IL-23 are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take PYZCHIVA® may also be more likely to get these infections.

Cancers: PYZCHIVA® is an immunosuppressant and may increase your risk of certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving PYZCHIVA® and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with PYZCHIVA®, tell your doctor if you develop any new skin growths.

Posterior Reversible Encephalopathy Syndrome (PRES): PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:

  • headache
  • seizures
  • confusion
  • vision problems

Serious Allergic Reactions: Serious allergic reactions can occur with PYZCHIVA®. Stop using PYZCHIVA® and get medical help right away if you have any of the following symptoms of a serious allergic reaction:

  • feeling faint
  • chest tightness
  • swelling of your face, eyelids, tongue, or throat
  • skin rash

Lung Inflammation: Cases of lung inflammation have happened in some people who receive PYZCHIVA®, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with PYZCHIVA®.

Before you receive PYZCHIVA®, tell your doctor about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed above for serious infections, cancers, or PRES
  • ever had an allergic reaction to PYZCHIVA® or other ustekinumab products. Ask your doctor if you are not sure
  • have recently received or are scheduled to receive an immunization (vaccine). People who take PYZCHIVA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving PYZCHIVA® or one year after you stop receiving PYZCHIVA®
  • have any new or changing lesions within psoriasis areas or on normal skin
  • are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with PYZCHIVA®. PYZCHIVA® may also increase your risk of having an allergic reaction to an allergy shot.
  • receive or have received phototherapy for your psoriasis
  • are pregnant or plan to become pregnant. It is not known if PYZCHIVA® can harm your unborn baby. You and your doctor should decide if you will receive PYZCHIVA®
  • received PYZCHIVA® while you were pregnant. It is important that you tell your baby’s doctor before any vaccinations are given to your baby
  • are breastfeeding or plan to breastfeed. PYZCHIVA® can pass into your breast milk
  • Talk to your doctor about the best way to feed your baby if you receive PYZCHIVA®

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed PYZCHIVA®:

  • use PYZCHIVA® exactly as your doctor tells you to
  • PYZCHIVA® is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that PYZCHIVA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of PYZCHIVA® at home, you should receive training on the right way to prepare and inject PYZCHIVA®. Your doctor will determine the right dose of PYZCHIVA® for you, the amount for each injection, and how often you should receive it. Do not try to inject PYZCHIVA® yourself until you or your caregiver have been shown how to inject PYZCHIVA® by your doctor or nurse

Keep PYZCHIVA® and all medicines out of the reach of children.

Common side effects for PYZCHIVA® include nasal congestion, sore throat, and runny nose; upper respiratory infections; fever; headache; tiredness; itching; nausea and vomiting; redness at the injection site; vaginal yeast infections; urinary tract infections; sinus infection; bronchitis; diarrhea; and stomach pain. These are not all of the possible side effects with PYZCHIVA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please see your doctor to discuss any questions you may have.

Please see full Prescribing Information, including Medication Guide, for PYZCHIVA®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.