Pfizer PANZYGA

PANZYGA (Immune Globulin Intravenous [Human] – ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older, chronic immune thrombocytopenia (cITP) in adults and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

PANZYGA is a liquid medicine for infusion that contains immunoglobulin G (IgG), which are proteins that help fight infection. It is made from human plasma that is donated by healthy people and contains antibodies. For patients with PI, PANZYGA helps replace the missing antibodies in the body. For patients with cITP, PANZYGA helps the body produce more platelets (the blood cells that help blood clot) to control or prevent bleeding. For patients with CIDP, PANZYGA may help improve mobility and hand strength.

PANZYGA is given into a vein (intravenously) in a hospital, infusion center, doctor’s office, or at home by a trained healthcare provider (HCP).

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

See full prescribing information for complete BOXED WARNING.

• Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain sucrose.
• For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer PANZYGA at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• Have had a severe allergic reaction to immune globulin or other blood products
• Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency, with antibodies against IgA and a history of hypersensitivity

• PANZYGA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) work less effectively for you. Before you get any vaccines, tell your healthcare provider that you take PANZYGA
• Decreased kidney function and kidney function failure can occur
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting can occur
• Elevated blood pressure can occur particularly in patients who have a history of hypertension (high blood pressure)
• If you are elderly, with heart or kidney problems, discuss with your healthcare provider prior to initiating treatment with PANZYGA 
• PANZYGA is made from human blood and therefore may have a risk of transmitting infectious agents, including viruses and, theoretically, the variant Creutzfeldt-Jakob disease (CJD) and CJD agent. The production and manufacturing process reduces this risk, but the risk cannot be eliminated

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction
• Bad headache with nausea, vomiting, stiff neck, fever, drowsiness, painful eye movements, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem (decreased kidney function or kidney failure)
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot, which could happen in the heart, brain, lungs, or elsewhere in the body
• Brown or red urine, swelling, fatigue, fast heart rate, difficulty breathing, or yellow skin or eyes. These could be signs of a liver or blood problem
• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem
• Fever over 100°F. This could be a sign of an infection
• Headache, fatigue or confusion, vision problem, chest pain, difficulty breathing, irregular heartbeat, or pounding in your chest, neck, or ears. These could be signs of high blood pressure  

Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine.

The most common side effects that may occur with PANZYGA are:

• Headache
• Nausea
• Fever
• Increased blood pressure
• Dermatitis
• Fatigue
• Abdominal pain
• Dizziness
• Anemia 

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away. 

Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.  

PANZYGA is an FDA-approved IVIg therapy to treat adults with CIDP or cITP, and people 2 years of age and older with PI.

• For adults with CIDP, PANZYGA may help improve arm and leg strength and mobility and general activity level
• For people 2 years of age and older with PI, PANZYGA helps replace antibodies that are missing from the immune system, which may help reduce the risk of infection
• For adults with cITP, PANZYGA helps boost platelet count, which may help control and prevent bleeding 

PANZYGA is a liquid medicine given by infusion that contains purified antibodies known as immunoglobulin G (IgG).

As part of its commitment to patients with CIDP, Pfizer is proud to offer the Pfizer Pledge Warranty Program^*† for adult patients with CIDP starting PANZYGA. With this program, eligible patients can get their out-of-pocket drug costs for PANZYGA refunded. See below to learn more.

---

• With this program, eligible patients can be refunded their out-of-pocket drug costs for up to the first 4 treatments of PANZYGA for chronic inflammatory demyelinating polyneuropathy (CIDP) if the treatment is discontinued by the patient’s healthcare provider for clinical reasons
• Per treatment and aggregate maximum refund limits apply. If the patient’s commercial insurance and/or other payers paid for all or a portion of the cost of PANZYGA, the plan(s) can be refunded those costs up to the program maximum limits minus any out-of-pocket drug costs paid by the patient

---

• The Pfizer Pledge Warranty Program is available to adult, cash-paying or commercially insured patients (those with employer-sponsored or private insurance) prescribed PANZYGA for CIDP whose healthcare provider discontinues treatment for clinical reasons before the fifth treatment^‡
• Patients are not eligible for the program if their PANZYGA was covered, in whole or in part, by Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico

---

• For information on the Pfizer Pledge Warranty Program and for access to resources, such as patient claim forms, please visit PanzygaInfo.com

---

*Not available for residents of Puerto Rico.
^†Terms and conditions/eligibility requirements apply. See full terms and conditions at PanzygaInfo.com.
^‡Single treatments may be given over 1 or more days.

Terms and Conditions

Pfizer, Inc. (referred to as “us,” “we” and similar terms) is proud to offer the Pfizer Pledge Warranty Program for PANZYGA (the “Program”) to each Patient (referred to as “you,” “your” and similar terms) who meets the Eligibility Requirements and follows the Program Procedures defined below, subject to all the terms and conditions in this document (the “Terms”). You should carefully review these Terms.

Overview of Program

For Patients who meet the Eligibility Requirements, Pfizer will refund the out-of-pocket amount that you paid for up to the first 4 Treatments of PANZYGA for the chronic inflammatory demyelinating polyneuropathy (CIDP) indication, up to a maximum of $16,500 per treatment. The total, per patient, Program refund shall not exceed $50,000 (the “Maximum”). Treatment is defined as the total prescribed dose, which may be administered by a healthcare provider over one or more days.  If your commercial insurance and/or other payers (“Your Plan(s)”) paid for all or a portion of the cost of PANZYGA, Pfizer will, on your behalf, refund Your Plan(s) the Average Sales Price as calculated by Pfizer up to the Maximum, less documented out-of-pocket payments provided by you or on your behalf. Payments to all parties must be equal to or less than the cost paid by each party and may reset Your Plan(s)’s out-of-pocket deductible cost in accordance with Your Plan(s)’s benefit design. The order of priority of Warranty payments is first to you and then to Your Plan that is primary and then to Your Plan(s) that are secondary as determined by information provided by you and the documented proof of payment that you provide to us. You are responsible for submitting proof of payment for you and for Your Plan(s). All claims payments will be reported to Your Plan(s).

Medication Eligible for the Program

PANZYGA [Immune Globulin Intravenous (Human) – ifas]

Carton NDC	Container NDC Number	Product Description
00069-1011-02	00069-1011-01	PANZYGA IVIG 1G/10ML SSOL 1X1 VL
00069-1109-02	00069-1109-01	PANZYGA IVIG 2.5G/25ML SSOL 1X1 VL
00069-1224-02	00069-1224-01	PANZYGA IVIG 5G/50ML SSOL 1X1 VL
00069-1312-02	00069-1312-01	PANZYGA IVIG 10G/100ML SSOL 1X1 VL
00069-1415-02	00069-1415-01	PANZYGA IVIG 20G/200ML SSOL 1X1 VL
00069-1558-02	00069-1558-01	PANZYGA IVIG 30G/300ML SSOL 1X1 VL

Eligibility Requirements

The Pfizer Pledge Warranty Program is available to adult, cash-paying or commercially insured patients. Patients are not eligible for the program if their PANZYGA was covered, in whole or in part, by Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Commercially insured or cash-paying adult patients must satisfy all of the following criteria in order to be eligible to use the Program: 

1. You are a resident of the 50 United States of America or the District of Columbia. The Program is void for any request made by anyone living outside the 50 United States or the District of Columbia.
2. You were prescribed PANZYGA by your healthcare provider to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
3. You used PANZYGA on-label according to the instructions provided by your healthcare provider.
4. You have not used another Immunoglobulin product in the past 12 months.
5. You discontinued PANZYGA for clinical reasons defined at the discretion of the healthcare provider. Discontinuation or switching to another Ig (intravenous or subcutaneous) product due to patient choice, affordability, or for a non-clinical reason does not qualify for the Program.
6. You must discontinue using PANZYGA prior to the administration of the fifth treatment of PANZYGA. 
7. PANZYGA treatment administered as a hospital inpatient is not eligible for the Warranty.
8. You are not eligible to participate in this Program if you are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
9. Your first treatment of PANZYGA must be administered on or after July 1, 2022, and on or before June 30, 2023 (the “Coverage Period”).
10. Only PANZYGA sold by Pfizer will be eligible for this warranty.  You may be able to identify this through the NDC codes listed in the “Medication Eligible for the Program” section. 

Costs other than for the drug will not be reimbursed (i.e., administration costs).

You must submit all Claims Information (as described below) within 180 days following the administration date of your last treatment of PANZYGA.

Benefit Request Process

1. To be eligible for a refund under this Program, you must satisfy the requirements and submit the information below (the “Claims Information”), 180 days following the date of your last treatment of PANZYGA. Call 1-800-276-0726 and a representative will provide you with a Patient Warranty Claim Form, a Patient Declarations and Authorizations Form, an Healthcare Provider Attestation Form, and a Pharmacy Attestation Form, or these forms may be downloaded from www.panzygainfo.com.
2. You will need to provide a copy/photo of the following: (1) both sides of your insurance card(s) for both prescription and medical benefit insurance, (2) the Explanation of Benefits (EOB) for each treatment from your Health Insurer(s). 
3. You will then need to return a fully completed and signed (1) Patient Warranty Claim Form, (2) Patient Declarations and Authorizations Form, (3) Healthcare Provider Attestation Form, and (4) Pharmacy Attestation Form in accordance with their instructions, which will include the following information:
   1. Patient Warranty Claim Form:
      • Your name, date of birth, phone number, address, gender, and email address
      • Prescribing healthcare provider name, phone number, and address
      • For each treatment, the dispensing pharmacy name, phone number, and address
      • For each treatment, Your Plan(s)’s information and amounts paid by Your Plan(s), including the following:
        • For each primary insurer, secondary insurer and prescription insurer: the insurance type, insurer name, phone number, address, policy beneficiary ID number, group number, policyholder name, policyholder relationship, and policyholder date of birth
   2. Patient Declarations and Authorizations Form, which includes your:
      • Consent for the Pfizer Pledge
      • Consent to receive communication from our representative to process your claim
      • Authorization to share health information to process your claim
      • Acknowledgment of laws
   3. Healthcare Provider Attestation Form, completed and signed by your prescribing healthcare provider, which includes the following information:
      • Your name and date of birth
      • Prescribing healthcare provider name, phone number and address
      • Prescribing healthcare provider’s attestation that PANZYGA was prescribed for on-label use for the chronic inflammatory demyelinating polyneuropathy (CIDP) indication, and the clinical rationale for discontinuance of PANZYGA (no confirmatory documentation required)
      • Attestation that you have discontinued PANZYGA prior to the fifth treatment of PANZYGA
   4. Pharmacy Attestation Form, completed and signed by the pharmacy dispensing PANZYGA or the clinic infusing PANZYGA, which includes the following information:
      • Your name and date of birth
      • The PANZYGA treatment dates
      • The number of vials of each strength of PANZYGA dispensed for each treatment date
      • For each treatment date: the amount of money you paid out-of-pocket, the amount of financial assistance from the Pfizer PANZYGA Co-Pay Program, and the amount of co-pay assistance from any other source other than the Pfizer PANZYGA Co-pay Program
      • The number of Pfizer vials of PANZYGA that were dispensed (Pharmacy) or infused (Clinic) 
      • The amount of money documented on the form was collected
      • Federal programs (including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”) were not billed for PANZYGA
4. If your Claims Information passes the verification process, we will notify you via telephone or email that you have been approved for coverage.
5. If your Claims Information does not pass the verification process, we will notify you via email that your request has been denied and the email will include the reason for the denial (such as incomplete information, mismatched information, etc.). You will be given the opportunity to resubmit your Claims Information within 30 days of the email notification.

Additional Terms and Conditions

By submitting your Claims Information under the Program, you are representing and warranting that you took the medication in accordance with the instructions that were provided by your prescribing healthcare provider.

• We reserve the right to modify the processes, procedures, parameters, or other terms of the Program, or terminate the Program entirely, at any time, without prior notice to you. If we terminate the Program, we will: continue to honor valid warranty claims for patients whose initial dose of PANZYGA occurred prior to the termination date of the program. The current status of the Program and applicable terms are available at www.panzygainfo.com
• We are refunding payments under this Program to you and Your Plan(s) based on the information provided by you. You are responsible for resolving any disagreements related to reimbursements made by us, on Your behalf, to Your Plan(s)

LIMITATION OF LIABILITY

IN NO EVENT, UNDER ANY CAUSE OF ACTION OR THEORY OF LIABILITY, SHALL PFIZER, ITS DISTRIBUTORS OR SUPPLIERS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OF ANY NATURE WHATSOEVER, ARISING OUT OF OR IN CONNECTION WITH THE PROGRAM, EVEN IF PFIZER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

NOTWITHSTANDING ANY DAMAGES THAT YOU MIGHT INCUR FOR ANY REASON WHATSOEVER, INCLUDING, WITHOUT LIMITATION, ALL DAMAGES REFERENCED HEREIN AND ALL DIRECT OR GENERAL DAMAGES IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, THE ENTIRE AGGREGATE LIABILITY OF PFIZER AND ANY OF ITS DISTRIBUTORS AND/OR SUPPLIERS SHALL BE LIMITED TO THE MAXIMUM AMOUNT SET FORTH ABOVE FOR THE PRODUCT THAT IS SUBJECT TO THE PROGRAM. SOME STATES AND/OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. THE LIMITATIONS OF LIABILITY SET FORTH ABOVE SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW.

ARBITRATION: Read the following arbitration provision (“Provision”) carefully. It limits certain of your rights, including your right to obtain relief or damages through court action.

To begin Arbitration, either you or we must make a written demand to the other party for Arbitration for the applicable claim (“Claim”). The Arbitration will take place before a single arbitrator. It will be administered in keeping with the Expedited Procedures of the Commercial Arbitration Rules (“Rules”) of the American Arbitration Association (“AAA”) in effect when the Claim is filed. You may get a copy of the AAA’s Rules by visiting www.adr.org. The filing fees to begin and carry out Arbitration will be shared equally between you and us. This does not prohibit the arbitrator from giving the winning party their fees and expenses for the Arbitration. Unless you and we agree, the Arbitration will take place in the county and state where you live. The Federal Arbitration Act, 9 U.S.C. Ch. 1, et seq., will govern, and not any state law on Arbitration. YOU AGREE AND UNDERSTAND THAT this Arbitration Provision means that you give up your right to go to court on any Claim covered by this provision. You also agree that any Arbitration proceeding will only consider your Claim. Claims by, or on behalf of, other individuals will not be arbitrated in any proceeding that is considering your Claim. THE DEGREE TO WHICH ARBITRATION CAN BE USED AS A DISPUTE RESOLUTION PROCESS FOR CONSUMER CLAIMS VARIES FROM STATE TO STATE, SO THIS ARBITRATION PROVISION MAY NOT APPLY TO YOU, DEPENDING ON YOUR STATE OF RESIDENCE. In the event this Arbitration provision is not approved by the appropriate state regulatory agency, and/or is stricken, severed, or otherwise deemed unenforceable by a court of competent jurisdiction, you and we specifically agree to waive and forever give up the right to a trial by jury. Instead, in the event any litigation arises between you and us, any such lawsuit will be tried before a judge, and a jury will not be impaneled or struck.

PANZYGA offers resources to help support patients on their IVIg therapy journey.

Pfizer IGuide^TM can help you understand your insurance coverage and out-of-pocket costs for your prescribed PANZYGA, as well as identify financial assistance options for which you may be eligible.

If you have been prescribed PANZYGA and have questions about your coverage, call Pfizer IGuide^TM Monday through Friday, 8 AM to 8 PM ET, at
1-844-448-4337.

Financial Assistance

• Pfizer IGuide^TM can help identify financial assistance resources for which you may be eligible to help with out-of-pocket costs for PANZYGA

Commercially Insured Patients

• If you have commercial, employer, or private coverage, including coverage purchased through a state health insurance marketplace, you may be eligible for the PANZYGA Co-Pay Program, which can help cover the cost of your co-pay. Eligible patients may pay as little as $0 per PANZYGA treatment. The value of the co-pay card is limited to a maximum of $5000* per calendar year

Medicare/Government-Insured Patients 

• If you have government-funded insurance and need help to cover the cost of PANZYGA, Pfizer IGuide^TM can help identify financial support options including alternate coverage resources, if available 

Uninsured Patients 

• If you do not have health insurance and cannot afford PANZYGA treatment, Pfizer IGuide^TM can connect you to potential resources that may help cover the cost of PANZYGA, including how to apply to Medicaid if you may be eligible 

Visit www.PfizerIGuide.com to learn more.

*Terms and conditions/eligibility requirements apply. See full terms and conditions here. Patients must be 2 years or older and have commercial insurance to be eligible. Patients are not eligible if they are enrolled in a state or federally funded insurance program.

Learn more about CIDP, PANZYGA treatment, and the support available to you. 

Learn more about PANZYGA and getting started on IVIg therapy. 

Document your treatment experience after each PANZYGA infusion.

Learn more about the financial resources that may be available to you.

---

You may be eligible for financial assistance options to help with out-of-pocket costs, including the PANZYGA Co-Pay Program, which can help cover the cost of your co-pay. 

Panzyga Co-Pay Program Video

Panzyga CIDP Brochure Video

Ig Companion Overview Video