Eligible PIDD patients may pay as little as ZERO copay for XEMBIFY!
Copay assistance program: Now with maximum copay support
- Eligible patients may pay $0 for XEMBIFY
- Offering double the amount of copay assistance, increased from $5,000 to $10,000 per calendar year
- Copay assistance program covers deductibles, copayment, and coinsurance medication costs for XEMBIFY
- Eligibility—patients must be enrolled in Xembify Connexions and have commercial insurance that:
- Covers medication costs for XEMBIFY
- Allows for copay or coupon assistance
Patient assistance program
- Provides uninsured PIDD patients access to the therapy they need
Supporting you and your office with guidance on coverage authorization, reimbursement, and access to XEMBIFY
Sample letters and checklists here help you and your staff with your patients' coverage authorization and appeals.
XEMBIFY Authorization Appeals Letter
This letter is required when coverage authorization is denied by your patient's health plan.
XEMBIFY Letter of Medical Necessity (LMN)
The purpose of an LMN, if necessary, is to explain the prescribing HCP's rationale when choosing XEMBIFY.
Coding and reimbursement guidance
Xembify Connexions can help you and your staff better understand health insurance reimbursement policies.
Consent, attestation, and referral guidance
This form authorizes us to use your patient's information to provide financial and dedicated medical support.
Your patient will complete this application to enroll in Xembify Connexions.
Patient Assistance Program Application
This form may help eligible patients receive their medication at no cost.
HCP Attestation Form
Please complete this form to verify the information you provided for the patient assistance program is true.
Manufactured to help protect a wide range of PIDD patients1,2*
Proven efficacy to reduce the impact of PIDD on patients' lives3
Proven tolerability profile3
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Want more information on XEMBIFY?
*In patients 2 years of age and older.
For all your questions regarding copay assistance, coverage authorization, or to access XEMBIFY through our distribution partners, call Xembify Connexions at 1-844-MYXEMBIFY (1-844-699-3624).
TERMS AND CONDITIONS FOR COPAY ASSISTANCE PROGRAM
- Eligible patient must be enrolled in the Xembify® Connexions program.
- Eligible patients may pay $0 for XEMBIFY® (immune globulin subcutaneous human–klhw) 20%. Benefits amount $10,000 annual maximum benefit.
- You may be eligible if you have commercial or private prescription insurance coverage for XEMBIFY®.
- You must have a valid on-label prescription for XEMBIFY®.
- This offer may not be combined with any other coupon, discount, prescription savings card, free trial, or other offer.
- Must NOT have drug coverage under any federally funded healthcare program, including, but not limited to, Medicare, Medicaid, TRICARE®, Department of Defense, Veterans Administration or any other federal- or state-funded healthcare program (collectively, Federal Healthcare Program or "FHCP"). Patients with this coverage will be ineligible to participate.
- Must confirm that they will not submit out-of-pocket costs paid by this program as a claim for payment to any third-party payer, pharmaceutical patient assistance foundation, or account such as a Flexible Spending Account (FSA), a Health Savings Account (HSA), or a Health Reimbursement Account (HRA).
- If your insurance situation changes, it is your responsibility to notify the Xembify® Connexions Copay Program at 1-855-636-8715 so that your eligibility can be reassessed under your new insurance coverage.
- Offer is only valid for residents in the US, Excluding Puerto Rico, or US Territories. Residents of certain US States may NOT be eligible to participate in the Program (subject to state law).
- It is important that you understand that you will be asked to provide personal information that may include your name, address, phone number, email address, and information related to your insurance and treatment. This information is necessary to permit Grifols, the maker of XEMBIFY®, and companies that work with Grifols, including affiliates and third-party service providers, to enroll you in the Xembify® Connexions Copay Program. Grifols may also use the information you give us to learn more about the people who use XEMBIFY®, and to improve the information we provide to people who are being treated with XEMBIFY®. Grifols will not share your information with anyone else except as required by law.
- As a condition of participating in this program, you must ensure that you comply with any cost sharing (copayments, coupons, rebates) disclosure requirements of your insurance carrier or third-party payer, including disclosing to your insurer the amount of financial support you receive from this program.
XEMBIFY® (immune globulin subcutaneous human–klhw) is a 20% immune globulin indicated for treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. XEMBIFY is for subcutaneous administration only.
IMPORTANT SAFETY INFORMATION
- Thrombosis may occur with immune globulin products, including XEMBIFY. Risk factors may include: advanced age, prolonged immobilization, estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors
- For patients at risk of thrombosis, administer XEMBIFY at the minimum dose and 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 of hyperviscosity
XEMBIFY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
Warnings and Precautions
Hypersensitivity. Severe hypersensitivity reactions may occur with immune globulin products, including XEMBIFY. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY contains IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Thrombosis. Thrombosis may occur following treatment with immune globulin products, including XEMBIFY. Thrombosis may occur in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Aseptic meningitis syndrome (AMS). AMS may occur with human immune globulin treatment, including XEMBIFY. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuation of treatment has resulted in remission within several days without sequelae.
Renal dysfunction/failure. Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose. XEMBIFY does not contain sucrose. Ensure patients are not volume-depleted prior to starting infusion. In patients at risk due to preexisting renal insufficiency or predisposition to acute renal failure, assess renal function prior to the initial infusion of XEMBIFY and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation.
Hemolysis. XEMBIFY may contain blood group antibodies that may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis. If signs and symptoms are present after infusion, perform confirmatory lab testing.
Transfusion-related acute lung injury (TRALI). Noncardiogenic pulmonary edema may occur in patients following treatment with immune globulin products, including XEMBIFY. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.
Transmissible infectious agents. Because XEMBIFY is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD, or CJD have ever been associated with the use of XEMBIFY.
Interference with lab tests. After infusion of XEMBIFY, passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
The most common adverse reactions in ≥5% of subjects in the clinical trial were local adverse reactions, including infusion-site erythema (redness), infusion-site pain, infusion-site swelling (puffiness), infusion-site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions including cough and diarrhea.
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (eg, measles, mumps, rubella, and varicella).
Please see accompanying full Prescribing Information for XEMBIFY.
- Alonso W, Vandeberg P, Lang J, et al. Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals. 2020;64:34-40.
- Data on file, Grifols.
- Sleasman JW, Lumry WR, Hussain I, et al. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study. Immunotherapy. 2019;11(16):1371-1386.
Terms to know
TERMS TO KNOW
SCIG, subcutaneous immune globulin.