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    Enzyvant CONNECT® Commercial Co-Pay Program Eligibility Guidelines

    Patient must be fully enrolled in Enzyvant CONNECT® Patient Support Program.

    Once Enzyvant CONNECT completes the Benefits Investigation, they will determine eligibility for the co-pay program in accordance with the guidelines and criteria.

    • Only commercially insured patients (no federal or state healthcare program, including Medicare, Medicaid, TRICARE, DoD, or any state medical or pharmaceutical assistance program) are eligible
    • Only valid in the United States and US territories (Puerto Rico and US Virgin Islands); this offer is void where prohibited by law, taxed, or restricted
      • California and Massachusetts legislation restricts if a generic equivalent is available
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        • Assistance requires that commercial insurance reimburse the product separately (and charge a product coinsurance separately)
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    HELP YOUR PEDIATRIC PATIENTS WITH CONGENITAL ATHYMIA

    Discover the wonder of childhood

    RETHYMIC is a first-of-its-kind, FDA-approved tissue-based treatment for congenital athymia engineered to help patients develop an immune system sufficient to fight infections.1,2

    RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency.1

    Brynlee, a patient with
    congenital athymia.

    Enzyvant Connect logo

    Enzyvant CONNECT is a program that connects your patients and their caregivers with personalized support and financial assistance as they navigate the congenital athymia journey.

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    Clinical trial results

    Explore the efficacy and safety of RETHYMIC across 10 clinical trials.1

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    Engineered through a complex process

    Unlike a transplant, RETHYMIC is engineered for one patient at a time using donor thymus tissue.1,3

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    Getting your patients started

    Learn how to access RETHYMIC and begin the referral process.

    Have us reach out to you

    If you’d like to discuss RETHYMIC with a representative, fill out the form below and they’ll reach out to you as soon as possible.

      By completing and submitting this form, you grant permission and agree to allow Sumitomo Pharma America, Inc. and its affiliates to store the information you provide so that Sumitomo Pharma America, Inc. may market or advertise to you across multiple channels. Sumitomo Pharma America, Inc. will not sell or share this information with third parties. For additional information regarding how Sumitomo Pharma America, Inc. handles your information, please see our privacy policy.

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      Indication and Important Safety Information
      Important Safety Information

      Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Given the immunocompromised condition of athymic patients, follow infection control measures until the development of thymic function is established as measured through flow cytometry. Monitor patients closely for signs of infection including fever. If a fever develops, assess the patient by blood and other cultures and treat with antimicrobials as clinically indicated. Patients should be maintained on immunoglobulin replacement therapy until specified criteria are met, and two months after stopping, IgG trough level should be checked. Prior to and after treatment with RETHYMIC, patients should be maintained on Pneumocystis jiroveci pneumonia prophylaxis until specified criteria are met.

      RETHYMIC may cause or exacerbate pre-existing graft versus host disease (GVHD). Monitor and treat patients at risk for the development of GVHD. Risk factors for GVHD include atypical complete DiGeorge anomaly phenotype, prior hematopoietic cell transplantation (HCT) and maternal engraftment. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea.

      Autoimmune-related adverse events occurred in patients treated with RETHYMIC. These events included: thrombocytopenia, neutropenia, proteinuria, hemolytic anemia, alopecia, hypothyroidism, autoimmune hepatitis, autoimmune arthritis, transverse myelitis, albinism, hyperthyroidism, and ovarian failure. Monitor for the development of autoimmune disorders, including complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function.

      Pre-existing renal impairment is a risk factor for death.

      In the clinical studies of RETHYMIC, 4 out of 4 patients with pre-existing cytomegalovirus infection died. The benefits/risks of treatment should be considered prior to treating patients with pre-existing CMV infection.

      Because of the underlying immune deficiency, patients who receive RETHYMIC may be at risk of developing post-treatment lymphoproliferative disorder. Patients should be monitored for the development of lymphoproliferative disorder.

      Transmission of infectious disease may occur because RETHYMIC is derived from human tissue and because product manufacturing includes porcine- and bovine-derived reagents.

      Immunizations should not be administered in patients who have received RETHYMIC until immune-function criteria have been met.

      All patients should be screened for anti-HLA antibodies prior to receiving RETHYMIC. Patients testing positive for anti-HLA antibodies should receive RETHYMIC from a donor who does not express those HLA alleles. HLA matching is required in patients who have received a prior HCT or a solid organ transplant. Patients who have received a prior HCT are at increased risk of developing GVHD after RETHYMIC if the HCT donor did not fully match the recipient.

      Of the 105 patients in clinical studies, 29 patients died, including 23 deaths in the first year (< 365 days) after implantation.

      The most common (>10%) adverse events related to RETHYMIC included: hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment/failure, thrombocytopenia, and graft versus host disease.

      To report suspected adverse reactions, please contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch

      Indication

      RETHYMIC® (allogeneic processed thymus tissue–agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia.

      Limitations of Use:
      RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

      References: 1. RETHYMIC [package insert]. Marlborough, MA: Sumitomo Pharma America, Inc; 2023. 2. Enzyvant Therapeutics GmbH. Enzyvant receives FDA approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for pediatric congenital athymia. Enzyvant Therapeutics, Inc. October 8, 2021. Accessed March 3, 2023. https://enzyvant.com/enzyvant-receives-fda-approval-for-rethymic-allogeneic-processed-thymus-tissue-agdc-a-one-time-regenerative-tissue-based-therapy-for-pediatric-congenital-athymia/ 3. Markert ML, McCarthy EA, Gupton SE, Lim AP. Cultured thymus tissue transplantation. In: Sullivan KE, Stiehm ER, eds. Stiehm’s Immune Deficiencies: Inborn Errors of Immunity. 2nd ed. Elsevier; 2020:1229-1239.