Access and Support for ELELYSO Patients

Pfizer Gaucher Personal Support (GPS)

The Pfizer Gaucher Personal Support (GPS) program can help address some of the financial and insurance benefit concerns of patients taking ELELYSO, and can provide them infusion support.

The GPS program offers patients, as well as their parents and caregivers, several support options.

Pfizer GPS Case Manager

  • A GPS Case Manager is the primary contact to help coordinate ELELYSO support offerings for patients, parents, and caregivers

  • The GPS team is available by phone to assist your patients

Call Pfizer Gaucher Personal Support (GPS) at 1-855-ELELYSO (1-855-353-5976)      

Financial Assistance & Access Support for Your Patients

  • $0 out-of-pocket costs for ELELYSO for eligible commercially insured patients*

  • Help with insurance benefits verification and understanding prior authorization requirements
  • Provide information regarding insurance coverage appeals process
  • Provide support to patients experiencing an insurance change

See below for the ELELYSO $0 Co-Pay Program Terms and Conditions.

Pfizer Patient Assistance Program

  • ELELYSO may be available at no cost to qualified uninsured or underinsured patients

   *ELELYSO $0 Co-Pay Program Terms and Conditions apply.

   The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

   Eligible patients must meet financial qualifications and also be diagnosed with the FDA-approved indication. They must be US residents who are treated by US physicians and must complete the Patient Assistance Program Application and Patient Authorization Form.




TERMS AND CONDITIONS

By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

  • Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran 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”).
  • Patient must have private insurance. Offer is not valid for cash paying patients. The value of this Co-pay Card is limited to a maximum of $15,000 per calendar year.
  • This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this co-pay card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if your insurer or health plan prohibits use of manufacturer co-pay cards.
  • This co-pay card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third party insurance.
  • This co-pay card is not valid where prohibited by law.
  • Co-pay card cannot be combined with any other savings, free trial or similar offer for the specified prescription.
  • Co-pay card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • This co-pay card is not health insurance.
  • The co-pay program is available only through the Gaucher Personal Support program. For any questions, please call Gaucher Personal Support at 1-855-ELELYSO (1-855-353-5976).
  • Offer good only in the U.S. and Puerto Rico.
  • Co-pay card is limited to 1 per person during this offering period and is not transferable.
  • No other purchase is necessary.
  • No membership fee.  
  • Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke or amend this offer without notice.
  • Offer expires 12/31/2021. 
For more information, visit our website www.elelyso.com, call 1-855-353-5976, or contact us at 2730 S. Edmonds Lane, Suite 300, Lewisville, TX 75067.

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Support & Resources

  • ELELYSO Request Form
  • Access and Support for ELELYSO Patients
  • Patient Support Offerings

Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with ELELYSO® (taliglucerase alfa) for injection. Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment.

In clinical trials, 2 of 72 (3.0%) patients treated with ELELYSO experienced signs and symptoms of anaphylaxis. This included urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions have occurred during ELELYSO infusion.

In clinical trials with ELELYSO, 21 of 72 (29%) patients experienced hypersensitivity reactions, including anaphylaxis. This included pruritus, angioedema, flushing, erythema, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions have occurred up to 3 hours after the start of infusion.

Due to the potential for anaphylaxis, appropriate medical support should be readily available when ELELYSO is administered. Observe patients closely for an appropriate period of time after administration of ELELYSO, taking into account the time to onset of anaphylaxis seen in clinical trials. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. If anaphylaxis occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated.

Base the management of hypersensitivity reactions on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of antihistamines, antipyretics, and/or corticosteroids for mild reactions.

Pretreatment with antihistamines and/or corticosteroids may prevent subsequent hypersensitivity reactions. Patients were not routinely premedicated prior to infusion of ELELYSO during clinical studies. If severe hypersensitivity reactions occur, immediately stop the infusion of ELELYSO and initiate appropriate treatment.

Consider the risks and benefits of re-administering ELELYSO in patients who have experienced a severe reaction associated with ELELYSO. Caution should be exercised upon rechallenge, and appropriate medical support should be readily available.

The most common adverse reactions with ELELYSO, either as initial therapy or as therapy following a switch from imiglucerase (≥5%) reported during clinical trials with ELELYSO were pruritus, flushing, headache, arthralgia, pain in extremity, abdominal pain, vomiting, diarrhea, fatigue, back pain, dizziness, nausea, and rash.

The most common adverse reaction (≥10%) for treatment-naïve pediatric patients was vomiting. Pediatric patients experienced a higher frequency of vomiting than adults and this may be a symptom of hypersensitivity reaction. The frequencies of other adverse reactions were similar between pediatric and adult patients.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other taliglucerase alfa products may be misleading.

In a clinical trial of treatment-naïve adult patients, 17 of 32 (53%) patients who were administered ELELYSO developed anti-drug antibodies (ADA) during treatment.

In a clinical trial of treatment-naïve pediatric patients, 2 of 9 (22%) patients developed ADA during treatment with ELELYSO.

In another clinical trial of 26 adults and 5 pediatric patients switched from imiglucerase treatment to ELELYSO treatment, 5 (16%) adults developed ADA after the switch.

The relationship between ADA and hypersensitivity reactions is not fully understood. Monitoring for ADA to ELELYSO may be useful in ADA-positive patients or in patients who have experienced hypersensitivity to other enzyme replacement therapies.

The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 Units per kg of body weight administered once every 2 weeks as a 60- to 120-minute intravenous infusion.

Patients switching from a stable dose of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage. Dose adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.

ELELYSO is supplied as 200 Units per vial and is available by prescription only.

ELELYSO® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.

Please see Full Prescribing Information.

Indication

ELELYSO® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.