Frequently Asked Questions

General Questions

When was EPICEL first used to treat patients?

EPICEL has been marketed since 1988 and has been used to treat over 1,500 patients. For detailed information on EPICEL’s history, click here. 

Is EPICEL actually the person's own skin, just grown rapidly in a lab?

Yes. The surgeon takes a skin biopsy from a non-damaged area of the patient’s body and sends it to Genzyme. In the first part of the EPICEL process, the patient’s keratinocytes (the major component of the epidermis) are isolated from the epidermis of the biopsy. The patient’s keratinocytes are then multiplied in culture until Genzyme has obtained enough cells to supply the number of grafts required by the surgeon at a specified date. Thus, the EPICEL grafts that a patient receives are made from the keratinocytes that were isolated from their own biopsy.

How can EPICEL be grown so quickly when normal skin takes longer to grow?

Similar body conditions are re-created inside a flask and both the ideal environment and climate promote normal cell growth and cell differentiation. It has been estimated that over a period of 3 to 4 weeks, a patch of biopsied skin measuring 2 cm² can be expanded in surface area by 10,000 times.¹ EPICEL is initially a translucent sheet of keratinocytes that ranges from 2 to 8 cell layers thick. Continued cell differentiation and maturation occur once the graft is transplanted to the wound bed.

What size are the EPICEL grafts?

Each graft is approximately 50 cm2 (about the size of a playing card) and between two to eight cell layers thick.

For any given patient, how many EPICEL grafts can be grown?

Although each graft order is customized to fit the treatment plan for each patient, from a biopsy, Genzyme can grow enough skin from one biopsy to cover the patient’s entire body.

Regulatory Questions

Is EPICEL approved by the FDA?

Yes, EPICEL is the only cultured epidermal autograft approved by the FDA. It is a regulated as a humanitarian use device (HUD), a special approval for devices intended to treat rare conditions, (i.e., fewer than 4,000 individuals in the US per year), provided the device meets safety conditions and will not expose patients to significant or unreasonable risk. In accordance with HUD regulations, the effectiveness of this device has not been demonstrated. For more information on HUDs, click here

Does a hospital Institutional Review Board (IRB) have to approve the use of EPICEL?

IRB approval is required before a HUD is used in a facility, except in emergencies where the physician determines that approval cannot be obtained in time to prevent serious harm or death to the patient. The IRB may be a local IRB or it may be an independent or national IRB. In addition, a local IRB may defer in writing to another similarly constituted IRB that has agreed to assume responsibility for review of the use of the HUD. Genzyme representatives are trained to work with healthcare practitioners to help make the IRB process as smooth as possible.

REIMBURSEMENT QUESTIONS

How does humanitarian device status affect the price of EPICEL?

Because EPICEL is a humanitarian use device, Genzyme does not sell EPICEL for a profit — i.e., the amount charged does not exceed the costs of the research, development, fabrication, and distribution of the product. However, as a global leader in cell therapy manufacturing, Genzyme continues to provide EPICEL as part of its commitment to serve patients in need.

Is EPICEL reimbursed?

In the inpatient setting of care, all services, products, and supplies used in the hospital generally are reimbursed according to a prospectively-set, all-inclusive reimbursement rate. This rate is driven by the primary medical or surgical procedure(s) as well as the patient's underlying diagnosis, age, gender, and discharge status.

Under Medicare, Medicaid, and many commercial payers, EPICEL is reimbursed as part of this inpatient payment amount; however, some commercial insurers may provide additional reimbursement outside of the prospective rate. Ultimately, commercial payment is driven by the negotiated rate agreed upon between the hospital and the insurer.

Surgeons are reimbursed separately for their procedural services, including the skin biopsy, preparing and creating the recipient site, and applying the EPICEL graft.

Does EPICEL have any reimbursement codes?

While EPICEL does not have a specific HCPCS product billing code, facilities will bill for EPICEL using ICD-9 CM diagnosis codes to denote the depth and site of burn, as well as ICD-9 CM procedure codes to denote graft application. In addition, surgeons use CPT procedure codes to bill separately from the hospital for their work performing the skin biopsy, surgical preparation or creation of recipient site, and for the application of EPICEL. 

For whom should EPICEL not be used?

EPICEL should not be used in patients with known hypersensitivity or allergy to substances used in the manufacture of Epicel.

EPICEL should not be used in patients who have a known history of anaphylaxis or allergic reactions to antibiotics, vancomycin, amikacin or amphotericin because EPICEL is cultured in media containing vancomycin and amikacin (and for certain patience, amphotericin is added). Trace quantities of these antibiotics may remain in the EPICEL autograft.

EPICEL should not be used in patients who have sensitivities to materials of cow or mouse origin. The cell culture medium used in the production of EPICEL contains cow serum and the cells are cultured together with mouse cells. The medium used to package and transport EPICEL does not contain cow serum; however, trace quantities of cow-derived proteins may still be present.

EPICEL should not be used on infected wounds.

I understand EPICEL is a tracked device. What does this mean?

The FDA requires manufacturers of certain medical devices such as EPICEL to track those devices and the patients who receive them. Tracking is done only so the manufacturer (Genzyme) and/or the FDA can notify each patient and their doctor quickly if a safety concern associated with EPICEL is identified. If you are treated with EPICEL, Genzyme will ask you, your family, or your doctor to provide us with your contact information for EPICEL tracking purposes. The information collected (for example, your address, telephone number, next of kin, or Primary Care Health Provider) is used only so that we may find and provide information to you if it is necessary.

Can patients donate blood or organs after being grafted with EPICEL?

No, if you have received EPICEL, you should never donate blood or blood parts, tissue, breast milk, egg, sperm, or other body parts for use in humans.

Although EPICEL is composed of cells from your skin; it is grown together with mouse cells and contains residual mouse cells, and therefore donation is not recommended.