((Date)) ATTN: ((Medical Review/Appeals)) ((Payer Name)) ((Payer Address)) Patient: ((Patient’s first and last name)) Subscriber ID#: ((Insert Subscriber ID#)) Subscriber Group #: ((Insert Subscriber Group #)) Re: Denial of CellCept® (mycophenolate mofetil) Dear Appeal Reviewer: Introductory Paragraph I am writing this letter of appeal on behalf of my patient, ((patient name)), who was denied coverage for CellCept on ((date of denial)) for the prophylaxis of ((kidney/heart/liver)) rejection. The denial reason stated that ((give denial reason)). Please see the enclosed documentation that supports the use of this FDAapproved medication for this patient. Patient’s Clinical History ((Patient’s name)) is a ((age))-year-old ((male/female)) who received a ((kidney/heart/liver)) transplant on ((date)). ((Provide rationale for prophylaxis, brief description of the patient’s immunosuppressive regimen and other factors that impact your treatment selection. Include supporting medical records [see Enclosures section below].)) Rationale and Treatment Information CellCept was first approved by the FDA on May 3, 1995, and is indicated for prevention of renal, cardiac, or liver allograft rejection in combination with cyclosporine and corticosteroids. CellCept is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent. CellCept is rapidly absorbed and metabolized to form MPA, a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. MPA sharply inhibits the growth and multiplication of lymphocytes and prevents the formation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells. MPA may also inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Conclusion In conclusion, please reconsider the denial of CellCept for my patient, ((patient’s name)), who is a ((kidney/heart/liver)) transplant recipient. ((Summarize the major points in your letter and restate what you want from the insurance company.)) I would appreciate prompt review of this appeal and approval of this FDA-approved therapy. I can be reached at ((phone number)) for additional information and discussion. Thank you. Sincerely, ((Physician Name)) Enclosures ((Suggested)): - CellCept FDA approval letter & package insert - Patient clinical/surgical notes & relevant laboratory reports - Denial letter 10566300