Aetna considers palifermin (Kepivance) medically necessary to prevent and treat severe oral mucositis in members with hematologic malignancies undergoing high-dose chemotherapy requiring hematopoietic cell transplantation, using preparative regimens predicted to result in WHO grade 3 or 4 oral mucositis in the majority of patients (see Table 4 in appendix).
Aetna considers palifermin experimental and investigational for gastrointestinal mucositis and all other indications.Background
Effective oral hygiene, appropriate analgesia, oral cryotherapy, infection management and parenteral nutrition are considered to be standard of care for oral mucositis.
Kepivance has been approved by the FDA to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ~ WHO Grade 3 mucositis in the majority of patients. The FDA labeling states that the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. The labeling states that Kepivance is not recommended for use with melphalan 200 mg/m2 as a conditioning regimen.
Guidelines from the European Society for Medical Oncology (Peterson, et al., 2011) state that palifermin is recommended in a dose of 60 lg/kg/day for 3 days before conditioning treatment and for 3 days posttransplant for the prevention of oral mucositis in patients with hematological malignancies receiving high-dose chemotherapy and total body irradiation with autologous stem cell transplantation.
Guidelines from the American Society for Clinical Oncology (ASCO, 2008) state that palifermin is recommended for use in patients undergoing autologous stem-cell transplantation for a hematologic malignancy with a total body irradiation conditioning regimen to decrease the incidence of severe mucositis. The ASCO guidelines state that there are insufficient data to recommend the routine use of palifermin for patients undergoing autologous stem-cell transplantation for a hematologic malignancy where the conditioning regimen is chemotherapy only. The ASCO guidelines also state that palifermin may be considered for use in patients undergoing myeloablative allogeneic hematopoietic stem-cell transplantation with a total body irradiation–based conditioning regimen; there are insufficient data to recommend its use in myeloablative conditioning regimens consisting of chemotherapy alone in this setting. The ASCO guidelines state that palifermin should be administered intravenously at 60 g/kg daily for 3 days preceding the start of the conditioning regimen and 60 g/kg daily for 3 days beginning on the day of stem-cell infusion; it should not be administered within 24 hours of the initiation of the conditioning regimen.
ASCO guidelines state that there are insufficient data to recommend the use of palifermin in the non–stem-cell transplantation setting, or for use in the treatment of solid tumors.
Table 1: Routine Oral Hygiene Care
Toothbrushing. [Note: Electric and ultrasonic toothbrushes are acceptable if the patient is capable of using them without causing trauma.]
Soft nylon-bristled brush (2-3 rows).
Use 0.9% saline or water if toothpaste causes irritation.
Atraumatic technique with modifications as needed.
0.9% saline plus sodium bicarbonate solution.
Use 8 to 12 oz of rinse, hold and expectorate; repeat every 2 to 4 hours or as needed for pain.
Apply once a day.
Topical antimicrobial rinses:
Repeat 2 to 4 times a day depending on severity of periodontal disease.
Guidelines for Management of Dentures and Orthodontic Appliances in Patients Receiving High-Dose Cancer Therapy
Minimize denture use during first 3 to 4 weeks posttransplant.
Discontinue use at all other times.
Remove orthodontic appliances (e.g., brackets, wires, retainers) prior to conditioning.
Table 2: Mucositis Management
Mucosal coating agents:
Table 3: Summary of Clinical Practice Guidelines for Care of Patients with Oral Mucositis
Basic Oral Care and Good Clinical Practices
Standard-Dose Chemotherapy Prevention
Standard-Dose Chemotherapy: Treatment
High-Dose Chemotherapy With or Without Total Body Irradiation Plus HCST: Prevention
Key: HSCT: hematopoietic stem cell transplantation; 5-FU: 5-fluorouracil; TBI: total-body irradiation; LLLT: low-level laser therapy.
Table 4: WHO Classification of Oral Mucositis
Grade 0 No oral mucositis
Grade 1 Soreness +/- erythema
Grade 2 Erythema and ulcers
Grade 3 Extensive erythema, ulcers and inability to swallow solid food
Grade 4 Mucositis that prevents any form of alimentation, including swallowing liquids
|CPT Codes / HCPCS Codes / ICD-10 Codes|
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":|
|ICD-10 codes will become effective as of October 1, 2015:|
|Other CPT codes related to the CPB :|
|38240||Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor|
|HCPCS codes covered if selection criteria are met:|
|J2425||Injection, palifermin, 50 micrograms|
|ICD-10 codes covered if selection criteria are met:|
|C81.00 - C88.9||Malignant neoplasm of lymphatic and hematopoietic tissue [in members with hematologic malignancies undergoing high-dose chemotherapy requiring hematopoietic cell transplantation, using preparative regimens predicted to result in WHO grade 3 or 4 oral mucositis]|
|K12.31||Oral mucositis (ulcerative) due to antineoplastic therapy|