Commercial payors pay for most of the hematopoietic stem cell transplant (HSCT) procedures performed in the United States. Very few commercial payors exclude coverage for transplant services entirely. Therefore, payors use several mechanisms to control utilization and cost including prior authorization, risk-sharing contracts, and preferred provider networks. The way that they implement these controls vary from plan to plan.
Virtually all commercial health insurance payors require prior authorization before any transplant services are performed. This is a process in which the payor determines if the prescribed treatment is "medically necessary and appropriate." The provider is required to submit a detailed treatment plan and the payor determines if it is appropriate based on evidence in the published medical literature. Payors typically exclude coverage for any procedures considered "experimental."
For providers of HSCT services, partial risk arrangements, often termed case rate contracts, have been extensively used. Under case rates, reimbursement for a grouping of services (such as a particular phase or phases of the transplant process) is fixed at a set rate. This rate is negotiated between the transplant center or providers and the payor. The negotiated rates vary significantly from center to center and payor to payor. Kepivance™ (palifermin) is likely to fall under a center's case rate.
Kepivance® is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance® have not been established in patients with non-hematologic malignancies.
Important Safety Information
In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance® was skin rash reported in less than 1% of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance® or placebo with the most frequent being fever, gastrointestinal events, and respiratory events. The most commonly reported adverse reactions attributed to Kepivance® were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.
* Results from a randomized, double-blind, placebo-controlled, phase 3 study (N = 212) in which patients with hematologic malignancies who were undergoing hematopoietic stem cell transplantation (HSCT) after myelotoxic therapy received either Kepivance® or placebo.1,2
† Analyses were performed in the overall patient population (patients who did not experience the event were assigned a duration of 0 days), and in a subset of patients who developed Grade 3/4 oral mucositis. Oral assessments were based on the World Health Organization (WHO) oral toxicity scale.2
‡ Mouth and throat soreness (MTS) and functional activity scores were collected with the use of a daily questionnaire and measured using a 5-point scale. MTS was a prespecified endpoint. Other functional activities were planned analyses.2
References
© 2006 Amgen All Rights Reserved. Prescribing Information for Kepivance®
