Like Medicare, Medicaid programs have clearly defined coverage policies for hematopoietic stem cell transplant (HSCT). Generally, state Medicaid programs follow Medicare restrictions on transplant eligibility. However, individual states may offer additional coverage and therefore coverage will vary state to state. Some states may use a case rate or diagnosis-related group (DRG) model similar to Medicare’s, while others base their reimbursement on allowable cost. The state Medicaid programs may also utilize similar controls to commercial payors such as prior or pre-authorization and preferred providers (i.e. directing patients to specific providers for transplant). State Medicaid programs may also use a managed care organization (MCO) to handle coverage for HSCT procedures. The extent to which state Medicaid programs use MCOs can vary.
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
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