June 19, 2014: New Medicaid Benefit, July 1, 2014: ado-trastuzumab emtansine (Kadclya™) PURPOSE HHSC is directing STAR, STAR+PLUS, and STAR Health Medicaid managed care organizations to have systems in place to be able to provide a new Medicaid physician-administered drug, ado-trastuzumab emtansine (Kadcyla™) (procedure code J9354; national drug codes (NDCs) 50242008701 and 50242008801)), by July 1, 2014. HHSC is seeking Legislative Budget Board (LBB) approval to add this new physician-administered drug. MCOs cannot submit encounters for the drug as a Medicaid benefit until LBB provides approval. HHSC will notify MCOs immediately once approval is received. Once approved, MCOs must submit all encounters for this procedure code with the corresponding NDC. MCOs may develop their own prior authorization criteria for this drug. HHSC recognizes this is a short timeline for implementation of this new drug. TMHP is working under the same timeline. BACKGROUND Pending LBB approval, Medicaid is adding a new benefit, ado-trastuzumab emtansine (Kadcyla™), procedure code J9354 (NDCs 50242008701 and 50242008801) payable to physicians, advanced practice nurses, and physician assistants in the office or outpatient hospital setting with an effective date of July 1, 2014. An interim rate of $29.79 per milligram will be used until J9354 is presented at the August Rate Hearing and the final rate is approved. At this time, Medicaid fee-for-service (FFS) will not require prior authorization for J9354. However, the following documentation requirements will apply. At the initiation of treatment: • Evidence of HER2 positive breast cancer as evidenced by immunochemistry (IHC) test or fluorescent in situ hybridization (FISH) test • Evidence of metastatic breast cancer • Evidence demonstrating prior treatment for this diagnosis with trastuzumab and a taxane oncology agent separately or in conjunction • Evidence demonstrating receipt of prior therapy for this diagnosis or recurrent disease, including the previous treatment protocol, within 6 months of completing adjuvant therapy. For ongoing courses of treatment documented evidence of: • Current laboratory testing to rule out hepatotoxicity defined as: o Elevated serum transaminases greater than 3 times the upper limit of normal and concomitant total bilirubin greater than 2 times the upper limit of normal • Left ventricular ejection fracture (LVEF) to rule out cardiac toxicity defined as: o Left ventricular ejection fracture (LVEF) less than 40% if repeat LVEF within 3 weeks of initial results confirms an LVEF of less than 40% o LVEF 40% to less than 45% and decrease is greater than or equal to 10% points from baseline if repeat LVEF if repeat LVEF within 3 weeks of initial results have not recovered to within 10% points from baseline Rebatable NDCs to be used in conjunction with procedure code J9354: NDC Strength 50242008701 Ado-trastuzumab emtansine (Kadyclya™) 160 mg vial 50242008801 Ado-trastuzumab emtansine (Kadyclya™) 100 mg vial AWP $5325.25 $3328.28 WAC $4437.71 $2773.57 Once LBB approval is received, ado-trastuzumab emtansine (Kadcyla™), procedure code J9354 (NDCs 50242008701 and 50242008801), will be payable as follows: • Physician service • Payable to physicians, advanced practice nurses, and physician assistants • Payable in the office or outpatient hospital setting • No age or gender restrictions • Interim pricing established by HHSC Rate Analysis Division is $29.79 per milligram • Effective date July 1, 2014 If you have any questions, please contact Michelle Erwin at [email protected].
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