Zevalin Completes Transition To ASP-Based Reimbursement In OPPS

Spectrum Pharmaceuticals' radiopharmaceutical Zevalin (ibritumomab tiuxetan) will be reimbursed like other Medicare Part B drugs administered in the hospital outpatient setting, according to the final outpatient prospective payment update for 2010.

The transition began with Cell Therapeutics working with CMS in 2008 to move to ASP reimbursement from its previous cost-to-charge method (¹ ). In March, CTI divested Zevalin to partner Spectrum (² (Also see "CTI Bags Cash, Turns Its Back On Zevalin" - Pink Sheet, 16 Mar, 2009.)). Other radiopharmaceuticals are eligible for ASP-based reimbursement if manufacturers provide ASP data.

"We believe that securing ASP methodology for Zevalin removes a significant historical barrier to its use," Spectrum CEO Rajesh Shrotriya said. In September the radiopharmaceutical received approval for an expanded indication for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma, bringing the total population that could potentially benefit from Zevalin to 43,000 patients annually.

The final OPPS rule update held firm CMS' proposal to keep reimbursement for Part B drugs administered in the hospital outpatient setting at average sales price plus 4 percent, despite recommendations from stakeholders and the Advisory Panel on Ambulatory Payment Classification to return it to ASP plus 6 percent (³ (Also see "Medicare Holds Hospital Outpatient Payment For Drugs At ASP+4% For 2010" - Pink Sheet, 4 Jul, 2009.)). Part B drugs administered in the physician's office are reimbursed at the statutorily set ASP plus 6 percent.

One change in the OPPS from its proposal to the final rule affects new drugs or non-implantable biologics eligible for pass-through payments. CMS had proposed to begin the 2- to 3-year eligibility period on the date of first sale in the U.S., but changed it to the date the first claim is paid.

CMS also adjusted its transparency rules for compendia in the final physician fee schedule update (⁴ (Also see "CMS Proposes Compendia Publish All Materials Related To Listing Decision" - Pink Sheet, 13 Jul, 2009.)), altering a proposal to require transcripts from meetings on off-label listings to simply providing meeting minutes. The agency also softened conflict-of-interest disclosure requirements related to immediate family members.

Both rules were posted Oct. 30 by CMS. The final OPPS rule is scheduled to be published in the Federal Register on Nov. 20 and the PFS rule is scheduled to be published on Nov. 25.

- Gregory Twachtman ( ⁵ [email protected] )