The delay in FDA approval of Idec's non-Hodgkin's lymphoma treatment Zevalin could also cause a delay in finalizing Medicare reimbursement for the product.

In order to secure reimbursement under the Medicare outpatient prospective payment system, Idec must file for an ambulatory payment classification code for Zevalin (ibritumomab). However, the company cannot apply until the radioimmunotherapy is approved.

The next deadline for APC code applications is March 31. CMS updates the OPPS system every three months. Assuming Zevalin is not approved by April 1, Idec would have to wait until at least summer before Medicare coverage is set.

"A new system is being implemented and Zevalin will be part of that system," Idec said. "Point of fact, the Medicare reimbursement for products like Zevalin is a little bit dicey at this point in time." Idec is looking at obtaining a temporary APC code, although "there is not currently a provision in the suggested guidelines for a temporary code."

The pass-through system established by the 1999 Balanced Budget Refinement Act adjusts the payment methodology for newly approved therapies covered by Medicare (¹ Also see "BIO Proposes Increased Base Rates For Drugs In 2002 Medicare OPPS" - Pink Sheet, 3 December, 2001., p. 24).

Idec received a "complete response" letter for Zevalin on its user fee date, Jan. 8. Idec says that the letter cites compliance issues at the contract fill/finish manufacturer, Catalytica.

The letter indicates that Idec will not have to submit any supplementary clinical data for Zevalin and that labeling discussions are complete, the company said during a Jan. 9 conference call.

FDA noted during the Sept. 11 advisory committee review of Zevalin that there were "some outstanding manufacturing issues that need to be resolved." Idec said it expected the issues would be resolved by the user fee date (² Also see "Idec Zevalin May Need Central Monitoring Of Bio-Images, FDA Cmte. Suggests" - Pink Sheet, 24 September, 2001., p. 27).

Idec CEO Bill Rastetter, PhD, maintained that upgrades have been completed. "All that FDA - as far as we know - wants to know is what's changed, what's been upgraded, what's the data...that shows you are now operating in compliance."

Idec is considering whether it should pursue a third-party certification rather than await a full reinspection for Zevalin. Idec believes Lilly may have used third-party certification to finalize pre-approval manufacturing requirements for Xigris , which is also filled by Catalytica (see ³ Also see "Catalytica Manufacturing Problems Cited In Recalls, Approval Delays" - Pink Sheet, 14 January, 2002. ).

If a reinspection by FDA is required, however, Idec does not foresee a lengthy waiting period. "The head of the biologics group has assured me that this will be prioritized and that it can be done in a matter of weeks of notice, not months of notice," Rastetter said.

Idec, however, is not offering a clear timeframe for resolution of the manufacturing issues. "The next step with the FDA is to sit down and put a box around the compliance issues that they would like to have addressed in detail."

Idec expects to launch within 30 to 60 days after approval. "With the understanding that labeling is complete, we can probably move forward a little quicker and try to hit closer to that 30 days," Idec President Bill Rohn said.

In anticipation of approval, Idec and Catalytica will be manufacturing Zevalin kit components, which include ibritumomab tiuxetan, a 50 mM sodium acetate solution, formulation buffer and a reaction vial.

Idec will also be conducting site training and licensure with radiopharmacies and hospitals, and finalizing coordination with its yttrium-90 supplier, MDS Nordion. Yttrium is the radioisotope linked to the therapeutic dose of Zevalin.

Idec is "printing new labels, packaging and package inserts, which is now possible with FDA concurrence that our labeling discussions have been finalized," Rohn said. Marketing materials for Zevalin have already been submitted to the FDA in preparation for launch and are "currently under active review," Rohn said.

Idec has also completed several marketing initiatives, including a sales force expansion. An estimated 75 sales reps will be in place to detail both Zevalin and Rituxan (rituximab). Idec has also made arrangements with a third party logistics firm to handle warehousing, shipping and billing.

Idec Zevalin Approval Delayed By Manufacturing Issues At Catalytica

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