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Congress Overrides Bush's Medicare Veto

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http://www.oncologystat.com/home/news/C ... _Veto.html


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Congress Overrides Bush's Medicare Veto

The Pink Sheet Daily. 2008 Jul 15, R Osborne

Congress' override July 15 of the veto by President Bush and passage of the new Medicare bill means doctors are protected from a 10.6 percent reimbursement cut.

For Cell Therapeutics and GlaxoSmithKline, the action provides another benefit: 18 more months of 2007-level payout for their radioimmunotherapies.

The Senate voted 70-26 to override Bush's veto of the Medicare Improvements for Patients and Providers Act. Members of the House voted 383-41.

"This is huge," said James Bianco, CEO of Seattle-based CTI, which sells Zevalin (ibritumomab tiuxetan) for relapsed or refractory non-Hodgkin's lymphoma.

"Physicians had been saying they would not take any new starts" if they were Medicare-insured under the guidelines that would have held sway, Bianco said - just as Zevalin was starting to overcome other obstacles to use.

The U.S. House of Representatives passed the Medicare bill June 24 and the Senate followed suit on July 9, after failing to reach agreement on the measure just before the Independence Day weekend.

"Initially, people were on the fence about whether or not Republicans in the Senate would switch their votes over," Bianco said, but it happened.

Last December, Congress froze reimbursement rates at the 2007 level for six months after the Centers for Medicare & Medicaid Services released rates for 2008, including some that were lower than the acquisition cost for radioimmunotherapies.

Those rates would have "killed [the class] right at a time when they were starting to make their mark," Bianco said.

Instead, the Medicare bill's passage despite President Bush's veto establishes radioimmunotherapies as therapies rather than diagnostics, and lets Zevalin doctors keep $6,500 of reimbursement (per $21,000 treatment course) that would have been lost.

In a recent update to its prospective payment system for 2009, CMS said it would consider switching Medicare Part B payment for the class to the average sales price formula ("The Pink Sheet" DAILY, July 11, 2008).

"No matter what CMS proposes, it can't implement that until the law expires 18 months from now," Bianco said.

The ASP method is much fairer than the original approach, which would average all U.S. hospitals' cost-to-charge ratios, Bianco said. Under that plan, CMS officials would have hurt hospitals that have differing ratios and "penalized patients at the endpoint, to make their job easier," he said.

GSK, of London, sells the radioactive therapy Bexxar (tositumomab), also for NHL.

New label, easier use could help Zevalin

CTI forecast only about $15 million in sales this year for Zevalin, though Bianco insisted the drug could reach "north of $100 million."

Biogen Idec sold Zevalin last summer to CTI for $10 million in up-front and $20 million in milestone payments if the drug is approved in front-line NHL ("The Pink Sheet DAILY, Aug. 16, 2007).

CTI will meet with FDA in September to talk about a label in the front-line setting. Likely to help in that effort are Phase III data from Berlin-based Bayer Schering, which tested Zevalin in first-line indolent patients.

Bayer Schering sells Zevalin outside the U.S. under an agreement with Biogen, and CTI got access to the trial results by way of a deal entered in June.

The first hurdle for Zevalin to win front-line acceptance has been proof of clinical benefit. Another has been difficulty of use, though Bianco said "300 out of 495 of the largest oncology practices could be Z-ready within a matter of a month," thanks to the prevalence of PET scanners.

Congress helped with the final hurdle by passing the Medicare bill.

"Doctors are all under this perception that they're losing money on the [Zevalin] proposition," Bianco said, but reimbursement - at least for the next 18 months - is reasonable, and CMS has shown signs of flexibility beyond.

Outpatient Zevalin use, especially, has "substantial economics to the end user," Bianco said.

Bush, in his veto, called the bill "fiscally irresponsible" and said it would "imperil the long-term fiscal soundness of Medicare by using short-term budget gimmicks."

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(Oncology Stat, R. Osborne, July 15, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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