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Apesar dos obstáculos regulatory, PET as drogas podem dão a imagem latente molecular um impulso

por Olga Deshchenko, DOTmed News Reporter | June 27, 2011
From the June 2011 issue of HealthCare Business News magazine


To turn that hope into reality will require developers of biomarkers and pharma products to collaborate on R&D initiatives, a growing trend in the market.

And the industry has no intentions of slowing down. “We’ve only seen the tip of the iceberg of what molecular imaging can accomplish for patients,” says Avid’s Skovronsky.

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Agent Update: Sodium Fluoride F 18
Sodium fluoride F 18, the PET agent for bone imaging, has been deemed safe and effective by the FDA, but its utilization has been relatively limited for a long time.

What’s standing in its way? According to Edward Plut, vice president, product management & marketing with PETNET Solutions, it’s a lack of reimbursement.

However, the company is collaborating with the imaging community to change that. To satisfy Medicare’s requirement for a large clinical trial in order to support reimbursement, PETNET is working with the Academy of Molecular Imaging to carry out a trial that compares sodium fluoride to traditional bone imaging tests. (To date, the trial is about halfway through.)

In 2010, the Centers for Medicare and Medicaid Services decided to cover PET with sodium fluoride under the CMS Coverage with Evidence Development program. The National Oncology PET Registry then established a registry for the agent, creating a pathway for clinicians to get reimbursed for using sodium fluoride for PET.

“Since that time, we’ve seen a pretty significant growth in utilization for sodium fluoride and there’s a lot of excitement in the community around PET bone imaging,” says Plut.

The next step is to use the combined results of the CED program through NOPR and the AMI clinical trial to petition CMS for a broad coverage decision on the agent, which the imaging community hopes to do in the next year or two, according to Plut.

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