News

Updated eviCore Oncology Guidelines List Ga68 Dotatate as Experimental

What is the news?

eviCore, one of the leading medical benefits management companies in the U.S., has updated its coding recommendations for PET imaging in oncology. Per this decision, eviCore will not cover Ga68 DOTATATE – listing it as experimental despite the June 1, 2016 FDA approval.

Why does this matter?

eviCore processes 12 million claims annually.
This decision could deprive patients of access to FDA-approved, commercially available, and highly valuable Ga68 Dotatate PET/CT.

What is NorCal CarciNET Community doing?

NorCal CarciNET's board sent a letter to eviCore expressing our concern and asking them to reconsider their position given the medical evidence and the success our community has had with the scan. Click here for the Society of Nuclear Medicine and Molecular Imaging letter.

What’s next?

NorCal CarciNET is working with our partner the SNMMI and other NET advocacy groups to hopefully have the guideline updated to include Ga68 Dotatate. This impacts only those whose insurance use eviCore to manage benefits, this does not include Medicare.

On June 1, 2016, the U.S. Food and Drug Administration (FDA) granted approval to NETSPOT form Advanced Accelerator Applications (AAA), the first kit for the preparation of Gallium-68 dotatate positron emission tomography (68Ga-dotatate PET) imaging. Gallium-68 dotatate is a positron-emitting analogue of somatostatin, and the radioactive probe helps locate tumors in patients with somatostatin receptor-positive neuroendocrine tumors.

“Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” said Libero Marzella, director of the FDA Division of Medical Imaging Products.

Three studies have established the safety and efficacy of Netspot by comparing 68GA-dotatate PET imaging to standard imaging options as well as clinical and histopathological data in patients with neuroendocrine tumors.

External links to this news: (your browser will open a new window)

FDA Announcement

AAA Press Release


NorCal CarciNET Community is once again working with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to host a free Patient Education Day during the Society's annual meeting in Denver on June 11th, 2017. This day long patient centered program is will cover the history and safety and future of nuclear medicine as well as understanding clinical trials as they pertain to your treatment. There will also be a NET breakout, that will focus exclusively on Neuroendocrine Tumors, imaging and treatment. 

There is no charge for registration, which also includes access to all SNMMI sessions Saturday - Tuesday.  

To view all NET related session click here and proceed to June's calendar.

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NorCal CarciNET Community is once again working with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to host a free Patient Education Day during the Society's annual meeting in San Diego on June 12th, 2016. This day long patient centered program is will cover the history and safety and future of nuclear medicine. There will also be a NET breakout, that will focus exclusively on Neuroendocrine Tumors, imaging and treatment. 

There is no charge for registration, which also includes access to all SNMMI sessions Saturday - Tuesday.  To view all NET related session click here and proceed to June's calendar.

Reg


 

AAA Opens Lutathera Expanded Access Program In U.S. to Eligible Patients And Announces Forthcoming NDA Filing to FDA and EMA.

AAA today announced that the company has initiated an expanded access program (EAP) in the United States for the investigational product, Lutathera. Through the program, Lutathera is being made available for patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy. Healthcare professionals and patients can learn more about the Lutathera EAP by visiting www.clinicaltrials.gov (trial number: NCT02705313). To read more visit AAA's website.