NEW FDA approval/indication for inject... - Lung Cancer Support

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NEW FDA approval/indication for injection that can now be given during lung surgery to detect cancer

Miranda_GO2 profile image
Miranda_GO2Partner
4 Replies

Last week the FDA approved a new indication for an injection that was already approved for ovarian cancer. The injection is call Cytalux and is given before lung surgery. With the use of this injection, during surgery an infrared light is used to make it cancer easier to detect and remove.

Read more about it at the sources below:

FDA: fda.gov/drugs/news-events-h...

Penn Medicine that took part of the trial for this use: pennmedicine.org/news/news-....

Additional coverage: prnewswire.com/news-release...

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Miranda_GO2 profile image
Miranda_GO2
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Denzie profile image
DenzieModeratorVolunteer

This certainly ushers in a new era in lung cancer surgery. Over the years I’ve met many who had surgery for early stage cancers. Within a year or so they have a later stage cancer because something that was too small to image or feel developed in the interim. I just gave this a cursory read and will be more thorough in a bit.

I wonder if that means they can take fewer lymph nodes. I’ll let you know if they answer that one.

Science is amazing! I’m so grateful for the research scientists, clinical trial participants, finders, and all who make these advances possible.

hopejunkie profile image
hopejunkie

Thank you for sharing this amazing news, Miranda! 🙏💕 Do you know if Medicare (and other carriers) have already allowed for reimbursement of Cytalux as part of standard of care treatment?

Miranda_GO2 profile image
Miranda_GO2Partner

“Great question. Since it is so new, insurance carriers will probably be making their determinations over time so I can’t speak for all of them. While it is FDA approved, it isn’t widely available yet and not all surgeons have adopted it as part of their practice. Sometimes a treatment is considered standard of care when organizations like the NCCN add it to guidelines.

As far as Medicare coverage of Ctyalux for lung cancer surgery, at this time, Cytalux is in the consideration process for a HCPCs code from the Centers for Medicare and Medicaid Services (CMS). They state: “This request is being deferred to a subsequent coding cycle because the scope of the request necessitates that additional consideration be given before CMS reaches a final decision.” HCPCS codes are alpha-numeric codes utilized for billing and claims. For general Medicare information regarding cancer treatment services and Medicare coverage, link here to medicare.gov/Pubs/pdf/11931....

The Cytalux website states: “Generally, there is no separate cost to the patient for CYTALUX above and beyond the cost of the surgical procedure. Contact your hospital and/or insurance provider for more details.” Also from their website: “As a new technology, CYTALUX is not widely available. Our patient brochure (visit our Ask About Cytalux page) can help you start a discussion about CYTALUX with your doctor.” However, we recommend coverage and benefits details be confirmed by your insurance company and/or hospital. Here is the link to that page: cytalux.com/frequently-aske...

Time and access will tell if this procedure becomes part of the standard of care.

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