HealingWell
Search Close Search
☰

ARA to offer prostate cancer imaging agent Pylarify pending CMS approval

Support Forums
>
Prostate Cancer
✚ New Topic ✚ Reply
❬ ❬ Previous Thread |Next Thread ❭ ❭
Posted 6/17/2021 8:24 PM (GMT -5)
NEWS
FDA APPROVES PYLARIFY AS FIRST AND ONLY COMMERCIALLY AVAILABLE PSMA PET IMAGING AGENT FOR PROSTATE CANCER

On May 27, 2021, Lantheus Holdings announced that the U.S. Food and Drug Administration (FDA) had approved Pylarify, an F 18-labeled prostate-specific membrane antigen (PSMA) PET imaging agent targeted to identify suspected metastasis or recurrence of prostate cancer. It is anticipated Pylarify will be broadly available across the U.S. by the end of the year.

A PARADIGM SHIFT IN PROSTATE CANCER IDENTIFICATION

Pylarify provides more accurate and earlier detection of prostate cancer than conventional imaging, so that doctors and patients can make better-informed treatment decisions. Conventional imaging, especially in patients with low PSA levels, is not able to identify the location and extent of prostate cancer in the majority of cases. However, Pylarify was developed to target PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Pylarify binds to the target, enabling the PET scan to detect and locate the disease.

ARA TO OFFER PYLARIFY PENDING CMS APPROVAL

As soon as the Centers for Medicare and Medicaid Services (CMS) approve coverage of Pylarify, ARA will be ready to offer this novel PET/CT imaging agent at multiple sites through our service region. Pylarify will also have a great second act in the future since a PSMA therapeutic agent is currently under evaluation for targeted prostate cancer therapy. Our molecular radiology team is poised to take advantage of this and other developments in the rapidly expanding field of theranostics in our new Midtown theranostic suite.

The advantages to patients that are becoming available through theranostics are immense and will increase the length and quality of life for patients with cancers treatable through this cutting-edge combination of targeted diagnostic imaging and therapy.

Download Press Release
If you have any questions regarding Pylarify or theranostics at ARA please contact our Provider Relations Associates at ProviderInfo@ausrad.com or (512) 799-0806.
Posted 6/18/2021 6:23 AM (GMT -5)
Thanks for providing this press release. There are two other threads regarding this approval and the similar approval given to the two educational institutions UCLA and UCSF, both in California.

All three have applied to the CMS for reimbursement approval and restrictions. The two educational institutions have been assigned reimbursement codes effective in July. They are also currently available, but third party reimbursements haven’t yet been communicated, nor the cost. Both have a phone number for those interested to inquire and schedule. That Lantheus is not yet available and they have not communicated the centers where it will be available, just the cities planned. There is a map on the website.

CMS, and then other third party payors, generally take several months to clarify the use eligibility and reimbursement amount before becoming effective. This should be a Medicare Part B procedure so Medicare will cover 80% of the cost for beneficiaries assuming approval. Then the commercial supplement insurance would cover 20% after the deductible and any relevant co-pay. Non Medicare patients will rely on the commercial insurers, labor unions, VA etc. for reimbursement approval subject to the applicable deductibles, co-pays, network limitations, etc.

The process is on the CMS website and Lantheus, UCLA and UCSF will issue updates on this as will the medical and investment press. You can also inquire with your insurance company as to the status.
Posted 6/18/2021 6:29 AM (GMT -5)
Thanks. Yesterday I found another image service in south Florida also announces they will be ready to provide PYL scan service as soon as CMS makes the decision.
Posted 6/18/2021 6:34 AM (GMT -5)
Who is the provider in South Florida?
Posted 6/18/2021 6:36 AM (GMT -5)
Link: https://www.petimagingflorida.com/psma-pet-scan/?keyword=pet%20psma%20prostate%20cancer&gclid=CjwKCAjwiLGGBhAqEiwAgq3q_q0l7e5-RQ3P_Yg_W2qXX6G1MRvi3EmsW7FrOzUS9FwvCX7772SG3xoCYUEQAvD_BwE
Posted 6/18/2021 8:06 AM (GMT -5)
https://www.petimagingflorida.com/psma-pet-scan/?keyword=pet%20psma%20prostate%20cancer&gclid=cjwkcajwilggbhaqeiwagq3q_q0l7e5-rq3p_yg_w2qxx6g1mrvi3emsw7frozus9fwvcx7772sg3xocyueqavd_bwe

Access was denied to the link.
Posted 6/18/2021 8:26 AM (GMT -5)
I just did several different searches for Atlanta and the only thing that showed up is recruiting for Account Managers. The search ads appear to be in the cities that are listed on the PYLARIFY map.

The Pet Imaging Florida website states that PSMA will be available in a few weeks and has a button to use to schedule and a Hotline phone number to use.
Posted 6/18/2021 8:45 AM (GMT -5)
I think we should refer to this as Pylarify or Pylarify PSMA (or 18F-DCFPyL, or PyL) to distinguish it from the already available 68Ga PSMA scan.

It's other name is piflufolastat F 18 injection. Try saying that three times fast. In fact, try saying it even once!

Djin

Post Edited (DjinTonic) : 6/18/2021 8:07:18 AM (GMT-6)

Posted 6/18/2021 10:53 AM (GMT -5)
For clarity, ARA, that released the press info that started the thread, is in Austin, TX.
Posted 6/18/2021 10:56 AM (GMT -5)
Yes. ARA have 17 location around Austin, TX. Link: https://www.ausrad.com/
✚ New Topic ✚ Reply