Health care coverage for CDNs doing trials in the US

[EvFC]

Hello,

My husband received an invitation for a trial in the US - we live in Canada. The trial involved a new type PSMA scan. We haven’t received the trial information yet, but as we understand things it would involve doing a regular PSMA scan and then doing this new one. My question is, if for some reason the scan caused medical issues that required treatment in the US, does anyone know who would cover the cost? I doubt our insurance would, so I am curious if the trials have insurance for this? I am not sure there is any benefit to him to do this trial, so we’ll have to read the documents they send over. We already have a PSMA scheduled in Canada (which we could cancel if we do this). We have to make a decision quickly, as they would need us to be there early next week.

Thanks! And sorry for all the questions! There is so much new info coming at us very quickly and I really appreciate all the help with interpreting things.

[tn12]

How did you get an invitation to a trial in the US? Did you apply for it? Are you paying for the PSMA here?

[EvFC in reply to tn12]

No! The clinic in Canada let us know about the trial. We said we are interested in more info, but not sure yet if we want to participate. We will be paying for the scan here if we don’t go to the trial, so that would be a benefit. If we don’t have health coverage while we’re there though, it probably isn’t worth the risk.

[tn12 in reply to EvFC]

Ok! Please keep us posted. I would like to know more about it too. Thanks

[EvFC in reply to tn12]

Will do. I think my husband said they were interested because he hasn’t had any hormone therapy yet.

[tn12 in reply to EvFC]

Can you share what this trial is called?

[EvFC in reply to tn12]

lol we have no idea! I will let you know once we get more info. It is with BAMF in Michigan.

[tn12 in reply to EvFC]

Ok no worries. I'd appreciate it, thanks.

[EvFC in reply to tn12]

I was searching and I think this might be the trial, based on the description and what my husband told me. If it is, I don’t think there is much benefit to my husband to do it, but perhaps it might be helpful for others. Based on the fact that they wanted him there no later than next Friday, and the estimated end date on the trial, I wonder if it’s ending soon.

clinicaltrials.gov/study/NC...

[Justfor_ in reply to EvFC]

In your shoes I would be there by now. Four reasons for this: a) the "test" radiopharmaceutical comes from down-under and the Aussies are very advanced in this domain. b) The scanner is of the latest generation and one of a kind. c) Standard trial protocol requires two readers and in case there is difference in assesment a third one to break the tie. d) Bonus standard imaging for baseline. Only one possible catch: they may not give you the imaging data before trial conclusion. You better inquire about that.

[EvFC in reply to Justfor_]

Thanks for your feedback. My biggest concern is insurance while we are down there. If anything were to happen, I don’t know that we would be covered for medical care. That could bankrupt us, as medical care in the US is so expensive. We are still going to read the trial information before we make a decision. How did you get the detail on the trial that you shared above? We are also concerned about the amount of radiation if they are performing multiple scans. We will ask about this when we hear from them. Good point about getting the results before the trial completes.

[Justfor_ in reply to EvFC]

They have been under my radar since 2-3 years ago. The company behind it is listed in the Australian Stock Exchange and for a while I was thinking of buying shares. (Delete from here ->) They are now trying to enter the US market and FDA approval is mandatory. This is what they are after now. (<- to here) As for the scanner it wasn't new to me either. I am a retired electrical engineer with more than 3 decades in TV production and as such imaging technology is among my interests. Regarding radiation exposure, your concerns are valid but not in proportion. A PSMA scan exposes the body to LESS irradiation than the combo of CT and bone scan. It is a couple of years now that I checked it against your country's Hazards at Work directive. It came out as the cumulative effect of 6 transatlantic flights. Insurance wise, could you buy some travel insurance?

[EvFC in reply to Justfor_]

Very interesting. I thought they were already FDA approved for this scan?

I don’t think travel insurance would cover us if a planned medical procedure went awry. Maybe I should call around tomorrow and ask.

Appreciate your insights into this!

[Justfor_ in reply to EvFC]

You are right, I was wrong:

"FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix® Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 20 December 2021. Telix PharmaceuticalsLimited (ASX: TLX, Telix, the Company), a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation (MTR), today announces that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix®....."

telixpharma.com/wp-content/...

[Justfor_ in reply to Justfor_]

I should had invested in them ...

Telix Pharmaceuticals ASX (AUD)

[positive-thinking]

I have never , with all the reading and research have heard of a Canadian doing any trial outside of Canada? When my husband was diagnosed last fall there was a trial we could not participate in because it was in the U.S . So I have no answers for you and I'm also curious about this . ?

[tn12 in reply to positive-thinking]

I was curious too, so I just found this.clinicalcenter.nih.gov/part...

[EvFC in reply to positive-thinking]

I have no idea either. I have been searching and I see a few private blog posts from people who did trials in the US and they were from Canada, but there isn’t much info out there from what I can see. Makes me think health insurance could definitely be an issue.

[Tall_Allen]

I never heard of a medical issue from a scan.

[fast_eddie]

I've had the axumin scan and the pylarify scan. Absolutely no issues (other than claustrophobia and shoulder pain holding the position) taking either scan. I can't imagine a scan causing a medical issue but I suppose it is possible. I would go for the trial.

[EvFC]

This is the info we received on the trial:

Illuccix®, an FDA approved imaging agent for prostate cancer, has a short half-life (short time to expiry) which limits its availability to patients, so Telix has developed a new variation of 68Ga-PSMA-11 called TLX007, which has a longer half-life (takes longer to expire). The aim of this study is to examine if there are any differences in how Illuccix® and TLX007, which are manufactured using two different methods, is distributed in your body and taken up by prostate cancer cells when visualized by PET imaging scans. It also aims in assessing if there are any differences in side effects between the two imaging agents.

The trial summary also noted this:

Participation in this study will not alter your medical treatment plan, and results will not be shared with you or your referring physician.

I think they said they would also do the PSMA scan and provide us those results. We didn’t clarify that as it’s not worth it for us to go. The only benefit would be saving the cost of the PSMA scan here, which isn’t worth the risk for us of going to the US without insurance.

I did get responses back from two insurance companies and they said they wouldn’t cover my husband to travel for a planned medical procedure.

[LongTimeRunning]

After PCA diagnosis but before I was found to be metastatic and found a trial in BC, I researched doing clinical trials in the US. The information for Canadians doing this is murky and might depend upon where the trial is located. From what I understand, the trial would cover the costs of the new technique being tested, but all other standard of PCA care would not be covered.

I wonder is something like living in BC and getting SOC from Canada (hormone treatment etc) then popping down every so often for the trial (scans etc) might be workable if your husband is otherwise healthy and not too much at risk from travel, if there are not too many scans.

[EvFC in reply to LongTimeRunning]

Thanks for your feedback! My husband decided not to go through with this trial, as the benefits to him weren’t worth the risks.