Frequency Therapeutics — Hearing Loss Regeneration

They can cover off label use but they often don't and use the excuse of it not being a labelled indication saying it's "experimental". If an off label drug is cheaper for them, insurance will cover it.

 

From what I’ve been seeing in the US when it comes to insurance coverage, it seems that some policies can choose to refuse coverage for certain treatments if they are actually not approved for a specific treatment use. So if FX-322 isn’t approved for age related hearing loss, then the insurance company can simply say they are not covering it. This happens in Australia too whereby certain insurance companies refuse to cover certain procedures unless they have been approved by the regulator for that specific indication.

I am actually thinking Frequency Therapeutics is trying to establish that FX-322 is a legitimate medicine for hearing and thus should be covered by taking it through the age related trial, because currently hearing aids are not. Therefore it could be entirely possible that without proof of FX-322’s effectiveness for age related hearing loss, insurance companies could refuse cover for FX-322 for the same reasons that they refuse to cover for hearing aids.

Hence by Frequency Therapeutics taking FX-322 through trials to demonstrate its effect on age related hearing loss, they can demonstrate it is a legitimate medicine. Demonstrating FX-322 is a legitimate medicine for age related hearing loss will then ultimately mean insurance companies will cover it for this purpose.

For what it is worth, Hough Ear Institute has claimed that they needed to complete their tinnitus proof of concept study for their pill in order to gain insurance coverage for tinnitus.

 

Wow I guess that makes sense. Perhaps since most of the most common prescriptions are now generic and cheap they don’t care anymore and just let it happen. It could be different with drugs like FX-322 since it’d be a lot more expensive than your typical prescription.

 

This also applies to the drug being used for workers compensation cases, employer insurance, and government-run insurance (Medicare). It also makes sense from a business standpoint. The more insurers that cover the drug, the bigger the market to sell it to. If the drug in the US starts at $2000/injection and isn’t covered by insurance, less are going to buy it. Covered under a typical drug plan might get it to 50% - 10% of that price.

Also, actuaries in the health insurance industry know the comprehensive cost of hearing loss over the life of an insured person.

If FX-322 is a cost effective route, and thereby modifies the lifetime cost of hearing loss to the insurer, by increasing quality of life measures, it may be considered a preferred/preventative treatment.

 

That’s a good point, if FX-322 is cost effective (it likely will be more cost effective then hearing aids) then hopefully insurers will get that.

 

It will be way more effective than the cost of hearing aids and also actually a lot more beneficial.

There are two things that have theoretically been demonstrated so far with FX-322:

1. There has theoretically been hearing restoration above 8 kHz based on the operation of the ear/medicine. There are very few hearing aids at present that are able to treat above 8 kHz and when they do they don't treat many frequencies above this. Therefore if FX-322 can consequently treat the frequencies above 8 kHz then it is immediately going to provide benefits which hearing aids are not able to.

2. If FX-322 can replicate the lab trials and actually attain full hearing restoration in ears (entirely possible) then even if it was sold at a cost of $4000 then this would still make FX-322 much more cost effective than using a hearing aid which the average cost of hypothetically sits at around $2000.

There are two reasons why this would make FX-322 more cost effective:

> The benefit delivered by FX-322 would hopefully and theoretically last longer than the time that two hearing aids would last for (8 to 10 years).

> FX-322 would provide a superior and more significant benefit than a hearing aid would.

 

Will you guys get FX-322 as soon as it’s available or will you hold off to see what results are like from other people on Tinnitus Talk?

 

I hope these future drugs can also help those who are born with hearing loss too

I was born with severe hearing loss and and had mild tinnitus all my life til a virus last year so now I got bad reactive tinnitus but I hope at least one of these drugs can help me too.

I’ve only read about the FX-322 potentially helping noise induced hearing loss or people who lost their hearing later in life from something but not about anybody born with hearing loss

I have sensorineural hearing loss in my left ear and it is at least 85 percent deaf I do have some conductive hearing loss on my right side but I know these drugs are will be more targeted for sensorineural hearing loss so I hope they can at least help my deaf ear

 

How long after phase 2a would you think?

 

Do we know why Frequency Therapeutics is doing another Phase 1 safety trial? I would have thought the safety had already been established by the first Phase 1 trial? Plus since they’re already in the middle of a Phase 2 trial?

 

Going for it ASAP.

 

They’re seeking another hearing loss approval for the same FX-322: Age-Related Sensorineural Hearing Loss. Have to start from the beginning since the patients are different.

 

I personally would get it as soon as it’s available. I tried to join the trials but wasn’t able.

 

ASAP for me.

Fuck this. Why didn’t people warn us about tinnitus and hyperacusis. If I had known that I could get these conditions other than just hearing loss I would have protected the fuck out of my ears.

 

It would depend on the price of FX-322, but if it's going to help me at all, I'll move all stones I can to get this stuff. Anything to help rid me of tinnitus, or at least bring it down to something I can tolerate.

But how would you go about getting a supply? Would you be able to contact Astellas Pharma Inc directly here in Australia and have them sort out the logistics of getting me some, or would I need to see my local GP to get some (he seems very limited on his understanding of tinnitus in general)...

 

There’s two ways I think that we can look at how the FDA might assess Frequency Therapeutics' trial processes:

1. Frequency Therapeutics is able to meet with the FDA after phase 2A and phase 2b trials individually to obtain trial validation and also apply for compassionate use (provided Frequency Therapeutics wishes to apply for this). Therefore it is possible that FX-322 could be available a few months after the phase 2a trial ends (provided Frequency Therapeutics can meet with the FDA quickly).

2. The FDA mandates that Frequency Therapeutics completes both phase 2 trials before being willing to assess and also validate the trial outcomes for FX-322. This is due to the FDA wanting more data to ensure the medicine is effective before approving the trial outcomes and also approving compassionate use too. This might take another year to get the trial through the phase 1b and 2b trials.

What I would say however is even if Frequency Therapeutics had to take FX-322 through the phase 2 trials for both indications before the FDA would consider granting approval, it would not necessarily be a bad thing.

This is because if Frequency Therapeutics obtains positive results from the phase 2a trial, then there is a very good chance that the trial results in the phase 2b trial will also be positive. While this may mean a delay in being allowed to use FX-322, it is also going to make it much more likely that the FDA will approve FX-322. This is because they will have more favourable data demonstrating that FX-322 works as intended.

Overall and ultimately however I hope that the FDA is willing to consider the results of the phase 2a trial individually and I hope the trial outcomes are positive too. This is because I am sure most people would want to obtain access to FX-322 and use it as quickly as possible.

 

It's crazy that most people only learn about tinnitus after they develop it. This is the kind of stuff that should be taught in schools.

 

I’m with you and I tend to think that these ear treatments will alleviate conditions such as tinnitus too. The lucky reality is that at least we are living in a time that medical treatments are relatively good and new ones are getting developed to treat conditions like ear issues.

 

Or maybe they see now that FX-322 is not getting desired results for causes like loud music and side effects from drugs? They might be trying at least to make it work out for age-related hearing loss???? You can't just create a new clinical trial out of the blue!

 

If the current Phase 2A study is a double-blinded placebo-controlled study, how can the company know of any results so far? I thought they only became aware of any results once the entire study is done. If this is the case, Frequency Therapeutics cannot be basing this new trial on newfound extra confidence derived from how the Phase 2A is going.

Or am I completely wrong and they can see trial patient's stats (audiograms etc) throughout the trial while just being oblivious to if they are a placebo or not and since it's hearing, they can make the assumption that improvements seen are because the patient likely received the drug?

 

I doubt this. All previous evidence points to FX-322 working reasonably well. Also, they just trademarked an official name for FX-322, along with taking several opportunities to educate doctors, ENTs etc on the drug. Everything so far is pointed towards laying groundwork to have this drug hit the market HARD when it is approved.

You might be right but I see no hints towards your idea.

 

That would go against the latest research findings that age related hearing loss actually is the same type of hearing loss as from loud music or ototoxic meds. Maybe it's because of these new findings they started this other trial?

 

It would be enough to see the patient's reaction when they get told "Hi, Good Morning"...

Can you imagine being able to hear for the first time? Watch this video:

Amazing People Hearing for the First Time!...

 

If it doesn't work acutely it wouldn't work chronically. That makes no sense. A better doomsday "plan B" would have been to pour more money into the MS drug. This is a good sign, not a bad one.

During the Tinnitus Talk Podcast, they were asked about other causes including age related and ototoxicity and he said that they believe it would work there too. This isn't new information for the company.

 

Yes, that was my point. I was just theorizing if the new findings that "age related hearing loss" doesn't exist but has the same cause as the types they're testing for now could be the reason for the new trial.

 

I realized that and was agreeing with you.

 

Right, but my impression of double-blinded placebo-controlled studies is that the company does not receive any information. They aren't present for the patient visits either. They receive the final information at the end.

Or maybe I'm wrong and the company can have access to updates in the trial as it comes, such as they see that X amount of patients have seen 40 dB improvement in all frequencies. Maybe they just can't see who gets the placebo or the drug.

 

Fun stat...

By June of 2021, a total of 110-112 FX-322 clinical trial participants will have received at least 1 injection.

 

Frequency Therapeutics gets NOTHING until the trial ends... no data, they're not there, no access to anything in the trial.

What they do get post-trial are things like "qualitative" patient feedback, feedback from doctors that treat the patients, on-going studies of the patients in the trials.

 

Officially you are correct, but in reality...