Frequency Therapeutics — Hearing Loss Regeneration

[Loui]

From what has been described by Frequency Therapeutics, there is a progenitor "support" cell for each Inner and Outer hair cell lining the cochlea. Frequency Therapeutics has described patients returning for repeat dosages; so I don't see the benefit in waiting until you get to a certain level.

That's comforting to know. Let's just hope that FX-322 proves to be successful and hits the market. I will get it ASAP if it does. If we all continue to protect our ears from loud sounds then hopefully we will never experience this cruel condition again.

 

[AfroSnowman]

In the current trials, are they testing for tinnitus improvement as well as hearing improvement?

Do you expect any tinnitus improvement data to be released in March or just hearing improvement results?

 

[Lucifer]

In the current trials, are they testing for tinnitus improvement as well as hearing improvement?

Do you expect any tinnitus improvement data to be released in March or just hearing improvement results?

They are testing for tinnitus improvement as well. Not sure if they will release tinnitus results in March or just hearing improvements though but since it was tested it will probably be a 50% chance they will talk about tinnitus improvement.

 

[Philip83]

In the current trials, are they testing for tinnitus improvement as well as hearing improvement?

Do you expect any tinnitus improvement data to be released in March or just hearing improvement results?

They are testing for tinnitus improvement, yes. My guess is that if the data regarding it is conclusive enough and positive in March already, I don't see why they wouldn't disclose it.

 

[weab00]

Is insurance likely to cover FX-322 if it shows meaningful reduction in TFI for patients?

 

[FGG]

They are testing for tinnitus improvement, yes. My guess is that if the data regarding it is conclusive enough and positive in March already, I don't see why they wouldn't disclose it.

There are a few reasons why they might not. One is that it's not the primary focus of the trial and the update isn't likely to be all inclusive since they won't have all the full study endpoint data at that point.

Another possible reason is if reversing the maladaptive neuroplasticity was not a relatively instantaneous process in total (just like there are often even greater improvements in mirror therapy for phantom limb over a longer time frame).

They would have an idea of that from Phase 1 anecdotes and would know whether those tinnitus changes happened with short term or long term follow up.

My guess is they will not update tinnitus info until May but I am obviously not sure.

 

[Lucifer]

Is insurance likely to cover FX-322 if it shows meaningful reduction in TFI for patients?

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

 

[FGG]

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

Maybe I got this wrong but I thought you weren't American. Or maybe you are worried for Americans getting coverage?

 

[FGG]

Is insurance likely to cover FX-322 if it shows meaningful reduction in TFI for patients?

I'm sure it would depend on the plan.

Many plans have no hearing coverage whatsoever (Sanders is trying to mandate hearing and vision coverage, but he hasn't been successful so far and I think it's likely this isn't going to change anytime soon, certainly not before the drug comes out) so I am sure it wouldn't be covered.

A few plans do cover hearing aids and even expensive yet questionable things like TRT though so I imagine in those plans, FX-322 would be cheaper for them then since it is not a long term therapy.

 

[serendipity1996]

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

Yeah, this is the one thing I do worry about even though I'm not from the US. Assuming this is offered in the UK, what if you can't get treatment on the NHS because you have a normal audiogram? And therefore have to shell out for private treatment or even go abroad. I hope it wouldn't be that way.

 

[AfroSnowman]

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

To me it would be a no brainer. Taking out a loan, going $10,000+ in debt would suck but would be endlessly better than living everyday with tinnitus and hyperacusis.

 

[Gb3]

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

Some insurance does cover hearing aids. You just have to do research. I don't know how it works for you and where you're from but in Massachusetts we have open enrollment every year and you can switch your insurance at that time.

 

[Jack V]

Is insurance likely to cover FX-322 if it shows meaningful reduction in TFI for patients?

If FX-322 receives approval for hearing loss, but not tinnitus (because while studied, the company hasn't sought FDA approval for tinnitus), then likely no.

This is actually the scenario we want!

The reason is, when a company develops a drug, it has to decide how broad its approval request will be. From the company's perspective, it's a gamble. Let's say they think their new drug will treat 3 things, 1 thing solidly, and 2 things likely. If they seek and receive FDA approval for all 3 things, then they stand to make insurance-reimbursable profits from all 3 conditions from the get go.

However, as I understand it, if 1 of those conditions doesn't pan out during the approval process, it can stall the entire application, even if 1 condition is solidly positive, thus delaying the drug's entrance into the market.

So the company has to make a decision: do they pursue approval for only the condition they feel most confident about first, the low hanging fruit, generating potentially X dollars per year, or do they get more ambitious (or greedy) and seek approval for additional conditions to generate XYZ dollars per year.

For FX-322, improvement with hearing loss is likely easier to establish than improvement with tinnitus.

Therefore, assuming FX-322 also helps with tinnitus, what gets it to tinnitus sufferers ASAP is for the drug to receive approval for hearing loss first - the fastest, most reliable route to market. At that point, it can be prescribed off-label for tinnitus, although it will likely not be covered by insurance.

And nothing stops the company from running additional trials, even after it's approved for hearing loss, to broaden the scope of insurance-reimbursable conditions to potentially include tinnitus. But in the meantime, it's available.

One last thought: assuming FX-322 is approved for hearing loss, it helps with tinnitus, insurance doesn't cover it, and it's expensive, Frequency Therapeutics, as many drug companies do, might have a program to provide it at a discount for patients with financial hardship.

 

[FGG]

If FX-322 receives approval for hearing loss, but not tinnitus (because while studied, the company hasn't sought FDA approval for tinnitus), then likely no.

This is actually the scenario we want!

The reason is, when a company develops a drug, it has to decide how broad its approval request will be. From the company's perspective, it's a gamble. Let's say they think their new drug will treat 3 things, 1 thing solidly, and 2 things likely. If they seek and receive FDA approval for all 3 things, then they stand to make insurance-reimbursable profits from all 3 conditions from the get go.

However, as I understand it, if 1 of those conditions doesn't pan out during the approval process, it can stall the entire application, even if 1 condition is solidly positive, thus delaying the drug's entrance into the market.

So the company has to make a decision: do they pursue approval for only the condition they feel most confident about first, the low hanging fruit, generating potentially X dollars per year, or do they get more ambitious (or greedy) and seek approval for additional conditions to generate XYZ dollars per year.

For FX-322, improvement with hearing loss is likely easier to establish than improvement with tinnitus.

Therefore, assuming FX-322 also helps with tinnitus, what gets it to tinnitus sufferers ASAP is for the drug to receive approval for hearing loss first - the fastest, most reliable route to market. At that point, it can be prescribed off-label for tinnitus, although it will likely not be covered by insurance.

And nothing stops the company from running additional trials, even after it's approved for hearing loss, to broaden the scope of insurance-reimbursable conditions to potentially include tinnitus. But in the meantime, it's available.

One last thought: assuming FX-322 is approved for hearing loss, it helps with tinnitus, insurance doesn't cover it, and it's expensive, Frequency Therapeutics, as many drug companies do, might have a program to provide it at a discount for patients with financial hardship.

Many drug companies do have those programs and there are also "medical credit cards" type services like Care Credit that are low to no interest as long as you pay them off on time (they are relying on you not to, so they can get predatory with fees).

Care Credit is already commonly used for hearing aids because in some states it's extremely difficult (or even impossible) to find plans that cover them.

They have similar companies outside the US as well.

 

[Jack V]

Many drug companies do have those programs and there are also "medical credit cards" type services like Care Credit that are low to no interest as long as you pay them off on time (they are relying on you not to, so they can get predatory with fees).

Care Credit is already commonly used for hearing aids because in some states it's extremely difficult (or even impossible) to find plans that cover them.

They have similar companies outside the US as well.

I didn't know that existed -- good to know, thanks!

The bottom line though is that what's most important is for something like FX-322 to emerge as an actual, genuine, treatment, and people shouldn't lose sleep at this point about the financial aspect. Once there's a treatment, all that other stuff will work itself out.

 

[AfroSnowman]

When approved by FDA, will insurers have to cover this if prescribed for hearing loss or can they opt out?

 

[Diesel]

When approved by FDA, will insurers have to cover this if prescribed for hearing loss or can they opt out?

No. Insurers can do whatever they want in the USA. I suspect they will create an add-on for hearing like we have for dental / vision.

 

[FGG]

No. Insurers can do whatever they want in the USA. I suspect they will create an add-on for hearing like we have for dental / vision.

Agree but in some areas, those add-on plans aren't available. But I do agree that shouldn't be the primary focus at the moment.

 

[Lucifer]

Maybe I got this wrong but I thought you weren't American. Or maybe you are worried for Americans getting coverage?

I'm worried that it won't be covered under insurance for Americans and New Zealanders.

In NZ they only cover a little for hearing aids under private insurance and you have to pay most of it from your own pocket. That's why I'm not sure if insurance will cover FX-322.

Just to let you know I'm on the highest premium plan and they only cover a little on hearing aids.

 

[Lucifer]

To me it would be a no brainer. Taking out a loan, going $10,000+ in debt would suck but would be endlessly better than living everyday with tinnitus and hyperacusis.

I just hope that if you had to pay for it in the beginning that in the future you could claim the cost back.

 

[FGG]

I just hope that if you had to pay for it in the beginning that in the future you could claim the cost back.

Most of us don't know much about the NZ healthcare system but maybe there is another Kiwi lurking that could answer that.

It should help to know though that drug prices are almost always much higher in the US so if it ends up being "roughly hearing aid price" in America, you can bet it will be a lot lower everywhere else.

 

[Lucifer]

Most of us don't know much about the NZ healthcare system but maybe there is another Kiwi lurking that could answer that.

It should help to know though that drug prices are almost always much higher in the US so if it ends up being "roughly hearing aid price" in America, you can bet it will be a lot lower everywhere else.

Let's hope that FX-322 is cheap to take and if it's not covered by insurance in the beginning then hopefully in the future you can claim the cost back.

I was more worried about hyperacusis sufferers as the audiograms will appear normal, therefore not allowed to claim for insurance.

 

[tommyd87]

This is the thing I'm worried about because right now insurance don't cover hearing aids.

What happens about hyperacusis and tinnitus sufferers who have audiograms that appear normal?

What happens if FX-322 works for pain hyperacusis but insurance won't cover it because they have normal audiograms?

Don't the New Zealand government cover costs currently for certain medications?

Most likely that FX-322 might make it onto the private prescription list however. I reckon Frequency Therapeutics won't make it ridiculously unaffordable however. How they will make money is by setting a price which is ultimately going to yield sufficient and significant profits, while also being affordable to many. More sales means more money. I am also thinking that if Frequency Therapeutics was smart, they would want to eliminate the possibility that some people might go to a country with cheaper medicine for treatment by making the comparable cost with flights and accommodation etc being cheaper or not actually worth doing. I could really see this becoming an actual possibility as it already occurs fairly frequently for other treatments presently.

 

[frpp]

Let's hope that FX-322 is cheap to take and if it's not covered by insurance in the beginning then hopefully in the future you can claim the cost back.

I was more worried about hyperacusis sufferers as the audiograms will appear normal, therefore not allowed to claim for insurance.

Really hoping it's no more than $2000 per shot and hopefully a lot less. It wouldn't be unreasonable for something that restores hearing and potentially ends this hell.

 

[Born To Slay]

I was more worried about hyperacusis sufferers as the audiograms will appear normal, therefore not allowed to claim for insurance.

Just fake the audiogram lol.

 

[Lucifer]

Don't the New Zealand government cover costs currently for certain medications?

Most likely that FX-322 might make it onto the private prescription list however. I reckon Frequency Therapeutics won't make it ridiculously unaffordable however. How they will make money is by setting a price which is ultimately going to yield sufficient and significant profits, while also being affordable to many. More sales means more money. I am also thinking that if Frequency Therapeutics was smart, they would want to eliminate the possibility that some people might go to a country with cheaper medicine for treatment by making the comparable cost with flights and accommodation etc being cheaper or not actually worth doing. I could really see this becoming an actual possibility as it already occurs fairly frequently for other treatments presently.

Yes a lot of prescription medications that you get in NZ are subsidised a lot due to Pharmac. Since I'm on private insurance I can get a max of $600 worth of prescription medication for free if it is under Pharmac list of subsidised medication.

 

[Lucifer]

Just fake the audiogram lol.

Hyperacusis sufferers can't fake an audiogram though because even if the sound is at the lowest it will cause us pain.

 

[Born To Slay]

Hyperacusis sufferers can't fake an audiogram though because even if the sound is at the lowest it will cause us pain.

I have pain hyperacusis and I forgot about that.

But honestly, there's so many ENTs. There's at least one that'll accommodate you.

And the insurance company ain't going to ask for an audiogram. And I know this because when I saw an audiologist, she offered me hearing aids for TRT and said the insurance would cover it all no questions asked.

 

[Lucifer]

I have pain hyperacusis and I forgot about that.

But honestly, there's so many ENTs. There's at least one that'll accommodate you.

And the insurance company ain't going to ask for an audiogram. And I know this because when I saw an audiologist, she offered me hearing aids for TRT and said the insurance would cover it all no questions asked.

That's why I hope that the ENTs I visit will be lenient towards me since I suffer from hyperacusis and if it ends up working for hyperacusis then it should also be covered under insurance as well.

 

[Born To Slay]

That's why I hope that the ENTs I visit will be lenient towards me since I suffer from hyperacusis and if it ends up working for hyperacusis then it should also be covered under insurance as well.

Unsure how insurance works in NZ, but in the US, it seems that unless something is extremely expensive, they just cover it if a medical professional things you need it. I've never once had an insurance company disagree. Even with the hearing aids.