MemberYes, I agree. I don't remember the name of that drug but they gave it systemically to the mice and most of them died of diarrhoea. I remember reading that it burned the mice' guts and those who survived were very thin.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Needless paranoia imo. No amount of disinformation will have any serious effect on Frequency Therapeutics. It might drive the share price down temporarily until we see the next round of hard data and then the market will be driven by published results only. If FX-322 safety and efficacy is proven it will be released. There's nothing anyone can do to stop it.
I agree and I also believe that the consequent concerns held by some about the appropriateness of the FX-322 will be extremely short lived. Especially when these people see that the outcomes are totally positive in those who have undergone the treatment. Most certainly the naysayers will make attempts to denigrate FX-322 however.
It is incredibly funny that there would be firms or people who would even try this.
The claims made by the taxi companies here to show why they were better than UBERs were utterly ridiculous. I reckon the best one was that taxis are always going to be safer vehicles because they have to be compliant with the regulations. Right after this there was a roadworthy blitz and 10 got done hard in a media story in about half an hour. It will be exactly the same story with FX-322 and similar medicine.
- Jan 16, 2020
- 434
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
A fair and competitive price for FX-322? I hope they become millionaires. But I'm of the view that it will help a percentage of sufferers. Imagine paying 5 grand for your four shots and you find that it doesn't work for you, but I pay 2 grand for two shots and it does work for me! Roll up, roll up ladies and gentlemen.
They will be competing with the hearing aid sector. Tinnitus Talk will enjoy a very vibrant discussion time when the drug gets released onto the market.
I think that if they were savvy and actually are super keen on smashing the hearing device industry then they would be wise to come out with a money back guarantee. Give people the chance to try it and if it isn't successful then they can claim a refund.
I reckon that it is incredibly unlikely money back guarantees would be offered, however it would put confidence in people that they firstly don't need to outlay obscene amounts of money for something that might not work. Secondly showing FX-322 works for others means that there is actually going to be a higher willingness to undergo the treatment.
For the "American Academy of Otolaryngology – Head & Neck Surgery (AAO-HNSF) 2020 Virtual Annual Meeting & OTO Experience" that's happening this Sunday, is there any way we'll know what is said?
The only problem is that in America many insurance plans don't cover hearing services. Including the largest insurance provider in the country, Medicare.
My understanding of how American health insurance works might be wrong, however isn't it true though that while most insurance policies/companies currently do not cover the cost of hearing aids, they do cover most medicines which have passed FDA trial requirements and obtained FDA approval? Thus the effect that this would have on PIPE-505, FX-322 etc etc would be that they would have their cost either fully or partially covered through their insurance, depending on their type(s) of coverage?
A number of people and also companies have stated that if hearing related restorative medicine is approved then there would be access to it under their insurance just like there is already for antibiotics or skin conditions for example?
Therefore Frequency Therapeutics would have a massive advantage also over hearing aids as they can not only challenge their market but they can also have the cost of FX-322 covered. This means more people would likely be able to undergo the treatment as they do not have to bear the financial burden of the treatment personally.
Insurance companies don't cover all medications, they give you a list of meds they cover and if FX-322 is expensive, they might not be willing to cover it. America sucks.
That is interesting. Insurance coverage is apparently one of the justifications that Hough Ear Institute has stated for their pill needing to be put through the phase 2 tinnitus trial.
The question is why would people and/or firms be claiming that they can obtain insurance coverage for a medicine if they ultimately cannot or is it a hit or miss scenario?
Being on label just means you can appeal the decision and sometimes win but it's a battle.
Because it's still better for some people to be able to get their medication covered. Not everyone has shit insurance, my insurance actually covers all hearing related stuff and when I was considering TRT I was told it'd be covered 100%.
All this said, it's strange Hough Ear Institute would say the tinnitus trial is required because once a drug is approved for any indication, doctors can prescribe it for reasons outside its approved purpose. It's called off-label prescribing, it's done all the time.
It sounds like Hough Ear Institute is wasting their time or they could be hoping that if their drug is approved for tinnitus, it'll be more profitable to them since they'll have the only drug in the market approved for tinnitus and therefore doctors will be more likely to try it first.
Regardless of Hough Ear Institute's motivation, it doesn't help patients for them to do that imo.
I agree, a large number of differences exist within the insurance market in America, based off of what I have found out about it. There seems to be different levels of coverage and also different requirements for what health insurance is going to cover between different states. I also agree that there might be some with insurance who would be unable to obtain this type of treatment through their coverage.
I am actually going to discuss the issues with what you have said in relation to Hough Ear Institute in the appropriate thread. However, what I will say here is that the lack of/gaps in information around the tinnitus aspect of it is confusing.
I think what you are saying about doctors more likely to prescribe something on label is true.
I think there is another factor though and it is how cost prohibitive this will be for many without insurance coverage.
A few members (I would tag them but I have forgotten who...) tried to price the drug from a research chemical compounding facility, and they were quoted something insane like $10k a dose minimum and possibly much more. I realize when you mass produce something the cost goes down but this is a very expensive drug and the pharmaceutical partners expect to make a good return on their investment, too.
With cochlear implant trauma, you could be looking at one dose at the time of surgery (with a surgery that already costs about $50k), but with other indications, who knows?
This could make the Hough Pill completely unaffordable to many unless they have a good insurance plan, which gives Hough Ear Institute great incentive to get it labelled.
To put it another way, if it's not labelled and not covered, most people with mild tinnitus might not fork over the money, therefore the market share would increase substantially with insurance coverage.
I wonder if this is one reason they are testing it for cochlear implant surgery trauma first, due to increased likelihood of being routinely used for an indication where cost is already high but insurance usually covers it.
I'm not as worried about the Hough Ear Institute setbacks because the pill does 2 things: helps with inflammation in the cochlea and regenerated synapses but it's not the *only* drug being tested for those things.
Drugs being tested for cochlear inflammation (indirectly):
SPI-1005
Otividex
Drugs being tested for synapse regeneration:
OTO-413
PIPE-505
In all probability, sensorineural noise-induced hearing loss treatment with FX-322 in the United States would not be covered by most individuals insurance plans with their employers or Medicare for that matter. There is a huge market out there for FX-322 and insurance companies will most likely steer clear with little coverage.
Lending sources such as CareCredit would likely be available for anyone with a reasonable good credit standing to help cover the cost of treatment with a payment plan.
It's my guess that this will be the reality but still well worth it!
Lending sources such as CareCredit would likely be available for anyone with a reasonable good credit standing to help cover the cost of treatment with a payment plan.
It's my guess that this will be the reality but still well worth it!
Michael01
Member
All I can say is that if it's released here in Australia they better offer a fair price, as various bodies here would frown on $5k price tag on drugs for people with severe hearing loss and such things. But another part of me wishes they'd just release the thing onto the market, as I could really use a pill just to start making all this go away...
My 2 cents:
My interpretation is that tinnitus is a combination of x + y + z.
Where x is structural damage, y is inflammation or neuroinflammation and z is intrinsic factors like neurotransmitters.
People who have more fluctuations, probably have more fluctuations in y and z or have causes (like TMJ, Meniere's etc etc) that vary more than others.
Drugs like FX-322 will assess "x" but in most people the equation is more like tinnitus = x + xy + XZ.
This is my theory based on everything I have read anyway.
Interestingly I had an appointment with my ENT yesterday - I asked him whether he had heard of FX-322 and when he said no I started to describe it. He immediately cut in that it was impossible to get delivery to the inner ear and that the therapy sounds like a pipe dream. I am not trying to criticize, I just think it's interesting how a doctor could have such a swift and adamant reaction. Very strange.
Hi,
Same happened here, it really depends on the ENT. I used to visit a so-called tinnitus clinic. I also told them about some clinical trials taking place. She was just laughing and advised me to develop my own ear drops...
The other ENT is quite optimistic about a future treatment, he always says that it's frustrating he can't do more.
I correspond with a top HCR Researcher. He is confident that within the next 5 years there will be treatments for some hearing conditions, but robust hair cell regeneration will take a little longer because of its complexity.
Maybe FX-322 won't be perfect, but a step in the right direction.
Pretty similar to the way my first ENT reacted. After this experience, I did some research and found a different one.
The first ENT didn't physically check my ears or nose and just told to learn how to live with it.
My new ENT is currently treating for a retracted eardrum on my right side, which he diagnosed after... checking my ears.
So far it hasn't done much for my tinnitus, but at least it's a starting point. He was also keen to learn about FX-322, and was pretty hopeful about a future cure.
ENTs really run the gamut. The ENT featured on Frequency Therapeutics' last video conference was super excited about it and its huge potential and then we have an ENT who thinks medicine won't reach the inner ear (despite the fact that they are currently already doing that with IT Dexamethasone and Gentamycin (in the case of Meniere's)).
It's like any other field/profession I guess. Some people are really on top of it and some aren't.
It's like any other field/profession I guess. Some people are really on top of it and some aren't.
I think it's important that professionals are openminded for solid research.
But we shouldn't forget that we put a lot of hope in Frequency Therapeutics in the perspective of patients, so our thinking is far more wishful than probably the results will be.
When I got sudden hearing loss in 2003, there was the discovery of the Atoh1 approach, almost 10 years later, it went to a clinical trial led by Genvec/Novartis. I thought this might be something which will help us soon. Wasn't so...
Frequency Therapeutics' approach sounds far more promising, but I guess only with the results of the Phase 2a we can see in which direction it will go.
I really pray that we can get some relief, I do not expect 100% relief, anything which helps in a causal way is welcomed.
I went into this a lot more in the Novartis thread but I really think if they did better patient selection (e.g., very severe vs profound), they wouldn't have had the problem they likely did with flat epithelial (which doesn't transduce with the genes used) and probably would have got better results.
Also, viral vectored therapies have to be directly infused surgically into the cochlea and cochleostomy is a destructive surgical procedure and can produce enough inflammation (it's sometimes quite pronounced, which is why Hough Ear Institute is testing their pill for "cochlear implant trauma") where they can actually do more harm than good.
Akouos is a lot more promising as far as viral vectors therapies go but they are starting with genetic deafness (for now, they are pre-clinical for hair cell regeneration) and, as I recall, have developed their own surgical technique. Even canalostomy, a relatively newer surgical technique would have very likely produced better results imo.
Viral vectored therapies still have a lot of potential and may ultimately be the best way to treat the very severe to profound hearing loss (once they get the right genes, they could maybe even transduce fibroblasts) some people have where they lack support cells. Once they get the surgery right anyway.
This makes good sense and is also helpful info.
As an Australian myself, I have learnt over time from researching and travelling that often the costs of non-PBS treatments (for those non-Australians, non-PBS means the cost of a pharma treatment not covered by the government) are often quite a lot higher than they cost in other countries. Furthermore medicines generally can be quite expensive even from an Australian pricing perspective.
One of the reasons I think that this happens is because like with most other things sold in Australia, Australians are rightly or wrongly seen to have the ability to pay a higher amount for stuff. Just look at things like the cost of food and utilities for example, when compared to many other places. The same thing happens with both the government subsidised and non-government subsidised medications. For example a packet of antibiotics costs $9.60 in Australia whereas in the Philippines it costs about $2 or $3.
I think that the unfortunate reality is that FX-322 is going to be around the $5,000 price point for two main reasons.
Firstly, this cost is comparable to the alternative treatment of a hearing aid. As a result Frequency Therapeutics know that people potentially will pay this sort of price for this treatment and therefore they can comfortably charge this.
Secondly, FX-322 will be under patent. Therefore firms like Frequency Therapeutics can usually charge what they want within reason, as they effectively have a monopoly on a treatment for the patent's duration. The reality is that Frequency Therapeutics is going to ensure that they are profitable from selling FX-322, as it is one of the two key aims of a pharmaceutical company (along with producing good treatments) and thus the price will reflect this aim.
However, Frequency Therapeutics also needs to recover all medicine development expenses first to enable it to turn a profit. As a result the medicine needs to be sold at a price which enables it to recover both development costs and also turn a profit in a relatively speedy manner. The main way pharma companies such as Frequency Therapeutics can do this is by following the new mobile phone pricing model just like how Samsung does when they release a new Galaxy Phone for example.
People want the new Galaxy immediately for a number of reasons such as the phone's look and better features. Therefore they will pay more money to get their hands on it earlier because they want the new technology and new product now. Samsung takes advantage of this by charging the maximum price that they know people will pay for this phone and holds the phone at that price until they have recovered enough money from sales to not only cover the costs of the phone's development but also to allow them to maximise profit from it. After the phone has been out for a while and Samsung feels that it has maximised benefit from it, Samsung will reduce its price.
The same scenario should play out with how Frequency Therapeutics prices FX-322.
However, instead of reducing the price per unit for individual customers (patented medicine holds its value for the duration of the patent, unless some superior medicine comes out), Frequency Therapeutics may be willing to enter into bulk buying discounts with pharmacy store groups or with governments so the treatment can be provided at a reduced cost. This happens regularly in Australia with many medicines and is the most likely way which we would be able to buy FX-322 at a discount.
Australian Government deals with pharma companies to get discounted medicines. It already happens with medicines like the flu shot and also a number of heart medicines. Heart medicines are probably the best example because they have been able to eliminate the need for people to have more expensive heart surgeries in many instances. This is because the medicine works just as well as, if not better than the surgery in a number of cases and yet is significantly cheaper. If FX-322 can demonstrate that it can provide a significant benefit to people which would reduce hearing aid use then it probably would be subsidised. The interest from Frequency Therapeutics at looking at age-related hearing loss (which is probably not much different to the hearing loss FX-322 is looking at currently) is probably the most relevant case as the government would certainly subsidise this since they already have hearing aid programs now which they fund. So just like in the case of the heart medicine, this would mean that FX-322 would be better than the current option. Thus the government would be much more likely to pay for it also.
Given that FX-322 is a novel treatment with seemingly high demand, I cannot see Frequency Therapeutics reducing the cost of it at all initially under any circumstance.
Furthermore, it is blatantly obvious that there are a significant number of factors which indicate FX-322 will be relatively expensive as highlighted above.
This sucks as it is going to mean a significant outlay of money to purchase FX-322, however I strongly feel that all the data and all the analysis points to the fact that people will pay a substantial amount for FX-322 and both customers and Frequency Therapeutics know this. Thus it will be priced accordingly.
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