Tinnitus Talk Support Forum

@Christiaan on October 10th, however I think I may be talking with my doctor before that. I don't know the best approach, like if my Doctor is very willing and will send a comprehensive request as my best shot, or if speaking and working with My Tomorrows with my doctor would be a better chance at gaining access?

Good question. I think it's good to have MyTomorrows on board as well. Even if Biohaven is positive towards our demand, the regulatory trajectory via medical authorities (e.g. FDA/EMA) contains many hurdles and variables.

MT provides assistance to help alleviate bureaucratic challenges, create more alignment and develop a strategy (e.g. means of data collection, which may support the case for future clinical trials for tinnitus) to help build a well-rounded compassionate use program.

You can find more info in this link:
https://mytomorrows.com/en/blog/key-considerations-operationalizing-expanded-access-program

There's also another reason why I personally consider MT: group access trajectory. Companies may be more eager to consider compassionate use if they have access to a large pool of potential participants in a specific location (trial site), which may be more cost effective & less bureaucratic than single patient mechanism trajectories.

It also offers the opportunity to gather more reliable and valid data, which makes it clinically more useful than case studies.

MT has already been contacted by many people with tinnitus. It stands to reason that an Early Access service provider with a specialisation in data collection (such as MT) has a large patient database. That gives the organisation the unique ability to inform and connect a lot of people with our background with this particular initiative in a specific location.

@Christiaan thank you for explaining all of that I really appreciate it. So I guess my question is, on Biohaven's expanded access page, it says a physician's request is required for expanded access. Does an advocacy company like MT take the place of the doctor with requesting it? Or do they try to help guide you AND your doctor as the doctor requests it?

@ErikaS, Np. Doctors are indeed essential. MT helps guiding you, your doctor and the pharmaceutical company in this process.

From the perspective of physicians, MyTomorrows can help ease their burden by informing them about the application protocol for EA/CU, providing assistance in how to fulfil regulatory requirements (e.g. collecting and processing Safety Update Reports), reducing administrative (unpaid) work , providing product training/training sessions, etc.

All the physicians I talked to know that this is a complex thing and that's part of the reason why most of them won't even think about applying for EA/CU.

@ErikaS Maybe this is of interest to your doctor. I've found a clip about the Healthcare Professionals Portal of MT's online platform: https://www.youtube.com/watch?v=hnrr7GN8grI

Starting at 02:07, you'll see that doctors can ask support for enrolling a patient in an EAP.

Thank you so much again Christian. Which doctor do you plan to have request for you? I at first thought about my new Neuro doc since BHV-7000 is clinically for epilepsy, by my ENT just knows me and my situation a lot more in depth, is younger and is more involved in ongoing research, and with tinnitus being my condition, I am thinking of asking him.

Another great point there @ErikaS :) I am also not entirely sure which doctor is the right one to act on my behalf. I happen to have a video call with my GP tomorrow and I'm planning to ask him your question. As a neutral 'arbiter' in the medical field, his opinion may shed some light on this matter.

@ErikaS Sorry, my GP wasn't able to meet with me today for my consult. Have you already an idea who you're going to ask for EAP application?

@Christiaan I am going to present it to both my ENT and Neuro doc and see who is willing! Sorry you weren't able to meet with them.

Oh wait! I got a message from my neurologist: ''ENTs are responsible for treatment and potential research options concerning tinnitus, since they have specific knowledge in this matter''. Well, that makes my choice a bit easier.

Just quickly spoke with my Neurologist on the phone. He said he is definitely willing to request on my behalf, although he wonders how open they will be to it since they are not trialing the drug for tinnitus...

Obviously our concern as well, but definitely worth a try still. Since I am new to him, I told him that I would send him all the research articles that support how this drug could very well potentially mitigate tinnitus, my history, the doc. @Justwaitinchilin kindly provided in the thread, etc. I told him about my discussion with MyTomorrows and that I would reach back out to him after I speak with them.

@Christiaan I find it a little funny how the neurologist told you ENTs "have specific knowledge of this (tinnitus) matter".. idk what ENT that person is talking about! lol

@ErikaS Nice! You're now already 1/3 on your journey towards early access:) How wonderful to hear that your neurologist wants to act on your behalf. He sounds like a very emphatic and caring doctor.

I am looking forward to your meeting with MT. Shall I share you my notes from my meeting? It may help you about what to expect, etc.