Happy rare diseases day

[braveheart]

:ybatty:

http://en.wikipedia.org/wiki/Rare_Disease_Day

http://www.rarediseaseday.org/

See Crohn is one of these rare diseases.
http://www.rarediseases.org/rare-disease-information/rare-diseases/byID/58/viewAbstract

 

[braveheart]

And this is why we have to pay thousands for our drugs and treatments.

http://en.wikipedia.org/wiki/Orphan_drug

 

[chrisnsteph1022]

Thanks! I posted it on my FB.

 

[Misty-Eyed]

Ok hang on a second. Crohn's disease is NOT classed as a rare disease when it comes to orphan drugs.

The FDA states that for an orphan drug the following must apply;

"(i) The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year as specified in § 316.21(b), or



(ii) For a drug intended for diseases or conditions affecting 200,000 or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 200,000 or more persons per year in the United States, there is no reasonable expectation that costs of research and development of the drug for the indication can be recovered by sales of the drug in the United States as specified in § 316.21(c). (9) A statement as to whether the sponsor submitting the request is the real party in interest of the development and the intended or actual production and sales of the product."

There are more than 200,000 suffers of Crohn's in the USA.

Also a lot of drugs developed for Crohn's are also developed with other indications in mind.

 

[braveheart]

So we are almost rare...

 

[DougUte]

2 edged sword. The orphan drug acts give incentives for pharmaceutical companies to do the research for treatments that otherwise would not be developed.

 

[Misty-Eyed]

So we are almost rare...

As the number of people in the USA that have crohn's is over double that.. no.

Like DougUte points out, it is so pharma companies will research into drugs for diseases that they wouldn't of otherwise. Like rare cancers or genetic disorders.

 

[nogutsnoglory]

I don't think we are as rare as we think. I think millions of people globally have crohns and just chalk it up to stomach pain or IBS until it gets really bad and they finally get diagnosed correctly.

 

[braveheart]

I understand.

I think even the FDA does not include Crohn in the rare diseases some of the problems of the rare diseases apply to us, such as:

-Being undiagnosed for long time.
-Expensive drugs.
-Lack of awareness.

I am not saying Crohn should be in the rare diseases list, but there are many things in common.

 

[Misty-Eyed]

Well the reasons why biologic drugs are expensive for crohns is that they are still reasonable new and still within their patent. That means that the drug companies are trying to reap back the millions which they spent to research and develop the drug. Once the patent has run out, generic versions will be made which should drive down the price somewhat. Although making generic versions biologicals is a whole new area in itself as they could only be biologically similar rather than exactly the same as with chemical generic drugs.

It's just a shame crohns is so complex or a diagnosis would be easier to come by.

 

[braveheart]

Once the patent has run out, generic versions will be made which should drive down the price somewhat

I really hope so. I mean, this is what should happen. Let's see if in the future we can have 5-10 versions of Entocort, Humira, and etc.

 

[DougUte]

As I understand it, biologics are not under the same set of rules. In fact there may never be a generic Humira or Remicade. See http://arthritis.emedtv.com/adalimumab/generic-adalimumab.html

 

[Misty-Eyed]

They won't be true generic versions, but they are called biosimilar drugs. There are different standards to approving them in comparison to generics but they will happen. The patents for monoclonal antibodies run out in 2013 which is when the first biosimilar monoclonal antibody drugs will be seen. Will be interesting to see what happens then and if problems arise.

 

[DougUte]

I'm not holdings my breath. Here in the states the drug companies have too much clout.

 

[Misty-Eyed]

But there will probably be a lot of money to be made on biosimilars depending on how much work it takes to get one marketed. Companies working on them now for them to be ready by the time the patent runs out will be being very hush hush about it. It's a very competitive market.

 

[braveheart]

It is good to know the patents for monoclonal antibodies run out in 2013, we are not that far to that.

And about the competitive market… Let me give you an example: Samsung does not have the "recipe" to build a Blackberry, but they managed to create something very similar and sell it at the half of the price. http://www.argimplus.net/comparar-equipos/228/273/
This also happens when we talk about generics.
But why Samsung did that, because there are millions of potential buyers and they want to take some of the Blackberry market share.

I wonder if the pharma companies find Crohns Disease attractive. If I were the owner of one of those I would prefer to sell something for very popular disease. They are 400.000 Crohnies in the US, vs. 133.000.000 of diabetics. Which one is more attractive?

I was prescribed different drugs and treatments during my 20+ years of Crohn life. And I concluded that if the drug is for general purpose, such as Flagyl, there are lots of generics and it is very affordable, but if the drug is only for Crohn Disease, such as Entocort it becomes very expensive, with no generics. I am not saying this is the universal truth, but it is at least what I could experience in my country so far.

Michelle do you pay more for Crohn-specific drugs in the UK?

 

[DougUte]

I know we pay a lot more for Crohns specific drugs in the US.

 

[Misty-Eyed]

Well I guess it depends on if the drug has other indications apart from Crohn's. For instance, Methotrexate is mainly used for cancer and luckily, a lot of the biologics are used in RA also. But you are right, there are definitely certain drugs which are more profitable to a pharma company which then become more attractive.

There are actually a couple of generics for Entocort that I know of here. Although it has a different brand name but is still budesonide. It can also be used for collagenous colitis and autoimmunne hepatitis.

I also have to be completely honest, I don't know that much about the cost of drugs. I don't deal with drug costs at work and every drug on prescription is the same price here of £7 something. If you have an infusion at the hospital it's free. I also get all my prescriptions for free now as I have a permanent ileostomy. Yes, I am extremely lucky, I know!

 

[braveheart]

Wow! All the meds cost 7 pounds! I have to move to the UK.

 

[Misty-Eyed]

Haha well it's good for people who live here, but it means that people don't realise the real cost of their medicines so a lot go to waste. There needs to be a label on the package to say how much the medicine would of cost. Maybe people would be more likely to only get what they need!

 

[braveheart]

Well, in an ideal world all medicines should cost the same, or just be free.
I think your government is pretty cool in paying for you the difference between the £7 and the real price of the drug.

If I only lived in the UK I would just pay £7... Hold on, Falkland Islands are not far from here... They become british from time to time

 

[Misty-Eyed]

It is very cool but we pay a lot of taxes! When my friends complain about how much tax they pay, I always thank them for paying for my healthcare and prescriptions lol. I think they are actually free to everyone in Scotland and Wales.. Plus if you buy a lot of prescriptions you can get a yearly prepayment certificate which is about £100 instead.

Haha! Plus you could even meet Prince William if you went.

 

[hawkeye]

Haha well it's good for people who live here, but it means that people don't realise the real cost of their medicines so a lot go to waste. There needs to be a label on the package to say how much the medicine would of cost. Maybe people would be more likely to only get what they need!

Here in Canada some of the pharmacies do this. Today I picked up 240 50mg tablets of Imuran (a 2 month supply) the receipt had the following Inuurance Pays $154.xx (don't remember to the last cent), Patient Pays $0

I and my wife have health insurance through our employers so what one plan does not cover, the other will. Government medicare covers most procedures with the exception of vision and dental care (except for lower income brackets).

 

[braveheart]

Haha! Plus you could even meet Prince William if you went.

It would be an honor to meet him. :king:
Even better than that, would be meeting Kate's sister :wub:

 

[braveheart]

I and my wife have health insurance through our employers so what one plan does not cover, the other will.

And what about pensioners who do not work?

 

[Misty-Eyed]

It would be an honor to meet him. :king:
Even better than that, would be meeting Kate's sister :wub:

Haha Kate is much prettier in my opinion but Pippa's bum did steal the limelight that day.