The Cost of Biologics & Specialty Drugs | Arthritis Information

Share
 

 
FROM AARP BULLETIN
 
MILLION DOLLAR MEDICINES
 
by Barbara Basler
 
October 1, 2008
 
Biologics, used to treat diseases such as cancer and multiple sclerosis, are engineered in the laboratory from living cells rather than chemicals.

The annual cost of these specialty drugs can run to tens, or even hundreds of thousands of dollars. Yet there is no regulatory process set up for companies to bring cheaper generic copies to market, so manufacturers of biotech drugs hold virtual monopolies and charge accordingly.

Stephen Schondelmeyer, an expert in drug pricing at the University of Minnesota, says brand-name biologics are so high-priced that even with the cost of research, competitors could sell their generics at a lower price.

A bipartisan bill now in Congress, the Access to Life-Saving Medicine Act, would give the Food and Drug Administration the authority to approve safe copies of biologics. Many groups, including AARP and the generic drug industry, support the bill. The trade group for the biotech industry opposes it, saying that the complexity of these biologics and development costs make it hard to duplicate them.
 
For rest of article see:
 
http://bulletin.aarp.org/yourhealth/medications/articles/million_dollar_medicines.html
 
[QUOTE=JasmineRain][/QUOTE]
 
Since I'm on a biologic, this caught my eye and thought I'd share it.  I wasn't aware of the particular bill mentioned in the article, but I had heard of this issue between the generic and biotech industries.
 
I'm concerned about the cost of biologics and their inaccessiblity for some, but I would also be concerned about the quality of generic versions of biologics, I'm not an educated chemist as yourself, but I am aware that the making of a biologic is a complex process.
 
Perhaps you can ridicule this subject as you aren't faced with the worry of being able to afford these drugs that many of us will have to take possibly for the rest of our lives. 
 
 
 
 
Joie2008-10-17 21:09:37obviously... these drugs are "duplicated" every time the main pharma company makes a batch........  so why are they saying that it can't happen by a generic pharma?
 
I call bull........... on this  monopoly
[QUOTE=Joie][QUOTE=JasmineRain][/QUOTE]

Pip

[QUOTE=Pip!]

Making them hard to duplicate is just doublespeak for 'we want to keep our invention with super high prices just for us'.

Pip

[/QUOTE]

Then don't take their evil drugs.
[QUOTE=JasmineRain] [QUOTE=Joie][QUOTE=JasmineRain][/QUOTE]
 
Since I'm on a biologic, this caught my eye and thought I'd share it.  I wasn't aware of the particular bill mentioned in the article, but I had heard of this issue between the generic and biotech industries.
 
I'm concerned about the cost of biologics and their inaccessiblity for some, but I would also be concerned about the quality of generic versions of biologics, I'm not an educated chemist as yourself, but I am aware that the making of a biologic is a complex process.
 
Perhaps you can ridicule this subject as you aren't faced with the worry of being able to afford these drugs that many of us will have to take possibly for the rest of our lives. 
 
 
 
 
[/QUOTE]

Ah yes, I'm filthy rich.

Give me a break.

I am not ridiculing the subject... just the one-sided reporting.
[/QUOTE]
 
 
 
I'm not implying you are filthy rich, but I don't believe you are on a biologic, so this may not be an issue for you.
 
Do I have to spoon feed people?  I only have one eye working, I 'm not able to search the internet for all sides of this issue.  I think its fairly obvious, since AARP is supporting this particular bill and it is in their publication, that the article reflects their point of view.  It is then up to the reader to further look into all sides of this issue.
 
As someone with severe RA and on enbrel, I'm not only concerned about increasing cost share of these meds to the user, but also the quality and effectiveness of a generic version.  So I'm on the fence on this issue, until I know more. 
 
It seems though that this will be an issue Congress will be dealing with, one attempt to deal with unsustainable health care costs.  I'm sure both sides, the generic and biotech industries will be spending big bucks on their lobbyists.  I posted this particular article so users of biologics would become aware of this issue, its up to them to decide, which side of the issue they are on. They can always google the subject to find more info and you are also welcome to present your point of view.
 
 
 
 
 
 
Jas,
 
What is your problem lately?  If I need a biologic, I sure as heck want a safe one that I can afford to take.  This is important info for whoever is on this NOW as they may need to contact their reps.
 
Pip
[QUOTE=Pip!]Jas, , a nonprofit research organization focusing on free-market solutions to healthcare reform.  I apologize in advance if this is appears to be one sided, unbalanced, but with my vision problem limiting my reading and my ancient computer, its time consuming to do a search for articles that would satisfy everyone on this forum.  If one wants further info on this issue, that Congress will be dealing with, I'm sure you can find more by googling.
 
by Grace-Marie Turner

Published in The American, October 1, 2008

American free-marketers often criticize Europe for its misguided regulation of the drug industry, rightly attributing the continent’s paucity of pharmaceutical innovation to its penchant for price controls. But when it comes to promoting innovation and investment in today’s most revolutionary medicines, biologic drugs, the Europeans have created a regulatory policy that provides the proper incentives. In this area, at least, U.S. lawmakers have much to learn from Europe.

Biologic drugs are highly complex pharmaceutical drugs grown in living organisms, such as plant and animal cells. Sometimes they’re even grown in mammalian cells.

The difference between a conventional drug and a biologic is like the difference between a matchbox car and a Ferrari. An Aspirin molecule has around 21 atoms. A biologic can have up to 25,000.

That higher complexity means higher efficacy. Biologics have shown unprecedented promise in treating an array of diseases, including cancer, rheumatoid arthritis, and anemia. Biologic sales in America exceeded billion in 2007 and are expected to grow at an annual rate of 20 percent. Worldwide biologic sales increased by 12.5 percent last year to billion. Understandably, generic drug manufacturers are eager to jump into this burgeoning market.

Unlike conventional generic drugs, which can be exact copies of the original, generic versions of biologic drugs are not identical to their brand-name counterparts. Biologics are far too complicated—both in their chemical makeup and their manufacturing process—to duplicate exactly. That’s why they’re known as “follow-on biologics.”

For rest of article see:
 
http://www.galen.org/component,8/action,show_content/id,13/category_id,7/blog_id,1091/type,33/
 
Thank you for posting this.   It is important to keep healthcare costs down by introducing generics, but only if the generic can match what the original drug is able to accomplish.   I think I'd be leery of trying a generic version of a biologic. Personally, I don't get why people argue thatb articles are "one-sided". Nothing stops them from just posting something from the "other side". It does seem kind of lazy, to think that someone with an obviously different point of view than them is supposed to support the other guy's side as well so the other guy doesn't have to.

I just think they get cranky because they don't like what the article says but they can't think of any good rebuttal. So they make it personal, and in the case posting to APers, throw in a little insult about their doctor prescribed, scientifically proven med of choice. Not at all appropriate.Gimpy-a-gogo2008-10-18 11:36:42Cathy -
 
That's my concern about generics in general.  They can be 20% + or - and that 20% scares me.  However, we've seen here too many people can't afford the 'real mccoy' and that's also a major problem. 
 
Pip
Agree, the cost is out of reach for some, especially without insurance.  The use of specialty drugs is on the rise for many conditions and it's fast becoming one of the top 10 (top 2 at our company) in prescription costs.   I have a feeling the copays people have on specialty drugs will soon be a thing of the past.   What concerns me is how for regular generics we're told that 20% is not a big deal and its a 'bioequivalent' and now they're saying there is no way to make them safe for the biologics.  Seems like this is all profit driven.
 
Pip
Articles on generics -
 
http://www.latimes.com/features/health/la-he-genericside17mar17,1,6333165.story
 
http://www.latimes.com/features/health/la-he-generic17mar17,0,2223948,full.story
 
http://www.latimes.com/features/health/la-he-aftertheswitch17mar17,1,4667183.story
 
http://www.latimes.com/features/health/la-he-legal17mar17,1,5153332.story
 
The last one is the most telling IMHO
 
Pip
Pip, I got an error 404 on that one.Trying to take a break and stay off the computer to rest my one working eyeball, should be cleaning my closet but that's no fun, so, just a quick post -- I think there's a distinction between a "generic" and a "follow-on biologic (whatever they call it).  A follow on biologic may not be a whole lot cheaper, as generics for other brand name drugs, cuz of the involved process in making them. 
 
Was just thinking, why can't biotechs lower their prices and then undermine the generic industry's push for this bill, they could continue their monopoly.
 
Well, back to cleaning . . . .
 
http://www.nashuatelegraph.com/apps/pbcs.dll/article?AID=/20080608/HEALTH/921054811The differences in generic and brand name prescriptions has been known for years.  I won't take a generic for time release drugs, cardiac drugs, or my thyroid meds.  One of the reasons generics are cheaper is they're made cheaper.  In time release the composition of the drug may not be the same through out the pill or capsule.  There may be less or more of the drug in one half of the pill.  It's not consistent.  I found out about generics when I put together a pharmacy program for an employee group of 9,000 individuals.  That was 10 years ago and maybe the industry has changed and quality control is better but I don't think I'll take a chance.  Lindy
Copyright ArthritisInsight.com