new drugs coming out when?

Question

I read an article online that said the FDA won't be approving the new treatment drugs til 2015, does anyone know if this is true??

willing · Answer

you might be able to do somewhat better. Somewhere near Chennai, Shasun Pharmaceutical likely has crates of the stuff awaiting shipment. Wonder whether any is finding  its way out of the warehouse?

willbb · Answer

Can you also get   Itneronfnon and raib   if so please send me some with the  Teraprevil and Boseprevil I will pay you Tues.  lol

WILL

murariji · Answer

On the bright side, everything in India gets copied.
Give me a couple of weeks after production starts and I am sure I'll be able to find large amounts of Teraprevil &  Boseprevil, one tenth the price of Telaprevir & Boceprevir. 
But of course...................Caveat emptor.

willbb · Answer

The insurance company's,as we all know,operate under the same auspices as the drug company's...there main ,if not only motivation is profit.  They will be weighing very heavily and their actuaries have most likely already been very busy weighing their costs of coverage vs their costs of letting people get very sick,premium adjustments and the like.l. Unfortunately, our well being will be a very low priority in that decision process.

 Deb..Again unfortunately like any serious illness that costs many tens of thousands of dollars to treat there will be those in both our countries that just won"t be treated...damn shame to be sure.

WILL

nygirl7 · Answer

If they are thinking it will be twice the cost of 'treatment' and assuming they only mean the typical interferon and riba part of that then the $40,000 plus price tag is going to kill it off for an awful lot of patients.

The insurance companies have to come through or it's just not going to be something most folks can afford and that would be a damn shame after waiting this long.

BeatTheBeast · Answer

I used the term "clinics" when I should have used a different term when giving info about when telaprevir would be "shovel ready" for patients who can pay for it.

BTB

Trinity4 · Answer

For sure Will and that's not counting rescue drugs.  In this country we have PCP coverage, HMO and other various and assorted versions of health coverage.  Once a drug is approved by the FDA I don't think the insurance companies can deny the drug but we don't know what stipulations they will put on actually approving the drug for use in conjunction with interferon and ribavirin.  I'm certain Boceprevir and Telaprevir will be considered a specialty drug like interferon and ribavirin and our out of pocket expense will be determined by the terms of the policy.  

Trinity

willing · Answer

agreed, like everything about inscos, the coverage approval process is clear as mud. A related question I haven't yet made much progress on is what law governs denial appeals? The insco docs always talk about  "terms of coverage" but those seem very skimpy on details.

My understanding from my Dr. is the  day after FDA approval he can write the rx and that can be used to start the insco coverage query. Asking them before then is likely a waste of time. I figure 5/9 for boce, 5/23 for tela. The package-inserts regulating on-label use are unknown but I'll be surprised if they don't match the phase III protocols. Availability in the pharmacy is another issue though Shasun Chemical in India seems well prepared in that regard. Price seems the biggest remaining unknown.

willbb · Answer

The one thing that we can count on though,is that either to the insurance co. or the patient,it will be significantly more expensive to treat with these meds.The Hepa said the buzz(in his circles anyway) was probaly close to double current costs.

Trinity4 · Answer

That's the thing, nobody knows the insurance or treatment protocol at this time.

FlGuy · Answer

I've wondered that for quite a long time.  Ever once in a while I try to research the question "how, when and why does a drug get added to an insurance company's coverage" The FDA kinds of points to the States. The States kind of point to the Insurance Companies. The insurance companies talk about tiers, preferred lists, medical review boards yada yada. A succinct answer is never found.  Sounds like a job for An Ambassador (hint, hint).

nygirl7 · Answer

Agrees with FLGuy - I am thinking they might give naives a really hard time with insurance approvals since it's not cost effective (especially if any of them realize the alle tests and stuff which wont matter as much but is probably cheaper).

I doubt highly they will be in clinics days of May 23, 2011 - why would they do that when it's taken so much money to get these drugs developed in the first place.  Somebody is going to have to pay them back so they make a profit, that is the name of the game. Clinics certainly wont be able to afford it as an add on I would think until much later.

Trinity4 · Answer

I know it's not funny but that cracks me up.  Yes indeed FlGuy, yes indeed.  

Trin

willbb · Answer

" PIs will be the name of the game for a while, but other drugs working their way through the approval process could become the preferred treatment relatively soon. "
-----------------------------------------------------------------------------------------------------------------------------------
My Hepa .a leading Dr. at a large liver centre in Canada  mentioned to me just  yesterday that  he feels that within a short period  time there will be 4  new major drugs available. Tela ,Boce and he said the 2 others that he feels will follow shortly after  and in his  opinion will have even better efficacy.(Just another docs opinion tho).

WILL

FlGuy · Answer

I expect that soon after FDA approval for these new meds (whenever that will be) we'll see a bunch of new threads titled "Why Won't My Insurance Company Cover Teleprivir (or Boceprivir) ? "

BeatTheBeast · Answer

Telaprevir should be approvedby the FDA on or before 5/23/11.  Rumor has it that the filing with the FDA for boceprevir was a few weeks before that, which would suggest that boceprevir will get FDA approval before telaprevir does.

Telaprevir reps have said that the drug will hit the clinics within days of FDA approval.  They've already staffed up to ensure that the distribution happens quickly.  That makes sense in light of the pipeline.  PIs will be the name of the game for a while, but other drugs working their way through the approval process could become the preferred treatment relatively soon.

BTB

scaredycat7 · Answer

Hi.  I've heard it's early this summer for the Telaprevir & Boceprevir. I also heard that the pharm companies have already set up a factory in India to manufacture one of the above.  I am pretty sure about the "early summer" for approval -about the manufacturing -who knows?  Now how to get it?  I don't know.  I am sure that I wouldn't treat with the current SOC -not until they add the third drug.

Even then -that 48 weeks sounds grueling.
Good luck
sc7

Trinity4 · Answer

Correction:

Did read:  protocol the drug companies will use to approve the use of the protease inhibitors as in genotype 1 only, relapsers, null responders. 

Should read:  protocol the INSURANCE companies will use to approve the use of the protease inhibitors as in genotype 1 only, relapser, null responders

Trinity4 · Answer

The FDA has given fast track approval for Telaprevir & Boceprevir which means these drugs should be approved and ready for market sometime this summer.  We still don't know what protocol the drug companies will use to approve the use of the protease inhibitors as in genotype 1 only, relapsers, null responders.  After approval, the new drugs will have to be included in the drug formulary that insurance companies use for drugs covered under their plan.  That may take a little time as well. 

Trinity