Biogen reports 6 new cases of PML with Tysabri

The article below is taken directly from Reuters.

If you are taking Tysabri, made by Biogen, we urge you to please go and speak with your doctors as the total number of deaths reported is now at 16, while 69 people remain in varying states of disability from PML–on top of having Multiple Sclerosis. More information on what PML is here at WebMd and here at Wikipedia.

Good source for all MS drugs is: Drugcompare.destinationrx.com.

More Tysabri information herehere and here.

Everything below is taken directly from Reuters.

Biogen reports 6 new cases of PML with Tysabri

(Reuters) – Biogen Idec Inc said six patients taking its multiple sclerosis drug Tysabri developed a potentially fatal brain infection in December, bringing the total number of such cases associated with the drug to 85.

The biotechnology company said that as of January 7, the overall incidence of progressive multifocal leukoecephalopathy, or PML, was 1.06 per 1,000 patients, up from 1.0 in 1,000 last year.

Biogen, which makes the drug with Irish drugmaker Elan Corp Plc, temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.

The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.

After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.

Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.

Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.

Biogen shares were down $2.02 or 2.9 percent to $66.76 in afternoon New York trading, while Elan shares were down 10 cents or 1.5 percent to $6.37.

(Reporting by Toni Clarke, editing by Gerald E. McCormick)

Analyzing Patient Assistance Programs for Multiple Sclerosis: AVONEX and AVONEX Services

As part of our continuing efforts to highlight all the patient assistance programs available through the pharmaceutical companies that make the disease modifying drugs for Multiple Sclerosis, we continue with AVONEX. The price of AVONEX is approximately $3,000 per month.

What we want to know about these programs is:

  1. How easy is it to apply?
  2. What is needed to apply?
  3. How easy is it to receive the assistance?
  4. Do they really work in terms of helping MS patients with financial assistance?
  5. What is offered?

AVONEX offers a program called AVONEX Services that covers a co-pay program and an access program. The only way to apply to these programs is via a phone call to them at 1-800-456-2255. There is no online application. From the phone call I placed to AVONEX Services, it seems that a prelimary phone interview is the way to get things rolling, where certain information is taken from you and then turned over to their financial assistance team. You must have a prescription for AVONEX to begin the process.

If you have insurance and cannot meet your co-pay, their financial assistance team will do insurance research to see if you do have coverage for the drug. If you still cannot afford your co-pay, a 2nd screening is done by the AVONEX Services financial assistance team. Eligibility, I was told, is done on a case-by-case basis.

I did not receive a clear answer on what the qualifiers are for the programs and I have asked them to contact me further so I can post them here.

As far as being underinsured or uninsured, AVONEX Services offers something called their access program. Again, details remain sketchy but I came away from my conversation with AVONEX Services with these points:

  • They do help those who are on government assistance.
  • They do help both new and current AVONEX users.
  • They do offer a temporary assistance program, of up to two (2) years, to get those who need AVONEX free of charge.

Beyond that, I am not certain on a few other issues. For example, it was said several times that “they partner with financial institutions,” to help you with payment. When asked what financial institutions they partner with, I was told that information comes from the financial assistance team. Again, it is unclear to me what that means.

Sending MS patients to charitable organizations to get their AVONEX was also mentioned, but that was it; it was mentioned with no further details. Why they would mention a program to send patients to charitable organizations when they have a program in place for up to two (2) years, leaves the overall impression of gaps within their patient assistance program. Again, I am waiting for more details from AVONEX.

I finally inquired about the Affordable Care Act and the impending six (6) month waiting period to apply for the new high risk pools and what, if anything, was Biogen doing about this. Are they prepared for this and would they be willing to begin a program that will get this group of people their drugs for free? I left my contact information and I await their response.

AVONEX is manufactured by Biogen Idec who also make Tysabri. Stock quote for Biogen can be found here.