Teva, maker of Copaxone, wants to keep it expensive, but at whose expense?

With the news that a generic version of Copaxone was possibly on the horizon, Teva, maker of the drug filed three Citizen Petitions with the FDA to block the approval of any new drug application that may result in a generic, and cheaper, version of Copaxone.

Taken from Teva’s website:

Teva Files Citizen Petition Surrounding Purported Generic Version of Copaxone®

Jerusalem, Israel, December 12, 2010 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that the company has filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of COPAXONE® (glatiramer acetate injection).

Teva’s requests in this CP are based on the inability to establish acceptable “sameness” of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence. Teva urges that any purported follow-on version of COPAXONE® undergo pre-clinical testing as well as full-scale clinical trials with measured clinical endpoints in multiple sclerosis (MS) patients to prove safety and efficacy.

Teva also requests that the FDA convene a multidisciplinary Advisory Committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.

Maybe in the interest of public health but more in the interest of Teva’s stock price. And in what we think is a sneaky way to keep the price of Copaxone high and out of generic hands and a lower cost, they also requested a new drug approval for a more concentrated injection of Copaxone. The FDA did not approve this, stating new clinical trials would be necessary. Of course, Teva is using that ruling as a means to keep a generic off the market. So what happened to their stock price? It climbed on the speculation that no generic would enter the market. Taken directly from Bloomberg.com on December 26, 2010:

Teva Pharmaceutical Industries Ltd. climbed the most in more than two weeks on speculation failure by the company to win U.S. approval for a new formulation of its multiple sclerosis drug Copaxone means it will be more difficult for competitors to enter the market.

The shares of the world’s largest maker of generic drugs increased 2.9 percent, the biggest gain since Dec. 9, to 187.70 shekels at the 4:30 p.m. close in Tel Aviv. The stock has lost 12 percent this year.

The two companies involved in the generic version of Copaxone are Novartis AG (maker of the $48,000 per year Gilenya) and Momenta Pharmaceuticals Inc.

Teva has sued to block both companies from making a copy of the drug. And Momenta, they are suing Teva for patent infringements. CAMBRIDGE, MA — December 2, 2010 — Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents.

And you with MS? You are still stuck with an expensive drug, with a mechanism of action that is not fully understood,while those out to make money from your disease, from pharmaceutical companies to investors the world over, have zero awareness of your lives and how it has been affected by MS.

Call us cynical but when we read where Teva settled for $169 million for misrepresenting their drug prices to Medicaid programs in our country, “The first settlement against Teva Pharmaceuticals was resolved last summer with Teva paying a 169 million dollars, more than 50 million of which went to Texas,” we have to take issue with a company who hid documents showing the true costs of their drugs so that they could take taxpayer money–your money. Their intentions have absolutely nothing to do with helping you with your disease and all the PR in the world can’t change that fact. You can find the articles here and here.

It’s time for a single payer system in our country and it’s time for Uncle Sam to step up and use his buying power to tame the health care industry beast.

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Analyzing Patient Assistance Programs for Multiple Sclerosis: Shared Solutions and Copaxone and Update*

The Foundation will be highlighting all the patient assistance programs available through the pharmaceutical companies that make the disease modifying drugs for Multiple Sclerosis.

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?

We started first with Copaxone, a daily injectable made by Teva.

Teva Neuroscience, has a patient assistance program called Shared Solutions. I called them today to find out what assistance they may offer in helping MS patients pay for Copaxone, especially those who do not have insurance and specifically, the group of people who must go without insurance before first applying to the new high risk pools.

The answers I received were disappointing and upsetting.

First, the cost of Copaxone per month is, according to Shared Solutions, anywhere from $3500 to $3700 per month.  Not sure why there is a $200 discrepancy as that was not clear to me.

Second, they do not offer an online application process, you must call and request an application. Now if you want to apply to be part of Team Copaxone (a marketing arm for Teva) then you can apply online. More information is here.

But back to Shared Solutions. The terms of acceptance for their financial assistance were not given over the phone as they had to look at each application.

Next, they only offer a $50 copay to help you if you are insured with a group or private plan. Knowing full well some people receive paltry co-pays on their prescription drug coverage, the $50 copay assistance is insulting. And considering the daily cost of Copaxone at $3500 per month which comes out to $117 per day, the copay does not cover the full cost of one injection!

Also, they do not help anyone who receives government assistance as that “is not our company policy.” That was the answer Shared Solutions gave me when I asked why they do not help those who receive government assistance.

Disappointed with the answers I received, I did request that Shared Solutions contact me regarding implementing a program to give out the drugs for free for those who need them for the six months before this certain group of MS patients can apply to the new high risk pools. This Foundation would be willing to work with Shared Solutions to get MS patients their much-needed therapies. It’s in Shared Solutions court right now. Here is the Copaxone link and the link for Insurance Assistance for Copaxone.

From their website:

If you do not have insurance or if you need help paying for COPAXONE®, Shared Solutions® can refer you to other financial assistance programs.

And so it was I was referred to their other financial assistance program, Assist-Rx. Assist-Rx has taken over for NORD. While they were as helpful as possible, Assist-Rx has been overwhelmed with applications and is simply at a standstill. Their number is 877-422-4412. Being inundated with applications, as I was told by Assist-Rx, obviously proves the need for payment relief and the need for more coordinated efforts on the part of MS patients. This Foundation is willing to step-up.

But we have another obstacle. Coverage for prescription drugs is left up to the health insurers and there are no provisions or regulations to help the consumer, even the ones who are well-insured, to make sure they can get affordable coverage. More information about the soaring costs of these drugs and their effectiveness here, here and here (this last one is a discussion but we too had the same reaction–how much less would it cost if they stop with all this expensive to-make and to-mail CD, DVD, calendar and other marketing promos they send out?)

So, what happens when you do not have insurance to cover all or part of your Copaxone, or your COBRA is about to run out and you still don’t have health benefits? What if you do not qualify for Medicaid or you are too young for Medicare? If you fall into one of those groups, then you have no place to turn.

This Foundation aims to change that.

Teva stock quote can be found here. More Teva information can be found here.

*Update, November 8, 2010: Shared Solutions contacted me today and we spoke about their patient assistance programs. They were unaware that Assist-Rx was overwhelmed with applications and said they would look into it further. They were not certain what, if anything, they would be doing regarding the Affordable Care Act and the 6-month waiting period prior to applying to the new high risk pool. In fact, I was told they were not fully certain of what the new law would bring, so I explained the guidelines for the high risk pool. I was told that my request to supply MS patients free of charge during this period, would be looked into by the people at Teva who can make those decisions. Also, please know that they do offer more extensive co-pay assistance than $50 per month, you must ask when applying.