Yippee! Yay! Go Federal Trade Commission!!

It's rare when I read about government lawsuit filings and I simply want to cheer and jump up and down. Well, it's happened.

Here's some background information first. In 2005, I was finally diagnosed with multiple sclerosis. One of the many problems I was experiencing was MS fatigue - not the I'm just a little tired fatigue, but I'm DEAD TIRED, USELESS, and UNCONSCIOUS at 2:00pm fatigue.

So my neurologist gave me some samples of Provigil (modafinil) to try. And it did help. He was able to give me more samples, but explained that eventually I'd have to fill a prescription. In 2006, I did just that for a 3-month supply.

What I didn't expect was that it would exhaust almost an entire year's allowance for prescription medication from my health insurance!!

$1442 for 3 months!! and that was the 'negotiated' rate with BCBS.

So research Cephalon did I.

Prescription Assistance? No way they said and NORD agreed.

Generic Options? uh-uh

News? Interestingly, yes. A deal with TEVA - maker of Copaxone and many other generic drugs.

Well, I was already peeved at TEVA and NORD, so this just sparked more research. I discovered where to read TEVA news and announcements which I did endlessly.

I also discovered that TEVA and three other generic drug makers were 'paid-off' by Cephalon to settle patent litigation filed to enter the generic market for modafinil. At the time, details of the deals were not disclosed so I didn't know how much money was involved. Now we know that the payments exceeded $200 million and that Cephalon sales of Provigil in 2007 exceeded $800 million. That's just insane.

You see, drug companies file suit to get a chance to enter the generic market of a drug which approaches coming off-patent and the first to receive the go-ahead gets 6 months exclusivity to market and sell their generic version of the drug. TEVA is one company which often races to the front of the line and is able to sell their generic version of a new drug at a price equal to the brand-name drug for those 6 months. This is what TEVA did with sertraline (generic of Zoloft.)

But back to the present -

The Federal Trade Commission has filed suit against Cephalon for anticompetitive conduct. A brief article on the WSJ Health Blog summed it up nicely:

"Governments have been worked up for a while over the prospect that the sellers of branded drugs can keep charging high prices by paying generics manufacturers to stay out of the market. Regulators have suggested that the branded manufacturers are basically gaming the system and forcing consumers to pay inflated prices."

The Antitrust Review has an easy-to-follow summary as well.

And today -

Dr. Wes discusses the recommendations of some bureaucrats who believe that the answer to improving cardiac care during the night shift is...
can you guess...here it comes...modafinil. Yep, that's it, dope the doctors.

But an angle which I hadn't thought of related to this Cephalon debacle comes from John Mack of the Pharma Marketing Blog. John discusses how we may benefit from the War in Iraq through increased generic pharmaceutical competition.

The value of money or the value of health - What do you see?

What does money look like to someone with multiple sclerosis?

This is what $7000 looks like to me....120 pre-filled syringes...120 mL.
Four months worth of daily self-injectable medication.

One syringe = 1 mL

120 mL = 4 ounces

1 ounce = $1750

But it won't pay the bills nor would it pay for an Italian vacation. You might look at it like an investment in future health and mobility. Put the money in now and hopefully reap the benefits later if all goes well.

This is what $7000 looks like to most people....$7000.

It could be used to pay the mortgage, to purchase a new french horn, or to provide for that Italian vacation. But for someone with multiple sclerosis, it likely goes to pay for out-of-pocket healthcare expenses.

Although I have a private, individual health insurance policy with a major carrier in the Washington, D.C. area, I still have to pay this $21,000 annual expense for a single medication designed to slow-down the MS disease progression. It might work, it might not work. I can only hope it does.

My insurance premiums now cost approximately $3500 each year, but the company still will not cover my medication in full. It will payout $1500 each year for medication, but the rest is my responsibility...my cost.

But what if you don't earn enough money to be able to spend an extra $21,000 each and every year in the hopes of avoiding some level of disability in the future?

Well, the patient contact organization created by the pharmaceutical company (in this case Shared Solutions) refers your case to their benefits investigation team. This team will also run a quick search for government programs in your area for which you might qualify.

What if your state or locality does not have a pharmaceutical program which will cover this medication?

Then your case is referred to the National Organization of Rare Disorders, Inc. (NORD) who administers the prescription assistance program for Copaxone/Teva.

What kind of information does NORD require?

Recent paystubs, federal tax return, 3 months of bank and investment statements, and a signed application form verifying assets, income, and expenses. If you are not single, all of the above information is also needed regarding your spouse.

What does it take to qualify for help in paying $21,000?

Well, what I do know is that with an income of $27,000, a single 37-year old female with some money in retirement and savings might qualify for a 25% award equal to 3 months of medication provided by NORD.

When that same single female, at age 38, earns an income of $19,400 (less than 200% federal poverty level), she discovers the magic threshold at which NORD will provide 100% of the $21,000 medication.

Ironically, today as I have prescription costs on my mind, I received the reapplication form from NORD. Within the letter accompanying the application, NORD reminds us -

"As the Program is one of last resort, we must remind you that continued participation in the program is not guaranteed. Also, allotments awarded may vary from year to year as they are based on dosage, financial need, and the relative size of the Program itself."

Nothing is guaranteed...and each year this now 39-year old female must submit all her financial information for evaluation.

How truly needy is she and how deserving of a helping hand?

It's a numbers game really. As a self-employed person, even I don't know exactly what I've earned until I sit down at year end and calculate all deposits and all expenses. But I did calculate once that I would need to gross an additional $30,000 to be able to pay the $21,000 (plus increased taxes and SEP contribution) and maintain the same take-home pay.

Anyway you look at it, that $7000 worth of medication is an expensive forfeiture of $10,000 earning power and the future financial security that the $10K might provide. I feel as though I have to give up alot in order to gain some hope of slowing this MonSter down.

How do you view your medication?

Odd Anniversaries - Health/Wellness, Rare Disorders, Insurance, Money and MS

Yesterday was an anniversary of sorts as is tomorrow.

Two years ago on Thursday, December 1, 2005, I took my newly acquired supply of Copaxone to the Neurology Center for injection training. It was both a big deal and not a deal big at the same time. Nurse Carol suggested injecting after a shower when the skin is warm and clean, skipping the alcohol swabs (alchohol on the skin burns on injection!!) It went fairly smoothly but I did develop a largish lump around the injection site.

Nowadays, injections are not a big deal at all. I just do it and go. No ritual. No extra prep. Just do it.

Now more interesting to me is the Saturday after Thanksgiving 2 years ago. I received a phone call from Shared Solutions (Teva's patient front) giving me the good news and congratulations. Below I discuss this particular pivotal point in my personal life, but first...

This year the Saturday after Thanksgiving I received an unexpected call, this time from Dr. Eric Berg, the chiropractor who I discussed previously on this blog. It seems that beyond becoming aware of my blog, he basically had a few things that he wanted me to share with me. One being the concern that an unidentified individual who had communicated to me was in fact under investigation for fraudulent claims. Investigation, that's an interesting word. A scientist may investigate the efficacy of a new drug or I may investigate the cause of my cat's persistent meowing from somewhere near his food bowl. That word alone doesn't indicate much. More information would be needed to supply the context.

Although, congratulations is an odd word to hear after you've recently been diagnosed with multiple sclerosis, your insurance will not pay for the prescribed medication, and you've been left hanging for six weeks after submitting an enormously personal application form to verify your lack of income or resources with which to pay for said medication.

Congratulations!!! You've been approved for 50% by NORD
(National Organization for Rare Disorders).

Yeah!! Wait....50%? What does that mean?

NORD has approved your application and awarded you 50%.

Huh?

You will be receiving six months of medication from NORD and will only need to pay a $100 shipping/handling fee for each 3-month supply.

What happens after six months?

You will need to pay for your medication.

But I don't have that kind of money. I can't afford that.

You can appeal for more assistance, if your financial situation
changes.

So I can appeal in the Spring after I've completed my taxes and have more recent information?

Yes.

(Whew! Okay. I'm alright for now. Now when does that med
arrive?)

Fast forward. Appeal denied!! "You still earned too much at $26K to qualify for additional $10K worth of meds. And you still have some money in the bank. Sorry." I'm paraphrasing, of course. But same result. I ended up spending $16K in medical costs while earning less than $20K.

Okay, finally I'm under that magical 200% Federal Povery Level and I was approved for 100% assistance from NORD this past March.

But the story's not over (is it ever?)

Tomorrow is the last day which I can conduct any banking activity which will not be represented in next spring's application. You see, NORD requires three months of statements from every financial institution which has any of my money. And if it looks like I am able to accumulate any significant amount, I risk forfeiting the opportunity for assistance in the coming year. Yuck!!

That means that I CAN'T take advantage of opportunities to increase investments such as that craziness which is occurring with Questcor's stock. I can't conduct business such as to maximize my own earning power. I basically can't be overtly successful. I just have to ride this out and smile gently each time Nurse Carol asks, "so when is that boyfriend of yours going to propose and ya'll get married? Marriage has benefits you know." Yes, it does, one of which is access to his company-sponsored health insurance which is pretty doggone good.

Health insurance really isn't a good reason to get married in my opinion, but trying to start a family before I turn 40 is. Wait...I think we just passed the point at which it is possible to have a child before I'm 40 next year. Oh well. In the meantime, tomorrow's the last day for any private banking decisions.

Maybe, I'd better investigate the opportunity to maximum the benefits of our relationship.

Rob, sweetie, if you are reading this....I love you and thank you for spending our 30-month + 1 week anniversary on Thanksgiving in Oklahoma with those energetic but adorable nephews of mine!