Earlier this week, the US Supreme Court heard arguments about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. As we have noted previously, at stake is a decision that could influence the cost of medicines for most Americans, because the ruling is expected to determine the pace at which lower-cost generic drugs become available. Drugmakers have struck dozens of these deals over the past decade or more, prompting increasing scrutiny at a time of rising health care costs.The pharmaceutical industry claims the deals save consumers money because lower-cost generics become available sooner than they would otherwise, while the US Federal Trade Commission argues the agreements are anticompetitive and hurt the public pocketbook. We spoke with one consumer, Karen Winkler, a church volunteer in Clarkston, Michigan, who has multiple sclerosis and contends one such deal cost her money...
Pharmalot: So you say these deals set you back? How so? What medication was involved?
Winkler: I had been diagnosed MS in late 2004 and shortly afterwards, I was prescribed Provigil. In the beginning, I wasn’t taking a full pill, because it was $5 each. Prior to that, I hadn’t taken any medication and it seemed extreme to spend nearly $150 a month. We had a lot of expenses to cover with three kids and some other things…
Pharmalot: Meanwhile, Cephalon (which sold Provigil) struck a settlement in 2006 with four generic drugmakers. (EDITOR’S NOTE: The deal was worth $200-plus million and added six years of patent protection). What happened then?
Winkler: Over the next three years, it was going up and up, and by the time I quit (taking Provigil), it was almost $17 a pill. That was in late 2010. When I realized they paid off all these generic companies to go away, that was one thing. If they had kept the pill at $5 each, maybe I could justify (the cost). But they paid out all that money so they were recouping that money and passing the cost along to the patients and insurance companies. And I couldn’t afford it. If they didn't do that deal, I may have had four and a half years of a drug that cost less.
They’re not the only drug company doing it, but if it isn’t stopped, I believe it‘ll be much longer before (lower cost generics) become available.
Pharmalot: The drugmakers argue these deals can actually save consumers money by resolving patent litigation sooner than may happen otherwise. And in doing that, generics can get to the market faster than if lawsuits keep running.
Winkler: I don’t believe that. A generic (Provigil) was supposed to be available and four generic companies were ready to go and then they paid them off. Cephalon paid them millions of dollars to go away for a while. So they were able to extend their patent and there were no generic versions available. I know it didn’t benefit me.
Pharmalot: Had you spoken with your doctor about the cost?
Winkler: Yes, I told her Provigil was going up in price. My doctor said I had an early Christmas present for you and showed me nuvigil. It was cheaper and $50 off a month for the first year. And it would have been cheaper even after the card she gave me. And so she gave me a sample, but I got an excruciating headache. I took it for the first week and stopped. And I didn’t fill the prescription. I later realized it was sold by the same company and learned they were just tweaking the old drug.
Pharmalot: What happened after you stopped taking the pill?
Winkler: Basically, I had to take an hour’s nap every day in the middle of the afternoon. I was volunteering. I could function from about 8 am to 1 pm and then came to a stop until I could rest. When I was taking Provigil, I always took an afternoon cat nap, but I needed much more rest after I stopped taking it.
Pharmalot: A generic is now available. You’re taking that?
Winkler: Yes, it went generic last year and I started taking it again. And I pay $16 every three months. That’s a lot less and what I was hoping to pay a few years ago. But that didn’t happen.