Last week, Daniel M. Hartung, PharmD, MPH, and coauthors, published an open-access article in Neurology on astronomical increases in disease-modifying drugs for multiple sclerosis (MS) –many developed decades ago. Notably, they report that first-generation drugs — now cost about $60,000 per year, when they originally cost about $8,000 to $11,000. Copaxone is an injection-based therapy. The original Copaxone came out in the 1990s and was part of the first-generation of disease-modifying therapies for MS. It required daily injections. Within the past few months, Teva-Sandoz introduced a new longer-acting brand formulation. The new version is injected three times per week and the company hopes to switch all on the older brand to the new short-acting brand. In fact, an ad on the Copaxone home page makes a compelling argument for the new brand: “With the 3-times-a-week dose, experience 208 fewer injections per year than with daily COPAXONE® 20 mg.” Yet just as this was going on, Teva-Sandoz got FDA approval for a generic version of Copaxone. Yet, Teva had long been adamantly opposed to a generic. What will happen to the pricing and affordability of MS drugs like Copaxone? When will the generic become available?
Patient POV asked a person with MS since the 1990s what he thought of these issues. David asked that his last name not be used. He tried one of the interferons for his MS shortly after he was diagnosed.He has been on Copaxone since 1999 and his MS has been stable. He told Patient POV: “The interferon didn’t help at all. I had side effect and flares with some disease progression.”
Learning that the first-generation MS drug prices are escalating far greater than inflation, what are your thoughts?
These are first-generation drugs that were developed a very long time ago. I don’t think the price hikes are defensible. The research and development costs are long since recovered. The manufacturing costs are not that high. The price in Europe might be a better reflection of the ‘real’ costs of the drug with a reasonable profit. David worries about people without insurance who don’t get the benefit of any reduced price an insurer negotiates. (David knows that his insurer and PBM negotiate the best rates and then establish a copay accordingly.)
David raises another reason why he thinks the price hikes are excessive. It’s not as if these drugs are orphan drugs where the market is so small. There is a significant worldwide patient population.
What do you think about negotiating prices for drugs?
I know that when the Affordable Care Act was being considered, this came up frequently, but obviously the government has shied away from negotiating best prices, except for state Medicaid. It seems like prices go up as the market can bear and it is very hard to rein in pharma. It’s certainly a deal breaker for the new hepatitis C drugs. I wish that Medicare D would allow negotiation for better prices.
What disease-modifying drug are you on? How long have you been taking them and how interchangeable do you think these medications are?
I have been on Copaxone since 1999. For two years before that, I tried another drug. Not only did I have terrible side effects, but I continued to have relapses with that drug. I think that patients react differently and should get the drug that gives them the best outcomes and quality of life. It can be hit-or-miss for a person with MS to find the best disease-modifying drug.
A few months ago Teva introduced its three times per week, long-acting Copaxone. Teva hopes to move all Copaxone users to this formulation. Is this something desirable?
Yes. I went on it a few months ago. It helps to not have to inject myself so frequently. I have scar tissue in areas where I have injected frequently. Another advantage of the three-times-weekly dosage is that the shots are less intrusive when I travel. But 99% is getting away from the daily shots that can be uncomfortable.
Teva/Sandoz has not said when it will release generic Copaxone. In fact, there have been numerous attempts to block its introduction. Do you think that generic Copaxone will get much market share?
Teva might have staked out its claim to market share by introducing a new dosage for Copaxone [its brand]. Sandoz has yet to establish a retail price for the generic version. Also, if PBMs can get better pricing on the generic then there might be pressure to switch.
Have you had to go through any hoops with your insurer to get your Copaxone over the years?
Until quite recently, I needed to get prior approval for Copaxone every year for 15 years. I don’t know what my insurer was thinking. This was very taxing. It took my doctor multiple attempts to get prior approval, sometimes hours on the phone, with faxing, and misplaced papers. There were a couple of years where I was running close to running out of my medicine, which was an additional stressor. Finally, I am at the point with my insurer where the Copaxone goes through year after year without these issues.
That sounds incredibly taxing.
Yes, and if you add to this that many people with MS have secondary conditions and must take additional medications, the red tape to get your needed meds can be endless. Obviously, this can trigger MS symptoms and wipe you out.