ARTICLE IN BRIEF

AS NEWER, MORE EXPENSIVE MS drugs come to market, prices are also rising steeply for older medications.

Neurologists are experiencing the fallout from the steep rise in the cost of MS drugs: Many patients are finding it difficult to comply with their therapy regimen. Among solutions, they recommend governmental intervention in negotiating prices.

When the first oral drug for multiple sclerosis, fingolimod (Gilenya), first entered the market last fall, neurologists and patients alike experienced sticker shock: the medication was priced at a jaw-dropping $48,000 a year. But, some pointed out, it was the first drug of its kind, with no direct competitors. Perhaps it shouldn‘t be surprising that it came at a premium.

And then the price hikes for other MS drugs followed. Teva's glatiramer (Copaxone) now comes at a rack rate of over $42,000 per year — a jump of nearly 40 percent over prices at the beginning of 2010. Biogen has also raised prices further for both natalizumab (Tysabri) and interferon-beta-1a (Avonex).

Why should older drugs — whose existing prices, one assumes, were already set to cover the costs of bringing the drugs to market in the first place — get a price increase when a new drug comes to market?

Companies want to get the most out of their investment, said Edward Fox, MD, PhD, clinical associate professor of neurology at the University of Texas Medical Branch and director of the MS Clinic of Central Texas. “With the onset of new medications that come at a premium, companies have raised the price of older medications in order not to appear inferior to the new drugs. They look at the price as being meaningful when it comes to expectations. If a certain drug is priced lowest, it must be less worthy somehow.”

Of course, virtually no patients are paying out of pocket the full listed price for these costly medications. “I have 1,400 MS patients and I don‘t have single patient paying full price. I can‘t even conceive of someone with a salary high enough where that would be a consideration,” Dr. Fox said.

But the price increases are still driving more and more people with MS and their families into desperate situations. That's because as the prices paid by third-party insurers have gone up, so too have patients‘ copays and other shared costs. “On a weekly basis, I‘m dealing with patients who have what I would call a medication crisis,” Dr. Fox said. “Many of my patients have copays of between $300 and $800 a month. There aren‘t too many families who can easily absorb that cost.”

Bruce A. Cohen, MD, professor of neurology and director of the Comprehensive Multiple Sclerosis Program at Northwestern University's Feinberg School of Medicine, said that he has a number of patients who are making treatment decisions based primarily on cost.

But that's getting harder and harder to do, said Dr. Fox: “It's become an across the board situation where all of the MS medications are so expensive that you can‘t just switch to a less costly alternative.”

DR. ROBERT LISAK: “I just saw a patient yesterday whose husband makes too much money for compassionate care, but his insurance plan does not cover his wifes MS drugs. The companies will only help so much.”

‘COMPASSIONATE CARE‘ PROGRAMS

All of the manufacturers of MS medications — Novartis, Teva, Biogen Idec, and others — have compassionate-care programs, which allow people under certain income thresholds to receive their medications for free or at greatly reduced cost. But with prices increasing at exponential rates, those income thresholds would need to be higher and higher in order to assist the growing number of families who are greatly burdened by the costs of a person's MS medications.

“I just saw a patient yesterday whose husband makes too much money for compassionate care, but his insurance plan does not cover his wife's MS drugs,” said Robert Lisak, MD, professor and chair of the department of neurology at Wayne State University School of Medicine. “The companies will only help so much.”

The assistance programs vary by manufacturer, leaving patients even more in the dark. “Every single company has their own separate system to determine if a patient is eligible for assistance,” Dr. Fox said. “Some are better than others at this. I have patients who make too much money for the drug they‘re on, but might get compassionate use with another company that makes a different medication.”

NEW HURDLES FROM INSURERS

For some patients, the escalating cost of MS drugs is creating new hurdles to overcome in order to get their medications covered at all — even with a high copay.

“In some cases, third-party payers are inventing novel indications for drugs that aren‘t part of the FDA requirements,” Dr. Cohen said. “With Ampyra [dalfampridine], I‘ve had an insurance company tell me that a patient has to demonstrate some sort of improvement in activities of daily living in order to support the use of the drug, which isn‘t part of the FDA indications and wasn‘t part of the clinical trials, and there is no evidence base supporting that requirement.”

DR. BRUCE A. COHEN said that he has a number of patients who are making treatment decisions based primarily on cost.

In the case of disease-modifying drugs, Dr. Cohen added, some insurers are saying that patients cannot have a particular medication unless they try a different one first, or that they won‘t cover a particular drug if the patient was previously on another and has not met a specific failure criterion.

“So clearly, there is a selection process going on which is cost-based rather than evidence-based, and that's no surprise,” Dr. Cohen said. “Ultimately, that does two things. It creates situations where people may not get access to the drug they need, and it increases the burden on neurologists in terms of staff time to do repeated appeals. Overall, this adds to the cost of health care in many ways and makes it more onerous for everyone. Perhaps the hope of the insurers is that if they make the burden of paying for these expensive drugs steep enough, people will just drop them.”

Something is going to have to give, Dr. Fox declared. “Much like the frog in the pan of water that's slowly being heated, we haven‘t realized how critical this was getting until we were past the tipping point. The average age of diagnosis for multiple sclerosis is in the 30s, so most people will have used more than a million dollars worth of medication long before reaching Medicare age. It's hard to imagine the 400,000 to 450,000 Americans with MS being able to sustain the price increases we‘ve had over the last several years. At some point, something is going to break and we‘re nearly at that point now.”

Over time, Dr. Fox predicted, insurance company restrictions on MS drug prescribing will become even stricter. Right now, the insurers generally want confirmation that the patient has relapsing-remitting MS and is ambulatory and not on combination therapy. “But probably over time, we‘ll have more strict guidelines for who we can put on medications, and what kind of outcomes we must have with them,” Dr. Fox said.

The National Multiple Sclerosis Society has long taken a clear position on MS medications: everyone with relapsing-remitting MS should have preventive medications available to them, they should be able to change medications as needed, and if one medication fails, the patient should be able to switch to another immediately. But that pledge may be in jeopardy, Dr. Fox worries.

“I‘m concerned that there will be a ‘preferred list‘ of medications because of being able to negotiate a better price with one, tying my hands and forcing me to give a medication with a worse tolerability or safety than the one I would choose,” he said. “That's where we‘re headed if we don‘t have some management of these prices; Medicare will have no choice but to try to negotiate with a single company for a better price at the expense of having other drugs to choose from.”

POSSIBLE SOLUTIONS?

What's the solution? Dr. Lisak thinks the government needs to step in. “They need to negotiate Medicare and Medicaid prices with the drug companies, just as they do for the Veteran's Administration and the Department of Defense. Obama needs to have another talk with the leaders of the drug companies, because the insurance companies aren‘t going to do it.”

“I‘ve always felt that when a medication is approved and a price is set, it should be set across the board,” Dr. Fox said. “I‘m a free market supporter, but I do not believe in differential pricing of medications for different health care plans. If it's got a price, it should be the same for Medicare, Blue Cross, Tricare, whatever. If you do that, and it's truly transparent pricing, companies are more likely to compete with one another in terms of reasonable pricing.”

And once a drug's price is set, Dr. Fox argues, manufacturers shouldn‘t be able to hike it at random. “They should have to get approval based on either the cost to manufacture the drug going up, or the utilization of the drug going down,” he said. “In return for that, I‘d give pharma a longer patent life. Shortening patent life gets drugs to generic faster, but I think it will only drive up prices because manufacturers will have a shorter window to recoup their money. If we had the same length of usable patent life once a drug reaches the market as, for instance, the semiconductor industry, they‘d better be able to predict profitability for a certain drug and might be willing to accept price controls.”

DR. EDWARD FOX: “On a weekly basis, I‘m dealing with patients who have what I would call a medication crisis. Many of my patients have copays of between $300 and $800 a month. There aren‘t too many families who can easily absorb that cost.”

Patent life for both the pharmaceutical and semiconductor industry is 20 years, but because drugs are usually patented before receiving FDA approval, the journey through the approval process can often cut the useful life of that patent in half, Dr. Fox explained.