July 20, 2011 -- Drugs that slow progression of multiple sclerosis (MS) offer health gains to some at very high prices, a new study shows.
The study seems likely to reignite the national debate about how best to rein in runaway health care costs. It found that adding an injectable disease-modifying drug to the treatment of MS patients roughly doubles the cost of care, while only providing small population-level improvements in survival and quality of life.
Doctors who were not involved in the study were alarmed by its findings.
"We know, unequivocally, that these drugs slow the progression of the disease and slow the course of the disease," says Karen Blitz-Shabbir, MD, director of multiple sclerosis care center at North Shore-LIJ Glen Cove Hospital in New York.
"When I first started training, people were hospitalized all the time and did much worse than they do now," she says, "So we know for sure these drugs are good."
But the cost of the drugs continues to soar.
Even in the face of new competition from a new pill, pharmaceutical companies recently announced increases of nearly 40% over 2010 prices. Disease-modifying drugs for MS carry wholesale prices of as much as $48,000 a year.
"Will the health care companies, the health care industry, prevent patients from accessing the drugs because of a study like this?" Blitz-Shabbir says. "The real problem is the pharmaceutical cost is out of control."
The study is published in Neurology.
Calculating Cost-Effectiveness of MS Drugs
Using mathematical models developed using data from a large, national patient survey, researchers found that the cost-effectiveness for the disease-modifying drugs Avonex, Betaseron,Copaxone, and Rebif exceeded $800,000 per quality-adjusted life year.
A quality-adjusted life year is a measure that tries to account for both the length of time a person could expect a treatment to extend life and how good he or she feels during that time.
For example, the study found that on average, patients taking Copaxone for 10 years could expect the drug to add less than one quality-adjusted month to their lives compared to patients who were only getting supportive therapy to control symptoms.
Patients taking Avonex, Betaseron, and Rebif gained about two quality-adjusted months compared to those getting supportive care.
The study also looked at how likely the drugs were to prevent relapses.
Those taking disease-modifying drugs spent on average nearly six out of 10 years with no relapses, compared to five years with no relapses for those who did not take disease-modifying drugs.
However, the effectiveness varied significantly among individuals, with some experiencing double the improvements and being able to live independently and prolong their employment and others not getting any meaningful effect.
Why Cost-Effectiveness Matters
"We were surprised how non-cost-effective they are," says study researcher Katia Noyes, PhD, MPH, assistant professor of health services research at the University of Rochester, N.Y.
Why Cost-Effectiveness Matters continued...
Cost-effectiveness is a metric used by economists to try to gauge the size of the benefit patients appear to get for their health care dollar.
It's become a buzzword as the government and health insurers try to figure out which treatments are worth covering and how to control skyrocketing health care costs.
In the U.S., there is no set threshold that determines cost-effectiveness, but other countries and some health care agencies use a figure around $50,000 per quality-adjusted life year as one cutoff.
The study found disease-modifying drugs for multiple sclerosis are about 16 times more expensive than that.
"When we talk about effectiveness, we're talking about average effectiveness. If we look at the individual person, many of them will have great benefits, and there will be some who have no benefit at all or even negative effects," Noyes says. "So here is a trade-off between national policy or population-based policy and individual patients."
For the study, researchers extracted data on 844 people with MS who were part of a large national patient database. They collected information on things like health care costs, lost work time, disease severity, disease progression, and medications, and they used that information to develop mathematical models.
Over 10 years, the models estimated that the average cost to treat one patient was $267,710 with supportive care, but nearly doubled when researchers added the costs of disease-modifying drugs to the equation.
Overall, health outcomes for patients on the disease-modifying drugs appeared to be only slightly better than for those on supportive care.
Making Improvements in Cost-Effectiveness
Other countries pay far less for the same medications.
Patients in the U.K., for example, get the drug Betaseron for about $12,000 a year, while it costs about $34,000 in the U.S.
Researchers say that if the U.S. were to see prices for these drugs like those paid by patients in the U.K., the treatments could achieve more accepted levels of cost-effectiveness.
The cost-effectiveness also improved when people were started on the drugs early in the course of their disease, when the medications could still prevent permanent nerve damage, perhaps keeping them healthier, longer.
The impact of the study will be "a good deal of discussion concerning where we are in the treatment of MS in terms of cost, obviously, and in terms of where we would like to go in the future," says Nicholas LaRocca, PhD, vice president of health care delivery and policy research at the National Multiple Sclerosis Society. The organization helped to fund the study.
"I would imagine that some people will look at this study and will feel that it will discourage the availability of treatment, but I don't really see that happening," he says. "We need to do more studies like this."
Other experts pointed out that the high costs are already hitting patients hard.
"Some patients will get a new prescription, but they don't get the prescription filled because it's so costly," says Kathleen A. Smyth, PhD, co-director of the Neurological Outcomes Center and associate professor of medicine at Case Western Reserve University.
Symth, who wrote an editorial that accompanied the study, says she thinks the message of the study isn't that patients shouldn't be treated with the drugs. "It's that we have to get drug prices under control in this country."
http://www.webmd.com/multiple-sclerosis/news/20110720/study-questions-cost-effectiveness-of-ms-drugsThis is what socialized medicine that Obamacare will bring to the US. It has failed there and will fail here. I better start looking at wheelchairs. You better not get sick.
UPDATE: July 22, 2011
Benefit of MS Drugs Comes at Steep Price, Study Finds
Published July 22, 2011
| Reuters
Drugs used in the hope of slowing multiple sclerosis progression may help some patients, but at a very high cost, according to a study out Wednesday.
The medications in question are the so-called disease-modifying drugs (DMDs) that have been available since the 1990s to treat multiple sclerosis.
The drugs include beta interferons (brand-names like Avonex, Rebif and Betaseron), glatiramer (Copaxone) and natalizumab (Tysabri). They are given by injection or infusion and can help prevent MS symptom flare-ups and delay long-term disability from the disease.
But the price tag is large, with each drug now costing upwards of $3,000 a month in the U.S.
The new study, published in the journal Neurology, estimates that people who use the medications for a decade would get a modest health benefit for the money.
They would gain an extra two months or less of good health over 10 years, the researchers say, compared with using only therapies that help ease MS symptoms — like medications for pain, fatigue and muscle spasms.
Overall, the study estimated, DMDs cost close to $1 million for each year of relatively healthy life a person with MS could expect to gain with 10 years of use.
In contrast, common thresholds used to define a "cost-effective" treatment range between $50,000 and $150,000 for each good-quality year of life gained.
The figure for DMDs is an "order of magnitude higher," said Katia Noyes, a researcher at the University of Rochester in New York who led the study.
However, she stressed that the findings do not mean that people with MS shouldn't take the drugs.
"This study was not designed to try to deprive people with MS of any therapy," Noyes said in an interview. It was not intended, she said, to tell doctors what to prescribe or insurance companies what to pay for.
But, Noyes added, in the age of healthcare reform, studies need to look at the value of different medical therapies, and what factors seem to affect their cost-effectiveness for patients overall.
In the case of DMDs for MS, she said, starting earlier in the course of the disease appears to be better.
The researchers estimate that starting the drugs before any noticeable disability makes the medications more cost-effective — though they still hover above $700,000 for each good-quality year of life gained.
Part of the issue is the nature of MS and how DMDs work. In MS, the immune system mistakenly attacks nerve fibers in the body, causing symptoms like muscle weakness, numbness, vision problems and difficulty with coordination and balance. In most cases, those symptoms wax and wane — worsening for a period of time, followed by a period of milder symptoms or none at all. Eventually, the cycle often leads to physical disability.
Early on, DMDs can reduce the number of symptom flare-ups. But their central effect on quality of life would be in stalling disability, Noyes noted.
"The main benefit of these drugs is in the long-term," she said. "That may be 10 or 20 years down the road."
Noyes also pointed out that MS is "not unique" in having therapies with a high price for the benefit.
Other examples include implanted defibrillators for people at high risk of cardiac arrest, many cancer treatments and some arthritis therapies. And there are many medical interventions, Noyes said, whose cost-effectiveness has never been studied.
"The good news from this study is that these drugs do seem to be effective, on average," said Kathleen A. Smyth, a researcher at the Neurological Outcomes Center at Case Western Reserve University in Cleveland.
"The bad news is, these positive outcomes come at a very high price," said Smyth, who wrote an editorial published with the study.
People already on the MS drugs know well the high costs, she noted in an interview, but the price tag might come as a shock to new patients.
However, Smyth said, people with MS need to make treatment decisions on an individual basis, after discussions with their doctor — and not based on cost alone.
Like Noyes, she pointed out that earlier treatment appeared more effective in this study. So while it may ultimately cost more, starting a DMD earlier may benefit patients more.
"I don't think there's anything in this study that should stop people from getting an early diagnosis or starting treatment," Smyth said.
She also noted that the picture may change in the future. When individual DMDs' patents eventually expire, for example, the cost of some could well come down. And then certain medications may become preferred by insurance companies.
Both Noyes and Smyth said the findings highlight a wider issue: the high price Americans pay for prescription drugs.
Avonex, for example, cost Americans with MS about $34,000 for the year in 2010. The price in the UK was equivalent to about $12,000 — because that's all the National Health Service will pay for the drug.
And costs are only going up. Makers of the DMDs have raised their prices since last year, in response to the approval of the first oral MS drug — Gilenya, made by Swiss drugmaker Novartis AG.
The annual cost of that medication in the U.S. will be about $48,000. But since it's a pill, the medication is expected to cut significantly into sales of the other DMDs.
As it stands, Smyth said, no particular DMD stands out as a "best buy" for Americans.
Manufacturers of the DMD drugs did not respond in time to Reuters Health requests for comment on the new study, however a spokesman for Biogen Idec, maker of Avonex, did offer a written statement on the question of drug costs:
"The overall cost of disease management for a chronic disease like MS is expensive and includes much more than medication," wrote Jeff Boyle. "Avonex is approved for the treatment of relapsing remitting multiple sclerosis (RRMS) and we believe the pricing is consistent with the real world value it delivers to patients with MS. Avonex remains the least expensive option for those looking to slow the progression of their MS and is the only once-a-week treatment for RRMS that is proven to reduce relapses, start working after the first attack and delay physical disability progression, helping patients stay active longer."
Read more: http://www.foxnews.com/health/2011/07/22/benefit-ms-drugs-comes-at-steep-price-study-finds/#ixzz1Sqxm6Bi4
No comments:
Post a Comment