Posted by Jeff Berk; BOLT International / MedPredict
A recent University of Rochester School of Medicine study (Noyes et.al; 2011; see http://www.neurology.org/content/early/2011/07/20/WNL.0b013e3182270402.abstract) compared disease modifying therapy to supportive care and found that “the cost-effectiveness of all DMTs far exceeded $800,000/QALY (quality adjusted life year)”. Many pharmacoeconomics groups have coalesced around a $50,000-$100,000/QALY as the upper limit of acceptable from a cost/benefit standpoint, but for severe medical conditions, many drugs are priced such that the QALYs are much higher (e.g. Erbitux / cetuximab; colorectal cancer $600,000/QALY).
Multiple Sclerosis Thought Leader Panel #15, commissioned by BOLT International / MedPredict, was designed to address a question asked by a number of our clients: What benefits make a multiple sclerosis therapeutic “worth the price”? Asked another way, should MS therapies be priced more like an acute life-saving drug, whose survival benefit is measured in weeks or months? Or should they be priced more like therapies prescribed to deliver both symptomatic benefit and disease modifying properties for other immunologic conditions (psoriasis, rheumatoid arthritis, Crohn’s disease)? These agents top out in the $30,000 – $35,000/yr range. Are the QALY figures that Noyes cites reflective of overpriced drugs, ineffective therapies, or a combination of these two factors? Or do they reflect an over-hyped academic perspective that fails to capture the full spectrum of benefit that the drugs deliver over the entire course of the disease?
Applying the “Goldilocks principle”, our Panel concluded the following: Gilenya (fingolimod) may be as effective as Tysabri in terms of reducing disease activity measured by MRI, but at $52,000/yr, it’s overpriced. The CRAB(E)s (interferon, Copaxone), are priced lower ($30,000 – $40,000, but are less effective even on this dimension. Tysabri (natalizumab), priced in the low $40,000/yr range, arguably has the best efficacy, and with the new diagnostic, can be timed for safe use. Tysabri is effective when measured by reduction in gadolinium enhancing lesions, and EDSS. In addition it is remarkably effective at returning patients to essentially normal function – meaning that they feel like they no longer have MS (also described as “improves existing symptoms”). The drug attenuates fatigue, early cognitive complaints, executive function problems and depression symptoms.
We’d like to tell you what the Panel said about pricing for BG-12, and some other upstream MS therapies. We really would. But since Jeff’s Street Glide is in dire need of some customized parts, and Mr. Harley dealer politely declined to do the work for free, we’d really REALLY like our Pharma readers to first go to the “buy now” page on the BOLT website, and buy this report. The usual rules of engagement hold for MS patients and their neurologists – contact me by email (email@example.com or firstname.lastname@example.org) and we’ll try to comp you sections of the report that may be helpful to you.
Since everybody likes a free taste, here’s a slice of the MS pharmacoeconomic pie for you to try…
- If you ask payers, they will tell you that hematology/oncology and cardiovascular disease are the most expensive therapeutic categories for them to cover patients. Number three? Multiple sclerosis. MS patients have a chronic disease, they live a long time, and they are potentially on therapy for a very long time. So an insurance company, or a national/provincial payer (Canada, UK, Italy etc) covering a patient who develops MS, is facing a sizeable financial liability. MS patients represent about 3% of chronically treated patients worldwide, but they consume 17% of healthcare budgets. And when they are looking at places that they can cut costs, mainly due to political costs, they regard cancer and cardiovascular drugs as untouchable. MS, however, they regard MS as “touchable”.
“I think there is going to be continued pushback though from the insurance companies. I think they in general try to do whatever they can to not to pay for things. I went to a recent payer conference. The only part that I went to was talking about MS drugs, and they are very concerned because after cancer MS has become their most expensive medical problem apparently. And when they are looking at places that they can cut costs they regard cancer as untouchable and cardiovascular drugs as untouchable and somehow they regard MS as touchable. That is an interesting comment. I don’t think there are nearly as many MS patients, so it has to be longevity of patient on therapy. Right. So people have a chronic disease, they live a long time, and they are potentially on therapy for a very long time. So it is a lot of dollars”.
“I can tell you that I have now a different experience. I am currently in Lebanon where I have opened an MS center. We have quite a different atmosphere here where we don’t have universal coverage; some people have private insurances, some people have the Ministry of Health paying for medication. And I had a meeting with the Minister of Health who requested my help in deciding how to approve certain medications. So this is a universal problem. Whether it is in the US or outside the US, we have to decide which medications can be covered, either by insurance companies or even by the government because the MS patients are I think like 3% of all the chronic diseases that the Ministry covers but they take up 17% of the budget”.
“If you really want to think about this from the society’s point of view, what you want is to keep them functional as long as possible. So controlling their symptoms is important as well as preventing progression. But there is a big difference between MS and cancer, let’s say. I know the number of patients who have cancer is much larger but they don’t live as long as MS patients. So if you wanted to look at the benefits from the point of view of society is it worthwhile keeping people cancer-free for a few more years versus keeping somebody out of a wheelchair or even just keeping them functional for a lot more years? I am glad I am not making these decisions”.