Multiple Sclerosis pills have been dreamed of as the “holy grail”. New MS pills are in the works, some in very late stages of the approval process that offers hope for the millions of MS sufferers worldwide. Most current treatment involves either injections or intravenous therapy that involves steroids, interferon, and similar toxic drugs. The Ms pills currently under study offer a lot more convenience but don’t offer significant improvement or relief from sometimes horrible side effects. The two most promising Multiple Sclerosis pills under study as of 2010 are cladribine, made by Merck and marketed under the name Serono, and Fingolimod, made by Novartis. Sereno is already approved by the FDA but not as one of the new MS pills. Instead, it is approved for treatment of some of the blood cancers. Both of the Multiple Sclerosis pills are shown to be effective, and both are being developed to treat the relapsing-remitting Multiple Sclerosis that is characterized by relapsing episodes, usually each a little worse than the previous, followed by some time where the symptoms either completely or mostly disappear. Extending the time between relapses is also considered progress and is as much a focus of the new MS pills as is relieving symptoms.
As with injections, side effects are a consideration when considering Multiple Sclerosis (MS) pills too.
Even though the Multiple Sclerosis pills offer convenience, the side effects appear just as serious. Somewhere between 20 and 30 percent of the patients taking Cladribine experienced a significant drop in their white blood cell count, and also developed shingles ( a painful condition in its own right) at a much higher rate.
With the Fingolimod new MS pills, the percentage of patients with serious side effects was 9 percent, as opposed to 6 percent of patients using interferon injections. The Fingolimod patients also had more heart problems. In the same study, 2.7 % had bradycardia (slow heart rate), compared with only .7% of the injected patients.
New MS pills are very expensive to manufacture
These new MS pills are very expensive to produce and those costs have to be passed on to the consumer. With most new drugs, the upfront cost of research and development, FDA approval, trials and marketing are absorbed upfront and then are factored in and “amortized in to the cost per dose over the time the manufacturer holds the patent. So the subsequent costs are not as expensive, and in fact can be pennies in some cases. The manufacturer keeps the price high during the patent period, recovers their initial investment, and by the time the patent runs out, the initial costs have been absorbed and the drug can be sold at a reasonable profit margin.
The Multiple Sclerosis pills are “biologic drugs”. These drugs remain expensive throughout the life of the manufacturing process; hence there are no savings to pass on. There are estimates that treatment with these new MS pills will exceed $33,000 yearly. That is not a cost many patients can absorb, and insurance will not cover for long. So, while promising, the new MS pills are a long way off for most victims of MS, and the search will continue.
