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AJPB® Translating Evidence-Based Research Into Value-Based Decisions®
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The large number of medications to treat neurologic conditions that are in the pipeline will require assessment of safety, efficacy, and cost-effectiveness.
I am a pipeline watcher. As I look at the drug pipeline, one of the things that stands out is the number of neurology drugs in development. Neurology and neuropharmacology in medical school were the most difficult subjects to understand. In residency and practice, neurologic conditions were often the most difficult to treat. As I continue to talk to my peers who still practice medicine today, many of them a
gree with my past
experience.
The presence in the pipeline of a large number of medications to treat neurologic conditions is a good thing. However, as with most new medications, these drugs will have a significant impact on payers’ drug benefits.
There is a huge unmet need for safe and effective medications for conditions such as epilepsy and Alzheimer’s disease. Although the prevalence of epilepsy in the United States is only 0.68%, the direct costs associated with the treatment of epilepsy have been put at $1.7 billion annually. Treatment for the condition varies according to a number of factors, including the type of seizures that a patient has and the patient’s age. A number of generics, both first- and second-generation anticonvulsants, are available today to treat epilepsy. Unfortunately, a number of these medications have significant side effects. There is hope that one of the antiseizure medications in the pipeline will address outstanding efficacy and side effect issues.
The global cost of Alzheimer’s disease and related dementias was approximately $604 billion in 2010. It is unclear what the payers’ costs are because a large portion are the indirect costs associated with caregiving. Today, 4 drugs to treat this condition are on the market. These drugs do not slow down or reverse the disease, and have only a slight to moderate systematic effect. There are 3 new classes of drugs in the pipeline to treat Alzheimer’s disease, as well as medications already on the market with indications for other conditions. One of the drugs that fits into that category is intravenous immunoglobulin. Up until now, many drugs tested in the pipeline have not shown significant effects. Some believe that this lack of effect is because these medications are being tested on people who already have significant disease.
As with any new medications that come to market, the role in treatment of the new neurology drugs will have to be assessed. Epilepsy and Alzheimer’s disease pose different questions. In the case of Alzheimer’s disease, for which there are few choices (none of them as effective as one would desire), questions of safety and efficacy will be the predominant focus. In the case of epilepsy, the questions to be answered will focus not only on safety and efficacy but also on whether the cost of these new-generation medications will be outweighed by improved clinical outcomes and safety attributes.
Once again, the responsibility to make recommendations to the payers of healthcare will rest on pharmacy and therapeutics committees. It is clear that I will once again have to dive into the world of neurology. Maybe it will be easier this time.