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Vital Signs - The Analyst's Perspective - May 2015 Issue

Vital Signs - The Analyst's Perspective - May 2015 Issue

In the second half of 2015, a new specialty class of high cholesterol (LDL-C) lowering drugs called PSCK9 inhibitors is likely to become available. Recent news published in the Annals of Internal Medicine reported that a new class of lipid lowering drugs is effective in lowering lipid levels in patients who are resistant to the already available lipid lowering statin drugs. A meta-analysis of 24 random control trials of 10,159 patients concluded PCSK9 inhibitors are safe and effective drugs in adults. A mutation in the PCSK9 gene is responsible for an inherited form of high cholesterol called familial hypercholesterolemia. Many patients with familial hypercholesterolemia do not respond well to treatment with existing statins, and are referred to as statin intolerant. .

The Analyst’s Perspective by Barbara Gilmore, Senior Industry Analyst, Life Sciences, North America

Cardiovascular disease can be predicted by checking the blood levels of low-density-lipoprotein (LDL) cholesterol, commonly referred to as “bad cholesterol.” Excessively high LDL-C has been associated with the development of atherosclerosis when the cholesterol floating in the blood is deposited onto the blood vessel walls. Historically the drugs prescribed to lower LDL-C levels are called statins such as Lipitor. Most statins have gone off patent so are available as inexpensive generic drugs.

Both Amgen (Repatha) and Sanofi/Regeneron (Praluent) have filed New Drug Applications (NDAs) with the Food and Drug Administration (FDA) for registration of their PCSK9 inhibitor drugs in the United States. Sanofi/Regeneron expects to hear from the FDA in Q3 2015 and Amgen in Q4 2015. Why is the soon to be available lipid-lowering therapy raising fear in insurance companies across the country? High cholesterol is a chronic disease, requiring life-long treatment. Both Amgen and Sanofi/Regeneron’s drugs are monoclonal antibodies and are expected to cost in the tens of thousands of dollars for annual treatment. Thus, the drugs have the potential to be blockbusters, generating over a billion dollars in sales. However, there is a large portion of patients with high LDL levels that are statin intolerant. With cheaper generic drugs available, it is likely that both public and private insurance companies will require proof that a patient is officially statin-intolerant prior to authorizing the use of a PCSK9 therapy. Furthermore, the drugs may have to be monitored to demonstrate their effectiveness thereby justifying the cost.

In 2015 Gilead launched a very expensive hepatitis C treatment called SOVALDI, which can cure the infection with a single course. This drug has generated billions of dollars for Gilead which in turn has caused immense concern for insurance companies who did not expect the high drug costs. Insurance companies are very concerned that there will be a similar cost crisis when the PSCK9 class hits the market. The concern is a valid one and should be monitored in the second half of 2015 as these drugs become available.


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