The FDA just announced that the anticipated approval of Sanofi/Regeneron alirocumab is July 24, 2015. Alirocumab is the first in the highly discussed PCSK9 class which will also include Amgen evolocumab and Pfizer bococizumab. These agents are a topic of conversation throughout the industry because they will be the first monoclonal anti-bodies (mAbs) that could provide wide benefit to an array of patients. The initial indication for the PCSK9 inhibitors will be to lower LDL-C, and the focus will be on patients who are uncontrolled with conventional therapies. However, agents in this new class are also in trials for other indications, including:
- Atherosclerotic cardiovascular disease (ASCVD)
- Type 2 diabetes
- High risk primary prevention
- Familial hypercholesterolemia (FH)
- Statin intolerant
Currently biologics are not mass-marketed for chronic conditions. The PCSK9’s are expected to have a high price tag, which is the aspect that has generated the greatest buzz in the market. Depending upon outcomes data, the agents have the potential to eventually be given to millions of patients, at many thousand dollars a year. If these expensive agents begin to be prescribed for patients with elevated cholesterol as a whole, this has the potential to have a substantial cost impact on the US healthcare system.
One of the questions is: at what point are drugs too expensive to give to patients for widespread chronic conditions? We have just a few months before these agents come to the market, and while they are likely to be approved for a small population there is always creep in prescribing. The managed markets organizations are already working on a strategy to limit the use of these agents and combat the potential cost implications to the market as the PCSK9s launch in the fall of 2015. We will have to wait and see how they are used, the benefits to the patients they are currently being test among, and whether the costs can be justified with an overall savings in the longer-term cost of care.