Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
Statins Recommended for Certain Adults by USPSTF (U.S. Preventive Services Task Force) beginning November 15th, 2017
The U. S. Preventive Services Task Force (USPSTF) has released a recommendation that will require plan sponsors to provide coverage of statins for certain individuals. USPSTF recommended that adults without a history of cardiovascular disease (such as coronary artery disease or stroke) use a low-to-moderate dose statin to prevent heart disease and mortality when the following criteria are met:
- The adult is age 40 to 75 years;
- has one or more cardiovascular risk factors (such as high cholesterol, diabetes, high blood pressure or smoking);
- has a calculated 10-year risk of a cardiovascular event of 10% or greater
Why is this important?
Non-grandfathered plans are required to provide 100 percent coverage for some statins for individuals who meet certain criteria. New recommendation goes into effect at the start of the plan year after 11/15/2017. This will translate into additional cost to plan sponsors. The good news is that ACC/AHA guidelines also do not endorse any one statin over another and all statins are available as generics.
FDA Approves First Biosimilar for the Treatment of Cancer
On September 14th, The U.S. Food and Drug Administration approved Amgen And Allergan's Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product.
Why is this important?
Avastin is a versatile cancer therapy from Roche that totals nearly $7 billion in global annual sales, including $3 billion in the United States. "Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies," said FDA Commissioner Scott Gottlieb.
It's unclear how Amgen and partner Allergan will price Mvasi. Even if it proves significantly cheaper than Avastin, there is a chance that discounts will mostly be seen pharmacy benefits managers and insurance companies. That scenario would likely translate to some out-of-pocket savings for patients.