In a recent post, my colleague George Papagelis talked about the rapid explosion of both utilization and cost in the specialty drug market and what this means to employers. One class of biologic specialty drugs in the late stages of clinical testing are PCSK9 inhibitors. If you haven’t heard of them, you will. PCSK9 is an abbreviation for an enzyme known as protein convertase subtilisin/kexin type 9. These drugs lower LDL-C (“bad”) cholesterol by increasing the ability of the liver to remove cholesterol from the body. Approximately 33% of U.S. adults have high LDL-C levels, of which half are currently being treated. PCSK9 inhibitors will be prescribed for those with statin intolerance, familial hypercholesterolemia, and those who cannot achieve adequate results with current therapies. Expect the third category to be the largest.
For most people, diet and exercise continues to be the most effective way to reduce LDL-C but effective therapies are often the most difficult. By 2018, global sales for cholesterol medications will reach $21-$24 billion. The pill prevails.
Currently there are no PCSK9 inhibitors on the U.S. market but two approvals are anticipated this summer: Alirocumab (PRALUENT), manufactured by Sanofi/Regeneron is expected to receive approval by July 24, 2015 and Evolocumab (REPATHA), manufactured by Amgen, is expected to receive approval on August 27, 2015.
Here’s why you should care - PCSK9 inhibitors have been shown to lower LDL-C (“bad”) cholesterol by up to 70% when added to statin therapy. These drugs will be covered under your pharmacy benefit. Sales are expected to reach $3.4 billion by 2020. This is just one class of specialty drugs contributing to the projected 40% of total prescription spend in 2020. Some other major disease classes with similar specialty drug pipelines and inflation curves are treatments for Hepatitis C, Cancer, Autoimmune Disorders and Multiple Sclerosis.
Does an employer have any control over this massive expense? Maybe. The answer depends on your strategy or lack thereof. Complexity prevails and that’s somewhat deliberate. An examination of multiple stakeholders with competing agendas reveals opportunities to ensure that employees get the best benefits possible while effectively managing overall spend. With a strategic approach, variables can be managed; payer considerations, prescription carve-out vs. integrated PBM, site of care selection (outpatient vs. home infusion vs. physician’s office) patient education/adherence, & contracting are a few of the major variables that progressive employers can influence. The new specialty drug pipeline will offer a better quality of life for some and save lives for others. Employers need to establish a strategy now to ensure employees have access to the best treatments available within a managed and financially responsible model.