The Next Big Thing Arrives in Specialty

On the heels of the pricing controversy that raged around the costly new class of hepatitis C drugs comes the next big drug launch, which is expected to have an impact that will reverberate throughout the specialty landscape.

On July 24, 2015, the FDA granted approval to the first cholesterol-lowering proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, Praluent (alirocumab). The PCSK9 inhibitor Repatha by Amgen is also expected to be approved by the FDA in the near future.

Praluent was approved for use in adult patients with heterozygous familial hypercholesterolemia or for patients with clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of low density lipoprotein (LDL) cholesterol.

As opposed to the currently available statins, which are taken orally and have less costly generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies that block the PCSK9 protein from inhibiting removal of LDL from the liver. Although these drugs could offer a significant benefit, the devil, as they say, is in the details.

Praluent was launched with a cost of $14,600 annually. If the drugs are broadly approved for the approximately 2.3 million people who could potentially use PCSK9 inhibitors with such a price tag, the cost could be in excess of $23 billion annually, according to pharmacy benefit manager Prime Therapeutics.

An analysis by Prime estimates PCSK9 inhibitors could add between $0.93 and $6.71 per member per month (PMPM) to commercial insurance coverage costs and up to $15.66 PMPM to Medicare coverage costs, depending on the conditions they are ultimately approved to treat. If the drugs are prescribed to 40% of the approximately 600,000 Americans with abnormally high cholesterol levels who do not respond to statins, it could add an additional $2.1 billion annually in coverage costs.

The question remains as to whether these new drugs will be approved for each patient in this potentially huge population because payers may still try to steer patients toward less costly statins.

The bottom line is PCSK9 inhibitors dramatically decrease the amount of harmful LDL cholesterol in the bloodstream, which translates into fewer heart attacks, strokes, and other issues that stem from clogged arteries. With this unprecedented efficacy, these drugs have the potential to improve the lives of millions of patients struggling to lower their cholesterol.

I urge you to read the to read the editorial by our esteemed editor-in-chief Dan Steiber, RPh, as he considers how specialty pharmacy could be poised to manage the use of this significant new drug class.

As always, Specialty Pharmacy Times will remain laser-focused on this debate to provide context and insight through this journal, our daily news website, and our e-newsletters covering breaking news and clinical developments. SPT

Thank you for reading!

Mike Hennessy

Chairman and CEO