Proprotein convertase subtilisin/kexin type 9 or PCSK9 inhibitors. What sounds like a code name has been drawing comparisons to the biggest blockbuster drug in recent history, Sovaldi®. This new class of drugs targets people with certain types of high cholesterol and related complications. In particular, it can help people with familial hypercholesterolemia – a rare genetic condition which leads to abnormally high cholesterol levels that doesn’t respond to traditional statins.
One year post-launch, we project that plan sponsors will likely see a per member per month (PMPM) cost increase of $0.93 to $3.29 for commercially insured coverage dependent on management strategies  With projected costs this significant, these drugs have the potential to create a huge impact on drug spend.
PCSK9 inhibitors help the body clear low density lipoprotein (LDL) or “bad” cholesterol from the blood by targeting a specific protein in the liver. They’re injected, not a pill, and will likely be distributed through specialty pharmacies. Currently, two products are slated for FDA review — Praluent™ (alirocumab) from Regeneron and Sanofi, and Repatha™ (evolocumab) from Amgen. An advisory committee recently recommended both drugs for approval. We expect both to be approved by the FDA in July and August.
Once the new drugs are approved, a number of factors will impact their initial use, including:
- FDA-approved indications for use: Approved indications for use are pending. This information will impact clinical strategy for drug management.
- Prescribing behavior: A lack of long-term safety and outcomes data could affect how doctors prescribe these drugs.
- Adherence: These drugs are self-administered by injection once or twice per month. And they don’t make the member “feel” differently. These factors may impact adherence.
What will the cost impact be?
At an estimated cost of $10,000 annually, these drugs are less expensive than some of the blockbusters of 2014. But many more people are expected to use them. And though there may be competition, prices are expected to remain high. This is because PCSK9 inhibitors are biologics, which means a pathway to lower-cost generics won’t exist for many years.
How can these drugs be managed?
We’re ready to work with you to aggressively manage PCSK9 inhibitors at launch and are currently evaluating several strategies, including:
- Robust utilization management (UM) criteria
- Benefit design
- Preferred product strategies, resulting in aggressive rebate opportunities
- Member support from Prime Therapeutics Specialty Pharmacy™
We’ll continue to actively communicate with you and your clients as new information is learned and strategies are finalized.