Health care in this country currently costs the American consumer $4 trillion per year. This emerging biological entity will contain the new monoclonal antibody agent PCSK9 Inhibitor (proprotein convertace subtilisin/kexin 9 inhibitor), which threatens to add significant cost to that total.
The PCSK9 inhibitors are injected once or twice a month and has shown to lower cholesterol by 50 + % alone and by 70% in combination with the statins. Studies are suggesting that it is relatively risk free, but necessary long term studies will verify early positive expectations. Data from long term studies confirming reduced cardiac event risks will not be available until late 2017. According to the CDC, 13.4% of the U. S. adult population has high cholesterol, 90% of which can be adequately controlled on a statin alone. So, candidates for use with PCSK9 inhibitors will come from the 10 percent of the population that is either inadequately controlled or has limiting side-effects that preclude statin use.
Here is the math that has Sanofi/Regeneron with Alirocumab (Praluent) and Amgen (Repatha) with Evolocumab so excited. Cost of the PCSK9 inhibitor is expected to range from $7K to $12K per year. Just treating the 10% population (3.5M) not under control with statins, at a presumed average cost of $9.6K per year, will increase the cost for cholesterol treatment by $33.6B. For a reality check, PBMs have conservatively estimated the costs for the PCSK9 inhibitors will be in the $3.4B range by 2020, and $10B by 2030.
How these drugs are labeled is yet to be revealed. Expectation is that initial labeling will be for Familial Hypercholesterolemia (FH) an inherited condition that leads to very high cholesterol levels not normally controlled with statins alone. This condition affects only 1 out of every 500 people in the U. S. Two relatively new specialty drugs Juxtapid and Kynamro have come to market for treatment of FH at a cost of $175K to $250K per patient per year. If these FH patients are successfully converted to the PCSK9 inhibitors, there may be a cost savings opportunity in these circumstances.
PBMs will be tasked to maintain high vigilance with their prior authorization (PA) process to keep control of the expected overlap into non-indicated areas where traditional statin therapies would show adequate response at a significantly lower cost. PBM Specialty Pharmacy services will also need a solid game plan to support treatment adherence for a relatively asymptomatic condition with an injectable route of administration.
Since there are two PCSK9 agents hitting the market in the third quarter of 2015, a market share bidding war with manufacturer rebates for PBM formulary status supremacy could break out and would be a windfall for the PBMs. PBMs will then have the responsibility to manage considerable rebates as has been the case with the new Hep-C treatment drugs.
With the introduction of Specialty treatments which are no longer limited to low prevalence or rare conditions, communication between the employer pharmacy benefit plan and the PBM is crucial for a smooth transition to where PCSK9 inhibitors are best utilized as they enter the marketplace. Closing barn doors after the cows have gone is a poor way to run a farm. With the knowledge of how the gate-keeping is maintained at the PBM, APC can help establish prior authorizations and/or step therapy before these new biologic agents are available.
