High cost of new PCSK9 inhibitors could plague payers

PCSK9 inhibitors, a new class of injectable cholesterol-lowering drugs, are important breakthrough drugs for patients who need them to control cholesterol. However, if not managed, the high cost of these medications will overwhelm patients and plans, according to one expert.

Praluent (alirocumab) injection, the first PCSK9 to be approved by FDA in July, is priced by the manufacturers Sanofi and Regeneron at $14,600 a year. Another PCSK9 inhibitor, Repatha (evolocumab) from Amgen, is poised for approval this month and is expected to be costly, as well.

Read: New cholesterol-lowering drugs draw attention

Kautzner“There is no question that PCSK9 inhibitors are a breakthrough for cholesterol management in patients who are unresponsive to statins,” says Adam Kautzner, PharmD, vice president, drug trend & formulary at Express Scripts, who recently presented a webinar on this topic. “However, these medications come with a [high price tag]-as much as 50 times higher than the annual price of the generic statins that are currently being used to treat the majority of these patients. This makes them unsustainable for payers, especially given the large population of patients with high cholesterol.”

Between 8 million and 10 million Americans could receive Praluent, or eventually Repatha, most commonly if they suffer from heterozygous familial hypercholesterolemia (FH) or have had a heart attack or stroke and are unable to lower their LDL cholesterol with statin therapy and diet. 

“If these specialty drugs are allowed to broadly replace statins, generic medications that effectively lower cholesterol in most patients for several hundred dollars a year, billions of dollars would be added to the nation’s prescription drug costs,” Kautzner says.

Next: What plans should do

What plans should do

Closely managing the use of these medications will ensure patients who need them most have access to them, while keeping the benefit affordable, according to Kautzner. 

“Compared to unmanaged plans, Express Scripts projects that plans that closely manage the use of PCSK9 inhibitors could see up to a 90% difference in drug spending over the next three years,” he says.

Kautzner listed three tools that should be used to manage this drug class:

#1. Formulary management.

“Engaging a preferred product strategy helps generate competition among drugs in the same therapy class and leverage a PBM’s size and scale to generate deep discounts from drug makers,” he says. 

Express Scripts National Preferred Formularies in 2014 and 2015 have achieved a cumulative $2.5 billion in savings for clients by employing this strategy, he says.  

#2. Utilization management.

“Statin therapy has been available for decades and is a proven safe and effective way to manage high cholesterol for the majority of patients,” Kautzner says.  “It is also the most cost-effective way to manage high cholesterol. When plans implement utilization management programs, such as prior authorization and clinical review, payers can limit coverage for these medications for only those patients who need them most, and ensure that new patients try existing therapies before moving to these newer and more expensive therapies.”

#3. Clinical management.

PCSK9 inhibitors work differently than statins. Both Praluent and Repatha are self-injectable and could be challenging for patients used to taking an oral medication.

“It is critical that all patients who are prescribed these medications receive proper training, close monitoring and ongoing support,” Kautzner says.

For example, Praluent is available to patients through Express Scripts’ Accredo Specialty Pharmacy. “PCSK9 specialist pharmacists and nurses will help them use these injectable drugs properly, remain adherent to the therapy, and achieve the best possible outcomes,” Kautzner says.

In addition to management challenges, labeling and physician education are also issues for payers.

Kautzner explains: “For Praluent, the FDA approved a relatively narrow list of indications but it still extends beyond just patients with heterozygous FH, thus broadening the population of patients for this medication.  Stricter labeling and physician educations are vitally important to ensure appropriate prescribing.

“Ensuring these medications are available for only those patients who need them most, and supporting these patients with clinical care to ensure the proper use of these medications, will help keep the pharmacy benefit affordable for patients and payers,” he says.