Newly approved PCSK9 inhibitor comes with hefty price

July 28, 2015

While the FDA’s approval of alirocumab (Praluent injection) for high cholesterol is an important new treatment for patients with cardiovascular disease, health plan executives and others are worried about the drug’s price tag.

While the FDA’s approval of alirocumab (Praluent injection) for high cholesterol is an important new treatment for patients with cardiovascular disease, health plan executives and others are worried about the drug’s price tag.

On July 27, alirocumab, from Sanofi and Regeneron Pharmaceuticals, became the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Alirocumab is prescribed as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein (LDL) cholesterol.

However, Sanofi and Regeneron are marketing Praluent for around $14,600 annually, which is substantially higher than the $7,000 to $12,000 price that some health plan executives had been expecting, according to The Wall Street Journal.

The pharmaceutical firms defended the cost of the drug, saying that it will reduce costs in the healthcare system by preventing heart attacks and strokes. “We came to a price that is reflective of value, not what the market will bear,” Elias Zerhouni, head of research and development at Sanofi, told The Wall Street Journal.

Alirocumab will help many patients who have difficulty achieving LDL cholesterol levels recommended by healthcare providers, despite treatment with standard of care including statins, according to Sanofi and Regeneron. “These include approximately 8 to 10 million patients with an inherited form of high LDL cholesterol known as heterozygous familial hypercholesterolemia and those with clinical ASCVD, defined as a build-up of plaque in the arteries which can lead to reduced blood flow and a number of conditions including heart attack, stroke, chest pain (stable or unstable angina), transient ischemic attack, revascularization and peripheral artery disease,” the two companies said in a statement.

Alirocumab is available in 75-mg and 150-mg doses, delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks.

 

The approval of alirocumab was based on data from the pivotal Phase 3 ODYSSEY program, which showed consistent, positive results compared to placebo and included current standard of care therapy (statins). In the ODYSSEY LONG TERM trial which evaluated alirocumab 150 mg every two weeks, alirocumab reduced LDL cholesterol by 58 percent versus placebo at week 24 when added to current standard of care, including maximally tolerated statins.

In ODYSSEY COMBO I, alirocumab 75 mg every two weeks as an adjunct to statins reduced LDL cholesterol by an additional 45 percent compared to placebo at week 12. At week 24 in the same trial, alirocumab reduced LDL cholesterol by an additional 44 percent compared to placebo. In this study, if additional LDL cholesterol lowering was required based on pre-specified criteria at week 8, alirocumab was up-titrated to 150 mg at week 12 for the remainder of the trial. Eighty-three percent of patients remained on their initial 75-mg dose.