Heart disease is the number one killer in America. A few factors contribute to this killer and high cholesterol is a major culprit. According to the U.S. Centers for Disease Control and Prevention (CDC) Over 90 million Americans face risk of high cholesterol which can lead to devastating cardiovascular disease. 55% of Americans that could benefit from taking cholesterol medicine are on it. It is believed that only 33% of this number are receiving adequate treatment. Finally, over 10 million in the USA cannot reach their LDL cholesterol goals even though they have been prescribed a first-line treatment such as statins. There are two types of medications prescribed to combat high (and bad) cholesterol including statins and PCSK9 inhibitors. The former has been Food and Drug Administration (FDA) approved since the 1980s. The latter, advanced biologic drugs, were first approved by the FDA in 2015.
Because statins have been around much longer the medical establishment understands their effects far more than PCSK9 inhibitors. PCSK9 inhibitors are only prescribed for certain kinds of people in certain situations as they are very expensive and given via injection only. Two primary drugs on the market are Praulent and Repatha (evolocumab). Because of these factors they are only prescribed in certain situations. For example. if a patient is considered a high-risk candidate for cardiovascular problems and statins are not controlling the bad cholesterol or in cases where genetic condition merits a prescription—such as familial hypercholesterolemia. In more risk-prone or extreme situations enter PCSK9 inhibitors. They are typically used in combination with maximally tolerated does of statins to accelerate and intensify the treatment against elevated cholesterol levels of adult patients afflicted with heart disease where lowering LDL-cholesterol is an absolute must.
So back to the news. Sanofi and Regeneron made drastic price cuts to their Praulent product—by 60%. In an age of drug price escalations this is notable news. In March 2018 the biopharma companies dropped the price to secure market acceptance and in the hopes to gain market share. This didn’t happen. A combination of market factors is forcing the price down. Now down to $5,850 per year—a 60% reduction from the previous price both for 75 mg and 150mg doses. As reported in the Sanofi press release Michelle Carnahan, American Head of Primary Care Business Unit stated “we were encouraged to see improvements in accessibility following our collaboration with payers last year to provide more straightforward, affordable access to Praluent, but only some patients had reduced out-of-pocket costs.” Ms. Carnahan continued “with today’s announcement, we are looking to help bridge the gap, and have now made Praluent available at a price that is approximately 60% lower. We hope that payers will do their part to help ensure savings are directly passed on to more patients, through lower out-of-pocket costs.”
As TrialSite News has reported, payers are pushing the industry to lower cost drugs. Sanofi and Regeneron agreed to lower prices if payers would reduce barriers for high-risk cardiac patients. Evidencing this heavy pressure on pricing, the team inked a deal with Express Scripts (now Cigna Corp) to supply the drug to their customer base at the $4,500 to $6,600 a year range. Could it be for this class of drug with this specific therapeutic area that market forces will drive down the price toward statin levels? That surely will impact the return on investment the commercial sponsors factored into their go-to-market plans.
There is evidence that the price of PSCK inhibitors will head toward $900 per year. According to one expert—Dr. Dhruv Kazi, associate director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center, Boston, “we do think these drugs are useful to patients, and cost is a major barrier to access at this point.”
Biopharmaceutical companies will have to understand the rapidly evolving patient buyer landscape—with intermediary payer forces shaping policies that are materially different than a decade ago. In the U.S. alone, nearly 150 million are covered by some form of public health access—e.g. Medicaid, Medicare, DOD, Department of Veterans Affairs, etc. Another large segment of the population is covered by self-insured corporations who are quite mindful of cost. Either way there are large swathes of the population with access under the ever-more frugal payer—mindful of value but focused on cost. For all the news about increasing drug prices could it be that the exact opposite situation is occurring—that the underlying trend could be to reduced drug prices?