Amgen (NASDAQ: AMGN) today announced that it is making Repatha (evolocumab), an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, available at a reduced list price of $5,850 per year. This 60 percent reduction from the medicine's original list price will improve affordability by lowering patient copays, especially for Medicare patients.
"Cardiovascular disease is one of the country's most significant health challenges, and every 40 seconds someone in America has a heart attack or stroke," said Robert A. Bradway, chairman and chief executive officer at Amgen. "Repatha can help to address this significant public health issue, but concerns over out-of-pocket costs have proven to be a barrier to its use for too many patients. We want to make sure that every patient who needs Repatha gets Repatha."
Bradway noted that an estimated 75 percent of Medicare patients prescribed a PCSK9 inhibitor never actually fill their prescriptions, mainly due to high out-of-pocket costs.
"Since turning 65 and going on Medicare I have had to make one of the hardest decisions of my life – can I afford to stay on Repatha, the only thing, even after nine stents and numerous statins, that has worked to lower my cholesterol?" says Repatha patient Bob C. from Boca Raton, Fl. "Given my family history of heart disease, today's announcement means that I can continue taking a therapy that has been so effective for me."
Today's action reflects the Company's active participation in the American Heart Association's (AHA) Value in Healthcare Initiative. It also reflects Amgen's support for the goal of President Trump and his Administration to lower the price of drugs for U.S. consumers. In May of this year, the Company decided not to proceed with price increases on its medicines that had been planned for July. No price increases on any Amgen medicines have been taken since then or are planned for the balance of the year.
Amgen is making Repatha available at a reduced list price by introducing new National Drug Codes (NDCs). SureClick®, the most commonly used delivery system, will be available immediately; the Pre-Filled Syringe and Pushtronex® (monthly, on-body infusor) delivery systems will be available in the next 2-3 months. The lower priced Repatha is identical to the Repatha currently available.
"This is a unique solution for a unique situation," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen.
Throughout 2018, Amgen has been offering payers significant rebates on Repatha in exchange for improved patient access through, for example, more simple utilization management criteria. The Company now has agreements in place with payers representing greater than 65 percent of Repatha's commercial revenue.
"Unfortunately, higher rebates don't typically result in lower out-of-pocket costs for patients, especially for Medicare patients," Gordon said. "We are confident today's action will address this challenge."
To allow for a smooth transition to these lower-priced options, Amgen will continue offering Repatha at its original list price for a period of time, with an expectation of discontinuing the original list price of Repatha by the end of 2020 or sooner.
"While we hope more patients will benefit from swift adoption of these lower-priced options, it is ultimately a payer decision," Gordon said.
"At Express Scripts, our goal is to ensure affordability and ensure patients get the novel medicines they need," said Steve Miller, M.D., senior vice president and chief medical officer of Express Scripts. "With a new lower list price for Repatha, Amgen is taking an important step forward to help payers be better positioned to provide breakthrough medicines and help people achieve better outcomes."
Patients or physicians who need help understanding these changes can contact RepathaReady® (1-844-REPATHA). The RepathaReady program provides a comprehensive suite of services to help patients and providers, including a Repatha $5 co-pay card for eligible commercially insured patients, insurance coverage support and injection training. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through the Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage.
Elevated "bad cholesterol" or low-density lipoprotein cholesterol (LDL-C) is one of the most important modifiable risk factors for heart attack and stroke prevention. According to a recent Centers of Disease Control (CDC) report, 39 million adults could benefit from managing their cholesterol. Within this population, patients with established cardiovascular disease are at greatest risk for heart attack and stroke.
Repatha Cardiovascular Outcomes (FOURIER) Study: Key Outcomes
The 27,564-patient Repatha cardiovascular outcomes study (FOURIER) demonstrated that adding Repatha to optimized statin therapy resulted in a statistically significant 20 percent (p<0.001) reduction in major adverse cardiovascular events (MACE) represented in the key secondary composite endpoint of time to first heart attack, stroke or cardiovascular death. The study found a statistically significant 15 percent reduction (p<0.001) in the risk of the primary composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.
The magnitude of risk reduction in both the primary and key secondary composite endpoints grew over time, with the robust benefit starting as early as six months and accruing through the median 2.2 years of the study.
Patients on Repatha experienced a reduction in the risk of heart attack (27 percent, nominal p<0.001), stroke (21 percent, nominal p=0.01) and coronary revascularization (22 percent, nominal p<0.001). Consistent with recent trials of more intensive LDL-C lowering, there was no observed effect on cardiovascular mortality. Similarly, there was no observed effect on hospitalization for unstable angina.
The safety profile of Repatha in the outcomes trial was generally consistent with the safety profile for the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Common adverse reactions included diabetes mellitus, nasopharyngitis, and upper respiratory tract infection.
Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event-driven and continued until at least 1,630 patients experienced a key secondary endpoint.
About Amgen in the Cardiovascular Therapeutic Area
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide. Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.