Enbrel, Amgen’s hugely profitable arthritis medication, has seen its sticker price skyrocket by almost ten times since 1998. This dramatic increase makes it a prime example of the aggressive tactics used by pharmaceutical companies to maintain high drug costs.
While more affordable generic versions have been available in Europe since 2016, American patients won’t see these cost-saving alternatives until at least 2029.
This stark price disparity has naturally placed Enbrel at the forefront of recent federal and state initiatives aiming to rein in drug expenditures.
When Enbrel was first introduced almost three decades ago, its annual list price was around $11,000. Today, that figure has ballooned to $106,000, though many insurance providers and government health programs do secure significant discounts.
A major shift is coming: starting next January, Medicare will implement a new negotiated price of approximately $30,000 per year for Enbrel. Following suit, Colorado plans to enforce this same price for specific insurance plans by 2027—a pioneering state-level initiative. Washington State is also reportedly examining Enbrel’s pricing.
Patients usually self-administer Enbrel as a weekly injection to manage various autoimmune conditions.
Colorado’s recently approved price cap for Enbrel, decided by a state legislative panel established in 2021, marks a significant ripple effect from the federal Medicare drug negotiation program, a Biden administration initiative designed to reduce medication costs.
Other states, including Oregon, Washington State, Maryland, Maine, and Minnesota, have also enacted legislation to establish similar panels. These groups are tasked with assessing the affordability of various medications, such as those for cancer, diabetes, and heart failure, though none have progressed as far as Colorado’s initiative.
Unsurprisingly, Amgen attempted to legally challenge Colorado’s price cap last year, but their lawsuit was dismissed. The company is currently appealing that decision.
Elissa Snook, a spokesperson for Amgen, argued that Colorado’s board acted “unlawfully” by setting a price cap for Enbrel. She further stated that this method would not effectively improve affordability for patients at the pharmacy.
Beyond Enbrel, Colorado’s panel has also examined four other medications. They found no evidence to deem Genvoya (for H.I.V.) or Trikafta (for cystic fibrosis) unaffordable, and thus didn’t recommend price reductions. However, the board did determine that Cosentyx and Stelara, both autoimmune treatments, were unaffordable, with votes on their price caps anticipated in the coming months.
Amgen claims that only 14 percent of Enbrel patients face out-of-pocket costs exceeding $100 per month for the drug.
According to I-MAK (Initiative for Medicines, Access & Knowledge), a nonprofit dedicated to tracking drug patents, Amgen and other entities have pursued over 260 U.S. patents for Enbrel. While more than 120 of these were granted, some have since expired. Amgen has disputed I-MAK’s figures but has not offered an alternative count.
Enbrel’s astonishing 30-year market exclusivity in the U.S. is remarkably prolonged, even when compared to other major drugs shielded by numerous patents, such as Humira (20 years for autoimmune conditions) and Keytruda (14 years for cancer). Typically, a patent grants protection for 20 years from its application date.
Mariah Leach, a Colorado resident, who previously relied on Enbrel for her rheumatoid arthritis.
Ms. Snook maintained that upholding and enforcing patent rights is essential for fostering innovation and justifying the substantial investments necessary to develop new medications for patients.
The foundational discovery behind Enbrel dates back to the 1980s, credited to Dr. Bruce Beutler, an immunologist and geneticist at the University of Texas Southwestern Medical Center. Dr. Beutler later received a Nobel Prize for his groundbreaking work on the immune system.
Initially developed by a Seattle biotechnology firm, the drug was launched in 1998 before being acquired by Amgen in 2002.
In a pivotal move in 2004, Amgen strategically strengthened its hold on two key patent applications. These qualified under a rule change for an extended, staggered protection period, effectively ensuring their market dominance until the late 2020s—a critical maneuver for preserving Amgen’s monopoly.
Despite the Food and Drug Administration’s approval of a lower-priced, copycat version of Enbrel by generic drugmaker Sandoz in 2016, Amgen’s patent stronghold prevented its sale in the U.S.
Consequently, Sandoz redirected its supply to Europe, where generic equivalents were permitted. Over the years, Enbrel’s price in Europe has significantly dropped, contrasting sharply with Amgen’s continuous price hikes in the United States.
During this same period, Amgen has amassed close to $38 billion in U.S. sales from Enbrel.
Richard Saynor, CEO of Sandoz, criticized Amgen, stating, “Through clever legal strategies, they’ve effectively blocked the access of this product.” Sandoz has engaged in a lengthy legal battle with Amgen over these delays, including initiating an antitrust lawsuit this year.
Tahir Amin, CEO of I-MAK, emphasized the government’s inaction, calling the sustained patent monopoly “a case to be studied.”
In Colorado, the newly established price for Enbrel will apply to state-regulated insurance plans, encompassing coverage for government employees and select small businesses.
However, a significant portion of the commercial market, consisting of federally regulated employer-sponsored plans, retains the option to decide whether to adhere to Colorado’s price cap or pay higher rates.
This price cap on Enbrel is expected to generate savings for both Colorado and some insurance providers. Advocates hope these savings will translate into lower premiums and improved benefits for patients.
Despite these intentions, it remains unclear if patients will actually see direct financial benefits. Specifically, it’s uncertain whether individuals with co-insurance or those facing high deductibles will qualify for the capped price.
Mariah Leach, a 42-year-old Louisville, Colorado resident who has taken Enbrel for rheumatoid arthritis, expressed doubts that the new price would genuinely save patients money.
She advocated for policies that would directly reduce out-of-pocket expenses for Enbrel, recalling instances where she paid around $800 for a month’s supply while covered by student health insurance in Colorado.
Ms. Leach manages Mamas Facing Forward, a website supporting parents with chronic illnesses, which has previously received modest grants from the pharmaceutical industry to compensate its writers.
Lila Cummings, Colorado’s deputy commissioner of health policy, acknowledged that the Enbrel price cap is “uncharted territory,” but expressed considerable optimism about its potential impact.
She concluded, “We’re planning on watching closely to see what will happen to benefit design and what will the specific experience of patients be.”