Patty Bernard of Falmouth is among the 1.3 million Americans, including 8,700 Mainers, who suffer from rheumatoid arthritis, a chronic and painful inflammatory condition that attacks the lining of joints and can lead to permanent joint damage. While it can begin at any age, the likelihood of onset increases with age and is highest among women in their sixties.
Mrs. Bernard is 80 years old and was diagnosed with rheumatoid arthritis at age 55. In the earlyyears of her diagnosis, she tried many different drugs, but her symptoms continued to get worse.
In 1998, when the RA drug Enbrel came to market, she was one of the first in Maine to try it. She calls the medicine “God-given.” Joint by joint, she felt her life come back.
For many years, her employer’s health insurance covered Enbrel at a cost to her that never exceeded $30 per month. When Mrs. Bernard retired last year, she learned that on Medicare she would have to pay $3,800 per month for the medication, an unaffordable cost.
|Example of rheumatoid arthritis|
As Chairman of the Senate Aging Committee, I invited Mrs. Bernard to testify at a recent hearing to examine why prices have soared for drugs used to treat RA. This hearing follows the Committee’s bipartisan investigation into the sudden, dramatic price increases of certain decades-old prescription drugs. In late 2016, the Committee published a report documenting cases in which certain companies that had not invested a single dollar in the research and development of a drug bought the rights to produce it and then hiked its price to unconscionable levels.
Prescription drugs are vital to the health and well-being of Americans, especially our nation’s seniors, 90 percent of whom take at least one prescription drug in any given month. For many Americans, access to affordable prescription drugs is not only critical for health, but also can be literally a matter of life or death.
Developing these medicines is a lengthy, expensive, and uncertain process. It often takes more than a decade to bring a new drug from the laboratory to the market; the process is often very costly, and most drugs fail during testing.
If we want new medicines to reach consumers who need them, the companies that invest in the research and take the risks necessary to develop these drugs must see a fair return on their investment.
At the same time, we cannot be blind to the costs of these drugs, nor to cases where patent laws are manipulated to preserve monopolies. Americans are expected to spend more than $387 billion on prescription drugs this year alone. Of this amount, individuals will pay about $48 billion out-of-pocket. The federal government is a major payer and will pick up another $172 billion in payments through Medicare, Medicaid, Veterans Affairs, and other programs. Of course, the cost of prescription drugs affects what we pay for private health insurance as well.
For example, the price of Humira, a self-administered drug approved at the end of 2002 to treat RA, has risen from about $19,000 per year in 2012 to more than $38,000 per year today. Enbrel, approved in 1998, costs about the same. Sales of Humira reached $16.1 billion in 2016. It is the world’s best-selling pharmaceutical drug, and Enbrel is number three.
The Food and Drug Administration approved biosimilars – almost identical versions of the original products -- for both Humira and Enbrel in 2016, but neither has come to market. That’s disturbing since we know that competition tends to drive down prices or at least curb increases. In the case of Remicade, a less expensive drug approved for treatment of RA, two biosimilars did come to market at discounts of 15 and 35 percent. That raises the important question: Why haven’t the competitors of Humira and Enbrel become available to consumers? According to reports, Humira is covered by more than 100 patents, many of which were added as the expiration date of the drug’s main patent approached in 2016.
Similarly, Enbrel’s main patent has expired, yet the drug remains protected by at least two other “submarine” patents nearly 20 years after it was first approved. According to a Congressional Research Service report from 2017, five of the seven biosimilars for RA that had been approved by the FDA “have been delayed, or alleged to be adversely impacted, by actions of the brand-name manufacturers.”
Treating rheumatoid arthritis costs the U.S. health care system an estimated $19 billion a year. As a result of the increasing costs of these drugs, older Americans face not only the pain of the disease, but also the financial pain associated with maintaining treatments.
I am committed to promoting innovation while improving access and affordability of prescription medications for patients, particularly for the 90 percent of our nation’s seniors who take prescription drugs. Last year, following the Aging Committee’s initial investigation, a bill that I authored to improve generic competition and lower the cost of prescription drugs was signed into law as part of the FDA Reauthorization Act.
The challenge we must meet was summed up by Mrs. Bernard in her testimony: “I am grateful that I do have something that works so that I can be productive for my family, church, and other friends who aren’t as fortunate as I am. But, I feel very strongly that people should be able to access the treatment they need at an affordable cost.”