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INSULIN Act
Mrs. SHAHEEN. Mr. President, I am really pleased to be able to come to the floor today with my cochair in the Diabetes Caucus and friend and colleague Senator Collins to discuss an issue that is near and dear to both of us and to the entire Diabetes Caucus, and that is what Congress can do to improve the lives of those living with this chronic disease.
More than 37 million Americans live with diabetes, and millions more are at risk for developing it. I think most people in this Chamber probably know someone who has been affected by this chronic disease, and they get a chance to see very briefly the challenges that those with diabetes face every day.
I understand those personal struggles all too well because my granddaughter Elle was diagnosed with type 1 diabetes in 2007, shortly after her 8th birthday. As a type 1 diabetic, she needs daily access to insulin. Maintaining healthy glucose levels is a worry that has kept her and her mother--her whole family--up too many nights. Without insulin, Elle would not be here because there is no alternative treatment.
There is no cure that can free her from those daily injections. Insulin truly is a lifesaving drug, and it has been for over 100 years. The 100th anniversary of insulin was 2 years ago.
When the Canadian researchers who discovered insulin realized what they had--a drug that would turn a death sentence into a manageable, chronic condition--they decided to sell the patent for $1 each.
They knew the drug they had was revolutionary, and they chose not to chase profits over the good of humankind. Unfortunately, that is not the reality that we live with today. Over the last several decades, insulin prices have skyrocketed beyond the reach of too many Americans.
I hear from far too many people about how they have to ration their needed insulin until the next paycheck or until their insurance coverage kicks in.
Let's be clear about what this means. Americans are literally risking their lives to stretch their insulin as far as possible because the costs are so great. And the cost burden is even heavier for uninsured Americans who have to pay fully out of pocket.
These costs quickly number into the thousands of dollars. The challenges aren't new, but, fortunately, we are making some progress. Congress last year capped Medicare beneficiaries' insulin costs at $35 a month. And, recently, the three largest insulin manufacturers announced they will finally lower their list prices.
Now, Senator Collins and I have commended those manufacturers for finally taking steps to make their insulins more affordable. But until patients are given true financial security and certainty with insulin pricing, the work remains unfinished. Those manufacturers could, at any time, decide again to raise the price of insulin.
There have to be mechanisms in place to systemically address the full scope of this issue. We need to lower costs, and we need to be able to keep those costs down. Insulin costs must be addressed across the board. We must address the root causes of the high cost of insulin.
That is what brings me to the floor today, to discuss legislation that Senator Collins and I recently introduced: the Improving Needed Safeguards for Users of Lifesaving Insulin Now--or INSULIN--Act.
First, I want to thank my friend and colleague Senator Collins for her longstanding partnership and leadership. Senator Collins and I cochair the Diabetes Caucus, but it was Senator Collins who founded the caucus in 1997, years before I got here, and there is no more fearless and relentless advocate for those living with diabetes than Senator Collins.
We began working on the INSULIN Act in 2019, recognizing that without a comprehensive bill to address the root causes of skyrocketing insulin prices, patients would never have long-term relief. At that time, unfortunately, there weren't a lot of people in Congress who were advocating for comprehensive insulin pricing reforms.
Since then, more and more Members of Congress have begun pressing for insulin reform legislation. That is encouraging. And it is a message of the commitment in this Chamber to finally get something done on this issue.
I am glad the issue is finally getting the attention it deserves, because we are long past time for Congress to act. Our INSULIN Act takes an across-the-board approach to insulin pricing.
First, our bill caps insulin out-of-pocket costs at $35 or 25 percent of list price monthly. That means that a patient could see monthly costs capped for as little as $15 to $20.
And that provision, which we did for Medicare last year, was actually something that has been promoted by the diabetes community, the JDRF--
Juvenile Diabetes Research Foundation--and other diabetes advocacy groups.
Second, our bill addresses one of the root causes of insulin price increases--ever-growing rebates collected by pharmacy benefit managers, or PBMs. Our bill mandates that PBMs pass 100 percent of rebates negotiated on the plan sponsors. So that benefits patients by lowering premiums.
Finally, our bill takes several steps to increase biosimilar competition, which is proven to lower list prices and improve patient access to their medications.
That includes legislation that I have championed for several years, the Ensuring Timely Access to Generics Act, which is designed to prevent pharmaceutical manufacturers from gaming the FDA's citizen petition process to delay generic drug approvals.
Now, Senator Collins and I have developed what we believe is a good piece of bipartisan legislation, and it has been done in consultation with drug-pricing experts and with the diabetes advocacy community.
Since 2019, we have been working on this. Last year, we invited input from lawmakers, stakeholders, and advocates, including the members of this Chamber.
This bipartisan bill is the product of countless conversations and negotiations to produce a bill that will be the most effective in lowering costs and keeping them there. And it will entice, we believe, the broadest coalition of lawmakers to get behind it.
In particular, I want to thank the American Diabetes Association, the JDRF, and the Endocrine Society for their input and for their endorsement of our legislation.
I look forward to working with the diabetes community, with Senator Collins, and with the rest of the Members of this Chamber and Congress to finally pass this comprehensive bill to give financial relief to all Americans living with diabetes. There is no more time to waste. And I urge the HELP Committee and Senate leadership to bring this bill to the floor as soon as possible.
I yield the floor.
The PRESIDING OFFICER. The Senator from Maine.
Ms. COLLINS. Mr. President, I am pleased to rise this evening with my colleague and dear friend Senator Jeanne Shaheen to discuss the compelling need to lower the cost of insulin for Americans with diabetes by reforming the system for getting the drug from the manufacturer to the consumer and by capping the out-of-pocket price.
I want to commend Senator Shaheen for her longstanding devotion and hard work on this issue. For her, this is both a matter of policy and personal, as she has described. And I could have no better cochair of the Senate Diabetes Caucus than my colleague from New Hampshire.
We are focused on policies that will improve the lives of those who are living with diabetes. Building on our past efforts, we have introduced a new bill, the Improving Needed Safeguards for Users of Lifesaving Insulin Now--or the INSULIN--Act of 2023.
A little background may be useful. As my colleague from New Hampshire has mentioned, when a team of three scientists at the University of Toronto first isolated insulin in 1921, they sold the patent for $1 each to the university--an act intended to ensure that those in need of insulin would always have an affordable access.
They explicitly stated that profit was not their goal nor their motive. And yet in recent years, the cost of insulin has soared, and insulin costs have become unaffordable for far too many individuals with diabetes.
Between 2007 and 2018, the average list price of insulin increased by 262 percent. In 2019, nearly 9 percent of patients with private insurance paid, on average, $403 per month for their insulin.
This shows the huge increase in the list price between 2012 and 2021. This is the net price. I will explain that in a moment.
Tens of millions of Americans rely on insulin as part of their daily treatment. For children, teens, and adults with type 1 diabetes, insulin is not optional. It is literally a matter of life and death. About 20 percent of those with type 2 diabetes rely on insulin.
I have heard far too many stories from people in my State and from across the country who, because of the escalating cost, have had to ration their insulin--an extremely dangerous practice. These drastic measures can result in major risks that can compromise their health and even jeopardize their lives.
Let me share one such story. Recently, I met with Bek Hoskins of Chelsea, ME, through her advocacy with JDRF. Bek was diagnosed with type 1 diabetes at age 10. When we discussed insulin affordability, Bek shared her insulin story. As a young adult, shortly after she was no longer covered by her parents' insurance, Bek was forced to ration her insulin to make it last longer because she simply could not afford the exorbitant price.
In one profoundly memorable instance, Bek pushed her body's limit too far. Her husband, Barrett, rushed her through a snowstorm to an emergency room as she was in excruciating pain. Bek nearly died because she tried to go without her lifesaving, fast-acting insulin for 2 days.
The situation that Bek faced, sadly, is not an isolated example. We simply must address this problem.
Senator Shaheen and I have long led action in the Senate to improve the lives of those living with diabetes and to reduce insulin prices. We spearheaded the bipartisan INSULIN Act last Congress to comprehensively reform the system that determines the cost of this lifesaving drug. And I am pleased that the market has been responding to our efforts.
The recent decisions by the three major manufacturers of insulin to cut list prices is certainly encouraging, but there is more work to be done. We need legislation to reform the fundamental factors that distort the insulin market, including a purchasing system that is rife with perverse incentives, conflicts of interest, and very limited biosimilar competition.
And we have introduced legislation to do just that. It would guarantee out-of-pocket limits for patients with commercial insurance, encourage biosimilar development to lower list prices through competition and reform the practices of Pharmacy Benefit Managers. That would improve the insulin market, giving patients long-term benefits.
First, our bill would limit cost sharing to no more than $35, or 25 percent of the list price per month, starting in 2024, for at least one insulin in each type or dosage form. Under our bill, insurers and Pharmacy Benefit Managers, known as PBMs, would be prohibited from placing utilization obstacles--such as prior authorizations or step therapy--on products with capped costs. These important protections deliver immediate out-of-pocket relief.
Second, our bill would tackle the perverse incentives that encourage the high list prices. Many people wonder why price variations of a product that has been available for more than 100 years has increased dramatically, and the answer is that the market is rife with conflicts of interest and lacks transparency. What happens is the PBMs negotiate discounts from the list price to the net price of insulin.
Well, what happens to the money that is in between? There is an incentive for the pharmacy benefit manager to select the high-cost insulin because they are paying based on a percentage of the cost in many cases. So that is what you see here. A lot of the benefit of this lower net price that has been negotiated does not reach the consumer.
In 2018, as chair of the Senate Aging Committee, I held a hearing that examined the role of PBMs and rebates and the insulin supply chain and their effect on the increasing insulin prices. At the hearing, an American Diabetes Association expert displayed this chart that I am showing on the Senate floor, which is called ``Insulin Supply Chain: A Complex System.'' I think that understates the situation. This is so convoluted and lacks transparency that no wonder we end up with a system that is rife with conflicts of interest.
One thing is clear: The way that the rebate functions in the current market is a key factor, not in lowering the cost to the consumer but in driving up insulin costs. The way the rebate system works encourages PBMs to select a higher priced insulin for an insurer's formulary. PBMs often choose the highest cost insulin because, as I mentioned, their compensation in the form of sharing part of the rebates is based frequently on percentage of the list price.
Let me now give you one case study that involves biosimilars. Biosimilar products are generic forms of biologics like insulin. And like generics, they are lower costs. But the PBM incentive structure can be stacked against them.
For example, Sanofi manufactures a popular product called Lantus. In 2021, Viatris launched two identical versions of its interchangeable biosimilar for Lantus. One was a branded interchangeable product with a high list price. The second was an unbranded interchangeable biosimilar with a low list price. The higher priced version of the exact same insulin-interchangeable drug was selected for formularies that are run by the insurers, while the lower price one was not.
Think about that.
This proves the perverse incentives in the system. No major formulary preferred the lower list price version, even though it is the exact same product and costs less. That is how this system operates. Rebating practices have slowed biosimilar adoption, and lower priced products are still struggling to compete. To date, no major formulary prefers the lower list price versions of the branded products.
Insulin rebates average between 30 and 50 percent and can reach as high as 70 percent for the most commonly used insulin products, significantly higher than the average rebate for other types of drugs.
Our INSULIN Act addresses the current distortions in the market that decrease affordability for patients by requiring PBMs to pass through 100 percent of the insulin rebates. By removing the PBM share of the rebate, the INSULIN Act would eliminate the incentive for PBMs to choose the higher list price product.
Finally, our bill takes a number of steps to promote biosimilar competition. More choices in the insulin market would drive down prices by creating competition.
The INSULIN Act would create a new expedited FDA pathway to promote biosimilar competition. This provision is modeled after a successful law I authored with former Senator Claire McCaskill in 2017 to improve competition for generic drugs. According to the FDA, nearly 200 products have benefited from the process we created. Let's extend that to biosimilars as the Shaheen-Collins bill would do.
The INSULIN Act would take similar steps to enhance that regulatory certainty for biosimilar drug companies. It is ironic that there is a biosimilar insulin available in Canada and Europe right now that cannot be produced for U.S. distribution because the FDA has taken nearly 10 months to reinspect the safety of the facility where the drug is being manufactured. What we want to do is expedite the regulatory process.
We know regulatory barriers are not the only challenge for biosimilars. The incentives in the current insulin market for PBMs often prohibit biosimilars from securing fair formulary placement as indicated by the example I described earlier.
One other step that our bill would take to ease some of the access challenges for biosimilar drugs is to provide CMS with the authority to approve midyear Medicare Part D formulary changes when a biosimilar enters the market.
The INSULIN Act of 2023 would address the fundamental issues facing the insulin market: convoluted and opaque rebates pocketed by PBMs, a lack of biosimilar competition, and patient affordability.
Like Senator Shaheen, I am so pleased that our bill has been endorsed by the American Diabetes Association, JDRF, and the Endocrine Society. I thank them for their support of this bipartisan legislation. I encourage our colleagues to join us in supporting these much needed reforms.
SOURCE: Congressional Record Vol. 169, No. 69
The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
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