WASHINGTON, D.C. — New data from the Centers For Medicare and Medicaid Services emphasized the need for Congress to pass the CREATES Act, a bipartisan bill that would lower drug prices and save taxpayers billions.
The CMS Drug Spending Dashboard revealed the cancer drug Revlimid, while taken by only 37,500 Americans on Medicare Part D, was responsible for the highest total spending for any drug in the program in 2017. Patients on Part D pay out-of-pocket costs based on the list prices of medications. Revlimid currently costs $21,000 per month, meaning Medicare Part D beneficiaries owe $2,600 for the first month’s supply of the medication.
“The CREATES Act would lower drug prices by stopping corporations like Celgene from blocking competition,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “This report reveals why this bill is so important. If passed, American patients would get access to less-expensive cancer drugs and taxpayers would save $3.9 billion.”
Celgene, the drug corporation that makes Revlimid, refuses to provide samples of the drug to generic drugmakers by hiding behind a federal safety program called Risk Evaluation and Mitigation Strategies.
The FDA released a list of 150 brand drugmakers blocking generic drugmakers’ access to their products. At the time, FDA Commissioner Scott Gottlieb said, “I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available.” Last week, Health and Human Services Secretary Alex Azarannounced that the Trump Administration supported passage of the CREATES Act.
According to polling conducted by the Republican-led research firm GS Strategy Group, voters support passage of the CREATES Act by an 83-to-9 margin.
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OLYMPIA, Wash. — Washington state lawmakers can take a stand today on one of the most important issues facing residents — rising prescription drug prices. This morning, a Washington House committee will hold a hearing on SB 5292, a drug price transparency measure. Currently, drug companies raise the prices of prescription drugs with no advance notice or explanation, making it impossible for the state of Washington and its residents to prepare for price increases. The bill would shed much-needed light into the pricing tactics of drug companies. By requiring Big Pharma to report and provide explanations for increases in drug prices, this bill is an important step toward ensuring that all patients can afford the medications they need.
Testifying at the House committee meeting today is retired forester Mike Gaffney from Olympia. Mike lives with a rare form of the blood cancer called multiple myeloma. The price for his cancer medication, Revlimid, skyrocketed 20 percent in 2017 alone. The drug now costs $250,000 a year.
“On behalf of more than 6,200 patients in Washington engaged in efforts to lower prescription drug prices, Patients For Affordable Drugs Now, a bipartisan national patient organization, strongly endorses Washington’s transparency efforts,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now.
The measure, SB 5292, would:
If passed, the legislation would ensure drug corporations won’t be able to blind side Washington patients or taxpayers with arbitrary price hikes. This bill is long overdue and a step in the right direction.
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WASHINGTON, D.C. — In response to a hearing today in the Energy and Commerce health subcommittee on a package of bills to lower drug prices, Ben Wakana, Executive Director of Patients For Affordable Drugs Now, issued the following statement:
“American patients are standing inside a burning house, and Congress needs to pick up the firehose. Today’s hearing was a step toward ending some of the most egregious practices by drug corporations, but the drug pricing crisis requires greater urgency and additional solutions from our nation’s leaders. Patients cannot wait any longer.”
BACKGROUND
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WASHINGTON, D.C. — During a noteworthy exchange at today’s Energy and Commerce Committee hearing, Health and Human Services Secretary Alex Azar publicly endorsed four legislative proposals to lower drug prices and help patients: curbing REMS abuses, ending pay-for-delay deals, banning evergreening, and ending sham Citizen Petitions.
“With the Trump Administration endorsing four common-sense solutions to address a problem eight out of 10 American voters agree must be solved, it’s time for Congress to act,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “Congress should pass these proposals immediately to crack down on anticompetitive behavior and stop insidious tactics that disrupt the free market and hurt patients.”
During today’s hearing, Secretary Azar told Democratic Congressman Peter Welch (VT), the administration supported legislation to fix:
REMS ABUSES: Brand drug companies use a safety program called Risk Evaluation and Mitigation Strategies (REMS) as a pretext for not selling drug samples to generic companies, which need the brand product in order to develop an equivalent and lower-priced competitor. The CREATES Act would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. The U.S. could save $3.9 billion by stopping this abuse, which the FDA has called “unfair and exploitative.”
PAY-FOR-DELAY: Brand drug companies pay off generic companies that plan to bring a competitor to market. In exchange for this payment, the generic manufacturer delays its product’s entry into the market. Legislation would limit deals in which brand and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic and biosimilar drugs from reaching patients.
EVERGREENING: Drug corporations often change drugs incrementally and patent the new product, which extends a corporations’ monopoly pricing power. For example, a company might move from a tablet to a capsule and apply for a new patent. This gaming of the system should not be permitted under U.S. law.
CITIZEN PETITIONS: Brand drug makers were behind 92 percent of all citizen petitions filed between 2011 and 2015 –– all aimed at blocking cheaper generic drugs. The FDA denied more than nine of every 10 of those petitions. Congress should stop sham citizen petitions.
TRANSCRIPT
Congressman Peter Welch: You do support, as I understand it, ending pay-for-delay. Is that the case?
Secretary Alex Azar: We do. In fact, our budget has a unique pay-for-delay provision in that if you do a pay-for-delay agreement, you would actually be penalized in the Medicare Part B system.
Welch: Right. And you want to curb the REMS abuses?
Azar: Absolutely do. So, the CREATES Act and working with you on that.
Welch: Right. And the product hopping that has been occurring is another way. Are you opposed to that as well?
Azar: I want to make sure I’m understanding.
Welch: It’s the abuse of Citizen Petitions, it’s product hopping, and other forms of evergreening.
[Crosstalk]
Azar: Yes, we want to crack down on any forms of manipulation or evergreening of patents and exclusivity beyond what the original deals were.
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The bargain that wasn’t. A fight with BIO. And who will replace the commish?
Welcome to the week in review in prescription drug pricing!
1. No deal
2. Patients take center stage
3. The gloves are off
4. Big shoes to fill
5. Maryland leads the way
ANNAPOLIS, Md. — Maryland lawmakers can take a stand today on one of the most important issues facing residents — rising prescription drug prices. Today, State House and Senate committees will hold hearings on proposed Prescription Drug Affordability Board legislation, HB 768 and SB 759. The measure would create an independent body with the authority to evaluate high-cost prescription drugs and set rates for Maryland residents to pay. Patients For Affordable Drugs Now today announced its endorsement of the legislation.
“Marylanders get it — Big Pharma sets prices that hurt patients and taxpayers,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “On behalf of the 4,500 Maryland residents in our community working to lower prescription drug prices, Patients For Affordable Drugs Now is proud to endorse this first-in-nation effort.”
The Prescription Drug Affordability Board bill, sponsored by Senator Katherine Klausmeier and Delegate Joseline Peña-Melnyk would:
According to recent polling from the Kaiser Family Foundation, only 25 percent of Americans say they trust drug corporations to price their products fairly, down from 41 percent in 2008.
Patients For Affordable Drugs Now is a bipartisan national patient organization focused exclusively on policies to lower drug prices. To maintain its independence, the group does not accept donations from organizations that profit from the development and distribution of prescription drugs.
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WASHINGTON, D.C. — Big Pharma’s price hikes are under the microscope of the Senate Aging Committee this week with a hearing featuring patients hurt by the skyrocketing costs of their medicines.
“This hearing in the United States Senate Special Committee on Aging Wednesday will be dedicated to the testimony of patients,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs. “Patients are sharing their stories and leading the fight to lower prescription drug prices. We are grateful Congress is listening. More importantly, millions of Americans are depending on Congress to move quickly to action.”
For patient interviews, contact [email protected].
Patient perspectives:
Among those testifying Tuesday are Pam Holt, a retired teacher from Granger, IN and Sheldon Armus, a retiree from Boynton Beach, FL. The Medicare beneficiaries rely on expensive medications to survive.
Holt needs a cancer drug priced at $250,000 per year.
“On Medicare Part D, I went into and out of the donut hole in January — paying $4,950 the first month and then $640 for Revlimid every 28 days for the rest of the year. That cost was unaffordable for me and after just one year, it sent me into debt quickly. I was entirely underwater, and I made the heartbreaking decision to refinance my house,” Holt will tell the Senate Aging Committee.
Of the blood thinner he needs, Xarelto, Armus plans to say:
“Xarelto is one of my drugs; it is a blood-thinner that prevents dangerous blood clots that can lead to heart attacks. It is a new and expensive drug with a list price of more than $450 for a 30 day supply! It is outrageous. You’ve probably heard of Xarelto because it is heavily advertised to consumers on TV. Janssen Pharmaceuticals, the company that makes Xarelto, has promised to start disclosing the list price of its medications on those ads.
But that wouldn’t make a difference for patients like me. There isn’t a generic on the market I could turn to instead.”
U.S. patients and taxpayers spend more than $450 billion each year on prescription drugs, by some estimates, nearly one-fifth of all health care costs. Patent-protected brand-name drugs drive spending, making up only about 10 percent of prescriptions but accounting for three-quarters of drug spending.
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A week of high drama. Pharma CEOs v. Congress. Jordyn v. Kardashians. Green Book v. Everyone.
Welcome to the week in review in prescription drug pricing!
1. How Pharma lost its edge in Washington
2. Big Pharma hurts one in four Americans
3. Firdapse Flops
4. Everybody’s wrong but me
5. Part B fix picking up steam?