New Data: Congress Must Pass the CREATES Act

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:

• Require that health insurance companies and pharmacy benefit managers provide a list to the Washington Health Care Authority (HCA) of the most frequently prescribed drugs, costliest drugs, and drugs with the highest year-over-year increases.
• Require drug corporations to compile a list of drugs that meet a certain threshold in price increases and will have a significant impact on state expenditures.
• Require drug manufacturers to list justification of those increases to the HCA.
• Mandate that the HCA analyze the data and provide annual reports to the state Legislature. 

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. — 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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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:

• Create a five-member board to review new brand-name prescription drugs that enter the market at $30,000 or more per year or course of treatment. It would also review existing brand name medications that increase in price by $3,000 or more.
• The Prescription Drug Affordability Board would evaluate high drug costs and work to set reasonable rates. 

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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WASHINGTON, D.C. — Executives from seven major drug corporations will testify before the Senate Finance Committee on Tuesday to explain their pricing practices and the fact that American patients and taxpayers pay more for drugs than anywhere in the world. In the lead up to the hearing, Patients For Affordable Drugs Now reviewed the pricing history of each corporation and developed questions patients want answered from the Pharma CEOs.
 
“We hear every day from patients suffering under the high cost of prescription drugs,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “Patients deserve answers, and we need Congressional action to stop this abuse of American patients from continuing.”
 
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.
 
You can read Patients For Affordable Drugs Now’s full testimony for the record here. Below please find a summary of pricing practices and key questions for the Pharma CEOs.
 
ABBVIE INC.

About AbbVie: AbbVie’s anti-inflammatory drug Humira is the top-selling drug in the world. The drug company doubled the price from about $19,000 per year in 2012 to $38,000 per year in 2018. AbbVie secured more than 100 patents on Humira, ensuring that patent thickets will keep competition off the U.S. market. Meanwhile, the company cut the price in Europe by 80 percent for the exact same drug. 
 
Questions: 

• Is it fair that Europeans have access to a less expensive biosimilar competitor for Humira, but your company bragged about blocking that competition in the U.S.?
• Do you partake in pay for delay or deals for delay? Do you support the Preserve Access to Affordable Generics and Biosimilars Act (S.64)?
• Since Humira has already been very successful with more sales than the revenue of eBay, will you commit to holding the price of Humira steady until a biosimilar comes to market? 

PFIZER

About Pfizer: Pfizer’s history of price hikes is as staggering as it is long. Here’s a look at the last three years: In 2017, Pfizer raised the price of 91 drugs by 20 percent — that was nearly 10 times the rate of inflation. In mid-2018, Pfizer announced price hikes on about 100 prescription drugs. After temporary freezes, Pfizer raised the raised the price of 40 drugs in January 2019.
 
Questions:

• Will you commit to limiting the increase in list price of your drugs to the rate of inflation?
• Will you commit to submitting to this committee at the end of this year (2019) a report of the ways you have utilized the $10 billion stock buyback to serve patients?

SANOFI 
 
About Sanofi: Almost 30 million Americans live with diabetes and 6 million need insulin to survive. From 2010 to 2015, Sanofi raised the price of the lifesaving diabetes drug Lantus by 168 percent.
 
Questions:

• If PBM rebates were eliminated, would you lower your list prices?
• Will you commit to undoing the dozens of times you’ve raised the price of Lantus and lower the list price this year?
• As the Chairman of the lobbying group, PhRMA, your organization spent $27.5 million on lobbying in 2018. Next year, will you agree to take half that money and use it to lower drug prices across the board for patients?

MERCK & CO., INC.

About Merck: Merck is no stranger to drug price increases. From January 2017 to mid-2018, Merck raised the price of Januvia by nearly 20 percent. In November 2018, the corporation raised the price on five drugs, including top-selling Gardasil and Keytruda.
 
Questions:

• Will you submit, for the record, the cost of research and development for the drug Keytruda, which reaped a total of $1.89 billion the third quarter of 2018 alone ––  an increase of 80% since 2017?
• Your company recently spent $10 billion on stock buybacks. This year, will you commit to decreasing drug prices by that same amount?

 
JOHNSON & JOHNSON

About Johnson & Johnson: Since 2012, Johnson & Johnson has raised the price of its blockbuster drug Xarelto by 87 percent. In January of 2019, the company raised the price on about two dozen drugs.
 
Questions:

• Will you commit to holding your price increases to inflation each year?
• Will you commit to striking a deal with the New York Drug Utilization Review Board if they deem it necessary to decrease the cost of Remicade for state taxpayers?

BRISTOL-MYERS SQUIBB CO. 
 
About Bristol-Myers Squibb: Over the last eight years, Bristol-Myers Squibb has spent over$25 million in lobbying expenditures and $1.75 million in campaign contributions, according to Open Secrets. The company raised the price of its blockbuster drug Eliquis by 6 percentin January 2019. Last year alone, U.S. patients paid Bristol-Myers Squibb $3.8 billion for Eliquis, a 30 percent year-over-year increase.
 
Questions:

• Will you commit to donating 50% less to candidates for public office in 2020 and investing that money toward research and development or decreasing price for patients?
• With your recent acquisition of Celgene, will you commit to ending Celgene’s use of the REMS program to prevent a generic from coming to market for its blockbuster drug, Revlimid?
• Do you support the CREATES Act?

ASTRAZENECA
 
About AstraZeneca: AstraZeneca has a history of charging cancer patients high prices. Here are three examples: Imfinzi costs $180,000 per year for lung cancer, Lynparza costs around $15,000 for 112 pills for ovarian cancer, and Iressa costs $8,000 for 30 pills for lung cancer. And before AstraZeneca faced a generic competitor for its high cholesterol drug, Crestor, the company raised prices multiple times, including by about 15 percent right before a generic competitor came to market.
 
Questions:

• Will you submit for the record the following information: the amount you have spent on research and development vs. AstraZeneca’s yearly budget for marketing and advertising?

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SALT LAKE CITY — Utah lawmakers can take a stand today on one of the most important issues facing residents — rising prescription drug prices. A Utah House committee will hold a hearing on legislation that would allow importation of wholesale prescription drugs from Canada, introducing lower drug prices at Utah pharmacies. The bill would help Utah patients avoid making the difficult decision to afford their life-saving drugs or skip doses. On behalf of more than 1,000 patients in Utah engaged in efforts to lower prescription drug prices, Patients For Affordable Drugs Now, a bipartisan national patient organization, strongly endorsed HB 267.
 
“We applaud the state of Utah for HB 267 — a pioneering approach to reducing the cost of prescription drugs,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “Canadians pay on average 30 percent less than Americans for the same prescription drugs. Since Big Pharma insists on gouging Americans, we should all be able to import safe bargains from abroad.”
 
Testifying at the Utah House hearing today in favor of HB 267 is Meg Jackson-Drage, 50, of Magna, Utah. Jackson-Drage relies on the Pfizer medication Lyrica to alleviate the symptoms of fibromyalgia. She is forced to pay $550 a month — even for a lower dose of the medication than what she needs — due to do the drug’s skyrocketing cost. According to Senate documents Pfizer increased the price of Lyrica by 145 percent from 2009 to 2015, with an increase of 19.3 percent in 2017 alone.
 
“This bill will not only bring relief to thousands of Utahns like me who have struggled to afford their drugs, but it will also reduce a massive financial expense on Utah taxpayers and patients,” Jackson-Drage said.
 
The Utah bill would:

• Instruct the state Department of Health to apply for a waiver that would allow for the importation of wholesale prescription drugs from Canada to be sold at local pharmacies at a lower costs than prescriptions produced in the U.S.
• Ensure a pipeline of regulated, safe, and effective drugs from Canada reach U.S. patients.
• Save Utah an estimated $70 million a year.
• Pressure US drug manufacturers to lower prices by increasing competition.

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 is at it again. On Wednesday, the drug lobby will roll out its objections to the proposed HHS Part B Demonstration. During a media briefing at its Washington headquarters, PhRMA is sure to pull out all the tired scare tactics: “socialized medicine,” ‘‘reducing access,” “interference in the doctor/patient relationship,” “rationing,” and other well-worn claims from its playbook.

Here are three questions for PhRMA and a fact check ahead of the media briefing:

3 Questions for PhRMA

1. Since the only way patients would receive worse care is if drug companies withhold drugs from Medicare, are PhRMA member companies willing to withhold drugs while being paid 126 percent more than other countries?
    
2. What are two proposals PhRMA supports to lower the list price of drugs? Not PBM reform or Medicare policy changes. How is PhRMA willing to lower drug prices, since drug companies collect 66 percent of Part D drug spending and an even higher share of Part B spending?
    
3. If high prices are necessary for quality care, how does PhRMA account for thesuperior outcomes and life expectancy in international countries despite lower prices for prescription drugs?

FACT CHECK: PhRMA’s False Claims About the Medicare Part B

MYTH #1: The Part B demonstration will restrict access to lifesaving drugs.
FACTS:

• Americans ration drugs today based on price.
  • NPR: “Insulin’s high cost leads to lethal rationing.”
  • Vox: “It means that our system, even if we don’t like to admit it, has to pick and choose who gets access to lifesaving drugs.”
• There is no evidence the Part B demonstration would harm patient access to drugs unless drug corporations choose to withhold drugs from patients. 
  • HHS: The proposal is to “lower drug prices—without any restrictions on patient access.”
• All protected classes of drugs in Medicare will be maintained.
  • HHS: “We propose no changes to the Medicare benefit, just more discounts from drug companies.”
  • Bloomberg: “The aim is to drive down the cost of those medications by 30 percent.”

MYTH #2: The Part B demonstration will establish drug prices that are impossibly low — damaging drug companies and hurting our health system.
FACTS:

• Americans would still pay Pharma more for drugs than other developed countries.
  • The New York Times: “A government study that said Medicare was paying 80 percent more than other advanced industrial countries for some of the most costly physician-administered medicines.”
  • Secretary Azar: “Over the next five years under this model, we will go from paying 180 percent of what other countries pay for these drugs to 126 percent of what they pay.”
• Lowering prices in Part B will have little to no impact on innovation.
  • National Academy of Sciences: “NIH funding contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010–2016. “
  • HHS: “The possible savings American patients would receive over five years represents less than 1 percent of pharmaceutical R&D spending during that time; and the pharmaceutical industry has offered no evidence of that amount having a meaningful impact on innovation.”
• Drug companies can easily make that up by reducing advertising and marketing spending.
  • Washington Post: “Nine out of 10 big pharmaceutical companies spend more on marketing than on research.”
  • JAMA: “From 1997 through 2016…DTC prescription drug advertising increased from $1.3 billion to $6 billion with a shift toward advertising high-cost biologics and cancer immunotherapies.”

MYTH #3: The demonstration will result in worse care for patients. The government should not replace a market-based system with government price setting.
FACTS: 

• The 16 countries used for reference by and large have better health outcomes and longer life expectancy than the U.S., while spending about half as muchper capita for health expenditures. 
  • Kaiser Family Foundation and Peterson Center on Healthcare: Of the 16 other developed economies in the IPI, Americans have worse health outcomes than: Austria, France, Germany, Japan, Sweden, and the United Kingdom.
  • Central Intelligence Agency: Of the 16 other developed economies in the IPI, Americans have shorter life expectancies than 13 of them: Austria, Belgium, Canada, Finland, France, Germany, Greece, Ireland, Italy, Japan, Spain, Sweden, and the United Kingdom.
  • World Bank: Of the 16 other developed economies in the IPI, Americans spend more on health care as a percentage of GDP than all of them: Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and the United Kingdom.
• The current system is broken.
  • CNN: “Americans pay anywhere from two to six times more than the rest of the world for brand name prescription drugs.”
  • Wall Street Journal: “Compared with the U.S., drug prices are far lower in many overseas countries…Critics have long held that the [U.S.] percentage-based ‘add-on’ fee create incentives for doctors to use higher-priced drugs.”
• The Part B demonstration does nothing to slow the FDA approval process.
  Multinational drug corporations will still want early access to the higher prices in the U.S. 

MYTH #4: Americans do not support the Part B proposed changes. 
FACTS: 

• According to a GOP pollster, Americans overwhelmingly support the International Pricing Index to lower drug prices.
  • Voters support the HHS proposal to lower drug prices by a 71-point margin (80 percent support vs. 9 percent oppose).
  • Majorities from both parties agree that Democrats and Republicans in Congress should support the proposal.
  • Notably, 8 in 10 voters believe the proposal will result in better care or have no impact on the care they receive.

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