WASHINGTON, D.C. — Today’s congressional briefing featured a bipartisan panel of experts who agreed that International Reference Pricing can lower drug prices in the U.S. while maintaining innovation.
The speakers refuted drug companies’ unfounded claim that reference pricing will harm access or the development of new drugs. And the speakers explained how reference pricing is not price setting any more than the current system of ASP + 6 is price setting. Right now, Medicare sets prices based on a domestic reference price.
John O’Brien, Senior Advisor to the Secretary at the U.S. Department of Health and Human Services, noted that under HHS’ International Pricing Index, Medicare would receive a share of the discounts that drug companies voluntarily give to other countries, saving patients and Medicare $17 billion over the next five years while protecting innovation and access to medicine.
Rena Conti, Associate Professor at Boston University, argued that an International Pricing Index will lower drug prices, increase quality of treatment, and realign incentives for innovation that will lead to the breakthrough drugs we want.
Peter Bach, Director at the Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center, focused on the fact that current incentives in Medicare Part B reward doctors for choosing higher-priced prescription drugs. He noted that innovative and effective drugs garner high prices in other countries. But drugs with competition or of limited value have lower prices. International reference pricing will reflect those market dynamics for this country.
Avik Roy, President of the Foundation for Research on Equal Opportunity, noted that there is no free market for drugs under Part B now. He explained how Medicare is required by law to pay for nearly all FDA-approved physician-administered drugs, regardless of a drug’s quality, price, or value. The IPIM as proposed by HHS would keep the coverage requirement in the US but peg prices to other nations that consider value and price.
David Mitchell, cancer patient and founder of Patients For Affordable Drugs Now,mentioned that there is no evidence the proposed HHS Part B demonstration or any current Congressional bills that utilize reference pricing would harm patient access to drugs, or hurt innovation.
BACKGROUND: How Reference Pricing Works
Right now, American taxpayers pay twice as much for prescription drugs as citizens in other wealthy nations. An International Pricing Index could bring American prices more in line with what other wealthy nations pay.
A Department of Health and Human Services Advanced Notice of Proposed Rulemaking as well as separate bills introduced by Senators Bernie Sanders, Jeff Merkley, Rick Scott, and Josh Hawley use International Reference Pricing as a tool to lower drug prices in the US while maintaining innovation and access.
Under an international reference price, Medicare would pay no more than a set percentage of the price other wealthy countries pay for certain prescription drugs.
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AUGUSTA, Maine — Maine patients will urge legislators to hold drug corporations accountable for exorbitant price hikes and give the state power to negotiate lower prices during hearings today and Wednesday before the Health Coverage, Insurance and Financial Services Committee. Patients For Affordable Drugs Now, a Washington, D.C.-based bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, is helping patients share their drug pricing stories in Maine, sending four patients to testify at this week’s hearings on a package of bills to lower prescription drug prices. Patients For Affordable Drugs Now also published a series of patient stories on its website to underscore the urgency of the drug pricing crisis in Maine.
“Drug corporations have a direct line into Maine’s state coffers and patients’ pockets, and it’s time for the legislature to act,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “We’ve heard from nearly 250 Mainers who are suffering under relentless prescription drug price hikes. We applaud consumer groups and the state legislature’s efforts to rein in drug prices, and we are proud patients are standing up against abusive pricing practices.”
Here’s how the pending legislation would benefit Mainers:
Testifying at the hearings today and Wednesday are:
Lori Dumont of Brewer: “My brother suffered ketoacidosis because he could not afford his insulin. Like so many others, his insulin costs were out of control. For both his long term and short term insulin he was paying about $1,500 a month. On a fixed income, high drug prices are literally a matter of life and death.”
Sabrina Burbeck of Old Town: “When my youngest son was 18 months old he was diagnosed with Type 1 diabetes. In order to survive, he relies on Humalog Insulin. One vial of Humalog costs $350.”
Glenda Smith of Kennebunk: “My Symbicort, Lostatin, Spiriva, and other medications cost me more than $1,200/month, not to mention the $5,000 we have to pay out of pocket before insurance even begins to pay its portion. That is not realistic on our fixed income. My drug costs alone are more than my entire Social Security check.”
Christina Raymond of Limestone: “In order to manage my disease, I require several medications –– Lupron, Tamoxifen, and Neulasta –– in addition to my regular chemo treatments. Lupron costs me $1,500 per month and my Neulasta runs $6,000 per shot.”
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WASHINGTON, D.C. — It’s easy to get lost in the day-to-day shuffle, but at the end of this week, one fact is undeniable: Big Pharma is on the run. Over the last week, Washington took meaningful steps on legislation that would curb drug company price gouging, end abuse of citizen petitions, stop drug companies from abusing the patent system, demand more transparency from pharmacy benefit managers, and protect people who are insulin dependent.
“At the end of this week, it’s undeniable that the momentum lies with patients working to fix our broken system,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “Drug corporations reach into the pockets of hardworking Americans through dirty tactics like evergreening, pay-for-delay deals and unfair price gouging — and it’s time it ends. The fact that both parties are coalescing around this issue should terrify the greedy executives running drug corporations.”
BIPARTISAN LEGISLATION CONSIDERED THIS WEEK WOULD:
END CITIZEN PETITION ABUSE: Brand-name drug makers were behind 90 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 petitions. The Ensuring Timely Access to Generics Act, introduced yesterday, would give the FDA the ability to reject citizen petitions if it determines the purpose of the petition is to delay generic drug entry.
Lead Sponsors: Senators Bill Cassidy (R-LA), Cory Gardner (R-CO), Jeanne Shaheen (D-NH), and Michael Bennet (D-CO)
STOP DRUG COMPANY EVERGREENING: Drug corporations make tiny changes to their products in order to extend patent protections and stall cheaper generic options from hitting the market. Introduced yesterday, the REMEDY Act would address evergreening by rooting out non-innovative patents filed by brand drug corporations.
Lead Sponsors: Senators Bill Cassidy (R-LA) and Dick Durbin (D-IL)
CLOSE AN INSULIN LOOPHOLE: The FDA is in the process of recategorizing insulin as a biologic. The Protecting Access to Biosimilars Act, introduced Thursday, would ensure recategorized insulins do not receive an extra 12 years of market protections. That would mean less-expensive insulins could come to market sooner, giving patients relief.
Lead Sponsors: Senators Bill Cassidy (R-LA) and Tina Smith (D-MN)
CURB DRUG COMPANY PRICE GOUGING: Currently, drug corporations can raise prices without notice or justification. Language included in the Prescription Drug STAR Act would require drug manufacturers provide written justification for price increases at least 10 percent or $10,000 over 1 year, 25 percent or $25,000 over 3 years, or a starting drug price of more than $26,000. The drug company’s justification would be made public on the HHS website and failure to report justification would result in a $10,000 per day fine. The bill passed out of the House Ways & Means Committee unanimously on Tuesday.
Lead Sponsors: Rep. Richard Neal (D, MA-01) and Kevin Brady (R, TX-08)
INCREASE PBM TRANSPARENCY: Pharmacy Benefit Managers –– the drug middlemen who are supposed to operate on behalf of patients –– are a black box. PBMs negotiate drug discounts, but the public doesn’t know how much, if any, of the rebate reaches patients and consumers. Language passed unanimously by the House Ways and Means Committee on Tuesday as part of the Prescription Drug STAR Act would make information on PBM rebates public on HHS’ website. The information would include, by drug class, the aggregate amount of rebates, discounts, or price concessions that are passed through to the plan sponsor.
Lead Sponsors: Rep. Richard Neal (D, MA-01) and Kevin Brady (R, TX-08)
BONUS (from last week, but still):
PROTECT AMERICANS FROM PAYING MORE THAN OTHER COUNTRIES: Americans pay two times more for prescription drugs than citizens in other developed countries. The Transparent Drug Pricing Act, referred to the Senate HELP Committee April 1, would ensure the list price for prescription drugs does not exceed the lowest retail list price for the drug among Canada, France, the United Kingdom, Japan, or Germany.
Lead Sponsors: Senators Rick Scott (R-FL) and Josh Hawley (R-MO)
RESTRICT SHADY PAY-FOR-DELAY DEALS: 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. HR 1499, the Protecting Consumer Access to Generic Drugs Act, which passed unanimously out of the Energy and Commerce Committee last week, 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.
Lead Sponsor: Rep. Bobby Rush (D, IL-1)
END 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 which passed unanimously out of the Energy and Commerce Committee last week 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.”
Lead Sponsors: Representatives David Cicilline (D, RI-1), James Sensenbrenner (R, WI-5), Jerry Nadler, (D, NY-10), Doug Collins (R, GA-9), Peter Welch (D, VT-At Large), David McKinley (R, WV-1)
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BOSTON — Massachusetts patients will speak out against high drug prices tomorrow during testimony in favor of sweeping state reforms that would require drug corporations to justify exorbitant prices and give the state negotiation power on behalf of patients and taxpayers. Patients For Affordable Drugs Now, a Washington, DC-based bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, is helping patients share their drug pricing stories in Massachusetts, sending two patients to testify before the Joint Committee on Health Care Financing tomorrow and publishing a raft of patient stories on its website to underscore the urgency of the drug pricing crisis in Massachusetts.
“Drug corporations have a direct line into Massachusetts’ state coffers and patients’ pockets, and it’s time for the legislature to act,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “We’ve heard from 265 Bay staters who are suffering under relentless prescription drug price hikes. We applaud Gov. Baker, consumer groups, and the state legislature’s efforts to rein in drug prices, and we are proud patients are standing up against abusive pricing practices.”
HB 1133 and SB 706 would:
Testifying at tomorrow’s hearing are:
Mary Mack of Nantucket: Mary lives with advanced heart failure due to a rare type of genetic muscular dystrophy. The symptoms of her disease—fatigue and shortness of breath—make it difficult to accomplish even the simplest task. Mary was on Entresto for only five months when the copay went up to $225 a month. The expense became too much for her family, so she stopped taking the drug.
Helen Fonseca of Tewksbury: Helen faces Crohn’s Disease. She plans to tell lawmakers: “I take Apriso. Before I retired, this drug cost $60 for a three-month supply. However, once I retired three years ago, the cost skyrocketed, going up to $500 for the same supply. There is no generic for this drug, even though its patent has run out. This cost is absurd. And for people like me who are on a fixed income, this cost is often impossible to pay.”
MORE PATIENT PERSPECTIVES:
Kathleen Rider, Otis, MA: “I am on a fixed income and am forced to shell out $145 for the medication every three months. It adds up. The stress of having such a costly medicine does affect my mental health. This is a necessary medication for me.”
Diane Sarmento, Lowell, MA: “I am a Medicare patient who was prescribed Ampyra, which is meant to strengthen my muscles and improve my overall quality of life. But the price of this drug is prohibitive: when I can’t get assistance, I can’t afford it.”
John Wood, West Springfield, MA: “I have type 2 diabetes that I work to keep at bay by living a healthy lifestyle. However, I also take Onglyza to help maintain my A1C levels. I usually fall into the Medicare donut hole within 6 months, causing a coverage gap. That’s when the price skyrockets to upwards of $450.”
According to recent polling from the Kaiser Family Foundation, only 25 percent of Americans say they trust drug corporations to price their products fairly. Nearly one in four Americans report difficulty affording their prescription medications.
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ANNAPOLIS, Md. — The Maryland legislature officially voted to create a groundbreaking Prescription Drug Affordability Board, an independent body with the authority to evaluate high-cost prescription drugs and set reasonable rates. The bill, HB 768, now moves to Gov. Larry Hogan’s desk, with a chance to set a model for the nation to make prescription drugs more affordable. Today, Patients For Affordable Drugs Now launched a new flight of digital ads that give residents tools to encourage Gov. Hogan to sign the bill into law.
P4ADNow, a bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, earlier endorsed the legislation and ran an aggressive campaign to support the bill. Today’s new digital ads continue a 5-figure effort to support state partners, including AARP Maryland, NAACP, MedChi, and the Maryland Health Care For All Coalition.
“The state needs this board to push back against Big Pharma’s unaffordable prices,” said Maryland resident David Mitchell, a cancer patient and the founder and president of Patients For Affordable Drugs Now. “The status quo needs to change, and the Prescription Drug Affordability Board is a national model.”
The Prescription Drug Affordability Board bill, sponsored by Senator Katherine Klausmeier and Delegate Joseline Peña-Melnyk, would:
To date, thousands of Maryland residents have reached out to state lawmakers in support of the measure.
According to recent polling from the Kaiser Family Foundation, only 25 percent of Americans say they trust drug corporations to price their products fairly. Among Maryland voters, 78 percent favor creating a prescription drug affordability board in Maryland, according to a January Gonzales Poll by Maryland Citizens’ Health Initiative.
Patient perspective
Stahis Panagides is a Marylander, Parkinson’s patient, and Medicare recipient whose life has been directly impacted by skyrocketing prescription drug prices.
“My doctor recently prescribed Rytary to mitigate my disease. But even with my robust Medicare plan, I am not able to afford the $400 monthly price tag on this drug. It’s heartbreaking to know that there’s a drug out there that could treat my symptoms, but I can’t access it because the price is just too high,” Stahis told Patients For Affordable Drugs Now.
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SALEM, Ore. — Oregon state lawmakers are weighing key measures this week that would protect residents from Big Pharma’s skyrocketing drug prices. One bill would require that drug makers give 60-day notice to the state before spiking drug prices, while a second reform would allow Oregon patients to purchase medication from Canada at fraction of the cost. A new, 5-figure campaign launched today to highlight stories of Oregon patients struggling under high drug prices and give Oregon residents tools to contact their state lawmakers in support of these drug pricing reforms.
Patients For Affordable Drugs Now, a bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, is proud to endorse the proposed legislation alongside the Oregon Coalition For Affordable Prescriptions. Hundreds of Oregonians have contacted P4ADNow to report harm caused by the cost of their prescription drugs.
Oregon’s HB 2658 would require that drug manufacturers provide 60-day advance notice before raising prices beyond certain thresholds over a 12-month period. HB 2689 and SB 409 would create a state program to import and distribute wholesale prescription drugs from Canada. At significant savings to patients, the program would ensure safety on par with the U.S. drug supply chain system.
Both measures are being considered by key committees in the Oregon House and Senate this week.
“Oregonians are desperate for relief from crushing drug prices,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “While there is still work to be done to lower the list prices of drugs, these important bills could give Oregonians safe and less-expensive options and protection from being blindsided by price hikes.”
Americans pay anywhere from two to six times more than the rest of the world for brand-name prescription drugs. According to one report, the retail price of a vial of insulin in the U.S. is over $300. In Canada, the same vial costs $32.
Patient Perspective
Hundreds of Oregon patients have written to Patients For Affordable Drugs Now to report how their lives have been directly impacted by skyrocketing prescription drug prices. Here’s a look at three of those stories:
David Schmor, St. Helens, OR: “I have stage 4 prostate cancer along with a heart condition. I began with surgery that cost over $100,000, followed by radiation which was another $100,000, and ongoing hormone therapy that cost me $200 out of pocket every three months. Just one of my pills, Xtandi, costs $400 a day.”
Sarah Esterman, Portland, OR: “Out of pocket, the drug would cost me $460 a month—which I can’t reliably afford.”
Pat Rubino, St. Helens, OR: “I have seen the impact high prescription drug prices have on many Americans and feel strongly that something must be done immediately. No one should ever have to consider not taking their medicine because they cannot afford it!”
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SACRAMENTO, Calif. — A first-in-the-nation California bill would stop Big Pharma from cutting deals that block less-expensive generic drugs for state residents — a tactic that limits patient choice and costs taxpayers billions each year. Californians have written hundreds of letters in support of Assembly Bill 824, which is being heard in the judiciary committee this week. The bill also received an endorsement today from Patients For Affordable Drugs Now, a Washington, DC-based patient advocacy organization that takes no money from the pharmaceutical industry or any other player in health care. The organization launched a 5-figure campaign to advance the bill.
“Big Pharma is reaching into the pockets of hard-working Californians through dirty tactics like pay-for-delay deals that block cheaper generic drugs,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “We’ve heard from more than 1,000 Californians who report struggling to afford skyrocketing prescription drugs. All the while, Big Pharma’s profit margins are soaring while players collude to cut monopolistic deals. AB 824 could put an end to this egregious scheme that’s gone unchecked for far too long.”
AB 824 would:
Patients For Affordable Drugs Now’s 5-figure campaign includes digital ads to give Californians tools to contact their representatives in support of the legislation through letter writing and phone calls.
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OLYMPIA, Wash. — Washington patients are one step closer to relief from skyrocketing prescription drug prices. SB 5292 and HB 1224 — legislation that would shed light on drug manufacturers’ pricing behavior — passed key policy committees recently and heads to the fiscal committees this week. Given the recent momentum, patients are speaking out about the devastating impact of rising drug prices and explaining how drug pricing legislation would help protect the state and residents from price hikes.
“Washington residents have been sending a clear message to lawmakers in support of the state’s effort to shed a light on rising prescription drug prices,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “We all pay for Pharma’s unfettered greed, and Washington residents are struggling to fill both the kitchen pantry and the medicine cabinet. The status quo needs to change, and SB 5292 and HB 1224 are a step in the right direction.”
Patients Take Action: Last week, Patients For Affordable Drugs Now launched a new digital campaign to give Washington residents tools to contact their elected officials in support of measures to address rising drug prices. The campaign has included:
Washington Legislation would:
Patients Speak Out:
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