Pharma: Biden Freezes Trumps Lower Cost Insulin And Epinephrine Rule
Posted on 01/22/2021
Big pharma is smiling big right now. The big three insulin producers are Eli Lilly and Company, Novo Nordisk A/S, and Sanofi S.A., in which they dominate more than 90% of the world insulin market by value. After swearing-in, U.S. President Joe Bidens HHS froze the Trump administrations December 2020 drug policy that mandates community health centers to pass on all their insulin and epinephrine discount savings to patients.
The rule was finalized in late December 2020. The drug rule was put in place to benefit patients who have a hard time paying for expensive insulin and allergy medication. Former President Trump campaigned on lowering the price of important pharmaceutical drugs like insulin, which is used to treat diabetes, and epinephrine. Diabetes afflicts over a quarter of Medicare beneficiaries and drives billions in Medicare spending every year. More than 20 million Americans have diabetes, in which the body fails to properly use sugar from food due to insufficient insulin, a hormone produced in the pancreas.
Democrats Drug Pricing Bill Is A Sneak Peek At The Partys 2020 Campaign Message
So far, Gold Vial advocates have delivered vials to six presidential candidates in addition to Janelles handoffs, there has been a California delivery to Bloomberg and a New Hampshire presentation for Yang as well as 11 more to members of Congress and 18 to state lawmakers and local government officials.
Soon, the Insulin for All movement could even have a lawmaker born of its own ranks: Quinn Nystrom, a longtime insulin advocate and Democrat running to represent Minnesotas 8th Congressional District on a largely health care-centric platform.
The informal grassroots groups have also enjoyed increasing backup from national organizations more closely tied to the political mainstream. Health Care Voter, the left-leaning group founded in 2017 to oppose repeal of the Affordable Care Act, recently announced a new spinoff organization: Affordable Insulin Now.
We had so many conversations with advocates and patients across the country who knew there was a void that needed to be filled, said Rosemary Enobakhare, the groups director. We decided to take this on not just at the local level but at the federal level, to make sure they know that people are literally pleading with them.
Despite the chance for a major victory in the state legislature, however, it was Lutgens success contacting the national political figures campaigning for the Democratic nomination that fueled the discussion.
Protest Part Survival Tactic: How Americans Are Using Pilgrimages To Canada To Get Cheaper Insulin
But she has relished the opportunity to ensure that even a Democratic president would address the issue dearest to her heart. Access to insulin, she says, shouldnt be partisan.
If I had to choose, she said, I liked what Andrew Yang had to say on drug prices.
And while she is a committed Republican, even Lutgen admitted she had reservations about Trumps efforts on drug pricing. He should be pushing Congress harder to pass a drug pricing bill, she said, citing the Senate package authored by Sen. Chuck Grassley, the Iowa Republican.
The more time passes without real reform, the more Lutgen has begun to doubt whether Azar, the former Eli Lilly executive, is likely to fix the problems that contributed to her sons death.
Im starting to have my doubts, she said. Maybe it would be better to have a doctor somebody who has the patients in mind first, and not pharmaceutical companies.
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The Blame Game: Everyone And No One Is Raising Insulin Prices
By Rachel BluthApril 10, 2019
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As Bernie Sanders Neared Canadian Officials Were Urged Not To Allow Us To Import Medicines
Advocacy campaigns like Lutgens have helped to elevate insulin from a health care obscurity to a central element in each Democratic candidates health policy agenda.
Sanders has spent $5.5 million on television ads in Iowa alone, according to FiveThirtyEight many of which spotlight his caravan to Canada or images of a patient drawing a syringe from an insulin vial.
Warren, whose proposal to let the federal government manufacture insulin and other generic drugs is a signature campaign plank, also orchestrated an investigation in which Senate aides around the country to ask whether they stocked a cheaper generic product from Eli Lilly, introduced in the wake of price criticisms.
Former Vice President Joe Biden, in interviews, has cited insulin as a key example of how Americans are getting ripped off on drug prices. Tom Steyer, the billionaire hedge fund manager and environmentalist, complains that drug companies charge Americans 10 times what they charge Canadians for insulin. And Klobuchar, in 2019, invited Nicole Smith-Holt, the mother of Alec Smith, as her guest for Trumps State of the Union address. When she declared her candidacy a week later, she retold Alecs story. Her message quickly caught fire, even spurring an impassioned tweet from the pop icon Cher.
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Insulin Makers Lit The Fusepbms Fanned The Flames
“Insulin manufacturers lit the fuse on skyrocketing prices by matching each other’s price increases step for step rather than competing to lower them, while PBMs, acting as middlemen for insurers, fanned the flames to take a bigger cut of the secret rebates and hidden fees they negotiate,” added Sen. Ron Wyden, the Committee’s highest-ranking Democrat, from Oregon.
The three US insulin makers deny working with each other or PBMs.
Eli Lilly spokesman Greg Andrew Kueterman told Medscape Medical News that the company “makes independent decisions about list price increases.”
Similarly, a Sanofi spokesman;said the company “makes all of its pricing decisions independently.”
And Michael Bachner, Novo Nordisk’s director of media relations, told Medscape Medical News that the company’s “pricing decisions are made independently and are based on a number of market dynamics, some of which include our competitors’ activities, current formulary access, and discussions with payers.”
Rising Insulin Prices Impact Patients Diabetes Management Holistic Wellness
Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices, according to Anne Webster, NP, with UnityPoint Health.
Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices, according to Anne Webster, NP, with UnityPoint Health.
Webster said she has been forced to prescribe less effective insulin options in recent months and has seen patients beginning to ration their medications. In addition to impacting their physical health, Webster said she has seen patients struggling with their mental and financial wellbeing over the last few months, and she sees no end in sight. The only solution, she said, is for Health and Human Services Director Xavier Becerra, JD, to enforce federal policies to ensure affordable medication access.
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There have been several initiatives carried out in the commercial sector to address insulin affordability. Last year, for example, the insurer Cigna and its pharmacy benefit management division Express Scripts announced a program designed to cap out-of-pocket costs for diabetic patients at $25 a month.
Moreover, the recent advent of biosimilar insulin products may help reduce out-of-pocket costs, as could the possibility of automatic interchangeability of biosimilar insulin and originator products.
Nevertheless, for a comprehensive approach to improving insulin affordability that reaches a larger number of diabetic patients the federal government would need to get involved, and it has to a certain extent.
Trump Administration has lowered out-of-pocket insulin costs for some
President Trump has made some dubious claims on insulin prices, including one he uttered during a September presidential debate. There, he boasted that he had helped lower the price of insulin to the point that its so cheap, its like water.
Trump also signed an executive order in July that would require federally qualified health centers to share the steep savings they receive through the 340B program with indigent patients, specifically for epinephrine and insulin products. But, this only applies to a very small portion hospitals participating in the 340B program. And, it doesnt resolve the much larger issue that the 340B program discounts arent generally winding up where theyre supposed to.
Overall Insulin Epipen Pricing Isn’t Affected
Nationally, 30 million Americans suffer from diabetes, according to the American Diabetes Association. And nearly one in 50 Americans are at risk for anaphylaxis brought on by certain foods, insect bites, medications and latex, according to a 2013 study by;the Asthma and Allergy Foundation of America.
But not all;of those patients require insulin or epinephrine.;And most who live in extreme poverty, or less than;200%;of the federal poverty level; an equation that works out to $34,840 for a family of two;;already receive free or discounted prescription drugs, a national health policy expert said.
Karyn Schwartz, a senior fellow at the Kaiser Family Foundation, a nonpartisan;nonprofit that analyzes health policy, said some patients served by the 1,400 federally backed health centers nationally, such as those;with high deductibles or those who are uninsured and paying list prices for the drugs,;would have benefitted from the new pricing rule.
But it’s hard to say how many, she said. It’s also difficult to speculate about how many new patients would switch care to a community health center;to take advantage of the discounted insulin and EpiPen prices, she said.
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Who Pays For What
Whos picking up the slack to cover these reduced prices? Weve made an effort to break it down:
Currently, Part D plan sponsors can offer prescription drugs at lower cost-sharing during the donut hole coverage gap. But the sponsors have to pick up the costs that would normally be paid by Pharma companies. Often, those costs are passed on to Medicare beneficiaries in the form of higher premiums.
This new policy makes two significant changes:
With the cost burden shifted to manufacturers, they will be paying an estimated $250 million additionally during the 5 years of this voluntary model, according to CMS. After that 5-year period starting in 2021, its unclear what happens next, but CMS will likely reassess whether to continue this policy, or make changes.
American Diabetes Association CEO Tracey Brown attended the presidential announcement in late May, praising this effort and noting that its an important first step, but more needs to be done.
Pick Up Insulin At Walmart
Through a partnership with an insulin producer, Walmart offers its ReliOn® brand of insulin for just $25 per vial. In addition to being cheap, the insulin can be purchased without a prescription. But the product comes with some notable downsides.
Most people with diabetes today take analog insulin, a newer insulin that works in predictable ways. Its extremely helpful to people who struggle to manage their blood sugar. ReliOn, on the other hand, is a synthetic human insulin, which is more difficult to manage. Unlike analogs, human insulin requires users to follow a strict diet with specific carbohydrate intakes at set times throughout the day.
Some people find it difficult to manage human insulin, especially children. And departure from the plan can be dangerous. In one instance, a man in Virginia died after switching to ReliOn. So consult with your doctor before making the switch.
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How The Cost Of Insulin Has Changed
According to;research published by the American Diabetes Association, the average price of insulin almost tripled between 2002 and 2013. In the United States, the cost is often passed onto the consumer directly. A;study done by RAND Health Care;found that the average manufacturer’s price for a unit of insulin in the US was more than 10 times the price in 32 countries.;;
According to The American Journal of Managed Care, when Eli Lilly first produced its Humalog insulin in 1996, a month-supply cost $21. In 2019, the one-month cost was around $275representing a 1,200% increase.;The rate of inflation during that same time period was only 63.67%.;
When the cost of insulin became a national talking point, Marissa said she heard a lot of comments about how you can get insulin for $25 a vial at Walmart. In reality, that kind of insulin is an older model that requires patients to follow a strict eating scheduleor experience large blood sugar fluctuations.;;
“That type of insulin is just not conducive to modern living,” she said.;
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Within the past two years, eight states passed laws that;capped the cost of insulin;to $100 or less for a month’s supply. These states include Colorado, Illinois, Maine, New Mexico, New York, Utah, Washington, and West Virginia. That still leaves most of the country without price caps.;
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The Trump administration is full of pharmaceutical executives, Tim OBrien, a Bloomberg adviser, said on a call with reporters. Azar, he added, in his work for Eli Lilly, prior to joining the administration, doubled the price of its top-selling insulin product over a five-year period.
Caitlin Oakley, a spokeswoman for Azar, said the criticism was old news, and that Azar has prioritized lowering drug costs more aggressively than any prior health secretary.
In fact, she said in a statement, it is his deep knowledge about the opaque drug pricing system that has driven this administration priority forward.
Even in the campaigns early stages, long-shot candidates spotlighted their own insulin bona fides. Eric Swalwell, the California congressman, whipped an insulin vial out of his pocket during a CNN town hall, telling a national audience that he had carried the medication on his person for three months after a constituent gifted it to him.
When you run for president, you cant go a couple of days without talking to somebody whos describing someone they love whos dependent on insulin or some medication, Buttigieg told a STAT reporter at a recent meeting with the Boston Globes editorial board.
One particular example, Buttigieg said, remained top of mind.
One affiliated advocacy network, the insulin-focused nonprofit T1 International, has grown to encompass chapters in 34 states.
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Senate Report Blasts Insulin Makers For High Prices
January 21, 2021 A new, bipartisan report from a key congressional committee is sharply critical of the three major drug manufacturers that sell insulin in the U.S. The companies Eli Lilly, Novo Nordisk, and Sanofi already have been all over the news recently for their pricing behavior. They also are the ringleaders of a group of drug companies that are circumventing federal law by refusing to provide 340B drug pricing program discounts to safety-net providers for drugs dispensed at community pharmacies.
The influential Senate Finance Committee released the report, which is the result of a two-year investigation by the panel. It concludes that the insulin-producing companies Eli Lilly, Novo Nordisk, and Sanofi aggressively raised the of their insulin products absent significant advances in the efficacy of the drugs. Those price increases often were the result of shadow pricing, where one company tracks whether its competitors are raising prices and raises its own price shortly after.
The investigation found that the three companies negotiated discounts with pharmacy benefit managers to be included in their drug formularies and then raised WAC prices. Each of the companies closely monitored the pricing decisions of their competitors and increased prices in lockstep. Sanofi and Novo Nordisk often announced price hikes within hours or days of each other, the report noted.
The committee reviewed pricing for insulin pens and reported that:
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What This Means For You
You or a loved one might be paying high prices for insulin. Check with your insulin manufacturer to see if you qualify for a patient assistance program. If you aren’t eligible for these programs, talk to your healthcare provider or certified diabetes care and education specialist about other options.
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Insulin Makers Middlemen Stonewall Strike Back
“This industry is anything but a free market when PBMs spur drug makers to hike list prices in order to secure prime formulary placement and greater rebates and fees,” Grassley said;in a statement.
“Our investigation worked to get to the bottom of this. We found that the business practices of and the competitive relationships between manufacturers and middlemen have created a vicious cycle of price increases that have sent costs for patients and taxpayers through the roof.”;
Wyden said, “Insulin manufacturers lit the fuse on skyrocketing prices by matching each other’s price increases step for step rather than competing to lower them, while PBMs, acting as middlemen for insurers, fanned the flames to take a bigger cut of the secret rebates and hidden fees they negotiate.”
The American Diabetes Association notes that determining actual costs to consumers is difficult: “out-of-pocket costs vary depending upon the type of health insurance each individual has and the type of insulin prescribed.”
A study by Ohio-based 3 Axis Advisors of 41,000 prescriptions from more than 1,500;independent pharmacies for a three-pack of Lantus Solostar insulin pens shows;an average co-pay;of about $34, and a median of about $9, for January through October 2020. About 1 in 12 co-pays topped $110.
J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the trade group representing pharmacy benefit managers, said in a statement: