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Geriatricians Can Help Aging Patients Navigate Multiple Ailments

For months, Teresa Christensen’s 87-year-old mother, Genevieve, complained of pain from a nasty sore on her right foot. She stopped going to church. She couldn’t sleep at night. Eventually, she stopped walking except when absolutely necessary.

Her primary care doctor prescribed three antibiotics, one after another. None worked.

“Doctor, can’t we do some further tests?” Teresa Christensen remembered asking. “I felt that he was looking through my mother instead of looking at her.”

Referred to a wound clinic, Genevieve was diagnosed with a venous ulcer, resulting from poor circulation in her legs. A few weeks ago, she had a successful procedure to correct the problem and returned home to the house where she’s lived for more than 50 years in Cottage Grove, Minn., a suburb of St. Paul.

Judith GrahamNAVIGATING AGING

Would her mother benefit from seeing a geriatrician going forward, wondered Christensen, her mother’s primary caregiver, in an email to me? And, if so, how would she go about finding one?

I reached out to several medical experts, and they agreed that a specialist in geriatrics could help a patient like Genevieve, with a history of breast cancer and heart failure, who’d had open heart surgery at age 84 and whose mobility was now compromised.

Geriatricians are “experts in complexity,” said Dr. Eric Widera, director of the geriatrics medicine fellowship at the University of California, San Francisco.

No one better understands how multiple medical problems interact in older people and affect their quality of life than these specialists on aging. But their role in the health care system remains poorly understood and their expertise underused.

Interviews with geriatricians offer insights useful to older adults and their families:

Basic knowledge. Geriatricians are typically internists or family physicians who have spent an extra year becoming trained in the unique health care needs of older adults.

They’re among the rarest of medical specialties. In 2016, there were 7,293 geriatricians in the U.S. — fewer than two years before, according to the American Geriatrics Society.

Geriatricians can serve as primary care doctors, mostly to people in their 70s, 80s and older who have multiple medical conditions. They also provide consultations and work in interdisciplinary medical teams caring for older patients.

Recognizing that training programs can’t meet expected demand as the population ages, the specialty has launched programs to educate other physicians in the principles of geriatric medicine.

“We’ve been trying to get all clinicians trained in what we call the ‘101 level’ of geriatrics,” said Dr. Rosanne Leipzig, a professor of geriatrics at the Icahn School of Medicine at Mount Sinai in New York City.

Essential competencies. Researchers have spent considerable time over the past several years examining what, exactly, geriatricians do.

A 2014 article by Leipzig and multiple co-authors defined 12 essential competencies, including optimizing older adults’ functioning and well-being; helping seniors and their families clarify their goals for care and shaping care plans accordingly; comprehensive medication management; extensive care coordination; and providing palliative and end-of-life care, among others skills.

Underlying these skills is an expert understanding how older adults’ bodies, minds and lives differ from middle-age adults.

“We take a much broader history that looks at what our patients can and can’t do, how they’re getting along in their environment, how they see their future, their support systems, and their integration in the community,” said Dr. Kathryn Eubank, medical director of the Acute Care for Elders unit at the San Francisco Veterans Affairs Medical Center. “And when a problem arises with a patient, we tend to ask ‘How do we put this in the context of other concerns that might be contributing?’ ”

Geriatric syndromes. Another essential competency is a focus on issues that other primary care doctors often neglect — notably falls, incontinence, muscle weakness, frailty, fatigue, cognitive impairment and delirium. In medicine, these are known as “geriatric syndromes.”

“If you’re losing weight, you’re falling, you can’t climb a flight of stairs, you’re tired all the time, you’re unhappy and you’re on 10 or more medications, go see a geriatrician,” said Dr. John Morley, professor of geriatrics at Saint Louis University.

“Much of what we do is get rid of treatments prescribed by other physicians that aren’t working,” Morley continued.

Recently, he wrote of an 88-year-old patient with metastasized prostate cancer who was on 26 medications. The older man was troubled by profound fatigue, which dissipated after Morley took him off all but one medication. (Most of the drugs had minimal expected benefit for someone at the end of life.) The patient died peacefully eight months later.

Eubank tells of an 80-year-old combative and confused patient whom her team saw in the hospital after one of his legs had been amputated. Although physicians recognized the patient was delirious, they had prescribed medications that worsened that condition, given him insufficient pain relief and overlooked his constipation.

“Medications contributing to the patient’s delirium were stopped. We made his room quieter so he was disturbed less and stopped staff from interrupting his sleep between 10 p.m. and 6 a.m.,” Eubank said. “We worked to get him up out of bed, normalized his life as much as possible and made sure he got a pocket talker [hearing device] so he could hear what was going on.”

Over the next four days, the patient improved every day and was successfully discharged to rehabilitation.

Finding help. A geriatric consultation typically involves two appointments: one to conduct a comprehensive assessment of your physical, psychological, cognitive and social functioning, and another to go over a proposed plan of care.

The American Geriatrics Society has a geriatrician-finder on its website — a useful resource. Also, you can check whether a nearby medical school or academic medical center has a department of geriatrics.

Many doctors claim competency in caring for older adults. Be concerned if they fail to go over your medications carefully, if they don’t ask about geriatric syndromes or if they don’t inquire about the goals you have for your care, advised Dr. Mindy Fain, chief of geriatrics and co-director of the Arizona Center on Aging at the University of Arizona.

Also, don’t hesitate to ask pointed questions: Has this doctor had any additional training in geriatric care? Does she approach the care of older adults differently — if so, how? Are there certain medications she doesn’t use?

“You’ll be able to see in the physician’s mannerisms and response if she takes you seriously,” Leipzig said.

If not, keep looking for one who does.

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Categories: Aging, Navigating Aging, Syndicate

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Docs In Northwest Tweak Aid-In-Dying Drugs To Prevent Prolonged Deaths

Two years after an abrupt price hike for a lethal drug used by terminally ill patients to end their lives, doctors in the Northwest are once again rethinking aid-in-dying medications — this time because they’re taking too long to work.

The concerned physicians say they’ve come up with yet another alternative to Seconal, the powerful sedative that was the drug of choice under Death with Dignity laws until prices charged by a Canadian company doubled to more than $3,000 per dose.

It’s the third drug mixture recommended by the doctors whose medication protocols help guide decisions for prescribers in the six U.S. states where aid-in-dying is allowed.

The first Seconal alternative turned out to be too harsh, burning patients’ mouths and throats, causing some to scream in pain. The second drug mix, used 67 times, has led to deaths that stretched out hours in some patients — and up to 31 hours in one case.

“[Twenty percent] of the cases were 3 hours or more before death, which we think is too long,” said Robert Wood, a retired HIV/AIDS researcher who volunteers with the advocacy group End of Life Washington, in an email. “The longest was 31 hours, the next longest 29 hours, the third longest 16 hours and some 8 hours in length.”

Patients and families are told to expect sleep within 10 minutes and death within four hours. When it takes far longer, family members get worried, even distressed, said Dr. Carol Parrot, a retired anesthesiologist who has prescribed drugs for dozens of aid-in-dying patients in Washington.

The doctors say this can be addressed with larger doses of the three drugs they have been using — diazepam, often used to treat anxiety; digoxin, used to treat heart issues; and morphine, a narcotic pain reliever — plus another heart medication, propranolol, in a four-drug cocktail aimed at quickly inducing death, Wood said.

Parrot and Wood are part of a seven-member group of doctors in the Northwest who came up with the three-drug protocol after Valeant Pharmaceuticals Inc., acquired the rights to secobarbital, known as Seconal, in 2015 and raised the price sharply.

“We wanted the new drug regime to be safe, reliable and effective — and cost $500 or less,” said Parrot.

Since 1997, when Oregon’s Death with Dignity law became the first in the nation, doctors had relied on fast-acting, relatively inexpensive barbiturates — either secobarbital or pentobarbital — for patients with terminal diagnoses who sought aid in dying in Oregon, Washington, California, Colorado, Montana and Vermont. The practice also has been approved in Washington, D.C., but is being reviewed by Congress.

Pentobarbital became unavailable after drugmakers blocked its use in U.S. death penalty executions.

Concerns about the overly long deaths surfaced last summer, Parrot said. Nearly all of the problems occurred in patients already taking high doses of opiates.

“We run into patients who are so tolerant or dependent on narcotics that even the astronomically high doses of oral narcotics in our prescription do not stop them from breathing,” she said.

If patients have diseases that slow or alter normal organ function, it can affect the speed and amount of drugs absorbed in the small intestine, metabolized in the liver and sent to the rest of the body. Very large patients, too, may require larger doses.

Deaths aren’t required to be supervised, and no doctor was present with the unidentified patient who took 31 hours to die, so doctors would only be speculating about the reason, Parrot said.

Not all patients — or doctors — experienced overly long deaths with the previous drug mixture. Dr. Lonny Shavelson , a Berkeley, Calif., physician who has supervised two dozen aid-in-dying deaths under California’s new law, said it worked fine.

“My personal experience is I haven’t had long deaths with it,” Shavelson said.

And not all doctors think long deaths are a problem. In Oregon, even with fast-acting barbiturates, time to death has ranged from one minute to 104 hours during the 20 years the law has been in effect, state records show.

“I’ve heard stories where it took quite a number of hours to die, and it was fine,” said Dr. David Grube, an Oregon-based medical director for the advocacy group Compassion & Choices.

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Pat Hansen, 69, of Wenatchee, Wash., chose to end her life with lethal medications under Washington’s aid-in-dying law. Hansen, who had end-stage kidney failure, congestive heart failure and other ailments, went to sleep within minutes after taking the drugs and stopped breathing within 20 minutes, her family said. (Courtesy of Scott Kreiter)

Scott and Amy Kreiter, of Wenatchee, Wash., didn’t know what to expect when Scott’s mother, Patricia Hansen, 69, decided to take the lethal drugs on Dec. 26, 2016. Hansen, a lively woman who once ran a gourmet ice cream business, had endured frequent hospitalizations for end-stage kidney failure, congestive heart failure and other ailments.

“She said, ‘I want to listen to Willie Nelson, I want to play a game of Scrabble, I want to drink a Rob Roy or two, and then I want to be done,’” Scott Kreiter, 47, said.

Hansen proceeded to “kick our butts” at Scrabble, her son said — including fulfilling a goal of getting a triple-word score with a dirty word. Then she mixed the drugs with scotch and drank the solution.

“She didn’t complain. She just took it,” her son recalled. “She said, ‘You thought I’d chicken out, didn’t you?’”

Within two minutes of downing the mixture, Hansen was asleep. Within 20 minutes, her breathing had stopped.

“We thought it would take one to two hours,” Amy Kreiter said. “It if had gone on for hours, we would have thought we did it wrong.”

Critics of aid-in-dying say growing reports of overly long deaths underscore their objections. Dr. David Stevens, CEO of Christian Medical & Dental Associations, which has tried to halt or reverse laws, said coming up with new drug protocols could eventually be a step toward Holland’s practice of allowing euthanasia by lethal injection “so the patient could be killed ‘humanely.’”

“We are heading down that same path,” Stevens said in an email.

But Parrot and other frequent prescribers of aid-in-dying drugs say they are looking for the best way to honor the wishes of patients in states where the practice is allowed. Doctors recently began using the newest drug mixture and will gather data about its effectiveness.

“We’re not experimenting,” Parrot said. “We are working with available drugs to provide dying patients a comfortable, peaceful death that is reliable and safe for them and comforting for their families as well.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

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Health Law’s 10 Essential Benefits: A Look At What’s At Risk In GOP Overhaul

As Republicans look at ways to replace or repair the health law, many suggest shrinking the list of services insurers are required to offer in individual and small group plans would reduce costs and increase flexibility. That option came to the forefront last week when Seema Verma, who is slated to run the Centers for Medicare & Medicaid Services in the Trump administration, noted at her confirmation hearing that coverage for maternity services should be optional in those health plans.

Maternity coverage is a popular target and one often mentioned by health law critics, but other items also could be watered down or eliminated.

There are some big hurdles, however. The health law requires that insurers who sell policies for individuals and small businesses cover at a minimum 10 “essential health benefits,” including hospitalization, prescription drugs and emergency care, in addition to maternity services. The law also requires that the scope of the services offered be equal to those typically provided in employer coverage.

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“It has to look like a typical employer plan, and those are still pretty generous,” said Timothy Jost, an emeritus professor at Washington and Lee University Law School in Virginia who is an expert on the health law.

Since the 10 required benefits are spelled out in the Affordable Care Act, it would require a change in the law to eliminate entire categories or to water them down to such an extent that they’re less generous than typical employer coverage. And since Republicans likely cannot garner 60 votes in the Senate, they will be limited in changes that they can make to the ACA. Still, policy experts say there’s room to “skinny up” the requirements in some areas by changing the regulations that federal officials wrote to implement the law.

Habilitative Services

The law requires that plans cover “rehabilitative and habilitative services and devices.” Many employer plans don’t include habilitative services, which help people with developmental disabilities such as cerebral palsy or autism maintain, learn or improve their functional skills. Federal officials issued a regulation that defined habilitative services and directed plans to set separate limits for the number of covered visits for rehabilitative and habilitative services.

Those rules could be changed. “There is real room for weakening the requirements” for habilitative services, said Dania Palanker, an assistant research professor at Georgetown University’s Center on Health Insurance Reforms who has reviewed the essential health benefits coverage requirements.

Oral And Vision Care For Kids

Pediatric oral and vision care requirements, another essential health benefit that’s not particularly common in employer plans, could also be weakened, said Caroline Pearson, a senior vice president at Avalere Health, a consulting firm.

Mental Health And Substance Use Disorder Services

The health law requires all individual and small group plans cover mental health and substance use disorder services. In the regulations the administration said that means those services have to be provided at “parity” with medical and surgical services, meaning plans can’t be more restrictive with one type of coverage than the other regarding cost sharing, treatment and care management.

“They could back off of parity,” Palanker said.

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Prescription Drugs

Prescription drug coverage could be tinkered with as well. The rules currently require that plans cover at least one drug in every drug class, a standard that isn’t particularly robust to start with, said Katie Keith, a health policy consultant and adjunct professor at Georgetown Law School. That standard could be relaxed further, she said, and the list of required covered drugs could shrink.

Preventive And Wellness Services And Chronic Disease Management

Republicans have discussed trimming or eliminating some of the preventive services that are required to be offered without cost sharing. Among those requirements is providing birth control without charging women anything out of pocket. But, Palanker said, “if they just wanted to omit them, I expect that would end up in court.”

Pregnancy, Maternity And Newborn Care

Before the health law passed, just 12 percent of health policies available to a 30-year-old woman on the individual market offered maternity benefits, according to research by the National Women’s Law Center. Those that did often charged extra for the coverage and required a waiting period of a year or more. The essential health benefits package plugged that hole very cleanly, said Adam Sonfield, a senior policy manager at the Guttmacher Institute, a reproductive health research and advocacy organization.

“Having it in the law makes it more difficult to either exclude it entirely or charge an arm and a leg for it,” Sonfield said.

Maternity coverage is often offered as an example of a benefit that should be optional, as Verma advocated. If you’re a man or too old to get pregnant, why should you have to pay for that coverage?

That a la carte approach is not the way insurance should work, some experts argue. Women don’t need prostate cancer screening, they counter, but they pay for the coverage anyway.

“We buy insurance for uncertainty, and to spread the costs of care across a broad population so that when something comes up that person has adequate coverage to meet their needs,” said Linda Blumberg, a senior fellow at the Health Policy Center at the Urban Institute.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

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Former FDA Chief Cites 5 Things To Watch On Drug Approvals, And Keeping Drugs Safe

The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump.

Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. His takeaways:

1. Faster drug approvals, being advocated by Trump and others, don’t necessarily mean less expensive drugs.

“What I’m concerned about is that when people hear ‘faster approval,’ you get an image of the FDA sitting on this application and, you know, twiddling thumbs,” Califf said. “That’s not what happens.”

Califf explained that the slow part of getting a drug into patients’ hands happens well before the drugmaker submits an application to the FDA. It can take decades to discover, tweak and test a new drug molecule, and that development process is what needs a boost.

“The real action [happens] before the application gets submitted and that can be a time frame from years to decades as people try to figure out what will work and what will not,” Califf said.

Although faster drug development could bring development costs down, Califf said, “There’s not a direct relationship between the cost of development and the price of drugs or devices.”

“The concept of safety is much more complex than most people think about until they look into it deeply,” said Robert Califf, just-departed FDA administrator. (Courtesy of the FDA)

“The concept of safety is much more complex than most people think about until they look into it deeply,” said Robert Califf, just-departed FDA administrator. (Courtesy of the FDA)

2. A law passed in December should streamline drug approvals — in a positive way.

The 21st Century Cures Act, a bipartisan bill signed by President Barack Obama late last year, is a “very well-rounded piece of legislation that will speed up product development.”

To begin with, it encourages the FDA to consider pieces of information in its approval process in addition to traditional clinical trials, including “real world evidence” and biomarkers. Biomarkers are used in studies in place of outcomes that are more difficult to measure. For example, tumor shrinkage is sometimes a biomarker for surviving cancer.

“Using real world evidence in clinical trials is one that I’m particularly excited about as a way to get better answers at a lower cost and faster at the same time,” Califf said.

3. But Califf has concerns about maintaining drug safety standards and ensuring thorough clinical trials.

“The concept of safety is much more complex than most people think about until they look into it deeply,” Califf said. “All drugs have risk. None of them are absolutely safe. And the actual safety risks are only revealed through clinical trials with the same quality and number of patients involved as it takes to look at efficacy.”

About 92 percent of drugs that get into human clinical trials don’t make it to market because they fail to show any benefit or, worse, they have unexpected toxicity, he said.

“Declaring a drug is safe after very little information is treacherous,” Califf said.

Califf recently wrote for JAMA on the FDA’s balancing act of protecting the public and encouraging innovation. And the FDA released a paper last month documenting examples of a promising drug, vaccine or device that each did well in a Phase 2 clinical trial but “bombed out” in Phase 3, Califf said. Drugs typically go through three “phases” of studies called clinical trials before gaining FDA approval. With each new phase, researchers test drugs or other products on more people and on more measures of safety and effectiveness.

“It’s 22 examples of why it’s a big mistake to think that you can judge the balance of risk and benefit from a small amount of data,” Califf said.

4. Faster, better drugs can’t be approved if the FDA is understaffed, he argued.

Califf called a potential FDA hiring freeze “unfortunate” and said new staff is needed to meet the faster approval timelines and to give advice to those developing drugs so “bad mistakes” aren’t made.

The FDA has been steadily hiring staff to keep up with the growing industry it oversees. But hundreds of openings are still left to be filled.

Califf said the drug industry’s most valued interaction with the FDA is “during the process of [drug] development,” which begins before a drug application is submitted for approval. FDA staff can provide timely feedback and advice that can help a company choose the right studies needed for approval and, effectively, speed up drug development.

“A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate. I hope that the dust will settle soon and the FDA can get back to its hiring,” Califf said.

5. The FDA is using big data to track the safety of drugs already on the market — and it plans to do that a lot more.

The FDA has an established adverse event database but after pain reliever Vioxx was pulled from the market in 2004, the agency began working on a system called Sentinel.

The initiative uses claims data to look at drug safety. It has 180 million individual electronic records and tracks every dispensed prescription, hospitalization as well as serious outcomes, Califf said. In addition, Sentinel is now being opened up to industry and academia.

“It’s used every day by the FDA,” Califf said, adding that the system is “getting better and better.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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Drugmaker Marathon ‘Pausing’ Delivery Of $89,000-a-year Muscular Dystrophy Drug

In a surprise move Monday, Marathon Pharmaceuticals told patient advocates that it would “pause” the launch of their drug Emflaza because of pricing concerns expressed by patients and advocacy groups.

The drugmaker had announced an $89,000 annual price tag for their newly-approved drug last week — but patients and lawmakers immediately cried foul.

“What you’re doing is robbing my insurance company,” said Dana Edwards, a mother from New Jersey whose 12-year-old has taken deflazacort, the generic version of the drug, since he was five years old.

Newly approved Emflaza treats Duchenne muscular dystrophy, a rare, devastating neuromuscular disorder. Patients have been importing the generic version of the drug from overseas for about $1,200 a year.

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A statement read to a conference of parents, patients and advocates in Washington, D.C., and attributed to Marathon CEO Jeffrey Aronin said: “Our goal in commercializing Emflaza all along has been to make it available to that broader set of patients who prior to FDA approval have not had access to the therapy… We are pausing our launch, which has not yet taken place. We have not sold any new product and will pause that process.”

Pat Furlong, the president and founder of Parent Project Muscular Dystrophy, which sponsored the Monday morning conference, read the statement to an outraged crowd in a conference room at the Mayflower Hotel.

The company will continue to offer patients an expanded access program, Furlong read, which allows about 800 patients to receive the drug from the company. More can join that program for free, and patients can continue importing drugs from Canada or “wherever they are getting it,” the statement said.

Furlong told the audience that complaints from patients helped to prompt Marathon’s action: “Since last week’s approval, they’ve heard from all of us,” he said.

Late Monday, Marathon released a statement and open letter to the Duchenne community, elaborating on its goals of patient access and promising that “price should not be a barrier.”

“Put simply we expect patients will pay a standard copay of typically $20 or less per prescription,” the statement reads.

A Marathon Pharmaceutical executive speaks at the Parent Project Muscular Dystrophy advocacy conference. (Sarah Jane Tribble/KHN)

A Marathon Pharmaceutical executive speaks at the Parent Project Muscular Dystrophy advocacy conference. (Sarah Jane Tribble/KHN)

The company also heard from Capitol Hill. On Monday morning, Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., sent a letter to Marathon demanding answers about the $89,000 price tag for a drug that has been routinely used by Duchenne patients since at least 2005.

“We believe Marathon is abusing our nation’s ‘orphan drug’ program, which grants companies seven years of market exclusivity to encourage research into new treatments for rare diseases — not to provide companies like Marathon with lucrative market exclusivity rights for drugs that have been available for decades,” Sanders and Cummings wrote.

Orphan drugs are medicines targeted at people with rare diseases, which often carry very high price tags. Emflaza was approved last Thursday for treating Duchenne disease. The drug is a steroid that manages symptoms for Duchenne’s sufferers; it does not cure the underlying disease.

In January, Kaiser Health News published an investigation that found that the orphan drug program intended to help desperate patients is being manipulated by drugmakers. While the companies aren’t breaking the law, they are using the Orphan Drug Act to secure lucrative incentives and gain monopoly control of rare disease markets, the investigation found.

Republican Rep. Robert Aderholt, the chairman of the Appropriations subcommittee that funds the FDA, said the 6000 percent increase in deflazacort’s price “makes me question whether the current construct of how FDA approves orphan drugs does more harm than good if companies have found a way to game the system.”

In addition to orphan status, the FDA gave Marathon a rare pediatric disease priority review voucher, which the company can sell for millions of dollars to another drugmaker who can use it to expedite their own drug’s approval.

At Monday’s meeting, Marathon executives presented a slideshow to a packed room that detailed different patient financial assistance programs as well as the drug’s expected availability. Emflaza was expected to be on the market by mid-March, said Eric Messner, vice president of sales and marketing for Marathon.

Messner explained that the drug would cost between $50,000 to $54,000 after rebates and discounts. And he emphasized that Marathon did not expect patients to pay that price. “We expect that patients will experience a low or zero out-of-pocket experience. I know there has been a lot of discussion about that. How did we arrive at the price?” Messner said. An audience member interrupted Messner asking if the company had talked to patients and families about the price.

He offered assurance that they did and said there would be an ongoing dialogue with patient groups.

Edwards, the New Jersey mother, said she hopes President Donald Trump will fulfill his vow to bring down high drug prices.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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