Wednesday, 31 August 2016
State Highlights: Another Strike Looms For Minn. Nurses; Deal Reached On Calif. Bill Backed By Planned Parenthood
Tuesday, 30 August 2016
Monday, 29 August 2016
Friday, 26 August 2016
Wednesday, 24 August 2016
Viewpoints: Public Option Would Boost Obamacare; Disturbing Trend Of Diagnosing Clinton And Trump's Physical And Mental Health
Tuesday, 23 August 2016
Monday, 22 August 2016
Aetna last week joined other health insurers in withdrawing from many of the health exchanges set up under the Affordable Care Act. The company cited an unsustainable financial situation. But that motive is being questioned: It was revealed last week that Aetna had earlier warned it would reduce its presence in the exchanges if the Justice Department sued to block its deal to acquire Humana. The government filed that suit last month. Regardless, this latest pullback from Obamacare leaves a lot of questions about competitive options in the exchanges, how consumers will be affected and the future of the law.
KHN's Julie Rovner joined a panel of guests on The Diane Rehm Show on Aug. 18 to discuss the move and how it might affect the presidential campaign.
Thursday, 18 August 2016
Wednesday, 17 August 2016
After being approved by a key committee last week, a bill that would have required drug companies to justify treatment costs and price hikes was pulled by its author on Wednesday.
California state Sen. Ed Hernandez (D-West Covina) said that he introduced the bill “with the intention of shedding light on the reasons precipitating skyrocketing drug prices.” But amendments by an Assembly committee last week make it difficult to accomplish this goal, he said in a statement.
“The goal was transparency, making sure drug companies played by the same rules as everyone else in the health care industry,” he said.
The original bill required that drug manufacturers notify state agencies and health insurers within 60 days of federal approval of a new drug with a price tag of $10,000 or more per year or for one course of treatment and provide information justifying those prices. It also required these companies to provide notice before they increased the price of a drug by more than 10 percent. It was approved by the Senate in June.
But amendments by the Assembly Appropriations committee raised the reporting threshold for drug price increases to more than 25 percent. The amendments also removed the requirement for drug companies to provide justification for the price increases and delayed by a year when these notifications would have to go into effect.
“I would have preferred to see the Legislature tackle the need for pharmaceutical pricing transparency this year, but I respect Senator Hernández's decision,” said Assemblywoman Lorena Gonzalez (D-San Diego), chair of the Assembly Appropriations committee. “I believe the amended version of SB 1010 [the bill] would have provided a first-in-the-nation framework this year that could have been built upon in the future.”
Hernandez said he will continue to work closely with health advocates and community organizations until they “get it right.”
“This is an issue that will not go away and the public demands answers,” he added.
The bill had gathered support from patient, labor, education and business groups and was opposed primarily by the pharmaceutical industry. The opponents have said the bill places the responsibility solely on drug companies, ignoring that other organizations also affect drug prices, including wholesalers, distributors, health plans and other purchasers.
Some groups representing seniors and patients with chronic diseases had also expressed concerns about the legislation.
“The voters are with us and will be even more so in the future,” said Anthony Wright, executive director of Health Access California, a Sacramento-based health care advocacy group. “Every new high-priced drug or unjustified price spike increases public attention and anger, not to mention contributes to rising health premiums.”
Supporters referred to the bill as a solution to battling rising health care costs. Allowing insurers and state purchasers to know the cost of drugs at least 30 days in advance would enable them to better negotiate prices, supporters had said.
Key state drug purchasers include the California Public Employees' Retirement System and Medi-Cal, the state's version of the Medicaid program for low-income people.
Researchers have said that while drug price transparency measures alone, such as Hernandez's bill, would not bring health care costs down, they could help prevent drug companies from raising prices without explanation.
Similar proposals in other states have included requiring drug companies to report closely held research and development costs to government agencies. California joins other states where efforts have been stalled this year.
Hernandez's bill is separate from a ballot initiative on drug prices also garnering publicity this summer. That initiative, Proposition 61, would prohibit the state from paying more for prescription drugs than the lowest prices negotiated by the U.S. Department of Veterans Affairs.
For consumers, the idea of getting a genetic test to determine risks for hereditary diseases is becoming an increasingly common proposition, but new research suggests that sometimes the accuracy of those results may depend on what ethnicity you are.
Take, for instance, hypertrophic cardiomyopathy, one of the most common hereditary heart diseases. It is also a silent disorder that has caused countless young athletes to suffer sudden collapse or cardiac arrest during team practices or sporting events.
African Americans have traditionally been considered at higher risk for the disorder. But a study out Wednesday in the New England Journal of Medicine concluded that common ways to determine that level of risk may be skewed because studies have traditionally had low numbers of black participants. It turns out that genetic characteristics based on ethnic differences caused some people to be diagnosed with a predilection for the disease - even though those markers were actually benign.
The researchers suggest these findings indicate a need for diversity in genomic research in interpreting these differences.
“Historically we've had less African American representation in these studies,” said Arjun Manrai, lead author of the study and research fellow at the Harvard Medical School. “Our paper highlights ethnicity as a key way to get a handle on classification of genetic variants.” Genetic variants are differences in DNA structure that determine human features and are unique to every person.
Manrai first looked at the data from the National Heart, Lung, and Blood Institute Exome Sequencing Project, which includes genomic data from 4,300 white Americans and 2,204 African Americans. He expected to find that 1 out of 500 individuals would have the genetic variants that cause the disease - that's the rate at which the disorder occurs in the general population. But instead, he found that 1 out of 4 individuals had those mutations and those individuals were disproportionately African Americans.
“This was the initial shocking revelation,” he said.
His team decided to figure out if those mutations were misclassified as harmful. They first looked at the initial studies that identified these genetic variants as disease-causing, focusing on five specific abnormalities that appear most frequently in the NHLBI population. They found that these studies had small sample sizes and none had representative samples of African Americans in their control groups.
They then compared genetic sequences of African Americans and whites through the 1000 Genomes Project, which has genome data from 14 populations worldwide, confirming the five variants they identified occurred most commonly among African Americans.
At the same time, they examined data from the Laboratory for Molecular Medicine operated by Partners HealthCare Personalized Medicine, a clinical lab that diagnoses and performs genetic testing for patients. By using the lab's classification system that includes data regarding the frequency of genetic variants in control populations, they determined that these five variants were actually benign. Four had been classified by the Human Gene Mutation Database in the most pathogenic category.
In the Partners' clinic records for the past decade, the authors found seven patients of African or unspecified ancestry between 2005 and 2007 who were told they had the disease-causing genes based on these misclassified variants. According to their calculations, inclusion of even a small number of African Americans in study control groups could have prevented the misclassifications.
In regard to hypertrophic cardiomyopathy, the misdiagnoses of risk may have resulted in unnecessary hardships for the patients and the families. But the lack of diversity in scientific studies and control groups can have other significant implications. Esteban Burchard, a professor at the University of California San Francisco, has studied how genetic differences can lead to higher rates of asthma among African Americans, but the drugs designed to treat diseases, he wrote, often work better in people of European origins.
Burchard published a study last year that showed less than 5 percent of lung disease studies funded by the National Institutes of Health in the last two decades have statistically meaningful number of participants from ethnic minorities.
“It's like basing your whole world … on one opinion or one biologic resource,” Burchard said. “And that's a problem because we miss the variation in genetics that is present worldwide.”
Genomic data from diverse populations is needed to find mutations specific to different ethnicities that indicate disease or in some cases, demonstrate responsiveness to treatments, he said.
Manrai points toward relatively new projects, such as the NHLBI Exome Sequencing Project and the 1,000 Genomes that now have genomic sequences from diverse populations, although there is still a need for data from Native Americans and Asian Americans.
“There is now an opportunity to use those resources to study hypertrophic cardiomyopathy and other diseases as well as reassess a lot of studies that support the genetic studies that might be decades old,” Manrai said. “Since studies in the past do not have perfect mixes and they shape the current literature, it's important to evaluate those studies with current data.”
Monday, 15 August 2016
Thursday, 11 August 2016
Wednesday, 10 August 2016
State Highlights: Strict Calif. Vaccine Law Likely To Cut Disease Rates; N.H. Workers' Comp Rates Fall For 5th Year In A Row
Tuesday, 9 August 2016
SAN FRANCISCO - Janet Prochazka was active and outspoken, living by herself and working as a special education tutor. Then, in March, a bad fall landed her in the hospital.
Doctors cared for her wounds and treated her pneumonia. But Prochazka, 75, didn't sleep or eat well at Zuckerberg San Francisco General Hospital and Trauma Center. She became confused and agitated and ultimately contracted a serious stomach infection. After more than three weeks in the hospital and three more in a rehabilitation facility, she emerged far weaker than before, shaky and unable to think clearly.
She had to stop working and wasn't able to drive for months. And now, she's considering a move to Maine to be closer to relatives for support.
“It's a big, big change,” said her stepdaughter, Kitty Gilbert, soon after Prochazka returned home. “I am hopeful that she will regain a lot of what she lost, but I am not sure.”
Many elderly patients like Prochazka deteriorate mentally or physically in the hospital, even if they recover from the original illness or injury that brought them there. About one-third of patients over 70 years old and more than half of patients over 85 leave the hospital more disabled than when they arrived, research shows.
As a result, many seniors are unable to care for themselves after discharge and need assistance with daily activities such as bathing, dressing or even walking.
“The older you are, the worse the hospital is for you,” said Ken Covinsky, a physician and researcher at the University of California, San Francisco division of geriatrics. “A lot of the stuff we do in medicine does more harm than good. And sometimes with the care of older people, less is more.”
Hospital staff often fail to feed older patients properly, get them out of bed enough or control their pain adequately. Providers frequently restrict their movements by tethering them to beds with oxygen tanks and IV poles. Doctors subject them to unnecessary procedures and prescribe redundant or potentially harmful medications. And caregivers deprive them of sleep by placing them in noisy wards or checking vital signs at all hours of the night.
Click to view slideshow.
Interrupted sleep, unappetizing food and days in bed may be merely annoying for younger patients, but they can cause lasting damage to older ones. Elderly patients are far different than their younger counterparts - so much so that some hospitals are treating some of them in separate medical units.
San Francisco General is one of them. Its Acute Care for Elders (ACE) ward, which opened in 2007, has special accommodations and a team of providers to address the unique needs of older patients. They focus less on the original diagnosis and more on how to get patients back home, living as independently as possible.
Early on, the staff tests patients' memories and assesses how well they can walk and care for themselves at home. Then they give patients practice doing things for themselves as much as possible throughout their stay. They remove catheters and IVs, and encourage patients to get out of bed and eat in a communal dining area.
“Bed rest is really, really bad,” said the medical director of the ACE unit, Edgar Pierluissi. “It sets off an explosive chain of events that are very detrimental to people's health.”
Such units are still rare - there are only about 200 around the country. And even where they exist, not every senior is admitted, in part because space is limited.
Prochazka went to the emergency room first, then intensive care. She was transferred to ACE about a week later. The staff weaned her off some of her medications and got her up and walking. They also limited the disorienting nighttime checks. Prochazka said she got “the first good night of sleep I have had.”
But for her, the move might have been too late.
“She will not leave here where she started,” Pierluissi said several days before Prochazka was discharged. “She is going to be weaker and unable to do the things you really need to do to live independently.”
Not A Priority
How hospitals handle the old - and very old - is a pressing problem. Elderly patients are a growing clientele for hospitals, a trend that will only accelerate as baby boomers age. Patients over 65 already make up more than one-third of all discharges, according to the federal government, and nearly 13 million seniors are hospitalized each year. And they stay longer than younger patients.
Many seniors are already suspended precariously between independent living and reliance on others. They are weakened by multiple chronic diseases and medications.
One bad hospitalization can tip them over the edge, and they may never recover, said Melissa Mattison, chief of the hospital medicine unit at Massachusetts General Hospital.
Click to view slideshow.
“It is like putting Humpty Dumpty back together again,” said Mattison, who wrote a 2013 report detailing the risks elderly patients face in the hospital.
Yet the unique needs of older patients are not a priority for most hospitals, Covinsky said. Doctors and other hospital staff focus so intensely on treating injuries or acute illnesses - like pneumonia or an exacerbation of heart disease - that they can overlook nearly all other aspects of caring for the patients, he noted.
In addition, hospitals face few consequences if elderly patients become more impaired or less functional during their stays. The federal government penalizes hospitals when patients fall, get preventable infections or return to the hospital within 30 days of their discharge. But hospitals aren't held accountable if patients lose their memories or their ability to walk. As a result, most don't measure those things.
“If you don't measure it, you can't fix it,” Covinsky said.
Improving care for older patients requires an investment that hospital administrators are not always willing to make, experts said. Some argue, however, that the investment pays off - not just for older people but for hospitals themselves as well as for a country intent on controlling health care spending.
Though research on the financial impact of problematic hospital care for the elderly has been limited, a 2010 report by the Department of Health and Human Services' Office of Inspector General found that more than a quarter of hospitalized Medicare beneficiaries had suffered an “adverse event,” or harm as a result of medical care.
Those events, such as bed sores or oxygen deficiency, cost Medicare about $4.4 billion annually, according to the report. Physicians who reviewed the incidents determined that 44 percent could have been prevented.
In addition to outright mistakes, poor or inadequate treatment in hospitals leads to needless medical spending on extended hospital visits, readmissions, in-home caregivers and nursing home care. Nursing home stays cost about $85,000 a year. And the average hospital stay for an elderly person is $12,000, according to the Agency for Healthcare Research and Quality.
“If you don't feed a patient, if you don't mobilize a patient, you have just made it far more likely they will go to a skilled nursing [facility], and that's expensive,” said Robert Palmer, director of the geriatrics and gerontology center at Eastern Virginia Medical School and one of the brains behind the idea of ACE units.
ACE units have been shown to reduce hospital-inflicted disabilities in older patients, decrease lengths of stay and reduce the number of patients discharged to nursing homes. In one 2012 Health Affairs study, Palmer and other researchers found that hospital units for the elderly saved about $1,000 per patient visit.
A Different Life
After coming home, Prochazka said she felt weak. It took weeks of walking her labradoodle, Gino, to regain strength.
Her stepdaughter, Gilbert, said Prochazka has started to improve. “We knew she was getting better when she was getting ornery,” she said.
But Prochazka, who is highly educated, still has some short-term memory loss, Gilbert said.
Prochazka knows that her life after hospitalization is different than before - she will have to depend more on others. It's not an easy adjustment, she said.
“I have been somebody who has always been both mentally and physically active,” she said. “Before I fell … I was respected for what I have and what I did and all of a sudden, I'm not.”
She said her time at San Francisco General was frustrating. Getting the infection just as she was starting to recover was especially hard, she said. “I felt like I had been dealt a blow I really didn't need.”
For other patients, being admitted proactively to the special geriatric unit can stave off such precipitous declines.
Rosenda Esquivel, 80, spent 18 days at San Francisco General, much of it in the unit, this spring. She suffered no noticeable setbacks, physical or mental, during her time in the hospital, according to Annelie Nilsson, a clinical nurse specialist in the unit.
Esquivel, an animated woman who used to work as a home caregiver, was admitted with intense arthritic pain and, while hospitalized, underwent a procedure to address an abnormal heartbeat.
Soon after her arrival, Pierluissi, the ACE unit medical director, speaking to Esquivel in her native Spanish, sought to determine how independent she was at home. He learned that a friend helped take care of her but that she took pride in cooking and cleaning for herself.
The doctor noticed that Esquivel needed help to get up from a chair but that she could get around with a walker. Her memory, though, wasn't too strong. A few minutes after hearing three words - “honesty,” “baseball” and “flower” - she could only recall one of them.
Pierluissi came up with a plan for her time in the hospital: Get Esquivel's pain under control. Make sure she walks three or four times a day. Arrange for her to have a caregiver at home to remind her to take her diabetes and blood pressure medications.
Then, release her as fast as possible.
“The less time she spends here, the better,” Pierluissi said.
This story was reported while its author, Anna Gorman, participated in a fellowship supported by New America Media, the Gerontological Society of America and The Commonwealth Fund.
In his new book, David Barton Smith takes us back to the mid-1960s, when a small band of civil rights activists-cum-government bureaucrats toiled to get the nascent Medicare program up and running. In the process, they profoundly changed the way health care is delivered in this country.
It stands in marked contrast to the political turmoil over health care of recent years.
“In four months they transformed the nation's hospitals from our most racially and economically segregated institutions to our most integrated,” Smith writes in “The Power to Heal: Civil Rights, Medicare, and the Struggle to Transform America's Health Care System.”
“In four years they changed patterns of use of health services that had persisted for half a century. The fundamental moral imperative - that those needing medical care should receive it - began for the first time to reflect actual use of services. A profound transformation, now taken for granted, happened almost overnight.”
Smith, a professor emeritus of health administration at Temple University in Philadelphia, spoke with Kaiser Health News consumer columnist Michelle Andrews about his book and the implementation of Medicare, which for the first time provided a guarantee of health insurance for the elderly. The promise of payment for care for the growing number of elderly patients was a big financial incentive for hospitals, even if it meant desegregating. “Basically the hospitals, except for a few very well-endowed ones, had a choice of participating in Medicare or going bankrupt,” he said.
Smith's work is also the subject of a companion documentary under development, which is being funded by the National Endowment for the Humanities.
Here is an edited version of that conversation.
Q. It's been exactly 50 years since the Medicare program began providing health coverage to older Americans. Given today's political gridlock, it's hard to imagine how such sweeping changes in health care could have been accomplished. What was different then?
Lyndon Johnson's landslide election in 1964 made it possible for him to do almost anything. He had the Congress, the Senate and he had the ambition. What is strikingly different is the level of trust that Republican politicians had back then in some of the federal bureaucrats. The Social Security Administration was pretty much given a free hand in terms of translating the law and implementing it. I can't imagine that happening today. Every step would be blocked.
Q. In your book, you describe how there were separate hospitals for blacks, for whites and for various religious groups. Hospitals that admitted both blacks and whites had segregated wings, waiting areas and patient rooms. To what extent did health care simply reflect prevailing norms of the day?
I would say it was even more rigidly segregated. The doctors were segregated and their patients were segregated. The degree of segregation between indigent patients and private patients was much more extreme than it is today. There were separate wings, separate china. Most medical offices in the South, particularly for primary care doctors, had separate waiting rooms, and black patients would be seen only after the white patients were seen.
One of the things that was strikingly different from today: At that time you talked about racial and ethnic differences in health care and in health. The implication was that there were cultural or even genetic differences that explained the differences in the use of health care and outcomes. Now we don't talk about differences, we talk about disparities. The implication is that if there are differences, it's the responsibility of providers and not the patients to correct them. Before, [the difference was attributed to] those ignorant people who don't know how to use health care or take care of themselves.
Q. Title VI of the Civil Rights Act - which was passed into law only a year before Medicare - prohibits discrimination on the basis of race, color or national origin in programs that receive federal financial assistance. The way you tell it, applying Title VI to Medicare and prohibiting hospitals that discriminated from participating in the program wasn't something that people focused on, at least at first. What happened?
In the entire debate over the passage of Medicare, there's no mention of what the implications are, related to Title VI. It didn't come up, nobody wanted to raise it. The assumption was that some accommodation would be made that would allow segregation to continue on a separate but equal basis. So everybody thought it was going to be business as usual.
The 1954 Brown v. Board of Education Supreme Court decision, which ended legal segregation in the schools, reinforced the assumption that little would happen because very little progress was being made in desegregating the schools. The decision ordered states to end segregation with “all deliberate speed” but that [meant] no deliberate speed. [So] the hospitals thought they would have to come up with a plan and would proceed very gradually and cautiously with doing this, which would mean it wouldn't get done.
Q. But that's not what happened. Over the course of several months, a small group of government workers implemented the Medicare program. From the start, they said that hospitals that discriminated couldn't participate. How did they manage it?
Wilbur Cohen and the people in the Social Security Administration were absolutely masterful in pulling this together in such a short period of time. They knew exactly how to get things done and they paid attention to the details. It's remarkable that without the computers that we have today or the Internet, they were able to do this all in 11 months. They were just good professionals.
What's different is the Title VI enforcement part. The Public Health Service was responsible for enforcing the Medicare nondiscrimination provisions. That created an interesting takeover by the civil rights movement. The three people who were writing the rules were really committed civil rights activists. They wrote the regulations following the direction and pleading of the civil rights organizations: You cannot have “all deliberate speed,” you cannot let anybody in the program unless they've complied with some very specific requirements, including no discrimination in terms of where patients are placed or where people could go to the cafeterias or where they could be employed.
Workers from the Social Security Administration and the Public Health Service volunteered to do the hospital inspections, people who were already committed to civil rights. What actually happened in many cases, if you read through inspectors' site visit reports, they relied very heavily on local people and civil rights activists and black employees at the hospitals to tell them if the hospital was complying or not.
Q. To what extent does the Affordable Care Act help to address the economic and racial disparities that persist in health care today?
I think it's a wonderful addition. I find it ironic that the hospitals in the same states that fought the desegregation with the implementation of Medicare are the states blocking the expansion of Medicaid. [The Medicaid program was signed into law the same day as the Medicare program and faced the same Title VI requirements.] Those are the states that are most in need and the hospitals are the ones that need the money. If they could, they'd sign on the dotted line.
Q. There has been talk at various times about creating “Medicare for All.” Given what you know, what are the odds of that ever happening here?
The odds are better now than a few years ago. Because of the ACA, but also because people are beginning to understand some of the limitations of a privately insured system. It's more complicated, it's more costly, it's harder to get good competitive pricing from hospitals or from drug companies. And this idea is something that's been resisted by the insurance industry. But I get the sense that people are getting a little bit more impatient. Although a lot of Republicans bash Obamacare, I don't hear a lot of them bashing Medicare. The resistance would be strong, certainly. This is a very interesting year.
Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.
Monday, 8 August 2016
State Highlights: Calif. Bill Would Allow Midwives To Practice Independently; A New Law Aims To Prevent Suicide At N.J. Colleges
Thursday, 4 August 2016
Wednesday, 3 August 2016
Tuesday, 2 August 2016
The federal government's penalties on hospitals will reach a new high as Medicare withholds more than half a billion dollars in payments over the next year, records released Tuesday show.
The government will punish more than half of the nation's hospitals - a total of 2,597 - having more patients than expected return within a month. While that is about the same number penalized last year, the average penalty will increase by a fifth, according to a Kaiser Health News analysis.
The new penalties, which take effect in October, are based on the rehospitalization rate for patients with six common conditions. Since the Hospital Readmissions Reduction Program began in October 2012, national readmission rates have dropped as many hospitals pay more attention to how patients fare after their release.
The penalties are the subject of a prolonged debate about whether the government should consider the special challenges faced by hospitals that treat large numbers of low-income people. Those patients can have more trouble recuperating, sometimes because they can't afford their medications or lack social support to follow physician instructions, such as reducing the amount of salt that heart failure patients consume. The Centers for Medicare & Medicaid Services says those hospitals should not be held to a different standard.
Medicare said the penalties are expected to total $528 million, about $108 million more than last year, because of changes in how readmissions are measured.
Medicare examined these conditions: heart attacks, heart failure, pneumonia, chronic lung disease, hip and knee replacements and - for the first time this year - coronary artery bypass graft surgery.
The fines are based on Medicare patients who left the hospital from July 2012 through June 2015. For each hospital, the government calculated how many readmissions it expected, given national rates and the health of each hospital's patients. Hospitals with more unplanned readmissions than expected will receive a reduction in each Medicare case reimbursement for the upcoming fiscal year that runs from Oct. 1 through September 2017.
The payment cuts apply to all Medicare patients, not just those with one of the six conditions Medicare measured. The maximum reduction for any hospital is 3 percent, and it does not affect special Medicare payments for hospitals that treat large numbers of low-income patients or train residents. Forty-nine hospitals received the maximum fine. The average penalty was 0.73 percent of each Medicare payment, up from 0.61 percent last year and higher than in any other year, according to the KHN analysis.
Under the Affordable Care Act, which created the penalties, a variety of hospitals are excluded, including those serving veterans, children and psychiatric patients. Maryland hospitals are exempted as well because Congress has given that state extra leeway in how it distributes Medicare money. Critical access hospitals, which Medicare also pays differently because they are the only hospitals in their areas, are also exempt.
As a result, more than 1,400 hospitals were automatically exempt from the penalties. Other hospitals did not have enough cases for Medicare to evaluate accurately and were not penalized. Of the hospitals that Medicare did evaluate, four out of five were penalized.
The KHN analysis found that 1,621 hospitals have been penalized in each of the five years of the program.
State Highlights: In Minn., Allina Nurses Vote Later This Month On Contract; Mass. Legislature Overrides Veto On Lyme Disease Treatment
Monday, 1 August 2016
Research released Monday finds comparable safety and efficacy for one type of biosimilar drugs, complex medicines intended to be near-copies of some of the most costly prescription drugs on the market, but highlights the need for more information on the products.
In the absence of generic alternatives to these pricey treatments, called biologics, biosimilar drugs hold great promise for U.S. patients and their wallets.
Biologics are drugs made or derived from living cells using cutting-edge biotechnology. But, because their molecules are more complex than those that make up typical drugs, exact-copy generics aren't possible. Instead, a new class of drugs called biosimilars have the potential to be generic-like substitutes needed to keep costs down.
Researchers at Johns Hopkins University and Brigham and Women's Hospital evaluated a series of studies regarding a very specific group of biosimilars - those that treat inflammation for patients with rheumatoid arthritis and inflammatory bowel syndrome, called TNF-alpha inhibitors. They systematically reviewed 19 studies to determine how these biosimilars compared with the brand-name drugs, focusing on safety and efficacy. They concluded the biosimilars are “interchangeable” with the original versions, such as Remicade and Humira. Their findings and an accompanying editorial were published in the Annals of Internal Medicine.
“We examined one very costly and commonly used class of biologic therapy,” said study author Dr. Caleb Alexander, codirector of the Johns Hopkins Center for Drug Safety and Effectiveness. “The totality of evidence strongly supports the comparability of the biosimilar and branded product.”
Although the analysis was reassuring, experts didn't find the results surprising.
“Honestly the data have been pretty consistent,” said Dr. Daniel Solomon, a rheumatologist at Brigham and Women's Hospital in Boston who was not involved in completing the review. “So I'm not sure we learned something new from the meta-analysis, but it does give confidence that indeed there's a good margin of safety and the risks are minimal.”
To complete the analysis, Alexander and his team studied overall patient outcomes, adverse events and whether patients had immune system reactions to the drugs.
Experts not involved in the analysis said that the authors did a good job, but they didn't have a robust body of studies with which to work.
“These are a patchwork of studies that show if you take the [original] drug and switch [to a biosimilar], that's fine,” said Dr. Vijay Yajnik, a gastroenterologist at Massachusetts General Hospital in Boston who was not associated with the study, adding that the studies include multiple biosimilars and multiple disease indications and were completed mostly outside the U.S. “It's a step in the right direction.”
But he pointed out that the studies included in the analysis are small and the review doesn't include many patients overall compared with other systematic reviews in general.
All told, about 1,400 people took part in clinical trials and more than 500 people were included in observational studies that made up the meta analysis. Those not involved in the study said these were low numbers on which to draw conclusions.
“It does raise an eyebrow,” Yajnik said.
However, others said this limitation is to be expected considering how relatively new biosimilars are and how many years it takes to complete these studies.
“People are thirsty for information about biosimilars and I'm sure that the journal felt an obligation to put out information,” said Solomon, who is also a professor at Harvard University's medical school.
Since their arrival on the market, biologics have been major moneymakers for drug companies. AbbVie saw its quarterly net revenue jump by 17.8 percent in earnings reported last week thanks to its biologic, Humira. And Remicade generated in $1.2 billion in U.S. sales for Johnson and Johnson in the second quarter of 2016. Both drugs are TNF-alpha inhibitors.
But a single Remicade infusion can reportedly cost $1,300 to $2,500. That's where experts hope biosimilars will provide lower-cost options to patients and providers.
“Biosimilars will be cheaper than originators. The variation in terms of 'discount' is large, however,” said Joshua Cohen, an economist at the Tufts Center for the Study of Drug Development. “In Europe, we see biosimilars that are 10 percent cheaper and those that are 70 percent cheaper.”
The Food and Drug Administration approved its first biosimilar, Zarxio, which is used to treat chemotherapy-associated infections, in September 2015. And in April, the FDA approved the Remicade biosimilar Inflectra.
“They really want to know that the molecules are almost identical,” Solomon said, explaining the FDA's evaluation is more about chemistry and pharmacology than it is about clinical trials. Still, the FDA requires one clinical trial for a single disease indication to prove biosimilarity, he said. No clinical trials are required for traditional generics, but, for typical new drugs, three phases of clinical trials are required before approval.
Inflectra has not yet launched in the U.S., but in Europe, where it was approved in 2013, it reportedly costs about 30 percent less than the original drug. Zarxio was about 15 percent cheaper than its precursor, Neupogen, when it launched in Europe in 2009.
Although Inflectra made it through the FDA approval process, Hopkins' Alexander said it's still important for researchers like him to complete systematic reviews of peer-reviewed literature and trial registries. He said his team's analysis is “one of the most rigorous and comprehensive assessments” of TNF alpha inhibitor biosimilars compared with original brand-name biologics.
Pharmacist Donald Miller, a professor at North Dakota State University, said the analysis is important because it is the first of its kind for these biosimilars. But the finding that the biosimilar drugs were “interchangeable” with the originals is interesting because the FDA has not yet awarded this designation to either Inflectra or Zarxio.
“It is very important to realize that interchangeability of biosimilars has a specific meaning under U.S. law and [the] FDA has not yet issued guidance for any product to define itself as interchangeable to date,” he said.
Miller said many physicians worry that insurance companies will force patients to switch from biologics to biosimilars to save money, risking reactions to the tweaked drug molecules. Indeed, the American College of Rheumatologists' position statement says that patients should be informed if they're switched to biosimilars to cut costs and their physician should sign off on it.
“Over time, biosimilars can save the health system billions, but only if they're adopted and only if patients and clinicians and policymakers develop and support mechanisms that promote their adoption,” Alexander said.
KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.