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Saturday, July 16, 2016

Health Care Reform Articles - July 16, 2016

Obama Offers Ways to Improve His Health Care Law

by Robert Pear - NYT

WASHINGTON — After defending the Affordable Care Act in all its intricacies for six years, President Obama proposed ways to improve it on Monday, saying that Congress should provide larger subsidies for private health insurance and create a public plan like Medicare to compete with private insurers in some states.
At the same time, he accused the pharmaceutical industry of trying to protect its profits by opposing any constraints on drug prices.
Mr. Obama offered his views in a valedictory message summarizing what he sees as his legacy on health care, together with his ideas to improve the Affordable Care Act.
He said he was proud of the progress of the last six years, especially the fact that 20 million people had gained coverage because of the law. But he acknowledged that — despite the title of the law — health care and health insurance were still unaffordable for some people.
“Too many Americans still strain to pay for their physician visits and prescriptions, cover their deductibles or pay their monthly insurance bills; struggle to navigate a complex, sometimes bewildering system; and remain uninsured,” Mr. Obama said in an article published online in The Journal of the American Medical Association.
Continue reading the main story
The article can be read as an effort by Mr. Obama to entrench his approach to health care, which is sure to be debated fiercely by candidates for president and Congress in this election year. Without mentioning names, Mr. Obama aligns himself more closely with the presumptive Democratic nominee, Hillary Clinton, who wants to build on the Affordable Care Act, and he rebuts her Republican counterpart, Donald J. Trump, who promises to replace “this horrible, stupid Obamacare” with “something that’s great.”
The number of uninsured has dropped to 29 million, from 49 million in 2010, Mr. Obama said. Many of those who remain uninsured want coverage but say they cannot afford it, he said. Accordingly, he wrote, Congress should increase federal financial assistance to help people buy coverage through public marketplaces like HealthCare.gov.
The online exchanges will be a viable source of coverage “for decades to come,” Mr. Obama said, but “further adjustments and recalibrations will likely be needed.”
Of the 11 million people with marketplace coverage, 85 percent receive tax credits that, on average, cover nearly three-fourths of their premium costs. But for some, said Kristie Canegallo, a deputy chief of staff at the White House, the “tax credits aren’t big enough.”
Mr. Obama said the health law was costing less than originally projected, so Congress could provide more generous subsidies while still keeping federal costs below initial estimates.
White House officials said that Mr. Obama’s purpose in writing the article was to start a discussion and suggest a direction for elected officials and future policy makers, but that he would not be offering detailed new legislative proposals to carry out his ideas.
Based on his experience in the last few years, Mr. Obama said, Congress should establish “a public plan to compete alongside private insurers in areas of the country where competition is limited.”
Most of the country has benefited from competition in the marketplaces, and 88 percent of the people who have enrolled live in counties where at least three insurers offer plans, Mr. Obama said. But, he said, the remaining 12 percent are in areas with only one or two insurers.
Jason Furman, the chairman of Mr. Obama’s Council of Economic Advisers, said, “A public option would be one way to make sure that there was competition everywhere.”
In the debate on health care in 2009 and 2010, Mr. Obama said he supported the idea of a public option, but he did not always insist on it, and the administration sent mixed signals about how important it was.
Reviving the idea on Monday, Mr. Obama said a public plan — in places lacking competition — would give consumers more affordable options while also saving money for the government.
“Public programs like Medicare often deliver care more cost-effectively,” by securing better prices from health care providers, Mr. Obama said. Critics say the savings result, in large part, from price controls imposed by federal laws and regulations.
Mrs. Clinton has proposed her own approach, which would allow people to buy into Medicare.
Medical journals nowadays are full of articles on health policy, but Mr. Obama’s is strikingly different in one respect. It includes a blistering attack on Republicans, who he said had tried to sabotage the health care law “through inadequate funding, opposition to routine technical corrections, excessive oversight and relentless litigation.”
Mr. Obama accused Republicans of “hyperpartisanship” without saying what he might have done differently. The law was adopted without any Republican votes, and to this day, polls show public opinion almost evenly split between favorable and unfavorable views of it.
The president described Medicaid as “a critical piece of unfinished business.” Because of Republican opposition, he said, 19 states have not expanded Medicaid eligibility. If they did, he said, four million fewer people would be uninsured.
Mr. Obama also assailed “special interests,” suggesting that the pharmaceutical industry has been particularly bad.
Drug companies, he wrote, “oppose any change to drug pricing, no matter how justifiable and modest, because they believe it threatens their profits.”
Continue reading the main story
In conclusion, Mr. Obama predicted that history would vindicate his work. “Looking back 20 years from now,” he said, “the nation will be better off because of having the courage to pass this law and persevere.”


Obama on Obamacare’s Flaws: An Assessment

by Reed Abelson and Margot Sanger-Katz - NYT
President Obama has published an essay on Obamacare in The Journal of the American Medical Association. While it hit a lot of the Affordable Care Act’s high points, it was also pretty frank that the health law has some weaknesses that need to be fixed. Margot Sanger-Katz and Reed Abelson, two New York Times reporters who have been covering Obamacare, discuss the policy changes that the president wants.
Margot: Were you surprised by his acknowledgment of problems? I know I was.
Reed: I thought he was pretty realistic in talking about the need to make various fixes to the law. That’s been an issue since it was passed in 2010. There is a fairly broad consensus that the law could be changed to make it work better, even among its supporters. What did surprise me was the president’s admission that affordability remains a real concern for many people, even with subsidies.
Margot: But the president wasn’t talking about little tweaks. I feel that he recommended at least two pretty substantial policy changes. The idea of offering more subsidies to buy health insurance has been talked about before, but certainly not by the Obama administration. His essay seems like a real acknowledgment that health insurance still isn’t affordable enough for some people. We’ve talked beforeabout hearing from higher-income people who still can’t afford health insurance. Between premiums and deductibles, some people are spending more than 25 percent of their incomes on care, according to an Urban Institute report.
Reed: Some of that problem with high prices was supposed to be solved by more competition among health insurance companies. Which gets to the second important change, I think: adding a Medicare-like public plan in areas of the country where there remain too few companies offering plans on the state marketplaces. (I notice the president didn’t dwell on the increasing number of failures among the co-ops, the nonprofit insurers created by the law to serve as something akin to the so-called “public option.”)
The fact that the president admitted that the law had not succeeded in increasing competition everywhere was an important concession. But what do you think of the idea of having a government-operated plan compete along with private insurers, something along the lines of what Medicare does today with the private Medicare Advantage plans?
Margot: I think the public option was definitely the biggest headline out of the president’s piece. And it’s interesting to see so many Democrats converge around this policy idea, which was talked about when the Affordable Care Act was being written, but was ultimately axed from the law because of lack of support. Hillary Clinton just came out strongly for something similar over the weekend, though she’s expressed milder support before. And Bernie Sanders was also cheering for a public option during his Clinton endorsement speech Tuesday. Seems like a real shift leftward for two out of three of them. Considering that a public option has almost no chance of passing in Congress, it’s unclear why it is having such a moment. I guess it’s a good political halfway point between Obamacare as it exists, and a single-payer system, which excites a lot of Democratic voters.
But even if it didn’t have political problems, do you think a government health plan could work the way the president described it? His essay said that it would become a sort of fallback, operating only in places where competition is limited. It’s hard to imagine a public plan that jumps in and out of the market in places every year.
Reed: I confess I have a hard time envisioning a government plan available in only certain places. Traditional Medicare is always an option everywhere. A lack of competition is a signal that the economics don’t work for a private insurer in a given geographic area, and I’m not sure how a public option in those markets changes things, although it does offer someone more choice. Another possibility would be that you could increase subsidies for those areas or try other ways to make it more attractive for insurers to sell policies in those markets.
Margot: When you talk to people who advocate a public option, the theory is that it’ll help keep insurers honest by providing some competition from low-cost plans. But I wonder how that will work in practice. One big advantage that a Medicare-like plan might have is the ability to pay less to doctors and hospitals than many commercial plans. But if the public option is really able to underprice the private options by a lot, why would they stay in the market?
Reed: When it was first floated, the insurers objected because they simply don’t have the pricing power of Medicare, which essentially dictates prices rather than negotiates with hospitals and doctors. They thought it was a path to single-payer because it would eventually drive all of them from the market. Maybe Bernie Sanders would approve, but I’m not sure there is any real political support for the idea. Karen Ignagni, who was the chief executive of the trade association representing the insurers, argued at the time that if we wanted a government-run system, we should have that discussion.
Still, Congress’s current position of just saying, “No, let’s overturn the law,” hasn’t helped fix any of the shortcomings that exist.
An area where I thought the president might be giving the law too much credit was in saying the law had managed to successfully control costs and improve quality. What do you think?
Margot: Cost control is one of those great unanswered questions in health policy. There are many theories about what is going on. But nearly all of the rigorous analyses say that Obamacare gets, at best, partial credit for why health spending growth has been slow. I can see why the president might want to congratulate himself for this welcome trend. But I think he’s on firmer ground touting a reduced uninsured rate than cost control as the legacy of Obamacare.


One striking chart shows why pharma companies are fighting legal marijuana
by Christopher Ingraham - Washington Post

There's a body of research showing that painkiller abuse and overdose are lower in states with medical marijuana laws. These studies have generally assumed that when medical marijuana is available, pain patients are increasingly choosing pot over powerful and deadly prescription narcotics. But that's always been just an assumption.
Now a new study, released in the journal Health Affairs, validates these findings by providing clear evidence of a missing link in the causal chain running from medical marijuana to falling overdoses. Ashley and W. David Bradford, a daughter-father pair of researchers at the University of Georgia, scoured the database of all prescription drugs paid for under Medicare Part D from 2010 to 2013.
They found that, in the 17 states with a medical-marijuana law in place by 2013, prescriptions for painkillers and other classes of drugs fell sharply compared with states that did not have a medical-marijuana law. The drops were quite significant: In medical-marijuana states, the average doctor prescribed 265 fewer doses of antidepressants each year, 486 fewer doses of seizure medication, 541 fewer anti-nausea doses and 562 fewer doses of anti-anxiety medication.
But most strikingly, the typical physician in a medical-marijuana state prescribed 1,826 fewer doses of painkillers in a given year.
These conditions are among those for which medical marijuana is most often approved under state laws. So as a sanity check, the Bradfords ran a similar analysis on drug categories that pot typically is not recommended for — blood thinners, anti-viral drugs and antibiotics. And on those drugs, they found no changes in prescribing patterns after the passage of marijuana laws.
"This provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws," they write.
In a news release, lead author Ashley Bradford wrote, "The results suggest people are really using marijuana as medicine and not just using it for recreational purposes."


Britain's diabetic leader reflects differing healthcare systems
by David Lazarus - LA Times
Britain has a new prime minister – Theresa May – and much of the coverage this week has focused on her being only the second woman in the country’s history to run the government.
An equally intriguing factoid is that, as far as anyone knows, May, 59, is the first contemporary world leader with Type 1 diabetes.
This provides an opportunity to look at how Britain’s universal-coverage health insurance system compares with the largely for-profit, market-oriented American approach.
The two key yardsticks in treating diabetes effectively are access to care and cost of drugs. In both cases, the Brits have it better.
“When you have a chronic condition, it’s just a fact that there will be regular charges to maintain your health,” said Shana Alex Charles, an assistant professor of health sciences at Cal State Fullerton.
“In this country, you might have to worry about being able to afford all the necessary supplies,” she said. “In Britain, that’s not a worry. It’s not a question that you’ll be able to get what you need.”
It’s simplistic to suggest that Britain and other nations with single-payer insurance systems do everything right, whereas the United States does everything wrong. For those who can afford it, U.S. healthcare is second to none.
Britain’s National Health Service, meanwhile, provides mostly free-of-charge, taxpayer-funded healthcare to all but, according to the British think tank King’s Fund, is grappling with money troubles, long wait times and hospital overcrowding.
Even so, a 2006 study in the Journal of the Royal Society of Medicine comparing diabetes management in Britain and the United States found that while the populations of the two countries were similar in many ways, a key difference was the large number of Americans who lacked adequate health insurance.
“Access to health coverage is a key determinant of quality of care for a chronic condition such as diabetes,” the study concluded. “For chronic diseases such as diabetes that can be largely managed without inpatient care, a system like the NHS that provides universal coverage free at the point of use may be substantially more cost-effective than the more mixed system found in the USA.”
The vast majority of people with diabetes worldwide have Type 2, which is frequently associated with obesity and can be treated in a variety of ways. Type 1 is an autoimmune disorder requiring multiple daily insulin injections.
Obamacare has helped provide coverage to people with diabetes. No longer are people with “pre-existing conditions” shown the door by profit-conscious health insurers. But medical costs, particularly for those with high-deductible health plans, can be burdensome.
A Reuters analysis of drug prices last year found that Americans with diabetes can pay as much as seven and a half times more for insulin than people in Britain. A recent report in the Journal of the American Medical Assn. found that U.S. insulin costs more than tripled between 2002 and 2013. Average annual spending on insulin per U.S. patient jumped to $736.09 from $231.48.
The drug industry says actual costs are lower once rebates and other discounts are taken into account.
“The U.S. system gives the best possible care for those who are insured or covered or can otherwise afford it, but those who are uninsured or are failing to get good access are sometimes quite poorly diagnosed and treated for chronic diseases,” said Alastair Gray, a health economist at the University of Oxford.
“The U.K. system puts less emphasis on providing the best for some and instead provides a more comprehensive coverage,” he said. “For the whole population it gives results that are equal to or slightly better than the U.S. performance and at much lower cost.”
Britain spends about 10% of its gross domestic product on healthcare, according to the Organization of Economic Cooperation and Development. The United States spends 17%.
Carol Propper, a health economist at Imperial College London, said that even with lower healthcare spending as a percentage of GDP, Britain has managed to make healthcare more accessible to the general population. “In the U.S.,” she said, “the allocation is probably more unequal,” favoring those with financial means.
Like May, I have Type 1 diabetes and can speak firsthand to the challenges of dealing day to day with a disease that afflicts nearly 10% of the U.S. population and is the country’s seventh leading cause of death.
About 6% of Britain’s population has diabetes, but the disease isn’t among the country’s top 10 killers. That speaks to significantly more effective efforts at managing the illness.
wrote on Tuesday about how healthier Americans are gravitating toward high-deductible insurance plans with lower monthly premiums, resulting in higher insurance costs for people who desire, or require, more comprehensive coverage. A Medicare-for-all system similar to Britain’s would address that.
It would also go a long way toward not just addressing the needs of people with chronic conditions but society as a whole. The U.S. economic cost of diabetes – treatment and lost productivity – is estimated by the American Diabetes Assn. to run at least $245 billion a year. Heart disease, cancer, stroke, Alzheimer’s – hundreds of billions more. Healthcare spending will account for a fifth of our economy by 2025, according to a recent study.
The British healthcare system isn’t perfect. But, more so than our own, it acknowledges that sickness touches us all, one way or another.
And dealing with that is everyone’s responsibility, from the head of government on down.

Employer-based health care is failing workers

By Kay Tillow
Daily Kos, July 14, 2016
Health care in the United States is the most costly in the world. The per capita the U.S. spends on health care is double the average of other industrialized countries, yet other nations have better outcomes in life expectancy, infant mortality, and most measures. In the U.S., we pay more but get less. About 40 percent of people in the U.S. forgo needed care because of cost.
The powerful, dynamic unions of the CIO established the highest standards for health care in the country lifting up the rest of the nation as they set the floor. Several decades later, after the rest of the industrialized world moved to universal health care systems, the collective bargaining power of U.S. unions is no longer sufficient to advance and protect health care benefits. Profiteers have rigged the system. For-profit insurers and pharmaceuticals are holding our health care, our collective bargaining, and our democracy hostage.
Reining in that control now requires far more than collective bargaining. It requires a dynamic movement that rallies the rank and file of the labor movement, links with communities and the public, takes on the corporate controllers of health care, and pushes relentlessly until it passes national single-payer health care, HR 676.
The evidence of the crying need to act is all around us. “Today, we said enough is enough, and went on strike for a restoration of health benefits and fair wages and working conditions,” said Fabia Sespedes, a housekeeper who has worked for nine years at the Trump Taj Mahal in Atlantic City. Nearly a thousand workers at the Taj Mahal casino walked out at dawn as the July 4 holiday weekend began. They are cooks, housekeepers, servers and other casino workers, members of Local 54 UNITE-HERE. They have been without health care and retirement benefits since those were taken away in October of 2014. Current owner of the Taj, billionaire Carl Icahn, is refusing to restore those benefits and threatening to shut down the casino.
Half of the workers rely on subsidized health insurance and a third have no health benefits at all. Icahn extracted $350 million from the property using bankruptcy proceedings to strip Taj workers of health care and pensions. “Now we’re going to take it to the streets,” said Mayra Gonzalez, a pantry chef at the Taj for 26 years.
In June over 4,000 coal miners from seven states rallied in Lexington, Kentucky, to demand passage of Senate Bill 1714 to shore up health and pension funds. Without that action, 22,000 retired miners and their families face the dropping of their health care benefits before the end of the year. “We’re not asking for welfare -- we’ve earned these benefits,” said Michael Partin, a retired miner from Bell County who worked underground for 30 years. In the compelling fiery rhetoric that is his custom, UMWA President Cecil Roberts called on the miners to go home, recruit five people each, and prepare to march on Washington, D.C. A rally has been set at the U.S. Capitol Building for September 8, 2016.
In June 5,000 Minnesota Nurses Association members who work for the Allina Hospitals struck for 7 days as Allina sought to shift $10 million in health care costs onto nurses and their families. Monica Proulx, a surgery nurse for more than 20 years, said that Allina has refused to negotiate over issues such as patient care and reducing workplace violence unless the union capitulates on the health insurance issue. The nurses are back at work but the struggle continues.
In May more than 350 workers at Honeywell Aerospace were locked out in South Bend, Indiana, and in Green Island, New York. Members of UAW Local 9 in South Bend who make airplane brakes and wheels say they voted the contract down by 270 to 30 because it would drastically increase what they pay for health insurance. Local President Adam Stevenson says those who were working nights were ushered out of the plant by security guards and the day shift was barred from entering. Stevenson said one of the sticking points in the negotiations is that Honeywell wants to be able to change the structure of union members' health care benefits, including what people pay for premiums and deductibles, during the term of the contract. The union has planned a rally for July 18.
At the Green Island location more than 500 supporters came out to rally with UAW Local 1508 where workers at the picket line say the average out-of-pocket expenses for a family under the plan included in the company's offer will rise by as much as $7,000 a year.
Tim Vogt, a 29-year Honeywell employee and president of UAW Local 1508, said, “We cannot accept a contract that destroys our ability to provide for our families’ health and well-being.” The lock out continues.
Last Christmas thousands of Honeywell retirees received a letter from their former employer announcing that at the end of 2016 they would no longer have health insurance. In Fostoria, Ohio, where over 1,000 of those retirees live, UAW Local 533 President David Angles said, “It is dishonorable that this corporation would do this to people that gave 30 or more years of their lives to this company helping them make billions of dollars in profit and then turn around and take this benefit away during a time in their life that they need it the most.”
“We are the only industrialized nation in the world that does not have a national health care system and it’s time. Stand up and do something, if not for yourself, your children and grandchildren, because they will need your help,” concluded Angles.
President Angles is right. “Stand up and do something.”
Begin by getting your union or organization to endorse HR 676, national single-payer health care. A sample resolution is here.
Organize your city, county, or state to endorse HR 676. Use as a model one of the resolutions that have already been passed. They are here.
UnitedHealth Group CEO Stephen J. Hemsley took home over $66 million in compensation in 2014, while the health care crisis continued for millions of workers.
As retired USW steelworker Steve Skvara asked in Chicago when he stood up at a 2007 AFL-CIO Presidential Candidates Debate: “Every day of my life, I sit at the kitchen table across from the woman who devoted 36 years of her life to my family and I can't afford her health care. What's wrong with America and what will you do to change it?”
Kay Tillow is a leader of Kentuckians for Single Payer Health Care and the All Unions Committee for Single Payer Health Care--HR 676. She can be reached at nursenpo@aol.com.
http://www.dailykos.com/stories/2016/7/14/1548153/-Employer-based-health-care-is-failing-workers-Time-to-Stand-Up-and-Do-Something?_=2016-07-14T05:24:30.858-07:00

Wealthy get more health care than other Americans

Trend toward more equal access to care is reversing

By Chris Tomlinson
Houston Chronicle, July 12, 2016
Money can't buy you love, but it can buy you health, according to a new study from Harvard Medical School.
Add inequality in health care to the growing evidence that the United States is becoming a more class-based society, with a shrinking middle class, a greater economic gap between the rich and poor and growing social unrest.
"In 2012, the wealthiest fifth of Americans got 43 percent more health care ($1,743 more per person) than the poorest fifth of Americans, and 23 percent more care ($1,082 per person) than middle-income people," the paper published in "Health Affairs" stated. "These numbers reflect a striking reversal of a long-term trend toward greater equality in health care use by all income groups."
The shift away from more equal access to health care came in the mid-2000s, at about the same time that conservative lawmakers began trying to rein in spending on Medicaid, the health program for the poor and disabled. Spending by poor people has actually dropped 3.7 percent since then, while spending by the wealthy is up 19.7 percent.
The study found no change in health care inequality in Medicare, the health program that covers almost every American over the age of 65.
President Lyndon Johnson's Medicare and Medicaid programs brought much more equal access to health care beginning in the 1960s. Prior to that, the wealthy used about twice as much health care than poor and middle class people.
The study's authors attribute the growing inequality to the "widening U.S. income inequality, the 2007-2009 recession, the slow recovery for the poor and middle class, and a sharp rise in health insurance co-payments and deductibles that discourage non-wealthy Americans from seeking care."
There is little debate that health care costs are growing too fast, and the United States needs to discourage over-utilization. Co-pays and deductibles can achieve those goals, but this study shows that people with higher incomes are not as deterred as lower-income Americans. There is also a risk that lower-income Americans who should be seeking early treatment are waiting until they are much more ill before getting help, creating a larger burden on the health care system.
The fact that Medicare doesn't have the same problem argues for a single-payer system for all Americans, not just the elderly. As long as we use price to ration health care, rather than science-based medicine, then greater income inequality will lead to greater health care inequality.
The middle and lower classes in America are becoming increasingly frustrated with the status quo, which is leading to greater inequality of every kind in this country. High health care costs is an important part of that frustration, and one that will political leaders need to address.

Chris Tomlinson is business columnist at the Houston Chronicle.

http://www.pnhp.org/news/2016/july/wealthy-get-more-health-care-than-other-americans

National Health Spending to Surpass $10,000 a Person in 2016

by Robert Pear - New York Times

WASHINGTON — National health spending will average more than $10,000 a person this year for the first time, the Obama administration said Wednesday, a milestone that heralds somewhat faster growth in health spending after several years of exceptionally low growth.
By 2025, the administration reported, health care will represent 20 percent of the total economy, up from 17.8 percent last year. By 2025, one of every five Americans will be on Medicare, and the program will spend an average of nearly $18,000 a year for each beneficiary. Medicare spent about $12,000 per beneficiary in 2015.
The administration, in a report published in the journal Health Affairs, predicts that the pace of health spending will pick up in the coming decade, driven by improvements in the economy, higher medical prices and the aging of the people born from 1946 to 1964.
From 2015 to 2025, health spending is expected to grow an average of 5.8 percent a year — 1.3 percentage points faster than the economy, measured by the gross domestic product. The numbers are not adjusted for inflation.
By 2025, the report says, Medicaid, a program for lower-income people, is expected to spend an average of nearly $12,500 a year for each beneficiary, up from about $8,000 in 2015, and spending by private insurers is expected to average almost $8,600 for each person covered. Private insurers spent $5,400 per insured last year.

Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Version

by Andrew Pollock - NYT
The best-selling drugs Humira and Enbrel have a lot in common. They both use biotechnology to treat rheumatoid arthritis, psoriasis and other autoimmune diseases. And they come with giant price tags approaching $50,000 a year.
Now the two companies behind the competing drugs have found common ground in keeping those prices so high: They are deploying new patents to prevent patients and insurers from getting two essentially generic versions of the drugs for less money.
This week, advisers to the Food and Drug Administration recommended approval of the near generic versions. But the patents could delay introduction. And even if the drugs get to market, some patient groups say they will resist efforts by insurers to force them to use the less expensive drugs.
The various developments show that six years after the Affordable Care Act cleared the way for biosimilars, as the generic versions of biotechnology drugs are called, progress has been slow. Only one biosimilar, a mimic of the white blood cell booster Neupogen, is available to patients.
“It’s a lost opportunity to reduce health care costs,” said Fiona M. Scott Morton, a professor at the Yale School of Management.
By contrast, according to a study she did, biosimilars have been available in Europe for years and have reduced costs for some drugs as much as 80 percent, though in many cases far less.
Humira and Enbrel are biologics, which are complex proteins made in living cells. Seven of the world’s top 10 selling drugs in 2015 were biologics. Humira was No. 1 with $14 billion in global sales and Enbrel was No. 3 at $8.7 billion, according to the website PharmaCompass.
Until the 2010 Affordable Care Act authorized the F.D.A. to approve biosimilars, biologics were insulated from the generic competition. Since then, it has taken time for the F.D.A. to lay out the ground rules for biosimilars. Some rules are still not in place.
“They are still behind when it comes to creating the infrastructure to push these molecules ahead,” said Bertrand C. Liang, chairman of a biosimilars council set up by the Generic Pharmaceutical Association.
Things now seem to be heating up, however. A biosimilar that mimics Johnson & Johnson’s autoimmune disease drug Remicade was approved by the F.D.A. in April. It is not yet on the market, in part because of patent issues. But Pfizer, which owns the marketing rights, hints that it is planning to introduce it this year.
There are about 60 biosimilars in clinical trials aimed at approval in the United States or Europe, according to Sanford C. Bernstein & Company, including 13 versions of Humira.
The makers of the brand-name biotechnology drugs for years argued that biologics were such complex molecules that they could not be exactly copied. It is for that reason the copycats are called biosimilars rather than generics.
Still, that argument is now falling by the wayside, in part because some of those same brand-name companies are developing biosimilars themselves.
Amgen, for example, was on both sides of this week’s debates among the F.D.A. advisers. The company developed the Humira biosimilar, but it also owns Enbrel, which is threatened by biosimilars.
At the meeting on Tuesday, the advisory committee voted 26 to 0 that Amgen’s Humira knockoff was similar enough to the original drug to be approved for essentially all uses of Humira. It made that decision even though Amgen had tested the drug in patients with only two of those diseases, rheumatoid arthritis and psoriasis.
The next day it voted 20 to 0 in favor of a broad approval of the Enbrel biosimilar, which was developed by Sandoz, the generic division of Novartis, and tested only in patients with psoriasis.
While the F.D.A. itself is expected to approve the two biosimilars in the coming months, patents might keep them off the market.





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