One Third of Knee Surgery Patients Still Have Pain

By Liz Szabo, Kaiser Health News

Danette Lake thought surgery would relieve the pain in her knees.

The arthritis pain began as a dull ache in her early 40s, brought on largely by the pressure of unwanted weight. Lake managed to lose 200 pounds through dieting and exercise, but the pain in her knees persisted.

A sexual assault two years ago left Lake with physical and psychological trauma. She damaged her knees while fighting off her attacker, who had broken into her home. Although she managed to escape, her knees never recovered. At times, the sharp pain drove her to the emergency room. Lake’s job, which involved loading luggage onto airplanes, often left her in misery.

When a doctor said that knee replacement would reduce her arthritis pain by 75 percent, Lake was overjoyed.

“I thought the knee replacement was going to be a cure,” said Lake, now 52 and living in rural Iowa. “I got all excited, thinking, ‘Finally, the pain is going to end and I will have some quality of life.’”

But one year after surgery on her right knee, Lake said she’s still suffering.

“I’m in constant pain, 24/7,” said Lake, who is too disabled to work. “There are times when I can’t even sleep.”

Most knee replacements are considered successful, and the procedure is known for being safe and cost-effective. Rates of the surgery doubled from 1999 to 2008, with 3.5 million procedures a year expected by 2030.

But Lake’s ordeal illustrates the surgery’s risks and limitations. Doctors are increasingly concerned that the procedure is overused and that its benefits have been oversold.

DANETTE LAKE (khn photo)

DANETTE LAKE (khn photo)

Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while 1 in 5 are dissatisfied with the results. A study published last year in the BMJ found that knee replacement had “minimal effects on quality of life,” especially for patients with less severe arthritis.

One-third of patients who undergo knee replacement may not even be appropriate candidates for the procedure, because their arthritis symptoms aren’t severe enough to merit aggressive intervention, according to a 2014 study in Arthritis & Rheumatology.

“We do too many knee replacements,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for affordable health care, in an interview. “People will argue about the exact amount. But hardly anyone would argue that we don’t do too many.”

Although Americans are aging and getting heavier, those factors alone don’t explain the explosive growth in knee replacement. The increase may be fueled by a higher rate of injuries among younger patients and doctors’ greater willingness to operate on younger people, such as those in their 50s and early 60s, said Rickert, an orthopedic surgeon in Bedford, Ind. That shift has occurred because new implants can last longer — perhaps 20 years — before wearing out.

Yet even the newest models don’t last forever. Over time, implants can loosen and detach from the bone, causing pain. Plastic components of the artificial knee slowly wear out, creating debris that can cause inflammation. The wear and tear can cause the knee to break. Patients who remain obese after surgery can put extra pressure on implants, further shortening their lifespan.

The younger patients are, the more likely they are to “outlive” their knee implants and require a second surgery. Such “revision” procedures are more difficult to perform for many reasons, including the presence of scar tissue from the original surgery. Bone cement used in the first surgery also can be difficult to extract, and bones can fracture as the older artificial knee is removed, Rickert said.

Revisions are also more likely to cause complications. Among patients younger than 60, about 35 percent of men need a revision surgery, along with 20 percent of women, according to a November article in the Lancet.

Yet hospitals and surgery centers market knee replacements heavily, with ads that show patients running, bicycling, even playing basketball after the procedure, said Dr. Nicholas DiNubile, a Havertown, Pa., orthopedic surgeon specializing in sports medicine. While many people with artificial knees can return to moderate exercise — such as doubles tennis — it’s unrealistic to imagine them playing full-court basketball again, he said.

“Hospitals are all competing with each other,” DiNubile said. Marketing can mislead younger patients into thinking, “‘I’ll get a new joint and go back to doing everything I did before,’” he said. To Rickert, “medical advertising is a big part of the problem. Its purpose is to sell patients on the procedures.”

Rickert said that some patients are offered surgery they don’t need and that money can be a factor.

Knee replacements, which cost $31,000 on average, are “really crucial to the financial health of hospitals and doctors’ practices,” he said. “The doctor earns a lot more if they do the surgery.”

Ignoring Alternatives

Yet surgery isn’t the only way to treat arthritis.

Patients with early disease often benefit from over-the-counter pain relievers, dietary advice, physical therapy and education about their condition, said Daniel Riddle, a physical therapy researcher and professor at Virginia Commonwealth University in Richmond.

Studies show that these approaches can even help people with more severe arthritis.

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In a study published in Osteoarthritis and Cartilage in April, researchers compared surgical and non-surgical treatments in 100 older patients eligible for knee replacement.

Over two years, all of the patients improved, whether they were offered surgery or a combination of non-surgical therapies. Patients randomly assigned to undergo immediate knee replacement did better, improving twice as much as those given combination therapy, as measured on standard medical tests of pain and functioning.

But surgery also carried risks. Surgical patients developed four times as many complications, including infections, blood clots or knee stiffness severe enough to require another medical procedure under anesthesia. In general, 1 in every 100 to 200 patients who undergo a knee replacement die within 90 days of surgery.

Significantly, most of those treated with non-surgical therapies were satisfied with their progress. Although all were eligible to have knee replacement later, two-thirds chose not to do it.

Tia Floyd Williams suffered from painful arthritis for 15 years before having a knee replaced in September 2017. Although the procedure seemed to go smoothly, her pain returned after about four months, spreading to her hips and lower back.

She was told she needed a second, more extensive surgery to put a rod in her lower leg, said Williams, 52, of Nashville.

“At this point, I thought I would be getting a second knee done, not redoing the first one,” Williams said.

Other patients, such as Ellen Stutts, are happy with their results. Stutts, in Durham, N.C., had one knee replaced in 2016 and the other replaced this year. “It’s definitely better than before the surgery,” Stutts said.

Inappropriate Surgeries

Doctors and economists are increasingly concerned about inappropriate joint surgery of all types, not just knees.

Inappropriate treatment doesn’t harm only patients; it harms the health care system by raising costs for everyone, said Dr. John Mafi, an assistant professor of medicine at the David Geffen School of Medicine at UCLA.

The 723,000 knee replacements performed in 2014 cost patients, insurers and taxpayers more than $40 billion. Those costs are projected to surge as the nation ages and grapples with the effects of the obesity epidemic, and an aging population.

To avoid inappropriate joint replacements, some health systems are developing “decision aids,” easy-to-understand written materials and videos about the risks, benefits and limits of surgery to help patients make more informed choices.

In 2009, Group Health introduced decision aids for patients considering joint replacement for hips and knees.

Blue Shield of California implemented a similar “shared decision-making” initiative.

Executives at the health plan have been especially concerned about the big increase in younger patients undergoing knee replacement surgery, said Henry Garlich, director of health care value solutions and enhanced clinical programs.

The percentage of knee replacements performed on people 45 to 64 increased from 30 percent in 2000 to 40 percent in 2015, according to the Agency for Healthcare Research and Quality.

Because the devices can wear out in as little as a few years, a younger person could outlive their knees and require a replacement, Garlich said. But “revision” surgeries are much more complicated procedures, with a higher risk of complications and failure.

“Patients think after they have a knee replacement, they will be competing in the Olympics,” Garlich said.

Danette Lake once planned to undergo knee replacement surgery on her other knee. Today, she’s not sure what to do. She is afraid of being disappointed by a second surgery.

Sometimes, she said, “I think, ‘I might as well just stay in pain.’”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Why U.S. Biologic Drugs Are So Expensive

By Sarah Jane Tribble, Kaiser Health News

Europeans have found the secret to making some of the world’s costliest medicines much more affordable, as much as 80 percent cheaper than in the U.S.

Governments in Europe have compelled drugmakers to bend on prices and have thrown open the market for so-called biosimilars, which are cheaper copies of biologic drugs made from living organisms. The brand-name products — ranging from Humira for rheumatoid arthritis to Avastin for cancer — are high-priced drugs that account for 40 percent of U.S. pharmaceutical sales.

European patients can choose from dozens of biosimilars, 50 in all, which have stoked competition and driven prices lower. Europe approved the growth hormone Omnitrope as its first biosimilar in 2006, but the U.S. didn’t follow suit until 2015 with cancer-treatment drug Zarxio. 

Now, the U.S. government stops short of negotiating and drugmakers with brand-name biologics have used a variety of strategies — from special contracting deals to overlapping patents known as “patent thickets”— to block copycat versions of their drugs from entering the U.S. or gaining market share.

As a result, only six biosimilars are available for U.S. consumers.

European countries don’t generally allow price increases after a drug launches and, in some cases, the national health authority requires patients to switch to less expensive biosimilars once the copycat product is proven safe and effective, said Michael Kleinrock, research director for IQVIA Institute for Human Data Science.

From $50 to $1,300 a month

If Susie Christoff, a 59-year-old who suffers from debilitating psoriatic arthritis, lived in Italy, the cost of her preferred medicine would be less than quarter of what it is in the U.S., according to data gathered by GlobalData, a research firm.

Christoff tried a series of expensive biologics before discovering a once-a-month injection of Cosentyx, manufactured by Swiss drugmaker Novartis, worked the best.

Without the medicine, Christoff said, her fingers can swell to the size of sausages.

SUSIE CHRISTOFF (KAISER HEALTH NEWS PHOTO)

SUSIE CHRISTOFF (KAISER HEALTH NEWS PHOTO)

“It’s 24/7 constant pain in, like, the ankles and feet,” said Christoff, who lives in Fairfax, Va. “I can’t sleep, [and] I can’t sit still. I cry. I throw pillows. It’s just … awful.”

At first, Christoff’s copay for Cosentyx was just $50 a month. But when a disability led her to switch to a Medicare Advantage plan, her out-of-pocket costs ballooned to nearly $1,300 a month — more than three times her monthly car loan.

Christoff, with the help of her rheumatologist, Dr. Angus Worthing, tried Enbrel, Humira and other drugs before finding Cosentyx, the only drug that provides relief. Christoff’s case is “heartbreaking,” Worthing said.

Novartis declined to respond to questions about Cosentyx’s price. Instead, like other pharmaceutical companies, Novartis says it offers patient assistance programs for those who can’t afford the drug. Christoff said she doesn’t qualify for financial assistance.

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Like other biologics, Cosentyx costs thousands of dollars per month. The annual cost of Christoff’s treatment runs about $65,000 in the U.S. In Italy, where competition and price negotiations play a bigger role, it would run about $15,000, according to GlobalData.

In England, Dr. Christopher Griffiths, a lead researcher at the National Institute for Health Research who treats patients with Cosentyx, said the National Health Service would pay about 10,000 pounds, or less than $13,000.

And those drastic price differences are true even though there is no biosimilar version of Cosentyx yet available in Europe, and might not be for years.

The cost of the drug is taking a toll on Christoff. This past summer, her progressive disease made it difficult to enjoy the annual family vacation with her three grown children and their kids in Virginia Beach, Va.

“I can’t get down on the sand to play with my kids without help. I can’t get up without help,” Christoff recalled. “I’m not ready to stop trying. But I’m also not ready to go through my entire retirement fund to walk.”

Unlike Cosentyx, rival drugs — Humira, Enbrel and Remicade — all face biosimilar competition in Europe. Only Remicade has competition from a lower-cost biosimilar in the U.S., and Humira isn’t expected to have a copycat competitor in the U.S. market until 2023. Humira, made by AbbVie, is the world’s top-selling drug.

In late October, Wall Street analyst Ronny Gal at Sanford C. Bernstein & Co. noted that AbbVie agreed to drop Humira’s price by 80 percent in one Nordic country to combat biosimilar competition. During the company’s quarterly conference call, AbbVie chief executive Richard Gonzalez said the drug’s discount was as low as 10 percent and as high as 80 percent across the continent, with the highest discounts in Nordic countries.

“These are markets where it’s ‘winner takes all’ across the entire… category, so includes Remicade and Enbrel as well,” Gonzalez said in November, adding that Nordic countries represent about 4 to 5 percent of overall revenue in AbbVie’s international business.

Concerned about how much biologics cost the U.S. health system and patients, Food and Drug Administration Commissioner Scott Gottlieb announced an “action plan” this summer that included tapping the Federal Trade Commission for help, saying he was “worried” about the biosimilar market.

“The branded drug industry didn’t build its success by being business naive; they are smart competitors,” Gottlieb told an audience full of advocates, industry insiders and researchers at the Washington, D.C.-based Brookings Institution in July. “But that doesn’t mean we need to embrace all of these business tactics or agree with them and think they are appropriate.”  

Rebate Traps

One of these business tactics involves so-called rebate traps, in which financial deals are cut to make sure patients can get only a biologic, not a biosimilar. International drugmaker Pfizer alleged in a September 2017 lawsuit that exclusionary contracts created by Johnson & Johnson prevented use of its biosimilar by health insurers, hospitals and clinics.

Johnson & Johnson’s wildly successful biologic Remicade, the brand-name version of infliximab, produced $6.3 billion in worldwide in 2017. Pfizer launched its copycat drug, Inflectra, in the U.S. in October 2016, noting in the announcement that it would price the drug at a 15 percent discount to Remicade’s wholesale price.

Still, health systems such as Geisinger Health, based in Pennsylvania, say they have had difficulty switching to the less expensive alternative.

“J&J has done a really good job of entrenching themselves in the market,” said Jason Howay, manager of formulary services at Geisinger.

The health system ultimately decided it wanted to switch all adults to Pfizer’s biosimilar, saying it provided the same quality of treatment. But Johnson & Johnson had “bundled” the prices of other drugs with Remicade. So if Geisinger stopped using Remicade on adult patients, J&J could stop providing discounts on other drugs, such as those used for cardiology, Howay explained. “It weaves a very tangled web.”

A spokeswoman for Janssen, Johnson & Johnson’s main pharmaceutical subsidiary, says the drugmaker does offer “more attractive contract terms” to buyers who use a wider range of J&J medicines. “Our contracting approach has always prioritized access for patients and their providers,” Meredith Sharp says.

Geisinger negotiated with biosimilar maker Pfizer and won still lower prices to make up for lost savings on the other J&J drugs. It’s now transitioning all adult patients to the less expensive biosimilar.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Supplements Often Tainted by Hidden Drugs

By Pat Anson, PNN Editor

Hundreds of dietary supplements – including some marketed to relieve joint and muscle pain – are tainted with pharmaceutical drugs, according to a new study published in JAMA Network Open.  

Researchers with the California Department of Public Health looked at 746 supplements that the Food and Drug Administration found to be adulterated from 2007 to 2016. About half of the supplements remained on the market, even after the FDA found they contained potentially harmful drugs.

"The FDA didn't even bother to recall more than half of the potentially hazardous supplements," Pieter Cohen, MD, a Harvard Medical School professor told NPR. "How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn't take the next obvious step, which is to ensure that they are removed from the marketplace?"

Over half of American adults take dietary supplements that contain minerals, vitamins, herbs, fish oil and other “natural” substances.  Most of the adulterated supplements were marketed for sexual enhancement, weight loss or muscle building.

Of the 14 supplements that were promoted as treatments for arthritis, muscle and joint pain, osteoporosis or other painful conditions, half contained diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and five contained dexamethasone, a steroid used to treat inflammation.

One supplement promoted as a treatment for arthritis – Pro ArthMax -- was found to contain four different NSAIDs, as well as a muscle relaxant and a non-narcotic pain reliever that was never approved for use in the United States. The manufacturer of Pro ArthMax voluntarily recalled the supplement in 2014 after being warned by the FDA.   

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Cohen chided the agency for relying on voluntary recalls to get tainted supplements off the market and accused the FDA of “dereliction of duty” in a JAMA commentary. He called on Congress to change the federal law that exempts the $35 billion dollar supplement industry from pre-market safety and clinical studies that are required for pharmaceutical drugs.   

“More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market,” Cohen wrote. “The process that the FDA is required to follow to remove supplements from the marketplace (is) cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Dietary supplements that are tainted with hidden drugs may interact with other medications and raise the risk of adverse events, particularly when consumers already may be using NSAID-containing products.  

Legal Battles Brew Over High Cost of Arthritis Drugs

By Julie Appleby, Kaiser Health News

Early last winter, Pfizer launched its new rheumatoid arthritis treatment, Inflectra, pricing it 15 percent below the $4,000-a-dose wholesale price of Remicade, the drug for which it is a close copy.

Pfizer figured its lower price would attract cost-conscious insurers.

A year later, though, its drug has barely scratched the market and Pfizer has filed an antitrust suit against its rivals, alleging they are thwarting lower-priced competition through “exclusionary contracts” and rebates.

The outcome of the case — filed in September in U.S. District Court against Johnson & Johnson, the maker of Remicade, and Janssen Biotech — could affect the future of biosimilars, a new class of drugs. Some policy experts say these near-copies of biologics are key to slowing spending on complex and expensive specialty medications like those used to treat rheumatoid arthritis.

At the heart of the case are rebates, which are discounts off the wholesale price of drugs.

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Manufacturers offer them to help keep their products on insurers’ lists of covered drugs. The money mainly goes back to insurers and pharmacy benefit managers, who say the rebates help reduce health care spending.

But Pfizer alleges that those rebates are being used to thwart biosimilars’ entry into the marketplace.

“This is the first antitrust case we’ve seen like this around biosimilars,” said Michael Carrier, a Rutgers Law School professor “Pfizer is claiming that one form of anti-competitive behavior involves withholding rebates from insurers.”

Biosimilars are costly to produce, so they are not likely to trigger the same sharp pricing drop triggered by generics. Still, their manufacturers say they could bring consumers some relief to rival biologics’ high price tags.

Pfizer’s Inflectra is one of the first biosimilars to hit the market since Congress passed legislation in 2010 to pave the way.

According to Pfizer, weeks after Inflectra gained Food and Drug Admininstration approval, J&J moved to stake out its biologic turf.

J&J began requiring insurers and PBMs to sign “exclusionary contracts … designed to block both insurers from reimbursing and hospitals and clinics from purchasing Inflectra or other biosimilars of Remicade despite their lower pricing,” alleges the case filed in federal district court in Philadelphia.

If insurers don’t agree to the J&J contracts, the loss of rebates could “for some insurers, run into the tens of millions of dollars annually,” the Pfizer case alleges.

Even with its lower price, Pfizer faced an uphill battle to win market share.

Remicade is the fifth-biggest-selling drug by revenue in the U.S., reaping more than $4.8 billion in 2016 for makers J&J and Janssen, the suit said. Often, patients are reluctant to switch once they are established on an RA drug that is working for them.

Still, Pfizer thought it would pick up newly diagnosed patients and gain ground that way. But its lawsuit says the drug accounted for only about 4 percent of total sales, with Remicade getting the rest, by early September.

“We stand by our contracts,” said J&J and Janssen Biotech in a written statement. The firms also defend rebates as “competition that is doing what competition is meant to do: driving deeper discounts that will lead to overall lower costs.”

Yet the price of Remicade has not fallen, the Pfizer case says.

Since approval of Inflectra, J&J has raised the list price of Remicade by close to 9 percent, the lawsuit alleges. As of September, Remicade’s average sales price –after discounts and rebates — is more than 10 percent higher than Inflectra.

“This case is a big deal, because it has the potential to bring to light some of the anti-competitive contracting practices at work to keep … prices extremely high,” said Jaime King, a professor at University of California-Hastings College of the Law.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Rising Cost of Arthritis Drugs Defies Economics

By Julie Appleby, Kaiser Health News

Renda Bower knows well the cost of drugs to treat rheumatoid arthritis – her husband, son and daughter all have the painful, disabling autoimmune disease. And the family’s finances revolve around paying for them.

Even with insurance, Bower’s family last year faced $600 a month in copayments for the drug, plus additional payments on another $16,000 in medical bills racked up in 2016 when a former insurer refused to cover all the doses her 9-year-old daughter needed.

Bowers, of Warsaw, Ind., said her family tries to keep up with prices by cutting back on her children’s sports and extracurriculars and skipping family vacations. She also works as a part-time teacher.

But financially, it’s hard. “The cost should not be this high,” she said.

Wholesale prices for Humira and Enbrel, the two most commonly used treatments for rheumatoid arthritis, known as RA, increased more than 70 percent in the past three years.

Since the first RA drug came to market a decade ago, nearly a dozen have been added. If basic economics prevailed, RA treatments and patients would have benefited from competition.

But, because of industry price-setting practices, legal challenges and marketing tactics, they haven’t. The first RA drug cost $10,000 a year. It now lists for more than $40,000 — even as alternatives have entered the U.S. market.

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“Competition generally doesn’t work to lower prices in branded specialty drugs,” said Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes.

Humira is the world’s No. 1 prescription drug by revenue. AbbVie manufactures and markets the drug and is on track to reach revenue from the product of $17 billion this year.

Other RA treatments are also among the top 10 drugs by revenue sold in the U.S. Enbrel, made by Amgen, ranks as No. 3. Remicade, by Janssen Biotech, is fifth. Some RA medications are approved for other conditions, including psoriatic arthritis, Crohn’s disease and psoriasis.

About 1.5 million Americans have rheumatoid arthritis. The Bowers found some relief this year but not because prices dropped. Rather, Renda’s husband left his job at an engineering firm to work as a machinist at a medical device company that has an insurance plan with lower copayments. Her daughter was accepted into a clinical trial at Cincinnati Children’s Hospital. The trial covers the drug’s cost but not the associated expense of weekly travel, among other things.

Middlemen Benefit As Wholesale Price Rises

The complicated pharmaceutical supply chain in the United States means middlemen — such as pharmacy benefit managers (PBM) and, in some cases, hospitals and doctors’ offices — can gain financially by choosing more expensive drugs. That’s because PBMs usually get a rebate from the drugmakers on top of whatever profit they get from selling or administering the drug.

Those rebates often are based on a percentage of the list, or wholesale, price. So, the middlemen who get the rebates take in more money when drugmakers raise those sticker prices.

But who pockets the rebates? PBM firms, which oversee drug benefits for millions of Americans, say they share all or part of them with the insurers or employers who hire them. In some cases, the rebates go directly to specialty pharmacies, medical clinics or physicians dispensing the treatments.

The rebates rarely end up directly in patients’ pockets.

Those rebates affect the market in another way: They can make it harder for some companies to offer new treatments or they can thwart less costly rival products.

“We could give [our new drug] away for free and … it would still be more economically advantageous” for insurers and PBMs to send patients to Humira first, said Andreas Kuznik, a senior director at Regeneron Pharmaceuticals, at a conference examining the cost and value of RA treatments.

Thomas Amoroso, medical director for medical policy at Tufts Health Plan, said at the same March conference that he has found drug industry sales representatives to be persistent in tracking how their drugs are positioned on plan formularies.

If insurers decide to add a new, lower-cost drug as the preferred alternative, “our Humira rep would be knocking on our door next week and saying, ‘Hey, that rebate we gave you? We’re taking it back,’” Amoroso said.

The roundtable at which they spoke was part of an assessment of RA drug pricing convened by the Institute for Clinical and Economic Review, a nonprofit that evaluates the value of medical tests and treatments for insurers and other clients.

PBMs won’t disclose the rebates they provide to clients, but studies provide a clue. It’s a huge amount of money.

The Berkeley Research Group, a consulting firm that advises major employers, said that rebates and other discounts paid to insurers, PBMs and the U.S. government for brand-name drugs grew from $67 billion in 2013 to $106 billion in 2015.

Most RA drugs are a complex type of medication, called biologics, which are made in living organisms. Nearly identical copies of biologics are called biosimilars. They hold the promise of lower prices, just as generic drugs did for less complex medications.

While several biosimilar RA treatments have won Food and Drug Administration approval, including replicas of Humira, Enbrel and Remicade, most are tied up in court battles over patents. And those biosimilars that have made it to market are now the subject of new areas of legal challenge.

In mid-September, Pfizer filed what will be a closely watched antitrust lawsuit against Johnson & Johnson. The case alleges that J&J is using exclusionary contracts and the threat of withdrawing rebates to protect Remicade from Pfizer’s lower-priced biosimilar, Inflectra, which hit the market last winter.

J&J defends its contracts, saying they are “driving deeper discounts that will lead to overall lower costs.”

Arguments For And Against Rebates

Rebates are under increasing scrutiny, amid growing alarm about soaring prescription drug prices in the United States. But the Pharmaceutical Care Management Association, the PBM industry’s trade lobby, said that complaints that rebates help fuel higher prices are unfounded.

These rebates, the lobby says, help save the health system millions of dollars by shifting dollars back to insurers or other clients, who can then use them to lower future premium increases. This year, it commissioned a study that found no correlation between rebates and the rising list prices of the top 200 brand-name drugs, suggesting higher rebates didn’t necessarily drive higher prices.

“The rebate system exists because [insurers, employers and other clients] want discounts,” said Steve Miller, chief medical officer for Express Scripts, one of the nation’s three largest PBMs.

Express Scripts offers clients an option to give patients the discount directly, but most choose not to, he said.

“While individual patients would get the benefit, everyone else’s premiums would go up [because the rebate savings would not flow back to the insurer],” Miller said. “Changing where the rebate goes doesn’t lower the price of the drug.”

But rebates play a role in what some patients pay at the pharmacy counter.

It stems from a simple calculation: whether a patient’s insurance copayment is based on a percentage of the drug’s wholesale price or the drug’s price after rebates are given to the middlemen.

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Heidi Barrett , a mother of five from Everett, Wash., faces a 10 percent copay whenever she or one of her four children who have RA, all of whom have been on medication for years, go for their monthly infusion of Remicade.

Although Barrett is shielded from much of the cost because she has good employer-based insurance through her husband’s job, the question of whether her monthly copayments are based on the wholesale price or the after-rebate price rankles her.

“I have asked that question of the insurance company. I’ve asked that of our union,” said Barrett, 47, a paralegal who isn’t working because she spends so much time on her children’s treatments. “I never got any answers back.”

Based on data analyzed by Bach’s group at Sloan Kettering to determine the cost of 100 milligrams of Remicade, it appears she is paying based on the pre-rebate price.

Here’s how that works: Barrett’s 18-year-old son recently received a 600 mg dose that required a copay of $655. That is close to 10 percent of Remicade’s average U.S. wholesale price for that dose of $6,450, the Bach analysis showed.

Barrett is not benefiting from the rebate that middlemen receive.

Rebates and discounts, however, drive down the price for pharmacy benefit managers, hospitals or doctors.

According to the analysis, the average net cost of a 600 mg dose is $4,140, once all discounts are calculated. If Barrett could use that base price as her copay, she would save more than $240. For her entire family — all her children and Barrett take similar doses — that equals a savings of $1,000 a month.

With her current insurance, Barrett quickly meets a yearly $12,900 deductible. She considers herself lucky that her insurer then picks up the drug’s full cost. But the experience has changed her motherly advice to her children, who are 10, 18, 19 and 25, about what to hope for in life.

“I tell them, you can be anything you want when you go grow up. But you need to go to a company with good health insurance, even before you look at the salary or whether you’ll be happy there, your first priority is health insurance,” Barrett said. “It’s an insane world we live in.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Let's Restore Reason and Sanity to Opioid Prescribing

By Sandie Hamilton, Guest Columnist

I am 62 years old and a full time worker employed in the social services area. I am a mother, grandmother, registered voter and taxpayer. I support this country and everything she stands for. I believe in our Constitution and in our Bill of Rights, which contain the basis for my point today: the pursuit of happiness.

I have been diagnosed with degenerative arthritis of the spine. The pain it causes makes doing my job, sitting through a movie or Sunday service, and driving in a car nearly impossible. I cannot sit for more than 20 minutes at a time, nor stand for prolonged periods of time. If it weren’t for my prescribed opioids, I would not be able to sit at this computer long enough to write this.

Opioid pain medication was not the first thing my doctor prescribed. It was the last. I did spinal epidurals, nerve blocks, chiropractic manipulation, physical therapy, ultra-heat therapy, deep tissue massage, and yoga (which sent me back to the doctor). I also used topical creams, ointments, essential oils, lots of prayer, and of course NSAIDs -- until peptic ulcers led to stomach bleeds and vomiting.

Then my doctor put me on a low dose of opioids. I am now able to continue working, sit here and write this column. And all the other little things most folks take for granted.

SANDIE HAMILTON

SANDIE HAMILTON

My dose could be a little higher and probably needs to be adjusted, but I don’t dare ask my doctor. He told me once that “they” have made him feel like a criminal for what he does do. It’s a shame that I can’t talk to him and he is afraid to do more to help me because of this crazy manufactured opioid crisis. Not to say prescribing hadn’t gotten too liberal, maybe it had. But that was before I needed help.

I seriously believe the liberal prescribing days are over. Way over. Where I live most people aren’t getting anything, unless they’re dying. And that is excessive. Because of opioids I am a productive taxpaying citizen, not a housebound miserable invalid drawing my little disability check and getting free medical care.

Because of opioids, I am not a burden to the state. I am able to exercise my right to the pursuit of happiness, which for me means getting some relief from the constant pain. More could be done, but I am afraid to ask and my doctor is afraid to offer. That is wrong.

Something within reason needs to be done for the millions of pain patients who live in fear of losing or who have already lost their one lifeline to normal living -- a prescribed medication that works. But that’s not possible with all the tightened opioid guidelines and the number of drug overdoses rising.

Hopeless people unable to accept their pain have committed suicide. And I understand why. Others have turned to the black market and are trying things coming in from Mexico that can kill them. Of course, a lot of people choose to do drugs to get high, and it is their misuse and abuse of our medication that has caused a lot of the issues and overdosing.

We are being called addicts and drug seekers, and lumped right in there with the thrill seekers, which we aren’t. We are people with varying conditions that cause pain. Chronic untreated pain kills people too. It has been documented the effect it has on the brain, the stress on your heart, and the drain on your emotions.

Did people take advantage of opioids and turn from medicinal to recreational use? Yes they did. But the overprescribing has stopped. In some hospitals, you can’t even get opioids now if you’re having surgery! That’s ridiculous.

If we are diagnosed by a physician who wants us treated with opioids, we should be able to get them in whatever degree we need them. People are different. What works well for one may work differently for another, but the doctor should be able to determine what his patient needs and prescribe accordingly.

Please stop this war on pain patients. I want to be able to talk to my doctor and not live in fear that what is working for me today might be taken away tomorrow. There should be pain management specialists, pain sufferers and patient advocates on government commissions that deal with pain. How can you possibly decide what we need or don’t need if you aren’t talking to us?

Please hear us. Restore some reason and sanity to prescribing regulations and give us back the doctor-patient relationship.

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Sandie Hamilton lives in Oklahoma.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

9 Holistic Approaches to Relieve Joint Pain

By Nicole Noel, Guest Columnist

Whatever your ailment may be, holistic medicine has an answer.

A therapeutic method that dates back to early civilizations, holistic medicine takes into account the mind, body, emotions and spirit -- with the aim of helping patients achieve or restore proper balance in life and prevent or heal a range of conditions, including musculoskeletal pain. Holistic treatments offer a ray of hope for many patients suffering from arthritis, osteoporosis, fibromyalgia and other conditions that cause joint pain.

Not all alternative medicine is created equal, and some natural healing methods will produce better and quicker results. If you want to treat arthritis and other joint aches with holistic treatments, here are a few natural pain relievers you can try.

1. Tai Chi

A low-impact activity that can increase range of motion and strengthen joints and surrounding muscle tissue, tai chi is an ancient physical and spiritual practice that can help arthritis patients soldier through their pain.

According to a 2013 study, tai chi can relieve pain, stiffness, and other side-effects of osteoarthritis. In addition to pain relief, tai chi can help improve range of motion and alleviate joint pain for people living with fibromyalgia and rheumatoid arthritis.

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2. Yoga

Another ancient technique which promotes natural healing, yoga is perfect for individuals suffering from lower back and joint pain. Gentle stretches and poses opening the joints can help prevent and alleviate chronic soreness in the shoulders, hips, and knees.

A form of yoga called mudras utilizes a series of hand gestures to increase energy, and improve mood and concentration.

3. Massage

An invigorating massage with warm essential oil can help many conditions, and joint pain is one of them.

By enhancing blood flow, relaxing the muscle tissue and soothing inflammation, a well-timed massage can ease joint stiffness and increase range of motion in individuals suffering from arthritis, fibromyalgia, and osteoporosis.

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4. Acupuncture

A 2013 review of medical studies has shown that acupuncture can help relieve musculoskeletal pain caused by fibromyalgia. By activating the body’s natural pain relief system and stimulating the nerves, muscles and connective tissue, acupuncture can relieve joint aches for people who are resistant to other holistic pain relief techniques.

A 2010 study found that acupuncture can also be a beneficial for peripheral joint osteoarthritis.

5. Diet Changes

An apple a day may or may not keep the doctor away, but a custom-tailored diet can help you with joint pain. Nutritional tweaks can begin with increased intake of chondroitin sulfate, glucosamine, and Omega 3 fatty acids, which can reduce joint pain in arthritis and osteoporosis patients.

To ease joint problems, your pantry should be stocked with foods that promote healing and reduce inflammation, such as onions, carrots, and flaxseed. Herbs and spices such as turmeric (curcumin) and cayenne pepper can also help with pain relief.

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6. Aromatherapy

If you think pain relief can’t smell good, you’re mistaken. Studies have shown that peppermint and eucalyptus oil can reduce swelling, pain and discomfort in patients with inflamed joints. For joint soreness and stiffness caused by arthritis, aromatherapy experts recommend regular application of myrrh, turmeric, orange, or frankincense oil to ease inflammation and pain, and to increase range of motion.

You can also combine aromatherapy with heat and cold treatments.  Be sure to keep the tender joints elevated during treatment to reduce swelling.

7. Spa Treatments

Few things can beat the appeal of a full-scale spa experience. If you’re suffering from knee, hip, shoulder or elbow pain and other holistic methods haven’t helped, try balneotherapy, which combines aqua massage with deep soaks in heated mineral water and medicinal mud baths.

One study found that balneotherapy significantly reduced knee and back pain in older adults.

8. Aquatic Sports

If you don’t want to immerse yourself in mud, you can supplement your holistic pain therapy with water aerobics, swimming, aqua jogging or aqua spinning. According to a 2014 study, water exercises can ease pain and improve joint function for osteoarthritis patients.

Additionally, a 2015 study found that aquatic circuit training can help relieve knee pain in cases of progressed osteoarthritis.

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9. Capsaicin cream

Another natural treatment for joint pain and stiffness is homemade capsaicin cream, which can help reduce swelling and increase range of motion. To stay on the safe side, you should be careful when handling hot peppers when preparing the cream, and avoid using it on sensitive and damaged skin.

As our bodies age, joint pain can become a chronic. If you don’t want to take your chances with conventional pharmaceuticals, you can always turn to holistic medicine for answers and help. When musculoskeletal pain hits home, one or more of these holistic treatments can help.

Nicole Noel is a lifestyle blogger who is passionate about yoga and healthy living. She enjoys sharing her experiences and ideas on how to lead a happy and healthy life. If you want to read more from Nicole, you can find her on Twitter and Facebook.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

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