(CNN) – More than 80% of physicians claim Medicare for 2016 for H.P. Acthar Gel, a drug best known for treating a rare infant infarction, received money or other benefits from drug manufacturers, according to a CNN analysis by publicly identified prescribers.
The analysis involving physicians claiming more than 10 part D claims that drug manufacturers – Mallinckrodt and Questcor – awarded more than $ 6.5 million to 288 prescribing physicians between 2013 and 2016 for counseling, doctoral speeches, and other Acthar paid for related services. Mallinckrodt bought Questcor in 201
At about the same time, Acthar's Medicare spending rose dramatically – more than tenfold in six years.
According to the agency, Medicare spent nearly $ 2 billion on Acthar in 2011-2016 – although some doctors would have said an equally effective treatment cost a tiny fraction of that amount. Medicare spending on Acthar from 2013-2016 accounted for nearly $ 1.8 billion. Much of the increase in Medicare spending coincided with a marketing push from Mallinckrodt to adults, especially seniors, after buying Acthar's previous manufacturer, Questcor, in 2014, according to company documents that CNN has reviewed.
On Friday, a separate study on Achar's payments and prescriptions revealed similar results to CNN's analysis. The authors of this study, published in the JAMA Network Open, said their findings "suggest that financial conflicts of interest could drive the use of [Acthar] in the Medicare program."
"We clearly saw that for doctors, more prescriptions were generated and more Medicare program spending on this drug," said Daniel Hartung, lead author of the study.
Acthar is best known for treating babies with infantile spasms, a rare and catastrophic form of epilepsy Hartung, an adjunct professor at Oregon State College of Pharmacy, said it was worrying that the drug was in of adult medicine, with taxpayers paying the bill for hundreds of millions of dollars.
"The evidence that drug is better than synthetic steroids is either weak or absent," said Hartung CNN.
Mallinckrodt's recent push in the areas of rheumatology, nephrology and multiple sclerosis, he said, was the result of the drug's aggressive marketing for a number of conditions that, while having an FDA complaint, are poorly supported by the medical evidence become."
Dennis Bourdette, another of the study's six authors, told CNN the nearly $ 2 billion spent by Medicare resulted from a tiny fraction of physicians who "join in [Acthar] without worrying about the cost."
"The problem is that it's unbelievably more expensive than synthetic corticosteroids and for some reason – maybe financial gain – a small number of doctors will prescribe it," said Bourdette, chair of neurology at Oregon Health & Science University CNN.
Some physicians who prescribed Acthar in adult medicine and received money from Mallinckrodt told CNN that they only used Acthar after steroids and other treatments failed. While Actor is not a steroid, it replicates some of its anti-inflammatory benefits.
A steroid like prednisone can cost as little as $ 2.50 for a bottle of pills – less than a starbucks coffee – compared with Acthar at nearly $ 39,000 a bottle of injectable liquid. In the course of treatment, these numbers become even more dramatic: $ 7.50 for three bottles of prednisone versus $ 117,000 for three vials of Actor.
"The continued growth in [Acthar] use is because of its very high cost, widespread negative media coverage, and notable lack of evidence supporting its use over lower cost corticosteroids," the authors wrote.
The results of the Friday 2015 study, which focused on Medicare claims 2015 and 2015 payment data, appeared to support CNN's data analysis, the Medicare claims for 2016 – the last year for which data are available – and payments from the 2013, the first year for which these figures are available.
The drug offenders have paid at least 18,810 physicians almost $ 27.5 million in Acthar-related payments from 2013 to 2016 showing CNN's analysis of government data.
In response to questions from CNN about his findings, Mallinckrodt published a statement in which she strongly defended her payers to doctors:
"In the period 2013-2016, all physicians prescribed the HP Acthar Gel, the Mallinckrodt or the Prior owners have made payments, more than 95% received only modest meals or nominally low-cost clinical reprints [of medical journal articles] – well within regulations and guidelines. "
Mallinckrodt said the" vast majority "of the remaining The physicians were" engaged for peer -to-peer lectures "and a small portion of them have been involved in other advisory services, such as to employees or investors and to expert advisory boards.
"It is our belief that many physicians prefer peer-to-peer presentations and dialogues about other methods of learning about the value that a product can bring to the patient they treat, the doctors who present to their colleagues They need to stay away from their practice and travel frequently to other cities – which leads to normal but sometimes substantial travel expenses – all reported payments include reimbursement of those costs. "
The drug maker emphasized that Acthar was approved by the FDA for 19 indications such as Multiple sclerosis, rheumatoid arthritis and kidney disease is approved and 'largely used as a late treatment prescribed by qualified health care providers, a small subset of eligible patients who need an alternative treatment option.' The drug is also the 'gold standard' in the treatment of infantile Spasms, said Mallinckrodt.
"HP Acthar Gel makes a significant difference in the lives of very ill patients with unmet medical needs and we are proud of the drug and the important investment we make in it," said the pharmaceutical company.
"Mallinckrodt has been substantially involved in HP Acthar Gel since its acquisition in 2014, generating additional data in support of its use and has made only moderate price adjustments, and continues to act and act responsibly and ethically in dealing with physicians and others."  Since Mallorckrodt bought the drug from Questcor in 2014, the price of Acthar has risen from $ 32,000 to nearly $ 39,000. Before Questcor bought it, it was $ 40. Questcor shocked the medical community when it received the award on August 27, 2007 Overnight increased from $ 1,600 to $ 23,000 per vial.
Last year, Mallinckrodt paid $ 100 million without settling for a lawsuit by the Federal Trade Commission and five states resulting from Questcor's acquisition of a contraceptive that said the FTC "threatened its monopoly."
How a Children's Drug Expands to Older People
Mallinckrodt bought Acthar as part of a $ 5.6 billion deal for Questcor in 2014, when Mallinckrodt's President and CEO Mark Trudeau described the drug key for the future of the pharmaceutical company.
Shortly after purchase After closing in August of this year, executives revealed their strategy: look for the 4 million Americans who have suffered "Acthar Indicated Conditions".
Gary Phillips, President of Mallinckrodt's Autoimmune and Rare Diseases Business "We are confident that awareness and evidence for the product will grow dramatically next year," said Phillips Investor Briefing in October 2014.  Phillips presented PowerPoint presentations that represented the company's strategy, including the need to bring Acthar into its "underserved patient population" in rheumatology, pulmonology, ophthalmology, dermatology and kidney disease.
A graph of 9,000 patients was currently treated with Acthar and 300,000 people had "addressable but currently untreated" conditions. The slide also found that a total of 4 million Americans suffered from "Acthar indicated conditions".
"Today, Acthar is only used in about 3% of these [300,000] patients," Phillips said. "The strategy is pretty simple."
He promised to significantly expand Acthar's sales force in the areas of rheumatology and pulmonology next year. In fact, the message was clear: there were more patients to treat and more money to earn.
The Mallinckrodt PowerPoint presentation appeared to be in stark contrast to the years before Steve Cartt, the then Executive Vice President of Questor, wrote an email
"Based on that experience, we realized that In the treatment of childhood cramps, the medical community has determined that Acthar delivers its true value to patients, Cartt wrote in an email in August 2007, which he shared with CNN.
The Mallinckrodt investor conference in October 2014 Outlined aggressive marketing thrust seems to have paid off: Medicare spent more than $ 600 million on more than 12,000 Acthar claims in 2016 – more than twice the 2013 figure, the year before Mallinckrodt's purchase.
Many of these prescriptions were made by rheumatologists , Nephrologists and Neurologists "The doctors from Mallinckrodt said they were planning a targeted treatment.
All in all, since 2011, Medicare has spent more than $ 1.98 billion on around 45,000 Acthar claims.
Is It Even Effective For Treating Elderly Patients? "19659030] Several Acthar-trusted doctors told CNN that the drug was of little use to adults in steroid treatment, saying it was somewhere between $ 2.50 for Prednisone and $ 5000 for a high intravenous dose of methylprednisolone could be. Even at the high end, these doctors said prescribing steroids over Acthar could have saved Medicare nearly $ 1.8 billion.
"Medicare nearly $ 2 billion for a drug Issuing the dubious benefit is very disconcerting, "said Rita Redberg, a cardiologist and professor at the University of California, San Francisco, School of Medicine.
Redberg is co-author of an editorial in JAMA last November on the high price tag Acthar, also known as ACTH, warns of "lack of evidence of its efficacy in all adult conditions. "
" The lack of high-quality evidence supporting the benefits of Acthar Gel under a variety of conditions, along with the unreasonable price increase by the manufacturer, should stop all practitioners, "wrote Redberg and her co-author, Dr. Saate Shakil , a UCSF resident.
"Not only should physicians consider the lack of evidence for the effectiveness of ACTH, but their history should lead us to rethink and strengthen our standards for FDA approval, Medicare and private Insurance protection and professional usage patterns.
The drug was first approved for the treatment of dozens of diseases ranging from arthritis and gout to lupus and kidney disease in 1952. Corticosteroids dramatically improved over the following decades, making Acthar almost obsolete in adult medicine until recently
FDA approval in 1952, Redberg said, has essentially scanned the drug for a range of adult conditions that most likely did not
"We have been looking for trials for this drug, and they really are not There, "she said.
In response to this criticism, Mallinckrodt said," There are significant clinical trials evidence of efficacy "from Acthar.
" Equally important, there are decades of clinical experience that doctors use with the product. " have a proven therapy for appropriate patients, "said Mallinckrodt.
The drug manufacturer added added that it has invested "nearly $ 400 million in the drug. In particular: Building on extensive clinical experience as well as previously completed and largely independent clinical case series and smaller trials; Modernization of man manufacturing; Expansion of medical affairs and research activities; and initiated six well-designed, enterprise-sponsored, randomized, controlled clinical trials targeting a combined recruitment of nearly 1,100 patients. "
Mallinckrodt said the nearly $ 400 million does not include marketing or payments to physicians.
Read Mallinckrodt's Full Statement
What about the cheaper alternative?
Why should Medicare be nearly two over five years? Billions of dollars pay if there was a much cheaper alternative?
Stephen Schondelmeyer says you can thank the legislature for that: Medicare can not negotiate drug prices or tell doctors what medications are prescribed.
"Our congress has the Medicare Said that you can not control drug prices, "says Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, who leads the PRIME of the College of Pharmacy Institute, which investigates economic and policy issues related to medicines." We have no government process to evaluate, regulate and manage drug price en s. "
In 2001, Questcor Pharmaceuticals only paid $ 100,000 for the rights to the drug, which initially raised the price from $ 40 to $ 750 per bottle shortly after it was purchased, and the price has risen over the next few years Then, on August 27, 2007, the price shot up overnight from $ 1,600 to $ 23,000 per bottle.
Questcor further increased the price of the drug to approximately $ 32,000 before Mallinckrodt bought Questcor in late 2014. Since then, the Price has risen another $ 7,000.
Acthar's extraordinary price increase of $ 23,000 to $ 23,000, Schadelmeyer said, was particularly problematic.
"It was not because of the competition. It was not because of the research and development costs, "he said." The company saw an opportunity to raise the price, and they did. "
He called the 97,000% drug migration from 2000 to today" one of the highest Price changes of all time "in US history.
No more than a handful of drugs have ever seen such a price increase," he said. "This is certainly a very extraordinary price increase and is without a doubt a competitive market price." Until we get politicians to stand up to these big interest groups, "said Schondelmeyer," I do not expect to see changes in politics. "
President Donald Trump had vowed to change the Medicare provision to save billions of taxpayer money." We do not do it. Why? Because of the drug companies, "he said a lot in New Hampshire in January.
But earlier in May, in unveiling his plan to" bring high-rising drug prices back to Earth, "Trump rejected plans to allow the federal government to bargain directly lower Pricing for Medicare.
Redberg of the UCSF said that drug traffickers consistently exploit Medicare that are unable to negotiate prices or insist on cheaper alternatives under the Medicare Modernization Act of 2003.
"There is none Competition and no upper limit for moral reasons for pricing, "she said. If doctors dictate it, Part D's plans will pay for whatever it costs.
In response to questions about the price increases, Mallinckrodt said:
"2007 HP Acthar Gel's previous owner was about to go bankrupt and increased the price of the drug significantly to keep the drug on the market and provide long-term supply of the drug to ensure the treatment of children with infantile spasms and other small patient populations of complex, devastating diseases. They only did so after extensive consultation with the FDA. "
" Today, the price per vial of H.P. Acthar Gel is $ 38,892. Since the acquisition of H.P. Acthar Gel, Mallinckrodt has made only moderate mid-single digit price adjustments. In addition, Mallinckrodt offers discounts for this list price that the previous owner has not generally offered.
An Unusually High Amount
Only 352 physicians submitted more than 10 Acthar-related claims to Medicare in 2016, a CNN analysis of the data shows: Medicare does not include physicians who filed 10 or fewer claims in their public data have, citing privacy concerns.
These 352 physicians make up less than 20% of all physicians who have prescribed Acthar through Medicare. According to the agency, the other 80% were excluded.
Nonetheless, these 352 physicians accounted for more than half of Acthar-related Medicare claims this year, bringing the program down to nearly $ 369 million, and more than $ 636 million for Acthar  A CNN analysis found that more than 80% or 288 of the 352 physicians who submitted Acthar claims publicly to Medicare in 2016 also received money or other benefits from Mallinckrodt or Questcor between 2013 and 2016. These benefits were sufficient for some Dollars from food or drink to hundreds of thousands of dollars in fees, compensation for services, travel and accommodation.
CNN 's analysis showed that out of these 288 physicians received an extraordinary amount of money from pharmaceutical manufacturers – more than 220,000 Dollar.
Dr. Grace Wright, a rheumatologist in New York City, received the most payments – 673 – and the largest sum of money: $ 370,970.49. More than half was for fee and travel and accommodation; the rest was compensation for services, advisory fees, food and drink and education. Wright filed 16 Part D claims for Acthar in 2016, yielding $ 940,839 in Medicare coverage.
Asked about their payments and demands, Wright told CNN: "I have always met the requirements of the PhRMA Code, including my interactions with Mallinckrodt. To my best knowledge, Mallinckrodt and Questcor also fully comply with the requirements of the PhRMA Code.  "Therapies like Acthar are used to bridge flares in some … patients, and may even be the only therapy available to them. … The mortality rate of these patients can be very high, as well as the burden of caring for the patient, the family and the nursing team.
"As an educator and speaker, it is important to me that the prescribing doctors understand how to – use and not use different therapies.These therapies all have potential adverse consequences and significant price tags.Unfortunately, we determine the doctors and prescribers Doctors, not the price of medicines. "
Here's the breakdown of payments and claims for the other seven doctors who showed CNN's analysis received unusually much money from drug manufacturers from 2013 to 2016:
Dr. Annette Howard from Houston, Texas, a specialist in psychiatry and neurology, received 609 payments $ 345,913.22 – about one third was compensation for services, another third was fee, about a quarter for travel and accommodation, and the remainder for counseling, Education and food and drink. Howard submitted 11 Part D claims for Acthar in 2016, resulting in $ 688,991.24 in Medicare coverage.
• Dr. Oklahoma City's Anupa Khastgir, a specialist in nephrology, received 538 payments worth $ 334,390.56 – about a third was compensation for services, about a third for travel and accommodation, more than a quarter for fees, and the remainder for counseling, education and a scholarship. Khastgir submitted 11 Part D proposals for Acthar in 2016, resulting in $ 642,813.58 in Medicare coverage.
• Dr. Ruwani Gunawardane of Fulton, Maryland, a neurology specialist, received 502 payments worth $ 332,393.36 – nearly half was compensation for services, about a third was fee, about one sixth was for travel and accommodation, and the rest was for consultation, education and food and drink. Gunawardane filed 38 claims resulting in $ 1,329,002.84 in Medicare coverage.
• Dr. Ara Dikranian from San Diego, California, a specialist in rheumatology, received 489 payments worth $ 273,937. Almost half of this was spent on services, about a quarter on fees, about a sixth on travel and accommodation, and the remainder on advice, food and drink and education. Dikranian filed 86 claims resulting in $ 4,443,774 in Medicare coverage.
• Dr. Howard Busch of Loxahatchee, Florida, a rheumatology specialist, received 488 payments worth $ 267,701.63. Of these, more than one-third was in services, more than a quarter in fees, around a fifth in travel and accommodation, and the rest in guidance, education and food and drink. Bush filed 44 claims, resulting in Medicare coverage of $ 3,271,920.07.
• Dr. Petros Efthimiou of Brooklyn, New York, a specialist in rheumatology, received 399 payments worth $ 243,234.04. Of these, more than a third were in fees, almost a third in services, more than a fifth in travel and accommodation, and the rest in guidance, education and food and drink. Efthimiou filed 13 claims resulting in $ 693,725.34 in Medicare coverage.
• Dr. Guillermo Valenzuela of Plantation, Florida, a rheumatology specialist, received 391 payments worth $ 224,713.96. Of these, nearly half were in services, almost one third in fees, around one fifth in travel and accommodation, and the rest in guidance, education and food and drink. Valenzuela filed 50 claims that yielded $ 2,036,129.13 in Medicare coverage.
Howard, Gunawardane, Dikranian, Busch and Valenzuela did not respond to requests from CNN for comment. Asked about their payments and claims, Khastgir said, "[Acthar] was provided to the Nephrology community in 2012, we were skeptical about its use and its mechanism of action." But she said that more research is in the making was promising.
She said that patients who had been treated with other drugs like steroids received a process from Acthar and some of them responded – including "slowing or even holding down the kidneys" and "dialysis and / or transplantation at the Stop or even prevent road ".
"Although it's expensive, it's worth trying a selective group of patients," she said. "Everything to keep these patients from going the ill-fated way to dialysis."
Khastgir said she has lost patients due to the side effects of other drug regimes, and this Acthar "seems relatively safe." She said she had worked with five other US doctors to produce a retrospective study that was funded by Mallinckrodt.
"I am a spokesman for the company and will be presenting the data on the drug to the nephrologist at lunch or dinner time, my expenses are paid by the company, and the contract with Mallinckrodt is in line with other past consultants.
"May I ask what you would do if you had a nephrotic syndrome that was resistant to other drug therapies Your only hope was an expensive drug or expensive organ replacement / dialysis. And what would you do if your 18-year-old daughter is diagnosed with a rare form of nephrotic syndrome and the choice is to use drugs that cause infertility for life and possible blood cancer on the street, or use a low-cost, expensive drug effects?
Well-known side effects include high blood pressure and fluid retention, but doctors who have been using Acthar for years to treat childhood cramps told CNN that the most dreaded side effect is immunosuppression that may lead to death.
Dr. Efthimiou also answered CNN's questions and said:
"I have talked with previous and current manufacturers of this drug from 2013-2016 about rheumatologic diseases where [Acthar] was reported and approved by the FDA. My efforts led to the development of two research studies approved by the Institutional Review Board [IRB] (at a previous institution) on the safety and efficacy of this drug, which has been used since 1952.
"Rheumatoid conditions not only affect the elderly Many patients are younger people with autoimmune disease Unfortunately, younger and older patients sometimes do not respond to first, second or even third-line treatments, including corticosteroids. [Acthar] based on published data that it might work differently than corticosteroids.
"While medication costs remain a global public health problem, my primary responsibility as a physician is for my patents. In rheumatology, as in other disciplines, we consider very expensive biological medicines for treatment, especially for rare and difficult to treat diseases. None of my patients had severe side effects of [Acthar]. All patients treated with this drug in my practice are carefully monitored for side effects.
"If I had a serious, refractory, immune-mediated disease, I would take this medication under medical supervision."
Doctors Are Also Paid
Between 2013 and 2016, Mallinckrodt and Questcor – the Acthar maker they bought in 2014 – paid at least 18,810 physicians for $ 27.5 million, according to a CNN analysis of government data Acthar-related counseling, doctoral interviews, and other services
The analysis shows that 16 physicians received an unusually large sum of money – more than $ 250,000 – compared to the rest. The average number of physicians between 2013 and 2016 was Mallinckrodt and Questcor were $ 1,461.18 and the median was $ 79.82
The following physicians were not among the high-frequency prescribers – those who raised more than 10 Acthar claims – were in 2016 but compensated to the best:
Dr. Ana Stankovic, a specialist in nephrology in Massachusetts, received the most payments and the highest amount of money – 988 payments worth $ 476,254.16. About 40% were in charge of services, such as lecture obligations. More than a quarter was for fee, another quarter for travel and accommodation, the rest for food and drink, guidance and education. Stankovic did not respond by phone, saying the payments were "two or three years ago".
Dr. Margaret Mitrane, a New Jersey rheumatologist and former Deputy Division Director at the FDA, received the second highest amount – $ 463,500 – almost everything for consultancy, according to the data. On her LinkedIn page, Mitrane has "over 25 years of clinical development and regulatory experience, including the FDA and major pharmaceutical companies."
Another doctor, dr. Alan Brown of South Carolina received more than $ 325,000. In 2015, Brown reported a case series on Acthar involving five patients with rheumatoid arthritis who had failed other treatment.
"The results of this case series show that ACTH gel is a safe and viable option for patients with refractory [rheumatoid arthritis] failed previous therapy with multiple RA treatments," Brown wrote.
In 2015, Brown filed 16 Medicare Part D claims for Acthar worth $ 719,093 in regulations. Teil D ist Medicare's Programm zur Finanzierung von verschreibungspflichtigen Medikamenten für Menschen mit Behinderungen und Menschen ab 65.
Aber Brown, Mitrane und Stankovic gehörten nicht zu den hochfrequenten Verschreibern – diejenigen, die mehr als 10 Acthar-Ansprüche eingereicht haben – in Medicares Part 2016 D-Verschreiberdaten
CNN konnte Mitrane nicht für einen Kommentar erreichen, und Brown reagierte nicht auf Anfragen von CNN für einen Kommentar.
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