More than 80% of physicians using Medicare 2016 for H.P. Acthar Gel, a drug best known for treating rare infant complaints, received money or other benefits from drug manufacturers, according to a CNN analysis by publicly identified prescribers.
The analysis directed to physicians, which more than 10 part D claims, the pharmaceutical companies Mallinckrodt and Questcor between 2013 and 2016, 288 prescribing doctors with more than 6.5 million US dollars for consulting, advertising and paid other Acthar-related services. Mallinckrodt bought Questcor in 2014.
Around the same time Acthar's Medicare spending rose dramatically ̵
Medicare spent nearly $ 2 billion on Acthar, according to the agency, though some doctors considered treatment of this amount to be just as effective for a tiny fraction of the cost. 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 records, CNN has conducted a review.
On Friday, a separate study on Achar's payments and prescriptions revealed similar results to CNN's analysis. The authors of the 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 stated that there were more prescriptions and more Medicare program spending on this drug for physicians," said Daniel Hartung, principal author of the study.
Acthar is best known for treating infants with infantile spasms, a rare and catastrophic form of epilepsy. Hartung, an adjunct professor at the Oregon State College of Pharmacy, said that it is worrying that the drug is being marketed in adult medicine, with taxpayers paying the bill for hundreds of millions of dollars.
"The evidence that this drug is better than synthetic steroids is either weak or absent," said Hartung CNN.
Mallinckrodt's recent push in the fields 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 indication, are being poored by the medical evidence supported. "
Dennis Bourdette, another of the six authors of the study, told CNN that the nearly $ 2 billion that was spent by Medicare was the result of a tiny fraction of the doctors" was around with the prescription [Acthar] without the costs. "
" The problem is that it's unbelievably more expensive than synthetic corticosteroids and for some reason – maybe fina "Some doctors will prescribe it," said Bourdette, chair of neurology at Oregon Health & Science University to CNN.
Some physicians who prescribed Acthar in adult medicine and received money from Mallinckrodt told CNN that they needed Acthar only 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 to Acthar at nearly $ 39,000 a vial of injectable fluid. 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 unusual given 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 has paid nearly $ 27.5 million to at least 18,810 physicians In Acthar-related payments from 2013 to 2016, CNN's analysis of government data shows
Asked by CNN about its findings, Mallinckrodt made a statement in which they strongly responded Defended Its Payments to Physicians:
"Over the period 2013-2016, all physicians who have paid HP Acthar Gel, Mallinckrodt or the previous owner, received more than 95% of modest meals or nominally inexpensive clinical reprints [of medical journal articles] – well within the regulations and guidelines. "
Mallinckrodt said the" vast majority "of the remaining physicians were" engaged in peer-to-peer lectures "and that a small proportion of them were involved in other counseling services, such as to talk to employees or investors and to participate in expert advisory boards.
"We believe that many physicians prefer peer-to-peer presentations and dialogues about other methods of learning about the value that a product can have for suitable patients who treat them." The doctors who present to their colleagues They need to stay away from their practice and travel frequently to other cities – resulting in normal but sometimes substantial travel expenses – all reported payments include reimbursement for those expenses. "
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 'widely used as a late treatment prescribed by qualified health care providers is 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 sick patients with unmet medical needs, and we are proud of the drug and the important investment we make in it," said the pharmaceutical manufacturer.
"Mallinckrodt has been significantly 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 Mallinckrodt bought the drug from Questcor in 2014, Acthar's price has risen from $ 32,000 to almost $ 39,000. In 2000, before Questcor bought it, it was $ 40. Questcor shocked the medical community when it overnight increased its price from $ 1,600 to $ 23,000 per bottle on August 27, 2007.
Last year, Mallinckrodt paid $ 100 million without pleading for a lawsuit by the Federal Trade Commission and five states Questor's Decision to Purchase Competitive Medicines "Threatens Its Monopoly," According to the FTC
How to Expand Children's Drugs to Older People
Mallinckrodt bought Acthar as part of a $ 5.6 billion deal for Questcor in 2014. At that time, Mallinckrodt's President and CEO Mark Trudeau described the drug key to the future of the pharmaceutical company.
Shortly after the purchase was completed in August this year, executives unveiled their strategy: Look for the 4 million Americans the company suffered from "Acthar specified conditions" – many of them elderly.
Gary Phillips, president of Mallinckrodts autoimmune and rare-disease business, promised to "go out"
"The one thing you can be sure of is that awareness and the evidence for the product Phillips revealed in a briefing with investors in October 2014
Phillips showed PowerPoint presentations that outlined the company's strategy, including the need for Acthar in rheumatology, pulmonology, ophthalmology, dermatology, and renal disease to bring it to its "underserved patient population".
A graph showed that 9,000 patients were currently treated Acthar and that 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," said Phillips. "The strategy is pretty simple."
He promised to significantly expand Acthar's sales force in 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 seemed to be in stark contrast to the years before Steve Cartt, the then executive vice president of Questor, wrote an email
"Because of this experience, we realized that at the Treating Infantile Spasms The medical community has determined that Acthar delivers its true value to patients, Cartt wrote in an email he shared with CNN in August 2007.
The Mallinckrodt executives at this 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 approved by rheumatologists, Nephrologists and other urologists – exactly the kind of doctors Mallinckrodt executives said they were planning to aim. [1965Allinallsince2011Medicarehasspentmorethan$198billiononaround45000Actharclaims
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"Medicare nearly $ 2 billion for a drug that is of questionable benefit issue is very disturbing," said Rita Redberg, a cardiologist and professor at San Francisco University of California Medical School
Redberg co-authored a feature article in JAMA last November about the high price of Acthar, also known as ACTH, and warns of "lack of evidence" for its effectiveness in all conditions for adults. "
" 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 re-examine and strengthen our standards for FDA approval, Medicare and private insurance protection and professional application patterns.
The drug was first approved for the treatment of dozens of diseases, from arthritis and gout to lupus and kidney disease, in 1952. The range of corticosteroids improved dramatically in the decades that followed and made Acthar in adult medicine until recently Nearly obsolete.
FDA approval in 1952, Redberg said, essentially grandfathered the drug for a number of adult conditions that most likely did not
"We have been looking for studies on this drug, and they really are not There, "she said.
In response to this criticism, Mallinckrodt said," There are significant clinical trials evidence of the efficacy "of Acthar.
" Equally important, there are decades of clinical experience that doctors use with the product. " have a proven therapy for suitable patients, "said Mallinckrodt.
The drug manufacturer adds "It has invested nearly $ 400 million in the drug. Specifically: Based on extensive clinical experience as well as previously completed and largely independent clinical case series and smaller studies; Modernization of production; Expansion of medical affairs and research activities; and initiated six well-designed, enterprise-sponsored, randomized, controlled clinical trials aimed at a combined recruitment of nearly 1,100 patients. "
Mallinckrodt said that 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 in five years Billions of dollars to pay when there was a much cheaper alternative?
Stephen Schondelmeyer says that lawmakers can be thanked for this: Medicare can not bargain drug prices or tell doctors which medicines to prescribe.
"Our congress has The Medicare program says you can not control drug prices, "says Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, and heads the PRIME Institute of the College of Pharmacy, which looks at economic and policy issues related to medicines." We have no government process to evaluate, regulate, and regulate drug prices In 2001, Questcor Pharmaceuticals paid only $ 100,000 for drug rights.
The company initially raised the price from $ 40 to $ 750 per bottle shortly after he purchased it. The price has doubled in 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 purchased Questcor in late 2014. Since then, the price has risen another $ 7,000.
Acthar's extraordinary overnight price increase to $ 23,000, Schondelmeyer 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 it."
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 an extraordinarily 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're not doing it, why? Because of the drug companies," he said to a crowd in New Hampshire in January.
But early in May, when he presented his plan to bring "rising drug prices back to earth," Trump rejected the federal government's plans to negotiate lower prices for Medicare.
Redberg of UCSF said that drug companies consistently use Medicare to avoid pricing or to insist on cheaper alternatives under the 2003 Medicare Modernization Act.
"There is no competition and no moral limit for pricing," she said. "If doctors dictate it, plans from Part D will pay, whatever it costs."
In response to questions about the price increases, Mallinckrodt said:
"In 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 care Of the drug for treating children with infantile spasms and other small patient populations to ensure of complex, devastating diseases, they only did so after extensive consultation with the FDA. "
" Today, the price per vial of HP Acthar Gel is $ Since the acquisition of HP Acthar Gel, Mallinckrodt has made only moderate mid-single-digit percentage price adjustments and Mallinckrodt is offering discounts on this list price that the previous owner has not generally offered. "
An unusually high amount of money  In 2016, only 352 physicians filed more than 10 Acthar-related claims at Medicare, a CNN analysis of the data shows. Medicare does not include physicians who have filed 10 or fewer allegations in their public data, citing privacy concerns.
These 352 physicians comprise less than 20% of all physicians who prescribed Acthar through Medicare in 2016, according to the agency. The other 80% were excluded.
Yet, these 352 physicians accounted for more than half of Acthar's claims Medicare covered that year, costing nearly $ 369 million. In 2016, Medicare covered nearly 13,000 claims for Acthar worth more than $ 636 million.
A CNN analysis found that more than 80%, or 288, of the 352 physicians who filed public Acthar claims filed with Medicare in 2016 also received money or other perks from Mallinckrodt or Questcor between 2013 and 2016. These perks ranging from a few dollars in food or drink to hundreds of thousands of dollars in fees, compensation for services, travel and accommodation.
CNN's analysis showed that Of those 288 physicians, eight received an unusually large sum of money – more than $ 220,000 – from drug manufacturers.
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 submitted 16 Part D applications for Acthar in 2016, yielding $ 940,839 in Medicare coverage.
Asked about their payments and claims, Wright told CNN, "I have always complied with the requirements of the PhRMA Code, including my interactions with Mallinckrodt and Questcor." As far as I know, Mallinckrodt and Questcor also meet the requirements of the PhRMA Code
"Therapies like Acthar are used to bridge flares in some … patients and may actually 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 them – and where not to use -various therapies.These therapies have all the adverse consequences and significant price tags." Unfortunately, we determine , the doctors and prescribers, not the price of the drugs. "
Here's the breakdown of payments and claims for the other seven doctors who, according to CNN's analysis of drug manufacturers, received unusually large amounts of money as of 2013. 2016:
• Dr. Annette Howard of Houston, Texas, a psychiatry and neurology specialist, received 609 payments worth $ 345,913.22 – about a third was compensation for services, another third was fee, about a quarter was for travel and accommodation, and the rest for advice, 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 nephrology specialist, received 538 payments worth $ 334,390.56 – about one third was compensation for services, about one third for travel and accommodation, more than a quarter for fees, and the remainder for advice , 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 one third was fee, about one sixth was for travel and accommodation, and the remainder was for guidance, education and food and care Drink. Gunawardane filed 38 claims resulting in $ 1,329,002.84 in Medicare coverage.
• Dr. Ara Dikranian, a specialist in rheumatology from San Diego, California, 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 that resulted in Medicare coverage of $ 3,271,920.07
. 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 that yielded $ 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 resulted in $ 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 made available to the Nephrology community in 2012, we were skeptical about its use and its mechanism of action." But she said that more research on the matter promising.
She said that patients treated with other drugs such as steroids were being given an attempt with Acthar and some of them – including "slowing or even slowing kidney loss" and "blocking or even preventing the need for dialysis and / or Transplant on the Road "
" Although it's expensive, it's worth trying on a select 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 doctors in the US to do a retrospective study that was funded by Mallinckrodt
"I'm a spokesperson for the company and will be working with nephrologists on lunch or dinner programs My expenses are paid by the company The contract with Mallinckrodt is in line with other agreements made in the past between consultants and speakers.
"May I ask what you would do if you had a nephrotic syndrome, That would be resistant to other drug therapies and your only hope would be an expensive drug? 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 hypertension 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, which can potentially lead to death.
Dr. Efthimiou also responded on CNN's questions and said:
"I've consulted with previous and current manufacturers of this drug from 2013 to 2016 on rheumatoid diseases where [Acthar] was specified and approved by the FDA. My efforts led to the development of two research studies (at a previous institution) approved by the Institutional Review Board [IRB] 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, both younger and older patients sometimes do not respond to first, second or even third-line treatments, including corticosteroids We consider situations [Acthar] based on published data that it may 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 severe, refractory, immune-mediated disease, I would take this medication under medical supervision."
Doctors Are Also Paid
Mallinckrodt and Questcor – the Acthar maker they bought in 2014 – paid at least 18,810 doctors for Acthar for $ 27.5 million between 2013 and 2016, according to a CNN analysis of government data -related advice, doctoral talks and other services. 19659002] The analysis shows that 16 physicians received an unusually large amount of money – more than $ 250,000 – compared to the rest. In this regard, the average number of physicians received between 2013 and 2016 by Mallinckrodt and Questcor was 1,461.18 US Dollars and the Median $ 79.82
The following physicians were not among the high-frequency prescribers – those who had submitted more than 10 Acthar claims in 2016, but were among 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 das Medicare-Programm für verschreibungspflichtige Medikamente 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 D-Verschreiber 2016 Daten
CNN konnte Mitrane nicht für einen Kommentar erreichen, und Brown reagierte nicht auf Anfragen von CNN für einen Kommentar.