[ad_1] Joe Raedle / Getty Images Joe Raedle / Getty Images 19659006] (CNN) - Over 80% of Doctors Who Filed Medicare Claims In 2016 For HP Acthar Gel - A Drug Known For One-Time Treatment rare childhood epileptic disorder - received money or other benefits from drug manufacturers, according to a CNN analysis of publicly identified prescribers. The analysis, which examined the 10 doctors' Part D claims, revealed that drug manufacturers - Mallinckrodt and Questcor - paid 288 prescribers over $ 6.5 million for medical services. consultation, promotional and other services related to Acthar between 2013 and 2016. Mallinckrodt bought Questcor in 2014. At the same time, Medicare's spending on Acthar has increased considerably - more than ten times in six years. Medicare spent nearly $ 2 billion on Acthar from 2011 to 2016, according to agency data - although some doctors say an equally effective treatment would have cost a tiny fraction of that amount. Medicare spending on Acthar's 2013-2016 accounted for nearly $ 1.8 billion Much of the increase in Medicare spending coincided with a Mallinckrodt marketing campaign to target adults, especially seniors, after buying the former manufacturer of Acthar, Questcor, in 2014, According to CNN company documents examined Friday, a separate study of Acthar payments and Prescription habits found similar results to CNN analysis. The authors of this study, published in JAMA Network Open, stated that their findings "suggest that conflicts of financial interests could lead to the use of [Acthar] in the Medicare program." "We have clearly found that you increase payments Daniel Hartung, lead author of the study, said:" Acthar is best known for treating infants with infantile spasms, a rare and catastrophic form of breastfeeding. Epilepsy Hartung, an associate professor at the College of Pharmacy of Oregon State, said he found it troubling that the drug was being marketed in adult medicine as taxpayers paid the bill for hundreds of millions of dollars "Evidence that this drug is better" Mallinckrodt's recent trend in the areas of rheumatology, nephrology and multiple sclerosis, he said, is a result of the "aggressive marketing of the drug. "For a number of conditions." Dennis Bourdette, another of the six authors of the study, told CNN that nearly $ 2 billion spent by Medicare was the result from a tiny fraction of the doctors who "went". "The problem is that it is incredibly more expensive than synthetic corticosteroids and, for some reason - perhaps a financial gain - a small Bourdette, professor of neurology at Oregon Health & Science University, has told CNN However, some doctors who prescribed Acthar in adult medicine and received money from Mallinckrodt told CNN that they were using Acthar only after steroids and medicines. other treatments have failed. Although Acthar is not a steroid, it does reproduce some of its anti-inflammatory effects. A steroid like prednisone can cost as little as $ 2.50 for a bottle of pills - less than a faded coffee from Starbucks - compared to Acthar at nearly $ 39,000 a vial of injectable liquid. During a treatment, these figures are even more spectacular: $ 7.50 for three vials of prednisone versus $ 117,000 for three vials of Acthar "Continued growth in use [Acthar] is particular considering its very high cost.The authors wrote: The results of Friday's study, which focused on Medicare 2015 claims and payment data 2015, appeared to support much of CNN's data analysis, which looked at Medicare's claims for 2016 - the last year for which data are available - and payments dating back to 2013, the first year for which these figures are available Drug manufacturers paid at least 18,810 physicians $ 27.3 million in payments related to Acthar from 2013 to 2016, analysis of government data by CNN. In response to CNN's questions knew In his conclusions, Mallinckrodt issued a statement in which he strongly defended his payment to physicians: "During the period 2013-2016, of all health practitioners prescribing HP Acthar Gel to whom Mallinckrodt or the previous owner made payments, more than 95% received only modest meals or clinical reprints nominatively price [of medical journal articles] - well in the regulations and guidelines. " Mallinckrodt says the" vast majority "of the rest the doctors were" engaged for peer-to-peer expression assignments "and that a small portion of them were participating in other consulting services, for example to address to employees or investors and to participate in advisory boards of medical experts that many doctors prefer peer-to-peer presentations and dialogue on other methods of learning the value that a product can bring to the appropriate patients that they treat.Physicians who present themselves to their peers must be away from their office. and frequent travel to other cities - incurring normal but sometimes substantial travel expenses. " The drug manufacturer pointed out that Acthar is FDA-approved for 19 indications, including the multiple sclerosis, rheumatoid arthritis and of kidney disease and "is widely used as a treatment of last line prescribed by qualified health care providers for a small subset of appropriate patients who need & # 39; 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. We are proud of the drug and the important investment that we make there, "said drug manufacturer " Mallinckrodt has invested heavily in HP Acthar Gel since the acquisition in 2014, generating data additional support for its use, and has made only modest price adjustments. The company has acted and continues to act responsibly and ethically in its relationships with health professionals and others. " Since Mallinckrodt purchased the drug at Questcor in 2014, the price of Acthar has gone from $ 32,000 to almost $ 39,000." Questcor shocked the medical community when, on August 27, 2007, he increased the price from $ 1,600 to $ 23,000 a night. Last year, Mallinckrodt paid $ 100 million without admitting the responsibility to settle a lawsuit brought by the Federal Trade Commission and five states arising out of Questcor's purchase of a competing drug that the FTC said "threatened its monopoly" How a child's drug is developing for one for the elderly Mallinckrodt's contract $ 5.6 billion for Questcor in 2014. At the time, Mallinckrodt President and CEO Mark Trudeau called the drug a key to the company's future. pharmaceutical industry closed in August of the same year, t unveiled their strategy: attacking the 4 million Americans whose society suffered "Acthar stated conditions" - many of them being elderly Gary Phillips, president of Mallinckrodt "" The only thing you can be sure of is that the awareness and evidence of the product will increase dramatically over the next year, "said Phillips in a statement. Investor briefing in October 2014. Phillips presented PowerPoint slides detailing the company's strategy, including the need to get Acthar to his "under-served patient population" in rheumatology, pulmonology , ophthalmology, dermatology and kidney disease . 9,000 patients were currently treated with Acthar and 300,000 people had "addressable but untreated" conditions. The slide also noted a total of 4 million Americans suffered from "conditions indicated by Acthar." "Today, Acthar is only used in about 3% of these [300,000] patients," Phillips said. "The strategy is pretty simple." He is committed to "significantly expanding" the Acthar sales force in the fields of rheumatology and pneumology over the next year. Indeed, the message was clear: there were more patients to heal and more money to gain. The Mallinckrodt PowerPoint presentation contrasted with previous years, when Steve Cartt, then Executive Vice President of Questor, wrote an e-mail "Based on this experience, it became clear to us that in the treatment of infantile spasms, the medical community has determined that Acthar brings its true value to patients. ", wrote Cartt in August 2007 in a shared email with CNN The aggressive marketing campaign described by leaders Mallinckrodt at this meeting of investors seems to have borne fruit: Medicare has spent more than $ 600 million for more than 12,000 2016 - more than double the figures of 2013, the year before the year before. Purchase of Mallinckrodt Several of these prescriptions were made by rheumatologists, nephrologists and neurologists - the very type of doctors that Mallinckrodt's leaders have said u • they had the intention to target. In total, since 2011, Medicare has spent more than $ 1.98 billion on some 45,000 Acthar claims . 19659033] Several doctors familiar with Acthar told CNN that the drug has little benefit in adults compared to steroidal treatments, which could range from $ 2.50 for prednisone to $ 5,000 for a high dose of methylprednisolone. Even at the high end, these doctors said, prescribing steroids on Acthar could have saved Medicare nearly $ 1.8 billion. "Medicare has to spend nearly $ 2 billion on a drug that is of dubious benefit," said Rita Redberg, a cardiologist and professor at the University of Medicine's medical school. California, San Francisco Redberg co-authored an editorial at JAMA last November on Acthar's high award, also known as ACTH, warning that there is a lack of evidence. "The lack of quality evidence supporting the benefit of Acthar gel under various conditions, as well as the inconceivable price increase by the manufacturer, should make all practitioners think," Redberg writes. and his co-author, Dr. Saate Shakil, a resident of the UCSF. "Not only should clinicians consider the lack of evidence supporting the effectiveness of ACTH, but its history should lead us to re-examine and strengthen our standards" The drug was approved for The first time in 1952 to treat dozens of diseases, arthritis and gout with lupus and kidney disease.The field of corticosteroids has improved considerably in the decades that followed, making Acthar obsolete until recently. FDA approval in 1952, said Redberg, essentially acquired rights for a range of adult conditions that probably would not be. "We searched for studies on this drug, and they really are not there, "she said. In response to such criticism, Mallinckrodt said:" Just as important, there are decades of experience clinic that the doctor It's with the product as a proven therapy for the right patients, "Mallinckrodt said. The drug maker added that he has "invested" nearly $ 400 million in the drug.Special: relying on substantial clinical experience as well as well-completed clinical case series and widely independent and smaller trials, modernization of the human ufacturing; develop medical business and research activities; and by launching six controlled, randomized and well-designed, company-sponsored, targeted clinical trials. Combined enrollment of nearly 1100 patients. " Mallinckrodt says the $ 400 million does not include marketing or payments to doctors. Stephen Schondelmeyer says you can thank lawmakers for this: Medicare is not allowed to negotiate drug prices or to tell doctors what medications "Our congress told the Medicare program that you can not control drug prices, "says Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, who heads the PRIME Institute of the College of Pharmacy, which studies economic and political policies. "We have no government process to evaluate, regulate and manage drug prices." In 2001, Questcor Pharmaceuticals paid only $ 100,000 for drug rights. The company first raised the price from $ 40 to $ 750 a flask shortly after the acquisition. The price has doubled over the next few years. Then, on August 27, 2007, the price jumped from $ 1,600 to $ 23,000 a night. Questcor continued to increase the price of the drug to about $ 32,000 before Mallinckrodt bought Questcor at the end of 2014. Since then, the price has risen According to Edmund Schondelmeyer, the extraordinary increase in the price of the night at $ 23,000 was particularly painful "This is not because of competition, it is not because of the costs of research and development". "The company saw an opportunity to raise the price and they did it." He called the 97,000% increase in the drug from 2000 to today "one of the highest price changes ever" in the history of the United States More than a handful of drugs have already seen a price increase like this, "he said." This is definitely an extremely extraordinary price increase and is, without a doubt, not a price of competitive market. "" Until we get politicians ready to stand up against these big interest groups, "said Schondelmeyer," I did not expect it " The President Donald Trump had promised to change the Medicare provision to save taxpayers billions of dollars: "We do not do it. Why? In 1965, in early May, unveiling his plan to "go back down to Earth," Trump abandoned plans to allow the federal government to Redberg's UCSF said that drug makers systematically benefit from Medicare's inability to negotiate on prices or insist on cheaper alternatives under the Medicare Modernization Act of 2003. "There is no competition and no limit" If the doctors prescribe it, the plans of Part D will pay all that it costs. " In response to questions about price increases, Mallinckrodt said: " In 2007, HP's Previous owner of Acthar Gel was close to bankruptcy and substantially increased the price of the drug in order to keep the drug on the market and to ensure the long-term supply of the drug for the treatment of children with inferior spasms antiles and other small groups of patients with complex and devastating diseases. They did it only after extensive consultations with the FDA. "" Today the price per bottle of H.P. Acthar Gel is $ 38,892. Since the acquisition of H.P. Acthar Gel, Mallinckrodt has only made modest price adjustments in the single-digit percentage range. In addition, Mallinckrodt offers discounts to this list price to payers, which the previous owner usually did not offer. " An Abnormally High Amount of Money Only 352 Doctors Filed More than 10 Acthar Medicare Claims in 2016, An Analysis of CNN Data Shows Medicare Does Not Include the physicians who filed 10 or fewer claims in his public data, citing privacy concerns. These 352 physicians account for less than 20% of all physicians who prescribed Acthar by Medicare in 2016, however, these 352 physicians accounted for more half of Medicare-covered Medicare claims this year, costing the program $ 369 million, claims for Acthar worth more than $ 636 million. CNN's analysis found that more than 80 %, or 288, of the 352 doctors who filed Acthar claims publicly available with Medicare in 2016 also received money or other benefits from Mallinckrodt or Questcor e These benefits ranged from a few dollars in food or beverages to hundreds of thousands of dollars in payments for fees, remuneration for services, travel and accommodation. CNN's analysis showed that 288 doctors, eight received an abnormally high sum - over $ 220,000 - from drug manufacturers . Grace Wright, a specialist in rheumatology in New York, received the most payments - 673 - and the largest amount: $ 370,970.49. More than half was for fees, travel and accommodation; the rest was a compensation for services, consulting fees, food and beverages and education. Wright filed 16 Part D claims for Acthar in 2016, which allowed him to get $ 940,839 in Medicare. Asked about his payments and claims, Wright told CNN: "I have always complied with the requirements of the PhRMA Code. To my knowledge, Mallinckrodt and Questcor are fully compliant with the requirements of the PhRMA Code "Therapies like Acthar are used to fill outbreaks in some ... patients, and may in fact be the only therapy available to them. ... The mortality rate in these patients can be quite high, as can the burden of care for the patient, the family, and the health care team. "As an educator and lecturer, it is essential for me that prescribers understand to use --- and in whom not to use --- various therapies. These therapies all have potential adverse consequences and labels Unfortunately, we, the doctors and prescribers, do not determine the price of drugs. " Here is the breakdown of payments and claims for the seven other physicians who, according to CNN's analysis, have received an unusually high amount from the manufacturers of 2013-2016: • Dr. Annette Howard of Houston, Texas, specialist in psychiatry and neurology, 609 payments worth $ 345,913.22 - about a Third party was a compensation for services, another third of fees, about a quarter for travel and accommodation and the rest for board, education and food and beverages. Howard filed 11 Part D claims for Acthar in 2016 with Medicare coverage of $ 688,991.24 • Dr. Anupa Khastgir of Oklahoma City, Oklahoma, a nephrology specialist, received 538 payments worth $ 334,390.56 - about a third for travel and accommodation, more than a quarter for fees and the rest for board, education and a grant. Khastgir filed 11 Part D claims for Acthar in 2016 with coverage of $ 642,813.58 in Medicare. • Dr. Ruwani Gunawardane of Fulton, Maryland, a specialist in neurology, received 502 payments worth $ 332,393.36. the third was a fee, about a sixth was for travel and accommodation, and the rest was for board, education and food and beverages. Gunawardane filed 38 claims for Medicare coverage of $ 1,329,002.84. • Dr. Ara Dikranian of San Diego, California, specialist in rheumatology, received 489 payments valued at $ 273,937. Of this number, almost half were compensated for services, about one-quarter for fees, about one-sixth for travel and accommodation, and the rest for consultation, food and beverages, and food and beverages. # 39; education. Dikranian filed 86 claims, which allowed him to get $ 4,443,774 in Medicare. • Dr. Howard Busch of Loxahatchee, Florida, a specialist in rheumatology, received 488 payments valued at $ 267,701.63. Of that number, over a third was compensated for services, over a quarter for fees, about one-fifth for travel and accommodation costs and the rest for council, Education and food and drinks. Busch filed 44 claims for Medicare benefits for $ 3,271,920.07. • Dr. Petros Efthimiou of Brooklyn, New York, specialist in rheumatology, received 399 payments worth $ 243,234.04. Of these, more than one-third was spent on fees, nearly one-third on pay for services, more than one-fifth on travel and lodging, and the rest on board , education, food and beverages. Efthimiou filed 13 claims for $ 693,725.34 in Medicare. • Dr. Guillermo Valenzuela of Plantation, Florida, specialist in rheumatology, received 391 payments worth $ 224,713.96. Of that number, nearly half was compensated for services, nearly one-third for fees, about one-fifth for travel and accommodation costs and the rest for the board, the rest. education and food and drinks. Valenzuela filed 50 claims for Medicare coverage of $ 2,036,129.13 Howard, Gunawardane, Dikranian, Busch and Valenzuela did not respond to CNN's requests to comment. Asked about his payments and claims, Khastgir said:] became available in 2012 to the nephrology community, we were skeptical about its use and mechanism of action. She said that other research was promising. She said that patients treated with other drugs such as steroids were tested by Acthar and that some of them reacted, including "slowing or even stopping kidney decline" and "Delay or even prevent the need for dialysis and / or transplantation on the road." "Although expensive, it is worth trying on a select group of patients", she says. "Anything that can prevent these patients from following the dangerous path of dialysis." Khastgir said that she lost patients under the side effects of other treatment regimens, and that Acthar "seems to be relatively safe". She said she had collaborated with five other doctors in the United States to perform a retrospective study funded by Mallinckrodt. "I am a corporate speaker and will talk to nephrologists about lunch or dinner programs presenting the drug data. My expenses are paid by the company. The contract with Mallinckrodt is in accordance with other agreements made with consultants / lecturers. "May I ask you what would you do if you had a nephrotic syndrome resistant to other medical treatments? your only hope was an expensive drug or an 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 will cause infertility for life and possible blood cancers? or use an expensive drug with a minimum of side Known side effects include hypertension and fluid retention, but doctors who have used Acthar for years to treat infantile spasms told CNN that The most feared side effect is an immunosuppression that can lead to death. Dr. Efthimiou answered CNN's questions, saying: "I have consulted the previous and current manufacturers of this drug, from 2013-2016, on rheumatological diseases where [Acthar] is indicated and Approved by the FDA.My efforts led to the development of two research studies approved by the Institutional Review Board (19459054) on the safety and effectiveness of this drug, used since 1952. [19659006] "Rheumatological conditions affect not only the elderly Many patients are younger people with autoimmune diseases ... Unfortunately, younger and older patients sometimes do not respond to first-, second- or second-line treatments. same third line, including corticosteroids. [Acthar] Based on published data indicating that it may work differently than corticosteroids. "While the costs of medications While still a global public health problem, my primary responsibility as a physician is in my patents. In rheumatology, as in other disciplines, we consider very expensive biologic drugs for treatment, especially for rare and difficult-to-treat diseases. None of my patients suffered from serious side effects of [Acthar]. All patients taking this medicine in my practice are carefully monitored for any adverse effects. "If I had a serious, refractory and immune-mediated disease, I would take this medication under the supervision of a doctor." Doctors Are Also Paid Between 2013 and 2016, Mallinckrodt and Questcor - the maker of Acthar purchased in 2014 - paid at least 18,810 physicians for nearly $ 27.5 million for services of consultation, promotion and other services related to Acthar, according to a CNN analysis of government data The analysis shows that 16 doctors received an abnormally high sum - more than $ 250,000 - compared to the rest. By context, the average physician received between 2013 and 2016 by Mallinckrodt and Questcor was $ 1,461.18 and the median $ 79.82 The following physicians were not among the high-frequency prescribers - those who filed more than 10 Acthar claims - - in 2016, but were among the highest paid: Dr. Ana Stankovic, a Massachusetts nephrology specialist, has received the largest number of payments and the highest amount of money - 988 payments worth $ 476,254.16. About 40% was used to pay for services, such as speaking engagements. More than a quarter was devoted to fees, another quarter to travel and accommodation and the rest to food and beverages, board and education. Received by phone, Stankovic declined to comment, saying the payments "were two or three years ago." Dr. Margaret Mitrane, a rheumatologist from New Jersey and former deputy director of the FDA's division, received the second highest amount - $ 463,500 - almost everything for consulting work, according to the data. Sur sa page LinkedIn, Mitrane revendique «plus de 25 ans d'expérience en développement clinique et affaires réglementaires, y compris la FDA et les grandes sociétés pharmaceutiques.» Un autre médecin, le Dr Alan Brown de Caroline du Sud, a reçu plus de 325 000 $. En 2015, Brown a rapporté une série de cas sur Acthar impliquant cinq patients atteints de polyarthrite rhumatoïde qui avaient échoué à un autre traitement. "Les résultats de cette série de cas indiquent que le gel ACTH peut être une option sûre et viable pour les patients réfractaires [rheumatoid arthritis] "Brown a écrit. En 2015, Brown a déposé 16 réclamations Medicare Partie D pour Acthar d'une valeur de 719 093 $ en prescriptions. La partie D est le programme de financement des médicaments d'ordonnance de Medicare pour les personnes handicapées et les personnes de 65 ans et plus. Mais Brown, Mitrane et Stankovic n'étaient pas parmi les prescripteurs à haute fréquence - ceux qui ont déposé plus de 10 réclamations Acthar D données sur les prescripteurs CNN n'a pas pu joindre Mitrane pour un commentaire, et Brown n'a pas répondu aux demandes de commentaires de CNN. [ad_2] Source link
