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	<title>drug &#8211; Cincy Link</title>
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		<title>New mobile methadone clinic offers life-saving care</title>
		<link>https://cincylink.com/2023/07/05/new-mobile-methadone-clinic-offers-life-saving-care/</link>
					<comments>https://cincylink.com/2023/07/05/new-mobile-methadone-clinic-offers-life-saving-care/#respond</comments>
		
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		<pubDate>Wed, 05 Jul 2023 04:25:53 +0000</pubDate>
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					<description><![CDATA[WOONSOCKET, R.I. — The sun barely rises when John Hayes gets behind the wheel of a 27-foot-long RV and starts to rev up the engine. Hayes sits on the edge of a mostly empty parking lot in Providence, Rhode Island, right outside of a methadone treatment clinic where, even at 5 a.m., patients start lining up. But &#8230;]]></description>
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<p>WOONSOCKET, R.I. — The sun barely rises when John Hayes gets behind the wheel of a 27-foot-long RV and starts to rev up the engine. </p>
<p>Hayes sits on the edge of a mostly empty parking lot in Providence, Rhode Island, right outside of a methadone treatment clinic where, even at 5 a.m., patients start lining up. </p>
<p>But Hayes is not there to help people inside the brick-and-mortar clinic. Instead, he's taking the converted RV about 30 minutes north— to Woonsocket, Rhode Island. It's a community with some of the highest opioid use rates in the state.</p>
<p>"They’re just nice people that hit a bump," Hayes said.</p>
<p>It does not take long for patients to arrive.</p>
<p>One of the first people to arrive is Raul Rodriquez. Addicted to drugs for more than 20 years, Rodriquez use to have to travel 30 minutes to Providence to receive the methadone treatment he needs to get better. </p>
<p>But now, this first-in-the-nation mobile methadone clinic is bringing the medicine to him.</p>
<p>"It's wonderful. I live around the corner, you don't have to drive. It's right here," he said. </p>
<p>Methadone is a medication used to help people reduce or quit their use of heroin or other drugs. By increasing ease and access, the mobile medical unit hopes to keep patients on the right path. </p>
<p>"Substance use disorder is just a disease of the brain," said Linda Hurley, president of CODAC Behavioral Health, which owns and operates the mobile unit. </p>
<p>Last month, CODAC received approval from the Drug Enforcement Administration (DEA) to dispense methadone at mobile treatment sites.  Aside from the convenience, it's a more cost-effective way for treatment centers to operate. Instead of $4 million for a new building, CODAC can spend closer to $400,000 to renovate an RV.</p>
<p>"This is a highly effective, efficient and kind way to provide care to individuals that are dying," Hurley said. </p>
<p>This type of innovative methadone treatment couldn't come at a more critical American juncture. According to the Centers for Disease Control and Prevention,  an estimated 107,000 people died of drug overdoses in the U.S. in 2021. An estimated 75 percent of those deaths involved an opioid but only 18 percent of people with an opioid use disorder received medication as treatment.</p>
<p>"With a mobile unit, we go to individuals and see them when they can be seen, and that’s really important," Hurley noted.</p>
<p> There's another layer to all of this. It's keeping patients from having to go to a traditional doctor's office setting, which comes with its own set of stigmas.</p>
<p>As a physician specializing in addiction medicine, the mobile medical unit is a new frontier for Dr. Cara Zimmerman.</p>
<p>"This is definitely meeting someone where they're at," Dr. Zimmerman said. </p>
<p>Not only can she offer patients methadone treatment, but she can also help with wound care or write a prescription.</p>
<p>"This is more we're here; we're coming to you on your schedule and whatever, as much or as little as you need," she added.</p>
<p>Communities across the country are visiting the mobile clinic to see what's working as more treatment centers apply for DEA approval to get other mobile methadone clinics rolling nationwide. </p>
<p>"Most of them are just regular people who are coming in early to go to work. They're coming in before their day starts, so they can get their methadone and live a life," Hayes said.</p>
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		<title>Mindfulness worked as well for anxiety as a drug, one study finds</title>
		<link>https://cincylink.com/2023/06/25/mindfulness-worked-as-well-for-anxiety-as-a-drug-one-study-finds/</link>
					<comments>https://cincylink.com/2023/06/25/mindfulness-worked-as-well-for-anxiety-as-a-drug-one-study-finds/#respond</comments>
		
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		<pubDate>Sun, 25 Jun 2023 04:31:05 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=179414</guid>

					<description><![CDATA[Mindfulness meditation worked as well as a standard drug for treating anxiety in the first head-to-head comparison.The study tested a widely used mindfulness program that includes 2 1/2 hours of classes weekly and 45 minutes of daily practice at home. Participants were randomly assigned to the program or daily use of a generic drug sold &#8230;]]></description>
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<p>
					Mindfulness meditation worked as well as a standard drug for treating anxiety in the first head-to-head comparison.The study tested a widely used mindfulness program that includes 2 1/2 hours of classes weekly and 45 minutes of daily practice at home. Participants were randomly assigned to the program or daily use of a generic drug sold under the brand name Lexapro for depression and anxiety.After two months, anxiety as measured on a severity scale declined by about 30% in both groups and continued to decrease during the following four months. Study results, published Wednesday in the journal JAMA Psychiatry, are timely. In September, an influential U.S. health task force recommended routine anxiety screening for adults, and numerous reports suggest global anxiety rates have increased recently, related to worries over the pandemic, political and racial unrest, climate change and financial uncertainties.Anxiety disorders include social anxiety, generalized anxiety and panic attacks. Affected people are troubled by persistent and intrusive worries that interfere with their lives and relationships. In the U.S., anxiety disorders affect 40% of U.S. women at some point in their lives and more than 1 in 4 men, according to data cited in U.S. Preventive Services Task Force screening recommendations.Mindfulness is a form of meditation that emphasizes focusing only on what's happening at the moment and dismissing intrusive thoughts. Sessions often start with breathing exercises. Next might be "body scans" — thinking about each body part systematically, head to toe. When worried thoughts intrude, participants learn to briefly acknowledge them but then dismiss them.Instead of ruminating over the troubling thought, "you say, 'I'm having this thought, let that go for now,''' said lead author Elizabeth Hoge, director of Georgetown University's Anxiety Disorders Research Program. With practice, "It changes the relationship people have with their own thoughts when not meditating." Previous studies have shown mindfulness works better than no treatment or at least as well as education or more formal behavior therapy in reducing anxiety, depression and other mental woes. But this is the first study to test it against a psychiatric drug, Hoge said, and the results could make insurers more likely to cover costs, which can run $300 to $500 for an 8-week session.The results were based on about 200 adults who completed the six-month study at medical centers in Washington, Boston and New York. Researchers used a psychiatric scale of 1 to 7, with the top number reflecting severe anxiety. The average score was about 4.5 for participants before starting treatment. It dropped to about 3 after two months, then dipped slightly in both groups at three months and six months. Hoge said the change was clinically meaningful, resulting in noticeable improvement in symptoms.Ten patients on the drug dropped out because of troublesome side effects possibly related to treatment, which included insomnia, nausea and fatigue. There were no dropouts for that reason in the mindfulness group, although 13 patients reported increased anxiety.The study "is reaffirming about how useful mindfulness can be when practiced effectively,'' said psychologist Sheehan Fisher, an associate professor at Northwestern University's Feinberg School of Medicine who was not involved in the study.Dr. Scott Krakower, a psychiatrist at Zucker Hillside Hospital in New York, said mindfulness treatments often work best for mildly anxious patients. He prescribes them with medication for patients with more severe anxiety.He noted that many people feel they don't have time for mindfulness meditation, especially in-person sessions like those studied. Whether similar results would be found with online training or phone apps is unknown, said Krakower, who also had no role in the study.Olga Cannistraro, a freelance writer in Keene, New Hampshire, participated in an earlier mindfulness study led by Hoge and says it taught her "to intervene in my own state of mind.''During a session, just acknowledging that she was feeling tension anywhere in her body helped calm her, she said. Cannistraro, 52, has generalized anxiety disorder and has never taken medication for it. She was a single mom working in sales during that earlier study — circumstances that made life particularly stressful, she said. She has since married, switched jobs, and feels less anxious though still uses mindfulness techniques.
				</p>
<div>
<p>Mindfulness meditation worked as well as a standard drug for treating anxiety in the first head-to-head comparison.</p>
<p>The study tested a widely used mindfulness program that includes 2 1/2 hours of classes weekly and 45 minutes of daily practice at home. Participants were randomly assigned to the program or daily use of a generic drug sold under the brand name Lexapro for depression and anxiety.</p>
<p><!-- article/blocks/side-floater --></p>
<p><!-- article/blocks/side-floater --></p>
<p>After two months, anxiety as measured on a severity scale declined by about 30% in both groups and continued to decrease during the following four months. </p>
<p>Study results, published Wednesday in the journal JAMA Psychiatry, are timely. In September, an influential U.S. health task force recommended routine anxiety screening for adults, and numerous reports suggest global anxiety rates have increased recently, related to worries over the pandemic, political and racial unrest, climate change and financial uncertainties.</p>
<p>Anxiety disorders include social anxiety, generalized anxiety and panic attacks. Affected people are troubled by persistent and intrusive worries that interfere with their lives and relationships. In the U.S., anxiety disorders affect 40% of U.S. women at some point in their lives and more than 1 in 4 men, according to data cited in U.S. Preventive Services Task Force screening recommendations.</p>
<p>Mindfulness is a form of meditation that emphasizes focusing only on what's happening at the moment and dismissing intrusive thoughts. Sessions often start with breathing exercises. Next might be "body scans" — thinking about each body part systematically, head to toe. When worried thoughts intrude, participants learn to briefly acknowledge them but then dismiss them.</p>
<p>Instead of ruminating over the troubling thought, "you say, 'I'm having this thought, let that go for now,''' said lead author Elizabeth Hoge, director of Georgetown University's Anxiety Disorders Research Program. With practice, "It changes the relationship people have with their own thoughts when not meditating." </p>
<p>Previous studies have shown mindfulness works better than no treatment or at least as well as education or more formal behavior therapy in reducing anxiety, depression and other mental woes. But this is the first study to test it against a psychiatric drug, Hoge said, and the results could make insurers more likely to cover costs, which can run $300 to $500 for an 8-week session.</p>
<p>The results were based on about 200 adults who completed the six-month study at medical centers in Washington, Boston and New York. Researchers used a psychiatric scale of 1 to 7, with the top number reflecting severe anxiety. The average score was about 4.5 for participants before starting treatment. It dropped to about 3 after two months, then dipped slightly in both groups at three months and six months. Hoge said the change was clinically meaningful, resulting in noticeable improvement in symptoms.</p>
<p>Ten patients on the drug dropped out because of troublesome side effects possibly related to treatment, which included insomnia, nausea and fatigue. There were no dropouts for that reason in the mindfulness group, although 13 patients reported increased anxiety.</p>
<p>The study "is reaffirming about how useful mindfulness can be when practiced effectively,'' said psychologist Sheehan Fisher, an associate professor at Northwestern University's Feinberg School of Medicine who was not involved in the study.</p>
<p>Dr. Scott Krakower, a psychiatrist at Zucker Hillside Hospital in New York, said mindfulness treatments often work best for mildly anxious patients. He prescribes them with medication for patients with more severe anxiety.</p>
<p>He noted that many people feel they don't have time for mindfulness meditation, especially in-person sessions like those studied. Whether similar results would be found with online training or phone apps is unknown, said Krakower, who also had no role in the study.</p>
<p>Olga Cannistraro, a freelance writer in Keene, New Hampshire, participated in an earlier mindfulness study led by Hoge and says it taught her "to intervene in my own state of mind.''</p>
<p>During a session, just acknowledging that she was feeling tension anywhere in her body helped calm her, she said. </p>
<p>Cannistraro, 52, has generalized anxiety disorder and has never taken medication for it. She was a single mom working in sales during that earlier study — circumstances that made life particularly stressful, she said. She has since married, switched jobs, and feels less anxious though still uses mindfulness techniques. </p>
</p></div>
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		<title>Former Honduras leader arrested, wanted on US drug charges</title>
		<link>https://cincylink.com/2022/02/16/former-honduras-leader-arrested-wanted-on-us-drug-charges/</link>
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		<pubDate>Wed, 16 Feb 2022 18:17:25 +0000</pubDate>
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					<description><![CDATA[Police in Honduras arrested former President Juan Orlando Hernández on Tuesday charging him with taking millions of dollars in bribes from drug traffickers to help them smuggle hundreds of tons of cocaine into the United States. The U.S. is now seeking extradition for Hernández. As the Wall Street Journal reported, police fitted the former president &#8230;]]></description>
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<p>Police in Honduras arrested former President Juan Orlando Hernández on Tuesday charging him with taking millions of dollars in bribes from drug traffickers to help them smuggle hundreds of tons of cocaine into the United States. The U.S. is now seeking extradition for Hernández.</p>
<p>As the <a class="Link" href="https://www.wsj.com/articles/u-s-seeks-extradition-of-former-honduras-president-on-drug-related-charges-11644925363" target="_blank" rel="noopener">Wall Street Journal reported</a>, police fitted the former president in a bulletproof vest and he was seen in images cuffed at his hands and feet and being led out to the street at his home in a wealthy area of Tegucigalpa, the capital city of Honduras. Police drove Hernández in a convoy of black SUVs to a police base where he was put on stage as cameras broadcast the moment his charges were announced. </p>
<p>According to an extradition request obtained by <a class="Link" href="https://www.theguardian.com/world/2022/feb/15/us-honduras-arrest-extradite-ex-president-juan-orlando-hernandez" target="_blank" rel="noopener">the Guardian</a>, Hernández is accused of being part of a "violent drug-trafficking" conspiracy and is said to have helped smuggle around 500,000 kilos of cocaine since 2004.</p>
<figure class="Figure" itemscope="" itemtype="https://schema.org/ImageObject">
<div class="Figure-container">
<p>Elmer Martinez/AP</p>
</div><figcaption class="Figure-caption" itemprop="caption">Former Honduran President Juan Orlando Hernandez, center in chains, is shown to the press at the Police Headquarters in Tegucigalpa, Honduras, Tuesday, Feb. 15, 2022. Police arrested Hernandez at his home, following a request by the United States government for his extradition on drug trafficking and weapons charges. (AP Photo/Elmer Martinez)</figcaption></figure>
<p>The accusations have reportedly been long-rumored and the indictment comes a little over two weeks after Hernández left office. </p>
<p>As he was arrested on Tuesday, Hernández was wearing a dark blue baseball cap when he was taken into custody where police patted him down before cuffing him. The scene was broadcast on national television. </p>
<p>Hernández was scheduled to attend a court hearing on Wednesday. </p>
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		<title>Vaccine could help with opioid addiction</title>
		<link>https://cincylink.com/2021/09/30/vaccine-could-help-with-opioid-addiction/</link>
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		<pubDate>Thu, 30 Sep 2021 04:18:46 +0000</pubDate>
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					<description><![CDATA[A new vaccine being tested could offer another solution to help opioid users with an addiction. “All my life, I've been working on drugs of abuse like substance abuse disorder, etcetera,” Marco Pravetoni, an associate professor of pharmacology and medicine at the University of Minnesota Medical School, said. Pravetoni has been working on a vaccine &#8230;]]></description>
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<p>A new vaccine being tested could offer another solution to help opioid users with an addiction.</p>
<p>“All my life, I've been working on drugs of abuse like substance abuse disorder, etcetera,” Marco Pravetoni, an associate professor of pharmacology and medicine at the University of Minnesota Medical School, said.</p>
<p>Pravetoni has been working on a vaccine for opioid use for more than a decade at the University of Minnesota.</p>
<p>“It’s a synthetic vaccine that is composed of the target opioid link to a carrier immunogenic protein,” he said. </p>
<p>The vaccine tells the body to make antibodies for oxycodone.</p>
<p>“These antibodies will be selective for the target opioids,” he said.</p>
<p>“The antibodies will bind to the oxycodone molecule and prevent it from getting into the brain, so it should blunt the effects of the oxycodone,” Sandra Comer, Director of the Opioid Laboratory at Columbia University, said.</p>
<p>This prevents the drug “high” and rewarding properties, Comer said.</p>
<p>Comer is leading the clinical trials. Right now, the vaccine for oxycodone addiction is in Phase 1 clinical trial, as approved by the FDA.</p>
<p>“The Phase 1 study is typically focused on safety,” she said. “That study is intending to enroll anywhere between 12 and 24 subjects and then we’ll have to see what they’ll allow us to do next.”</p>
<p>This vaccine will work with other treatments that are currently in use.</p>
<p>“What we’re hoping is that if we give a combination of the vaccine and methadone for example, if somebody relapses after a few months, at least the vaccine-generated antibodies would still provide some protection against overdose,” Comer said.</p>
<p>Emergency physician Dr. Donald Stader said he can see this new, novel solution being helpful.</p>
<p>“We do not know if this is going to be significant in our patient population, but I think it’s very promising,” he said. “We know opioid addiction, even in the midst of the COVID pandemic we’re currently facing, is still the number one killer of Americans under the age of 50.”</p>
<p>“We do see the ravishes of the opioid crisis every day in terms of patients who have overdosed, in terms of patients who come to us in withdrawal, or patients coming to us seeking help with an opioid use disorder. And I will tell you it has gotten much, much worse over the past two years,” Dr. Stader said.</p>
<p>While a vaccine for oxycodone is in Phase 1 trials -- and still has Phase 2 and Phase 3 to go -- Pravetoni said they are developing them for heroin and other drugs as well.</p>
<p>“I've been working on it for so long, but it's also true that this is the first clinical trial ever for an opioid vaccine. And if this works it will open up the field for other medications so that other folks working on cocaine and meth or whatever other type of vaccine that could still help people, that will create a precedent for other teams working on this,” Pravetoni said.</p>
<p>Comer said it will be a while before the vaccine is commercially available, but they hope to eventually create a multivariate vaccine.</p>
<p>“Our overall goal is to develop a series of vaccines that can actually prevent the negative effects of multiple opioids,” Pravetoni said.</p>
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		<title>Fact Check Friday: Ivermectin</title>
		<link>https://cincylink.com/2021/09/04/fact-check-friday-ivermectin/</link>
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		<pubDate>Sat, 04 Sep 2021 04:18:03 +0000</pubDate>
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					<description><![CDATA[Ivermectin has been called a wonder drug, and some people are wondering if it can, or should, be used to treat COVID-19. While misinformation flies online, the Centers for Disease Control and Prevention warn against using the drug. The idea of using Ivermectin as a COVID-19 treatment started as a video emerged of a chairperson &#8230;]]></description>
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<p>Ivermectin has been called a wonder drug, and some people are wondering if it can, or should, be used to treat COVID-19. While misinformation flies online, the Centers for Disease Control and Prevention warn against using the drug.</p>
<p>The idea of using Ivermectin as a COVID-19 treatment started as a video emerged of a chairperson in the Japanese Medical Association saying he recommended doctors in Japan start using the drug to treat COVID-19.</p>
<p><b>RELATED</b>: Butler Co. judge orders doctors to treat COVID-19 patient with Ivermectin</p>
<p>Many posts online containing the video make it seem like the video was filmed in August, however it was filmed in February. Seven months later and Japan has not approved of Ivermectin to be used to treat COVID-19.</p>
<p>While it hasn't been approved to treat COVID-19, the Food and Drug Administration has approved Ivermectin to treat infections caused by parasites. COVID-19 however, is not an illness caused by parasites.</p>
<p>The CDC said since early July, Ivermectin prescription fills went up "24-fold" despite a warning from the organization that improper usage or dosage could cause serious health issues.</p>
<p>The CDC said one patient was hospitalized for nine days with hallucinations, confusion, rapid breathing and tremors after drinking one dose meant for cattle. Another patient five tablets of unknown strength for five days and was disoriented and had difficulty answering questions until they were hospitalized and taken off the drug.</p>
<p>Small sample studies have been performed to look at the efficacy of Ivermectin on COVID-19, but those studies haven't shown conclusive evidence of the drug's benefit for the pandemic.</p>
<p>"Maybe someday a larger study may show some benefit," Dr. Steve Feagins with Mercy Health said. "But so far there's really not in the, and there's more harm than, than benefit."</p>
<p>Clinical trials are underway in Florida, including studies to determine if Ivermectin is effective for high risk patients in preventing hospitalizations, but so far the FDA has not approved the drug to treat COVID-19 and the FDA and CDC warn against its use.</p>
<p><b>RELATED</b>: Hearing set in case of West Chester hospital ordered to treat COVID-19 patient with Ivermectin</p>
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		<title>How will insurers cover a new Alzheimer&#8217;s drug? Here&#8217;s everything you need to know</title>
		<link>https://cincylink.com/2021/06/09/how-will-insurers-cover-a-new-alzheimers-drug-heres-everything-you-need-to-know/</link>
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		<pubDate>Wed, 09 Jun 2021 04:28:23 +0000</pubDate>
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					<description><![CDATA[Federal regulators have approved the first new drug for Alzheimer’s disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment.Health care experts expect broad coverage of the drug, which was approved Monday. But what that means for patients will vary widely depending on their insurance plan. In &#8230;]]></description>
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<p>
					Federal regulators have approved the first new drug for Alzheimer’s disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment.Health care experts expect broad coverage of the drug, which was approved Monday. But what that means for patients will vary widely depending on their insurance plan. In some cases, that could mean coming up with several thousand dollars to pay for what the insurer didn’t cover.And there's no guarantee that every case will be covered. Here’s what you need to know:WHAT WAS APPROVED?The Food and Drug Administration said it granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than just manage symptoms. The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline. It slowed it in one study.The FDA’s decision came despite the conclusion of its advisory committee that there wasn’t enough evidence that the drug slowed the brain-destroying disease.WHAT DOES IT DO?It aims to help clear harmful clumps of a protein called beta-amyloid from the brain. The medication will be marketed as Aduhelm and is to be given as an infusion every four weeks.WHAT WILL IT COST?Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and it said the price would not be raised for four years. HOW WILL INSURERS COVER IT?They will likely request some documentation first that the patient needs the drug. Many plans will require doctors to submit records and other paperwork justifying the treatment before they agree to cover it.Insurers also will likely require pre-approval for brain scans needed to determine that the patient is a candidate for treatment, said Lance Grady of Avalere Health consultants.He noted that some plans also may want to see the results of a scan before they decide to cover the next infusion, which could delay treatment.IS COVERAGE GUARANTEED?Medicare is widely expected to cover the treatment. Insurers that offer private or commercial coverage also will pay for care that doctors deem medically necessary. That may not mean every case, though. If the treatment is proposed for a patient with advanced Alzheimer’s, and research shows the drug isn’t effective in that population, then the insurer may not pay for it. “That happens all the time with drugs,” said Robert Laszewski, a health care consultant and former insurance executive. “Just because the FDA says its safe doesn’t mean it’s appropriate for everybody.”WHAT WILL PATIENTS PAY?That’s impossible to say broadly. It can depend on the person’s coverage and their out-of-pocket maximum, which is a plan’s limit for how much a patient pays in a year for in-network care before insurance picks up the rest of the bill.Some patients who are already receiving a lot of care may not wind up with a huge added expense from the drug before they hit that limit.Patients who have a supplemental plan for their Medicare coverage also may wind up with few out-of-pocket costs for the drug. Patients with Medicare Advantage coverage, which is run by private insurers, or individual health insurance could pay several thousand dollars before they hit their plan’s annual limit, depending on the plan. “That could be very burdensome for someone, especially if a person is looking at this cost every single year, and they don’t have an option to get a better health plan,” said Stacie Dusetzina, an associate professor at Vanderbilt University and drug pricing expert. “It can add up.” ARE THE DRUGMAKERS HELPING?Cambridge, Massachusetts-based Biogen plans to begin shipping millions of doses within two weeks.The company says it will help patients figure out their options for financial assistance and find providers and care infusion sites. The drugmaker also is offering programs to help reduce the out-of-pocket cost for some patients with commercial coverage.But people with Medicare and Medicare Advantage coverage cannot get drugmaker discounts like that. Health care researchers say most of the people who will need this drug will have some form of Medicare coverage. ___Follow Tom Murphy on Twitter: @thpmurphy ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
				</p>
<div>
<p>Federal regulators have approved the first new drug for Alzheimer’s disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment.</p>
<p>Health care experts expect broad coverage of the drug, which was approved Monday. But what that means for patients will vary widely depending on their insurance plan. In some cases, that could mean coming up with several thousand dollars to pay for what the insurer didn’t cover.</p>
<p>And there's no guarantee that every case will be covered. </p>
<p>Here’s what you need to know:</p>
<p>WHAT WAS APPROVED?</p>
<p>The Food and Drug Administration said it granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer’s patients. </p>
<p>It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than just manage symptoms. The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline. It slowed it in one study.</p>
<p>The FDA’s decision came despite the conclusion of its advisory committee that there wasn’t enough evidence that the drug slowed the brain-destroying disease.</p>
<p>WHAT DOES IT DO?</p>
<p>It aims to help clear harmful clumps of a protein called beta-amyloid from the brain. The medication will be marketed as Aduhelm and is to be given as an infusion every four weeks.</p>
<p>WHAT WILL IT COST?</p>
<p>Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and it said the price would not be raised for four years. </p>
<p>HOW WILL INSURERS COVER IT?</p>
<p>They will likely request some documentation first that the patient needs the drug. Many plans will require doctors to submit records and other paperwork justifying the treatment before they agree to cover it.</p>
<p>Insurers also will likely require pre-approval for brain scans needed to determine that the patient is a candidate for treatment, said Lance Grady of Avalere Health consultants.</p>
<p>He noted that some plans also may want to see the results of a scan before they decide to cover the next infusion, which could delay treatment.</p>
<p>IS COVERAGE GUARANTEED?</p>
<p>Medicare is widely expected to cover the treatment. Insurers that offer private or commercial coverage also will pay for care that doctors deem medically necessary. </p>
<p>That may not mean every case, though. If the treatment is proposed for a patient with advanced Alzheimer’s, and research shows the drug isn’t effective in that population, then the insurer may not pay for it. </p>
<p>“That happens all the time with drugs,” said Robert Laszewski, a health care consultant and former insurance executive. “Just because the FDA says its safe doesn’t mean it’s appropriate for everybody.”</p>
<p>WHAT WILL PATIENTS PAY?</p>
<p>That’s impossible to say broadly. </p>
<p>It can depend on the person’s coverage and their out-of-pocket maximum, which is a plan’s limit for how much a patient pays in a year for in-network care before insurance picks up the rest of the bill.</p>
<p>Some patients who are already receiving a lot of care may not wind up with a huge added expense from the drug before they hit that limit.</p>
<p>Patients who have a supplemental plan for their Medicare coverage also may wind up with few out-of-pocket costs for the drug. </p>
<p>Patients with Medicare Advantage coverage, which is run by private insurers, or individual health insurance could pay several thousand dollars before they hit their plan’s annual limit, depending on the plan. </p>
<p>“That could be very burdensome for someone, especially if a person is looking at this cost every single year, and they don’t have an option to get a better health plan,” said Stacie Dusetzina, an associate professor at Vanderbilt University and drug pricing expert. “It can add up.” </p>
<p>ARE THE DRUGMAKERS HELPING?</p>
<p>Cambridge, Massachusetts-based Biogen plans to begin shipping millions of doses within two weeks.</p>
<p>The company says it will help patients figure out their options for financial assistance and find providers and care infusion sites. The drugmaker also is offering programs to help reduce the out-of-pocket cost for some patients with commercial coverage.</p>
<p>But people with Medicare and Medicare Advantage coverage cannot get drugmaker discounts like that. Health care researchers say most of the people who will need this drug will have some form of Medicare coverage. </p>
<p>___</p>
<p>Follow Tom Murphy on Twitter: @thpmurphy </p>
<p>___</p>
<p>The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.</p>
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