{"id":405,"date":"2024-02-14T11:48:33","date_gmt":"2024-02-14T11:48:33","guid":{"rendered":"https:\/\/retirednurseblog.com\/index.php\/2024\/02\/14\/doctors-and-parents-are-scrambling-after-asthma-inhaler-switch-takes-popular-medication-off-the-market\/"},"modified":"2024-02-14T11:48:33","modified_gmt":"2024-02-14T11:48:33","slug":"doctors-and-parents-are-scrambling-after-asthma-inhaler-switch-takes-popular-medication-off-the-market","status":"publish","type":"post","link":"https:\/\/retirednurseblog.com\/index.php\/2024\/02\/14\/doctors-and-parents-are-scrambling-after-asthma-inhaler-switch-takes-popular-medication-off-the-market\/","title":{"rendered":"Doctors and parents are scrambling after asthma inhaler switch takes popular medication off the market"},"content":{"rendered":"
\n

Editor\u2019s Note: Dr.\u00a0Edith Bracho-Sanchez is a primary care pediatrician, director of pediatric telemedicine and assistant professor of pediatrics at Columbia University Irving Medical Center.<\/p>\n

Flovent, one of the most commonly prescribed childhood asthma medications, is no longer being manufactured in the United States. GSK, the pharmaceutical company that made it, took if off the shelves January 1\u00a0and replaced it with\u00a0an identical generic version, fluticasone. <\/p>\n

But what seemed to be a straightforward swap has left\u00a0some\u00a0doctors,\u00a0nurses and parents of children with asthma\u00a0scrambling for medications to care for young patients. <\/p>\n

Flovent and its generic belong to a class of asthma medications known as controllers. They work by reducing inflammation in the airways of children with asthma that puts them at risk of\u00a0flaring\u00a0\u2014\u00a0having an asthma attack\u00a0\u2014\u00a0when exposed to a trigger. <\/p>\n

For children with severe asthma,\u00a0the medication\u00a0is both necessary and lifesaving. <\/p>\n

Four-year-old\u00a0Bryce Cohen is one of those children. He was only 8 months old when he was first in the pediatric ICU for\u00a0trouble\u00a0breathing. He\u00a0was hospitalized again\u00a0two months after that. In the years since, he has been able to stay out of the hospital,\u00a0due\u00a0in large part to Flovent. His asthma has flared up\u00a0only\u00a0one time: last summer, when his family and doctors attempted to give him a break from the daily inhaler and he caught a cold. <\/p>\n

Bryce lives in New York City and is a patient at Columbia University Irving Medical Center. His family hasn\u2019t been able to get the new generic version of Flovent in the\u00a0past month. <\/p>\n

\u201cThis is a really big issue, and it\u2019s scary to think that we are in the middle of cold season,\u201d said\u00a0Rebecca\u00a0Baye Cohen, Bryce\u2019s mom. She said she has been calling friends and relatives for\u00a0weeks in search of\u00a0extra Flovent inhalers. <\/p>\n

Some physicians across the country are also reporting that they can\u2019t get their patients\u2019 asthma medications. The reason: Their insurance does not cover\u00a0<\/strong>the generic that GSK introduced after Flovent was taken off the shelves and alternative medications may not work or can be hard to find. <\/p>\n

Experts who follow the industry pointed out\u00a0that\u00a0the switch happened at precisely the time a provision in the 2021 American Rescue Plan Act went into effect. In it, a change in Medicaid rebates would have caused GSK to have to pay large penalties after increasing the price of Flovent at a rate higher than inflation for years.\u00a0The penalties could have incurred rebates to Medicaid greater than the price of the drug,\u00a0meaning GSK would have had to sell Flovent to Medicaid at a loss.\u00a0<\/strong> <\/p>\n

The authorized generic, fluticasone,\u00a0would be the same product, but without the branding and history of price increases that would leave the medicine vulnerable to large rebates to Medicaid. <\/p>\n

\u201cObviously, Pharma doesn\u2019t want to be selling at a loss on anything in its portfolio,\u201d Andrew Baum, an analyst who covers the stock of GSK and other pharmaceutical companies for the financial firm Citi, said in December. \u201cSo it seeks to evade impact by, one: discontinuation; two: authorized generic.\u201d <\/p>\n

Substituting one medication with the other\u00a0\u201cseems like it should be great,\u201d said Dr. Stephanie Lovinsky-Desir, chief of the Division of Pulmonology at Columbia University Irving Medical Center. \u201cThe problem is that insurance companies have not listed fluticasone as the preferred medication on their formularies.\u201d <\/p>\n

Lovinsky-Desir and I are colleagues from different departments at Columbia. For this story, I also spoke with other pediatricians across the country who reported similar struggles in getting patients the care they need. <\/p>\n

Insurance formularies are a list of prescription drugs that are covered by specific insurance plans, and the lists are based on how appropriate the medication is for a given condition, as well as on cost. If a medication is not on the formulary, providers must submit a prior authorization\u00a0\u2014\u00a0a request for approval to get the medication covered without the patient having to pay out of pocket. <\/p>\n

\u201cIt\u2019s all a big game,\u201d says Victoria Piane, a pediatric nurse practitioner at Columbia University Irving Medical\u00a0Center\u00a0who said her\u00a0team\u00a0has been receiving 10 to 15 requests per day for prior authorizations from local pharmacies\u00a0for the Flovent generic and age-appropriate medications not listed as preferred. <\/p>\n

\u201cIt\u2019s not just \u2018send a simple prescription\u2019 anymore,\u201d\u00a0she added, explaining\u00a0that\u00a0she spends\u00a0an average of an\u00a0hour on the phone per request, sometimes without resolution. <\/p>\n

In addition to the volume of paperwork, when it comes to children with asthma, the process\u00a0is flawed,\u00a0Lovinsky-Desir said. <\/p>\n

Some of the alternatives covered on formularies are not clinically appropriate for small children, she said. <\/p>\n

Although Flovent\u00a0and its generic\u00a0are easy to deliver in a minute or two, commonly listed alternatives such as dry powder inhalers or\u00a0breath-actuated\u00a0pumps\u00a0require children to take deep breaths and hold their breath for at least 10 seconds,\u00a0a maneuver young children are not able to do. Nebulizer treatments are another alternative, but those require 10 to 15 minutes twice a day for a young child to sit still, Lovinsky-Desir said. <\/p>\n

And in some cases, insurance companies require patients to show\u00a0that\u00a0they have tried preferred medications and failed before they can grant approval for one that\u2019s not listed. <\/p>\n

Four-year-old Ana, also a patient at Columbia University Irving Medical Center, has been to the intensive care unit twice, both times requiring continuous positive airway pressure, or CPAP, to breathe. On Flovent, she finally stabilized and stayed out of the hospital, said her mother, Mariluz.\u00a0<\/em><\/strong> <\/p>\n

\u201cSo you\u2019re telling me,\u00a0as a mother who has had her daughter in the ICU twice on a CPAP machine,\u00a0that she should try and fail something?\u201d said Mariluz, who did not want to use their last name to protect her daughter\u2019s privacy. \u201cDoes trying and failing mean we have to go to the ICU again?\u201d\u00a0<\/em><\/strong> <\/p>\n

Why\u00a0<\/strong>wouldn\u2019t insurance companies add\u00a0<\/strong>fluticasone to the formularies? <\/p>\n

In an emailed statement, Optum Rx, the pharmacy care services business of UnitedHealth Group,\u00a0said\u00a0GSK introduced the generic version of Flovent at a \u201cmuch higher net\u00a0price\u201d than the prior price of the\u00a0name-brand drug. <\/p>\n

Optum Rx has instead added QVAR and Arnuity, both breath-actuated pumps, to\u00a0<\/strong>its\u00a0formulary. The net cost to plan sponsors is 70% to\u00a080% less than the newly launched fluticasone alternative, Optum Rx said.\u00a0It\u00a0also described the move by GSK as one that \u201cputs profits before patients.\u201d <\/p>\n

In response,\u00a0a spokeswoman for GSK\u00a0said the company made \u201ca business decision\u201d to launch the generic version of Flovent \u201cas a way to ensure patients continue to have access to these important medicines, potentially at a lower cost, knowing that we had been planning to discontinue the branded products for some time.\u201d <\/p>\n

GSK said it partnered with Prasco LLC to manufacture and distribute the generic version of Flovent \u201cand Prasco alone determines the market price for those authorized generics.\u201d <\/p>\n

GSK proactively notified payers and pharmacy benefit managers, also known as PBMs, of the change beforehand, the spokeswoman noted. <\/p>\n

But with Flovent now off the market, some doctors say they are struggling to get the generic or other alternatives for their patients.\u00a0The change is happening as the United States is still experiencing high levels of respiratory viruses including flu, RSV and Covid-19.\u00a0<\/strong> <\/p>\n

\u201cThe discontinuation of Flovent has been an unmitigated disaster,\u201d said Dr. Christopher Oermann, a pediatric pulmonologist and director of the Division of Allergy, Immunology, and Pulmonary at Children\u2019s Mercy Kansas City. <\/p>\n

With Flovent gone, some payers have added\u00a0the\u00a0medication Asmanex to formularies.\u00a0It\u2019s an inhaled corticosteroid also aimed at decreasing airway inflammation and is delivered via a metered-dose inhaler, in the same way Flovent is.\u00a0Within a few days, it was hard to find, Oermann noted, and it\u2019s now in\u00a0<\/strong>short supply around the country. <\/p>\n

In Boston, Dr. Ben Nelson, a pediatric pulmonologist at Mass General for Children, said\u00a0that\u00a0even when his team is able to identify an alternative and file the appropriate paperwork, the medications are labeled as \u201ctier 3 drugs\u201d by insurance formularies, which require a higher copay. <\/p>\n

\u201cMany families cannot afford the 150 dollars per month (or more) for their child\u2019s life saving medication,\u201d Nelson\u00a0wrote\u00a0in an email. <\/p>\n

Dr. Christy Sadreameli, a pediatric pulmonologist and assistant professor of pediatrics at Johns Hopkins in Baltimore, Maryland,\u00a0said \u201cmany kids\u201d are falling through the gaps. <\/p>\n

\n
    <\/ul>\n<\/div>\n

    \u201cThis is the worst I have ever seen in my career with respect to difficulty getting the right drug in the right type of inhaler to the right age patient,\u201d\u00a0she said. <\/p>\n

    Lovinsky-Desir said she and her team are doing everything they can to keep children out of the hospital but have had to send several\u00a0young patients\u00a0to the ER\u00a0<\/strong>when their symptoms could not be controlled. <\/p>\n

    The only medication Ana has been able to get is a budesonide nebulizer, Mariluz said.\u00a0The noise of the machine reminds Ana of her time in the ICU, which inevitably makes her cry.\u00a0Mariluz puts a pillow over the machine every morning and night to hide the\u00a0reminder. <\/p>\n

    Bryce has also been unable to get authorization for the Flovent generic\u00a0from his parents\u2019 insurance. Instead, he got authorization for Asmanex, which his family couldn\u2019t find in New York. <\/p>\n

    He is OK for now;\u00a0an aunt who lives in Arizona was able to get an inhaler there and shipped it to New York. <\/p>\n<\/p>\n

    This post appeared first on cnn.com<\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"

    Editor\u2019s Note: Dr.\u00a0Edith Bracho-Sanchez is a primary care pediatrician, director of pediatric telemedicine and assistant professor of pediatrics at Columbia University Irving Medical Center. Flovent, one of the most commonly prescribed childhood asthma medications, is no longer being manufactured in the United States. GSK, the pharmaceutical company that made it, took if off the shelves …<\/p>\n","protected":false},"author":1,"featured_media":406,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"loftocean_post_primary_category":0,"loftocean_post_format_gallery":"","loftocean_post_format_gallery_ids":"","loftocean_post_format_gallery_urls":"","loftocean_post_format_video_id":0,"loftocean_post_format_video_url":"","loftocean_post_format_video_type":"","loftocean_post_format_video":"","loftocean_post_format_audio_type":"","loftocean_post_format_audio_url":"","loftocean_post_format_audio_id":0,"loftocean_post_format_audio":"","loftocean-featured-post":"","loftocean-like-count":0,"loftocean-view-count":534,"tinysalt_single_post_intro_label":"","tinysalt_single_post_intro_description":"","tinysalt_hide_post_featured_image":"","tinysalt_post_featured_media_position":"","tinysalt_single_site_header_source":"","tinysalt_single_custom_site_header":"0","tinysalt_single_custom_sticky_site_header":"0","tinysalt_single_custom_sticky_site_header_style":"sticky-scroll-up","tinysalt_single_site_footer_source":"","tinysalt_single_custom_site_footer":"0","footnotes":""},"categories":[35],"tags":[],"class_list":["post-405","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/405","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/comments?post=405"}],"version-history":[{"count":0,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/405\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media\/406"}],"wp:attachment":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media?parent=405"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/categories?post=405"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/tags?post=405"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}