{"id":6045,"date":"2017-02-17T20:18:39","date_gmt":"2017-02-18T02:18:39","guid":{"rendered":"http:\/\/admin.patheos.com\/blogs\/janetheactuary\/?p=6045"},"modified":"2017-02-18T08:20:17","modified_gmt":"2017-02-18T14:20:17","slug":"dont-know-89000-drug","status":"publish","type":"post","link":"https:\/\/www.patheos.com\/blogs\/janetheactuary\/2017\/02\/dont-know-89000-drug.html","title":{"rendered":"What you don’t know about that $89,000 drug"},"content":{"rendered":"\n<\/head>

\"from<\/p>\n

Well, what you probably won\u2019t know, unless you\u2019re a diligent reader of Fortune<\/a> or spent some time trying to find more information.<\/p>\n

The headline news is this: \u00a0a new drug for Duchene muscular dystrophy is on the market, deflazacort, and this is being hailed as<\/a> \u201cthe first drug in the United States approved for use by patients who are 5 years or older with DMD, regardless of genetic mutation.\u201d \u00a0The catch? \u00a0This drug, which had been available abroad at a cost of $1,000 per year, is now being priced at $89,000 per year. \u00a0The manufacturer, Marathon Pharmaceuticals, says that most patients will pay a $20 copay and that they expect to, in the end, net $54,000 per year per patient after taking into account discounts for uninsured patients, and negotiations with insurers. \u00a0(Does Medicaid get discounts or pay the sticker price? \u00a0It\u2019s not clear.) \u00a0But $54,000 per year per patient is still a huge sum of money. \u00a0 \u00a0(See the Chicago Tribune<\/a> for the $54,000 estimate.)<\/p>\n

According to Yahoo Finance<\/a>, there are 15,000 DMD patients. \u00a0If all of them take this drug, that\u2019s a revenue of $810 million per year, far outstripping the estimates of the cost for clinical trials I was able to find<\/a>, somewhere around $100 million. \u00a0That\u2019s massive.<\/p>\n

But here\u2019s the catch:<\/p>\n

Other such drugs with massive pricetags either come by that pricetag because they\u2019re under patent, and offer a radically new treatment (the drugs offering cures for Hepatitis C), or because they\u2019re in so little use that there\u2019s only one manufacturer, even if it\u2019s a generic (the case of the \u201cpharma bro\u201d\u2018s massive price hike<\/a>), or because people haven\u2019t paid enough attention to generic options (the case of the Epipen, available as a generic, but with too many users not realizing they had the option and asking for the generic prescription).<\/p>\n

This is different.<\/p>\n

This is a generic drug, which has been given 7 year marketing exclusivity in the United States by the FDA, under \u201corphan drug\u201d provisions, because the company in question put forth the effort to conduct the clinical trials to allow for its FDA approval.<\/p>\n

And that\u2019s the wrinkle: \u00a0the drug was being widely used abroad, but U.S. policy is that the approval processes in Europe and Canada are not good enough, and no matter how widely a drug is used abroad, the FDA requires a full set of clinical trials, from scratch, in the U.S., with U.S. patients, which massively increases the actual cost as well as the pricing.<\/p>\n

The Fortune article defends this system:<\/p>\n

Senator Ted Cruz has argued that drugs approved by European or Canadian regulators should automatically be approved in the U.S. That\u2019s not a good idea, because it would lead to manufacturers of new medicines always going to whoever set the lowest bar.<\/p><\/blockquote>\n

But that\u2019s lunacy, to imagine that the approval process in such countries as Europe and Canada is deficient. \u00a0Sure, I wouldn\u2019t want to have approval reciprocity with China, say, but surely the drug-approval bodies in sufficiently \u201ccivilized\u201d countries could come to an agreement on common protocols, or, if the United States truly felt that those other processes were insufficient, that they could identify supplemental studies rather than redoing everything entirely from scratch.<\/p>\n

Yes, everyone always trots out the example of thalidomide<\/a>. \u00a0But that was 60 years ago. \u00a0Are we really going to withhold treatments from Americans because of this single incident, not repeated, from 60 years ago?<\/p>\n

After all, if deflazacort had previously been approved for anything at all in the U.S., doctors would have been prescribing it for DMD in an off-label manner years ago. \u00a0And if DMD hadn\u2019t been a condition for which Orphan Drug law applied, there would have been no one with the financial incentives to conduct the tests, and it wouldn\u2019t have ever been available in the U.S.<\/p>\n

Makes you wonder how many other drugs there are in this situation, doesn\u2019t it? \u2014 and how many people could be helped, but aren\u2019t, because of our drug approval policies.<\/p>\n

UPDATE: \u00a0Here\u2019s another article to read on the subject of reciprocity, from Marginal Revolution<\/a>.<\/p>\n

Image: \u00a0from pixabay.com; https:\/\/pixabay.com\/en\/diet-pills-medication-pharmacy-sick-1328802\/; public domain<\/p>\n<\/body><\/html>\n","protected":false},"excerpt":{"rendered":"

Well, what you probably won\u2019t know, unless you\u2019re a diligent reader of Fortune or spent some time trying to find more information. The headline news is this: \u00a0a new drug for Duchene muscular dystrophy is on the market, deflazacort, and this is being hailed as \u201cthe first drug in the United States approved for use […]<\/p>\n","protected":false},"author":2209,"featured_media":6047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[567,566,564,565],"class_list":["post-6045","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-big-pharma","tag-defalzacort","tag-drugs","tag-fda"],"yoast_head":"\nWhat you don't know about that $89,000 drug<\/title>\n<meta name=\"description\" content=\"Well, what you probably won't know, unless you're a diligent reader of Fortune or spent some time trying to find more information. 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