{"id":127499,"date":"2017-07-13T09:18:20","date_gmt":"2017-07-13T13:18:20","guid":{"rendered":"https:\/\/today.uconn.edu\/?p=127499"},"modified":"2017-08-22T12:17:38","modified_gmt":"2017-08-22T16:17:38","slug":"op-ed-limit-spending-lifesaving-drugs","status":"publish","type":"post","link":"https:\/\/today.uconn.edu\/2017\/07\/op-ed-limit-spending-lifesaving-drugs\/","title":{"rendered":"Op-ed: Should We Limit Spending on Lifesaving Drugs?"},"content":{"rendered":"

\u201cIt was the best of times, it was the worst of times\u201d is a familiar quote from the opening of Charles Dickens\u2019 \u201cA Tale of Two Cities<\/a>,\u201d but the phrase is also applicable to the specialty drug market in the United States today.<\/p>\n

Specialty drugs, usually complex biologic products created by genetic alterations of living tissues or organisms,\u00a0have revolutionized patient care<\/a>\u00a0by creating human proteins, enzymes, and antibodies that can treat diseases much more specifically than previously. These breakthroughs have come through a collective national choice to let drugmakers set prices and reap the profits with limited oversight \u2013\u00a0as opposed to many other countries<\/a>\u00a0with strict controls.<\/p>\n

However, this choice has come at a steep price: Health care costs are soaring at an unsustainable pace,\u00a0putting the finances of states, the federal government<\/a>, companies, and\u00a0millions of Americans<\/a>\u00a0at risk.<\/p>\n

Every American \u2013 especially our lawmakers preparing to\u00a0remold our health care system<\/a>\u00a0for the second time in eight years \u2013 needs to understand the choice we have made and grapple with where to go from here. In the end, it comes down to one difficult question: What value should we place on a human life?<\/p>\n

Drug costs are crippling us financially<\/strong><\/p>\n

Between premiums, deductibles, and co-pays, a typical family of four will directly\u00a0pay U.S. $11,000 of the estimated $27,000<\/a>\u00a0it is expected to spend on health care in 2017, up 22 percent since 2013. That\u2019s quite a lot, especially considering the\u00a0average American worker<\/a>\u00a0made only $46,120 in 2015.<\/p>\n

But it will be impossible to control these spiraling costs without getting a handle on prescription drug spending, which is growing at a rate\u00a0at least three times faster<\/a>\u00a0than every other major medical category.<\/p>\n

What many people don\u2019t know is that\u00a0spending on traditional drugs<\/a>\u00a0such as statins, acid controllers, and antibiotics\u00a0hasn\u2019t changed much<\/a>. It\u2019s specialty and biologic drugs that are really taking a toll.\u00a0Such drugs have been responsible for 73 percent<\/a>\u00a0of spending growth over the past five years.<\/p>\n

A single prescription for\u00a0one of the top five specialty drugs<\/a>, for example, cost $6,621 in 2015, compared with $60 for traditional drugs like Nexium and Crestor. The situation for so-called orphan drugs, which are specialty biologic drugs used for rare diseases, is even worse. The average orphan drug\u00a0cost $111,820 per person per year in 2014<\/a>.<\/p>\n

Specialty drugs are godsends for patients<\/strong><\/p>\n

So the obvious question is, are the costs worth it? And the answer is \u2013 for those whose lives are affected \u2013 clearly yes.<\/p>\n

Specialty drugs can do amazing things<\/a>, especially in the\u00a0realm of rare diseases<\/a>\u00a0(those that afflict fewer than 200,000 patients), in which there had been no serious research in the past. The term orphan drug\u00a0was codified in 1983<\/a>\u00a0to describe medications intended to treat diseases so rare that pharmaceutical companies are reluctant to develop them.<\/p>\n

That changed<\/a>\u00a0with the passage of the\u00a0Orphan Drug Act of 1983<\/a>, which allowed special grants for research, a 50 percent tax credit on trial costs, shorter FDA approval times, and a guaranteed seven years of patent exclusivity. Before the act, the\u00a0FDA approved 34 drugs<\/a>\u00a0that would have qualified as orphan drugs from 1967 to 1983. The FDA approved 10 times as many \u2013 347 \u2013 over the next 26 years, reflecting how the act helped provide the financial incentive to produce these specialty drugs.<\/p>\n

Let\u2019s look at just one rare disease, Liposomal Acid Deficiency. Also known as Wolman\u2019s Disease, it affects only a handful of infants, but\u00a0without this vital enzyme<\/a>\u00a0they accumulate fats in their digestive organs, leading to organ swelling, failure, and death within the first year of life.<\/p>\n

Before 2015, there were no treatments, but now chickens are genetically modified so that their eggs produce this human enzyme, sold under the name sebelipase alpha. Injecting this enzyme clears up patients\u2019 debilitating symptoms and prolongs their lives, in some cases as long as decades, experts believe.<\/p>\n

Make no mistake, this is a miracle for parents of a baby with this terrible infliction. But this miracle is expected to cost about $700,000 a year\u00a0for the rest of the child\u2019s life<\/a>.<\/p>\n

What Europe does<\/strong><\/p>\n

Things work a lot differently in Europe, and it\u2019s worth considering whether we\u2019d be wise to follow its general approach.<\/p>\n

Unlike in the U.S., countries in Europe have some form of socialized health care system in which the government covers the costs of drugs that meet certain criteria. That decision is made at the national level, while the European Medicine Agency determines whether to approve the drug for use.<\/p>\n

Drugs\u00a0are generally covered<\/a>\u00a0if the cost relative to benefits \u2013 known as a quality adjusted life year (QALY) \u2013 is under a certain threshold. Simply put, an\u00a0extra year of life lived in perfect health<\/a>\u00a0is worth 1 QALY, while a sliding scale is used to quantify the value of an extra year in poor health (between 0 and 1 QALY).<\/p>\n

In Britain, for example,\u00a0medications are usually covered<\/a>\u00a0if each QALY gained costs less than \u00a330,000 ($36,600) \u2013 although they do have some exceptions.<\/p>\n

That means that few orphan drugs get reimbursed. Of the 116 orphan drugs the FDA approved for use outside of the hospital from 1983 to 2012, the U.K.\u2018s National Health Service\u00a0didn\u2019t even review<\/a>\u00a0about two-thirds of them for reimbursement, presumably because the cost was too high. Of the rest, it offered conditional reimbursement for a dozen, while 15 were denied.<\/p>\n

In an\u00a0assessment of orphan drugs<\/a>\u00a0that cost more than $225,000 per year per patient in the U.S., none of these drugs had been reviewed in Britain.<\/p>\n

So what should we do?<\/strong><\/p>\n

The U.S. has created market incentives to study rare diseases, and with the help of human ingenuity we have created some amazing breakthroughs in solving complex problems.<\/p>\n

This mentality has been radically different from in Europe, where similar research never would have gotten off the ground because policymakers efficiently target their health care dollars for maximum impact on society \u2013 not for creating miracles for unfortunate outliers with rare diseases.<\/p>\n

However, the inherent generosity built into the Orphan Drug Act is one factor leading so many Americans to\u00a0struggle to afford their premiums<\/a>\u00a0and move into high-deductible plans that make a simple visit to the doctor effectively unaffordable. And employers as well as state and federal governments\u00a0are being financially crushed<\/a>\u00a0under increasing health care costs.<\/p>\n

So what can be done? Unfortunately, there are no easy answers, and every potential solution has costly or even life-and-death consequences.<\/p>\n

The debate shouldn\u2019t be simply about what we can do to control costs but rather how much are we willing to spend to sustainably encourage new medical breakthroughs. I believe that we will need to apply a cost-effectiveness analysis to new and existing drugs, and determine that at some point the costs outweigh the benefits.<\/p>\n

Drawing that line \u2013 which comes down to defining how much a human life is worth \u2013 has been difficult for lawmakers, which is why the legislation underpinning the Affordable Care Act and its possible replacements have not addressed effective ways to control prescription drug spending.<\/p>\n

But not choosing simply pushes the burden on those individuals, companies, and taxpayers who fund health care. That burden is immense, and will only continue to grow.<\/p>\n

Originally published in The Conversation<\/a>.<\/em><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Specialty drugs have been responsible for three-quarters of spending growth on medications in the U.S. in the past five years. Pharmacy professor C. Michael White debates the options for how society can respond.<\/p>\n","protected":false},"author":76,"featured_media":127657,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_crdt_document":"","wds_primary_category":0,"wds_primary_series":0,"wds_primary_attribution":0,"footnotes":""},"categories":[2231,1862,1864,2225],"tags":[],"magazine-issues":[],"coauthors":[175],"class_list":["post-127499","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-well-being","category-busn","category-pharm","category-uconn-storrs"],"pp_statuses_selecting_workflow":false,"pp_workflow_action":"current","pp_status_selection":"publish","acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-19 22:24:07","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/posts\/127499","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/users\/76"}],"replies":[{"embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/comments?post=127499"}],"version-history":[{"count":10,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/posts\/127499\/revisions"}],"predecessor-version":[{"id":127645,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/posts\/127499\/revisions\/127645"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/media\/127657"}],"wp:attachment":[{"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/media?parent=127499"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/categories?post=127499"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/tags?post=127499"},{"taxonomy":"magazine-issue","embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/magazine-issues?post=127499"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/today.uconn.edu\/wp-rest\/wp\/v2\/coauthors?post=127499"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}