{"id":6427,"date":"2022-07-07T07:22:18","date_gmt":"2022-07-07T12:22:18","guid":{"rendered":"https:\/\/www.appliedpolicy.com\/staging\/7403\/?p=6427"},"modified":"2022-07-07T08:38:19","modified_gmt":"2022-07-07T13:38:19","slug":"emerging-pharmacology-and-patient-expectations","status":"publish","type":"post","link":"https:\/\/www.appliedpolicy.com\/staging\/7403\/emerging-pharmacology-and-patient-expectations\/","title":{"rendered":"Emerging pharmacology and patient expectations"},"content":{"rendered":"

[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]The first half of 2022 saw several encouraging developments in the pharmaceutical sector. In June alone, we learned<\/a> that all of the rectal cancer patients in clinical study of dostarlimab were in remission after 12 months and saw the results of a study<\/a> of the use of trastuzumab deruxtecan (Enhertu) for HER2-low metastatic breast cancer described as \u201cunheard of\u201d in a New York Times story<\/a>.<\/p>\n

It is, unquestionably, an exciting time in medicine, with biologics and gene therapies affording treatments with survival rates undreamed of just a few decades ago.<\/p>\n

But each scientific advancement carries with it the weight of patient hope and expectations and, all too frequently, misunderstanding.<\/p>\n

Confusing terminology<\/h4>\n

One of the greatest sources of confusion for the general public may be the term \u201cbreakthrough\u201d which the media alternately uses in both its colloquial and regulatory sense, sometimes in the same news story.<\/p>\n

The \u201cbreakthrough therapy designation\u201d (BTD) was established by the U.S. Food and Drug Administration Safety and Innovation Act of 2012<\/a> as a means of facilitating the rapid review of treatments for serious conditions. For a drug to qualify under BTD, there must be preliminary clinical evidence that it \u201cdemonstrate(s) substantial improvement over existing therapies on one or more clinically significant endpoints.\u201d<\/p>\n

However, for those not versed in Food and Drug Administration (FDA) terminology, \u201cbreakthrough\u201d remains synonymous with \u201cenhanced,\u201d \u201cimproved,\u201d or \u201cadvanced.\u201d Unsurprisingly, the word\u2019s use in news stories about emerging treatments can lead to critical misinterpretations.<\/p>\n

In a randomized trial<\/a> assessing the impact of language on perceived drug efficacy, researchers found that the use of the word \u201cbreakthrough\u201d led non-clinical participants to rate a drug as \u201cvery\u201d or \u201ccompletely effective\u201d despite the fact that the designation refers to the expedited track for its approval and not to how well it works or to how well it ultimately works in comparison to other treatments for the same condition. Subsequent research<\/a> identified the same cognitive phenomena among physicians\u2014including oncologists\u2014 who, like their non-clinical peers tended to associate the \u201cbreakthrough\u201d designation with greater efficacy of a theoretical pharmaceutical.<\/p>\n

In fact, a 2018 review<\/a> of cancer medicines published in the Journal of Clinical Oncology<\/em> found no statistically significant evidence that drugs approved under the BTD process performed better than those approved through the regular steps.<\/p>\n

Timelines<\/h4>\n

Patients expect immediate access to the best therapies and treatments, and it is reasonable to assume that many patients with rectal cancer asked their providers about dostarlimab last month. But personal urgency is often thwarted by regulatory timelines. Even under a BTD designation, or the FDA\u2019s Fast Track Designation, Accelerated Approval Pathway, or Priority Review Designation, it can take the agency up to six months to act on an application. And frequently the studies that make headlines and bring a potential treatment to a patient\u2019s attention involve small sample sizes or have design flaws that necessitate the overlooked caveat that \u201cfurther testing is needed to confirm.\u201d<\/p>\n

The cautionary tale of Aduhelm approval<\/h4>\n

While delays in drug approval can frustrate patients, expedited decisions can be confounding.<\/p>\n

For the families of the approximately 6.5 million Americans living with Alzheimer\u2019s disease, there may be no better example of this than the expedited approval of aducanumab (Aduhelm).<\/p>\n

A recombinant human monoclonal antibody developed by Biogen for the treatment of Alzheimer\u2019s disease, Aduhelm first came to public attention after its phase 1 trial results were published in the September 2016 issue<\/a> of Nature<\/em>. Biogen reported that aducanumab infusions were associated with a reduction in the amyloid-\u03b2 (A\u03b2) plaques in the brain which characterize Alzheimer\u2019s.<\/p>\n

In its discussion<\/a>, the Cleveland Clinic referred to the study as demonstrating \u201cperhaps even some cognitive effect.\u201d But the popular media was less measured. A CNBC story<\/a> with the headline “New Biogen drug stops memory loss in Alzheimer\u2019s patients<\/em>\u201d quoted scientists as describing the Aduhelm study as the \u201cbest news they\u2019ve seen for treating (Alzheimer\u2019s) in 25 years.\u201d The Australian Broadcasting Corporation even suggested<\/a> that the Biogen study \u201cvindicated\u201d Colin Masters, the Australian researcher who had proposed that amyloid plaques were not only a symptom of Alzheimer\u2019s, but its cause.<\/p>\n

Confusion followed as Biogen subsequently halted large-scale Phase 2 studies of the drug and withdrew its application for Aduhelm\u2019s approval in the spring of 2019, only to submit a new application based on a \u201cnew analysis of a larger dataset\u201d later that year.<\/p>\n

The FDA granted Aduhelm accelerated approval in June of 2021, against the recommendations of its own advisory committee, but with the enthusiastic support<\/a> of patient advocacy groups, which had argued that patients and their families favored approval and were entitled to some measure of hope after decades without new treatment options.<\/p>\n

Two members of the FDA advisory committee panel resigned in protest, one telling<\/a> the Washington Post that he would not take part in a \u201csham process.\u201d The American Academy of Neurology issued a position statement<\/a> in which it described the approval of Aduhelm as indicative of \u201ca lowering of the standards of scientific evidence used for drug approvals.\u201d<\/p>\n

In light of Biogen\u2019s announcement that Aduhelm would cost $56,000 annually\u2014not inclusive of infusion costs or monitoring services\u2014the Centers for Medicare & Medicaid Services (CMS) ultimately made the decision<\/a> restrict coverage for the drug to those participating in clinical trials. Private payers similarly declined<\/a> to include Aduhelm on their formularies, expressing concerns about both its cost and efficacy.<\/p>\n

Once optimistic at the prospect of a new treatment, patients and their families were ultimately left with limited access to a drug of questionable efficacy and conflicting opinions expressed as widely differing policies on the part of key government agencies.<\/p>\n

Treatments for rare diseases<\/h4>\n

Among patients with rare diseases\u2014defined by the FDA as occurring in less than 200,000 individuals in the U.S.\u2014hope is often placed in the Orphan Drug Act (ODA), which was adopted in 1983. Under ODA, a manufacturer may apply for orphan-drug designation from the FDA and qualify for \u201ctax credits for qualified clinical trials, exemption from user fees (and a) potential seven years of market exclusivity after approval.\u201d<\/p>\n

ODA policies have led to treatments for such rare conditions as Alagille syndrome and Glioma. But, despite any waiflike imagery evoked by the term orphan, pharmaceutical companies holding ODA authorizations have been found to be in sounder financial standing than their counterparts. While originally approved as a non-orphan drug, Adalimumab (Humira), one of the world\u2019s top selling drugs, received subsequent orphan drug designation for the treatment of certain forms of uveitis in 2014.<\/p>\n

When drugs are delayed in development or approval, desperate patients may seek experimental treatment under \u201ccompassionate use\u201d or \u201cexpanded access\u201d policies. Under the FDA\u2019s Expanded Access<\/a> program, a patient with an immediately life-threatening disease or condition (defined as \u201cdisease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment\u201d) can seek treatment with an investigative drug without being enrolled in a clinical trial.<\/p>\n

This access to unapproved treatments is echoed in the Right to Try Act<\/a>, which was signed into law in 2018, but which, unlike the Expanded Access, does not require oversight by an institutional review board. In choosing options under either Expanded Access or Right to Try, patients and families under extreme emotional stress may be inclined to believe assertions that \u201cpromising\u201d or \u201cproven\u201d treatments have been withheld.<\/p>\n

Costs<\/h4>\n

While discussions of drug pricing can have uncomfortable political undercurrents, the fact remains that drug development is expensive.<\/p>\n

A 2021 study by the Congressional Budget Office concluded that the cost of developing a drug can range from less than $1 billion to over $2 billion. Adjusted for inflation, pharmaceutical companies are spending 10 times more for research and development (R&D) today than they did four decades ago. And according to the Government Accountability Office<\/a>, pharmaceutical companies spend more on R&D as a percentage of total sales than such obviously R&D intensive sectors as semiconductor and other electronic components.<\/p>\n

Americans are spending nearly $500 billion annually on prescription drugs with an increasingly large percentage of this spending going toward what are called \u201cspecialty drugs\u201d developed specifically for chronic, complex, or rare conditions such as cancer, hepatitis C, and multiple sclerosis.<\/p>\n

The American Association of Retired Persons (AARP) found that the average annual cost of specialty drug therapy per drug was $84,442 in 2020. And in May of this year, Forbes<\/em><\/a> reported that health plans and prescription benefit managers were \u201cbracing\u201d for specialty drugs to \u201c(eclipse) 50% of prescription spending\u201d even though they might still represent 2% or less of claims.<\/p>\n

The cost of drug development plays a key role in drug pricing, which ultimately factors into formulary decisions by payors. That a treatment option exists does not guarantee its availability to a given patient.<\/p>\n

Pressure on physicians<\/h4>\n

Americans continue to place special trust<\/a> in their medical providers. But doctors aren\u2019t always available, while the internet, social media, and disease-specific online forums are just a click away. A patient sleepless with anxiety over a chronic or newly diagnosed life-threatening condition can find comfort and an online cohort in wandering the internet in the wee hours of the morning. And we can assume that countless individuals shared hopeful \u201cDid you see this?\u201d links to the Enhertu story with loved ones with breast cancer.<\/p>\n

While online research can be a means of empowerment<\/a> for patients, it can also be a source of misinformation<\/a>, with even factual data frequently provided without appropriate context. Doctors can play an important role in helping their patients sort fact from fiction, interpret scientific literature, and to appreciate the nuances of regulatory processes.<\/p>\n

But managing patient expectations about the promise of new drugs may come at some cost to clinicians. In position paper published in 2021, the American Academy of Neurology recognized the issues attendant to the management of high-cost drugs as adding to the administrative burdens that contribute to physician burnout. Further, mismatched understandings of available treatments options can complicate the doctor-patient relationship.<\/p>\n

There are many adages equating hope with medicine, and the powers of both the placebo effect and faith have been demonstrated by research. However, medicine, while inexact, is ultimately an evidence-based science and clinicians make decisions based on data, not on hope.<\/p>\n

Physicians can play an important role in helping patients and their families interpret the data, understand the broader regulatory context of drug approval, and cut through the noise of “breakthrough” headlines. Yet, in a culture of greater scientific literacy, regulatory consistency, and measured journalism they might not need to do so quite as often.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]The first half of 2022 saw several encouraging developments in the pharmaceutical sector. In June alone, we learned that all of the rectal cancer patients in clinical study of dostarlimab were in remission after 12 months and saw the results of a study of the use of trastuzumab deruxtecan (Enhertu) for HER2-low metastatic […]<\/p>\n","protected":false},"author":12,"featured_media":6432,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-6427","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nEmerging pharmacology and patient expectations - Applied Policy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.appliedpolicy.com\/emerging-pharmacology-and-patient-expectations\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Emerging pharmacology and patient expectations - Applied Policy\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]The first half of 2022 saw several encouraging developments in the pharmaceutical sector. 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