The Open Dermatology Journal

ISSN: 1874-3722 ― Volume 13, 2019

Patient Informational Sheet on Why Some Physicians are Hesitant to Prescribe Biologics

Craig G Burkhart

Article Information

Identifiers and Pagination:

Year: 2018
Volume: 12
First Page: 12
Last Page: 13
Publisher Id: TODJ-12-12
DOI: 10.2174/187437220181201012

Article History:

Electronic publication date: 25/04/2018
Collection year: 2018

Article Metrics:

CrossRef Citations:

Total Statistics:

Full-Text HTML Views: 595
Abstract HTML Views: 766
PDF Downloads: 790
ePub Downloads: 288
Total Views/Downloads: 2439

Unique Statistics:

Full-Text HTML Views: 349
Abstract HTML Views: 410
PDF Downloads: 269
ePub Downloads: 188
Total Views/Downloads: 1216
Geographical View

© 2018 Craig G Burkhart.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: ( This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Biologics are a range of pharmaceutical products that interfere with specific parts of the immune system. In dermatology, most biologics are of receptor constructs that eliminate certain proteins involved with the normal body protective forces. These drugs have merit when treating psoriatic arthritis and erythrodermic, pustular psoriasis, but there are alarming concerns that trouble me when treating patients with limited psoriasis. And there is little doubt that pharmaceutical companies are advertising their biologic therapies to patients with minimal psoriasis, who in turn are expecting to be treated with these agents.

So first, are biologics as good as advertised on the media. I suggest they are not. Indeed, most pharmaceutical studies with these agents seek an end point of only 75% reduction in body coverage and severity. If this is their study results, let their advertising also reflect these less than glorious results.

Secondly, are biologics safe? I would suggest that any product that has a box warning stating that the product has been associated with serious infections and malignancies, are not free of side effects. In truth, the FDA and indeed the pharmaceutical company themselves, are saying that these side effects are real by providing information on the drug leaflet.

A third parameter might be, are these drugs expensive. I would say the cost borders on ridiculous. The wholesale acquisition cost of biologics can exceed $15,000 per month. Assuming a patient acquires psoriasis at age ten and lives to 80, then the cost of biologic therapy for her psoriasis would be close to $14,000,000, using present costs. This does not include physician visits nor any topical therapy that might be added to psoriasis therapy. And of course, this amount would not include care for other skin problems or other medical and surgical needs unrelated to the psoriasis. If one believes that health care professionals have to give care in a fiscally responsive manner, this makes little sense.

The last issue that I raise relates to prior authorization approval that needs to accompany patients who request these drugs. These forms require physicians to sign that the medication is medically necessary and that the patient was a failure when treated with methotrexate. My major point would be that very few patients do not respond to methotrexate. A physician may prefer the side effect profile of biologics over methotrexate, but that's not what a doctor is attesting to on the prior authorization form. In short, the physician normally has to lie and state that the patient did not respond to methotrexate. I am not sure that these inaccuracies may not come back to haunt these physicians in the future.

I have recently put my thoughts into an informational sheet (see below) for my patients to read. Truly, medicine is the interaction between physician and patient. In this era, where the media is on a large scale providing drug information it is this one-on-one relationship in which physicians should discuss his/her concerns and thoughts related to psoriasis treatment. This patient handout below is how I started discussing biologics with patients. I welcome your feedback.

Patient informational sheet

Craig G. Burkhart, MPH, MD

5600 Monroe Street, Suite 106B, Sylvania, Ohio 43560

Information on why some physicians are hesitant to prescribe biologics (such as Enbrel, Humira, Taltz, Stelara, Remicade, Cimzia).

Biologics are actually a range of pharmaceutical products that interfere with specific parts of the immune system. In dermatology, most biologics are of receptor constructs that eliminate specific proteins involved in the normal immune response. Because these drugs interfere with the normal body immune response, they are associated with side effects, such as serious bacterial infections and malignancies as stated in their package inserts (boxed warnings stressing the significance of concern).

To clarify, biology is a natural science concerned with the study of life and living organisms. There is very little association between biology and biologics except they both sound scientific and positive.

Biologics are expensive. A study looking at the wholesale acquisition cost of some biologics was as high as $15,000 per month [1]. Also, it should be kept in mind that psoriasis is a chronic disease, and so these costs compound over the duration of therapy. In this era of co-pay reduction cards, the pharmaceutical companies hope that we are simplistic enough to believe that the cost for their drugs are low because the patients' co-pays are low. Even if patients don't pay the high cost at the pharmacy, their insurance premiums will be raised to compensate for the cost. Also, eventually the costs also have to be shouldered by society at large. One of my tenets is a health care professional, I have to provide care in a fiscally responsive manner.

Biologics help, but rarely cure psoriasis. Indeed, most studies performed are for an end point of 75% reduction in psoriasis area on body and severity. Please note that it is not 100%. I do wish to note that some patients may find these drugs life changing, especially those with psoriatic arthritis.

The media blitz of all the rewards of skin psoriasis from biologics may be overstated in commercials, but they have certainly increased patients' expectations. Ten years earlier, this suggesting to patients that they should wear long pants in order to hide lesions on the legs was acceptable.. Today, many patients don't want to look in the mirror and see any psoriasis.

Because of the expense of biologics, health insurances require all patients to first try oral methotrexate for their psoriasis. The technical terms would be that physicians must seek prior authorization for patients to receive biologics; prior authorization means that the treatment is medically necessary; and the physician must verify that such patients failed to respond to methotrexate prior to asking health insurances to pay for biologics. Methotrexate is an antimetabolite (it blocks folinic acid) and is one of the standard medications known as anti-cancer drug. This drug is used because almost 100% of psoriasis patients respond to methotrexate. It works even better than biologics, but it has an even higher propensity for serious side effects, especially the liver toxicity. I ask health insurance companies to pay for biologics, for those who don’t respond to methotrexate, The scenario is that the doctor has to lie to the health insurance agencies for the patient to get biologics, and I refuse to lie to the health insurance agencies.


[1] D'Souza LS, Payette MJ. Estimated cost and efficacy of systemic treatments that are approved by the US Food and Drug Administration for treatment of moderate to severe psoriasis. J Am Acad Dermatol 2015;72:589-598


"Open access will revolutionize 21st century knowledge work and accelerate the diffusion of ideas and evidence that support just in time learning and the evolution of thinking in a number of disciplines."

Daniel Pesut
(Indiana University School of Nursing, USA)

"It is important that students and researchers from all over the world can have easy access to relevant, high-standard and timely scientific information. This is exactly what Open Access Journals provide and this is the reason why I support this endeavor."

Jacques Descotes
(Centre Antipoison-Centre de Pharmacovigilance, France)

"Publishing research articles is the key for future scientific progress. Open Access publishing is therefore of utmost importance for wider dissemination of information, and will help serving the best interest of the scientific community."

Patrice Talaga
(UCB S.A., Belgium)

"Open access journals are a novel concept in the medical literature. They offer accessible information to a wide variety of individuals, including physicians, medical students, clinical investigators, and the general public. They are an outstanding source of medical and scientific information."

Jeffrey M. Weinberg
(St. Luke's-Roosevelt Hospital Center, USA)

"Open access journals are extremely useful for graduate students, investigators and all other interested persons to read important scientific articles and subscribe scientific journals. Indeed, the research articles span a wide range of area and of high quality. This is specially a must for researchers belonging to institutions with limited library facility and funding to subscribe scientific journals."

Debomoy K. Lahiri
(Indiana University School of Medicine, USA)

"Open access journals represent a major break-through in publishing. They provide easy access to the latest research on a wide variety of issues. Relevant and timely articles are made available in a fraction of the time taken by more conventional publishers. Articles are of uniformly high quality and written by the world's leading authorities."

Robert Looney
(Naval Postgraduate School, USA)

"Open access journals have transformed the way scientific data is published and disseminated: particularly, whilst ensuring a high quality standard and transparency in the editorial process, they have increased the access to the scientific literature by those researchers that have limited library support or that are working on small budgets."

Richard Reithinger
(Westat, USA)

"Not only do open access journals greatly improve the access to high quality information for scientists in the developing world, it also provides extra exposure for our papers."

J. Ferwerda
(University of Oxford, UK)

"Open Access 'Chemistry' Journals allow the dissemination of knowledge at your finger tips without paying for the scientific content."

Sean L. Kitson
(Almac Sciences, Northern Ireland)

"In principle, all scientific journals should have open access, as should be science itself. Open access journals are very helpful for students, researchers and the general public including people from institutions which do not have library or cannot afford to subscribe scientific journals. The articles are high standard and cover a wide area."

Hubert Wolterbeek
(Delft University of Technology, The Netherlands)

"The widest possible diffusion of information is critical for the advancement of science. In this perspective, open access journals are instrumental in fostering researches and achievements."

Alessandro Laviano
(Sapienza - University of Rome, Italy)

"Open access journals are very useful for all scientists as they can have quick information in the different fields of science."

Philippe Hernigou
(Paris University, France)

"There are many scientists who can not afford the rather expensive subscriptions to scientific journals. Open access journals offer a good alternative for free access to good quality scientific information."

Fidel Toldrá
(Instituto de Agroquimica y Tecnologia de Alimentos, Spain)

"Open access journals have become a fundamental tool for students, researchers, patients and the general public. Many people from institutions which do not have library or cannot afford to subscribe scientific journals benefit of them on a daily basis. The articles are among the best and cover most scientific areas."

M. Bendandi
(University Clinic of Navarre, Spain)

"These journals provide researchers with a platform for rapid, open access scientific communication. The articles are of high quality and broad scope."

Peter Chiba
(University of Vienna, Austria)

"Open access journals are probably one of the most important contributions to promote and diffuse science worldwide."

Jaime Sampaio
(University of Trás-os-Montes e Alto Douro, Portugal)

"Open access journals make up a new and rather revolutionary way to scientific publication. This option opens several quite interesting possibilities to disseminate openly and freely new knowledge and even to facilitate interpersonal communication among scientists."

Eduardo A. Castro
(INIFTA, Argentina)

"Open access journals are freely available online throughout the world, for you to read, download, copy, distribute, and use. The articles published in the open access journals are high quality and cover a wide range of fields."

Kenji Hashimoto
(Chiba University, Japan)

"Open Access journals offer an innovative and efficient way of publication for academics and professionals in a wide range of disciplines. The papers published are of high quality after rigorous peer review and they are Indexed in: major international databases. I read Open Access journals to keep abreast of the recent development in my field of study."

Daniel Shek
(Chinese University of Hong Kong, Hong Kong)

"It is a modern trend for publishers to establish open access journals. Researchers, faculty members, and students will be greatly benefited by the new journals of Bentham Science Publishers Ltd. in this category."

Jih Ru Hwu
(National Central University, Taiwan)

Browse Contents

Webmaster Contact:
Copyright © 2019 Bentham Open