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Biological Treatment of Psoriasis, Research Paper Example

Pages: 12

Words: 3164

Research Paper

Abstract.

Psoriasis is a chronic skin disease resulting from skin cells dividing more than ten times faster than the standard rate. It causes red bumpy patches on the skin, which are typically covered by white scales. The exact cause of the Psoriasis is yet to be identified. Experts believe it is caused by the negative response of the immune system to the skin. In healthy growth, skin cells are replaced in a range of ten to thirty days; for Psoriasis, new cells grow after every three to four days. It’s estimated that around 1.1 million patients suffer from the disease in the United Kingdom, which makes up 1.7 % of the total population. Some of the available treatment options include ultraviolet, topical, systemic, and biological treatment. Due to Psoriasis’ chronic nature, it’s advisable to choose an efficient and cost-effective treatment plan. The skin is a crucial organ covering 16 % of your body and seen by other people. Effective treatment of the skin is essential in giving patients self-esteem, dignity, and respect among family members and society.

Introduction

Biologic treatment targets the immune response that leads to the development of Psoriasis. The introduction of biologics is attributed to high efficacy and bearable safety. The high performance of biologic treatment has contributed to understanding the pathogenesis of Psoriasis. Biologic therapy is subdivided into three categories depending on the working mechanism. This research focuses on the cost-benefit analysis of five approved biologics drugs by the European Medicines Agency. They include Etanercept, Adalimumab, Infliximab, Ustekinumab, and Secukinumab. This paper will research on treatment of Psoriasis through biologic drugs and conduct a cost-benefit analysis based on statistics from The National Health Service (U.K).

Mode of action for five leading biologics

This section will analyze the mode of operation of five biologics. The discussion will entail their performance on Psoriasis, their prescriptions, and essential details required for the use of the drugs.

interleukin (IL)-23 inhibitors IL-17 inhibitors Tumor necrosis factor (TNF)-α inhibitors
Ustekinumab Secukinumab Etanercept, Adalimumab and Infliximab.

 

Ustekinumab.

Over the past few years, biologic agents targeting IL-12/23 indicate a brighter future for Psoriasis patients. In psoriasis plaques IL-23 and IL-12, they share the p40 subunit. Ustekinumab binds with p40 units preventing interactions with IL12Rβ1 receptors (Bahner, Pg. 122). In a study involving 18 subjects, Ustekinumab showed 12 out of 18 items achieved 67 % of PASI 75 between 8 and 16 weeks after administration. The required dosage ranged between 45-90 mg depending on the severity of Psoriasis for a period of 8 to 16 weeks.

Infliximab

Infliximab is a TNF-α monoclonal antibody consisting of mouse variables and a human constant (Campanati, Pg. 945-963). The biologic drugs treat moderate and severe Psoriasis. It is administered through intravenous infusion for 2 to 3 hours. Patients who have Psoriasis receive a dose of 5 mg at the first, second, and sixth weeks. A maintenance dose is given 6 to 8 weeks. The advantages of using the drug include improving PASI within two weeks after starting treatment (Bahner, Pg. 113). Finally, the drug has a higher efficacy in treating moderate to severe Psoriasis. It neutralizes membrane-bound TNF-α in a relatively high affinity, specificity, and avidity, thus reducing inflammation.

Adalimumab

Adalimumab is a human antibody (TNF-α monoclonal IgG1) that functions by blocking soluble and membrane-bound TNF-α from natural receptors. The initial dose of the drug starts by 80 mg in the first week, after which 40 mg is administered every week (Bahner, Pg. 119). Adalimumab can be used in the treatment of patients as young as four years old. It has high efficacy, with improvements noted within the first week of starting treatment. In case of discontinuation of the drug, a rebound is uncommon.

Etanercept

Etanercept is a fusion protein that works by extracellular ligand-binding domain to a constant fragment (Fc domain) of human immunoglobulin G1 (IgG1). The biologic can be administered for children as young as four years old. It treats moderate to severe Psoriasis by administering through subcutaneous injection. Treatment starts by prescribing a dose of 50 mg twice per week in 12 weeks, followed by 50 mg weekly (Bahner, Pg. 112). PSA is realized in the first two weeks. The skin starts improving after 48 weeks of treatment. The biologic loses efficacy with continuous use due to the development of antibodies.

Secukinumab

Secukinumab is a human IgG1κ monoclonal antibody. It selectively binds and neutralizes IL‐17A (Blauvelt, Pg. 60-69). In a study conducted by the British Journal, Secukinumab indicated high efficacy and tolerability in patients (Paul, Pg. 1082-1090). In a similar study response to Secukinumab was witnessed from week 12 but stabilized around the 16th week. Treatment starts with an initial dosage of 300 mg, where it is administered weekly for five weeks (Mease, Pg. 326). Later a dosage of 300 mg is prescribed every four weeks.

Benefits for the use of biologics for patients

Initially, the actual cause of Psoriasis was unknown, and many speculations surrounded the same. Some attributed the condition to weather, foods, and genetics. These thoughts led to the invention of treatment methods such as methotrexate, phototherapy, retinoid, corticosteroids, and topical creams. These methods are mostly used to treat mild and moderate Psoriasis (Raut, Rashmi, and Vandana). Over time the body gets used to the treatment and fails to respond, hence the ineffectiveness of chemical drugs.

Biologics have indicated the ability to treat moderate to harsh conditions of Psoriasis.

Other treatment methods, such as methotrexate, phototherapy, retinoid, corticosteroids, and topical creams, have side effects. They include stomach upset, nausea, mouth sores, and skin cancer (Kuchekar et al., Pg. 5). Though you might be treating one condition, the treatment methods would be raising other conditions and diseases which are challenging to manage. In their performance, biologics work by selectively targeting specific proteins associated with Psoriasis. When the causes are targeted, side effects are minimal.

The treatment of Psoriasis through the use of methotrexate and Soriatane leads to pregnancy defects. This drug can stay in the body system for more than three months. Those using the medicine either males or females should restrain this treatment three months before conceiving to prevent the newborn from developing defects (Kaushik, Pg. 43-53). Halting treatment accelerates Psoriasis, which interferes with healthy life leading to embracement in public. Biologic therapy of Psoriasis is safe with patients intending conceiving.

Patients can be trained to self-administer biologic drugs on their own without the intervention of medical experts (van den Bemt, Pg. 384-392). This chance ease reduces wastage of time among the patients, and in case of a severe condition, patients do not have to suffer from low-esteem involved with public appearance.

Administration cost for biologic drugs

Before the administration of a drug, The National Health Service of U.K (NHS) considers the current, future, and impacts arising from the use of a particular medicine. Administration costs are divided into the cost of psychical administration and proximal cost. The former indicates the value of NHS in hiring professionals involved, i.e., Nurses and doctors, the cost of concomitant medication and equipment, and consumables. Proximal costs include pharmacy cost( dispensing, preparation, dispensing, inventory), laboratory tests, post-treatment checks, pretreatment tests, expenses incurred for education, or training patients for self-administration.

According to NHS figures 2018, it spent around 1.46 billion on hiring agency nurses to fill in the shortage. The amount is estimated to hire 108000 qualified nurses who would save 1.56 billion euros on agency staff. The lack arises from the need to have different teams in each treatment procedure. In evaluating other treatment procedures such as radiotherapy, they require a radiologist, a doctor to examine the severity of the condition, pharmaceutics, and clinical observation. The treatment process ends up requiring large medical staff straining NHS funds.

The pretreatment costs incurred by NHS are minimal compared to treatment options; the use of topical creams requires extensive examination of the body’s reaction towards the agent. It leads to the conducting of tests on patients to ascertain their compatibility with the drug. After some time, the body gets used to a single drug necessitating a change in the drug used and additional laboratory tests. Treatment optioning requiring the use of different lights at different wavelengths demands NHS acquire specialized equipment, for example, the Excimer laser, psoralen plus Ultraviolet A, and the UV narrowband (Ling Pg.24-55). In a private hospital, a single session using an Excimer laser costs $ 100, where patients need two to three doses a week. The NHS spends 2.5 billion euros on the purchase of laboratory and imaging equipment. According to a post on their website, the organization will save 130 million euros on shift to better treatment methods such as biologics (England NHS).

In an attempt to reduce its cost and offer inpatient services for persons with severe conditions, NHS aims at freeing 2000 to 3000 beds (England NHS. Para 4). Through the use of treatment options such as Goeckerman therapy, this objective might be challenging to achieve. Patients spent 24 hours while receiving Goeckerman therapy though currently, they spend 3 to hours under the examination of a physician, which requires inpatient services (Reddy, Pg.1-10). Unless the NHS shifts to biological drugs that are administered within minutes, and the patient leaves the hospital facility, this projection will be difficult to achieve.

Post-treatment checkups’ cost is minimal for patients treated through the use of biologic drugs compared to daily therapies. In the administration of Ustekinumab, the patient is given a 45 mg dose at 0 weeks and the fourth week. After which they receive a maintenance dose of 45 mg every 12 weeks (Gordon, Pg. 650-661). The time interval between each dose saves human resources required in the treatment of daily therapies. This is a two-end benefit for both the patient and NHS. Patients can utilize and work while NHS medical staff can cater to other patients. Reduction in time spent in hospitals reduces the emotional and mental suffering encountered by patients.

The fact Psoriasis affects the skin interferes with the mental wellbeing of patients where they tend to avoid public places, family members, and workplaces. NHS spent 12.2 Euros on the mental health of patients in the fiscal year 2017/2018 (NHS Health facts, Para.1). Included in the budget is the cost of counseling Psoriasis patients to cater to their mental wellbeing. Through the use of biologic drugs, treatment results are visible even in weeks for Infliximab. The fewer time patients spend after recovering, the lesser they suffer from mental related issues easing budget on NHS.

Shift from biologic drugs to biosimilars.

The initial stages of the introduction of biologic drugs were challenging for The National Health Service (NHS). The organization has an obligation of providing health services to all citizens. Due to this reason, it has the responsibility of promoting drug manufacturers by purchasing their drugs. On the other hand, it has to choose a cost-effective drug considering the current price, future price, administration cost, and other factors to determine the overall cost-benefit. This section will focus on the cost-benefit analysis of using biologic medicines compared to other treatment options.

For conducting more recent research, this paper focuses on biosimilars that work similarly to biologics. Biologics are manufactured from large living molecules, making the production process quite expensive, on the contrary, produced from the original version of the biologics. Their efficacy, safety, and functionality are similar to biologics. These biologic classes arise after the patents of the manufacturing companies producing biologics expires, and other companies start building the same version of the drug. It is expected in the next five years; most biologic patents will expire to produce more biosimilars. An example of Adalimumaba was manufactured from an original drug Humira.

The chief Executive officer of NHS Simon Steven stated NHS would save up to 150 million Euros by switching to biosimilars. According to the NHS report, it spends up to 400 million Euros on the purchase of Adalimumab each year (England NHS). The expiry of its patents increased NHS spending on biologics drugs. Compared to other non-biologic drugs, they have been forced to drop their prices to compete with biologic drugs, lowering costs for the NHS.

The NHS stated that more than 46,000 patients are under the prescription of Humira. The increase in the use of biologic drugs in the treatment of Psoriasis will reduce the cost of expenditure on non-biologic drugs (England NHS. Para. 3). According to Simon Steve, he believes hospitals will pay a quarter of what the current pay of the 400 million Euros. In his statement, the NHS CEO stated the organization is ensuring they are spending every penny they receive wisely by increasing competition between drug companies (England NHS. Para.2). This competition will see the continued dropping of prices for biologic drugs for the benefits of NHS.

By 2021 the NHS aims at reducing its expenditure on drugs by 300 million euros. Through this saving, NHS stated they would use the extra funds in paying for 11,700 community nurses or treat 19800 breast cancer patients (England NHS. Para 1). This is a significant number of people receiving treatment. The saving can be used for other expenses entailing the improvement of national health. A single nurse can handle more than twenty people in a single day hence providing health facilities on large numbers of people.

Cost-benefit analysis discussion

NHS has an obligation of evaluating the purchasing, administration, safety, and future trend of a drug before deciding on its use among patients. In Consideration of the above data gathered from various sources, it’s evident biologic drugs bear success in Psoriasis’s treatment. The use of biologic reduces NHS spending on multiple factors ranging from the cost of hiring labor by 1.56 billion euros. The cost of purchasing medical equipment by 130 million at the same time freeing hospital beds for other patients (England NHS, para. 7). The NHS has reported it has increased its spending on health by 7.4 % in the past decade. Saving on these expenditures will reduce expenditure, which will be spent on other essential services.

The safety of biologic drugs is high compared to other Psoriasis treatment options such as light therapies, which lead to the development of skin diseases such as cancer (Egeberg, Pg. 509-519). Topical treatments are known to cause pigment alteration and slow healing of wounds. Some drugs such as dithranol, calcineurin inhibitors, vitamin D analogues, salicylic acid, and topical retinoids cannot work because of conditions of pregnancy. Biologic drugs have minimal side effects because they are manufactured from a living organism.

The expiry of patents for manufactures producing biologic drugs promises a brighter future for reduced prices (Price, Pg. 1023). The future price of biologic drugs is guaranteed after the recent introduction of biosimilars. According to the laws of demand and supply, an increase in manufactures will intensify research on biologics hence their improvement. According to NHS CEO Simon Steven, the prices are expected to continue reducing as manufacturers use price mechanisms to win NHS drug tenders. The intense competition will save the NHS 300 million Euros, which would not have happened in other treatment options involved in the treatment of Psoriasis.

In conducting a cost-benefit analysis, these saved costs are of the essence because they determine the overall healing cost required to combat an ailment. Apart from the cost, the mental health of both the patients should be considered. How disease affects a patient can change their overall living, bearing adverse effects. There is an additional cost spent on the recovery of the health status of patients. Doctors and clinicians suffer mental due to increased working hours and complicated medical processes. While considering the psychological effect, a disease might cause a doctor; the effectiveness and working hours are reduced to considerable levels.

A quick response to medical treatment associated with biologics reduces the time spent by patients in a hospital facility. This time can be used in carrying out other personal activities that transform into the success of a patient. People suffering from Psoriasis can be trained to administer the injections by themselves, which reduces drug administration costs on NHS and expenditure of hospital facilities such as beds.

Conclusion

Through this cost-benefit analysis, its evident biologic drugs are the best treatment options for Psoriasis patients. Advancement in technology will continue improving biologic drugs’ quality, offering a better opportunity for patients to recover from the dreadful disease. The response to biologic drugs, safety, and effectiveness of biologic drugs can never be compared to the cost incurred in acquiring biologic drugs. NHS should continue contributing to the research for biologic medicines even in the treatment of other disease conditions. Biologic is the next drug that will assist in fighting chronic conditions such as Psoriasis and lung cancer.

References

“Mental Health Spending In The English NHS.” Full Fact, 2020, https://fullfact.org/health/mental-health-spending-england/.

“NHS Releases Commissioning Framework For Biologics, Biosimilars.” Center For Biosimilars, 2020, https://www.centerforbiosimilars.com/news/national-health-service-releases-commissioning-framework-for-biologics-biosimilars

Bahner, Jennifer D., Lauren Y. Cao, and Neil J. Korman. “Biologics in the management of psoriasis.” Clinical, cosmetic and investigational dermatology: CCID 2 (2009): 111.https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3047928/

Blauvelt, Andrew, et al. “Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study.” Journal of the American Academy of dermatology 76.1 (2017): 60-69.https://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.12751

Campanati, Anna, et al. “Biologic therapy in psoriasis (Part I): efficacy and safety of tumor necrosis factor-α inhibitors.” Current pharmaceutical biotechnology 18.12 (2017): 945963.https://www.ingentaconnect.com/content/ben/cpb/2017/00000018/00000012/art00003

Egeberg, A., et al. “Safety, efficacy and drug survival of biologics and biosimilars for moderate‐to‐severe plaque psoriasis.” British Journal of Dermatology 178.2 (2018): 509-519. https://portal.findresearcher.sdu.dk/files/129514114/Safety_efficacy_and_drug_survival_of_biologics_and_biosimilars_for_moderate_to_severe_plaque_psoriasis.pdf

England, NHS. “NHS England » Funding And Efficiency.” England.Nhs.Uk, 2020, https://www.england.nhs.uk/five-year-forward-view/next-steps-on-the-nhs-five-year-forward-view/funding-and-efficiency/.

England, NHS. “NHS England » NHS Set To Save £150 Million By Switching To New Versions Of Most Costly Drugs”. England.Nhs.Uk, 2020, https://www.england.nhs.uk/2018/10/nhs-set-to-save-150-million-by-switching-to-new-versions-of-most-costly-drug/.

England, NHS. “NHS England » NHS Set To Save Record £300 Million On The NHS’S Highest Drug Spend”. England.Nhs.Uk, 2020, https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/.

Ewbank, L., et al. “The Rising Cost of Medicines to the NHS: What’s the Story? King’s Fund; 2018.”https://www.kingsfund.org.uk/publications/rising-cost-medicines-nhs

Gordon, Kenneth B., et al. “Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomized, placebo-controlled and ustekinumab-controlled phase 3 trials.” The Lancet 392.10148 (2018): 650-661. https://dl.uswr.ac.ir/bitstream/Hannan/80416/1/2018%20Lancet%20Volume%20392%20Issue%2010148%20August%20%2815%29.pdf

Kaushik, S. B., & Lebwohl, M. G. (2019). Psoriasis: which therapy for which patient: focus on special populations and chronic infections. Journal of the American Academy of Dermatology80(1), 43-53.https://www.jaad.org/article/S0190-9622(18)32214-X/full text

Kuchar, Ashwin B., et al. “Psoriasis: A comprehensive review.” International Journal of pharmacy & life sciences 2.6 (2011).https://d1wqtxts1xzle7.cloudfront.net/53443952/12.pdf?1496995552=&response-content-disposition=inline%3B+filename%3DINTERNATIONAL_JOURNAL_OF_PHARMACY_and_LI.pdf&Expires=1592508473&Signature=U9w9dfRVa-sif3Jbj7g1p2bX-lQKWdQ60rzBriFF0EDLtKcjkJ~oKsAmwVVn3493xfezZzWJbLTutEu1nP1Q5lIrKi5OFTRQmVikoRDsv0S68-srEqus8bo~aq4XTJcUn5wX4606xFi75sifRcqvtnGD0-CEAtIe-WL~qg-b1xMavPVSe47a-4baSflkTe~-QOJ6LPpT6PFV7Aups4N9dyGCtjRzxcQYv51MpwLXnoPR9bZwGI1~U66H-NdTjYxHwBmxA~1r~c6wTpRbTbEY-h1CPfU32H2heA-X9afW4fkFmt5GX~HYtaqaXAQJEKQ9zuLQWBYGGC0IgaIahzHFqQ__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA

Ling, T. C., et al. “British Association of Dermatologists and British Photodermatology Group guidelines for the safe and effective use of psoralen–ultraviolet A therapy 2015.” British Journal of Dermatology 174.1 (2016): 24-55. https://onlinelibrary.wiley.com/doi/pdf/10.1111/bjd.14317

Mease, Philip J., et al. “Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis.” New England Journal of Medicine 373.14 (2015): 1329-1339.https://www.nejm.org/doi/pdf/10.1056/NEJMoa1314258

Paul, C., et al. “Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).” Journal of the European Academy of Dermatology and Venereology 29.6 (2015): 1082-1090.https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.12110

Price, W., I. I. Nicholson, and Arti K. Rai. “Manufacturing barriers to biologics competition and innovation.” Iowa L. Rev. 101 (2015): 1023. http://repository.law.umich.edu/cgi/viewcontent.cgi?article=2826&context=articles

Raut, Ashlesha S., Rashmi H. Prabhu, and Vandana B. Patravale. “Psoriasis clinical implications and treatment: a review.” Critical Reviews™ in Therapeutic Drug Carrier Systems 30.3 (2013).http://www.dl.begellhouse.com/journals/3667c4ae6e8fd136,2c11cd7727222f89,64d3fc8d3f7104bb.html

Reddy, Vidhatha, et al. “Psoriasis Vulgaris Successfully Treated with Goeckerman Treatment at Home: A Patient and Physician’s Experience.” Dermatology and therapy (2020): 1-10. https://link.springer.com/content/pdf/10.1007/s13555-020-00364-0.pdf

van den Bemt, Bart JF, et al. “A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience.” Drug delivery 26.1 (2019): 384-392. https://www.tandfonline.com/doi/pdf/10.1080/10717544.2019.1587043

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