Severe psoriasis and it's   		treatments
                   North American phaymacotherapy Journal,  6/2/04 10:53 page 187  
                       
                    psoriasis is a common chronic skin condition that is not well understood   		outside the sphere of dermatology. It is a complex immune disease that   		manifests itself in the skin and joints. While psoriasis can present   		itself in many ways, three characteristic components of psoriasis   		lesions are erythema (redness), induration (thickness), and scale. The   		inciting event or etiology for psoriasis is unknown, although, like many   		diseases, there is likely to be interplay between specific genetic and   		environmental factors. 
                   psoriasis should not be thought of simply as a disease of the skin with   		little import on health. Psoriasis poses as much if not more of a threat   		to quality of life than other common major medical conditions. The   		lesions may be itchy and sore and may bleed. There are effects on every   		dimension of the patients  quality of life, including home, social, and   		work facets. Patients with psoriasis are commonly depressed and thoughts   		of suicide are not uncommon in severe cases. Psoriasis of the palms,   		soles, or other areas critical to functioning may disable the patient. 
                   For treatment purposes, psoriasis patients generally fall into one of   		two categories: those with a localized disease; and those with a more   		severe or generalized disease. For localized psoriasis, patients are   		treated with topical agents. About 15% of patients with psoriasis have a   		severe disease; these patients receive ultraviolet, light therapy   		(phototherapy) or systemic drugs. Furthermore, concurrent inflammatory   		arthritis, or  
                    psoriatic arthritis, is present in greater than 30% of psoriatics and   		can be disabling and deforming. The presence of significant arthritis   		necessitates systemic treatment in order to prevent permanent loss of   		function.  
                   The traditional treatments for severe psoriasis are not ideal. Office   		phototherapy is very inconvenient, as patients need to come in for   		visits three to five times per week   a significant disruption to work   		schedules. Phototherapy increases the risk of skin cancer, and not all   		psoriasis patients respond to the light. Systemic treatments include   		methotrexate and cyclosporine, immune suppressants that are associated   		with liver and kidney toxicity respectively. Patients with severe   		psoriasis have been almost uniformly dissatisfied with their treatment.  
                   The past 10 years have been a time of unprecedented growth in the   		psoriasis arena. The knowledge base has been expanded as both underlying   		immune mechanisms are better understood, the impact of psoriasis on   		quality of life has been elucidated, and new treatments have become   		available. Still, no cure is yet available and there are somewhere   		between four and seven million people suffering from psoriasis in the   		US.  
                   An improved understanding of immune mechanisms has led to targeted   		biologic treatments for psoriasis. These medications include humanized   		antibodies, soluble cytokine receptors, and unique fusion proteins. They   		must be administered by injection, as proteins would be digested if   		taken orally. Because of the specificity of these agents for the immune   		system, they offer some safety advantages over current systemic agents   		that cause liver or kidney toxicity. They may have efficacy advantages   		as well.  
                   
                   The first of the biologics   		approved to treat psoriasis is alefacept (Amevive). This drug targets   		the activated memory T cells that cause psoriasis inflammation. The   		second agent approved to treat psoriasis is efalizumab (Raptiva).  It blocks the movement of immune cells trying to cause psoriasis.  Etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira) are  
					tumour necrosis factor alpha (TNF) inhibitors, FDA-approved for the  treatment of rheumatoid arthritis. Of these, Enbrel is approved to  treat psoriatic arthritis, but all biologics are likely to be effective  for the skin lesions of psoriasis as well as joint disease.  
                   The development of these new   		agents represents the start of a new era in dermatology. Dermatologists   		are excited by the improvements they are seeing in truly debilitated   		patients who were previously resistant to all attempts at controlling   		their disease. Seeing patients with thick, red, scaling, cracking,   		bleeding lesions over much of their body suddenly clear with biologic   		treatment is extraordinarily gratifying for all involved. 
                   patients with extensive   		disease, with or without joint involvement, may suddenly feel a new   		level of energy and life as the inflammation clears from their body.   		There are reports of practically bed-bound patients becoming 
					dermatology   		active again after starting therapy with these new agents. Such   		treatment does not come cheap. The cost of bringing such biologic   		therapies to market is substantial, and these medications range in cost   		from approximately US$15,000 to US$30,000 per patient per year. This is   		considerably higher than for traditional treatments such as methotrexate   		(approximately US$2,000 a year) and phototherapy (US$3,000 a year).   		Nevertheless, these new biologic treatments are an important advance for   		those patients who fail traditional treatments, those who are not   		candidates for traditional treatments, and those who wish to avoid the   		risks and inconveniences of traditional approaches. Dermatologists are   		not unaware of the implications of high-cost treatments. As small   		business people who pay for the healthcare insurance of their employees,   		they are acutely aware of the rising cost of healthcare. As psoriasis   		affects about 2% of the population and 15% of psoriasis patients have a   		severe disease, treating these patients with a US$16,000-per-year drug   		would add about US$32 a year to everyone s healthcare bill, and that is   		just for psoriasis.  
                   perhaps surprisingly, prior   		authorization of biologics is not likely to be of much value, as it is   		unlikely that a dermatologist (generally a very conservative group of   		physicians) would prescribe a biologic treatment for a patient who does   		not need it. Onerous prior authorization requirements cause unnecessary   		frustration for physicians, cause patients to suffer needlessly, and   		create an environment of antagonism between healthcare providers and   		healthcare payers. If prior authorization is used at all, a rapid,   		simple determination of eligibility can be made based on the severity of   		the disease and the response to or suitability of alternative   		treatments. 
                   For those patients who truly   		need a biologic treatment, the cost is not unreasonable. Once the   		decision has been made to cover a biologic treatment, it is probably   		wise to give physicians the choice of the most effective agent, rather   		than limit that choice to products with an FDA-approved indication for   		psoriasis. No one benefits from patients receiving a less effective   		biologic treatment when a more effective treatment is available. If the   		insurer is going to cover a US$16,000 per year treatment, it does not   		benefit them to limit the choice to a less effective, FDA-approved   		treatment if there is a more effective agent available at similar cost,   		regardless of the FDA-approved indications of the latter.  
                   Healthcare systems do need to address the potential high costs of new   		psoriasis treatments. Psoriasis patients pay the same premium as other   		patients and deserve treatment for their severe disease. At the same   		time, healthcare systems should work to limit the biologic treatments to   		those patients who are appropriate candidates: patients with extensive   		psoriasis (greater than 5% to 10% body surface area affected) and those   		who are disabled by their disease (for example by painful palm or sole   		involvement or by facial or genital involvement unresponsive to topical   		treatment). Healthcare systems should encourage use of less expensive,   		safe, and effective therapies. As a first step, healthcare systems   		should eliminate impediments to lower cost traditional treatments. For   		example, phototherapy is quite effective for most severe psoriasis, yet   		healthcare systems have discouraged its use through low provider   		reimbursement and high co-pays required by subscribers. Many   		dermatologists stopped offering phototherapy, in part because of low   		compensation rates, but primarily because managed care systems   		discouraged patients from choosing these treatments patients who are   		required to pay a US$10 30 co-pay for each phototherapy visit are   		generally dissuaded from this treatment. This exposes payers to   		substantially greater costs for biologic treatment.  
                   Phototherapy reimbursement   		rates should be increased to encourage more physicians to offer this   		treatment option to psoriasis patients. The phototherapy procedure and   		the number of visits required is more than enough of a deterrent to   		limit overuse by patients. Co-pays for phototherapy should be   		eliminated; indeed, it probably would make more sense for payers to   		encourage patients to undergo phototherapy by covering their   		out-of-pocket expenses in order to further reduce payers exposure to   		US$15 30,000/year biologic treatments. Moreover, patients treated with a   		course of office phototherapy may be able to maintain control of their   		disease nearly indefinitely with continued use of a home UV treatment   		device. At a one-time cost of US$2,000 for such a machine, these devices   		are a relative bargain maintenance therapy for psoriasis. Insurers (and   		the companies that contract with these insurers) should be grateful for   		the opportunity to cover the cost of these units given the alternative,   		yet, all too often, these devices are not covered by payers (or the   		contracting employer) who do not understand the implications of severe   		psoriasis and its treatment. 
                   Psoriasis is a serious   		disease requiring serious treatment. New biologic agents are a major   		advance for the subset of psoriasis patients with severe disease that   		cannot be safely managed with traditional treatments. At the same time,   		traditional treatments, particularly phototherapy, offer many patients a   		safe, effective, and cost-effective approach to control their disease.   		payers can encourage use of these treatments, and such measures will   		help reduce overall exposure to high-cost medications while improving   		patients  access to effective and safer options.  
                   Here we have compiled some useful information for psoriasis   	patients. If you have recently been diagnosed you may find this information   	helpful in understanding psoriasis and your treatment options. 
				   
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