Managed Care Aspects of Psoriasis and Psoriatic Arthritis

The chronic and systemic nature of psoriasis has a significant impact on direct costs, indirect costs, and patient quality of life. Psoriasis is associated with comorbid conditions that add to the burden of the disease, especially in moderate to severe disease. The total estimated annual healthcare burden of psoriasis may be as high as $35.2 billion, with $12.2 billion in direct costs and $23 billion in indirect costs (attributed to reduced health-related quality of life and lost productivity). These costs vary based on the severity of the disease; pharmacy costs account for the majority of the burden, especially in severe disease. Biologic therapies are largely responsible for the pharmacy costs. Approval of biosimilar products in the near future may ease some of this burden for payers and patients, although new agents have also been recently approved, with more in the pipeline.

The healthcare costs of psoriasis management substantially increase with comorbid conditions, such as heart disease, hyperlipidemia, hypertension, diabetes, and lung disease. These comorbidities also include psychiatric conditions, such as social stigmatization, depression, and suicide. The overall costs associated with comorbidities are estimated to be an additional $22,713 per patient per year. Appropriate treatment selection and timing may curtail the progression of psoriasis, and, as a result, can decrease the economic burden. As treatment options vary based on comorbidities, long-term remission goals, and medication costs, conducting a comprehensive patient assessment is imperative. Drug utilization reviews steered by specialty pharmacists may help reduce costs and improve outcomes by providing treatment monitoring and patient education.

Am J Manag Care. 2016;22:S238-S243

Psoriasis vulgaris, commonly called psoriasis, is a systemic and chronic immunemediated disorder that is characterized by scaly, erythematous patches, papules, and plaques that are often pruritic.¹ Psoriasis is not solely a cosmetic problem. Patients with severe psoriasis die an average of 4 years earlier than controls, with a 50% greater risk of early death (likely due to comorbidities).² The disfiguring and potentially painful patches resulting from psoriasis can significantly impact quality of life.¹ Psoriasis is associated with various comorbidities, significantly adding to the disease burden, especially in moderate to severe disease.³ Available treatment modalities for psoriasis include traditional topical and systemic treatments, newer biologic and biosimilar agents, and phototherapy.

Innovations in treatment options may help expand the armamentarium available for patients with psoriasis and provide greater efficacy with more tolerable adverse effects (AEs). However, the costs of new medications are typically high. One systematic review of 2013 costs reported that the estimated total cost burden of psoriasis was $35.2 billion, with $12.2 in direct costs and $23 billion in indirect costs (from reduced health-related quality of life and lost productivity).⁴ These costs may be even higher; another systematic review of 2013 costs reported direct costs of $51.7 billion to $63.2 billion and indirect costs of $23.9 billion to $35.4 billion.⁵

Understanding the Economic Impact of Psoriasis

New and emerging therapeutics, especially in the case of biologic therapeutics, have undoubtedly improved the treatment paradigm because of their increased clinical efficacy. However, these medications are also associated with increased healthcare resource utilization and immediate costs.^3-6

Costs of Psoriasis

A systematic review of selected peer-reviewed articles (N = 91), published between January 2003 and June 2013, examined the clinical, economic, and/or social burdens of psoriasis in the United States. The annual incremental per-patient healthcare cost to payers was estimated to be $1757.4 This did not include the estimated out-of-pocket costs of $527 per patient per year.

Those with mild disease made up 83% of the population of patients with psoriasis. However, because the treatment modalities recommended are substantially different based on severity, it is important to differentiate between patients with limited disease and those with extensive disease.^1,3 The cost amounts varied substantially based on disease severity; total healthcare costs ranged from an average of $1820 for mild disease to $9733 for moderate to severe disease. Accounting for 43% of the cost, outpatient costs were the largest source of expense for treatment of mild disease. Pharmacy costs, which were 10 times greater for moderate to severe versus mild disease, accounted for almost 64% of costs for patients in this population.⁴

from $8705 to $15,236 and $12,505 to $14,257, respectively. The increased expense for infliximab was attributed to treatment infusion costs (an additional $1013). Cost estimates at 1 year assumed continuous use over the course of a year, although this may not always occur in clinical practice. Taking this into account, infliximab was more cost efficacious over a year (range of $1667 to $2138). Figure 16 shows the total medication costs per treatment period over 1 year.⁶ Although this analysis of costs was thorough in its inclusion of all available systemic therapies, it did not take into consideration the impact of potential AEs, comorbidity risk reduction, and combination treatments.

Direct Costs of Psoriasis Comorbidities

Psoriasis is not limited to the skin; immune dysregulation and resulting inflammation of psoriasis affects many body systems, and the disease is associated with multiple comorbid conditions, including psoriatic arthritis (PsA), heart disease, stroke, and diabetes.^1,7 Psoriasis and its comorbidities impose considerable economic burden. Although the exact cost burden is defined differently

by various sources, the numbers are staggering. In a systematic review of the annual national burden of psoriasis, including related comorbidities, the cost was estimated at $112 billion in 2013 US dollars.⁵ Estimates were derived by identifying studies that assessed direct, indirect, intangible, and comorbidity costs of US adults with psoriasis: medical comorbidities contributed $36.4 billion annually, and over a lifetime, a patient with psoriasis would pay $11,498 out of pocket for relief of physical symptoms and emotional health.⁵

(15.8% vs 9.7%), and lung disease (9.2% vs 6.2%). Patients with psoriasis were more likely to have any medication filled (98.8% vs 76.6%, psoriasis vs control, respectively; odds ratio [OR], 27.5), including antidiabetic drugs (11.3% vs 6.8%; OR, 1.7). They also incurred significantly greater all-cause medical service utilization, as well as greater corresponding costs (Figure 2³). Patients with

psoriasis had higher annual total healthcare costs per patient ($22,713 vs $4993; adjusted cost difference [ACD], $18,960; P <.001) than the control group. This was led by significantly higher all-cause medication costs ($14,698 vs $1101; ACD, $13,990; P <.001), the majority of which were attributed to treatment costs for systemic psoriasis therapies ($12,958) that included biologics, nonbiologic agents, and phototherapies (Figure 3³).³ A similar study was conducted comparing patients with psoriasis and PsA (N = 1230) to psoriasis- and PsAfree matched controls (N =1230), and the results were similar. Patients with moderate to severe psoriasis and PsA had a higher prevalence of comorbidities, healthcare utilization, and costs than matched controls. Patients with psoriasis plus PsA had significantly more related comorbidities than controls, with the 3 most common being hypertension (35.8% vs 23.5%, respectively; OR, 1.9), hyperlipidemia (34.6% vs 28.5%; OR, 1.3), and diabetes (15.9% vs 10.0%; OR, 1.6) (P <.0001 for all comparisons). Compared with controls, patients with psoriasis plus PsA were also more likely to have inpatient admissions (OR, 1.6), emergency department visits (OR, 1.3), and outpatient visits (OR, 62.7) (all P <.05). The adjusted annual cost differences per patient were $23,160 higher for total costs; $17,696 higher for pharmacy costs; and $5077 higher for medical costs for patients with psoriasis plus PsA than for controls (all P <.01).⁸

Indirect Medical Costs

In terms of loss of productivity and decreased quality of life, psoriasis imparts a profound economic impact on patients, payers, and employers.^4,5,9-11 A National Psoriasis Foundation survey from 2003 to 2005 of adults older than 30 years found that an adult with psoriasis lost an average of 26 days of work a year due to their illness.⁹ Those with severe psoriasis were less likely to work full time, and were significantly more likely to report psoriasis as the reason for not working than patients with mild psoriasis (P = .01). Those with severe disease were also significantly more likely to have an income lower than $30,000 compared with patients with mild disease (P = .0002).

The social burden of psoriasis in the United States, in terms of productivity loss related to presenteeism (working while sick), was estimated at $4.4 billion annually in a systematic analysis of peer-reviewed articles published between January 2003 and June 2013. In addition, an estimated 16.7% of patients with psoriasis are unemployed because of their disease; this results in estimated lost productivity due to unemployment of $700 per patient and a total of $4 billion annually. The aggregated productivity losses caused by psoriasis (including presenteeism, absenteeism, and unemployment) were $11.2 billion.⁴

As with direct costs, these numbers go up substantially when the cost of comorbidities are considered. Another systemic review of studies published between 2008 and 2013 found the estimated indirect costs of psoriasis (absenteeism and lost productivity on the job due to psoriasis and/or its comorbidities) to be upwards of $4000 per person annually (2013 dollars).⁵

Impact on Quality of Life

Psychiatric comorbidities are important among dermatology patients because dermatologic ailments have a substantial impact on body image, a major contributor to depression and suicide. Of the major dermatologic disorders that can be cosmetically disfiguring, patients with psoriasis with extensive disease and residing in an institution had the highest rate of depression—8.9% of outpatients and 10.3% inpatients answered yes to the question, “I often wish I were dead.”¹⁰ Low quality of life among patients with psoriasis has repeatedly been seen using the Dermatology Life Quality Index.^4,12,13 In a recent US survey of dermatologists and patients, increasing severity of psoriasis was associated with increased symptoms, including pain, reduced quality of life, decreased work productivity, and greater impairment.¹² Patients with psoriasis have also demonstrated

significantly lower levels of self-esteem and higher levels of anxiety, loneliness, and social isolation than patients without psoriasis.¹³ Unfortunately, these psychosocial issues are often under-recognized in patients with the condition. The feelings of depression, suicidal tendencies, and social stigmatization associated with psoriasis should not be trivialized; they should be addressed in a professional setting with appropriate referrals and, when necessary, pharmacotherapy.¹¹ Depression symptoms correlate with PASI scores; clinical improvement of the skin is associated with improved depression.^14,15 Quality of life symptoms are often difficult to quantify in economic terms; however, using conservative values for quality-adjusted life-year values, it is estimated that patients with psoriasis experience a $2203 reduction in quality of life per patient per year, accounting for $11.2 billion annually.⁴

Impact of Payment and Reimbursement on Treatment Selection

The development of biologic therapies has dramatically affected the treatment of many chronic diseases, including psoriasis.^16,17 Managed care organizations are continuously debating the appropriate use of these injectable drugs because of the associated acquisition costs and administration requirements.¹⁷ Important considerations from a managed care perspective include the ability to produce off-treatment remissions, the ability to improve patients’ quality of life, safety and tolerability profiles, and the availability of biosimilars.

Role of Treatment Selection

Appropriate treatment selection and timing may curtail the progression of disease; as a result, the economic burden decreases. As treatment options vary based on the individual patient profile, reviewing the patient’s complete profile is imperative. The selection process must also consider not only the effects on the joints and cutaneous symptoms, but also on the comorbidities. In addition, treatment options for patients experiencing psoriasis versus psoriasis plus PsA may differ.

PsA has the potential to result in irreversible, lifelong deformities of the hands and other joints. These patients are at higher risk for developing comorbidities; therefore, they may require more careful selections. Longterm remission goals must be taken into account, as they may overwhelm short-term costs. For example, although MTX and cyclosporine are the most cost-effective pharmacotherapies, their potential toxicities may limit their long-term use.⁶ The patient’s economic standing should also be considered. Many of the treatment options for psoriasis are cost-prohibitive for patients with private insurance, based on their co-pay; however, the same medication may cost $0 for patients receiving support from Medicaid.

Proactive Disease Management Drug utilization reviews (DURs) conducted by managed care professionals and led by specialty pharmacists can maintain costs by monitoring patient data, ensuring open communication between healthcare providers, and providing educational interventions.¹⁸ The complexity of psoriasis and PsA treatment includes disruptions in therapy (dose escalations, dose reductions, switches discontinuations, and restarts), which tend to result in increased overall costs. These disruptions may be curtailed through increased healthcare provider communication through a DUR.¹⁹ A retrospective DUR may help change prescribing habits and optimize future drug utilization. Pharmacist-initiated DUR interventions have demonstrated effectiveness in targeted educational initiatives

on guidelines, treatment options and protocols, and cost management.^18,20,21 One retrospective analysis of a DUR found that use of automated reminders to physicians about the requirement of prior laboratory testing—based on a drug’s package insert&mdash;curtailed use of the agent in inappropriate patients and improved physician prescribing behavior for the targeted agent.²² When evaluating

cost in these situations, it should be considered that the most severely affected patients may also require the most expensive or creative care.

Role of Biosimilars In 2009, Congress passed the Biologics Price Competition and Innovation Act of 2009 as part of the Affordable Care Act (ACA). Biosimilar agents are similar, but not structurally identical, to a biologic therapy (the reference product). The intent of the law was to establish a balance between innovation and consumer needs and interests.²³ The law gave the FDA latitude to define the process and standards it uses in approving a drug and to create an abbreviated pathway for approval of biosimilar agents. However, unlike generic products, biosimilar products still have to show clinical trial data for product safety, efficacy, and purity. The difference in the manufacturing processes for biosimilars and the cost of implementing clinical trials makes development of biosimilars more expensive than generic products. Estimates for developing a biosimilar are around $100 million over a 5- to 6-year period compared with $2 to $5 million for a generic drug within 3 years.¹⁶ Although the constraints of clinical trials and theexpense of the manufacturing process will make costs ofbiosimilars higher than those of generic treatments, they will still remain substantially lower than biologic agents.¹⁶ Currently, biologic agents, although effective, are expensive and responsible for a significant portion of the cost of psoriasis and PsA treatment. Patents for some biologics used to treat psoriasis are due to expire over the next few years, and it is expected that the biosimilars that will subsequently enter the marketplace will reduce treatment costs associated with the biologics.

Because of the administrative resources needed for dosing and administration of biologics, the payment algorithm for these products within the ACA ensures that reimbursement for physicians is the same regardless of the product they prescribe.¹⁶ However, the government and patients do benefit from the reduced pricing of biosimilars. The Congressional Budget Office estimates that biosimilars could result in $25 billion in savings from 2010 to 2020.²⁴ However, a recent report in the Wall Street Journal suggests that the cost savings may be much less than predicted. Insurers, drug benefit managers, and pharmaceutical industry consultants report that pharmaceutical manufacturers have been increasing the price of biologic therapies about to lose patent protection sometimes 2 to 3 years in advance. Manufacturers of biosimilars are planning on setting the price of these medications just below that of the reference product.²⁵ Medicare Part B recently announced a pilot program in certain parts of the country to look at lowering the amounts doctors are paid to administer medications in the office. Currently, Medicare pays doctors the average price of a drug plus 6%, which is thought to incentivize the use of more expensive drugs.²⁶ The program would reduce the 6% add-on to 2.5% plus a flat fee of about $16. This may affect some biologics for psoriasis, such as infliximab, which are administered by the physician.

Conclusion

The substantial direct and indirect costs related to psoriasis and its comorbidities make the cost versus benefit ratio an important consideration in treatment. Although the cost of systemic treatments is increasing (at a much higher rate than inflation),²⁷ the cost of biologic therapies may put effective treatment outside of the reach of many privately insured patients.⁶ The availability of

biosimilars may somewhat help reduce this burden on patients. However, the keys to effective management of psoriasis are understanding the role of comorbidities, AEs, and quality of life in the overall cost of treatment, and ensuring long-term remission be taken into account when making decisions based on costs.

A more extensive study of treatment costs for moderate to severe psoriasis assessed the cost efficacy of currently approved systemic medications by standardizing each therapy based on stimated cost per number needed to treat to achieve a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Methotrexate (MTX), cyclosporine, and acitretin required more frequent office visits than phototherapy, as well as more frequent office visits and laboratory costs than biologic medications.⁶ On a monthly basis, MTX was the least expensive treatment modality to achieve PASI 75, with adjusted monthly costs of $794 to $1503. Considerable variability was observed for the adjusted monthly costs across different studies of the same medications, especially for acitretin, for which the adjusted cost/PASI ranged from $4138 to $14,149, with 34% of patients achieving PASI 75. Infliximab and ustekinumab 90 mg were the most expensive, with adjusted monthly costs ranging To understand the full impact of psoriasis and its comorbidities on cost, records over a 5-year period from the OptumHealth Reporting and Insights claims databases were reviewed. A total of 5492 matched pairs of patients with moderate to severe psoriasis and controls were compared for the prevalence of comorbidities, healthcare resource utilization, and costs. Patients with psoriasis were significantly more likely to have comorbidities than the control patients. The 4 most common comorbidities were hyperlipidemia (33.3% vs 27.3%, respectively), hypertension (32.8% vs 23.5%), iabetes

Author affiliation: Evans Dermatology Partners, Austin, Texas.

Funding source: This activity is supported by educational grants from Lilly and Novartis.

Author disclosure: Dr Evans has disclosed being a volunteer board member for the National Psoriasis Foundation, being a consultant to Celgene; receiving honoraria from About.com, Celgene, and Cigna; and being on speakers’ bureaus for Abbvie and Celgene.

Authorship information: Concept and design, analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for important intellectual content.

Address correspondence to: drevans@evans-dermatology.com.

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