Abstract
Aim: Psoriasis is a chronic inflammatory skin disease that requires treatment to manage co-morbidities and improve patient quality-of-life. This study estimated the budget impact to National Organization for Health Care Services Provision (EOPYY) of changing reimbursement of psoriasis treatment with topical and systemic, non-biologic, agents (75%) to bring it on par with that of biologic agents (100%) in Greece.
Methods: The Business Intelligence database of EOPYY was used to identify and provide analytics on patients with plaque psoriasis. Permission for use of anonymized data was obtained by the administration of EOPYY. EOPYY is responsible for funding healthcare and pharmaceutical care services for ∼95% of the permanent population in the country. Pre-defined ICD-10 codes were applied to identify patients with plaque psoriasis and at least one reimbursed prescription between 1 June 2014 and 31 May 2015. Age, gender, medications, and cost were recorded for these patients.
Results: Of the 45,581 unique patients identified through completely anonymized data on the e-prescription system, 72% were on treatment with topicals only and accounted for 5% of EOPYY psoriasis expenditure. Another 9% of patients were on methotrexate or a per os (POS, orally administered) systemic agent and accounted for 2.35% of total expenditure. Approximately 12% of total patients were on treatment with a biologic-containing regimen and accounted for almost 90% of psoriasis expenditure. Patients on biologics were younger than patients on topical and systemic treatments. The burden to EOPYY of adjusting reimbursement levels for topical and systemic, non-biologic, treatments to 100% of their cost was estimated at €2.05 per patient per month for topical treatments (monotherapy) and an additional €9.5 per patient per month for treatment with methotrexate, POS systemic agents, and their combinations with topical agents. This additional cost is expected to be offset by averting 200 earlier than clinically necessary switches from topical and systemic, non-biologic, treatments to expensive biologics a year.
Conclusion: In circumstances of severe funding constraints for social health insurance in Greece, bringing patient copayment levels for psoriasis treatment on par with each other may aid proper clinical management of the condition, whilst achieving adequate treatment outcomes at optimal cost.
Introduction
Psoriasis is a chronic, inflammatory, immune-mediated skin disease, which is influenced by genetic as well as environmental factorsCitation1. It carries a substantial mortalityCitation2,Citation3 and morbidityCitation4–8 burden, together with an increasing economic burden for healthcare systemsCitation9,Citation10. The most frequent type of psoriasis among adults is plaque psoriasis (80%–90%)Citation11,Citation12. Data and analysis in this paper refer to plaque psoriasis.
Psoriasis is estimated to affect 2–4% of the population in the western world or ∼125 million peopleCitation13. Psoriasis prevalence ranges from 0.91% of the population in the USCitation14 to 8.5% in NorwayCitation13.
Psoriasis is most commonly treated with topical treatments, phototherapy, systemic, non-biologic (hereafter referred to as systemic) treatments and treatment with biological agents, alone or in combination with other options. Biologics are much more expensive than topical and systemic treatments and, therefore, usually restricted for use after failure on other agents.
Nonetheless, in Greece, there are no prescription guidelines in place to restrict use of biologic agents to after failure on other agents, and physicians are relatively free to select the clinically appropriate treatment option for the patient. Reimbursement for pharmaceutical treatments for psoriasis differs substantially between treatment options. Treatment with topical and systemic agents is reimbursed at 75% of the price of the lowest price generic available in the same therapeutic (ATC4 level) category and the patient has to pay the remaining 25% of the cost as well as any difference between the price of his therapy and the price of the generic (reference price) out of his pocket. Conversely, treatment with a biologic agent is reimbursed at 100% of the cost. This reimbursement practice provides substantial financial incentive for starting treatment with a biologic, even in cases where such clinical practice may be too forthcoming.
This practice may get a patient on treatment with biologics early, and clinical practice in Greece shows he/she is unlikely to discontinue biologics in the future. On the contrary, the patient may continue switching between biologics-containing treatment options, potentially even limiting his or her available options in case of non-responsiveness or relapse in the long-term.
Equally, EOPYY (National Organization for Health Care Services Provision), which is responsible for funding healthcare and pharmaceutical care services for ∼95% of the permanent population in the country, will continue to reimburse in full the cost of more expensive biologics, eventually for the lifetime of the patient.
This paper discusses a potential strategy for EOPYY to change reimbursement levels for first and second line treatment options for plaque psoriasis to bring them on par with each other at 100%. It specifically examines the value of changing reimbursement levels for treatment with topical and systemic agents from the current 75% rate to 100%. It also discusses the framework within which such an adjustment should be made, supported by prescription guidelines, treatment protocols, and, potentially, a patient registry that would allow the implementation of evidence-based, integrated disease management to optimize outcomes, clinical and economic.
The alternative strategy, i.e. of introducing a co-payment level of 25% for biologic agents, has been ruled out due to its expected impact on access as well as long-term compliance to treatment for psoriasis patients, who actually require treatment with biologics. As biologics are a far more expensive treatment option, the introduction of cost sharing on them may impact patient ability to pay in the long run, thus potentially ‘punishing’ patients in need of treatment.
Methods
This is a restrospective, observational study based on EOPYY’s anonymized health administrative data. The Business Intelligence database of EOPYY was used to provide analytics on individuals (date of birth and gender), based on the unique citizens’ social security number (AMKA). Eligibility criteria included unique patients, who had received at least one reimbursed pharmacotherapy through the e-prescription system for pre-defined ICD-10 codes (L40, L.40.0, and L 40.9). The study period was determined to maximize population coverage and quality of data, since nearly 95% of the Greek population was registered in the EOPYY database by June 2014. To avoid double counting, each unique patient AMKA was matched to the most frequently reported pre-defined psoriasis ICD 10 code for the period under study.
Patient demographics (age and gender), type and number of treatments administered for plaque psoriasis (anti TNF-a agents, other biologics, topicals, methotrexate and orally administered treatments) and costs per treatment option were retrieved from the database.
Total and average per AMKA treatment cost to EOPYY was calculated per pharmacotherapy option and patient age group. The additional burden to EOPYY of bringing pharmacotherapy reimbursement levels for topical, systemic, and biologic agents to par was also calculated by pharmacotherapy option.
This analysis excludes treatments purchased out of pocket by patients (particularly low cost topical or systemic POS treatments) or pharmaceuticals included in the negative list and, therefore, not reimbursed by EOPYY.
It is, thus, possible that the analysis under-estimates the total number of psoriasis patients currently on treatment and constitutes a conservative, or base-case scenario for future analysis.
Results
Of the 45 581 unique patients receiving reimbursed pharmaceutical care for plaque psoriasis (ICD10 L40, L40.0, and L40.9), 24 045 (52.75%) were men and 21 536 (47.25%) were women. The majority of patients (20.06%) were 55–60 years old, followed by the 45–54 age group and the 65–74 age group ().
Table 1. Age group distribution of psoriasis patients by sex.
The majority of these patients (82.3%) are on topical treatments. In total, 32 859 patients or 72% of the total are on a topical treatment as monotherapy and another 4715 patients (10.3% of total) are on a combination that includes a topical agent; 3123 patients (6.9% of total) are on a biologic agent as monotherapy and an additional 2101 patients (4.6% of total) are on a biologic plus at least one other treatment. Less frequent are treatments with POS systemic agents (2455 patients or 5.38% of total and an additional 3116 or 6.8% of total on a combination containing a POS systemic agent) ().
Table 2. Distribution of patients by pharmacotherapy option.
Of the total of patients on topicals-containing treatments (37 574), a mere 12.5% is on combination treatment with another pharmacotherapy. Of the total of patients on biologics-containing treatments (5224), 40.2% is on a combination treatment that includes at least one additional agent (). Patients on combination treatments including at least one POS systemic agent account for 56% of the total of patients on POS systemic treatments.
The overall patient age distribution presented in is confirmed for patients on topical agents (). Almost 20% (19.6%) of patients on topical treatment for psoriasis are aged 55–64 years old, 18.4% are aged 65–74 and 17.8% are aged 75+ years old. Equally, the majority of patients on methotrexate are aged 55–64 (22.9%) and 65–74 (24.2%).
Table 3. Patient distribution per pharmacotherapy option and age group.
On the contrary, patients on treatments containing biologics are much younger. One in four patients on biologics-containing treatments (25%, 1320 patients of a total of 5224) is aged 45–54 and one in five (20.7%, 1083 patients of a total of 5224) is aged 35–44.
The respective annual cost to EOPYY was estimated at almost €47 million. Total and average costs per pharmacotherapy option for the study year are presented in .
Table 4. Pharmacotherapy costs for plaque psoriasis, June 2014–June 2015.
Treatment with topical agents, which covers 72% of patients (32,859 patients), accounts for a mere 5% of total EOPYY expenditure (€2,423,234.83) ().
Treatment with a systemic agent (methotrexate or POS) covers an additional 9% (8.92%) of total market and accounts for 2.35% of total EOPYY expenditure (€1 098 013.73).
Another 7.54% of total patients are on treatment with a combination of topical and systemic agents, which account for 3.16% of total EOPYY expenditure (€1,477,981.70).
On the contrary, biologics-containing treatments (as monotherapy or in combination, where the cost driver remains the cost of the biologic agent) cover almost 12% of the patient population (11.5%) and account for almost 90% (89.3%) of total expenditure (€41,729,614.76).
Moreover, they result in a median annual per patient cost of €8075.22 for EOPYY (from €6983.78 to €9166.66, depending on the combination). If this annual per patient cost is combined with the on average earlier age at which a patient is prescribed a biologic-containing treatment and the practice of life time administration of biologics, it is clear that the social insurance’s future financial burden is expected to increase exponentially.
For example, a patient aged 45 years old on treatment with a biologic agent is estimated to continue treatment with his current treatment option or another of approximately the same cost for the rest of his life, i.e. on average an additional 30 years. If each such treatment course results in an average annual per patient cost of €8075.22, the total burden is expected to exceed €240,000 over a patient’s lifetime (2015 prices, not discounted). Over a total of 1088 patients aged 45–54 currently on a biologic-containing treatment, EOPYY’s respective lifetime expenditure is expected to exceed €260,000 000 (2015 prices, not discounted).
This is further confirmed by our analysis, which indicates limited scale switches from one biologic agent to another, of the same or different mode of action (69 patients switched from an anti-TNF biologic agent to another biologic agent within the study period) but no discontinuations or switches from biologics to topical treatments.
Additionally, the €2,423,235, which EOPYY reimburses for topical treatments, corresponds to 75% of a total market value of €3,230,980, with an additional €807,745 constituting patient copayments (25%). Equally, the €2,575,995.43 that EOPYY pays for treatment with systemic agents, alone or in combination with topical treatments, corresponds to 75% of a total market value of €3,434,660.57, with an additional €858 665.14 constituting patient copayments (25%).
An increase in the reimbursement level of topical treatments to bring this on par with the reimbursement level for biologics in psoriasis (100%) would result in an additional cost for EOPYY of €807,745 per year or €24.6 per patient per year or €2.05 per patient per month.
Equally, an increase in the reimbursement level of systemic, non-biologic, treatments to bring this on par with the reimbursement level for biologics in psoriasis (100%) would result in an additional cost for EOPYY of €858,665.14 per year or €114.5 per patient per year or €9.5 per patient per month.
This combined additional expenditure of €11.55 per patient per month would remove any financial (counter) incentives to switch patients from cheaper topical or systemic treatments (that carry a 25% copayment) to more expensive biologics (that are 100% reimbursed by social insurance). This additional direct EOPYY cost could be offset by averting 200 switches to a biologic agent a year or, else, by preventing 200 newly-diagnosed patients eligible for topical or systemic, non-biologic, treatment from getting on treatment with biologics.
Results underline that, in Greece, an ∼12% of patients on reimbursed pharmacotherapy for psoriasis is on treatment with a biologic-containing regimen that accounts for almost 90% of the total social insurance cost for the therapy area. Such market shares appear to be equivalent to those reported in other countries in Europe, such as ItalyCitation15 and SwedenCitation16,Citation17. The severity of the disease amongst patients on file in this study was not recorded and, therefore, could not be taken into account. This means that the 12% of total patients on a biologics-containing treatment may be a large percentage, if patients are suffering primarily from mild-to-moderate psoriasis, or a reasonable percentage if patients on record are suffering primarily from severe psoriasis.
Still, the economic burden that treatment with biologics results in today and prospectively, given the relative young age at which a patient starts on biologics in Greece, may seriously affect the sustainability of the Greek social health insurance system. This onset of biologics at a younger age in Greece is not in line with the typical disease pathway described in the literatureCitation18, which allows for a mean age of onset for the first presentation of psoriasis at 15–20 years of age, with a second peak at 55–60 years, i.e. much later than the age at which patients are primarily prescribed biologics in Greece. Such a trend may reflect the reality of the evolution of psoriasis treatment in general, which has resulted in a paradoxical situation in which the use of lower-cost psoriasis treatments, with longer safety track records, is discouraged relative to newer optionsCitation19. Nonetheless, it results in a growing share of biologics-containing treatments in the total therapy area budget in the country, from 78% in 2005Citation20 to 89% in 2014.
Treatment with biologics constitutes a necessary option for patients with moderate-to-severe psoriasis, who have not responded to previous treatment with topical or systemic agents. This may be particularly relevant for younger patients, where prompt improvement in scores related to quality-of-life and functionality is critical to leading a normal family, professional, and social life.
For this reason, it is critical that biologic containing treatments remain available and accessible to all patients, for who they are clinically necessary.
It is equally critical that their administration is not driven by different cost-sharing arrangements within the same disease area. Especially when, in psoriasis, out of pocket patient costs are a major contributor to selecting a treatment optionCitation21, third only to efficacy (90% of respondents) and safety (65% of respondents) and followed by total treatment cost (46% of respondents). This finding combined with the financial hardship, with which most Greek households are faced, may contribute to a premature administration of biologics-containing treatments in psoriasis, where access to such treatments, given their high cost and the prospect of lifetime administration, should be restricted to those patients, for whom there is clear, evidence-based medical need. Removing financial counter objectives, such as a 25% patient copayment level for treatments with topical and systemic agents in moderate-to-severe psoriasis vs a 0% patient copayment level for treatments with biologics, would aid the implementation of evidence-based access rules to expensive treatments. It would equally result in an increase in physician visits to obtain a 0% copayment prescription, which could in turn contribute to better adherence to treatment and overall disease monitoring and management. This has been documented to delay disease progression or transition to a biologic agentCitation22,Citation23.
It would, also, offer a unique opportunity for the rationalization of pharmaceutical expenditure on the basis of clinical guidelines within a therapy area in line with the Government’s resolution to restore equity in the healthcare system through correcting patient copayment ratesCitation24.
Such an approach would confirm previous research findingsCitation25 that highlighted that, for EOPYY to save on costs, one could allow lower cost-sharing arrangements for lower priced products. Authors stressed that this would serve as an additional incentive for patients to buy cheaper products and for the industry to reduce product prices.
This integrated, structured approach to policy-making in a given therapy area would need the support of prescription guidelines and treatment protocols, which could aid clinical decision to the benefit of personal and public health and economy. Such protocols should be clearly prioritized in line with copayment level adjustments to support proper management of patients on topical and systemic treatments.
Such protocols should pay adequate attention to monitoring and increasing patient compliance to treatment, especially for treatments with topical agents, and could be implemented through a personalized health card or a patient registry.
The latter could help follow patient pathway and treatment outcomes to produce statistically relevant indicators on the condition, its epidemiology, relative resource consumption, and cost per outcome. Such information would be critical for evidence-based planning of health services for the future as well as reimbursement negotiations.
Our analysis is a cost-only analysis and is limited by the fact that EOPYY maintains no actual effectiveness data per patient per treatment. Such data could be combined with patient pathways to confirm clinical need for switches from topical and systemic treatments to treatments containing biologics or from one biologic agent to another, especially of the same mode of action, upon relapse.
Further, this analysis is limited by our inability to confirm the number of newly-diagnosed psoriasis patients and match these to a treatment option. As the use of ICD 10 codes was launched in the second half of 2013 and became fully compulsory in the first half of 2014, we were unable to compare the total number of patients with a diagnosis of psoriasis (ICD 10 L40, L40.0, L40.9) to that of the previous year (June 2013–June 2014). This limitation does not allow us to validate the distribution of newly diagnosed patients to treatments with topical agents, systemic agents or biologics. Therefore, we cannot calculate the prospective burden to EOPYY from early administration of a biologic agent, when a different, cheaper option would also be clinically appropriate, especially among newly-diagnosed patients.
Finally, this analysis is based on a snapshot of the year under study and cannot be combined with retrospective patient pathway information, and, thus, report and evaluate succession of treatment options to date. Therefore, it cannot explain how patients ended up on a specific treatment option today (lack of response to other options, relapse, etc.). To complete such an analysis, it would be necessary to have access to a patient registry.
Conclusion
Administering a biologics-containing treatment for psoriasis, especially at relatively younger patients, results in a significant economic burden for social health insurance. This burden is borne 100% by social health insurance, many times for the lifetime of a patient.
Conversely, given the counter incentives to prescribing topical or systemic treatments in psoriasis, such as the 25% patient copayment rate (vs a 0% copayment rate for biologics), combined with the lack of prescription guidelines and treatment protocols to aid clinical decision-making, as well as compliance monitoring and enhancing tools, creates an environment positive to early administration of biologics, even where it may yet be potentially clinically not necessary. Such a practice may carry risks to personal and public health as well as the economy of the social insurance system. It may also result in future restrictions in access to biologics, due to large-scale, horizontal budget cuts to the (ever increasing) therapy area budget.
In circumstances of severe funding constraints and with innovative biologic treatments about to enter the market, bringing patient copayment levels for psoriasis treatment on par with each other (at 0% of cost) may substantially aid the proper clinical management of the condition, void of financial counter incentives. Further, in combination with systematic, evidence based, ongoing management of patient pathways, it could ensure improved treatment outcomes at optimal cost.
It would equally constitute EOPYY’s first integrated intervention in a therapy area, where, after assessing current challenges on the basis of real life data and supported by prescription guidelines, treatment protocols and, potentially, a patient registry, the Organization implements a change in a copayment level to the benefit of both patients (reduction in out of pocket expenditure, irrespective of treatment option for psoriasis) and healthy insureds (optimal allocation of health budget).
Transparency
Declaration of funding
No funding was received for this manuscript.
Declaration of financial/other relationships
The authors have no financial relationships to disclose. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
Authors are grateful to the EOPYY Administration for providing permission to use their anonymized data in the study.
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