Jenny M. Norlin

Analysis of three outcome measures in moderate to severe psoriasis : a registry-based study of 2450 patients

Summary Background  As moderate to severe psoriasis is a systemic disease with large effects on health‐related quality of life, generic measures that include overall health, not only skin involvement, are necessary. Knowledge about the relationship between the generic preference‐based EuroQol 5D (EQ‐5D) and dermatology‐specific measures in psoriasis is limited.

Switch to Biological Agent in Psoriasis Significantly Improved Clinical and Patient-Reported Outcomes in Real-World Practice

Background: Although clinical studies have shown efficacy of biological agents in moderate to severe psoriasis, observational studies of real-world effectiveness are rare. Objective: To analyse the psoriasis area and severity index (PASI) and quality of life by the EQ-5D questionnaire and dermatology quality of life index (DLQI) in psoriasis patients who switched from conventional systemic treatment to biological agents in clinical practice. Furthermore, to analyse patient groups with the highest benefit of biological agents. Methods: Longitudinal, observational study based on the Swedish National Registry for Systemic Treatment of Pso-riasis, PsoReg. Outcomes of biological-naïve patients who switched to a biological agent (n = 267) were analysed before switch and at the first follow-up. Results: Patients significantly improved in EQ-5D, DLQI and PASI (p < 0.001). Patients with DLQI ≥10 and/or PASI ≥10 had the greatest benefits from biological agents in terms of EQ-5D. Conclusions: Patients with moderate to severe psoriasis benefit from biological agents in clinical practice; the patients with the highest benefits were those with high pretreatment PASI and DLQI scores.

Resource Use in Patients with Psoriasis After the Introduction of Biologics in Sweden

The introduction of biologics has changed treatment patterns as well as costs in patients with psoriasis. This study was performed to estimate direct and indirect costs of the psoriasis population in Sweden, and to analyse changes in costs between 2006 and 2009. The study population was identified in national registers. Direct costs included health care visits with primary psoriasis diagnoses in specialist care and drugs relevant for treating psoriasis. Productivity loss, including costs of long-term sick leave and disability pension, was estimated as the difference between psoriasis patients and matched controls from the general population. Total direct cost increased from SEK 348 million (~ €39) in 2006 to SEK 459 million (~ €51) in 2009, whereas the total productivity loss decreased from SEK 1,646 (~ €183) to 1,618 million (~ €180) between 2006 and 2009. Although direct costs, especially for biologic agents, have increased for patients with psoriasis over time, this study indicates that costs related to productivity loss are still more substantial.

Register-Based Evaluation of Relative Effectiveness of New Therapies: Biologics Versus Conventional Agents in Treatment of Psoriasis in Sweden

BackgroundThe Swedish National Register for Systemic Treatment of Psoriasis (PsoReg) was established in 2006. This article analyzes the implementation phase of biologics in the treatment of moderate to severe psoriasis in Sweden in the period 2006–2012. Clinical studies have shown efficacy of biologic agents in psoriasis, but their relative effectiveness in real-world clinical practice has rarely been studied.ObjectiveTo estimate the incremental changes in clinical health-related quality-of-life measures in patients receiving biologics versus conventional systemic agents.MethodsPatients fulfilling the clinical criteria for moderate to severe psoriasis were included. Average treatment effects were estimated from longitudinal data as incremental changes in: (1) the Psoriasis Area and Severity Index (PASI) score, (2) the Dermatology Life Quality Index (DLQI) score, and (3) the EQ-5D score, by matching patients switching to biologics with patients remaining on conventional systemic agents.ResultsThe study included 239 biologic-treated patients and 378 conventionally treated patients. The matched patient groups were essentially equivalent in terms of important patient characteristics. The average treatment effects of biologics versus conventional systemic agents were 2.2 for PASI, 3.5 for DLQI, and 0.11 for EQ-5D. The estimated incremental benefits of biologics for the subgroup of patients not responding to their conventional systemic agent were even greater.ConclusionRegister-based research complements knowledge from randomized controlled trials regarding relative effectiveness in clinical practice. This information can be used to support health care decision making. This research suggests that there is both under- and overtreatment with biologics in Swedish clinical practice. Reallocation of biologics to more severe cases of psoriasis could improve overall health in the total patient population.

A Cost-effectiveness Analysis of Diagnostic Algorithms of Deep Vein Thrombosis at the Emergency Department

INTRODUCTION Suspected cases of deep vein thrombosis are common at emergency departments and they often require extensive and costly diagnostic testing. The objective of this study was to evaluate whether a diagnostic algorithm based upon pre-test probability and D-dimer in diagnosing deep vein thrombosis may be cost-effective from a societal perspective in a Swedish setting. MATERIAL AND METHODS The cost-effectiveness of two alternative diagnostic algorithms were calculated using decision analysis. An algorithm which out ruled deep vein thrombosis among low probability patients with negative D-dimer was compared to a traditional algorithm including compression ultrasonography and/or contrast venography for all patients. For sensitivity analysis, a third reversed algorithm, where D-dimer was followed by pre-test probability, was analyzed. Estimates of probabilities were obtained from a prospective management study, including 357 outpatients with clinical suspicion of deep vein thrombosis. Direct costs were estimated using prices from Scania, Sweden. Indirect costs were estimated using time spent at the local emergency department and gross average wages in Sweden. RESULTS The total cost of the pre-test probability and D-dimer algorithm was estimated to euro406 per patient and the traditional algorithm was estimated to euro581 per patient. Reversing the order of the score and test resulted in an estimate of euro421 per patient. CONCLUSION At no significant difference in diagnostic efficacy the algorithm based upon pre-test probability and D-dimer was cost-effective, while the reversed algorithm and diagnostic imaging for all patients were not.

Multi-indication and Combination Pricing and Reimbursement of Pharmaceuticals: Opportunities for Improved Health Care through Faster Uptake of New Innovations

Many pharmaceuticals are effective in multiple indications and the degree of effectiveness may differ. A product-based pricing and reimbursement system with a single price per product is insufficient to reflect the variable values between different indications. The objective of this article is to present examples of actual pricing and reimbursement decisions using current value-based pricing in Sweden and to discuss their implications and possible solutions. The value of several cancer drugs was estimated for various indications based on a willingness-to-pay threshold of 1 million SEK (EUR 104,000) per QALY gained. For some drugs, the estimated value was higher than the drug acquisition cost in several indications, whilst in others, the estimated value was lower than the drug acquisition cost. Drugs used in combination present a special case. If a drug prolongs survival and consequently also a continued use of the anchor drug, the combination use may not be cost effective even at a zero price. In a product-based pricing and reimbursement system, patients may not get access to drugs or access may be delayed and manufacturers may be discouraged to invest in future indications. To overcome these issues, there are several approaches to link price and value. One approach is a “weighted-average” price based on an average of the value across all indications. Another is “multi-indication pricing,” which enables price differentiation between indications. However, there are several barriers for applying multi-indication pricing and reimbursement schemes. One barrier is the lack of existing administrative infrastructure to track patients’ indications.

Real-world outcomes in 2,646 psoriasis patients : one in five has PASI ≥ 10 and/or DLQI ≥ 10 under ongoing systemic therapy

Abstract Background: Although biologics introduced a new era in psoriasis care when available a decade ago, it is unclear to what extent the available systemic treatments treat patients adequately. Objective: To analyse the clinical severity and quality of life of the psoriasis population in Sweden treated with systemics. Methods: Data included 2646 patients from the Swedish Registry for Systemic Treatment of Psoriasis. Average Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI) and EQ-5D were reported. A subgroup of persisting moderate-to-severe psoriasis as defined by PASI ≥10 and/or DLQI ≥10 after >12 weeks treatment was analysed. Results: Mean (SD) PASI, DLQI and EQ-5D were 4.12 (4.57), 4.11 (5.24) and 0.79 (0.22). Eighteen percent had persisting moderate-to-severe psoriasis (n = 472). These patients were younger, had higher BMI, had psoriasis arthritis and were smoking to a larger extent (p < 0.01) compared with lower-severity patients (n = 2174). Mean (SD) EQ-5D was also considerably lower 0.63 (0.29) vs. 0.82 (0.19) (p < 0.01). Conclusion: Almost one in every five patients had persisting moderate-to-severe psoriasis, despite ongoing systemic treatment. Both comorbidities and life style factors were associated with persisting moderate-to-severe psoriasis. The considerably lower generic quality of life in these patients demonstrates an unmet need. Subsequently, improved access to biologics and continuous drug development is needed in psoriasis.