Real-world treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriasis

Objective: This study compared real-world treatment patterns and healthcare costs among biologic-naive psoriasis patients initiating apremilast or biologics.

Methods: A retrospective cohort study was conducted using the Optum Clinformatics? claims database. Patients with psoriasis were selected if they had initiated apremilast or biologics between January 1, 2014, and December 31, 2015; had 12?months of pre-index and post-index continuous enrollment in the database; and were biologic-naive. The index date was defined as the date of the first claim for apremilast or biologic, and occurred between January 1, 2014, and December 31, 2015. Treatment persistence was defined as continuous treatment without a?>?60-day gap in therapy (discontinuation) or a switch to a different psoriasis treatment during the 12-month post-index period. Adherence was defined as a medication possession ratio (MPR) of ≥ 80% while persistent on the index treatment. Persistence-based MPR was defined as the number of days with the medication on hand measured during the patients’ period of treatment persistence divided by the duration of the period of treatment persistence. Because patients were not randomized, apremilast patients were propensity score matched up to 1:2 to biologic patients to adjust for possible selection bias. Treatment persistence/adherence and all-cause healthcare costs were evaluated. Cost differences were determined using Wilcoxon rank-sum tests.

Results: In all, 343 biologic-naive patients initiating apremilast were matched to 680 biologic-naive patients initiating biologics. After matching, patient characteristics were similar between cohorts. Twelve-month treatment persistence was similar for biologic-naive patients initiating apremilast vs biologics (32.1% vs 33.2%; p?=?0.7079). While persistent on therapy up to 12?months, per-patient per-month (PPPM) total healthcare costs were significantly lower among biologic-naive cohorts initiating apremilast vs biologics ($2,214 vs $5,184; p?p?p?p?Limitations: Data were limited to individuals with United Healthcare commercial and Medicare Advantage insurance plans, and may not be generalizable to psoriasis patients with other insurance or without health insurance coverage.

Conclusion: Biologic-naive patients with similar patient characteristics receiving apremilast vs biologics had significantly lower PPPM costs, even when they switched to biologics during the 12-month post-index period. These results may be useful to payers and providers seeking to optimize psoriasis care while reducing healthcare costs.     

A cost-effectiveness and budget impact analysis of apremilast in patients with psoriasis in the Italian setting

Abstract

Aims: The aim of this study was to conduct a cost-effectiveness analysis, as well as a budget impact analysis, on the use of apremilast for the treatment of adult patients with moderate-to-severe plaque psoriasis (defined as a psoriasis area severity index [PASI]?≥?10), who failed to respond to, had a contraindication to, or were intolerant to other systemic therapies, within the Italian National Health Service (NHS).

Materials and methods: A Markov state-transition cohort model adapted to the Italian context was used to compare the costs of the currently available treatments and of the patients’ quality of life with two alternative treatment sequences, with or without apremilast as pre-biologic therapy. Moreover, a budget impact model was developed based on the population of patients treated for psoriasis in Italy, who would be eligible for treatment with apremilast.

Results: Over 5?years, the cost-effectiveness analysis showed that the strategy of using apremilast before biologic therapy was dominant compared with the sequence of biologic treatments without apremilast. In addition, it is important to underline that the use of apremilast slightly increases the quality-adjusted life years gained over 5?years. Furthermore, within the budget impact analysis, the strategy including apremilast would lead to a saving of €16 million within 3?years. Savings would mainly be related to a reduction in pharmaceutical spending, hospital admissions and other drug administration-related costs.

Conclusion: These models proved to be robust to variation in parameters and it suggested that the use of apremilast would lead to savings to the Italian healthcare system with potential benefits in terms of patients’ quality of life.     

Treatment patterns and healthcare system burden of managed care patients with suspected pulmonary arterial hypertension in the United States

Abstract

Objectives:

To describe treatment patterns and healthcare burden among individuals with suspected pulmonary arterial hypertension (PAH), as identified through a practice guideline-based healthcare claims algorithm.

Methods:

Adults with evidence of PAH from 1 January 2004 (commercial and Medicaid) or 1 July 2006 (Medicare Advantage) through 30 June 2008 were identified. Given the lack of an ICD-9 code for PAH, an algorithm was developed requiring: (1) ≥1 claim for PAH medication (index date); (2) ≥1 claim with a pulmonary hypertension diagnosis code in the 6-month pre-index period (baseline) or within 90 days post-index; (3) a right heart catheterization or pulmonary hypertension-related inpatient stay during baseline or within 90 days post-index; and (4) continuous health plan enrollment for 6 months pre-index and ≥6 months post-index. Patients with PAH-specific medications during baseline were excluded. Treatment patterns, healthcare utilization, and costs were assessed during the period ending with the earlier of health plan disenrollment or 31 December 2008.

Results:

Among the 521 included patients, 69% were female. Most patients (94%) initiated treatment with monotherapy (most commonly sildenafil or bosentan), and 12.7% of all patients augmented their therapy by the end of the observation period. The medication possession ratio was 0.96 each for ambrisentan (SD?=?0.04), bosentan (SD?=?0.04), and sildenafil (SD?=?0.05). Overall, 72.6% of patients discontinued therapy with a mean of 149 (SD?=?170) days until discontinuation. A mean (SD) of 2.14 (1.82) all-cause office and 1.64 (1.98) outpatient visits occurred per patient per month. Mean PAH-related healthcare costs were $6617 per patient per month, comprising 71% of all-cause costs. The guideline-based algorithm may not have perfectly captured patients with PAH.

Conclusions:

Patients with suspected PAH were likely to initiate treatment with oral monotherapy, had high compliance rates, and received close ambulatory follow-up. PAH-related costs constituted the majority of all-cause healthcare costs.     

Economic consequences of sequencing biologics in rheumatoid arthritis: a systematic review

Abstract

Background and objectives:

Tumor necrosis factor-alpha (anti-TNF) blocking agents are effective for the treatment of rheumatoid arthritis (RA), with mean response rates of 60–70%. Patients with incomplete response to initial anti-TNF treatment often are switched to other biologic treatments with some success. However, little is known about whether or not switching to anti-TNF or other non-TNF biologic treatments is cost-effective. This study sought to review the economic evidence of sequencing various biologic treatments in RA.

Methods:

A systematic review was conducted of published and unpublished literature (January 2000 to October 2012) on the cost-effectiveness of sequencing biologic treatments in RA after failure of an initial biologic treatment. It included modeling and other economic studies that assessed cost-effectiveness of one or more sequences of biologics. Studies were excluded that evaluated non-biologic sequencing.

Results:

This review of the available evidence suggests that there is limited evidentiary support favoring the cost-effectiveness of switching from one anti-TNF agent to another within the anti-TNF category of biologics. This is due, in large part, to the limited clinical evidence base supporting the incremental efficacy of second- and third-line anti-TNF treatments and to variation on how and when to assess non-response to the first-line biologic. When compared to anti-TNF agents, biologic treatments with a different mechanism of action are more cost-effective as second-line agents.

Limitations:

Not all sequences and patterns of switching, either within or outside of therapeutic class, have been evaluated for clinical benefit and cost-effectiveness, limiting the interpretation of these findings.

Conclusions:

Switching from one anti-TNF agent to another after first-line treatment failure may not be a cost-effective treatment strategy. However, when non-TNF biologics are included in the sequence they are likely to be more cost-effective than anti-TNF specific cycling sequences.     

The cost-effectiveness of biologic versus non-biologic treatments and the health-related quality of life among a sample of patients with inflammatory bowel disease in a tertiary care center in Saudi Arabia

Abstract

Aims

This study’s objectives were to examine and compare the cost-effectiveness of biologic and non-biologic therapies in the improvement of the health-related quality of life (HRQoL) of patients with inflammatory bowel disease (IBD) in Saudi Arabia.     

The economic burden of psoriasis with high comorbidity among privately insured patients in the United States

Objective: To evaluate the impact of comorbidities on healthcare resource use (HRU), and direct and indirect work-loss-related costs in psoriasis patients.

Methods: Adults with psoriasis (≥2 diagnoses, the first designated as the index date) and non-psoriasis controls (no psoriasis diagnoses, randomly generated index date) were identified in a US healthcare claims database of privately-insured patients (data between January 2010 and March 2017 were used). Psoriasis patients were stratified based on the number of psoriasis-related comorbidities (0, 1–2, or ≥3) developed during the 12?months post-index. All outcomes were evaluated during the follow-up period, spanning the index date until the end of continuous health plan eligibility or data cut-off. HRU and costs per-patient-per-year (PPPY) were compared in psoriasis and non-psoriasis patients with ≥12?months of follow-up.

Results: A total of 9,078 psoriasis (mean age?=?44?years, 51% female) and 48,704 non-psoriasis (mean age?=?41?years, 50% female) patients were selected. During the 12?months post-index, among psoriasis vs non-psoriasis patients, 71.0% vs 83.0% developed no psoriasis-related comorbidities, 26.3% vs 16.0% developed 1–2, and 2.6% vs 1.0% developed ≥3 psoriasis-related comorbidities. Compared to non-psoriasis patients, psoriasis patients had more HRU including outpatient visits (incidence rate ratios [IRRs]?=?1.52, 2.03, and 2.66 for 0, 1–2, and ≥3 comorbidities, respectively [all p?p?p?p?Conclusions: HRU and cost burden of psoriasis are substantial, and increase with the development of psoriasis-related comorbidities.     

The budget impact of brodalumab for the treatment of moderate-to-severe plaque psoriasis on US commercial health plans

Introduction: Brodalumab is a new biologic approved by the US Food and Drug Administration in 2017 for the treatment of moderate-severe psoriasis. This study evaluated the impact of the introduction of brodalumab on the pharmacy budget on US commercial health plans.

Methods: An Excel-based health economic decision analytic model with a US health plan perspective was developed. The model incorporated published moderate-to-severe psoriasis prevalence data; market shares of common biologic drugs, including adalimumab, ustekinumab, secukinumab, ixekizumab, and etanercept, used for the treatment of moderate–severe psoriasis; 2017-year Wholesale Acquisition Costs for the biologic drugs; drug dispensing fee; patient co-pay; and drug contracting discount. Total annual health plan costs for the biologic drugs were estimated. Scenarios with different proportions of patients treated with brodalumab were compared to a control scenario when no brodalumab was used.

Results: In a hypothetical commercial health plan covering two million members, 7,038 moderate-to-severe psoriasis patients were estimated to be eligible for treatment with brodalumab. Prior to brodalumab approval, the proportions of patients treated by other biologics were estimated at 50.8% for adalimumab, 13.5% for ustekinumab, 14.1% for secukinumab, 4.4% for ixekizumab, and 17.2% for etanercept. With a 20% drug price discount applied to all biologics, the annual health plan costs for brodalumab, adalimumab, ustekinumab, secukinumab, ixekizumab, and etanercept were estimated at $37,224, $49,166, $55,084, $56,061, $64,396, and $57,170, respectively. When no brodalumab is used, the total annual pharmacy budget for the biologics used among these patients was estimated at $414,362,647. Among scenarios where the proportions of brodalumab usage were 3%, 8%, 16%, and 30%, the total annual pharmacy cost was estimated to be reduced by $3,698,129, $9,861,677, $19,723,355, and $36,981,290, respectively.

Conclusion: Based on the economic model, brodalumab has the potential to substantially reduce pharmacy expenditures for the treatment of patients with moderate-to-severe plaque psoriasis in the US.     

Cost-effectiveness analysis of sequential biologic therapy with ixekizumab versus secukinumab as first-line treatment of moderate-to-severe psoriasis in the UK

Aims: Patients with psoriasis often undergo treatment with a sequence of biologic agents because of poor/loss of response to initial therapy. With the availability of newer agents like ixekizumab and secukinumab, there is a need for cost-effectiveness analyses to better reflect current clinical practice. This study aimed to assess the cost-effectiveness of a sequence of biologic therapies containing first-line ixekizumab vs first-line secukinumab in patients with moderate-to-severe plaque psoriasis in the UK.

Materials and methods: A Markov model with a lifetime horizon was developed to compare the cost-effectiveness of ixekizumab and secukinumab treatment sequences: ixekizumab → ustekinumab → infliximab → best supportive care (BSC) vs secukinumab → ustekinumab → infliximab → BSC. The model used monthly cycles, and included four health states: trial period, treatment maintenance, BSC, and death. At the end of the trial period, responders transitioned to maintenance therapy; non-responders transitioned to the next biologic in the sequence. An annual discontinuation rate of 20% was assumed for maintenance therapy.

Results: The ixekizumab sequence provided cost savings of £898 (£176,203 vs 177,101) [year 2015 values] and gained 0.03 more quality-adjusted life-years (QALYs: 1.45 vs 1.42) vs the secukinumab sequence over the lifetime horizon. Probabilistic sensitivity analysis showed an 89.8% likelihood that the ixekizumab sequence would be cost-effective at a threshold of £20,000 per QALY gained.

Limitations: The analysis used list prices for drugs rather than confidential, preferentially priced Patient Access Scheme costs. In addition, efficacy input data were based on a network meta-analysis, as there were no head-to-head trials comparing ixekizumab and secukinumab.

Conclusion: First-line treatment with ixekizumab as part of a specific sequential biologic therapy for moderate-to-severe plaque psoriasis in the UK provided slight advantages in cost savings and QALYs gained over a similar treatment sequence initiated with secukinumab. In view of the small magnitude of these differences, factors such as patient preferences (e.g. for number of injections) and long-term safety (e.g. related to time on the market) may also be important for clinical decision-making.     

A comparison of treatment patterns,healthcare resource utilization,and costs among young adult Medicaid beneficiaries with schizophrenia treated with paliperidone palmitate or oral atypical antipsychotics in the US

Abstract

Background: Much of the burden associated with schizophrenia is attributed to its early onset and chronic nature. Treatment with once monthly paliperidone palmitate (PP1M) is associated with lower healthcare utilization and better adherence as compared to oral atypical antipsychotics (OAAs). This study aimed to evaluate real-world effectiveness of PP1M and OAA therapies among US-based adult Medicaid patients with schizophrenia, overall and among young adults aged 18–35 years.

Methods: Adult patients with a diagnosis of schizophrenia and at least two claims for PP1M or OAA between January 1, 2010 and December 31, 2014 were selected from the IBM Watson Health MarketScan Medicaid Database. Treatment patterns and healthcare resource utilization and costs were compared between PP1M and OAA treatment groups following inverse probability of treatment (IPT) weighting to adjust for potential differences. Utilization and cost outcomes were estimated using OLS and weighted Poisson regression models.

Results: After IPT weighting, the young adult PP1M and OAA cohorts were comprised of 3,095 and 3,155 patients, respectively. PP1M patients had a higher duration of continuous treatment exposure (168.2 vs 132.5 days, p?=?.004) and better adherence on the index medication (proportion of days covered ≥80%: 19.0% vs 17.1%, p?<?.049). Young adults treated with PP1M were 37% less likely to have an all-cause inpatient admission (odds ratio [OR]?=?0.63, 95% confidence interval [CI]?=?0.53–0.74) and 33% less likely to have an ER visit (OR?=?0.67, 95% CI?=?0.55–0.81) compared to OAA young adult patients, but 27% more likely to have an all-cause outpatient office visit (OR?=?1.27, 95% CI?=?1.02–1.56). PP1M patients incurred significantly lower medical costs as compared to OAA patients.

Conclusions: Medicaid patients with schizophrenia treated with PP1M have higher medication adherence and have fewer hospitalizations as compared to patients treated with OAAs. PP1M may lead to reduced healthcare utilization and improved clinical outcomes.     

Annual costs of tumor necrosis factor inhibitors using real-world data in a commercially insured population in the United States

Abstract

Objective:

To calculate annual cost per treated patient of tumor necrosis factor (TNF) inhibitors etanercept, adalimumab, and infliximab for common approved indications, based on actual TNF-inhibitor use in clinical practice.

Methods:

Adults with ≥1 claim for etanercept, adalimumab, or infliximab between January 2005 and March 2009 were identified from the IMS LifeLink? Health Plan Claims Database. Patients new to therapy or continuing therapy (i.e., a prior claim for a TNF-inhibitor) were analyzed separately. Included patients had been enrolled from 180 days before the first TNF-inhibitor claim (index date) through 360 days after the index date and had a diagnosis during the pre-index period for rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis. Patients with Crohn’s disease, ulcerative colitis, or juvenile idiopathic arthritis were excluded. Annual costs were calculated using wholesale acquisition costs for the TNF-inhibitor and Medicare Physician Fee Schedule for drug administration. Costs from restarting or switching TNF-inhibitor therapy during the first year were included.

Results:

A total of 27,704 patients (11,528 new, 16,176 continuing) had claims for etanercept, adalimumab, or infliximab, most commonly (65%) for treatment of rheumatoid arthritis. The most commonly used agent was etanercept (14,777 patients; 53%), followed by adalimumab (6862 patients; 25%) and infliximab (6065 patients; 22%). Annual cost per treated patient was etanercept $14,873, adalimumab $17,766, and infliximab $21,256 across all indications. Annual cost per treated patient by disease was (etanercept/adalimumab/infliximab): rheumatoid arthritis ($14,314/$17,700/$20,390), psoriasis ($17,182/$17,682/$23,935), psoriatic arthritis ($15,030/$18,483/$24,974), and ankylosing spondylitis ($14,254/$16,925/$23,056). New and continuing patients showed similar results, with etanercept having the lowest costs.

Limitations:

This analysis is limited to three TNF-inhibitors and a US managed-care population.

Conclusions:

Based on this analysis of real-world use of TNF-inhibitors among patients in nationwide clinical practice settings, the annual TNF-inhibitor cost per treated patient was lowest for etanercept across all indications.     

Adalimumab,etanercept, and infliximab utilization patterns and drug costs among rheumatoid arthritis patients

Abstract

Objectives:

To evaluate the utilization patterns of the anti-tumor necrosis factor (anti-TNF) agents Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) in patients with rheumatoid arthritis (RA) and compare medication costs during the first year of treatment. (Humira is a registered trademark of Abbott Laboratories, IL; Enbrel is a registered trademark of Immunex Corporation, CA; and Remicade is a registered trademark of Janssen Biotech, Inc., PA).

Methods:

This retrospective analysis of medical and pharmacy claims included patients who were aged ≥18 years, had ≥2 RA diagnosis codes, and had ≥365 days of persistence with the index anti-TNF. Patients excluded had claims for anti-TNF agents within 6 months before the index date. Refill patterns for adalimumab and etanercept, number of infliximab infusions, time between infusions, and dose per infusion were analyzed for 12 months. Direct anti-TNF medication costs were compared among anti-TNFs for the initial treatment year.

Results:

Infliximab-treated patients (n?=?457) were significantly older than adalimumab- (n?=?337) or etanercept-treated patients (n?=?902). Time between refills was longer than recommended for 28% and 30% of adalimumab and etanercept refill periods, respectively. Potential cumulative time without therapy was 33 days for adalimumab and 43 days for etanercept. Statistically significant differences in mean per-patient anti-TNF medication costs for the first year were reported for adalimumab, etanercept, and infliximab ($14,991, $13,361, and $18,139, respectively; p?<?0.0001); however, a cost assessment using labeled dosing of the anti-TNF agents with optimal treatment compliance yielded comparable annual medication costs.

Limitations:

This analysis only evaluated utilization patterns for selected anti-TNF agents and was not inclusive of other medications that patients may have been using for RA. Absolute patient adherence could not be assessed due to lack of information on how patients were self-administering adalimumab and etanercept or if samples of the agents were made available.

Conclusions:

This study identified gaps in patients’ refills compared with prescriber recommendations. The infliximab-treated group had infusion patterns consistent with prescribing information. Potential clinical and economic implications of dose attenuation with adalimumab and etanercept should be explored further.     

Cost per additional responder for ixekizumab and other FDA-approved biologics in moderate-to-severe plaque psoriasis

Background: Evidence of the cost-efficacy of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (PsO) in the US is limited.

Objective: To estimate the number needed to treat (NNT) and monthly cost of achieving one additional Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responder for ixekizumab and other Food and Drug Administration (FDA)-approved biologics in PsO.

Methods: A network meta-analysis estimated the probability of achieving PASI 75, 90, or 100 response during induction for each biologic. NNTs were calculated using response difference of each respective biologic vs placebo at the end of induction. Monthly costs per additional PASI responder were based on FDA-approved doses, wholesale acquisition costs, and induction NNTs.

Results: Induction NNTs for ixekizumab 80?mg once every 2 weeks (Q2W) relative to placebo were consistently lower across all levels of clearance compared with the other biologics. Monthly cost per additional responder was lowest for ustekinumab 45?mg at PASI 75 and for secukinumab 300?mg and ixekizumab 80?mg Q2W at PASI 90. Ixekizumab 80?mg Q2W had the lowest cost for PASI 100.

Conclusion: In this analysis, ixekizumab is the most cost-efficient biologic in the US when targeting complete resolution, as measured by PASI 100 in PsO.     

Healthcare costs in psoriasis and psoriasis sub-groups over time following psoriasis diagnosis

Aims: To quantify healthcare costs in patients with psoriasis overall and in psoriasis patient sub-groups, by level of disease severity, presence or absence of psoriatic arthritis, or use of biologics.

Methods: Administrative data from Truven Health Analytics MarketScan Research Database were used to select adult patients with psoriasis from January 2009 to January 2014. The first psoriasis diagnosis was set as the index date. Patients were required to have ≥6 months of continuous enrollment with medical and pharmacy benefits pre-index and ≥12 months post-index. Patients were followed from index until the earliest of loss to follow-up or study end. All-cause healthcare costs and outpatient pharmacy costs were calculated for the overall psoriasis cohort and for the six different psoriasis patient sub-groups: (a) patients with moderate-to-severe disease and mild disease, (b) patients with psoriatic arthritis and those without, and (c) patients on biologics and those who are not. Costs are presented per-patient-per-year (PPPY) and by years 1, 2, 3, 4, and 5 of follow-up, expressed in 2014?US dollars.

Results: A total of 108,790 psoriasis patients were selected, with a mean age of 46.0 years (52.7% females). Average follow-up was 962 days. All-cause healthcare costs were $12,523 PPPY. Outpatient pharmacy costs accounted for 38.6% of total costs. All-cause healthcare costs were highest for patients on biologics ($29,832), then for patients with psoriatic arthritis ($23,427) and those with moderate-to-severe disease ($21,481). Overall, all-cause healthcare costs and outpatient pharmacy costs presented an upward trend over a 5-year period.

Conclusions: Psoriasis is associated with significant economic burden, which increases over time as the disease progresses. Patients with moderate-to-severe psoriasis, those with psoriatic arthritis, or use of biologics contributes to higher healthcare costs. Psoriasis-related pharmacy expenditure is the largest driver of healthcare costs in patients with psoriasis.