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Mauskopf J.,RTI Health Solutions | Brogan A.,RTI Health Solutions | Martin S.,Johnson and Johnson Pharmaceutical Services | Smets E.,Johnson and Johnson Pharmaceutical Services LLC

Introduction: Darunavir is a new protease inhibitor (PI) that is co-administered with low-dose ritonavir and has demonstrated substantial efficacy in clinical trials of highly treatment-experienced patients when combined with an optimized background regimen (with or without enfuvirtide). This study estimates the cost effectiveness of darunavir with ritonavir (DRV/r) in this population over 5-year and lifetime time horizons in the USA. Methods: AMarkov model was used to follow a treatment-experienced HIV-1 cohort through six health states, based on CD4 cell count: greater than 500, 351-500, 201-350, 101-200, 51-100 and 0-50 cells/mm 3, and death. The magnitude of the CD4 cell count increase and duration of increasing and stable periodswere derived fromweek 48DRV/r clinical trial results (POWER1 and 2). The treatment pathway assumed one regimen switch following treatment failure on the initial regimen. The use of antiretroviral drugs was based on usage in DRV/r clinical trials. US daily wholesale acquisition costs were calculated using the recommended daily doses. For each CD4 cell count range, utility values, HIV-1-related mortality rates and costs for medical resources (other than antiretroviral drug costs) were obtained from published literature. Non-HIV-1-related mortality rates were calculated by applying a relative risk value to theUS general population age and gender-specific mortality rates. Costs and outcomes were discounted at 3% per year. One-way and probabilistic sensitivity analyses and variability analysis were performed. Results: In a 5-year analysis, patients receivingDRV/r experienced 3.80 qualityadjusted life-years (QALYs) and incurred total medical costs of US$217 288, while those receiving control PIs experienced 3.60QALYs and incurred costs of US$218 962. DRV/r was both more effective and less costly than control PIs. For the lifetime analysis, the QALYs and lifetime medical costs with DRV/r were 10.03 and US$565 358, compared with 8.76 and US$527 287 with control PIs. The incremental cost-effectiveness ratio for DRV/r compared with control PIs was US$30 046. One-way sensitivity analyses for both time horizons indicated that the results were most sensitive to changes in the rate of CD4 cell count change during stable and declining periods (lifetime only), duration of stable period (5-year only) andHIV-1-relatedmortality rates. The results of the variability analysis weremost sensitive to themodel time horizon.Nevertheless, for all ranges and scenarios tested in these analyses, the incremental cost perQALY gained remained below US$50 000. The probabilistic sensitivity analysis showed that there was a 0.921 and 0.950 probability of a cost-effectiveness ratio below US$50000 per QALY for the 5-year and lifetime time horizon, respectively. Conclusions: DRV/r is predicted to be cost effective compared with control PI in highly treatment-experienced patients and is predicted to yield an average of 0.20 additional QALYs per treatment-experienced patient over 5 years and 1.27 additional QALYs over a lifetime in this population. © 2010 Adis Data Information BV. All rights reserved. Source

Gregorian Jr. R.S.,Canal Partners | Gasik A.,Canal Partners | Kwong W.J.,Johnson and Johnson Pharmaceutical Services LLC | Voeller S.,Canal Partners | Kavanagh S.,Health Economics
Journal of Pain

This study examined the relative impact of pain relief and opioid side effects on patients' and physicians' preferences for medication. An Internet survey was completed by 618 patients (302 acute pain, 316 chronic pain) and 325 physicians (83 primary care, 80 pain specialists, 41 oncologists, 40 general surgeons, 40 orthopedic surgeons, 20 rheumatologists, 21 neurologists). Respondents completed an Adaptive Conjoint Analysis (ACA) exercise in which they indicated their relative preference for 20 pairs of hypothetical opioid pain medications described by varying levels of pain relief and side-effect incidence. Almost all patients (96% of chronic, 92% of acute) reported experiencing at least 1 side effect while on opioid medication, but physician-estimated incidence rates of most opioid side effects were much lower than those reported by patients. Opioid side effects, rather than pain relief, explained the majority of variance for medication preference for both patients (74% for chronic, 73% for acute) and treating physicians (73% for chronic, 74% for acute) in this exercise. Nausea and vomiting were major determinants of opioid medication preference, with each explaining as much of the variance in preference as did pain relief (21% to 25%). Nausea and vomiting were the most important side effects based on the amount of pain relief that respondents were willing to give up for reducing the incidence of side effects. The importance of side effects was confirmed in an open-ended question where 51% of patients and 58% of physicians identified side-effect reduction as an unmet need for pain medications. Perspective: This study provided insights into patient and physician preferences of the risk and benefit balance of opioid therapy. This information could improve understanding of patient needs and facilitate the incorporation of patient preference into therapy choice. © 2010 by the American Pain Society. Source

Brogan A.,RTI Health Solutions | Mauskopf J.,RTI Health Solutions | Talbird S.E.,RTI Health Solutions | Smets E.,Johnson and Johnson Pharmaceutical Services LLC

Introduction: The phase III TITAN trial evaluated the use of darunavir with low-dose ritonavir (DRV/r) 600/100mg twice daily (bid) compared with lopinavir with low-dose ritonavir (LPV/r) in treatment-experienced, lopinavirnaive patients. This study estimates the cost effectiveness of DRV/r from a US societal perspective when compared with LPV/r in treatment-experienced patients with a profile similar to those TITAN patients who had one or more International AIDS Society - USA (IAS-USA) primary protease inhibitor (PI) resistance-associated mutations (RAMs) at baseline. This population had less advanced HIV disease and a broader range of previous PI exposure/failure (0-≥2 PIs) at enrolment than those in the darunavir phase IIb POWER trials. Methods: An existing Markov model containing six health states defined by CD4 cell count range (>500, 351-500, 201-350, 101-200, 51-100 and 0-50 cells/mm 3) and an absorbing state of death was adapted. Baseline demographics, CD4 cell count distribution and antiretroviral drug usage, virological response (at week 24), and immunological response estimates and matching transition probabilities were based on data collected directly from the one or more IAS-USA PI mutation subpopulation during the first 48 weeks of the TITAN trial, as well as from published literature. Patients were assumed to switch to a regimen containing tipranavir plus an optimized background regimen after treatment failure. For each CD4 cell count range or health state, the utility values, HIV and non-HIV-related mortality rates, and non-antiretroviral-related cost of HIV care estimates were derived from published literature. Unit costs were derived from official local sources. A lifetime horizon was taken in the base-case analysis. Results: The base-case analysis predicted discounted quality-adjusted survival gains of 0.493 quality-adjusted life-years (QALYs) for DRV/r compared with LPV/r, resulting in an incremental cost-effectiveness ratio (ICER) of US$23 057 per QALY gained over a lifetime horizon. Probabilistic sensitivity analysis indicated a 0.754 probability of an ICER below the threshold of US$50 000 per QALY gained. DRV/r remained cost effective over all parameter ranges tested in extensive one-way sensitivity analyses and variability analyses, which examined the impact of input parameter uncertainty and changes in model assumptions and treatment patterns, respectively. Shortening the model time horizon had the largest impact on the ICER, reducing it most notably to US$4919 with a 10-year time horizon. Conclusion: From a US societal perspective and based on an analysis of the patients with primary IAS-USA PI RAMs enrolled in the darunavir phase III TITAN trial, a highly active antiretroviral therapy (HAART) regimen containingDRV/r 600/100mg bid is estimated to be a cost-effective therapy when compared with a HAART regimen containing LPV/r, for the management of treatment-experienced, PI-resistant, HIV-infected adults with a broad range of previous PI use/failure. © 2010 Adis Data Information BV. All rights reserved. Source

Kwong W.J.,Johnson and Johnson Pharmaceutical Services LLC | Kwong W.J.,Daiichi Sankyo | Diels J.,Worldwide Health Economics and Pricing | Kavanagh S.,Worldwide Health Economics and Pricing
Annals of Pharmacotherapy

Background: Gastrointestinal (GI) adverse effects are common with oral opioid treatment. objective: To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective. methods: Medical and pharmacy claims from the PharMetrics' Patient-Centric Database were used to identify opioid-naive patients who received a new prescription for oxycodone-or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases - 9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities. results: Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits ( 0.36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001). conclusions: The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system. Source

Boswell K.,Xcenda | Kwong W.J.,Johnson and Johnson Pharmaceutical Services LLC | Kavanagh S.,Worldwide Health Economics and Pricing
Journal of Opioid Management

Opioid analgesia is the mainstay of treatment for moderate to severe acute and chronic pain and is highly effective in relieving pain but can be limited by side effects, the most common of which affect the gastrointestinal (GI) and central nervous systems. A growing body of evidence demonstrates that opioid-associated GI side effects constitute an important health problem with significant humanistic and economic consequences that warrant consideration by healthcare professionals and administrators in optimizing patients' pain management. This article documents the frequency of opioid-associated GI side effects and describes its clinical and economic burdens based on a systematic review of the medical literature between 1966 and 2008. © 2010 Journal of Opioid Management, All Rights Reserved. Source

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