Evaluation of Patient Registries Supporting Reimbursement Decisions: The Case of Oxaliplatin for Treatment of Stage III Colon Cancer

Mohseninejad, Leyla; Gils, Chantal van; Groot, Carin A. Uyl–de; Buskens, Erik; Feenstra, Talitha

doi:10.1016/j.jval.2014.10.008

Cited by 12 publications

(10 citation statements)

References 26 publications

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“…Firstly, our results are not the first to describe the antiinflammatory effect of pioglitazone on colitis. Secondly, although it has been reported that intrathecal or systematical of pioglitazone attenuates hyperalgesia in a neuropathic pain model [20,50]. However, we only observe the effects of systematical administration of pioglitazone on colitis and related pain hypersensitivity.…”

Section: Limitationscontrasting

confidence: 54%

Pioglitazone Attenuates Experimental Colitis-Associated Hyperalgesia through Improving the Intestinal Barrier Dysfunction

et al. 2020

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Impaired intestinal mucosal integrity during colitis involves the peroxisome proliferator-activated receptor-γ (PPARγ), an important anti-inflammatory factor in intestinal mucosa homoeostasis, which is a potential target in colitis. Recurrent chronic pain is a vital pathogenetic feature of colitis. Nevertheless, potential functions of PPARγ in the colitis-associated hyperalgesia remain unclear. This study aimed to investigate biological roles of pioglitazone in relieving colitis-associated pain hypersensitivity by a PPARγ tight junction protein-dependent mechanism during the course of dextran sodium sulfate (DSS)-induced intestinal inflammation. The DSS-induced colitis model was generated in C57BL/6 mice. Changes in colitis induced the injury of intestinal mucosal barrier and hyperalgesia after a 6-day treatment of pioglitazone (25 mg/kg, IP injection) were assessed through immunofluorescent, hematoxylin and eosin (H&E) staining, western blot analysis, and determination of paw withdrawal mechanical threshold. A significant reduction of paw withdrawal mechanical threshold occurred after DSS treatment. Follow-up data showed that systematic administration of PPARγ agonist pioglitazone ameliorated the DSS-induced colitis and the development of colitis-associated hyperalgesia by repairing the intestinal mucosal barrier. The tight junction proteins ZO-1 and Claudin-5 were upregulated by PPARγ signaling, which in turn promoted the improvement of intestinal barrier function. Moreover, pioglitazone inhibited phosphorylation of ERK and NF-κB in the colon and decreased the levels of inflammatory cytokines in both colon spine tissues. Furthermore, systemically pioglitazone treatment inhibited the activation of microglia and astrocytes, as well as DSSinduced phosphorylation of NR2B subunit in spinal cord, which was correspondingly consistent with the pain behavior. Pioglitazone ameliorates DSS-induced colitis and attenuates colitis-associated mechanical hyperalgesia, with improving integrity of the Yulin Huang and Chenchen Wang contributed equally to this work.

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Section: Limitationscontrasting

confidence: 54%

Pioglitazone Attenuates Experimental Colitis-Associated Hyperalgesia through Improving the Intestinal Barrier Dysfunction

et al. 2020

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“…Several examples of difficulties with outcomes-based agreements are available in the literature. A Dutch evaluation of an outcomes-based managed entry agreement of oxaliplatin for treatment of stage III colon cancer that collected additional data through a patient registry found that patient heterogeneity made it problematic to estimate incremental cost-effectiveness of the treatment using the collected data (Mohseninejad et al, 2015 ). A Dutch hematological malignancies registry reported that the three main issues were confounding by indication, missing data, and insufficient comparable patient numbers (Blommestein et al, 2015 ).…”

Section: Resultsmentioning

confidence: 99%

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

2018

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As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach in a sustainable way. This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe. We found that during 2006–2016 outcomes-based managed entry agreements were not commonly used for products with a conditional marketing authorization or authorized under exceptional circumstances. The barriers and enablers to develop workable managed entry agreements models for adaptive pathways products were discussed through interviews and a multi-stakeholder workshop with a number of recommendations made in this paper.

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“…Organising and performing data collection are two of the most frequently discussed barriers for implementation of OBAs for payers, developers and healthcare providers (Sudlow and Counsell, 2003;de Pouvourville, 2006;Carlson et al, 2010;McCabe et al, 2010;Raftery, 2010;Stafinski et al, 2010;Williamson, 2010;Jaroslawski and Toumi, 2011b;Klemp et al, 2011;Neumann et al, 2011;Cascade et al, 2012;Goldenberg and Bachman, 2012;Xoxi et al, 2012;Bibeau et al, 2014;Gibson and Lemmens, 2014;Li et al, 2014;Garattini et al, 2015;Lu et al, 2015;Lucas and Wong, 2015;Mohseninejad et al, 2015;Barlas, 2016b;Carr and Bradshaw, 2016;Malik, 2016;Pouwels et al, 2016;van de Wetering et al, 2017;Duhig et al, 2018;Ernst and Young, 2018a;Ernst and Young, 2018b;EXPH, 2018;Goldenberg et al, 2018;Jorgensen et al, 2018;Stirnadel-Farrant et al, 2018;Urbinati et al, 2018;Federici et al, 2019;Macaulay and Turkstra, 2019;Mundy et al, 2019;Pace et al, 2019;Kannarkat et al, 2020). First, experiences with OBAs in the Netherlands and the United Kingdom highlight that...…”

Section: The Organization Of Data Collectionmentioning

confidence: 99%

“…Therefore, Makady et al recommend to invest in the extensive training of healthcare professionals, manufacturers and payers on analysis and interpretation of the results for OBAs . Furthermore, progress of data collection could be monitored by frequent payer audits to correct for errors during the course of the agreement and to verify if the registry is providing useful information (Mohseninejad et al, 2015;Annemans and Pani, 2017;Gerkens et al, 2017;FoCUS, 2019b).…”

Section: The Organization Of Data Collectionmentioning

confidence: 99%

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

et al. 2020

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Background: The challenging market access of high-cost one-time curative therapies has inspired the development of alternative reimbursement structures, such as outcome-based spread payments, to mitigate their unaffordability and answer remaining uncertainties. This study aimed to provide a broad overview of barriers and possible opportunities for the practical implementation of outcome-based spread payments for the reimbursement of one-shot therapies in European healthcare systems.Methods: A systematic literature review was performed investigating published literature and publicly available documents to identify barriers and implementation opportunities for both spreading payments and for implementing outcome-based agreements. Data was analyzed via qualitative content analysis by extracting data with a reporting template.Results: A total of 1,503 publications were screened and 174 were included. Main identified barriers for the implementation of spread payments are reaching an agreement on financial terms while considering 12-months budget cycles and the possible violation of corresponding international accounting rules. Furthermore, outcome correction of payments is currently hindered by the need for additional data collection, the lack of clear governance structures and the resulting administrative burden and cost. The use of spread payments adjusted by population- or individual-level data collected within automated registries and overseen by a governance committee and external advisory board may alleviate several barriers and may support the reimbursement of highly innovative therapies.Conclusion: High-cost advanced therapy medicinal products pose a substantial affordability challenge on healthcare systems worldwide. Outcome-based spread payments may mitigate the initial budget impact and alleviate existing uncertainties; however, their effective implementation still faces several barriers and will be facilitated by realizing the required organizational changes.

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Evaluation of Patient Registries Supporting Reimbursement Decisions: The Case of Oxaliplatin for Treatment of Stage III Colon Cancer

Cited by 12 publications

References 26 publications

Pioglitazone Attenuates Experimental Colitis-Associated Hyperalgesia through Improving the Intestinal Barrier Dysfunction

Pioglitazone Attenuates Experimental Colitis-Associated Hyperalgesia through Improving the Intestinal Barrier Dysfunction

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

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