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Y. Lievens

Moderator of

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    MS19 - New Health Technology for Lung Cancer; Assessment and Implementation (ID 36)

    • Event: WCLC 2013
    • Type: Mini Symposia
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 4
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      MS19.1 - Assessing New Technology in Lung Cancer Radiotherapy (ID 546)

      14:05 - 14:25  |  Author(s): F. Macbeth

      • Abstract
      • Presentation
      • Slides

      Abstract
      The past 15 years has seen dramatic developments in radiotherapy (RT) technology and techniques many of which are being applied to patients with lung cancer. The most important of these are PET imaging for RT planning, 3D conformal RT, Intensity Modulated RT, stereotactic body RT (SBR), Image Guided RT and techniques to compensate for respiratory movement such as gating. These are now in widespread use and becoming the ‘standard of care’ in developed countries. But significant questions remain about how fully they have been evaluated and whether or not they have actually led to improvements in clinical outcomes, let alone whether they are in fact cost effective innovations. In this presentation I will address the following questions: · Why are new RT technologies difficult to evaluate for anything beyond efficacy and safety? · Should they be subjected to the same rigorous evaluations as new pharmaceuticals through randomised controlled trials (RCTs) before entering wide clinical practice? · What strategies could be used to assess ‘value for money’ in the absence of high quality evidence? The model for assessing new technologies is derived from pharmaceutics where the new drug is first evaluated for safety and dosage (Phase I), then for efficacy (Phase II) and finally for clinical effectiveness compared to standard therapy (Phase III) before (in some health systems) being assessed for cost effectiveness. New non-pharmacological technologies are not subject to the same regulatory regime and, other than meeting routine requirements for radiation safety, RT technologies can be introduced into routine practice without evidence of clinical effectiveness – improving outcomes. Novel RT technologies are difficult to evaluate formally because: · They often develop incrementally over time with new refinements, especially in associated computer software. · There may be competing manufacturers with slightly different products. · There is often a ‘learning curve’ before they are used most effectively. · There are demonstrable improvements in planned dose distributions, imaging and accurate dose delivery which lead to a reasonable belief that clinical outcomes will be better. · There is always a need for capital investment, sometimes substantial, which means that only centres that already have the technology can participate in comparative clinical trials and those clinicians may be reluctant because they may already be convinced that their new technology is better. · The important clinical outcomes, local control, survival, late radiation toxicity take years to evaluate. · Funding for such research may be hard to find. Does this really matter? It can be argued that demonstration of better-looking computerised plans and apparently more accurate and consistent delivery of radiation dose is a good in itself and one should always try to use the best tools available. That is true – up to a point. But there are two important considerations. First does this apparent improved ‘accuracy’ give false reassurance and result in in unsafe margins and poorer local control? This problem can be partly addressed by careful and well planned prospective follow up studies. Secondly these innovations come with a real cost in capital investment, staff time and, often, longer individual treatment times and lower throughput. How much is that cost and could that money be used in another area to deliver more health benefit? In other words are these innovations cost effective? There are increasing concerns everywhere about the escalating costs of healthcare and whether the payer is the state, an insurance system, a health maintenance organisation or an individual, health professionals have a responsibility to deliver cost effective care. Given the difficulty of carrying out RCTs in this area, what can be done to help those deciding on the best use of resources? One option is to undertake modelling studies not only of dosimetric and clinical consequences but also of costs and consequences. It may then be possible to make to some high level decisions about whether the benefits are likely to large enough and the costs low enough to justify introduction into routine clinical practice, whether comparative research (ideally an RCT) is needed or whether further evaluation of efficacy and safety is needed in institutions experienced in such research. I would therefore argue for better coordinated efforts, preferably at an international level, to address this difficult problem and provide more information about how best to use these new and important resources.

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      MS19.2 - Cost Effectiveness of Prevention of Lung Cancer (Developed and Developing World) (ID 547)

      14:25 - 14:45  |  Author(s): C. Dresler, R. Herbst, A. Hutson

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MS19.3 - Resource Constraints as a Barrier to Lung Cancer Management: Developing Nations (ID 548)

      14:45 - 15:05  |  Author(s): S. Thongprasert, U. Premsuwan

      • Abstract
      • Presentation
      • Slides

      Abstract
      Resource Constraints is an important barrier to Lung Cancer Management. In order to understand this issue in Developing Nations, the questionnaires was set up and send to an experts in Asian countries to find out the fact about this issues. Data gather from the questionnaires will be present at the meeting. Specific information in the questionnaires are Drug lagging period, time to get new cancer drug approval, the important of economic analysis during the approval of new anticancer drug. The other information related to man power including specialist in all related subspecialties and the availability and accessibilty to diagnostic and treatment will be captured by questionnaires. Pattern of Health Insurance and other cost was also the information gathered at the same time.

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      MS19.4 - Resource Constraints as a Barrier to Lung Cancer Management: Developed Nations (ID 549)

      15:05 - 15:25  |  Author(s): W. Evans

      • Abstract
      • Presentation
      • Slides

      Abstract
      The chronic disease burden of developed countries is increasing as the postwar “baby boomers” enter their senior years. The cost of managing these chronic diseases is compounded by the increasing availability and use of expensive technologies. Cancer drug costs are a key driver of health care costs and the expenditure on cancer drugs is rising faster than spending in most other areas of healthcare. Because of this and the fiscal constraint most developed countries have put in place a rigorous drug review process. The United Kingdom’s National Institute for Health and Care Excellence (NICE), amongst others has led the way in establishing drug review processes. These reviews are generally viewed by the pharmaceutical industry, healthcare providers and the public itself as a barrier to access. The pan-Canadian Oncology Drug Review (pCODR) evaluates the clinical benefits and safety of new cancer drugs, as well as their cost-effectiveness and alignment with patient values using a standardized clinical and economic review process, an expert panel, a deliberative framework and broad public engagement (1). Commonly, recommendations are conditional on the drug price being lowered because the drug is not felt to be cost-effective. The determination of incremental cost-effectiveness or cost-utility is critical to drug funding approval in most jurisdictions except the United States. This is determined by assessing the incremental cost of the new drug or regimen over the standard treatment and dividing by the incremental benefit usually measured as years of life gained. In Canada, $50,000 per life year gained or less was generally accepted as cost-effective. As drug costs have increased, this "threshold" has crept higher and $100,000 per LYG is increasingly accepted as “reasonable”. To take account of morbidity from the disease and its treatment, the quantity of life gained is weighted by the quality of that life into a single multidimensional measure (i.e. the quantity adjusted life year or QALY). The availability of other resources, not related to the cost of drugs, can be a barrier to access. In 2008, Cancer Care Ontario began to measure concordance with guidelines developed through its Program in Evidence-based Care and to report this information through a Cancer System Quality Index (CSQI) (3). In 2010- 2011, it was noted that only 41% of resected stage II/IIIA patients received guideline recommended adjuvant chemotherapy (AC) at Ontario’s regional cancer centres. There was also substantial variation in guideline adherence between centers ranging from 42.9% to 72.1%. Men were significantly less likely to be treated with AC (38.2% compared to 52.7% for women) (p=0001), as were patients over age 65 (65% < 65 yrs. vs. 34% > 65 yrs.)(p=.0001). Patients from regions with the highest tercile of immigrants were significantly less likely to be treated: 14.3% for the highest, 46% for the middle and 51% for the lowest tercile. Similar variations were seen for the uptake of the guideline recommendation for the use of combined modality therapy in the treatment of stage III NSCLC. To better understand the reasons for these variances, a survey and key informant interviews were undertaken with clinicians and administrators. The perception of respondents was that the most common barriers to implementing practice guidelines were the slow referral process of patients to the treatment centers, lack of support from the organization’s leadership to implement the recommended regimens and the difficulties that patients had in getting to the treatment centers. These results suggested that greater efforts are required to communicate best practices to providers, (including primary care physicians), to improve the efficiency of clinic processes and to arrange patient transportation. For aboriginal and immigrant populations, culture and language are known barriers. Resources to lower language barriers, to assist patients in health system navigation and to educate health providers in the provision of culturally sensitive care may be necessary to ensure equitable access to appropriate care. Some developed countries have experienced resource constraints that have delayed access to cancer surgery and to radiation treatment. Excessive wait times result from inadequate capacity and/or inefficiencies in the health system. To resolve these issues first requires recognition of the problem, the development of a plan of action, appropriate funding to address capacity issues, process improvements to increase efficiency and incentives to providers to prioritize cancer treatments. In a recent review of access to cancer care services in Canada, Maddison et al. noted that inequity of access occurs across the continuum of care for different disease sites (4). The review suggested that access to cancer services is most inequitable at the beginning (i.e. screening) and at the end (i.e. end-of-life care). Income level appeared to have the most influence on screening while age and geography were most influential on access to end-of-life services. As the results of the NLST are implemented as population-based screening programs, low dose CT will compete for diagnostic service resources and other services. Smokers at risk from lower socioeconomic levels, in particular, may encounter barriers to access. At the other end of the cancer spectrum, access to palliative care resources varies widely in developed countries. Conclusions: Access to optimal lung cancer care across the continuum from screening and early detection through treatment and end-of-life care can encounter numerous resource barriers, which are not all monetary in nature. Although the cost of new drugs is the most significant potential resource barrier, numerous other barriers can exist in developed countries related to the resources available for screening or diagnosis, radiation and surgery, access to knowledge specialists, supportive care services and accessible end-of-life care in the home or community. References: 1. Pan-Canadian Oncology Drug Review (pCODR) (website). Toronto, Ontario. (Accessed August 1, 2013) Available at http://www.pCODR.org 2. Cancer System Quality Index (CSQI) (website). Toronto, Ontario: Cancer Quality Council of Ontario (accessed August 6, 2013). Available from: http://www.csqi.on.ca 3. Maddison AR, Asada Y, Urquhart R. Inequity in access to cancer care: a review of the Canadian literature. Cancer Causes Control 2011; 22:359-366

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Author of

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    MO17 - Radiotherapy I: Stereotactic Ablative Body Radiotherapy (ID 106)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      MO17.07 - The cost of stereotactic body radiotherapy in early-stage lung cancer: a multicenter cost-calculation. (ID 1772)

      16:55 - 17:00  |  Author(s): Y. Lievens

      • Abstract
      • Presentation
      • Slides

      Background
      In the framework of a coverage with evidence development program on innovative radiotherapy techniques in Belgium, the cost of stereotactic body radiotherapy (SBRT) was calculated and compared to the cost of more standardized 3D-conformal (3D-CRT) and intensity-modulated (IMRT) radiotherapy treatments.

      Methods
      Activity-Based Costing methodology was used to calculate resource costs of radiotherapy treatments delivered in ten operational Belgian departments. Cost inputs were defined as personnel costs (number of full-time equivalents (FTE) devoted to the actual radiotherapy process times reference wages according to the guidelines of the Belgian Health Care Knowledge Centre (KCE)), equipment costs (including maintenance and upgrade) and specific material costs. Following KCE guidelines, overhead was accounted at 56% of global costs excluding physician wages. The activities in scope comprised all activities performed during the radiotherapy process from the first consultation, over treatment preparation, delivery and quality assurance until completion of the treatment. Products included all radiotherapy treatments delivered in each specific department and combined indication with treatment site and technical complexity. In view of the comparative analysis, products were aggregated into larger categories.

      Results
      The average cost of all SBRT treatments was calculated at 6,221€ (range 3,104€ - 12,649€) and compared favorably to the average cost of standard fractionated 3D-CRT (5,919€, range 4,557€ - 6,564€) and IMRT (7,379€, range 5,054€ - 8,733€). The average cost of hypofractionated 3D-CRT and IMRT was lower (3,993€ res. 4,730€). Apart from differences in investment costs, the relatively larger variability in fraction number and in time requirements for individual personnel types performing the radiotherapy activities explain the larger spread in treatment cost of SBRT compared to more standardized radiotherapy treatments. The figure demonstrates these differences for various technical SBRT solutions and for different 3D-CRT and IMRT fractionation schedules. The overall averages are shown by the bars, minimum and maximum center averages by the error bars. The number of centers is mentioned between brackets. Activity times shown combine time per personnel with number of FTE. Figure 1

      Conclusion
      Cost calculation of radiotherapy treatments at the multi-institutional level using Activity-Based Costing is feasible. SBRT shows larger variation in cost than more standardized radiotherapy approaches in line with the larger variability in technical solutions, time requirements and resource consumption. Its average cost however does not exceed the average cost of standard curative radiotherapy. Careful interpretation of these variables within the applicable economic context is required when using such cost data for determining financing levels.

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    P2.06 - Poster Session 2 - Prognostic and Predictive Biomarkers (ID 165)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.06-030 - Radiation-induced lung damage quantification with CT scans: Correlation with single nucleotide polymorphisms (ID 2420)

      09:30 - 09:30  |  Author(s): Y. Lievens

      • Abstract

      Background
      Radiation-induced lung damage (RILD) is a dose-limiting toxicity of lung radiotherapy. Individual sensitivity can be measured by changes in Hounsfield Units over time (delta HU) on CT scans (De Ruysscher et al. Acta Oncol 2013). This endpoint is specific for lung damage and does not correlate with dyspnoea, which is multi-factorial. In this study, we investigated the association between density changes over time and SNPs aiming at finding individual sensitivity for RILD.

      Methods
      Delta HU/Gy and delta HU/Gy x MLD (Mean Lung Dose), the latter to take into account a volume factor for RILD, were correlated with 314 SNPs related to fibrosis and inflammation. The outcome variables were square root transformed because both were not normally distributed. Univariate ANOVA analyses were performed for comparisons of means. P-values of less than 0.01 were considered to be significant.

      Results
      Eighty-nine lung cancer patients were studied, 63 men and 26 females. Twenty patients were treated with radiotherapy alone, 31 with sequential chemo-RT and 38 with concurrent chemo-RT. Twenty percent of the patients developed grade 2 or more clinical dyspnoea after treatment. Three SNPs were significantly correlated with delta HU/Gy: rs2252070 (p=0.006, MMP13), rs2230588 (p=0.009, JAK1) and rs12901071 (p=0.009, SMAD3) [Table 1A]. For delta HU/Gy x MLD, significant associations were found for rs3819122 (p=0.008, SMAD4), rs2230529 (p=0.009, ITGB2) and rs2230588 (p=0.009, JAK1) [Table 1B]. Figure 1

      Conclusion
      Quantification of CT density changes due to radiotherapy, measured as HU changes over time as a specific and quantitative endpoint for RILD correlates with specific SNPs in genes involved in signal transduction of cytokines (SMAD3/4, JAK1), in the extracellular matrix (MMP13) and in cell adhesion (ITGB2). External validation will follow.

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    P2.08 - Poster Session 2 - Radiotherapy (ID 198)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P2.08-013 - Proton radiotherapy for locally-advanced non-small cell lung cancer, a cost-effective alternative to photon radiotherapy in Belgium? (ID 1657)

      09:30 - 09:30  |  Author(s): Y. Lievens

      • Abstract

      Background
      As part of a feasibility study for a Hadron Therapy Centre in Belgium, an economic evaluation was performed to assess the potential cost-effectiveness of proton radiotherapy (PT) delivered concurrently with chemotherapy for locally-advanced non-small cell lung cancer (LA-NSCLC), compared to concurrent chemoradiotherapy employing photon therapy, either 3D-conformal (3D-CRT) or intensity-modulated (IMRT) radiotherapy.

      Methods
      A Markov decision-analytic model was developed using Microsoft Excel 2007 software. The model was defined for a time horizon of 10 years, allowing patients to transition between 5 health states (treatment, controlled disease, loco-regional progression, distant progression and death) using transition cycles of 3 months. Transition probabilities were derived from photon and proton literature on LA-NSCLC and from nationally available data. Results were to be expressed in cost per (quality adjusted) life years (LY and QALY). The occurrence of grade 3 toxicity or higher in terms of radiation pneumonitis, radiation esophagitis/dysphagia and pulmonary radiation fibrosis was accounted for in the calculation of QALYs. Treatment costs of the standard 3D-CRT and IMRT treatments were obtained from an Activity-Based Costing (ABC) exercise in Belgian radiotherapy centers (KCE report 198). Similarly, the cost of PT was calculated using ABC in different technical (proton-only vs. combined proton and carbon-ion center) and financing (private vs. public) scenarios. Toxicity and follow-up costs were based on literature evidence but adapted to the Belgian context.

      Results
      The base case analysis used the scenario of a publicly financed combined center. The survival curves generated by the model demonstrated it accurately predicts survival of published literature and of the Belgian Cancer Registry. Compared to 3D-CRT res. IMRT, PT generates 0.837 res. 0.664 extra LYs and 0.549 res. 0.452 extra QALYs. When combined with the higher cost (18,875€ res. 14,257€), this translates into an incremental cost-effectiveness ratio (ICER) of 22,543€/LY for PT compared to 3D-CRT and of 21,489€/LY compared to IMRT. Expressed in cost per QALY, the ICERs amount to 34,396€/QALY and 31,541€/QALY respectively. Assessing the effect of different technical scenarios and/or financing methods, the ICER ranges between 21,489€ to 53,685€/LY and 31,541€ to 78,873€/QALY, with the highest figures found for a combined center with private financing. One-way sensitivity analyses reveal that the results are most sensitive to the effect of proton therapy on disease control, loco-regionally as well as at distance, and to the quality of life pre-progression.

      Conclusion
      Based on a public financing scenario for a combined center, PT delivered concurrently with chemotherapy is found borderline cost-effective in the Belgian health care context, compared to the best available photon radiotherapy alternatives. These results are however highly sensitive to the cost of PT (hence the financing scenario) and the expected clinical advantage of PT, both in terms of improved survival and decreased long-term toxicity impacting on quality of life. Apart from clinical appropriateness and budgetary possibilities, such results support decision-making on the feasibility and desirability of introducing hadron therapy in Belgium.