Safer radiation therapy treatment resulting from an equipment transition: A mixed-methods study.

PURPOSE: To realize individualized safe radiation therapy, reliable treatment equipment is essential in combination with a system-level improvement approach. We hypothesized that implementation of a system that integrated all required treatment equipment would result in improved safety and stability of the irradiation treatment process. METHODS AND MATERIALS: Seven accelerators, portal imaging, and the treatment planning software were replaced by an integrated system that included 6 accelerators. The number of reported safety incidents and root causes were recorded between 2010 and 2014. Time series analysis was performed, and quantitative results were explored by structured interviews. Additionally, downtime was recorded. RESULTS: From January 2010 to July 2014, 5085 incidents were reported. Reports related to the accelerators decreased from 33% (2010) to 20% (2013-2014) of total reports, whereas the number of delivered fractions per accelerator increased by 20% (2010: 643 per month; 2013: 795 per month). Reports related to portal imaging decreased from 16.5 reports per month (2010) to 3.1 (2013-2014). Of these portal imaging reports, 316 had at least 1 technical cause in 2010, which decreased to 13 in 2013-2014. Interviewees attributed the decreased reporting to the equipment transition, not to decreased safety awareness. Downtime decreased by 46%, from 5.4% in 2010 to 2.9% in 2013. CONCLUSIONS: The number of reported accelerator- and portal imaging-related incidents decreased significantly, whereas safety awareness remained stable. In addition, accelerator downtime decreased, possibly resulting in less rescheduling of patients and fewer disruptions of work processes. Therefore, we conclude that the risk for serious safety incidents and patient harm decreased after implementation of the new integrated system.

Cost-Effectiveness of Reduced Waiting Time for Head and Neck Cancer Patients due to a Lean Process Redesign.

BACKGROUND: Compared with new technologies, the redesign of care processes is generally considered less attractive to improve patient outcomes. Nevertheless, it might result in better patient outcomes, without further increasing costs. Because early initiation of treatment is of vital importance for patients with head and neck cancer (HNC), these care processes were redesigned. OBJECTIVES: This study aimed to assess patient outcomes and cost-effectiveness of this redesign. METHODS: An economic (Markov) model was constructed to evaluate the biopsy process of suspicious lesion under local instead of general anesthesia, and combining computed tomography and positron emission tomography for diagnostics and radiotherapy planning. Patients treated for HNC were included in the model stratified by disease location (larynx, oropharynx, hypopharynx, and oral cavity) and stage (I-II and III-IV). Probabilistic sensitivity analyses were performed. RESULTS: Waiting time before treatment start reduced from 5 to 22 days for the included patient groups, resulting in 0.13 to 0.66 additional quality-adjusted life-years. The new workflow was cost-effective for all the included patient groups, using a ceiling ratio of €80,000 or €20,000. For patients treated for tumors located at the larynx and oral cavity, the new workflow resulted in additional quality-adjusted life-years, and costs decreased compared with the regular workflow. The health care payer benefited €14.1 million and €91.5 million, respectively, when individual net monetary benefits were extrapolated to an organizational level and a national level. CONCLUSIONS: The redesigned care process reduced the waiting time for the treatment of patients with HNC and proved cost-effective. Because care improved, implementation on a wider scale should be considered.

Spacers in radiotherapy treatment of prostate cancer: is reduction of toxicity cost-effective?

BACKGROUND AND PURPOSE: To compare the cost-effectiveness of treating prostate cancer patients with intensity-modulated radiation therapy and a spacer (IMRT+S) versus IMRT-only without a spacer (IMRT-O). MATERIALS AND METHODS: A decision-analytic Markov model was constructed to examine the effect of late rectal toxicity and compare the costs and quality-adjusted Life Years (QALYs) of IMRT-O and IMRT+S. The main assumption of this modeling study was that disease progression, genito-urinary toxicity and survival were equal for both comparators. RESULTS: For all patients, IMRT+S revealed a lower toxicity than IMRT-O. Treatment follow-up and toxicity costs for IMRT-O and IMRT+S amounted to €1604 and €1444, respectively, thus saving €160 on the complication costs at an extra charge of €1700 for the spacer in IMRT+S. The QALYs yielded for IMRT-O and IMRT+S were 3.542 and 3.570, respectively. This results in an incremental cost-effectiveness ratio (ICER) of €55,880 per QALY gained. For a ceiling ratio of €80,000, IMRT+S had a 77% probability of being cost-effective. CONCLUSION: IMRT+S is cost-effective compared to IMRT-O based on its potential to reduce radiotherapy-related toxicity.

Health economic controversy and cost-effectiveness of proton therapy.

Owing to increasing healthcare costs, there is a need to examine whether the benefits of new technologies are worth the extra cost. In proton therapy, where the evidence in favor is limited, it is heavily debated whether the expected benefit justifies the higher capital and operating costs. The aim of this article was to explore the existing methodologies of economic evaluations (EEs) of particle therapy and recommend an approach for future data collection and analysis. We reviewed the published literature on health economics of proton therapy using accepted guidelines on performing EE. Different cost strategies were assessed and comparisons with other treatment modalities were made in terms of cost-effectiveness. Potential bias in the existing studies was identified and new methodologies proposed. The principal cause of bias in EEs of proton therapy is the lack of valid data on effects as well as costs. The introduction of proton therapy may be seriously hampered by the lack of outcome and cost data and the situation is likely to continue not only in terms of justifying the capital investment but also covering the operational costs. We identified an urgent need to collect appropriate data to allow for reimbursement of such novel technology. In the absence of level 1 evidence, well-performed modeling studies taking into account the available cost and outcome parameters, including the current uncertainties, can help to address the problem of limited outcome and health economic data. The approach of coverage with evidence development, in which evidence is collected in an ongoing manner in population-based registries along with dedicated financing, may allow technological advances with limited initial evidence of benefit and value, such as protons, to become available to patients in an early phase of their technology life cycle.

Protons in head-and-neck cancer: bridging the gap of evidence.

PURPOSE: To use Normal Tissue Complication Probability (NTCP) models and comparative planning studies to explore the (cost-)effectiveness of swallowing sparing intensity modulated proton radiotherapy (IMPT) compared with swallowing sparing intensity modulated radiotherapy with photons (IMRT) in head and neck cancer (HNC). METHODS AND MATERIALS: A Markov model was constructed to examine and compare the costs and quality-adjusted life years (QALYs) of the following strategies: (1) IMPT for all patients; (2) IMRT for all patients; and (3) IMPT if efficient. The assumption of equal survival for IMPT and IMRT in the base case analysis was relaxed in a sensitivity analysis. RESULTS: Intensity modulated proton radiation therapy and IMRT for all patients yielded 6.620 and 6.520 QALYs and cost €50,989 and €41,038, respectively. Intensity modulated proton radiation therapy if efficient yielded 6.563 QALYs and cost €43,650. The incremental cost-effectiveness ratio of IMPT if efficient versus IMRT for all patients was €60,278 per QALY gained. In the sensitivity analysis, IMRT was more effective (0.967 QALYs) and less expensive (€8218) and thus dominated IMPT for all patients. CONCLUSIONS: Cost-effectiveness analysis based on normal tissue complication probability models and planning studies proved feasible and informative and enables the analysis of individualized strategies. The increased effectiveness of IMPT does not seem to outweigh the higher costs for all head-and-neck cancer patients. However, when assuming equal survival among both modalities, there seems to be value in identifying those patients for whom IMPT is cost-effective.

When to wait for more evidence? Real options analysis in proton therapy.

PURPOSE: Trends suggest that cancer spending growth will accelerate. One method for controlling costs is to examine whether the benefits of new technologies are worth the extra costs. However, especially new and emerging technologies are often more costly, while limited clinical evidence of superiority is available. In that situation it is often unclear whether to adopt the new technology now, with the risk of investing in a suboptimal therapy, or to wait for more evidence, with the risk of withholding patients their optimal treatment. This trade-off is especially difficult when it is costly to reverse the decision to adopt a technology, as is the case for proton therapy. Real options analysis, a technique originating from financial economics, assists in making this trade-off. METHODS: We examined whether to adopt proton therapy, as compared to stereotactic body radiotherapy, in the treatment of inoperable stage I non-small cell lung cancer. Three options are available: adopt without further research; adopt and undertake a trial; or delay adoption and undertake a trial. The decision depends on the expected net gain of each option, calculated by subtracting its total costs from its expected benefits. RESULTS: In The Netherlands, adopt and trial was found to be the preferred option, with an optimal sample size of 200 patients. Increase of treatment costs abroad and costs of reversal altered the preferred option. CONCLUSION: We have shown that real options analysis provides a transparent method of weighing the costs and benefits of adopting and/or further researching new and expensive technologies.

Simulating demand for innovative radiotherapies: an illustrative model based on carbon ion and proton radiotherapy.

BACKGROUND AND PURPOSE: Innovative therapies are not only characterized by major uncertainties regarding clinical benefit and cost but also the expected recruitment of patients. An original model was developed to simulate patient recruitment to a costly particle therapy by varying layout of the facility and patient referral (one vs. several countries) and by weighting the treated indication by the expected benefit of particle therapy. MATERIAL AND METHODS: A multi-step probabilistic spatial model was used to allocate patients to the optimal treatment strategy and facility taking into account the estimated therapeutic gain from the new therapy for each tumour type, the geographical accessibility of the facilities and patient preference. Recruitment was simulated under different assumptions relating to the demand and supply. RESULTS: Extending the recruitment area, reducing treatment capacity, equipping all treatment rooms with a carbon ion gantry and inclusion of proton protocols in carbon ion facilities led to an increased proportion of indications with the highest expected benefit. Assuming the existence of a competing carbon ions facility, lower values of therapeutic gain, and a greater unwillingness of patients to travel for treatment increased the proportion of indications with low expected benefit. CONCLUSIONS: Modelling patient recruitment may aid decision-making when planning new and expensive treatments.

The cost-effectiveness of particle therapy in non-small cell lung cancer: exploring decision uncertainty and areas for future research.

PURPOSE: To review and synthesize all available evidence in order to explore the cost-effectiveness of particle therapy (carbon-ions, protons) compared to the best current treatments for non-small-cell lung cancer (NSCLC), and the value of additional research. The present study focuses on stage I NSCLC, as no data is available for more advanced stages. METHODS: A probabilistic decision-analytic Markov model was constructed to synthesize all available evidence. Comparative treatments were carbon-ions, protons, conventional radiotherapy (CRT) and stereotactic radiotherapy (SBRT) for inoperable stage I NSCLC; and carbon-ions and SBRT for operable stage I NSCLC. The expected value of perfect information (EVPI) was calculated to support research decisions. RESULTS: For inoperable stage I NSCLC, carbon-ion therapy costed euro 67.257 per quality-adjusted-life-year gained compared to SBRT. Both treatments dominated protons and CRT. Considerable uncertainty surrounded these results, resulting in a high EVPI. For operable stage I NSCLC SBRT dominated carbon-ion therapy. CONCLUSIONS: Due to the considerable uncertainty in stage I NSCLC, and the lack of data on more advanced stages, it is recommended not to adopt particle therapy as standard treatment in NSCLC yet. More evidence is needed to reduce the decision uncertainty and to support evidence-based treatment decisions. It might be worthwhile to invest in a particle facility for clinical research. Future research should also weigh the investment risk, value of information and costs of delay.

How costly is particle therapy? Cost analysis of external beam radiotherapy with carbon-ions, protons and photons.

PURPOSE: Particle therapy has potentially a better therapeutic ratio than photon therapy. However, investment costs are much higher. This study provides an estimation and comparison of the costs of these therapies. METHODS: Within an extensive analytical framework capital and operational costs, cost per fraction, and four tumor specific treatment costs are calculated for three facilities: combined carbon-ion/proton, proton-only, and photon. RESULTS: Capital costs for the combined, proton-only and photon facilities are: euro 138.6 million, euro 94.9 million, euro 23.4 million. Total costs per year are: euro 36.7 million, euro 24.9 million, euro 9.6 million. Cost per fraction is: euro 1128 (euro 877-1974), euro 743 (euro 578-1300), euro 233 (euro 190-407). Cost ratio particle/photon therapy is 4.8 for the combined and 3.2 for the proton-only facility. Particle treatment costs vary from euro 10,030 (c-ion: lung cancer) to euro 39,610 (proton: head & neck tumors). Cost difference between particle and photon therapies is relatively small for lung and prostate cancer, larger for skull-base chordoma and head & neck tumors. CONCLUSION: Investment costs are highest for the combined carbon-ion/proton facility and lowest for the photon facility. Cost differences become smaller when total costs per year and specific treatment costs are compared. Lower fractionation schedule of particle therapy might further reduce its costs.

Cost-effectiveness of particle therapy: current evidence and future needs.

PURPOSE: Questions are being raised regarding the cost of particle therapy (PT), and with them criticism that PT is too expensive to allow the expected gain in effectiveness. This paper aims to get more insight in the cost and cost-effectiveness of particle therapy and to discuss a future strategy that allows for critical assessment of this health technology. MATERIAL AND METHODS: A systematic literature review based on an earlier published comprehensive review was performed and updated until June 1st 2008. Besides, current business plans of PT projects were examined. Additionally, results retrieved from a cost-simulation tool developed under auspice of the ENLIGHT were discussed. RESULTS: The current literature on cost-effectiveness of PT is scarce, non-comparable, and largely not performed according to standard health technology assessment criteria. Besides, different perspectives for cost evaluations have been used, making it difficult to compare and to determine the relative impact in terms of costs for this new treatment modality. CONCLUSIONS: Evidence on the cost-effectiveness of PT is scarce. Adequate reimbursement is necessary to support such innovative yet costly treatments. For now, model-based economic evaluations performed at least from a health care perspective may help us to gain evidence-based insight into cost-effectiveness.

A systematic literature review of the clinical and cost-effectiveness of hadron therapy in cancer.

BACKGROUND: In view of the continued increase in the number of hadron (i.e. neutron, proton and light or heavy ion) therapy (HT) centres we performed a systematic literature review to identify reports of the efficacy of HT. METHODS: Eleven databases were searched systematically. No limit was applied to language or study design. Established experts were contacted for unpublished data. Data on outcomes were extracted and summarised in tabular form. RESULTS: Seven hundred and seventy three papers were identified. For proton and heavy ion therapy, the number of RCTs was too small to draw firm conclusions. Based on prospective and retrospective studies, proton irradiation emerges as the treatment of choice for some ocular and skull base tumours. For prostate cancer, the results were comparable with those from the best photon therapy series. Heavy ion therapy is still in an experimental phase. CONCLUSION: Existing data do not suggest that the rapid expansion of HT as a major treatment modality would be appropriate. Further research into the clinical and cost-effectiveness of HT is needed. The formation of a European Hadron Therapy Register would offer a straightforward way of accelerating the rate at which we obtain high-quality evidence that could be used in assessing the role of HT in the management of cancer.

Health related quality of life assessment instruments: a prospective study on preference and acceptability among cancer patients referred for radiotherapy.

The aim of this study was to determine the preferences for and acceptability of existing Quality of Life (QoL) questionnaires among cancer patients. Sixty-two patients completed a set of questionnaires. Criteria were the percentage of missing values, difficult items and the preferences for the answer options. Results indicated small proportions of missing values and difficult items for the EORTC QLQ-C30, the MFI, RSCL, and the MQ (0.0-1.0%). Considerably higher proportions of missing values and difficult items were found for the VAS and the PFS (2.5-3.4%). The answer option of the RSCL subscale 'activity level' was most preferred (29% of subjects), whereas the VAS and PFS were least preferred (19% and 21%, respectively). Our results indicate that patients prefer answer categories that have descriptors in words or a narrow range of answer options, rather than non-described answer options or a broad range of answer options per question.