Cost per patient and potential budget implications of denosumab compared with zoledronic acid in adults with bone metastases from solid tumours who are at risk of skeletal-related events: an analysis for Austria, Sweden and Switzerland.

OBJECTIVES: To assess cost implications per patient, per year, and to predict the potential annual budget impact when patients with bone metastases secondary to solid tumours at risk of skeletal-related events (SREs) transition from zoledronic acid (ZA; 4 mg every 3-4 weeks) to denosumab (120 mg every 4 weeks) in Austria, Sweden and Switzerland. METHODS: Country specific costs for medication and administration, patient management and SREs (defined as pathologic fracture, radiation to bone, surgery to bone and spinal cord compression) were assessed over a 1-year time horizon. Drug administration and patient management costs were taken from available public sources. SRE costs were based on local unit costs applied to country specific healthcare resources obtained from a multinational retrospective chart review study. Due to lack of real world data for the included countries, SRE rates were derived from phase III clinical trials in patients with advanced cancer and bone metastases. These trials demonstrated that denosumab was superior to ZA in the reduction of SREs. RESULTS: Estimated total annual cost savings for each patient transitioned from ZA to denosumab varied by country and cancer type, ranging from €1583 to €2375 in Austria, from €1980 to €2319 in Sweden (9.1 SEK/€) and from €3408 to €3857 in Switzerland (1.2 CHF/€). Cost savings were mainly driven by the lower SRE related costs and lower administration costs of denosumab compared with ZA. CONCLUSIONS: Denosumab offers superior efficacy compared with ZA in patients with solid tumours and bone metastases. Cost savings are predicted in the Austrian, Swedish and Swiss healthcare systems following treatment transition from ZA to denosumab.

Costs and clinical outcome of neoadjuvant systemic chemotherapy followed by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from gastric cancer.

BACKGROUND: The costs for loco-regional treatment of peritoneal carcinomatosis from gastric cancer are not well investigated. The aims of this study were to evaluate the costs and clinical outcome of systemic chemotherapy followed by cytoreductive surgery and intraperitoneal chemotherapy compared to systemic chemotherapy only in patients with peritoneal carcinomatosis from gastric cancer. MATERIAL AND METHODS: Ten patients were scheduled for systemic chemotherapy followed by loco-regional treatment. A reference group of 10 matched control patients treated with systemic chemotherapy only were used and both groups were evaluated with respect to clinical outcome and cost. RESULTS: The mean overall cost in the loco-regional group was $145,700 (range $49,900-$487,800) and $59,300 (range $23,000-$94,800) for the control group. The mean overall survival for the loco-regional group was 17.4 months (range 6.0-34.3), and 11.1 months (range 0.1-24.2) for the systemic chemotherapy only group. The gain in life-years was 0.52 and in quality-adjusted life-years 0.49, leading to incremental cost per life-year and quality-adjusted life-years gained of $166,716 and $175,164, for loco-regional group compared to systemic chemotherapy. DISCUSSION: Treatment of peritoneal carcinomatosis from gastric cancer is costly irrespective of treatment modality. If the survival benefit from adding loco-regional treatment to systemic chemotherapy indicated from this comparison is true, the incremental cost is considered high.

Cost-effectiveness of intensive smoking cessation therapy among patients with small abdominal aortic aneurysms.

INTRODUCTION: Smoking cessation is one of the few available strategies to decrease the risk for expansion and rupture of small abdominal aortic aneurysms (AAAs). The cost-effectiveness of an intensive smoking cessation therapy in patients with small AAAs identified at screening was evaluated. METHODS: A Markov cohort simulation model was used to compare an 8-week smoking cessation intervention with adjuvant pharmacotherapy and annual revisits vs nonintervention among 65-year-old male smokers with a small AAA identified at screening. The smoking cessation rate was tested in one-way sensitivity analyses in the intervention group (range, 22%-57%) and in the nonintervention group (range, 3%-30%). Literature data on the effect of smoking on AAA expansion and rupture was factored into the model. RESULTS: The intervention was cost-effective in all tested scenarios and sensitivity analyses. The smoking cessation intervention was cost-effective due to a decreased need for AAA repair and decreased rupture rate even when disregarding the positive effects of smoking cessation on long-term survival. The incremental cost/effectiveness ratio reached the willingness-to-pay threshold value of €25,000 per life-year gained when assuming an intervention cost of > €3250 or an effect of ≤ 1% difference in long-term smoking cessation between the intervention and nonintervention groups. Smoking cessation resulted in a relative risk reduction for elective AAA repair by 9% and for rupture by 38% over 10 years of follow-up. CONCLUSIONS: An adequate smoking cessation intervention in patients with small AAAs identified at screening can cost-effectively increase long-term survival and decrease the need for AAA repair.

The societal burden of poor persistence to treatment of osteoporosis in Sweden.

OBJECTIVES: Poor persistence to prescribed treatment regimens is a well-documented health problem. The issue is of particular importance in treatment of chronic diseases, such as osteoporosis. The objective of this study was to estimate the annual societal burden of real-world persistence to treatment of osteoporosis in Sweden. A second aim was to estimate the monetary net benefit of improved persistence. METHODS: The annual societal burden was evaluated in relation to perfect persistence to a five-year treatment duration and performed using a published Markov model by Ström and colleagues. The target population was extracted from the Swedish Prescribed Drug Register and based on all treatment-naïve patients who started therapy of primary osteoporosis in Sweden during 2009. Five hypothetical interventions were investigated, with improvements in the persistent proportion of between 10% and 50%. RESULTS: Annually, a total of 1018 fractures were estimated to be caused by non-persistence to treatment of osteoporosis in Sweden. These fractures resulted in a substantial waste of health care resources related to morbidity (€26 million annually) and a loss, in total, of 771 quality-adjusted life-years (QALYs). Using a societal willingness-to-pay for a QALY of €60000, the total annual societal burden, incorporating both monetary consequences and health effects, was estimated at €62.76 million. Given current Swedish cost-effectiveness guidelines, between approximately €225 and €1130 could be spent per patient to increase persistence, depending on the level of improvement (between 10% and 50%). CONCLUSIONS: The total annual societal burden of current, real-world persistence was estimated at €63 million. The estimated additional fracture-related costs associated with poor persistence were larger than the current total annual expenditure on all osteoporosis medications in Sweden. Poor persistence to treatment of osteoporosis should consequently be acknowledged as an important and costly health problem, and be taken into account when evaluating osteoporosis interventions.

Challenges in analysis and interpretation of cost data in vascular surgery.

OBJECTIVE: Health economic arguments have become increasingly important in clinical decision making, especially when new treatment modalities are introduced. This study reviews the methods used in health economic reports of abdominal aortic aneurysm (AAA) repair and uses original cost data to study how different methods affect interpretation of results in terms of cost differences and economic efficiency. DESIGN: Publications referenced in PubMed from 2003 to 2008 studying cost of AAA repair were reviewed. Original population-based cost data of AAA repair were analyzed, comparing open (OR) and endovascular repair (EVAR). Means, medians, and cost distributions were calculated, and differences were analyzed with four different statistical methods. RESULTS: The review showed a mixture of statistical methods used in AAA treatment cost-comparison studies. Presentation of cost data and inclusion criteria varied between studies. The analysis of original data showed skewed distribution of cost data, with large differences between mean and median cost. Although mean values indicated a lower total, perioperative, and postoperative cost for EVAR, the median values indicated OR was the least costly method. Exclusion of extreme values lowered mean perioperative cost of OR by 10%, while cost of EVAR was unaffected. Inferential testing of cost differences by means of four statistical methods showed that P values were highly dependent on test methodology. CONCLUSIONS: Conclusions of health economic reports can be highly dependent on how the data are presented and the statistical methods that are used. We recommend that cost data be presented as mean values with distributions. Exclusion of outliers and focus on P values should be avoided.

Improved long-term survival after abdominal aortic aneurysm repair.

BACKGROUND: Treatment of abdominal aortic aneurysm (AAA) has changed significantly over the past 2 decades. In this perspective, time trends in long-term survival were studied. METHODS AND RESULTS: We identified 8663 primary intact and 4171 ruptured AAA repairs in the Swedish Vascular Registry from 1987 to 2005. Mortality was obtained from the national population registry. Crude survival was analyzed, including all mortality. To analyze the long-term outcome among those surviving the AAA repair, relative survival, which denotes the survival rate of patients compared with that of the general population adjusted for age, sex, and calendar year, was calculated, excluding 90-day mortality. In a comparison of AAA repairs from 1987 to 1999 and 2000 to 2005, age (71.4 versus 72.5 years; P<0.001), patients with comorbidities (65.0% versus 68.5%; P<0.001), and endovascular repair (1.6% versus 17.0%; P<0.001) increased. After intact AAA repair, crude 5-year survival was 69.0% (99% confidence interval [CI], 67.7 to 70.4), and relative 5-year survival excluding 90-day mortality was 90.3% (99% CI, 88.6 to 92.0). Relative 5-year survival was better for those operated on from 2000 to 2005 compared with 1987 to 1999 (difference, 4.7%; 99% CI, 1.3 to 8.1), for men versus women (4.6%; 99% CI, 0.4 to 8.8), and for octogenarians versus patients <80 years of age (10.2%; 99% CI, 1.5 to 18.8); no difference was observed between open and endovascular repair (6.0%; 99% CI, -1.5 to 13.4). After ruptured AAA repair, crude 5-year survival was 41.7% (99% CI, 39.6 to 43.7) and relative 5-year survival was 87.1% (99% CI, 83.9 to 90.3). No significant differences in relative 5-year survival were observed between time periods, sex, or age groups. CONCLUSIONS: Long-term survival improved over time after intact AAA repair despite a change in case mix toward older patients with more comorbidities. Long-term survival was stable after ruptured AAA repair.

Cost-benefit of WC/rBS oral cholera vaccine for vaccination against ETEC-caused travelers' diarrhea.

BACKGROUND: The most common infectious health problem encountered by travelers to countries in the developing region is travelers' diarrhea (TD), with enterotoxigenic Escherichia coli (ETEC) being the most common pathogen isolated. Although mild in most cases, the disease still leads to the loss of a significant part of a vacation or business trip. There is currently a lack of knowledge about the costs in relation to the benefits of vaccination against TD caused by ETEC, and the purposes of this study were to estimate and develop a cost-benefit analysis of vaccination using whole-cell/recombinant-B-subunit oral cholera vaccine. METHODS: The consequences of the vaccination were identified and quantified in monetary terms. The cost-benefits for leisure and business travelers were assessed separately. The value of the travel was separated into the cost of the trip and of lost leisure time/business opportunities. A person with TD was in base case estimated to lose on average 3.5 days of a 7-day leisure trip and 2.5 days of a 4-day business trip. Results are presented for a Canadian traveler to endemic areas in year 2007 in US$. RESULTS: The average cost of a TD event was estimated at $1,460 and $1,996 for leisure and business travelers, respectively. The net value of the vaccination, however, varied with the risk of the disease. Through extensive literature searches, an updated ETEC map illustrating the proportion of ETEC-caused TD was created. CONCLUSIONS: The analysis indicated that vaccination would be considered cost-effective at incidence rates of ETEC-caused TD above about 13 and 9% for leisure and business travelers, respectively. It is, however, important to keep in mind that it is the value of the travel for the individual traveler that will decide if the vaccination provides good value for money.

Cost-effectiveness of maintenance rituximab treatment after second line therapy in patients with follicular lymphoma in Sweden.

INTRODUCTION: Rituximab has significantly improved the prognosis for patients with both indolent and aggressive non-Hodgkin's lymphoma. An economic evaluation was carried out to assess the cost-effectiveness in Sweden of rituximab as maintenance therapy for patients with follicular lymphoma in remission after second line therapy. MATERIALS AND METHODS: The incremental cost and effectiveness of rituximab maintenance therapy versus observation were evaluated in a health-state transition model. Primary effect measures were quality-adjusted life-years (QALY) and life-years gained (LYG). Model state transitions were calculated based on progression-free and overall survival data from the EORTC20981 trial. The analysis was made from the perspective of the healthcare provider, including direct medical costs presented in euro, 2007 value. Effects and costs were discounted at a 3% annual rate. The stability of the base case results were tested in one-way and probabilistic sensitivity analyses. RESULTS: The evaluation assessed rituximab maintenance therapy to be associated with an incremental cost per QALY gained of euro 12,600 and an incremental cost per LYG of euro 11,200. The average discounted life expectancy for patients on rituximab maintenance was 1.0 year longer than for patients on observation (5.96 vs. 4.94 years). Rituximab maintenance was associated with an additional 0.9 QALY, and total costs per patient were euro 11,500 higher in the treatment arm, compared to observation. DISCUSSION: The results indicate that rituximab maintenance treatment after successful induction therapy for patients with relapsed/refractory follicular lymphoma in Sweden is cost-effective compared to observation.

Similar cost for elective open and endovascular AAA repair in a population-based setting.

PURPOSE: To compare cost differences between elective open repair (OR) and endovascular repair (EVAR) of abdominal aortic aneurysm in a population-based setting. METHODS: Clinical data and hospital-related costs (pre-, peri-, and postoperative) were analyzed for 109 consecutive AAA procedures (98 men; mean age 73 years, range 48-95; mean aneurysm diameter 61 mm, range 42-120) performed from 2001 to 2005 (58 OR, 51 EVAR) in our primary catchment area. Data were obtained through case records and hospital accounting systems. Nonparametric bootstrap was used for cost comparison. RESULTS: EVAR patients were older (76 versus 70 years, p<0.001) and had more comorbidities (ASA class 2.6 versus 2.3, p = 0.025). OR patients more often had anatomically complex aneurysms (52% versus 14%, p<0.001). Comparison of data with diagnosis-based reimbursement levels nationally and internationally indicated adequate cost level in the study. No difference was observed in total cost between OR and EVAR (euro29,786 versus euro26,382; p = 0.336). Preoperative cost was lower for OR compared to EVAR (euro661 versus euro1494, p = 0.002). OR patients had higher cost of intensive care [36% (euro8921) of perioperative cost versus 7% (euro1460), p = 0.001], while EVAR had higher implant cost [36% (euro7468) versus 2% (euro448), p<0.001]. Mean follow-up was 2.5 years (range 0.5-5.4). Mean postoperative cost was similar (OR euro4613 versus EVAR euro4403, p = 0.209; 16% and 17% of total cost, respectively). Postoperative cost after OR was high early on, with lower cost thereafter. Postoperative cost after EVAR was more homogeneously distributed, leveling off at euro500 to euro1000 annually over 5 years. CONCLUSION: In a population-based setting, total cost was similar for OR and EVAR. There were, however, important differences in patient characteristics and cost structure.

Health economic evaluations alongside clinical trials: a review of study protocols at the Swedish Medical Products Agency.

OBJECTIVES: Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005. METHODS: A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included. RESULTS: A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen. CONCLUSIONS: This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.

Economic evaluations of leukemia: a review of the literature.

OBJECTIVES: Leukemia, together with lymphoma and multiple myeloma, are hematological malignancies, malignancies of the blood-forming organs. There are four major types of leukemia: acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). There is a growing amount of literature of the health economic aspects of leukemia. However, no comprehensive review is yet performed on the health economic evidence for the disease. Hence, our aim was to review and analyze the existing literature on economic evaluations of the different types of leukemia. METHODS: A systematic literature search used electronic databases to identify published cost analyses and economic evaluations of leukemia treatments. After reviewing all identified studies, sixty studies were considered relevant for the purpose of the review. RESULTS: The identified studies were published after 1990, with a few exceptions. Many of the identified economic evaluations in leukemia, particularly for ALL and AML, may be defined as cost-minimization analyses, where only the costs of different treatment strategies are compared. In CML, a new treatment, imatinib, was introduced in 2001 and several cost-effectiveness analyses have since then been conducted comparing imatinib with previous first line treatments. CONCLUSIONS: This review indicates that there is a shortage of cost-effectiveness information in leukemia. The introduction of new therapies will stress the need for new economic evaluations in this group of diseases. More information about the total costs, that is, including indirect costs, and quality of life effects would be valuable in future evaluations in leukemia.

Cost-effectiveness of extended prophylaxis with fondaparinux compared with low molecular weight heparin against venous thromboembolism in patients undergoing hip fracture surgery.

A model was developed to estimate costs and clinical effectiveness of fondaparinux compared with enoxaparin after hip fracture surgery in Sweden. Outcomes and costs of venous thromboembolism (VTE)-related care from a health care perspective were incorporated, with symptomatic deep-vein thrombosis and pulmonary embolism, recurrent VTE, post-thrombotic syndrome, major haemorrhage and all-cause death being included. Event probabilities were derived from fondaparinux clinical trial data and published data. VTE-related resource use and associated costs as well as costs of prophylaxis were based on local Swedish data. Extended prophylaxis with fondaparinux could avoid an additional 28 symptomatic VTE per 1,000 patients compared with extended prophylaxis with enoxaparin in hip fracture surgery patients. Although the prophylaxis costs were higher in the fondaparinux group, these were offset by the lower costs associated with treating fewer VTE, which thus indicates that extended fondaparinux prophylaxis is the dominant alternative when compared with enoxaparin in hip fracture surgery.

Cost-effectiveness of exemestane versus tamoxifen as adjuvant therapy for early-stage breast cancer after 2-3 years treatment with tamoxifen in Sweden.

Aromatase inhibitors are rapidly becoming the cornerstone of endocrine treatment for advanced disease and are now also used as adjuvant treatment in early-stage disease. The objective of this study was to assess the cost-effectiveness of adjuvant treatment with exemestane versus tamoxifen for early-stage breast cancer after 2-3 years treatment with tamoxifen in Sweden. The results are based on findings in the Intergroup Exemestane Study (IES). IES was a randomized controlled trial in which postmenopausal women who had received 2-3 years of tamoxifen therapy following primary treatment of early-stage breast cancer, were randomized to either continue on tamoxifen therapy or be switched to exemestane therapy. The results showed a disease-free survival hazard ratio of exemestane relative to tamoxifen in IES of 0.69. A Markov state-transition model was developed to simulate consequences after the end of the clinical trial, and to integrate the trial data with external data on mortality, costs and quality of life specific for Swedish women. The cost per QALY gained was about euro 20,000 in the base case analysis without inclusion of consequences of coronary heart disease. Inclusion of these events increased the cost-effectiveness ratio to about euro 31,000. This means that, based on our assumption, sequential exemestane treatment in early breast cancer is a cost-effective option compared with tamoxifen alone, although more long-term data on overall survival and consequences of adverse events would be valuable to increase the validity of the analysis further.

Cost of hypoglycemia in patients with Type 2 diabetes in Sweden.

OBJECTIVES: Hypoglycemia is a common side effect of antidiabetic therapy. In addition to reducing well-being, hypoglycemic events may lead to substantial costs of medical care and lost productivity. The cost of hypoglycemia is, however, not well identified, particularly in patients with Type 2 diabetes. The purpose of this study was to assess the cost of hypoglycemia in Type 2 diabetes in Sweden. METHODS: A cost-of-illness approach, based on an incidence methodology, was used to estimate the cost of hypoglycemia in patients with Type 2 diabetes. A hypoglycemic event was defined as an episode with symptoms of low blood glucose levels during which the patient required assistance from another person. The events were divided into mild, moderate, and severe, and the incidence and costs of the different events were estimated based on data in the literature. RESULTS: Assuming that there are 300,000 patients with Type 2 diabetes in Sweden, it was estimated that 26,942 hypoglycemic events would occur annually in these patients, corresponding to a rate of 0.09 events per patient-year. The total cost of hypoglycemia was, in base case, estimated at about Euro 4,250,000 (Euro 14 per patient with Type 2 diabetes) per year. Moderate hypoglycemia contributed the largest proportion of these costs. CONCLUSIONS: The results indicate that hypoglycemic events lead to substantial costs, but data are scarce and more studies are needed to better understand the cost and consequences of hypoglycemia.

Cost-effectiveness of screening women for abdominal aortic aneurysm.

BACKGROUND: Women are usually not considered for abdominal aortic aneurysm (AAA) screening because of their lower prevalence of disease. This position may, however, be questioned given the higher risk of rupture and the longer life expectancy among women. The purpose of this study was to assess the cost-effectiveness of screening 65-year-old women for AAA. METHODS: A systematic review of the literature was conducted to obtain data of importance to evaluate the effectiveness of screening women for AAA. Data were entered into a Markov simulation cohort model. RESULTS: The review suggested some main assumptions for women with AAA. Prevalence is 1.1%. In 6.8%, the AAA is of a size that merits surgery, and the patients are fit for a procedure. For patients with an AAA, the yearly risk for elective surgery and the rupture incidence was 3.1% and 2.4%, respectively, in the invited group and 1.1% and 5.7% in the noninvited group. The operative mortality for elective surgery was 3.5%, and the total mortality for ruptured AAA was 86.3%. The long-term mortality for AAA patients was 3.6 times higher than for an age-matched healthy population. Screening reduced the AAA rupture incidence by 33% and the AAA-related death rate by 35%. The cost per life year gained was estimated at $5911. CONCLUSION: The incremental cost-effectiveness ratio was similar to that found for screening men, which reflects the fact that the lower AAA prevalence in women is balanced by a higher rupture rate. Screening women for AAA may be cost-effective, and future evaluations on screening for AAA should include women.

The costs and benefits of regulations for reimbursement of new drugs.

INTRODUCTION: An increasing regulation for pricing and reimbursement decisions is associated with both costs and benefits. One potential cost is a delayed introduction of drugs on the market. The objective of this study was to discuss and analyse the time lag between drug authorisation and reimbursement for new chemical entities (NCEs) in Sweden and Finland. MATERIALS AND METHODS: The study was based on a sample of 242 NCE drugs, authorised by the regulatory authorities in Sweden or Finland between January 1995 and April 2003. Data on authorisation dates, reimbursement dates, capacity of manufacturing companies, requirements for economic evaluations by reimbursement authorities, anatomic therapeutic classification, therapeutic value and sale statistics were collected for the drugs. A hypothesis, saying that the lag is affected by the increasing regulation associated with the introduction of formal requirements for cost-effectiveness information for pricing and reimbursement decisions, was tested. RESULTS: One hundred and thirty-eight of the 242 drugs included in the analyses were reimbursed in Sweden and 104 in Finland. The total mean lag time was 175 days, and the mean lag times in Sweden and Finland were 114 and 256 days, respectively. Regression analysis demonstrated that drugs with low sale and drugs from companies with large capacity of introducing new drugs were associated with a longer and shorter lag times, respectively. The results also demonstrated that authorisation during first year after introduction of requirement for cost-effectiveness information was associated with an increased lag time. DISCUSSION: The results demonstrated that there are considerable time lags between authorisation and reimbursement of new drugs, both in Sweden and Finland. The results further indicated that an increased regulation for reimbursement by introducing requirements for cost-effectiveness information is associated with an increased time lag, at least for drugs authorised early after introduction of the new requirements. It is therefore important to further discuss the costs and benefits of an increased regulation for reimbursement, in order to find the optimal regulatory requirements.

Proton therapy of cancer: potential clinical advantages and cost-effectiveness.

Proton therapy may offer potential clinical advantages compared with conventional radiation therapy for many cancer patients. Due to the large investment costs for building a proton therapy facility, however, the treatment cost with proton radiation is higher than with conventional radiation. It is therefore important to evaluate whether the medical benefits of proton therapy are large enough to motivate the higher costs. We assessed the cost-effectiveness of proton therapy in the treatment of four different cancers: left-sided breast cancer, prostate cancer, head and neck cancer, and childhood medulloblastoma. A Markov cohort simulation model was created for each cancer type and used to simulate the life of patients treated with radiation. Cost and quality adjusted life years (QALYs) were used as primary outcome measures. The results indicated that proton therapy was cost-effective if appropriate risk groups were chosen. The average cost per QALY gained for the four types of cancer assessed was about pounds 10,130. If the value of a QALY was set to pounds 55,000, the total yearly net benefit of treating 925 cancer patients with the four types of cancer was about pounds 20.8 million. Investment in a proton facility may thus be cost-effective. The results must be interpreted with caution, since there is a lack of data, and consequently large uncertainties in the assumptions used.

Cost-effectiveness of new drugs: a systematic review of published evidence for new chemical entity drugs introduced on the Swedish market 1987-2000.

OBJECTIVES: The number of published economic evaluations has increased dramatically during the past decades, but the number of studies performed for different drugs varies substantially. The objective of this study was to analyze the amount of cost-effectiveness evidence for new drugs, by systematically reviewing the published evidence of cost-effectiveness. METHODS: The study included 442 new chemical entities, approved in Sweden between 1987 and 2000. The amount of cost-effectiveness evidence was rated and analyzed together with information about sales and the therapeutic benefit of the drugs. Information about cost-effectiveness was obtained from the Health Economic Evaluation Database. RESULTS: The results showed that most cost-effectiveness evidence was published approximately 1 to 5 years after the approval year and that very few articles were published before or during the approval year. More than half of the drugs did not have any evidence of their cost-effectiveness. A total of 51 of the evaluated drugs were considered having much evidence of cost-effectiveness, 84 drugs were considered having some evidence, and the remaining 307 drugs had little evidence. The analyses indicated that drugs with improved effectiveness or safety compared with other marked drugs had more evidence of cost-effectiveness and that drugs with low sale were likely to have less evidence of cost-effectiveness than drugs with high sale. CONCLUSIONS: The study indicated that the publication of cost-effectiveness information for new drugs introduced between 1987 and 2000 may be considered rather rational, that is, the economic evaluations were performed for drugs for which this information was most important.