Infliximab for the treatment of adults with psoriasis

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of infliximab for the treatment of moderate to severe plaque psoriasis, in accordance with the licensed indication, based on the evidence submission from Schering-Plough to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer’s definition of the decision problem were severity [Psoriasis Area and Severity Index (PASI) score], remission rates, relapse rates and health-related quality of life. The main evidence in the submission comes from four randomised controlled trials (RCT) comparing infliximab with placebo and eight RCTs comparing either etanercept or efalizumab with placebo. At week 10, patients on infliximab had a significantly higher likelihood of attaining a reduction in PASI score than placebo patients. There were also statistically significant differences between infliximab and placebo in the secondary outcomes. In the comparator trials both the efalizumab and etanercept arms included a significantly higher proportion of patients who achieved a reduction in PASI score at week 12 than the placebo arms. No head-to-head studies were identified directly comparing infliximab with etanercept or efalizumab. The manufacturer carried out an indirect comparison, but the ERG had reservations about the comparison because of the lack of information presented and areas of uncertainty in relation to the included data. The economic model presented by the manufacturer was appropriate for the disease area and given the available data. The cost-effectiveness analysis estimates the mean length of time that an individual would respond to infliximab compared with continuous etanercept and the utility gains associated with this response. The base-case incremental cost-effectiveness ratio (ICER) for infliximab compared with continuous etanercept for patients with severe psoriasis was £26,095 per quality-adjusted life-year. A one-way sensitivity analysis, a scenario analysis and a probabilistic sensitivity analysis were undertaken by the ERG. The ICER is highly sensitive to assumptions about the costs and frequency of inpatient stays for non-responders of infliximab. The guidance issued by NICE in August 2007 as a result of the STA states that infliximab within its licensed indication is recommended for the treatment of adults with very severe plaque psoriasis, or with psoriasis that has failed to respond to standard systematic therapies. Infliximab treatment should be continued beyond 10 weeks in people whose psoriasis has shown an adequate response to treatment within 10 weeks. In addition, when using the Dermatology Life Quality Index (DLQI), care should be taken to take into account the patient’s disabilities, to ensure DLQI continues to be an accurate measure.

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Gemcitabine for the treatment of metastatic breast cancer

Health Technology Assessment ◽

10.3310/hta13suppl2-01 ◽

2009 ◽

Vol 13 (Suppl 2) ◽

pp. 1-7

Author(s):

J Jones ◽

A Takeda ◽

SC Tan ◽

K Cooper ◽

E Loveman ◽

...

Keyword(s):

Breast Cancer ◽

Sensitivity Analysis ◽

Metastatic Breast Cancer ◽

Cost Effectiveness ◽

Indirect Comparison ◽

Metastatic Breast ◽

Base Case ◽

Health State ◽

Single Technology Appraisal ◽

Quality Adjusted Life

This paper presents a summary of the evidence review group (ERG) report into the evidence for the clinical effectiveness and cost-effectiveness of gemcitabine with paclitaxel for the first-line treatment of metastatic breast cancer (MBC) in patients who have already received chemotherapy treatment with an anthracycline, compared with current standard of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence for gemcitabine as a treatment for MBC comes from the unpublished JHQG trial (some data commercial-in-confidence): overall survival was 3 months longer for the gemcitabine/paclitaxel arm (18.5 months) than for the paclitaxel arm (15.8 months) (p = 0.0489); gemcitabine/paclitaxel also improved tumour response and time to documented progression of disease compared with paclitaxel monotherapy, but haematological serious adverse events were more common. In the absence of any formal methods of indirect comparison there is insufficient robust evidence to compare the relative effectiveness of gemcitabine/paclitaxel with docetaxel monotherapy or docetaxel/capecitabine combination therapy. The manufacturers used a Markov state transition model to estimate the effect of treatment with five different chemotherapy regimes, adopting a 3-year time horizon with docetaxel monotherapy as the comparator. Health state utilities for different stages of disease progression and for patients experiencing treatment-related toxicity are used to derive quality-adjusted life expectancy with each treatment. The base-case cost-effectiveness estimate for gemcitabine/paclitaxel versus docetaxel is £17,168 per quality-adjusted life-year (QALY). When longer survival with docetaxel is assumed in a sensitivity analysis, the incremental cost-effectiveness ratio (ICER) is £30,000 per QALY. Probabilistic sensitivity analysis estimates a 70% probability of gemcitabine/paclitaxel being cost-effective relative to docetaxel at a willingness-to-pay threshold of £35,000. There is considerable uncertainty over the results because of the lack of formal quality assessment or assessment of the comparability of the 15 trials included in the input data, and the questionable validity of the indirect comparison method adopted. An illustrative analysis using a different method for indirect comparison carried out by the ERG produces an ICER of £45,811 per QALY for gemcitabine/paclitaxel versus docetaxel. The guidance issued by NICE in November 2006 as a result of the STA states that gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of MBC only when docetaxel monotherapy or docetaxel plus capecitabine is also considered appropriate.

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Ustekinumab for the treatment of moderate to severe psoriasis

Health Technology Assessment ◽

10.3310/hta13suppl3-10 ◽

2009 ◽

Vol 13 (Suppl 3) ◽

pp. 61-66

Author(s):

E Gospodarevskaya ◽

J Picot ◽

K Cooper ◽

E Loveman ◽

A Takeda

Keyword(s):

Sensitivity Analysis ◽

Cost Effectiveness ◽

Adverse Events ◽

Supportive Care ◽

Clinical Effectiveness ◽

Severe Psoriasis ◽

Base Case ◽

Mixed Treatment Comparison ◽

Single Technology Appraisal ◽

Treatment Comparison

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of ustekinumab for the treatment of moderate to severe psoriasis based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s main evidence came from three randomised controlled trials (RCTs), of reasonable methodological quality and measuring a range of clinically relevant outcomes. Higher proportions of participants treated with ustekinumab (45 mg and 90 mg) than with placebo or etanercept achieved an improvement on the Psoriasis Area and Severity Index (PASI) of at least 75% (PASI 75) after 12 weeks. There were also statistically significant differences in favour of ustekinumab over placebo for PASI 50 and PASI 90 results, and for ustekinumab over etanercept for PASI 90 results. A weight-based subgroup dosing analysis for each trial was presented, but the methodology was poorly described and no statistical analysis to support the chosen weight threshold was presented. The manufacturer carried out a mixed treatment comparison (MTC); however, the appropriateness of some of the methodological aspects of the MTC is uncertain. The incidence of adverse events was similar between groups at 12 weeks and withdrawals due to adverse events were low and less frequent in the ustekinumab than in the placebo or etanercept groups; however, statistical comparisons were not reported. The manufacturer’s economic model of treatments for psoriasis compared ustekinumab with other biological therapies. The model used a reasonable approach; however, it is not clear whether the clinical effectiveness estimates from the subgroup analysis, used in the base-case analysis, were methodologically appropriate. The base-case incremental cost-effectiveness ratio for ustekinumab versus supportive care was £29,587 per quality-adjusted life-year (QALY). In one-way sensitivity analysis the model was most sensitive to the number of hospital days associated with supportive care, the cost estimate for intermittent etanercept 25 mg and the utility scores used. In the ERG’s scenario analysis the model was most sensitive to the price of ustekinumab 90 mg, the proportion of patients with baseline weight > 100 kg and the relative risk of intermittent versus continuous etanercept 25 mg. In the ERG’s probabilistic sensitivity analysis ustekinumab had the highest probability of being cost-effective at conventional NICE thresholds, assuming the same price for the 45-mg and 90-mg doses; however, doubling the price of ustekinumab 90 mg resulted in ustekinumab no longer dominating the comparators. In conclusion, the clinical effectiveness and cost-effectiveness of ustekinumab in relation to other drugs in this class is uncertain. Provisional NICE guidance issued as a result of the STA states that ustekinumab is recommended as a treatment option for adults with plaque psoriasis when a number of criteria are met. Final guidance is anticipated in September 2009.

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Omalizumab for the treatment of severe persistent allergic asthma

Health Technology Assessment ◽

10.3310/hta13suppl2-05 ◽

2009 ◽

Vol 13 (Suppl 2) ◽

pp. 31-39

Author(s):

J Jones ◽

J Shepherd ◽

D Hartwell ◽

P Harris ◽

K Cooper ◽

...

Keyword(s):

Sensitivity Analysis ◽

Cost Effectiveness ◽

Allergic Asthma ◽

Standard Therapy ◽

Sensitivity Analyses ◽

Base Case ◽

Life Questionnaire ◽

Exacerbation Rate ◽

Single Technology Appraisal ◽

Significant Difference

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of omalizumab for the treatment of chronic severe persistent allergic asthma, in accordance with the licensed indication, based upon the evidence submission from Novartis to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence comes from a randomised controlled trial comparing omalizumab as an add-on to standard therapy with placebo and standard therapy over a 28-week treatment period. For the primary outcome of the rate of clinically significant asthma exacerbations, there was no statistically significant difference between treatment groups. However, after making a post hoc adjustment for a suggested ‘clinically relevant’ imbalance between trial arms in baseline exacerbation rate, the difference became marginally statistically significant. In terms of secondary outcomes, there were statistically significant differences favouring omalizumab over placebo in total emergency visits, Asthma Quality of Life Questionnaire scores, total symptom scores and lung function. Adverse events appeared to be similar between the trial arms. Results from three other publications are included in the manufacturer’s submission as supporting evidence for the effectiveness of omalizumab, despite not meeting the inclusion criteria which adhere strictly to the licensed indication. The ERG checked and provided commentary on the manufacturer’s model using standard checklists as well as undertook one-way sensitivity analysis, scenario analysis and a probabilistic sensitivity analysis. The cost-effectiveness analysis estimates the incremental costs and consequences of omalizumab as an add-on to standard therapy. The base-case analysis of the trial’s primary intention-to-treat population estimates a cost per quality-adjusted life-year of £30,647. The ERG conducted one-way sensitivity analyses for parameters omitted from the manufacturer’s submission sensitivity analysis. The results were most sensitive to variation in the utility values for omalizumab responders, and the unit cost of omalizumab. The guidance issued by NICE in November 2007 as a result of the STA states that omalizumab is recommended as a possible treatment for adults and young people over 12 years with severe persistent allergic asthma when their asthma meets certain conditions. Omalizumab treatment should be given along with the person’s current asthma medicines. It should be prescribed by a doctor who is experienced in asthma and allergy medicine at a specialist centre. If omalizumab does not control the asthma after 16 weeks, treatment should be stopped.

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The cost-effectiveness of treatment of relapsed/refractory chronic lymphocytic leukemia with a combination of venetoclax and rituximab

Modern Oncology ◽

10.26442/18151434.2019.2.190397 ◽

2019 ◽

Vol 21 (2) ◽

pp. 29-32

Author(s):

Alla V Rudakova ◽

Vladimir V Strugov

Keyword(s):

Sensitivity Analysis ◽

Cost Effectiveness ◽

Chronic Lymphocytic Leukemia ◽

Time Horizon ◽

Indirect Comparison ◽

Weighted Average ◽

Lymphocytic Leukemia ◽

High Rate ◽

Base Case ◽

The Cost

Background. Current treatment of relapsed/refractory chronic lymphocytic leukemia implies the use of regimens that include innovative drugs such as ibrutinib and a combination of venetoclax with rituximab. Herewith the combination of venetoclax with rituximab provides a high rate of eradication of minimal residual disease and, in contrast to ibrutinib, in the standard version it is canceled after 2 years from the start of therapy. Aim. Evaluation of the cost-effectiveness of treatment of relapsed/refractory chronic lymphocytic leukemia with a combination of venetoclax + rituximab and ibrutinib. Materials and methods. The evaluation was carried out from a position of the health care system using the Markov model. The study’s time horizon was 4 years. There were no statistically significant differences in overall and progression-free survival according to data of an indirect comparison of the study MURANO for the combination of venetoclax + rituximab and the studies RESONATE and HELIOS for ibrutinib. Venetoclax price (excluding VAT) used for calculation was corresponded to the manufacturer's price list and it was: film coated tablets, 10 mg №14 - 5830.2 rubles; 50 mg №7 - 14 576.86 rubles; 100 mg №7 - 29 152.65 rubles; 100 mg №14 - 58 306.37 rubles; 100 mg №112 - 466 446.67 rubles. Prices for rituximab and ibrutinib were corresponded to a median of the prices quoted. In all cases the analysis considered VAT and weighted average wholesale surcharge given population size in the Russian Federation. In the base case, costs of therapy after a transition to progression were not considered. When carrying out the sensitivity analysis, the option of monotherapy with venetoclax in patients who had progression on ibrutinib and monotherapy with ibrutinib in patients who had progression on venetoclax + rituximab was also evaluated. As part of the sensitivity analysis, a decrease and increase in the price of venetoclax by 15% and a decrease in the price of ibrutinib by 30% were also evaluated. In addition, an increase in a proportion of patients who moved to progression followed venetoclax withdrawal after 2 years of therapy was evaluated, by 15% per year, as well as a change in a frequency of progression by 15% compared with the base case and a decrease in the study’s time horizon to 3 years. The analysis was performed with discounting at 3.5% per year. Results. The analysis showed that the use of a regimen that includes venetoclax reduces the cost volume by on average of 31.3% compared to ibrutinib (the cost volume for 1 patient per 4 years - 13.341 million rubles and 19.413 million rubles, respectively). The sensitivity analysis demonstrated a reliability of the data obtained (with all analyzed modeling options, including options with an increase in venetoclax price by 15%, a decrease in ibrutinib price by 30% and a decrease in the study’s time horizon to 3 years, the combination of venetoclax + rituximab reduces costs by 1.9-41.0%). Conclusions. Treatment of relapsed / refractory chronic lymphocytic leukemia with a combination of venetoclax and rituximab is comparable in clinical efficacy with ibrutinib monotherapy and can reduce the cost and, therefore, increase the availability of innovative therapy for this group of patients. The main contribution to cost reduction is made by the fact that treatment with venetoclax and rituximab in the absence of progression stops 2 years after the start of treatment, and is not performed until the response is lost, as in the case of ibrutinib.

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Cost-effectiveness of dual-mobility components in patients with displaced femoral neck fractures

The Bone & Joint Journal ◽

10.1302/0301-620x.103b12.bjj-2021-0495.r2 ◽

2021 ◽

Vol 103-B (12) ◽

pp. 1783-1790

Author(s):

Spencer Montgomery ◽

Jonathan Bourget-Murray ◽

Daniel Z. You ◽

Leo Nherera ◽

Amir Khoshbin ◽

...

Keyword(s):

Sensitivity Analysis ◽

Cost Effectiveness ◽

Femoral Neck ◽

Incremental Cost ◽

Probabilistic Sensitivity Analysis ◽

Cost Effective ◽

Physiological Age ◽

Base Case ◽

Dual Mobility ◽

Displaced Femoral Neck Fractures

Aims Total hip arthroplasty (THA) with dual-mobility components (DM-THA) has been shown to decrease the risk of dislocation in the setting of a displaced neck of femur fracture compared to conventional single-bearing THA (SB-THA). This study assesses if the clinical benefit of a reduced dislocation rate can justify the incremental cost increase of DM-THA compared to SB-THA. Methods Costs and benefits were established for patients aged 75 to 79 years over a five-year time period in the base case from the Canadian Health Payer’s perspective. One-way and probabilistic sensitivity analysis assessed the robustness of the base case model conclusions. Results DM-THA was found to be cost-effective, with an estimated incremental cost-effectiveness ratio (ICER) of CAD $46,556 (£27,074) per quality-adjusted life year (QALY). Sensitivity analysis revealed DM-THA was not cost-effective across all age groups in the first two years. DM-THA becomes cost-effective for those aged under 80 years at time periods from five to 15 years, but was not cost-effective for those aged 80 years and over at any timepoint. To be cost-effective at ten years in the base case, DM-THA must reduce the risk of dislocation compared to SB-THA by at least 62%. Probabilistic sensitivity analysis showed DM-THA was 58% likely to be cost-effective in the base case. Conclusion Treating patients with a displaced femoral neck fracture using DM-THA components may be cost-effective compared to SB-THA in patients aged under 80 years. However, future research will help determine if the modelled rates of adverse events hold true. Surgeons should continue to use clinical judgement and consider individual patients’ physiological age and risk factors for dislocation. Cite this article: Bone Joint J 2021;103-B(12):1783–1790.

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Ixekizumab for Treating Moderate-to-Severe Plaque Psoriasis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

PharmacoEconomics ◽

10.1007/s40273-018-0629-2 ◽

2018 ◽

Vol 36 (8) ◽

pp. 917-927 ◽

Cited By ~ 3

Author(s):

Bram L. T. Ramaekers ◽

Robert F. Wolff ◽

Xavier Pouwels ◽

Marije Oosterhoff ◽

Anoukh Van Giessen ◽

...

Keyword(s):

Plaque Psoriasis ◽

Evidence Review Group ◽

Technology Appraisal ◽

Single Technology Appraisal ◽

Review Group ◽

Severe Plaque Psoriasis ◽

Evidence Review

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Abstract 200: Cost-Effectiveness of Newer Anticoagulants for Stroke Prevention in Atrial Fibrillation

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.6.suppl_1.a200 ◽

2013 ◽

Vol 6 (suppl_1) ◽

Author(s):

Brendan L Limone ◽

William L Baker ◽

Craig I Coleman

Keyword(s):

Atrial Fibrillation ◽

Cost Effectiveness ◽

Stroke Prevention ◽

Indirect Comparison ◽

Cost Effective ◽

The United States ◽

Base Case ◽

Treatment Comparison ◽

Newer Anticoagulants ◽

The Cost

Background: A number of new anticoagulants for stroke prevention in atrial fibrillation (SPAF) have gained regulatory approval or are in late-stage development. We sought to conduct a systematic review of economic models of dabigatran, rivaroxaban and apixaban for SPAF. Methods: We searched the Medline, Embase, National Health Service Economic Evaluation Database and Health Technology Assessment database along with the Tuft’s Registry through October 10, 2012. Included models assessed the cost-effectiveness of dabigatran (150mg, 110mg, sequential), rivaroxaban or apixaban for SPAF using a Markov model or discrete event simulation and were published in English. Results: Eighteen models were identified. All models utilized a lone randomized trial (or an indirect comparison utilizing a single study for any given direct comparison), and these trials were clinically and methodologically heterogeneous. Dabigatran 150mg was assessed in 9 of models, dabigatran 110mg in 8, sequential dabigatran in 9, rivaroxaban in 4 and apixaban in 4. Adjusted-dose warfarin (either trial-like, real-world prescribing or genotype-dosed) was a potential first-line therapy in 94% of models. Models were conducted from the perspective of the United States (44%), European countries (39%) and Canada (17%). In base-case analyses, patients typically were at moderate-risk of ischemic stroke, initiated anticoagulation between 65 and 73 years of age, and were followed for or near a lifetime. All models reported cost/quality-adjusted life-year (QALY) gained, and while 22% of models reported using a societal perspective, no model included costs of lost productivity. Four models reported an incremental cost-effectiveness ratio (ICER) for a newer anticoagulant (dabigatran 110mg (n=4)/150mg (n=2); rivaroxaban (n=1)) vs. warfarin above commonly reported willingness-to-pay thresholds. ICERs (in 2012US$) vs. warfarin ranged from $3,547-$86,000 for dabigatran 150mg, $20,713-$150,000 for dabigatran 110mg, $4,084-$21,466 for sequentially-dosed dabigatran and $23,065-$57,470 for rivaroxaban. In addition, apixaban was demonstrated to be an economically dominant strategy compared to aspirin and to be dominant or cost-effective ($11,400-$25,059) vs. warfarin. Based on separate indirect treatment comparison meta-analyses, 3 models compared the cost-effectiveness of these new agents and reported conflicting results. Conclusions: Cost-effectiveness models of newer anticoagulants for SPAF have been extensively published. Models have frequently found newer anticoagulants to be cost-effective, but due to the lack of head-to-head trial comparisons and heterogeneity in clinical characteristic of underlying trials and modeling methods, it is currently unclear which of these newer agents is most cost-effective.

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Cost-effectiveness of mobile health-based integrated care for atrial fibrillation: Model development and data analysis (Preprint)

10.2196/preprints.29408 ◽

2021 ◽

Author(s):

Xueyan Luo ◽

Wei Xu ◽

Quan Yuan ◽

Han Lai ◽

Chunji Huang

Keyword(s):

Atrial Fibrillation ◽

Sensitivity Analysis ◽

Cost Effectiveness ◽

Integrated Care ◽

Mobile Health ◽

Cost Effective ◽

Sensitivity Analyses ◽

Base Case ◽

Life Years ◽

Mhealth Technology

BACKGROUND Mobile health (mhealth) technology is increasingly used in disease management. Using mhealth tools to integrate and streamline care was found to improve atrial fibrillation (AF) patients’ clinical outcomes. OBJECTIVE This study aimed to investigate the potential clinical and health economic outcomes of mhealth-based integrated care for AF from the perspective of a public healthcare provider in China. METHODS A Markov model was designed to compare outcomes of mhealth-based care and usual care in a hypothetical cohort of AF patients in China. The time horizon was 30 years with monthly cycles. Model outcomes measured were direct medical cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to examine the robustness of base-case results. RESULTS In the base-case analysis, mhealth-based care gained higher QALYs of 0.0818 with an incurred cost of USD1,778. Using USD33,438 per QALY (three times gross domestic product) as the willingness-to-pay threshold, mhealth-based care was cost-effective, with an ICER of USD21,739 per QALY. The one-way sensitivity analysis found compliance to mhealth-based care had the greatest impact on the ICER. In probabilistic sensitivity analysis, mhealth-based care was accepted as cost-effective in 80.91% of 10,000 iterations. CONCLUSIONS This study suggested that the use of mhealth technology in streamlining and integrating care for AF patients was cost-effective in China.

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Budget impact analysis of trastuzumab in early breast cancer: A hospital district perspective

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462310000103 ◽

2010 ◽

Vol 26 (2) ◽

pp. 163-169 ◽

Cited By ~ 12

Author(s):

Timo T. Purmonen ◽

Päivi K. Auvinen ◽

Janne A. Martikainen

Keyword(s):

Breast Cancer ◽

Sensitivity Analysis ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Probabilistic Sensitivity Analysis ◽

Budget Impact ◽

Base Case ◽

Adjuvant Trastuzumab ◽

Hospital District ◽

Number Of Patients

Objectives:Adjuvant trastuzumab is widely used in HER2-positive (HER2+) early breast cancer, and despite its cost-effectiveness, it causes substantial costs for health care. The purpose of the study was to develop a tool for estimating the budget impact of new cancer treatments. With this tool, we were able to estimate the budget impact of adjuvant trastuzumab, as well as the probability of staying within a given budget constraint.Methods:The created model-based evaluation tool was used to explore the budget impact of trastuzumab in early breast cancer in a single Finnish hospital district with 250,000 inhabitants. The used model took into account the number of patients, HER2+ prevalence, length and cost of treatment, and the effectiveness of the therapy. Probabilistic sensitivity analysis and alternative case scenarios were performed to ensure the robustness of the results.Results:Introduction of adjuvant trastuzumab caused substantial costs for a relatively small hospital district. In base-case analysis the 4-year net budget impact was €1.3 million. The trastuzumab acquisition costs were partially offset by the reduction in costs associated with the treatment of cancer recurrence and metastatic disease.Conclusions:Budget impact analyses provide important information about the overall economic impact of new treatments, and thus offer complementary information to cost-effectiveness analyses. Inclusion of treatment outcomes and probabilistic sensitivity analysis provides more realistic estimates of the net budget impact. The length of trastuzumab treatment has a strong effect on the budget impact.

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