- Email: [email protected]
Beyond Cervical Cancer: The Cost-Effectiveness Of Hpv Vaccination In The Netherlands
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the medicinal products) versus paritaprevir/ritonavir/ombitasvir + dasabuvir (Paritaprevir/r/ Ombitasvir + Dasabuvir) in treatment-experienced and treatmentnaive groups of patients (HCV genotype 1b) without liver cirrhosis and with liver cirrhosis in the Russian Federation. Methods: The study was based on the global pharmacoeconomic model «The MONARCH Cost-effectiveness Model». Only direct costs were taken into account (antiviral medicines, monitoring costs, outpatient treatment and hospitalizations in case of complications development (decompensated cirrhosis, hepatocellular carcinoma and liver transplantation)). Cost data was based on median prices for medicines and medical services in National healthcare system in the Russian Federation. Effectiveness data (concerning sustained virologic response) was taken from the published results of clinical trials (indirect comparison). Characteristics of patients (number of patients, age, F0-F4 distribution etc.) were taken from the local statistics. Results: In comparison with Paritaprevir/r/ Ombitasvir + Dasabuvir, the use of DCV + ASV among treatment-naive patients leads to lower QALY 15,99 vs 16,31 , lower costs 11 996 € vs 14 216 € and lower CER 750 vs 872, respectively. The use of DCV + ASV among treatment-experienced patients leads to lower QALY 15,59 vs 16,35 , lower costs 12 658 € vs 14 154 € and lower CER 812 vs 866 compared to Paritaprevir/r/ Ombitasvir + Dasabuvir, respectively. Conclusions: Obtained results showed that DCV + ASV in groups of treatment-naïve and treatment-experienced patients had lower cost-effectiveness ratio in comparison with Paritaprevir/r/ Ombitasvir + Dasabuvir. PIN52 Inclusion Of Costs And Effects Related To Toxicity/Safety In Cost -Effectiveness Analysis; An Illustration For Influenza Vaccines Fens T1, de Boer PT1, Postma MJ2 1University of Groningen, Groningen, The Netherlands, 2University Medical Center Groningen, Groningen, The Netherlands
Objectives: To assess the inclusion of cost and quality of life (QoL) impacts emerging from adverse events (AE) after administration of seasonal influenza vaccines in cost-effectiveness analysis. Methods: A systematic literature review in PubMed and EMBASE was conducted to detect recent cost-effectiveness studies for seasonal influenza vaccines in the period 2008-2015. Only full-text articles published in peerreviewed journals were included in our review. Mean outcome measures were inclusion of AE, and its related cost and QoL-impacts. Results: Adhering to our search criteria, we included 48 studies. The number of studies that included AE was 24 out of 48 (50%), with AE present as: local AE, systematic AE, reactogenicity, medically significant wheezing, anaphylaxis and Guillain-Barré syndrome. Included AE-related outcomes contained probability of occurrence of AE (17 studies), duration of AE (5 studies), direct costs (18 studies), indirect costs (3 studies) and reductions in QoL (9 studies). Overall, studies including AE generally applied the societal or combined societal/third-part-payer perspectives. Furthermore, AE were predominantly taken into account in studies where trivalent inactivated influenza vaccines were compared with live-attenuated influenza vaccines. No articles discussing the recent issue of quadrivalent influenza vaccines vs. trivalent influenza vaccines included AE-related impacts. Conclusions: We found that half of the cost-effectiveness studies on seasonal influenza vaccination included the impact of AE. When AE were included, it mostly concerned direct costs, while indirect costs and QoL were scarcely included. Studies that used the societal perspective more often included AE as compared with studies only considering health care costs. Few studies including the whole spectrum of costs and effects of AE reported some moderate impact on cost-effectiveness. Finally, economic analyses that did not include costs and/or effects of AE generally commented that their occurrence is not influencing cost-effectiveness outcomes. PIN53 Economic Evaluation Of Yellow Fever Routine Vaccination In Colombia Hoestlandt C1, Broban A2, Houillon G1, Caicedo A3, Martinez JF3, Kieffer A1 1Sanofi Pasteur, Lyon, France, 2Sanofi Pasteur, Istanbul, Turkey, 3Sanofi Pasteur, Bogota, Colombia
Objectives: This research aims to explore the intrinsic value of a live-attenuated YF vaccine, its public health impact, and the savings achieved through routine immunization programs, taking Colombia as an example. Methods: We used a static cost-effectiveness model to define the health impact and economic benefit of a live-attenuated 17D YF virus strain vaccine used in an infant routine immunization program in Colombia. We considered the epidemiology of the pre-vaccination era in the country to estimate the intrinsic value of such vaccine. Incidence rate of toxic cases was estimated based on cases notified to WHO over a non-epidemic period (1980-2002). An underreporting factor was applied to incidence, as referenced in the literature. Costs related to health care resources was assessed based on WHOCHOICE. Results: From a payer perspective, routine immunization was on the edge of the very cost-effective threshold with an incremental cost-effectiveness ratio of 9,415 USD per DALY saved. When societal perspective was considered, the vaccine became very cost-effective. Finally, using the 3 times GDP per capita as willingness to pay in Colombia, a YF vaccine would have been cost-effective up to approximately $5 per dose, holding all other parameters constant. The sensitivity analysis highlighted the importance of the underreporting factor and the level of wastage rate as strong value drivers. Conclusions: The significant uncertainty around the human burden of YF disease has a strong impact on the value of YF vaccines, and therefore on the measurement of the health benefits of vaccination. Taking the more conservative range of underreporting factor and epidemiological parameters, we showed a good “value for money”. In such context, a potential of more than 3 times the current price could have been reached while remaining costeffective. This study provides insights on the significant discrepancy between the price of the vaccine and its value in an upper middle-income country. PIN54 Cost Of Dengue Illness And Cost-Effectiveness Of The Cdy-Tdv Dengue Vaccine In Ecuador
Lucio-Romero R1, Henriquez-Trujillo AR2, Bermudez-Gallegos K1, Tello-Ponce B3, Caicedo Navas AG4, Vandeputte C4 1Sur-Este Ltd., Quito, Ecuador, 2Universidad de Las Américas, Quito, Ecuador, 3Pontificia Universidad Catolica del Ecuador, Quito, Ecuador, 4Sanofi Pasteur, Bogota, Colombia
Context: Ecuador has shown a multiplying tendency of dengue cases, reaching an unprecedented rate of 380 cases per 100,000 inhabitants in 2015, with the highest rates between 10-15 years old. The average annual cost of dengue in the period 2008-2015 is estimated at US $4 million and US $33 million respectively, with or without under-reporting, and it can reach US $16 million and US $96 million in an outbreak year such as 2015 it can reach US $12 million and US $96 million, respectively. Objectives: To estimate the burden of dengue disease, and assess the impact and cost-effectiveness of the introduction of the CDYTDV tetravalent dengue vaccine in Ecuador. Methods: A dynamic transmission model of the disease was used to estimate the burden of the disease and related costs for several vaccination scenarios with dengue vaccine compared with no vaccination over a 10 year period (2017-2026). Results: Using as a reference ≤ GDP per capita (US $18,960) as cost-effectiveness threshold in Ecuador, from the societal perspective, and with under-reporting adjustment, the maximum price per dose for the intervention to be cost-effective was estimated in $26.88 for a routine vaccination scheme at age 9 years old, $27.61 for a routine scheme at 9 years plus catch-up cohorts aged 10-12 years, and $26.82 for a routine scheme of vaccination at the age of 9 years plus catch-up cohorts aged 10-15 years. In this last scenario, 795 thousand cases of dengue, 9 thousand hospitalizations and 21 deaths can be reduced. Conclusions: Implementing an immunization schedule against dengue infections could be a very effective and efficient way to fight dengue, with important benefits for the Ecuadorian society and the Government as a third-party payer. PIN55 Cost-Effectiveness Of Ombitasvir/Paritaprevir/Ritonavir With Or Without Dasabuvir For The Treatment Of Chronic Hepatitis C Patients Infected With Genotype 1 Or 4 In France Sroczynski G1, Conrads-Frank A1, Mühlberger N2, Kühne F1, Jeanblanc G3, Samp JC4, Durand-Zaleski I5, Siebert U1 1UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, 2UMIT - University for Health Sciences, Medical Informatics and Technology, Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, Hall i.T., Austria, 3AbbVie Inc., Rungis, France, 4AbbVie Inc, North Chicago, IL, USA, 5APHP URC Eco Ile de France Hôpital de l’Hotel Dieu, Paris, France
Objectives: Treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin (OBV/PTV/r±DSV±R) achieved high sustained virologic response rates (SVR). We evaluated long-term clinical and economic outcomes of OBV/PTV/r±DSV±R compared with other antiviral treatments for treatment-naïve and -experienced chronic hepatitis C (CHC) patients infected with genotype-1 (GT1) or genotype-4 (GT4) in France. Methods: A Markov cohort simulation model for the French health care setting was developed and applied to evaluate the following antiviral treatment regimens: peginterferon+ribavirin (P+R), telaprevir+P+R (TVR+P+R), boceprevir+P+R (BOC+P+R), sofosbuvir+P+R (SOF+P+R), simeprevir+P+R (SIM+P+R), SOF+R, SOF+SIM, SOF+daclatasvir±R (SOF+DAC±R), SOF+ledipasvir±R (SOF+LDV±R), OBV/ PTV/r±DSV±R. Disease progression rates were abstracted from international literature. Treatment regimens were based on European and French treatment guidelines. Treatment related changes in quality-of-life (QoL), SVR, and adverse events were based on international clinical trial data. We used French data on population characteristics, disease-related QoL, and costs (index year 2014/15) from published literature, databases and original studies. Analyses were conducted from the collective payer’s perspective with 4% annual discount rate for costs and effects and a lifelong time horizon. Outcomes included lifetime costs, life years (LY), qualityadjusted life years (QALY), and the incremental cost-effectiveness ratio (ICER). Comprehensive sensitivity analyses were performed. Results: Compared to no antiviral therapy, OBV/PTV/r±DSV±R gained 1.1-1.6 LYs (1.6-2.0 QALYs) depending on treatment history and genotype. OBV/PTV/r±DSV±R achieved ICERs of 30,089 Euro/QALY (vs. SIM+P+R) in GT1 and 30,422 Euro/QALY (vs. SIM+P+R) in GT4 treatment-naïve patients. The corresponding ICERs in treatment-experienced patients were 18,790 Euro/QALY in GT1 (vs. SIM+P+R) and 9,479 Euro/QALY in GT4 (vs. no treatment). Parameters with the greatest influence on the ICER in deterministic sensitivity analyses were the SVR, discount rate, progression to advanced disease and the relative utility for being HCV-RNA positive. Conclusions: Based on our analyses, antiviral treatment with OBV/PTV/r±DSV±R prolongs life and can be considered cost-effective in treatment-naïve and -experienced CHC patients infected with genotype-1 or genotype-4.
PIN56 Beyond Cervical Cancer: The Cost-Effectiveness Of Hpv Vaccination In The Netherlands Setiawan D1, Cao Q1, Westra TA2, Postma MJ3 1University of Groningen, Groningen, The Netherlands, 2GlaxoSmithKline, Zeist, The Netherlands, 3University Medical Center Groningen, Groningen, The Netherlands
Objectives: To assess the clinical implication and cost-effectiveness of HPV vaccination with respect to the addition of non-cervical HPV-related cancer in the Netherlands. Methods: a dynamic transmission model was implemented to predict the nature of 7 types of HPV-related cancer in the Netherlands population. The HPV infection profile before- and after-vaccination periods were extracted from the dynamic model and adjusted with the actual age-specific incidence of HPV-related cancer in the Netherlands using regression model. The regression formula was used to predict the incidence of HPV-related cancer after vaccination. The impact of cervical cancer screening was implemented in the model and vaccine uptake
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was considerably low (50%) in the model. Results: the average reduction of HPV related cancer was 87.47% with the lowest and highest reduction were generated on oropharyngeal cancer (82.60%) and vulvar cancer (90.48%), respectively. Although the proportion of HPV-related oral cancer were low, the total benefit of HPV vaccination were considerably high due to its high national incidence of oropharyngeal cancer in the Netherlands. HPV vaccine was also substantially cost-effective since the ICER was € 10.422. Conclusions: HPV vaccine has potential benefit not only for cervical cancer but also other types of HPV-related cancer in the Netherlands PIN57 The Cost Of Treating Mucormycosis With Isavuconazole Compared With Liposomal Amphotericin B Followed By Posaconazole In The United Kingdom: Economic Evaluation Of The Phase Iii Vital Study And Fungiscope Matched Case-Control Analysis Kuessner D1, Bagshaw E2, Blackney M2, Cornely OA3, Heimann SM3, Posthumus J1 1Basilea Pharmaceutica International Ltd., Basel, Switzerland, 2Covance Market Access, London, UK, 3University Hospital of Cologne, Cologne, Germany
Objectives: Mucormycosis is a rapidly progressive fungal infection, associated with high mortality, particularly when appropriate treatment is not promptly initiated. Until recently, the only licensed treatments were amphotericin B (AMB) formulations, which have considerable limitations. AMB deoxycholate is nephrotoxic, while the less nephrotoxic liposomal AMB (L-AMB) – standard treatment in the United Kingdom (UK) – is costly. Isavuconazole (ISAV) is a new intravenous and oral triazole antifungal for the treatment of mucormycosis in adults for whom AMB is inappropriate. A cost-minimisation model was developed to explore the cost of treating mucormycosis with ISAV versus L-AMB followed by maintenance treatment with off-label, oral posaconazole (POSA) in the UK. Methods: The costminimisation analysis estimated per-patient treatment costs for mucormycosis from the UK National Health Service perspective. The time horizon was until end of treatment. A matched case-control analysis of the phase III, single-arm VITAL study of ISAV in mucormycosis and the FungiScope™ registry showed similar efficacy of ISAV and AMB (mainly L-AMB) ± POSA. Treatment-related costs comprised on-treatment drug acquisition, monitoring and administration costs, and hospitalisation costs. Clinical inputs, including treatment durations and dosing regimens, were derived from the VITAL study and FungiScope™ analysis. Monitoring requirements were based on adverse events and precautions reported in Summary of Product Characteristics documentation. Unit costs were from publicly available UK sources. Results: The estimated per-patient cost of treating mucormycosis with ISAV and L-AMB + POSA was £26,810 and £41,855, respectively. Savings were primarily driven by reduced drug acquisition costs with ISAV relative to L-AMB + POSA, alongside lower hospitalisation costs since ISAV patients could be switched from IV to oral treatment earlier than LAMB + POSA patients. Conclusions: Based on the matched case-control comparison between patients receiving treatment with ISAV or L-AMB, ISAV is expected to reduce costs by 36% compared with standard mucormycosis treatment in the UK. PIN58 Cost Minimization Analysis Of Tedizolid For The Treatment Of Acute Bacterial Skin And Skin Sub-Structure Infections (Absssi) In Greece Insinga R1, Dalakaki E2, Retsa MP2, Karokis A2, Sarpong EM1 1Merck & Co., Inc., Kenilworth, NJ, USA, 2MSD Greece, Athens, Greece
Objectives: To compare cost per ABSSSI patient treated with Tedizolid as empiric antibiotic therapy compared to alternative methicillin-resistant staphylococcus aureus (MRSA)-targeted therapies in Greece. Methods: Tedizolid was compared to Linezolid in trials and found to have similar efficacy. There is a lack of data to support a long-term health benefit relative to use of other comparators (Vancomycin, Daptomycin, Ceftaroline, Tigecycline). A cost-minimization analysis was thus employed, incorporating clinical trial data, and Greek resource use and costs. Patients are initially treated with empiric therapy until MRSA status is known. Non-MRSA patients are de-escalated to alternate treatments. MRSA patient non-responders to first-line therapy switch to second-line treatment. Modelling of hospital length of stay (LOS) for IV/oral treatments (Tedizolid/Linezolid) allowed for potential early discharge to outpatient treatment, while patients on IV-only treatments incurred LOS encompassing full duration of treatment (DOT). LOS reductions only occur among MRSA patients for whom antibiotic use is a rate limiting step for hospital discharge. Results: In the base case, total costs per treated ABSSSI patient were 2,129€ and 2,072€ for Tedizolid and Linezolid, respectively. Tedizolid is cost-saving versus Linezolid provided a reduction in LOS of 2.0 days is achieved among early discharge (ED) eligible patients. This is less than the 4-day difference in DOT between Linezolid (10 days) and Tedizolid (6 days). Tedizolid would also be cost-saving versus Vancomycin (DOT = 14 days) with an LOS reduction of 2.2 days among ED eligible patients. Tedizolid is cost-saving versus all other comparators, irrespective of ED eligibility. If Tedizolid could reduce LOS by 4 days vs. Linezolid in this ED-eligible group, a net cost savings of 55€ would result. Conclusions: Tedizolid has the potential to be a cost saving alternative versus comparator therapies. Real world data are needed to determine the degree to which hospital LOS reductions may be achievable in clinical practice. PIN59 Economic Evaluation Of Abbvie’s Regimen (Viekirax/Exviera) For Patients With Genotype 1a Hcv In Greece Mylonas C1, Kourlaba G2, Vernadaki A3, Kakouros M3, Maniadakis N1 School of Public Health, Athens, Greece, 2Collaborative Center of Clinical Epidemiology and Outcomes Research (CLEO), Non-Profit Civil Partenrship, Athens, Greece, 3AbbVie Pharmaceuticals S.A, Athens, Greece
1National
Objectives: To conduct a cost – utility analysis of the AbbVie’s regimen versus other established maintenance treatment options in the Greek health care setting, for patients within genotype 1a chronic hepatitis C virus (HCV). Methods: A Markov model was adapted locally to reflect the natural progression of patients with
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genotype 1a through different health states. Efficacy and safety data considered in the model were extracted from the relevant clinical trials and other published studies. Utilities values were extracted from the literature. Direct medical costs were incorporated in the model reflecting the year 2015. The model evaluated the comparators over a lifetime horizon in the course of a 1-year cycle. The outcomes are measured in terms of Quality Adjusted Life Years gained. While outcomes can vary, the outcomes in this analysis were measured in terms of life-years gained. The analysis was performed from a payer’s perspective. Costs and outcomes that occurred beyond one year were discounted at a 3.5% annual rate which is the standard practice in Greece as well as other jurisdictions. Results: The base case results indicate that the AbbVie Regimen is a dominant option (in the most cases) and costeffective option for naïve patients with genotype 1a HCV. The sensitivity analysis shows that the overall cost-effectiveness results are sensitive to the model time horizon and changes in the SVR rate for patients on the comparator treatment. AbbVie’s regimen appears cost-effective based on traditional standards in the vast majority of sensitivity analyses. In the CEAF, it is the optimal choice (on the optimality frontier) when payers are willing to pay over about 15,000€ /QALY in the majority of analyses. Conclusions: Using conservative assumptions, the present economic evaluation suggests that AbbVie’s regimen provides greater health outcomes and is less costly compared to majority of comparators. PIN60 Systematic Review Of Studies Estimating The Cost-Effectiveness Of Hiv Pre-Exposure Prophylaxis (Prep) In Men Who Have Sex With Men (Msm) Damm O, Scholz S, Greiner W School of Public Health, Bielefeld University, Bielefeld, Germany
Objectives: Oral pre-exposure prophylaxis (PrEP) with tenofovir and emtricitabine has been shown to be effective in reducing the risk of HIV infection in men who have sex with men (MSM). The aim of our study was to systematically review the existing evidence on the cost-effectiveness of PrEP in MSM. Methods: We performed a systematic PubMed literature search to identify relevant studies published from January 2000 through February 2016 in English or German. A study was included if it reported cost per quality-adjusted life year (QALY) estimates for the USA, Canada, Australia, or European countries. All monetary values were converted to euros. Results: Eight studies on the cost-effectiveness of PrEP in MSM, which reported results for the USA, Canada, and Australia, were included in the review. Most studies focused on the evaluation of PrEP use in the general MSM population and/or in high-risk MSM. Two studies additionally assessed the cost-effectiveness of PrEP use in monogamous serodiscordant relationships. Results varied considerably across and within studies, with some scenarios yielding incremental cost-effectiveness ratios (ICERs) of several hundred thousand euros per QALY. In studies that assessed PrEP use in high-risk MSM as well as in the general MSM population, strategies targeting high-risk MSM resulted in lower ICERs than strategies without differentiation by risk status. Three studies even showed that targeting high-risk MSM could lead to cost savings. Conclusions: Since results of the included studies varied considerably, it is difficult to draw a clear conclusion on the cost-effectiveness of PrEP in MSM. However, in studies that evaluated PrEP use in both high-risk MSM and the general MSM population, strategies targeting high-risk MSM were found to be more cost-effective. None of the currently available studies reported results for European countries. Hence, future models evaluating the cost-effectiveness of PrEP in MSM should address this research gap. PIN61 Economic Evaluation Of Abbvie’s Regimen (Viekirax/Exviera) For Patients With Genotype 1b Hcv In Greece Mylonas C1, Kourlaba G2, Vernadaki A3, Kakouros M3, Maniadakis N1 School of Public Health, Athens, Greece, 2Collaborative Center of Clinical Epidemiology and Outcomes Research (CLEO), Non-Profit Civil Partenrship, Athens, Greece, 3AbbVie Pharmaceuticals S.A, Athens, Greece
1National
Objectives: To conduct a cost – utility analysis of the AbbVie’s regimen versus other established maintenance treatment options in the Greek health care setting, for patients within genotype 1b chronic hepatitis C virus (HCV). Methods: A Markov model was adapted locally to reflect the natural progression of patients with genotype 1b through different health states. Efficacy and safety data considered in the model were extracted from the relevant clinical trials and other published studies. Utilities values were extracted from the literature. Direct medical costs were incorporated in the model reflecting the year 2015. The model evaluated the comparators over a lifetime horizon in the course of a 1-year cycle. The outcomes are measured in terms of Quality Adjusted Life Years gained. While outcomes can vary, the outcomes in this analysis were measured in terms of life-years gained. The analysis was performed from a payer’s perspective. Costs and outcomes that occurred beyond one year were discounted at a 3.5% annual rate which is the standard practice in Greece as well as other jurisdictions. Results: The base case results indicate that the AbbVie Regimen is a dominant option (in the most cases) and cost-effective option for naïve patients with genotype 1b HCV. The sensitivity analysis shows that the overall cost-effectiveness results are sensitive to the model time horizon and changes in the SVR rate for patients on the comparator treatment. AbbVie’s regimen appears cost-effective based on traditional standards in the vast majority of sensitivity analyses. In the CEAF, it is the optimal choice (on the optimality frontier) when payers are willing to pay over about 15,000€ /QALY in the majority of analyses. Conclusions: Using conservative assumptions, the present economic evaluation suggests that AbbVie’s regimen provides greater health outcomes and is less costly compared to majority of comparators. PIN62 Determening The Optimal Price For New Non-Nucleoside Reverse Transcritase Inhbitor Using Early Economic Modeling Musina N1, Pogorelova E2, Savilova A2, Korzinov O2
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the medicinal products) versus paritaprevir/ritonavir/ombitasvir + dasabuvir (Paritaprevir/r/ Ombitasvir + Dasabuvir) in treatment-experienced and treatmentnaive groups of patients (HCV genotype 1b) without liver cirrhosis and with liver cirrhosis in the Russian Federation. Methods: The study was based on the global pharmacoeconomic model «The MONARCH Cost-effectiveness Model». Only direct costs were taken into account (antiviral medicines, monitoring costs, outpatient treatment and hospitalizations in case of complications development (decompensated cirrhosis, hepatocellular carcinoma and liver transplantation)). Cost data was based on median prices for medicines and medical services in National healthcare system in the Russian Federation. Effectiveness data (concerning sustained virologic response) was taken from the published results of clinical trials (indirect comparison). Characteristics of patients (number of patients, age, F0-F4 distribution etc.) were taken from the local statistics. Results: In comparison with Paritaprevir/r/ Ombitasvir + Dasabuvir, the use of DCV + ASV among treatment-naive patients leads to lower QALY 15,99 vs 16,31 , lower costs 11 996 € vs 14 216 € and lower CER 750 vs 872, respectively. The use of DCV + ASV among treatment-experienced patients leads to lower QALY 15,59 vs 16,35 , lower costs 12 658 € vs 14 154 € and lower CER 812 vs 866 compared to Paritaprevir/r/ Ombitasvir + Dasabuvir, respectively. Conclusions: Obtained results showed that DCV + ASV in groups of treatment-naïve and treatment-experienced patients had lower cost-effectiveness ratio in comparison with Paritaprevir/r/ Ombitasvir + Dasabuvir. PIN52 Inclusion Of Costs And Effects Related To Toxicity/Safety In Cost -Effectiveness Analysis; An Illustration For Influenza Vaccines Fens T1, de Boer PT1, Postma MJ2 1University of Groningen, Groningen, The Netherlands, 2University Medical Center Groningen, Groningen, The Netherlands
Objectives: To assess the inclusion of cost and quality of life (QoL) impacts emerging from adverse events (AE) after administration of seasonal influenza vaccines in cost-effectiveness analysis. Methods: A systematic literature review in PubMed and EMBASE was conducted to detect recent cost-effectiveness studies for seasonal influenza vaccines in the period 2008-2015. Only full-text articles published in peerreviewed journals were included in our review. Mean outcome measures were inclusion of AE, and its related cost and QoL-impacts. Results: Adhering to our search criteria, we included 48 studies. The number of studies that included AE was 24 out of 48 (50%), with AE present as: local AE, systematic AE, reactogenicity, medically significant wheezing, anaphylaxis and Guillain-Barré syndrome. Included AE-related outcomes contained probability of occurrence of AE (17 studies), duration of AE (5 studies), direct costs (18 studies), indirect costs (3 studies) and reductions in QoL (9 studies). Overall, studies including AE generally applied the societal or combined societal/third-part-payer perspectives. Furthermore, AE were predominantly taken into account in studies where trivalent inactivated influenza vaccines were compared with live-attenuated influenza vaccines. No articles discussing the recent issue of quadrivalent influenza vaccines vs. trivalent influenza vaccines included AE-related impacts. Conclusions: We found that half of the cost-effectiveness studies on seasonal influenza vaccination included the impact of AE. When AE were included, it mostly concerned direct costs, while indirect costs and QoL were scarcely included. Studies that used the societal perspective more often included AE as compared with studies only considering health care costs. Few studies including the whole spectrum of costs and effects of AE reported some moderate impact on cost-effectiveness. Finally, economic analyses that did not include costs and/or effects of AE generally commented that their occurrence is not influencing cost-effectiveness outcomes. PIN53 Economic Evaluation Of Yellow Fever Routine Vaccination In Colombia Hoestlandt C1, Broban A2, Houillon G1, Caicedo A3, Martinez JF3, Kieffer A1 1Sanofi Pasteur, Lyon, France, 2Sanofi Pasteur, Istanbul, Turkey, 3Sanofi Pasteur, Bogota, Colombia
Objectives: This research aims to explore the intrinsic value of a live-attenuated YF vaccine, its public health impact, and the savings achieved through routine immunization programs, taking Colombia as an example. Methods: We used a static cost-effectiveness model to define the health impact and economic benefit of a live-attenuated 17D YF virus strain vaccine used in an infant routine immunization program in Colombia. We considered the epidemiology of the pre-vaccination era in the country to estimate the intrinsic value of such vaccine. Incidence rate of toxic cases was estimated based on cases notified to WHO over a non-epidemic period (1980-2002). An underreporting factor was applied to incidence, as referenced in the literature. Costs related to health care resources was assessed based on WHOCHOICE. Results: From a payer perspective, routine immunization was on the edge of the very cost-effective threshold with an incremental cost-effectiveness ratio of 9,415 USD per DALY saved. When societal perspective was considered, the vaccine became very cost-effective. Finally, using the 3 times GDP per capita as willingness to pay in Colombia, a YF vaccine would have been cost-effective up to approximately $5 per dose, holding all other parameters constant. The sensitivity analysis highlighted the importance of the underreporting factor and the level of wastage rate as strong value drivers. Conclusions: The significant uncertainty around the human burden of YF disease has a strong impact on the value of YF vaccines, and therefore on the measurement of the health benefits of vaccination. Taking the more conservative range of underreporting factor and epidemiological parameters, we showed a good “value for money”. In such context, a potential of more than 3 times the current price could have been reached while remaining costeffective. This study provides insights on the significant discrepancy between the price of the vaccine and its value in an upper middle-income country. PIN54 Cost Of Dengue Illness And Cost-Effectiveness Of The Cdy-Tdv Dengue Vaccine In Ecuador
Lucio-Romero R1, Henriquez-Trujillo AR2, Bermudez-Gallegos K1, Tello-Ponce B3, Caicedo Navas AG4, Vandeputte C4 1Sur-Este Ltd., Quito, Ecuador, 2Universidad de Las Américas, Quito, Ecuador, 3Pontificia Universidad Catolica del Ecuador, Quito, Ecuador, 4Sanofi Pasteur, Bogota, Colombia
Context: Ecuador has shown a multiplying tendency of dengue cases, reaching an unprecedented rate of 380 cases per 100,000 inhabitants in 2015, with the highest rates between 10-15 years old. The average annual cost of dengue in the period 2008-2015 is estimated at US $4 million and US $33 million respectively, with or without under-reporting, and it can reach US $16 million and US $96 million in an outbreak year such as 2015 it can reach US $12 million and US $96 million, respectively. Objectives: To estimate the burden of dengue disease, and assess the impact and cost-effectiveness of the introduction of the CDYTDV tetravalent dengue vaccine in Ecuador. Methods: A dynamic transmission model of the disease was used to estimate the burden of the disease and related costs for several vaccination scenarios with dengue vaccine compared with no vaccination over a 10 year period (2017-2026). Results: Using as a reference ≤ GDP per capita (US $18,960) as cost-effectiveness threshold in Ecuador, from the societal perspective, and with under-reporting adjustment, the maximum price per dose for the intervention to be cost-effective was estimated in $26.88 for a routine vaccination scheme at age 9 years old, $27.61 for a routine scheme at 9 years plus catch-up cohorts aged 10-12 years, and $26.82 for a routine scheme of vaccination at the age of 9 years plus catch-up cohorts aged 10-15 years. In this last scenario, 795 thousand cases of dengue, 9 thousand hospitalizations and 21 deaths can be reduced. Conclusions: Implementing an immunization schedule against dengue infections could be a very effective and efficient way to fight dengue, with important benefits for the Ecuadorian society and the Government as a third-party payer. PIN55 Cost-Effectiveness Of Ombitasvir/Paritaprevir/Ritonavir With Or Without Dasabuvir For The Treatment Of Chronic Hepatitis C Patients Infected With Genotype 1 Or 4 In France Sroczynski G1, Conrads-Frank A1, Mühlberger N2, Kühne F1, Jeanblanc G3, Samp JC4, Durand-Zaleski I5, Siebert U1 1UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, 2UMIT - University for Health Sciences, Medical Informatics and Technology, Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, Hall i.T., Austria, 3AbbVie Inc., Rungis, France, 4AbbVie Inc, North Chicago, IL, USA, 5APHP URC Eco Ile de France Hôpital de l’Hotel Dieu, Paris, France
Objectives: Treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin (OBV/PTV/r±DSV±R) achieved high sustained virologic response rates (SVR). We evaluated long-term clinical and economic outcomes of OBV/PTV/r±DSV±R compared with other antiviral treatments for treatment-naïve and -experienced chronic hepatitis C (CHC) patients infected with genotype-1 (GT1) or genotype-4 (GT4) in France. Methods: A Markov cohort simulation model for the French health care setting was developed and applied to evaluate the following antiviral treatment regimens: peginterferon+ribavirin (P+R), telaprevir+P+R (TVR+P+R), boceprevir+P+R (BOC+P+R), sofosbuvir+P+R (SOF+P+R), simeprevir+P+R (SIM+P+R), SOF+R, SOF+SIM, SOF+daclatasvir±R (SOF+DAC±R), SOF+ledipasvir±R (SOF+LDV±R), OBV/ PTV/r±DSV±R. Disease progression rates were abstracted from international literature. Treatment regimens were based on European and French treatment guidelines. Treatment related changes in quality-of-life (QoL), SVR, and adverse events were based on international clinical trial data. We used French data on population characteristics, disease-related QoL, and costs (index year 2014/15) from published literature, databases and original studies. Analyses were conducted from the collective payer’s perspective with 4% annual discount rate for costs and effects and a lifelong time horizon. Outcomes included lifetime costs, life years (LY), qualityadjusted life years (QALY), and the incremental cost-effectiveness ratio (ICER). Comprehensive sensitivity analyses were performed. Results: Compared to no antiviral therapy, OBV/PTV/r±DSV±R gained 1.1-1.6 LYs (1.6-2.0 QALYs) depending on treatment history and genotype. OBV/PTV/r±DSV±R achieved ICERs of 30,089 Euro/QALY (vs. SIM+P+R) in GT1 and 30,422 Euro/QALY (vs. SIM+P+R) in GT4 treatment-naïve patients. The corresponding ICERs in treatment-experienced patients were 18,790 Euro/QALY in GT1 (vs. SIM+P+R) and 9,479 Euro/QALY in GT4 (vs. no treatment). Parameters with the greatest influence on the ICER in deterministic sensitivity analyses were the SVR, discount rate, progression to advanced disease and the relative utility for being HCV-RNA positive. Conclusions: Based on our analyses, antiviral treatment with OBV/PTV/r±DSV±R prolongs life and can be considered cost-effective in treatment-naïve and -experienced CHC patients infected with genotype-1 or genotype-4.
PIN56 Beyond Cervical Cancer: The Cost-Effectiveness Of Hpv Vaccination In The Netherlands Setiawan D1, Cao Q1, Westra TA2, Postma MJ3 1University of Groningen, Groningen, The Netherlands, 2GlaxoSmithKline, Zeist, The Netherlands, 3University Medical Center Groningen, Groningen, The Netherlands
Objectives: To assess the clinical implication and cost-effectiveness of HPV vaccination with respect to the addition of non-cervical HPV-related cancer in the Netherlands. Methods: a dynamic transmission model was implemented to predict the nature of 7 types of HPV-related cancer in the Netherlands population. The HPV infection profile before- and after-vaccination periods were extracted from the dynamic model and adjusted with the actual age-specific incidence of HPV-related cancer in the Netherlands using regression model. The regression formula was used to predict the incidence of HPV-related cancer after vaccination. The impact of cervical cancer screening was implemented in the model and vaccine uptake
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was considerably low (50%) in the model. Results: the average reduction of HPV related cancer was 87.47% with the lowest and highest reduction were generated on oropharyngeal cancer (82.60%) and vulvar cancer (90.48%), respectively. Although the proportion of HPV-related oral cancer were low, the total benefit of HPV vaccination were considerably high due to its high national incidence of oropharyngeal cancer in the Netherlands. HPV vaccine was also substantially cost-effective since the ICER was € 10.422. Conclusions: HPV vaccine has potential benefit not only for cervical cancer but also other types of HPV-related cancer in the Netherlands PIN57 The Cost Of Treating Mucormycosis With Isavuconazole Compared With Liposomal Amphotericin B Followed By Posaconazole In The United Kingdom: Economic Evaluation Of The Phase Iii Vital Study And Fungiscope Matched Case-Control Analysis Kuessner D1, Bagshaw E2, Blackney M2, Cornely OA3, Heimann SM3, Posthumus J1 1Basilea Pharmaceutica International Ltd., Basel, Switzerland, 2Covance Market Access, London, UK, 3University Hospital of Cologne, Cologne, Germany
Objectives: Mucormycosis is a rapidly progressive fungal infection, associated with high mortality, particularly when appropriate treatment is not promptly initiated. Until recently, the only licensed treatments were amphotericin B (AMB) formulations, which have considerable limitations. AMB deoxycholate is nephrotoxic, while the less nephrotoxic liposomal AMB (L-AMB) – standard treatment in the United Kingdom (UK) – is costly. Isavuconazole (ISAV) is a new intravenous and oral triazole antifungal for the treatment of mucormycosis in adults for whom AMB is inappropriate. A cost-minimisation model was developed to explore the cost of treating mucormycosis with ISAV versus L-AMB followed by maintenance treatment with off-label, oral posaconazole (POSA) in the UK. Methods: The costminimisation analysis estimated per-patient treatment costs for mucormycosis from the UK National Health Service perspective. The time horizon was until end of treatment. A matched case-control analysis of the phase III, single-arm VITAL study of ISAV in mucormycosis and the FungiScope™ registry showed similar efficacy of ISAV and AMB (mainly L-AMB) ± POSA. Treatment-related costs comprised on-treatment drug acquisition, monitoring and administration costs, and hospitalisation costs. Clinical inputs, including treatment durations and dosing regimens, were derived from the VITAL study and FungiScope™ analysis. Monitoring requirements were based on adverse events and precautions reported in Summary of Product Characteristics documentation. Unit costs were from publicly available UK sources. Results: The estimated per-patient cost of treating mucormycosis with ISAV and L-AMB + POSA was £26,810 and £41,855, respectively. Savings were primarily driven by reduced drug acquisition costs with ISAV relative to L-AMB + POSA, alongside lower hospitalisation costs since ISAV patients could be switched from IV to oral treatment earlier than LAMB + POSA patients. Conclusions: Based on the matched case-control comparison between patients receiving treatment with ISAV or L-AMB, ISAV is expected to reduce costs by 36% compared with standard mucormycosis treatment in the UK. PIN58 Cost Minimization Analysis Of Tedizolid For The Treatment Of Acute Bacterial Skin And Skin Sub-Structure Infections (Absssi) In Greece Insinga R1, Dalakaki E2, Retsa MP2, Karokis A2, Sarpong EM1 1Merck & Co., Inc., Kenilworth, NJ, USA, 2MSD Greece, Athens, Greece
Objectives: To compare cost per ABSSSI patient treated with Tedizolid as empiric antibiotic therapy compared to alternative methicillin-resistant staphylococcus aureus (MRSA)-targeted therapies in Greece. Methods: Tedizolid was compared to Linezolid in trials and found to have similar efficacy. There is a lack of data to support a long-term health benefit relative to use of other comparators (Vancomycin, Daptomycin, Ceftaroline, Tigecycline). A cost-minimization analysis was thus employed, incorporating clinical trial data, and Greek resource use and costs. Patients are initially treated with empiric therapy until MRSA status is known. Non-MRSA patients are de-escalated to alternate treatments. MRSA patient non-responders to first-line therapy switch to second-line treatment. Modelling of hospital length of stay (LOS) for IV/oral treatments (Tedizolid/Linezolid) allowed for potential early discharge to outpatient treatment, while patients on IV-only treatments incurred LOS encompassing full duration of treatment (DOT). LOS reductions only occur among MRSA patients for whom antibiotic use is a rate limiting step for hospital discharge. Results: In the base case, total costs per treated ABSSSI patient were 2,129€ and 2,072€ for Tedizolid and Linezolid, respectively. Tedizolid is cost-saving versus Linezolid provided a reduction in LOS of 2.0 days is achieved among early discharge (ED) eligible patients. This is less than the 4-day difference in DOT between Linezolid (10 days) and Tedizolid (6 days). Tedizolid would also be cost-saving versus Vancomycin (DOT = 14 days) with an LOS reduction of 2.2 days among ED eligible patients. Tedizolid is cost-saving versus all other comparators, irrespective of ED eligibility. If Tedizolid could reduce LOS by 4 days vs. Linezolid in this ED-eligible group, a net cost savings of 55€ would result. Conclusions: Tedizolid has the potential to be a cost saving alternative versus comparator therapies. Real world data are needed to determine the degree to which hospital LOS reductions may be achievable in clinical practice. PIN59 Economic Evaluation Of Abbvie’s Regimen (Viekirax/Exviera) For Patients With Genotype 1a Hcv In Greece Mylonas C1, Kourlaba G2, Vernadaki A3, Kakouros M3, Maniadakis N1 School of Public Health, Athens, Greece, 2Collaborative Center of Clinical Epidemiology and Outcomes Research (CLEO), Non-Profit Civil Partenrship, Athens, Greece, 3AbbVie Pharmaceuticals S.A, Athens, Greece
1National
Objectives: To conduct a cost – utility analysis of the AbbVie’s regimen versus other established maintenance treatment options in the Greek health care setting, for patients within genotype 1a chronic hepatitis C virus (HCV). Methods: A Markov model was adapted locally to reflect the natural progression of patients with
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genotype 1a through different health states. Efficacy and safety data considered in the model were extracted from the relevant clinical trials and other published studies. Utilities values were extracted from the literature. Direct medical costs were incorporated in the model reflecting the year 2015. The model evaluated the comparators over a lifetime horizon in the course of a 1-year cycle. The outcomes are measured in terms of Quality Adjusted Life Years gained. While outcomes can vary, the outcomes in this analysis were measured in terms of life-years gained. The analysis was performed from a payer’s perspective. Costs and outcomes that occurred beyond one year were discounted at a 3.5% annual rate which is the standard practice in Greece as well as other jurisdictions. Results: The base case results indicate that the AbbVie Regimen is a dominant option (in the most cases) and costeffective option for naïve patients with genotype 1a HCV. The sensitivity analysis shows that the overall cost-effectiveness results are sensitive to the model time horizon and changes in the SVR rate for patients on the comparator treatment. AbbVie’s regimen appears cost-effective based on traditional standards in the vast majority of sensitivity analyses. In the CEAF, it is the optimal choice (on the optimality frontier) when payers are willing to pay over about 15,000€ /QALY in the majority of analyses. Conclusions: Using conservative assumptions, the present economic evaluation suggests that AbbVie’s regimen provides greater health outcomes and is less costly compared to majority of comparators. PIN60 Systematic Review Of Studies Estimating The Cost-Effectiveness Of Hiv Pre-Exposure Prophylaxis (Prep) In Men Who Have Sex With Men (Msm) Damm O, Scholz S, Greiner W School of Public Health, Bielefeld University, Bielefeld, Germany
Objectives: Oral pre-exposure prophylaxis (PrEP) with tenofovir and emtricitabine has been shown to be effective in reducing the risk of HIV infection in men who have sex with men (MSM). The aim of our study was to systematically review the existing evidence on the cost-effectiveness of PrEP in MSM. Methods: We performed a systematic PubMed literature search to identify relevant studies published from January 2000 through February 2016 in English or German. A study was included if it reported cost per quality-adjusted life year (QALY) estimates for the USA, Canada, Australia, or European countries. All monetary values were converted to euros. Results: Eight studies on the cost-effectiveness of PrEP in MSM, which reported results for the USA, Canada, and Australia, were included in the review. Most studies focused on the evaluation of PrEP use in the general MSM population and/or in high-risk MSM. Two studies additionally assessed the cost-effectiveness of PrEP use in monogamous serodiscordant relationships. Results varied considerably across and within studies, with some scenarios yielding incremental cost-effectiveness ratios (ICERs) of several hundred thousand euros per QALY. In studies that assessed PrEP use in high-risk MSM as well as in the general MSM population, strategies targeting high-risk MSM resulted in lower ICERs than strategies without differentiation by risk status. Three studies even showed that targeting high-risk MSM could lead to cost savings. Conclusions: Since results of the included studies varied considerably, it is difficult to draw a clear conclusion on the cost-effectiveness of PrEP in MSM. However, in studies that evaluated PrEP use in both high-risk MSM and the general MSM population, strategies targeting high-risk MSM were found to be more cost-effective. None of the currently available studies reported results for European countries. Hence, future models evaluating the cost-effectiveness of PrEP in MSM should address this research gap. PIN61 Economic Evaluation Of Abbvie’s Regimen (Viekirax/Exviera) For Patients With Genotype 1b Hcv In Greece Mylonas C1, Kourlaba G2, Vernadaki A3, Kakouros M3, Maniadakis N1 School of Public Health, Athens, Greece, 2Collaborative Center of Clinical Epidemiology and Outcomes Research (CLEO), Non-Profit Civil Partenrship, Athens, Greece, 3AbbVie Pharmaceuticals S.A, Athens, Greece
1National
Objectives: To conduct a cost – utility analysis of the AbbVie’s regimen versus other established maintenance treatment options in the Greek health care setting, for patients within genotype 1b chronic hepatitis C virus (HCV). Methods: A Markov model was adapted locally to reflect the natural progression of patients with genotype 1b through different health states. Efficacy and safety data considered in the model were extracted from the relevant clinical trials and other published studies. Utilities values were extracted from the literature. Direct medical costs were incorporated in the model reflecting the year 2015. The model evaluated the comparators over a lifetime horizon in the course of a 1-year cycle. The outcomes are measured in terms of Quality Adjusted Life Years gained. While outcomes can vary, the outcomes in this analysis were measured in terms of life-years gained. The analysis was performed from a payer’s perspective. Costs and outcomes that occurred beyond one year were discounted at a 3.5% annual rate which is the standard practice in Greece as well as other jurisdictions. Results: The base case results indicate that the AbbVie Regimen is a dominant option (in the most cases) and cost-effective option for naïve patients with genotype 1b HCV. The sensitivity analysis shows that the overall cost-effectiveness results are sensitive to the model time horizon and changes in the SVR rate for patients on the comparator treatment. AbbVie’s regimen appears cost-effective based on traditional standards in the vast majority of sensitivity analyses. In the CEAF, it is the optimal choice (on the optimality frontier) when payers are willing to pay over about 15,000€ /QALY in the majority of analyses. Conclusions: Using conservative assumptions, the present economic evaluation suggests that AbbVie’s regimen provides greater health outcomes and is less costly compared to majority of comparators. PIN62 Determening The Optimal Price For New Non-Nucleoside Reverse Transcritase Inhbitor Using Early Economic Modeling Musina N1, Pogorelova E2, Savilova A2, Korzinov O2