scholarly journals IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES

2015 ◽  
Vol 31 (1-2) ◽  
pp. 2-11 ◽  
Author(s):  
Andres Pichon-Riviere ◽  
Osvaldo Ulises Garay ◽  
Federico Augustovski ◽  
Carlos Vallejos ◽  
Leandro Huayanay ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Developing Countries ◽  
Latin American ◽  
Transition Probabilities ◽  
Cancer Prognosis ◽  
World Health ◽  
Base Case ◽  
Pricing Policies ◽  
Life Years ◽  
Innovative Drugs

Objectives:Differential pricing, based on countries’ purchasing power, is recommended by the World Health Organization to secure affordable medicines. However, in developing countries innovative drugs often have similar or even higher prices than in high-income countries. We evaluated the potential implications of trastuzumab global pricing policies in terms of cost-effectiveness (CE), coverage, and accessibility for patients with breast cancer in Latin America (LA).Methods:A Markov model was designed to estimate life-years (LYs), quality-adjusted life-years (QALYs), and costs from a healthcare perspective. To better fit local cancer prognosis, a base case scenario using transition probabilities from clinical trials was complemented with two alternative scenarios with transition probabilities adjusted to reflect breast cancer epidemiology in each country.Results:Incremental discounted benefits ranged from 0.87 to 1.00 LY and 0.51 to 0.60 QALY and incremental CE ratios from USD 42,104 to USD 110,283 per QALY (2012 U.S. dollars), equivalent to 3.6 gross domestic product per capita (GDPPC) per QALY in Uruguay and to 35.5 GDPPC in Bolivia. Probabilistic sensitivity analysis showed 0 percent probability that trastuzumab is CE if the willingness-to-pay threshold is one GDPPC per QALY, and remained so at three GDPPC threshold except for Chile and Uruguay (4.3 percent and 26.6 percent, respectively). Trastuzumab price would need to decrease between 69.6 percent to 94.9 percent to became CE in LA.Conclusions:Although CE in other settings, trastuzumab was not CE in LA. The use of health technology assessment to prioritize resource allocation and support price negotiations is critical to making innovative drugs available and affordable in developing countries.

Cost-effectiveness of subcutaneous pertuzumab, trastuzumab, and hyaluronidase-zzxf for the treatment of high-risk HER2+ early breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18846-e18846
Author(s):  
Jesse Sussell ◽  
Joshua A. Roth ◽  
Svenn Hansen ◽  
Craig S. Meyer ◽  
Anita M. Fung
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Cost Effectiveness ◽  
High Risk ◽  
Neoadjuvant Therapy ◽  
Early Breast Cancer ◽  
Standard Therapy ◽  
Healthcare Sector ◽  
Base Case ◽  
Life Years

e18846 Background: Standard therapy for high-risk HER2+ early breast cancer (EBC) begins with neoadjuvant dual targeted therapy with pertuzumab (P) + trastuzumab (T) + chemotherapy (CTX). After surgery, patients who achieve pathological complete response (pCR) should complete one year of dual targeted therapy, while patients with residual disease should receive ado-trastuzumab emtansine (T-DM1). Recently, a subcutaneously administered formulation of P, T, and hyaluronidase-zzxf (Phesgo) was approved for use in the U.S. This study assesses the value of this new formulation in EBC patients vs. a strategy in which patients initiate standard therapy, but discontinue P following ascertainment of pCR. Methods: We developed a six-state Markov model to assess EBC costs and quality-adjusted life years (QALYs) from a healthcare sector perspective over a lifetime time horizon. Two strategies were modeled: 1) Neoadjuvant therapy with subcutaneous P, T, and hyaluronidase-zzxf + CTX with adjuvant continuation if pCR is achieved, and T-DM1 if not (“intervention”), and 2) neoadjuvant therapy with infused P, T + CTX with adjuvant infused T if pCR is achieved, and T-DM1 if not (“comparator”). Event-free and invasive-disease free survival were derived from the PEONY and KATHERINE/APHINITY trials, respectively. Utility values, drug prices, and procedure costs were derived from KATHERINE EQ-5D data, Wholesale Acquisition Costs, and claims analyses, respectively. We assessed comparator costs using both biosimilar and branded T pricing. The primary outcome was the incremental cost-effectiveness ratio (ICER). Outcomes were discounted at 3%/year and costs are presented in 2020 U.S. dollars. Uncertainty in outcomes was assessed through Monte Carlo simulation (1,000 replicates). Results: The table shows key results. The intervention resulted in a gain of 0.092 QALYs. With biosimilar T pricing in the comparator (base case), the intervention increased costs by $7,575 (ICER = $81,793). With branded T pricing in the comparator (scenario analysis), the intervention increased costs by $982 (ICER = $10,602). In probabilistic analyses, the intervention was favored in 52% and 81% of simulations at a willingness-to-pay of $100,000/QALY with biosimilar and branded T pricing, respectively. Conclusions: This study provides additional evidence to support adjuvant continuation of P+T among patients achieving pCR. Neoadjuvant P, T, and hyaluronidase-zzxf + CTX (with adjuvant continuation of dual targeted therapy) is expected to be cost-effective ( < $100,000/QALY) vs. neoadjuvant P and T + CTX (with adjuvant T continuation) for patients with high-risk HER2+ EBC irrespective of whether the comparator uses biosimilar or branded T.[Table: see text]

scholarly journals Improving patient access to cancer drugs in India: Using economic modeling to estimate a more affordable drug cost based on measures of societal value

2011 ◽  
Vol 27 (1) ◽  
pp. 23-30 ◽  
Author(s):  
George Dranitsaris ◽  
Ilse Truter ◽  
Martie S. Lubbe ◽  
Nitin N. Sriramanakoppa ◽  
Vivian M. Mendonca ◽  
...  
Keyword(s):  
Economic Value ◽  
World Health ◽  
Cancer Drug ◽  
Base Case ◽  
Public Healthcare ◽  
Monthly Cost ◽  
New Drug ◽  
Societal Value ◽  
Life Years ◽  
Per Capita

Background: Using multiples of India's per capita gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), decision analysis modeling was used to estimate a more affordable monthly cost in India for a hypothetical new cancer drug that provides a 3-month survival benefit to Indian patients with metastatic colorectal cancer (mCRC).Methods: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without the new drug. Costs for chemotherapy and side-effects management were obtained from both public and private hospitals in India. Utility estimates measured as quality-adjusted life-years (QALY) were determined by interviewing twenty-four oncology nurses using the Time Trade-Off technique. The monthly cost of the new drug was then estimated using a target threshold of US$9,300 per QALY gained, which is three times the Indian per capita GDP.Results: The base-case analysis suggested that a price of US$98.00 per dose would be considered cost-effective from the Indian public healthcare perspective. If the drug were able to improve patient quality of life above the standard of care or survival from 3 to 6 months, the price per dose could increase to US$170 and US$253 and offer the same value.Conclusions: The use of the WHO criteria for estimating the cost of a new drug based on economic value for a developing country like India is feasible and can be used to estimate a more affordable cost based on societal value thresholds.

Estimated life years saved with trastuzumab in first-line HER2+ metastatic breast cancer from 1999 to 2013.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 625-625
Author(s):  
Mark Danese ◽  
Deepa Lalla ◽  
Melissa Brammer ◽  
Eduardo Santos ◽  
Abraham Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Median Overall Survival ◽  
Metastatic Breast ◽  
The United States ◽  
Sensitivity Analyses ◽  
Base Case ◽  
First Line ◽  
Life Years

625 Background: Trastuzumab was approved in the United States (US) in September 1998 for the treatment of HER2+ metastatic breast cancer (MBC). This model estimates the total number of life years saved (LYS) in US women treated with trastuzumab over a 15-year period (1999-2013). Methods: Using US population estimates and cancer registry-based incidence data, we estimated the number of women with recurrent stage I-III or de novo stage IV HER2+ MBC by year, age, hormone receptor, and nodal status. Trastuzumab utilization was based on published studies of HER2 testing rates, true positive rates in the community, and treatment initiation rates. Survival was estimated by extrapolating survival data pooled across 5 trials and 2 observational studies separately for women treated with trastuzumab and with chemotherapy alone. Few studies reported survival in women with HER2+ MBC without trastuzumab (N=3). Sensitivity analyses were conducted by estimating overall survival from the initial phase 3 trial (67% of placebo patients crossed over to trastuzumab after progression; HR=0.80), and assuming a higher risk reduction to account for crossover effects in clinical trials (HR=0.60). Results: In the base case, approximately 83,462 women with HER2+ MBC were estimated to receive 1st line trastuzumab over a 15-year period. The pooled median overall survival across studies without and with trastuzumab was 21.2 and 35.5 months, respectively. Patients were projected to live a total of 216,290 life years if trastuzumab had not been available and if they received chemotherapy only. These same patients were estimated to live a total of 294,877 life years with first-line trastuzumab, for an incremental benefit of 78,587 LYS. In sensitivity analysis, total LYS ranged from 48,334-96,360. Conclusions: Real-world evidence supports a median overall survival of approximately 36 months in women with HER2+ MBC receiving 1st line trastuzumab. Using a population-based, conservative model, we found that trastuzumab use has resulted in > 75,000 life years over 15 years in women with HER2+ MBC. Future research is warranted to examine the characteristics, experiences, and outcomes among women living longer with HER2+ MBC.

Is neratinib following trastuzumab in early-stage HER2-positive breast cancer cost-effective?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6625-6625
Author(s):  
Naomi RM Schwartz ◽  
Meghan Rose Flanagan ◽  
Joseph B Babigumira ◽  
Lotte Maria Gertruda Steuten ◽  
Joshua A. Roth
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Clinical Benefit ◽  
Cost Effective ◽  
Phase Iii ◽  
Base Case ◽  
Recurrence Rates ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer ◽  
Life Years

6625 Background: Neratinib after adjuvant trastuzumab significantly improves disease-free survival (DFS) in human epidermal growth factor receptor 2-postiive (HER2+) breast cancer, but the median absolute DFS gain is only 1.3 months. There has been much controversy in the clinical and lay media as to whether the substantial cost of neratinib is justified by its effects, including a prominent ASCO Post article from Dr. Vogl about a year ago. We performed a cost-utility analysis to formally assess the value of adding neratinib based on Phase III ExteNET trial results. Methods: We developed a Markov state-transition model to assess the value of neratinib in Stage I-III HER2+ breast cancer. Five-year recurrence rates were derived from ExteNet. Mortality and recurrence rates after 5 years were derived from the HERceptin Adjuvant (HERA) trial. Costs were derived from wholesale acquisition costs and peer-reviewed literature. Health state utilities were derived from ExteNET and prior publications. Outcomes included life years (LY), quality-adjusted life years (QALYs), direct medical expenditures, and cost per QALY gained. The analysis took a payer perspective over a lifetime horizon and results were discounted at 3% per year. One-way and probabilistic analyses were conducted to evaluate uncertainty. As neratinib conferred more clinical benefit in hormone receptor-positive (HR+) disease, we also assessed value in that specific subgroup. Results: Base case results are presented in Table. At typical U.S. willingness to pay thresholds of $100,000 and $150,000 per QALY gained, neratinib had 16.7% and 27.2%, probabilities of cost-effectiveness, respectively. In the HR+ subgroup, neratinib had a cost of $275,311 per QALY gained (19.9% & 31.2% probability of cost-effectiveness at $100,000 & $150,000 per QALY). Conclusions: In the first independent assessment of the value of neratinib after adjuvant trastuzumab, neratinib is not projected to be cost-effective, even among patients who derived the most clinical benefit. Future analyses should reassess the cost-effectiveness of neratinib treatment as trial data mature. Base case results. [Table: see text]

scholarly journals Implications of Global Pricing Policies of Pharmaceuticals for Access the Innovative Drugs: The Case of Trastuzumab in Seven Latin American Countries

2013 ◽  
Vol 16 (7) ◽  
pp. A668-A669
Author(s):  
A. Pichon Riviere ◽  
U. Garay ◽  
F. Augustovski ◽  
C. Vallejos ◽  
L. Huayanay ◽  
...  
Keyword(s):  
Latin American ◽  
Pricing Policies ◽  
Innovative Drugs ◽  
Latin American Countries

scholarly journals The contribution of social participation to differences in life expectancy and healthy years among the older population: A comparison between Chile, Costa Rica and Spain

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248179
Author(s):  
Sarahí Rueda-Salazar ◽  
Jeroen Spijker ◽  
Daniel Devolder ◽  
Cecilia Albala
Keyword(s):  
Costa Rica ◽  
Life Expectancy ◽  
Latin American ◽  
Social Participation ◽  
Transition Probabilities ◽  
Functional Limitation ◽  
Healthy Life Expectancy ◽  
Social Activities ◽  
Healthy Life ◽  
Life Years

We study the health trajectories of the population aged over 60, comparing between one European and two Latin American countries (Spain, Chile and Costa Rica) which have similar longevity patterns. Our focus is on functional limitation and mortality risks, considering differences by gender, education and social participation. Data come from national panel surveys (EPS, CRELES, SHARE). Multistate modelling is used to estimate transition probabilities between two health states: healthy to unhealthy, unhealthy to healthy as well as the transition to death from healthy or unhealthy states, to estimate the duration of stay in a specific state (computing healthy and unhealthy life expectancies) and the effect of the selected covariates. Results show that older Costa Ricans have the smallest gender gap in life expectancy but women have a lower healthy life expectancy compared to those in Chile and Spain. Participation in social activities leads to higher healthy life expectancy among the elderly in Costa Rica and Spain, whilst there were no relevant educational differences observed in longevity in the analysed countries. To conclude: despite the different patterns observed in health transitions and survival across the three countries, social participation is associated with greater health and longevity among people of old age, with little effect coming from educational attainment. Public policies should therefore be aimed at reducing unhealthy life years and dependency at advanced ages by promoting more engagement in social activities, especially among vulnerable groups who are more likely to experience impairment from a younger age.

21-gene RT-PCR assay in lymph node negative (LN-), estrogen receptor positive (ER+) breast cancer: An economic analysis including prognostic and predictive information

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6024-6024
Author(s):  
L. E. Cosler ◽  
N. M. Kuderer ◽  
J. Hornberger ◽  
G. H. Lyman
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Life Expectancy ◽  
Base Case ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Life Years ◽  
Response To Chemotherapy ◽  
Significant Difference ◽  
Risk Patients

6024 Background: The prognostic accuracy of a 21-gene RT-PCR assay has undergone validation in 668 evaluable LN-, ER+ early stage breast cancer patients receiving tamoxifen on NSABP B-14 (Paik, NEJM 2004) and its economic evaluation (Hornberger, Am J Man Care 2005). Assay predictive accuracy for response to chemotherapy or tamoxifen has also undergone recent validation in 651 patients on NSABP B-20 and 645 patients on NSABP B-14 (Paik, SABCS 2004). Methods: Based on the model recurrence score (RS), women with LN−, ER+ breast cancer with and without adjuvant chemotherapy (C) or tamoxifen (T) were classified as high (RS ≥31), intermediate (RS 18–30) or low (RS <18) risk of distant recurrence at 10 years. Incremental costs ($), life-years (LYs), quality-adjusted LYs (QALYs) and cost-effectiveness (C/E; cost per LY gained) were estimated for: RS-guided treatment (RSGT) with T for low and intermediate risk patients and C+T for high-risk patients, compared to either T alone or C+T for all patients. Results: Under base case assumptions, no significant difference in life expectancy at 10 years is estimated between the RSGT and C+T strategies whereas RSGT is associated with a gain in individual life expectancy of 2.7 LYs compared to T alone. RSGT is estimated to yield a net cost savings of $4,502 compared to C+T with an incremental C/E of $1,059 per LY saved compared to T alone. At a utility of 90% associated with adjuvant chemotherapy, RSGT is associated with a gain in individual QALYs of 1.82 compared to T alone at a cost utility of $1,573/QALY and a gain in 3.21 QALYs compared to C+T. RSGT is associated with lower expected cost than C+T for total chemotherapy costs above $3,998. The gain in LYs with RSGT compared to T alone increases with healthy age-specific life expectancy (years) while the cost per LY gained decreases. Conclusions: Treatment based on the RSGT compared to T alone is associated with acceptable C/E ratios and substantially lower toxicity and cost compared to C+T. [Table: see text] [Table: see text]

TPF versus PF as induction therapy in unresectable head and neck cancer: A pharmacoeconomic analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6075-6075
Author(s):  
N. L. Liberato ◽  
L. Licitra ◽  
J. Bogaerts ◽  
G. Danese ◽  
M. Marchetti ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Induction Therapy ◽  
Transition Probabilities ◽  
Pharmacoeconomic Analysis ◽  
Sensitivity Analyses ◽  
Base Case ◽  
System Perspective ◽  
Life Years

6075 Background: Adding docetaxel to induction therapy with PF has been shown to improve overall survival of patients with head and neck cancer. On the basis of the raw data from the EORTC trial 24971/TAX 323 a pharmacoeconomic analysis has been performed. A National Healthcare System perspective and a 5-years temporal horizon have been adopted. Methods: A decision-analytic approach has been adopted, and a Markov model has been used to represent patient's weekly transitions among different health states, related to treatment (chemotherapy, radiotherapy, surgeries, palliative care) and disease status (complete/partial/no response, progression, recurrence). Constant or time-variant costs and quality of life adjustment factors have been assigned to each health state, together with transition probabilities to other states. A 3% discount factor has been used for costs sustained after the first year. The model allowed calculating expected life years (LYs), quality adjusted life years (QALYs) and costs. From these figures, incremental cost/effectiveness (ICER) and cost/utility (ICUR) ratios have been calculated. Robustness of results obtained with baseline values has been tested with probabilistic multivariate sensitivity analysis. Results: In the base case analysis, treatment with TPF yields an expectancy of 2.38 LYs and 1.53 QALYs at a cost of Euro (E) 23,018, which for PF were 1.93 LYs, 1.11 QALYs, and E 19,567, respectively. ICER and ICUR were E 7,669/LY and E 8,217/QALY, respectively. Sensitivity analyses were performed varying transition probabilities of 10%, costs of 30% and utility scores of 20% of their basal values. The analyses showed that 86% and 84% of the results lie below the threshold of E 50,000/LY and E 50,000/QALY, respectively. Conclusions: In our analysis TPF induction chemotherapy proved to be cost-effective with respect to PF, having an ICER and ICUR comparable to other widely accepted healthcare interventions. [Table: see text]

A Cost-Effectiveness Analysis of Adjuvant Trastuzumab Regimens in Early HER2/neu–Positive Breast Cancer

2007 ◽  
Vol 25 (6) ◽  
pp. 634-641 ◽  
Author(s):  
Allison W. Kurian ◽  
Rebecca Newton Thompson ◽  
Allison F. Gaw ◽  
Sally Arai ◽  
Rafael Ortiz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Randomized Clinical Trials ◽  
Early Stage ◽  
Base Case ◽  
Health State ◽  
Adjuvant Trastuzumab ◽  
Life Years ◽  
International Research Group ◽  
Positive Breast Cancer

Purpose One-year adjuvant trastuzumab (AT) therapy, with or without anthracyclines, increases disease-free and overall survival in early-stage HER2/neu-positive breast cancer. We sought to evaluate the cost effectiveness of these regimens, which are expensive and potentially toxic. Methods We used a Markov health-state transition model to simulate three adjuvant therapy options for a cohort of 49-year-old women with HER2/neu-positive early-stage breast cancer: conventional chemotherapy without trastuzumab; anthracycline-based AT regimens used in the National Surgical Adjuvant Breast and Bowel Project B-31 and North Central Cancer Treatment Group N9831 trials; and the nonanthracycline AT regimen used in the Breast Cancer International Research group 006 trial. The base case used treatment efficacy measures reported in the randomized clinical trials of AT. We measured health outcomes in quality-adjusted life-years (QALYs) and costs in 2005 United States dollars (US$) and subjected results to probabilistic sensitivity analysis. Results In the base case, the anthracycline-based AT arm has an incremental cost-effectiveness ratio (ICER) of $39,982/QALY, whereas the nonanthracycline AT arm is more expensive and less effective; this result is insensitive to changes in recurrence rates, but if there is no benefit after 4 years, ICERs exceed $100,000/QALY for both AT arms. Results are moderately sensitive to variation in breast cancer survival rates and trastuzumab cost, and less sensitive to variations in cardiac toxicity. Conclusion AT has an ICER comparable to those for other widely used interventions. Longer clinical follow-up is warranted to evaluate the long-term efficacy and toxicity of different AT regimens.

scholarly journals Atezolizumab Plus Chemotherapy vs. Chemotherapy in Advanced or Metastatic Triple-Negative Breast Cancer: A Cost-Effectiveness Analysis

2021 ◽  
Vol 9 ◽  
Author(s):  
Xiaoyan Liu ◽  
Yitian Lang ◽  
Yahui Liao ◽  
Yizhun Zhu
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Triple Negative Breast Cancer ◽  
Survival Data ◽  
Triple Negative ◽  
Chinese Patients ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Chinese Drug ◽  
Life Years

Purpose: The IMpassion130 trial demonstrated the efficacy of adding atezolizumab to paclitaxel for advanced or metastatic triple-negative breast cancer (TNBC). The current study evaluated the cost-effectiveness of adding atezolizumab to nab-paclitaxel for TNBC from the perspective of Chinese health sector.Methods: A partitioned survival model was implemented for patients with TNBC. The survival data were derived from IMpassion130 trial. Direct costs and utility values were collected from the Chinese Drug Bidding Database and published literatures. The primary analysis outcomes were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to observe model stability.Results: In the base-case analysis, the ICER of atezolizumab plus nab-paclitaxel vs. nab-paclitaxel is respectively, $176,056/QALY, $118,146/QALY, and $323,077/QALY in the ITT, PD-L1(+) and PD-L1(–) group.Conclusion: Adding atezolizumab to nab-paclitaxel could improve survival time significantly in the PD-L1-positive group, but it is not a cost-effective strategy compared to nab-paclitaxel monotherapy for Chinese patients with advanced or metastatic triple-negative breast cancer in the current economic context of China.

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