Publications by authors named "Anita Katharina Wagner"

13 Publications

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Can locally developed me-too drugs aid price negotiation? An example of cancer therapies from China.

Semin Oncol 2021 Apr 6. Epub 2021 Apr 6.

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Rapid growth in pharmaceutical expenditures and high prices have greatly hampered access to medicines, especially targeted anticancer medicines. Confronted with such difficulties, the Chinese government has put more effort into supporting local research and development of cancer medicines, resulting in locally developed me-too drugs. Since 2016, the government has implemented a central reimbursement-linked drug price negotiation policy aimed at reducing the prices of expensive medicines. Locally developed me-too drugs marketed at lower prices may inject price competition and help negotiate reduced prices of similar internationally-developed products. As an example, we selected 3 tyrosine kinase inhibitors (TKIs) developed for the therapy of advanced non-small cell lung cancer harboring mutations in the epidermal growth factor receptor (EGFR). Descriptive analysis was applied to data from the Chinese Medical Economic Information database to describe the impact on the price and utilization of three TKIs after the introduction of icotinib, a locally developed me-too TKI and two national negotiations regarding the price of EGFR-TKIs in China. After two national negotiations, the daily costs of all three EGFR-TKIs were reduced to around $30. From the first quarter of 2013 to the second quarter of 2016, the market share of the purchasing volume of icotinib, China's locally developed TKI, increased from 13% to 40%, while the market shares of two internationally developed TKIs decreased from 35% to 15% and from 52% to 45%, for erlotinib and gefitinib, respectively. The prices of EGFR-TKIs decreased and China's locally developed TKI accounted for a considerable proportion of market share. Locally developed me-too drugs aid price negotiation by injecting price competition and helping negotiate reduced prices of similar internationally-developed products. Through efforts to develop me-too drugs, combined with national drug price negotiation and reimbursement policies, developing countries might improve access to more affordable targeted cancer therapies.
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http://dx.doi.org/10.1053/j.seminoncol.2021.03.001DOI Listing
April 2021

Anticancer medicines in China: Trends in daily therapy cost and relative procurement volume and spending.

Cancer Commun (Lond) 2021 Apr 20;41(4):345-348. Epub 2021 Feb 20.

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, 100191, P. R. China.

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http://dx.doi.org/10.1002/cac2.12144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045901PMC
April 2021

What are the volume and budget needs to provide chemotherapy to all children with acute lymphoblastic leukaemia in Thailand? Development and application of an estimation tool.

BMJ Open 2020 10 26;10(10):e041901. Epub 2020 Oct 26.

Department of Population Medicine, Division of Health Policy and Insurance Research, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Objective: Insufficient access to anticancer medicines may contribute to the wide survival differences of children with cancers across the globe. We developed a tool to estimate the volume of medicines and budget requirements to provide chemotherapy to children with acute lymphoblastic leukaemia (ALL).

Design: Development and application of an estimation tool.

Setting: Paediatric oncology hospital departments in Thailand.

Participants: 318 children aged 0-14 years diagnosed with ALL and 215 children with undiagnosed ALL.

Interventions: Estimates of volume and budget requirements for administering a full course of chemotherapy for ALL and a further course for children who relapse, according to National Treatment Guidelines.

Primary And Secondary Outcome Measures: Primary outcome measures were the volume (mg) and cost (US$) of medicines needed to treat children with ALL. For medicines whose main indication is paediatric ALL (asparaginase and 6-mercaptopurine), we estimated the difference between volume needed and actual sales in 2017 (secondary outcome).

Results: Ten anticancer medicines and four chemoprotective agents are needed for the treatment of paediatric ALL according to the Thai treatment guidelines. Of these 14 medicines, 13 are included in the WHO essential medicines list for children. All are available as generics. We estimated that essential chemotherapy and chemoprotective agents to treat all children diagnosed with ALL in Thailand in 2017 would cost US$ 814 952 (US$ 1 365 422 for diagnosed and undiagnosed children), which corresponds to 0.005% (0.008%) of the country's total health expenditure. The volumes of asparaginase and 6-mercaptopurine available on the Thai market in 2017 were more than sufficient (2.3 and 1.5 times the amounts needed, respectively) to treat all children diagnosed with ALL.

Conclusions: Procuring sufficient quantities of essential medicines to treat children with ALL requires relatively modest resources. Medicine cost should not be a major barrier to ALL treatment in similar settings.
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http://dx.doi.org/10.1136/bmjopen-2020-041901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592266PMC
October 2020

Differences in reimbursement listing of anticancer therapies in China: an observational study.

BMJ Open 2020 01 6;10(1):e031203. Epub 2020 Jan 6.

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Objective: Access to highly priced anticancer medications usually requires insurance coverage. A first step towards coverage of such medications is their inclusion in reimbursement lists. We assessed listing for reimbursement in China between 2009 and 2018 of anticancer medications on the WHO's Essential Medicines List.

Setting And Study Design: Using publicly available data, we assessed which anticancer medications listed in the 20th WHO Model List of Essential Medicines (EML) were included in China's National Reimbursement Drug List (NRDL). For five targeted anticancer medications on the WHO EML, we also assessed inclusion in the 31 Chinese Provincial Reimbursement Drug Lists (PRDLs). Logistic regression was used to test whether inclusion of targeted anticancer medications was associated with provincial economic levels.

Primary Outcome Measures: Inclusion of five targeted anticancer medications in the NRDL and PRDLs before and after 2017.

Results: The 2017 NRDL included all anticancer medications on the WHO EML (except for one not approved in China at the time), and by 2018, all 31 PRDLs listed the targeted anticancer medications except for nilotinib; four provinces had covered all five targeted medications before the 2017 NRDL coverage mandate. Provincial economic level and regional incidence of specific cancers seemed unrelated to the inclusion of five targeted anticancer medications in PRDLs.

Conclusion: Our findings suggest that by including medications in the national and provincial reimbursement lists, China has taken an important first step in promoting access to targeted anticancer medications. Further research is needed to determine whether inclusion in PRDLs improved the availability, appropriate use and affordability of highly priced targeted anticancer medications in China.
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http://dx.doi.org/10.1136/bmjopen-2019-031203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955534PMC
January 2020

Medication Use During Pregnancy in Mainland China: A Cross-Sectional Analysis of a National Health Insurance Database.

Clin Epidemiol 2019 10;11:1057-1065. Epub 2019 Dec 10.

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, People's Republic of China.

Purpose: This study aims to illustrate the prevalence and patterns of medication use among pregnant women in mainland China.

Patients And Methods: Hospital and drugstore service data for a nationally representative sample of basic medical insurance (BMI) beneficiaries in 2015 were obtained from the China Health Insurance Association (CHIRA) database. A total of 7946 women who had singleton deliveries in 2015, aged between 12 and 54, and whose records in the CHIRA database covered at least one trimester were included in this study. We conducted descriptive analyses of sample characteristics, medication use prevalence, and number and types of medications used.

Results: We found that 11.7% of women used at least one medication during the course of pregnancy (median number of medications used = 6.7). Medication use was more common among those who were older, residing in Eastern China, or employed. Most commonly used medication groups by the Anatomical Therapeutic Chemical Classification System were B (Blood and blood forming organs, 49.3%), A (Alimentary tract and metabolism, 48.1%), G (Genito urinary system and sex hormones, 38.1%) and J (Antiinfectives for systemic use, 31.6%). Intravenous solutions, vitamins and minerals, progestogens, and beta-lactam antibacterials were the most frequently used medications from each of these four ATC groups, respectively. Moreover, 7.1% used at least one medication contraindicated in pregnancy.

Conclusion: This study showed that around one in 10 women used medication during pregnancy in mainland China and found possible cases of inappropriate or unsafe medication use.
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http://dx.doi.org/10.2147/CLEP.S230589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6911329PMC
December 2019

Costs and effectiveness of the supervision, performance assessment and recognition (SPARS) strategy for medicines management in Uganda.

J Pharm Policy Pract 2019 3;12:36. Epub 2019 Dec 3.

USAID/Uganda Health Supply Chain Program, Management Sciences for Health, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.

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http://dx.doi.org/10.1186/s40545-019-0196-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6889344PMC
December 2019

Influence of government price regulation and deregulation on the price of antineoplastic medications in China: a controlled interrupted time series study.

BMJ Open 2019 11 28;9(11):e031658. Epub 2019 Nov 28.

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Background: In October 2012, the Chinese government established maximum retail prices for specific products, including 30 antineoplastic medications. Three years later, in June 2015, the government abolished price regulation for most medications, including all antineoplastic medications. This study examined the impacts of regulation and subsequent deregulation of prices of antineoplastic medications in China.

Methods: Using hospital procurement data and an interrupted time series with comparison series design, we examined the impacts of the policy changes on relative purchase prices (Laspeyres price index) and volumes of and spending on 52 antineoplastic medications in 699 hospitals. We identified three policy periods: prior to the initial price regulation (October 2011 to September 2012); during price regulation (October 2012 to June 2015); and after price deregulation (July 2015 to June 2016).

Results: During government price regulation, compared with price-unregulated cancer medications (n=22, mostly newer targeted products), the relative price of price-regulated medications (n=30, mostly chemotherapeutic products) decreased significantly (β=-0.081, p<0.001). After the government price deregulation, no significant price change occurred. Neither government price regulation nor deregulation had a significant impact on average volumes of or average spending on all antineoplastic medications immediately after the policy changes or in the longer term (p>0.05).

Conclusion: Compared with unregulated antineoplastics, the prices of regulated antineoplastic medications decreased after setting price caps and did not increase after deregulation. To control the rapid growth of oncology medication expenditures, more effective measures than price regulation through price caps for traditional chemotherapy are needed.
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http://dx.doi.org/10.1136/bmjopen-2019-031658DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924745PMC
November 2019

Pharmaceutical system strengthening in Uganda: implementing a holistic, evidence-informed, long-term strategy.

J Pharm Policy Pract 2018 15;11:23. Epub 2018 Oct 15.

Management Sciences for Health, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.

A strong pharmaceutical sector is a precondition for effective and efficient health care and financing systems, and thus for achieving the best possible health of a population. Supported by visionary, long-term donor funds, in conjunction with mutual trust, the USAID-funded Securing Ugandans Rights to Essential Medicines (SURE) and Uganda Health Supply Chain (UHSC) program engaged in a close, more than 10 year-long (in 2018) collaboration with the Ministry of Health of Uganda. Over time, the partnership implemented numerous multi-pronged comprehensive changes in the pharmaceutical sector and conducted research to document successes and failures. We describe the evolution and key characteristics of the SURE/UHSC interventions.
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http://dx.doi.org/10.1186/s40545-018-0150-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192003PMC
October 2018

Competency in supportive supervision: a study of public sector medicines management supervisors in Uganda.

J Pharm Policy Pract 2017 11;10:33. Epub 2017 Oct 11.

USAID/Uganda Health Supply Chain Program, Management Sciences for Health, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.

Background: Supportive supervision has been found to be more effective than corrective fault-oriented inspections. Uganda's Ministry of Health in 2012 implemented a comprehensive strategy (SPARS) to build medicines management capacity in public sector health facilities. The approach includes supportive supervision. This structured observational study assesses supportive supervision competency among medicines management supervisors (MMS).

Method: The study used structured observations of two groups of five purposely selected MMS-one group supervising facilities with greater medicines management improvement during one year of SPARS and one group with less improvement, based on quantitative metrics. We observed and scored behaviors and skills of supervisors in 11 categories deemed critical for effective and supportive supervision.

Results: Supportive supervision was not evenly or adequately implemented, with the median supportive supervision competency score for all observed supervisors being 38%. Supervisors' main strengths were and (45%-47%). Their weakest areas were a and (17%), and most MMS were fair to strong in and MMS of facilities with little improvement in medicines management over time were weak in and . There was a 33 percentage point difference in the median supportive supervision competency scores between MMS of facilities with more versus less improvement (57%-24%) and a 77 percentage point difference in competency between the highest and lowest scoring MMS (77%-0%). We did not find a relationship between MMS experience (number of visits implemented) and their supportive supervision competency or facility improvement in medicines management. However, there is a likely relationship between supportive supervision competency and facility improvement.

Conclusion: Competency of MMS in supportive supervision among the sampled MMS was generally weak, but with much individual variation. Our results suggest that MMS' supportive supervision competency is positively related to the SPARS effectiveness scores of the facilities they supervise. We recommend strategies to strengthen supportive supervision behaviors and skills.
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http://dx.doi.org/10.1186/s40545-017-0121-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5637320PMC
October 2017

Article 1: Supervision, Performance Assessment, and Recognition Strategy (SPARS) - a multipronged intervention strategy for strengthening medicines management in Uganda: method presentation and facility performance at baseline.

J Pharm Policy Pract 2016 31;9:21. Epub 2016 May 31.

Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215 USA.

Background: Uganda introduced a multipronged intervention, the supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public and not-for-profit health facilities. This paper, the first in a series, describes the SPARS intervention and reports on the MM situation in Uganda before SPARS (baseline).

Methods: To build MM capacity at health facilities, health workers were trained as MM supervisors to visit health facilities, assess MM performance, and use the findings to provide support and standardize MM practices. Performance is assessed based on 25 MM indicators covering five domains: dispensing quality (7 indicators), prescribing quality (5), stock management (4), storage management (5) and ordering and reporting (4). From the end of 2010 to 2013, MM supervisors assessed baseline MM performance of 1384 government (85 %) and private not-for-profit facilities at all levels of care in about half of Uganda's districts.

Results: The overall MM baseline median score was 10.3 out of a maximum of 25 with inter-quartile range (IQR) of 8.7-11.7. Facility domain scores (out of a maximum of 5) were as follows: storage management, median score of 2.9 (IQR 2.3-3.4); stock management 2.3 (IQR 2.0-2.8), ordering and reporting 2.2 (IQR 1.3-2.5), and dispensing quality 2.1 (IQR 1.7-2.7). Performance in prescribing quality was 0.9 (IQR 0.4-1.4). Significant regional differences were found: overall scores were highest in the Northern region (10.7; IQR 9.2-12.4) and lowest in the Eastern region (9.6; (IQR 7.8-11.2) (p < 0.001). Overall scores did not differ by facility ownership; however, government facilities scored lower in dispensing and storage and higher in ordering and reporting. Hospitals scored higher overall and in domains other than prescribing and stock management. Districts classified a priori as having high capacity for implementing SPARS had higher scores at baseline compared to lower-capacity districts.

Conclusion: Assessing and building national capacity in MM is needed in both private not-for-profit and government facilities at all levels of care. The indicator-based, multipronged SPARS assessment has been described here, while the strategy's impact has yet to be documented.
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http://dx.doi.org/10.1186/s40545-016-0070-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4888637PMC
June 2016

Prescribing for acute childhood infections in developing and transitional countries, 1990-2009.

Paediatr Int Child Health 2015 Feb 6;35(1):5-13. Epub 2014 Feb 6.

Background: Evidence of global progress in treating acute paediatric infections is lacking.

Objectives: To assess progress over two decades in prescribing for childhood infections and interventions to improve treatment by reviewing empirical evidence in developing and transitional countries.

Methods: Data were systematically extracted on the use of medicines for diarrhoea, respiratory infections and malaria from published and unpublished studies (1990-2009) in children under 5 years of age. Medians of each indicator were calculated across studies by study year, geographic region, sector, country income level and prescriber type. To estimate intervention effects from studies meeting methodologically accepted design criteria [randomised controlled trials (RCTs), pre-post with control, and time series studies], the medians of the median effect sizes (median MES) were calculated across outcome measures.

Results: Data were extracted from 344 studies conducted in 78 countries with 394 distinct study groups in public (64%), private (22%) and other facilities to estimate trends over time. Of 226 intervention studies, only the 44 (19%) with an adequate study design were used to estimate intervention effects. Over time, use of anti-diarrhoeals for acute diarrhoea decreased significantly (P<0.01). However, treatment of malaria and acute respiratory infection remained largely sub-optimal. Multi-component interventions resulted in larger improvements than single-component ones. The median MES indicated a 28% improvement with community case-management, an 18% improvement with provider education combined with consumer education, but only 9% improvement with provider education alone.

Conclusions: While diarrhoea treatment has improved over the last 20 years, treatment of other childhood illnesses remains sub-optimal. Multi-component interventions demonstrated some success in improving management of acute childhood illness.
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http://dx.doi.org/10.1179/2046905514Y.0000000115DOI Listing
February 2015

Improving access to medicines in low and middle income countries: corporate responsibilities in context.

South Med Rev 2012 Dec 27;5(2):3-8. Epub 2012 Dec 27.

Novartis Foundation for Sustainable Development, Basel, Switzerland.

More than two billion people in low- and middle-income countries (LMIC) lack adequate access to essential medicines. In this paper, we make strong public health, human rights and economic arguments for improving access to medicines in LMIC and discuss the different roles and responsibilities of key stakeholders, including national governments, the international community, and non-governmental organizations (NGOs). We then establish a framework of pharmaceutical firms' corporate responsibilities - the "must," the "ought to," and the "can" dimensions - and make recommendations for actionable business strategies for improving access to medicines. We discuss controversial topics, such as pharmaceutical profits and patents, with the goal of building consensus around facts and working towards a solution. We conclude that partnerships and collaboration among multiple stakeholders are urgently needed to improve equitable access to medicines in LMIC.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606933PMC
December 2012

Impact of universal health insurance coverage in Thailand on sales and market share of medicines for non-communicable diseases: an interrupted time series study.

BMJ Open 2012 28;2(6). Epub 2012 Nov 28.

Drug Policy Research Group and WHO Collaborating Center in Pharmaceutical Policy, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Objective: In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes.

Design: Interrupted time-series design, with a non-equivalent comparison group.

Setting: Thailand, 1998-2006.

Data: Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006.

Intervention: UCS implementation, April-October 2001.

Outcome Measures: Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status.

Results: The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors.

Conclusions: Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed.
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http://dx.doi.org/10.1136/bmjopen-2012-001686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533018PMC
November 2012