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

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.

Heterogeneity of the HIV epidemic in the general population of Karnataka state, south India.

BACKGROUND: In the context of AVAHAN, the India AIDS Initiative of the Bill & Melinda Gates Foundation, general population surveys (GPS) were carried out between 2006 and 2008 in Belgaum (northern), Bellary (mid-state) and Mysore (southern) districts of Karnataka state, south India. Data from these three surveys were analysed to understand heterogeneity in HIV risk. METHODS: Outcome variables were the prevalence of HIV and sexually transmitted infections (STIs). Independent variables included age, district, place of residence, along with socio-demographic, medical and behavioural characteristics. Multivariate logistic regression was undertaken to identify characteristics associated with HIV and differences between districts, incorporating survey statistics to consider weights and cluster effects. RESULTS: The participation rate was 79.0% for the interview and 72.5% for providing a blood or urine sample that was tested for HIV. Belgaum had the highest overall HIV (1.43%) and Herpes simplex type-2 (HSV-2) (16.93%) prevalence, and the lowest prevalence of curable STIs. In Belgaum, the HIV epidemic is predominantly rural, and among women. In Bellary, the epidemic is predominantly in urban areas and among men, and HIV prevalence was 1.18%. Mysore had the lowest prevalence of HIV (0.80%) and HSV-2 (10.89%) and the highest prevalence of curable STIs. Higher HIV prevalence among men was associated with increasing age (p<0.001), and with history of STIs (AOR=2.44,95%CI:1.15-5.17). Male circumcision was associated with lower HIV prevalence (AOR=0.33,95%CI:0.13-0.81). Higher HIV prevalence among women was associated with age (AOR25-29years=11.22,95%CI:1.42-88.74, AOR30-34years=13.13,95%CI:1.67-103.19 and AOR35-39years=11.33,95%CI:1.32-96.83), having more than one lifetime sexual partner (AOR=4.61,95%CI:1.26-16.91) and having ever used a condom (AOR=3.32,95%CI:1.38-7.99). Having a dissolved marriage (being widowed/divorced/separated) was the strongest predictor (AOR=10.98,95%CI: 5.35-22.57) of HIV among women. Being a muslim woman was associated with lower HIV prevalence (AOR=0.27,95%CI:0.08-0.87). CONCLUSION: The HIV epidemic in Karnataka shows considerable heterogeneity, and there appears to be an increasing gradient in HIV prevalence from south to north. The sex work structure in the northern districts may explain the higher prevalence of HIV in northern Karnataka. The higher prevalence of HIV and HSV-2 and lower prevalence of curable STIs in Belgaum suggests a later epidemic phase. Similarly, higher prevalence of curable STIs and lower HIV and HSV-2 prevalence in Mysore suggests an early phase epidemic.

Using pharmacoeconomic modelling to determine value-based pricing for new pharmaceuticals in malaysia.

BACKGROUND: Decision analysis (DA) is commonly used to perform economic evaluations of new pharmaceuticals. Using multiples of Malaysia's per capita 2010 gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), DA was used to estimate a price per dose for bevacizumab, a drug that provides a 1.4-month survival benefit in 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 bevacizumab. Costs for chemotherapy and management of side effects were obtained from public and private hospitals in Malaysia. Utility estimates, measured as quality-adjusted life years (QALYs), were determined by interviewing 24 oncology nurses using the time trade-off technique. The price per dose was then estimated using a target threshold of US$44 400 per QALY gained, which is 3 times the Malaysian per capita GDP. RESULTS: A cost-effective price for bevacizumab could not be determined because the survival benefit provided was insufficient According to the WHO criteria, if the drug was able to improve survival from 1.4 to 3 or 6 months, the price per dose would be $567 and $1258, respectively. CONCLUSION: The use of decision modelling for estimating drug pricing is a powerful technique to ensure value for money. Such information is of value to drug manufacturers and formulary committees because it facilitates negotiations for value-based pricing in a given jurisdiction.

Determinants of HIV prevalence among female sex workers in four south Indian states: analysis of cross-sectional surveys in twenty-three districts.

OBJECTIVE: In four states in southern India we explored the determinants of HIV prevalence among female sex workers (FSW), as well as factors associated with district-level variations in HIV prevalence among FSW. METHODS: Data from cross-sectional surveys in 23 districts were analysed, with HIV prevalence as the outcome variable, and sociodemographic and sex work characteristics as predictor variables. Multilevel logistic regression was applied to identify factors that could explain variations in HIV prevalence among districts. RESULTS: HIV prevalence among the 10 096 FSW surveyed was 14.5% (95% confidence interval 14.0-15.4), with a large interdistrict variation, ranging from 2% to 38%. Current marital status and the usual place of solicitation emerged as important factors that determine individual probability of being HIV positive, as well as the HIV prevalence within districts. In multivariate analysis, compared with home-based FSW, the odds of being HIV positive was greater for brothel-based FSW [adjusted odds ratio (AOR) 2.17, P

Declines in risk behaviour and sexually transmitted infection prevalence following a community-led HIV preventive intervention among female sex workers in Mysore, India.

OBJECTIVE: To investigate the impact on sexual behaviour and sexually transmitted infections (STI) of a comprehensive community-led intervention programme for reducing sexual risk among female sex workers (FSW) in Mysore, India. The key programme components were: community mobilization and peer-mediated outreach; increasing access to and utilization of sexual health services; and enhancing the enabling environment to support programme activities. METHODS: Two cross-sectional surveys among random samples of FSW were conducted 30 months apart, in 2004 and 2006. RESULTS: Of over 1000 women who sell sex in Mysore city, 429 participated in the survey at baseline and 425 at follow-up. The median age was 30 years, median duration in sex work 4 years, and the majority were street based (88%). Striking increases in condom use were seen between baseline and follow-up surveys: condom use at last sex with occasional clients was 65% versus 90%, P < 0001; with repeat clients 53% versus 66%, P < 0.001; and with regular partners 7% versus 30%, P < 0.001. STI prevalence declined from baseline to follow-up: syphilis 25% versus 12%, P < 0.001; trichomonas infection 33% versus 14%, P < 0.001; chlamydial infection 11% versus 5%, P = 0.001; gonorrhoea 5% versus 2%, P = 0.03. HIV prevalence remained stable (26% versus 24%), and detuned assay testing suggested a decline in recent HIV infections. CONCLUSION: This comprehensive HIV preventive intervention empowering FSW has resulted in striking increases in reported condom use and a concomitant reduction in the prevalence of curable STI. This model should be replicated in similar urban settings across India.