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Background Two million individuals with chronic hepatitis B (CHB) in the United States are at risk for premature death due to liver cancer and cirrhosis. CHB can be prevented by vaccination and controlled with treatment. Methods We created a lifetime Markov model to estimate the cost-effectiveness of strategies to prevent or treat CHB in 6 high-risk populations: foreign-born Asian/Pacific Islanders (API), Africa-born blacks (AbB), incarcerated, refugees, persons who inject drugs (PWID), and men who have sex with men (MSM). We studied 3 strategies: (a) screen for HBV infection and treat infected (“treatment only”), (b) screen for HBV susceptibility and vaccinate susceptible (“vaccination only”), and (c) screen for both and follow-up appropriately (“inclusive”). Outcomes were expressed in incremental cost-effectiveness ratios (ICERs), clinical outcomes, and new infections. Results Vaccination-only and treatment-only strategies had ICERs of $6000–$21 000 per quality-adjusted life-year (QALY) gained, respectively. The inclusive strategy added minimal cost with substantial clinical benefit, with the following costs per QALY gained vs no intervention: incarcerated $3203, PWID $8514, MSM $10 954, AbB $17 089, refugees $17 432, and API $18 009. Clinical complications dropped in the short/intermediate (1%–25%) and long (0.4%–16%) term. Findings were sensitive to age, discount rate, health state utility in immune or susceptible stages, progression rate to cirrhosis or inactive disease, and tenofovir cost. The probability of an inclusive program costing <$50 000 per QALY gained varied between 61% and 97% by population. Conclusions An inclusive strategy to screen and treat or vaccinate is cost-effective in reducing the burden of hepatitis B virus among all 6 high-risk, high-prevalence populations.

ObjeCtivesTo describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study.

IntroductionIn 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource‐constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource‐constrained settings. Although the tFDA was originally intended to support the United States’ President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in‐depth review of the relevant legal and regulatory processes.Discussion USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use.ConclusionsIn this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource‐constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example.

BackgroundHaiti is the poorest country in the Western Hemisphere and faces numerous challenges, including inadequate medication access for its residents. The objective of this study was to determine the availability, prices, and affordability of essential medicines in Haiti and compare these findings to other countries.MethodsWe conducted a cross–sectional nationwide survey in 2011 of availability and consumer prices of 60 essential medicines in Haiti using a standardized methodology developed by the World Health Organization and Health Action International. The survey was conducted in 163 medicine outlets in four health care sectors (public, retail, nonprofit and mixed sectors). Medicine prices were expressed as ratios relative to the International Reference Price. Affordability was calculated by comparing the costs of treatment for common conditions with the salary of the lowest paid government worker and was compared to available data from four Latin American countries.ResultsFor generic medicines, the availability in public, retail, nonprofit and mixed sectors was 20%, 37%, 24% and 23% of medications, respectively. Most of the available medicines were priced higher than the International Reference Price. The lowest paid government worker would need 2.5 days’ wages to treat an adult respiratory infection with generic medicines from the public sector. For treatment of common conditions with originator brands (OB) purchased from a retail pharmacy, costs were between 1.4 (anaerobic bacterial infection) and 13.7 (hyperlipidemia) days’ wages, respectively. Treatment of pediatric bacterial infections with the OB of ceftriaxone from a retail pharmacy would cost 24.6 days’ wages. Prices in Bolivia, Colombia, Mexico and Nicaragua were frequently lower for comparable medications.ConclusionsThe availability of essential medicines was low and prices varied widely across all four sectors. Over 75% of Haitians live on less than US$ 2.00 /day; therefore, most medication regimens are largely unaffordable. Inclusion of essential medications on the national formulary and working with organizations responsible for importing medications into Haiti, particularly drug donation agencies, are important first steps to increasing medication access.