Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

BACKGROUND: Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. OBJECTIVE: The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company's global portfolio while balancing its business needs with broader social expectations. METHODS: Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease-based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. CONCLUSIONS: The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come.

The Race for COVID-19 Vaccines: Accelerating Innovation, Fair Allocation and Distribution.

Racing to develop and distribute a vaccine against COVID-19 has proven to be a challenging endeavor. Not only has there been the enormous scientific-technical challenge of developing the world's first vaccines against a coronavirus, the subsequent ethical issues involved in vaccine allocation have been equally complex. This contribution focuses on the policy and strategic aspects of accelerating innovation, fair allocation, and distribution. We take a holistic approach to describing the various tasks and how they are interconnected. Through comparative analysis we explore the issues through the lens of multiple stakeholders: i.e., public health authorities, governments of industrialized and developing countries, and industry. At each step of the consecutive process-from vaccine development to delivery-common ground has to be found between global community stakeholders, to move the project to the next stage, until completion: (1) accelerated innovation, (2) centralized purchasing, (3) selecting suppliers, (4) equitable allocation, (5) global access and affordability, (6) compulsory vs. voluntary licensing, and (7) a universal pandemic treaty. Conclusions: Public-private partnership is essential with regards to inventing and allocating new vaccines to fight infectious disease pandemics. The nature of pandemics requires collaboration at both the national and international levels. Seven important lessons have been identified that we can learn from based on the experience gathered during the COVID-19 pandemic. We trust that these findings will be helpful in drafting preparedness guidelines and a global pandemic treaty to manage future pandemics.

Equity in Pharmaceutical Pricing and Reimbursement: Crossing the Income Divide in Asia Pacific.

OBJECTIVES: The article takes a three-dimensional approach (triangulation) in defining international pricing policy for pharmaceuticals using cost-effectiveness analysis (CEA), willingness-to-pay (WTP) analysis, and ability-to-pay (ATP) analysis. It attempts to find a balance between the various economic methods of which some focus on effectiveness while others are geared toward incorporating equity in the equation. METHODS: A critical review of the first two established economic methods and their ability to evaluate not only "efficacy" but also "fairness" in pricing decisions identifies a gap in the latter. Therefore, a third analytic method is presented that measures the ATP based on a country's score in the human development index of the United Nations Development Program for 120 countries. This approach allows practicing differential pricing among and within countries. To refine this equity-driven pricing concept, two additional parameters can be added to the model: the Oxford "Multidimensional Poverty Index" and the "Out-of-Pocket" or "Self Pay" health expenditure as reported by the World Bank. RESULTS: There is no hierarchy between the above three pricing methods. Because one method provides further insight into the other, however, it is recommended to start with CEA followed by WTP analysis. These types of analysis are closely linked in that the first provides the CE ratio for the compound investigated and the other sets the anticipated ceiling threshold of the payer's WTP (in a particular country). The ATP method provides a supplementary "equity" check and facilitates the process of equity-based differential pricing. CONCLUSIONS: A third method should be used in conjunction with the standard CEA and WTP analysis that measures the ATP with the human development index as yardstick to provide sustainable and equitable access to medicines. We recommend that ATP analysis becomes an additional practice in policy decision making and in defining international pricing strategies for pharmaceuticals.

Delivering the promise of the Decade of Vaccines: opportunities and challenges in the development of high quality new vaccines.

The Decade of Vaccines (DoV) initiative, launched in 2010, has as its mission "to extend, by 2020 and beyond, the full benefits of immunization to all people, regardless of where they are born, who they are, or where they live". Through their life-saving vaccines, the research-based vaccine companies represented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Biotechnology Industry Organization (BIO) make a major contribution toward this vision. In this article, we begin by summarizing progress made over the past three decades in research and development (R&D) of new and future vaccines, and identify the opportunities and challenges faced by the research-based vaccine industry. We then review the Global Vaccine Action Plan (GVAP) and provide IFPMA and BIO consensus perspectives on its six strategic objectives. Finally, we identify policy measures to support R&D of, and access to, high-quality, innovative vaccines.