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1. Pricing for Medicine Innovation: A Regulatory Approach to Support Drug Development and Patient Access

Author:
Rosie Collington and William Lazonick
Publication Date:
02-2022
Content Type:
Working Paper
Institution:
Institute for New Economic Thinking (INET)
Abstract:
The United States represents the world’s largest market for pharmaceutical drugs. It is also the only advanced economy in the world that does not regulate drug prices. There is no upper threshold for the prices of medicines in the United States. List prices are instead set by manufacturers in negotiation with supply-chain intermediaries, though some federal programs have degrees of discretion in price determinations. In practice, this deregulated system means that drug prices in the United States are generally far higher than in other advanced economies, adversely affecting patient accessibility and system affordability. In this paper, we draw on the “theory of innovative enterprise” to develop a framework that provides both a critique of the existing pricing system in the United States and a foundation for developing a new model of pricing regulation to support safety and effectiveness through drug development as well as accessibility and affordability in the distribution of approved medicines to patients. We introduce a regulatory approach we term “Pricing for Medicine Innovation” (PMI), which departs dramatically from the market-equilibrium assumptions of conventional (neoclassical) economics. The PMI approach recognizes the centrality of collective investments by government agencies and business firms in the productive capabilities that underpin the drug development process. PMI specifies the conditions under which, at the firm level, drug pricing can support both sustained investment in these capabilities and improved patient access. PMI can advance both of these objectives simultaneously by regulating not just the level of corporate profit but also its allocation to reinvestment in the drug development process. PMI suggests that although price caps are likely to improve drug affordability, there remain two potential issues with this pricing approach. Firstly, in an innovation system where a company’s sales revenue is the source of its finance for further drug development, price caps may deprive a firm of the means to invest in innovation. Secondly, even with adequate profits available for investment in innovation, a firm that is run to maximize shareholder value will tend to use those profits to fund distributions to shareholders rather than for investment in drug innovation. We argue that, if implemented properly, PMI could both improve the affordability of medicines and enhance the innovative performance of pharmaceutical companies.
Topic:
Health Care Policy, Drugs, Innovation, Medicine, and Price
Political Geography:
North America and United States of America

2. How to tackle the COVID-19 curveball in cancer care

Author:
Emma Woodford
Publication Date:
02-2022
Content Type:
Policy Brief
Institution:
European Policy Centre (EPC)
Abstract:
To battle Europe’s second-largest killer, the von der Leyen Commission proposed on World Cancer Day 2020 to create the Europe’s Beating Cancer Plan (EBCP). With a committed budget of €4 billion, it was the largest regional initiative on cancer undertaken by the EU institutions to date. Then COVID-19 threw a spanner in the works. Cancer services – from screening programmes to treatment centres and survivorship programmes – were temporarily stopped or heavily disrupted, creating disastrous effects. The EBCP was adapted to deal with the new situation, but on closer examination of the issues caused by the pandemic, clearly more needs to be done to better support patients living with cancer and their families. This Policy Brief argues that to mitigate the effect of the COVID-19 curveball in cancer care, the EU must not lose any time in implementing the EBCP. It should also urgently harness member states’ concerns to commit, beyond the newly invested EU4Health programme, to a deeper European Health Union. This should be empowered through 4 EU policy options to provide sustainable and effective protection for current and future cancer patients: protect and support the cancer care workforce by investing in training, remuneration and staff retention, and ensuring cross-border recognition of qualifications; design telemedicine in a way that works for everyone; rebuild public trust in healthcare providers; treat health as a long-term investment. Through strong investment in both primary prevention and early detection, the EBCP has the potential to reduce the number of people developing cancer in the EU. Improving access to quality cancer care and cancer survivorship will improve treatment outcomes and the quality of life of people living with or who have survived cancer.
Topic:
Health Care Policy, COVID-19, Medicine, and Cancer
Political Geography:
Europe

3. Estimating Japan’s Return on Investment from an Ambitious Program to Incentivize New Antibiotics

Author:
Rachel Silverman and Adrian Towse
Publication Date:
12-2022
Content Type:
Policy Brief
Institution:
Center for Global Development (CGD)
Abstract:
Anti-microbial drugs form the backbone of modern medicine. Yet their lifespan is naturally limited; over time, use of these drugs selects for mutations that survive exposure those same drugs, driving “anti-microbial resistance,” or AMR. Already, drug-resistant infections kill an estimated 23,210 Japanese citizens every year. In the absence of sufficient research and development (R&D) investment for new antimicrobials, deaths from drug-resistant infections could increase dramatically in the coming decade. To address this growing crisis and solve market failures that prevent the development of new antibiotics, the government of Japan is considering a new program that would provide minimum guaranteed revenue to the successful developers of new antibiotics. In this note, we present the results of a modelling exercise to estimate the likely return on investment (ROI) from such a program, assuming it is paired with complementary and proportionate efforts from Japan’s G7 partners. The results are necessarily imprecise due to several uncertain parameters, but nevertheless provide evidence of a very high expected ROI that is robust to different inputs and assumptions.
Topic:
Health, Science and Technology, Health Care Policy, and Medicine
Political Geography:
Japan and Asia

4. Estimating the UK's Return on Investment from an Ambitious Program to Incentivize New Antibiotics

Author:
Rachel Silverman and Adrian Towse
Publication Date:
12-2022
Content Type:
Policy Brief
Institution:
Center for Global Development (CGD)
Abstract:
Anti-microbial drugs form the backbone of modern medicine. Yet their lifespan is naturally limited; over time, use of these drugs selects for mutations that survive exposure those same drugs, driving “anti-microbial resistance,” or AMR. Already, drug-resistant infections kill an estimated 7,600 citizens of the United Kingdom (UK) every year. In the absence of sufficient research and development (R&D) investment for new antimicrobials, deaths from drug-resistant infections could increase dramatically in the coming decade. To address this growing crisis and solve market failures that prevent the development of new antibiotics, the UK has set up “subscription models” for purchasing antibiotics; this has been applied to two drugs thus far, and the model is under consideration for a broader rollout. In this note, we present the results of a modelling exercise to estimate the likely return on investment (ROI) from an expanded program to incentivize new antibiotics, assuming it is paired with complementary and proportionate efforts from the UK’s G7 partners. The results are necessarily imprecise due to several uncertain parameters, but nevertheless provide evidence of a very high expected ROI that is robust to different inputs and assumptions.
Topic:
Health, Science and Technology, Health Care Policy, and Medicine
Political Geography:
United Kingdom and Europe

5. Estimating the EU's Return on Investment from an Ambitious Program to Incentivize New Antibiotics

Author:
Rachel Silverman and Adrian Towse
Publication Date:
12-2022
Content Type:
Policy Brief
Institution:
Center for Global Development (CGD)
Abstract:
Anti-microbial drugs form the backbone of modern medicine. Yet their lifespan is naturally limited; over time, use of these drugs selects for mutations that survive exposure those same drugs, driving “anti-microbial resistance”, or AMR. Already, drug-resistant infections kill an estimated 33,000 citizens of the European Union (EU) every year. In the absence of sufficient research and development (R&D) investment for new antimicrobials, deaths from drug-resistant infections could increase dramatically in the coming decade. To address this growing crisis and solve market failures that prevent the development of new antibiotics, the EU is considering incentive programs that would help provide predictable and value-based compensation to the successful developers of new antibiotics. In this note, we present the results of a modelling exercise to estimate the likely return on investment (ROI) from such a program, assuming it is paired with complementary and proportionate efforts from the EU’s G7 partners. The results are necessarily imprecise due to several uncertain parameters, but nevertheless provide evidence of a very high expected ROI that is robust to different inputs and assumptions.
Topic:
Regional Cooperation, Science and Technology, European Union, and Medicine
Political Geography:
Europe

6. Estimating Canada’s Return on Investment from an Ambitious Program to Incentivize New Antibiotics

Author:
Rachel Silverman and Adrian Towse
Publication Date:
12-2022
Content Type:
Policy Brief
Institution:
Center for Global Development (CGD)
Abstract:
Anti-microbial drugs form the backbone of modern medicine. Yet their lifespan is naturally limited; over time, use of these drugs selects for mutations that survive exposure those same drugs, driving “anti-microbial resistance,” or AMR. Already, drug-resistant infections kill an estimated 5,400 Canadian citizens every year. In the absence of sufficient research and development (R&D) investment for new antimicrobials, deaths from drug-resistant infections could increase dramatically in the coming decade. To address this growing crisis and solve market failures that prevent the development of new antibiotics, the Government of Canada is considering a new program that would provide minimum guaranteed revenue to the successful developers of new antibiotics. In this note, we present the results of a modelling exercise to estimate the likely return on investment (ROI) from such a program, assuming it is paired with complementary and proportionate efforts from Canada’s G7 partners. The results are necessarily imprecise due to several uncertain parameters, but nevertheless provide evidence of a very high expected ROI that is robust to different inputs and assumptions.
Topic:
Health, Science and Technology, Investment, and Medicine
Political Geography:
Canada and North America

7. An Ambitious USG Advanced Commitment for Subscription-Based Purchasing of Novel Antimicrobials and Its Expected Return on Investment

Author:
Rachel Silverman and Adrian Towse
Publication Date:
11-2022
Content Type:
Working Paper
Institution:
Center for Global Development (CGD)
Abstract:
Antimicrobial drugs form the backbone of modern medicine. Yet their lifespan is naturally limited; over time, use of these drugs selects for mutations that survive exposure to those same drugs, driving “antimicrobial resistance,” or AMR. Already, drug-resistant infections kill an estimated 35,000 Americans and 1.27 million global citizens every year. In the absence of sufficient research and development (R&D) investment for new antimicrobials, deaths from drug-resistant infections could increase dramatically in the coming decade. However, the R&D pipeline for new antimicrobials remains sparse, constrained by an array of market failures that prevent private companies from capturing a sufficient private return on investment (ROI) despite the very high social value of new antimicrobials. Widespread recognition of these market failures among experts and policymakers has driven a search for creative solutions, and generated enthusiasm for the use of pull mechanisms which could help incentivize antibiotic development. One particularly promising pull approach—so-called “subscription models”—would offer guaranteed annual payments to successful antibiotic developers delinked from sales volumes. A subscription approach is included in the pending PASTEUR Act, which is legislation introduced by lawmakers in the US House of Representatives and Senate and endorsed in President Biden’s 2023 budget request. In this paper, we consider the expected return on investment for such a program—that is, an ambitious new program to incentivize antibiotic development via a US government subscription-based pull mechanism (though not necessarily the PASTEUR Act, per se). We construct an illustrative subscription program from first principles, with parameters drawn (where possible) from the literature and some simplifying and deliberately conservative assumptions about program design and remuneration. We model the 10- and 30-year costs and benefits of such an initiative, both from the US domestic perspective and from a global welfare perspective. We find that the program is likely to generate a very high social ROI in both the short and long-term. From the US domestic perspective—considering both the value of averted death/disease and associated hospital costs—ROI is calculated at 6:1 over a 10-year time horizon and 28:1 over a 30-year time horizon. From the global perspective—exclusively considering the health value of DALYs (Disability Adjusted Life Years) averted—ROI grows to 27:1 over a 10-year time horizon and 125:1 over the full 30-year program duration. Sensitivity analysis suggests that the overall high returns are robust under a wide variety of alternative assumptions and scenarios. Based on these high social returns, we encourage the US Congress to urgently finance and authorize a subscription program for new antimicrobials, with particularly consideration for the PASTEUR Act.
Topic:
Health, Science and Technology, Innovation, and Medicine
Political Geography:
North America and United States of America

8. Costing Healthcare Services Using Time-Driven Activity-Based Costing: A Simple Step-By-Step Guide for Data Collection and Analysis

Author:
Lumbwe Chola, Ryan McBain, and Y-Ling Chi
Publication Date:
10-2022
Content Type:
Working Paper
Institution:
Center for Global Development (CGD)
Abstract:
Cost information is essential for priority setting and optimized resource allocation in the healthcare sector, especially in low- and middle-income countries (LMICs) where resource constraints and opportunity costs are significant. In recent years, a costing approach labelled time-driven activity-based costing (TDABC) has gained prominence, as a means for more closely estimating unit costs. TDABC is a process-based micro-costing methodology that adopts a patient perspective to identify resources that are allocated over the course of service provision, mapping each step of a patient journey. Unlike other activity-based costing methods, TDABC includes the recording of the amount of time that resources are utilized for each activity. The manuscript is developed as a step-by-step guide for researchers, students and policy makers intending to undertake TDABC. While there are many academic resources explaining the theory and steps to conduct TDABC, in this paper, we provide easily accessible descriptions of methods for collecting data, tools that can be adapted to diverse research questions and settings, as well as practical data collection “tips” we learned from applying approaches on the ground.
Topic:
Science and Technology, Health Care Policy, Medicine, and Cost-Benefit Analysis
Political Geography:
Global Focus

9. Are Financial Barriers Affecting the Health Care Habits of American Men?

Author:
Munira Z. Gunja, Evan D. Gumas, and Reginald D. Williams II
Publication Date:
07-2022
Content Type:
Policy Brief
Institution:
Commonwealth Fund
Abstract:
Whether it’s stubbornness, an aversion to appearing weak or vulnerable, or other reasons, men go to the doctor far less than women do.1 While behavioral and cultural norms may have a lot to do with the care-seeking habits of American men, the fact remains that the United States is the only high-income country that does not ensure all its residents have access to affordable health care. Roughly 16 million U.S. men are without health insurance, and affordability is the reason that people most often cite for why they do not enroll in a health plan.2 Do income level and financial stress help explain why men do not get needed care and experience worse health outcomes? Using data from the Commonwealth Fund’s 2020 International Health Policy Survey and the Organisation for Economic Co-operation and Development (OECD), we compare health care accessibility, affordability, and health status for adult men in 11 high-income countries. We also examine measures of income and income-related stress, where the data allow, to understand the role income insecurity might play in American men’s relatively low use of health care.
Topic:
Health, Finance, Medicine, and Gender
Political Geography:
North America and United States of America

10. Global Health Security COVID-19 and Its Impacts – Vaccine Resilience: Next Stage in ASEAN’s War?

Author:
Jose M. L. Montesclaros
Publication Date:
08-2022
Content Type:
Commentary and Analysis
Institution:
Centre for Non-Traditional Security Studies, S. Rajaratnam School of International Studies
Abstract:
The next stage in ASEAN’s COVID-19 war lies in partnerships to establish local vaccine manufacturing centres within member states, to strengthen the region’s “vaccine resilience”.
Topic:
Public Health, Vaccine, Resilience, COVID-19, and Medicine
Political Geography:
Asia and ASEAN