Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Why are our medicines so expensive? Spoiler: Not for the reasons you are being told .

Often described as a natural economic trend, the prices that pharmaceutical companies charge for new medicines have skyrocketed in recent years. Companies claim these prices are justified because of the 'value' new treatments represent or that they reflect the high costs and risks associated with the research and development process. They also claim that the revenues generated through these high prices are required to pay for continued innovation.This paper argues that high prices are not inevitable but the result of a societal and political choice to rely on a for-profit business model for medical innovation, selling medicines at the highest price possible. Instead of focusing on therapeutic advances, it prioritises profit maximisation to benefit shareholders and investors over improving people's health outcomes or equitable access.As a result, people and health systems worldwide struggle to pay for the increasingly expensive health products, with growing inequities in access to even life-saving medicines while the biopharmaceutical industry and its financiers are the most lucrative business sectors.As the extreme COVID-19 vaccine inequities once again highlighted, we urgently need to reform the social contract between governments, the biopharmaceutical industry, and the public and restore its original health purpose. Policymakers must redesign policies and financing of the pharmaceutical research and development ecosystem such that public and private sectors work together towards the shared objective of responding to public health and patients' needs, rather than maximising financial return because medicines should not be a luxury.

From Pharmaceutical Innovation to Revenue Generation: The Asian Experience.

Asia's pharmaceutical sector has experienced remarkable growth over the last two decades, with companies in the region producing bulk of the world's specialty generics, biologicals, and active pharmaceutical ingredients (APIs). The Asian pharma growth story has had several pillars for a strong and sustainable foundation that provided non-linear growth. This report introduces three models showing how Asian countries at different development stages - India, South Korea, and Singapore - have nurtured their own, self-sustaining pharmaceutical sectors.

Impact of China's National Centralized Drug Procurement Policy on pharmaceutical enterprises' financial performance: a quasi-natural experimental study.

Introduction: In China, the interest relationship between pharmaceutical enterprises and medical institutions has harmed the healthy development of pharmaceutical enterprises. In November 2018, the National Centralized Drug Procurement (NCDP) policy was published. The NCDP policy severs the interest relationship and significantly impacts on pharmaceutical enterprises's financial performance. Methods: Using the implementation of China's National Centralized Drug Procurement (NCDP) policy as a quasi-natural experiment, this study evaluated the impact of participation in the NCDP policy on pharmaceutical enterprises' financial performance. We developed a difference-in-difference model to estimate the change in financial performance after NCDP implementation, based on financial data on Chinese listed pharmaceutical enterprises. Results: We found that the bid-winning enterprises' financial performance significantly improved after participating in NCDP. This may be related to lower costs, market share expansion, and increased research and development investment by the bid-winning enterprises. Discussion: To further promote the high-quality development of pharmaceutical enterprises in China, the government should expand the variety of drugs on the NCDP list (NCDP drugs), while improving the drug patent protection system and the policies to support the bid-winning enterprises.

The Problem of Limited-Supply Agreements for Medicare Price Negotiation.

This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US.

Consent document translation expense hinders inclusive clinical trial enrolment.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Replenishing the pipeline: A quantitative approach to optimising the sourcing of new projects.

Large pharmaceutical companies maintain a portfolio of assets, some of which are projects under development while others are on the market and generating revenue. The budget allocated to R&D may not always be sufficient to fund all the available projects for development. Much attention has been paid to the selection of optimal subsets of available projects to fit within the available budget. In this paper, we argue the need for a forward-looking approach to portfolio decision-making. We develop a quantitative model that allows the portfolio management to evaluate the need for future inflow of new projects to achieve revenue at desired levels, often aspiring to a certain annual revenue growth. Optimisation methods are developed for the presented model, allowing an optimal choice of number, timing and type of projects to be added to the portfolio. The proposed methodology allows for a proactive approach to portfolio management, prioritisation, and optimisation. It provides a quantitatively based support for strategic decisions regarding the efforts needed to secure the future development pipeline and revenue stream of the company.

Corporate financialization, financing constraints, and innovation efficiency-Empirical evidence based on listed Chinese pharmaceutical companies.

The relationship between financialization and innovation has become a common focus of academic attention. This paper analyzes the influence of corporate financialization on innovation efficiency based on balanced panel data of listed Chinese pharmaceutical companies from 2015 to 2020. Also, it examines the relationship between corporate financialization and innovation efficiency under different levels of financing constraints and the moderating mechanisms that exist. The results of the study show that corporate financialization negatively affects innovation efficiency and that this effect has a lag; corporate financialization hurts innovation efficiency across the different regions and firm nature, with a less inhibiting effect for eastern firms and non-state-owned firms; further tests of the mechanism of action show that there is a non-linear negative relationship between corporate financialization and innovation efficiency. And the inhibition of corporate financialization on innovation efficiency decreases as the level of financing constraints rises. Based on the above findings, this study provides warnings and recommendations for pharmaceutical companies to finance their innovative activities through financialization.

Reducing biopharmaceutical manufacturing costs through continuous processing in a flexible J.POD® facility.

In this work, process models were developed to capture the impact of biomanufacturing costs on a commercial scale and emphasize the way in which facility design and operation must balance meeting product demand while minimizing production costs. Using a scenario-based modeling approach, several facility design strategies were evaluated, including a traditional large stainless-steel facility and a small footprint, portable-on-demand (POD)-based facility. Bioprocessing platforms were compared by estimating their total production costs across different facility types and specifically illustrating how continuous bioprocessing has gained in popularity as a novel and cost-effective approach to manufacture high-quality biopharmaceuticals. The analysis showed how fluctuations in market demand have a dramatic effect on manufacturing costs and plant utilization, with far-reaching implications on the total cost to patients.

Cross-sectional analysis of pharmaceutical payments to Japanese board-certified gastroenterologists between 2016 and 2019.

OBJECTIVES: Limited evidence is available regarding the financial relationships between gastroenterologists and pharmaceutical companies in Japan. This study analysed the magnitude, prevalence and trends of personal payments made by major pharmaceutical companies to board-certified gastroenterologists in Japan in recent years. DESIGN: Cross-sectional analysis SETTING AND PARTICIPANTS: Using payment data publicly disclosed by 92 major pharmaceutical companies, this study examined the non-research payments made to all board-certified gastroenterologists by the Japanese Society of Gastroenterology. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were payment amounts, the prevalence of gastroenterologists receiving payments, yearly trends in per-gastroenterologist payment values and the number of gastroenterologists with payments. Additionally, we evaluated the differences in payments among influential gastroenterologists, including clinical practice guideline authors, society board member gastroenterologists and other general gastroenterologists. RESULTS: Approximately 52.8% of all board-certified gastroenterologists received a total of US$89 151 253, entailing 134 249 payment contracts as the reimbursement for lecturing, consulting and writing, from 84 pharmaceutical companies between 2016 and 2019. The average and median payments per gastroenterologist were US$7670 (SD: US$26 842) and US$1533 (IQR: US$582-US$4781), respectively. The payment value per gastroenterologist did not significantly change during the study period, while the number of gastroenterologists with payments decreased by -1.01% (95% CI: -1.61% to -0.40%, p<0.001) annually. Board member gastroenterologists (median: US$132 777) and the guideline authoring gastroenterologists (median: US$106 069) received 29.9 times and 17.3 times higher payments, respectively, than general gastroenterologists (median: US$284). CONCLUSION: Most gastroenterologists received personal payments from pharmaceutical companies, but only very few influential gastroenterologists with authority accepted substantial amounts in Japan. There should be transparent and rigorous management strategies for financial conflicts of interest among gastroenterologists working in influential positions.

Commentary: Reconsidering Pharmaceutical Research and Development Investments.

Following Lee and colleagues' (2023) article explaining how Canadians are being shortchanged by drug companies when it comes to investments in research and development (R&D), this rejoinder adds context and appends two other very problematic elements in the debate between wishful narratives over the industry's contribution in R&D and actual numbers. First, even the current stricter definition of R&D investment might simply be too large considering that elements such as seeding trials - a well-known marketing device - can be accounted for as R&D expenditures. Second, this rejoinder identifies how Statistics Canada acted in concert with Innovative Medicines Canada to reinforce the industry's preferred narratives around R&D expenditures. This situation puts into question the trustworthiness of Canada's statistical agency.

Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising.

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021.

This study quantifies the revenue earned on all brand-name inhalers approved by the US Food and Drug Administration from 2000 to 2021 and compared earnings before and after expiration of primary patents on these products.