Assessing US Pharmaceutical Policy and Pricing Reform Legislation in Light of European Price and Cost Control Strategies.

This article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas-H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)-and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices; the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform.

Japan's Special Approval for Emergency System During the COVID-19 Pandemic.

The development of drugs for coronavirus disease 2019 (COVID-19) is a global challenge. In Japan, remdesivir was approved in May 2020 for COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2021, a vaccine against COVID-19 was approved. These two approvals were made using the Special Approval for Emergency system in Japan. This Japanese system was started in 2010 and has been used to approve four drugs to date, including remdesivir and the Pfizer COVID-19 vaccine. This paper discusses future challenges for Japan's Special Approval for Emergency system and organizes what can be learned from experiences to date. As a result, I would like to point Out the following issues. (i) Special Approval for Emergency is a system for approving drugs approved overseas, not a system for approving drugs originally developed in Japan. A system to approve drugs that have not been approved in foreign countries needs to be considered. (ii) In the Special Approval for Emergency system, it is necessary to ensure that postmarketing activities are conducted in accordance with the Risk Management Plan and the conditions of approval, to disclose the results in a timely and speedy manner, and to judge the appropriateness of continued approval based on the results of postmarketing activities.

The implications of the use of cannabidiol-related products in a safety-sensitive drug testing environment: A medical-legal perspective.

Cannabis access laws allow for the use of cannabis in private and the trade, purchase and use of hemp-related products as a complementary medicine and for other benefits. Cannabidiol (CBD) has the treatment potential for several conditions but, with the lack of resources in South Africa to maintain the legislation, products contaminated with delta-9-tetrahydrocannabinol (Δ9-THC) are sold by some suppliers who do not comply with the legislative provisions in terms of the threshold concentrations for Δ9-THC. This dilemma complicates a medical review officer's decision regarding intentional use of Δ9-THC or otherwise, since a CBD user may have purchased the product legally and in good faith. Hemp- and CBD-containing products were analysed by gas chromatography-mass spectrometry and compliance was assessed for CBD and Δ9-THC purity against the legislative thresholds. A strategy based on metabolite ratios is suggested to distinguish between intentional or irresponsible cannabis use and legitimate CBD use.

Projected impact of biosimilar substitution policies on drug use and costs in Ontario, Canada: a cross-sectional time series analysis.

BACKGROUND: Several Canadian provinces have introduced reimbursement policies mandating substitution of innovator biologics with lower-cost biosimilars. We estimated the number of patients affected and cost implications if such policy changes were to be implemented in Ontario, Canada. METHODS: We conducted a cross-sectional time series analysis of Ontarians dispensed publicly funded biologics indicated for inflammatory diseases (rheumatic conditions, inflammatory bowel disease: infliximab, etanercept, adalimumab) between January 2018 and December 2019, and forecasted trends to Dec. 31, 2020. The primary source of data was pharmacy claims data for all biologics reimbursed by the public drug program. We modelled the number of patients affected and government expenditures (in nominal Canadian dollars) of several biosimilar policy options, including mandatory nonmedical biosimilar substitution, substitution in new users, introduction of a biosimilar for adalimumab, and price negotiations. In a secondary analysis, we included insulin glargine. RESULTS: In 2018, 14 089 individuals were prescribed a publicly funded biologic for inflammatory diseases. A mandatory nonmedical biosimilar substitution would potentially have affected 7209 patients and saved $238.6 million from 2018 to 2020. A new-user substitution would have affected 757 patients and saved $34.2 million. If an adalimumab biosimilar were to become available, 12 928 patients would be affected by a mandatory nonmedical substitution and the 3-year savings would increase to $645.9 million (all biosimilars priced at 25% of innovator biologics). Finally, an expanded nonmedical substitution policy including insulin glargine would affect 115 895 patients and save $288.7 million (not including adalimumab). INTERPRETATION: Policies designed to curb rising costs of biologics can have substantially different effects on patients and government expenditures. Such analyses warrant careful consideration of the balance between cost savings and effects on patients.

Implementation of MPOWER Package in the South-East Asia Region: Evidence from the WHO Report on the Global Tobacco Epidemic (2009-2021).

The WHO MPOWER package is a set of six evidence-based and cost-effective measures which was introduced on 7 February 2008 to facilitate the implementation of the provisions of the WHO Framework Convention on Tobacco Control at the ground level. These measures are: Monitoring tobacco use and prevention policies (M); Protecting people from tobacco smoke (P); Offering help to quit tobacco use (O); Warning about the dangers of tobacco (W); Enforcing bans on tobacco advertising, promotion and sponsorship (E); and Raising taxes on tobacco (R). Since its launch, the MPOWER package has become the guiding principle for all the countries of the South-East Asia Region in their crusade against the tobacco epidemic. This review article tracks the implementation of the MPOWER measures in the 11 member countries of the Region based on the last seven WHO Report on the Global Tobacco Epidemic (GTCR), i.e., GTCR2/2009-GTCR8/2021. This is with an aim to enable the countries to review their progress in implementing the MPOWER measures and to take steps to improve their advancement towards reducing the demand for tobacco products at the country level.

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.

BACKGROUND: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins. OBJECTIVES: The aim of this study was to analyse the short- and long-term safety and interchangeability data of biosimilar mAbs and fusion proteins to provide unbiased information to prescribers and policy makers. METHODS: Data on the safety, immunogenicity and interchangeability of EU-licensed mAbs and fusion proteins were examined using European Public Assessment Reports (EPARs) and postmarketing safety surveillance reports from the European Medicines Agency (EMA). As recent biosimilar approvals allow self-administration by patients by the subcutaneous route, the administration devices were also analyzed. RESULTS: Prelicensing data of EPARs (six different biosimilar adalimumabs, three infliximabs, three etanercepts, three rituximabs, two bevacizumabs, and six trastuzumabs) revealed that the frequency of fatal treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of treatment, serious adverse events (SAEs), and main immune-mediated adverse events (AEs) were comparable between the biosimilars and their reference products. The availability of new biosimilar presentations and administration devices may add to patient choice and be an emerging factor in the decision to switch patients. Analysis of postmarketing surveillance data covering up to 7 years of follow-up did not reveal any biosimilar-specific adverse effects. No product was withdrawn for safety reasons. This is in spite of considerable exposure to biosimilars in treatment-naïve patients and in patients switched from the reference medicinal product to the biosimilar. Analysis of data from switching studies provided in regulatory submissions showed that single or multiple switches between the originator and its biosimilar versions had no negative impact on efficacy, safety or immunogenicity. CONCLUSIONS: In line with previous reports of prelicensing studies of biosimilar mAbs and etanercepts, this study demonstrated comparable efficacy, safety, and immunogenicity compared with the reference products. This is the first study to comprehensively analyze postmarketing surveillance data of the biosimilar mAbs and etanercept. An analysis of more than 1 million patient-treatment years of safety data raised no safety concerns. Based on these data, we argue that biosimilars approved in the EU are highly similar to and interchangeable with their reference products. Thus, additional systematic switch studies are not required to support the switching of patients.

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks.

Background: Prior studies investigated regulatory actions that reflected a negative impact on drug risks. We aimed to evaluate occurrence of regulatory actions that reflected a negative or positive impact on benefits or risks, as well as relations between them.Research design and methods: We followed EMA-approved innovative drugs from approval (2009-2010) until July 2020 or withdrawal to identify regulatory actions. We assessed these for impact on benefits or risks and relations between actions. Additionally, we scrutinized drug lifecycles for time-variant characteristics that may contribute to specific patterns of regulatory actions.Results: We identified 14 letters and 361 label updates for 40 drugs. Of the label updates, 85 (24%) reflected a positive impact, mostly concerning indications, and 276 (76%) a negative impact, mostly adverse drug reactions. Many updates (54%) occurred simultaneously with other updates, also if these reflected a different impact. Furthermore, levels of patient exposure, innovativeness, needs for regulatory learning and unexpected risks may contribute to patterns of regulatory actions.Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.

A practical review of buprenorphine utilization for the emergency physician in the era of decreased prescribing restrictions.

INTRODUCTION: Opioid abuse and overdose deaths have reached epidemic proportions in the last couple decades. In response to rational prescribing initiatives, utilization of prescription opioids has decreased; however, the number of deaths due to opioid overdoses continues to rise, largely driven by fentanyl analogues in adulterated heroin. Solutions to the opioid crisis must be multifaceted and address underlying opioid addiction. In recent years, buprenorphine has become a cornerstone in the treatment of opioid use disorder (OUD) and initiation of therapy in the emergency department (ED) has become increasingly common. There have also been calls by many organizations to remove the requirement for additional training and X-waiver to prescribe buprenorphine. In April 2021, the Biden Administration eased prescribing restrictions on the drug. These initiatives are expected to increase ED utilization of the buprenorphine. The purpose of this paper is to provide an updated overview of the role and use of buprenorphine in the ED setting so physicians may adapt to the changing practice environment. OBJECTIVES: This is a narrative review describing the role of buprenorphine in the ED. A PubMed search was conducted using the keywords "opioid epidemic" "buprenorphine," and "medication assisted therapy", and "emergency department". All the articles that contained information on the opioid epidemic, medication assisted therapy, and the biological effects of buprenorphine, that were also relevant to pain management and the ED, were included in the review. DISCUSSION: Multiple studies have pointed to the effective use of buprenorphine as a treatment for OUDs in ED patients and are superior to standard care; however, there are various barriers to its use in the ED setting. CONCLUSION: Emergency physicians can influence opioid related morbidity and mortality, by familiarizing themselves with the use of buprenorphine to treat opioid withdrawal and addiction, particularly now that prescribing restrictions have been eased. Further ED research is necessary to assess the optimal use of buprenorphine in this care setting.