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Global Health Econ Sustain Impact of new drug indications in Brazil

presenting challenges for health-care systems. The rise remain confidential. Other indirect methods of controlling
in the drug price has affected governments, insurers, and drug prices in the UK include a voluntary agreement
patients. Projections indicate that health-care costs will between the industry and the government, which covers
significantly increase in the US in the coming years, and the profits that companies can make on drugs, and cost-
Europe has also seen an increase in cancer treatment drug effectiveness assessments by the National Institute for
costs. This reality has forced physicians and patients to make Health and Care Excellence (NICE) for new drugs before
treatment decisions based on the availability of financial recommendations for use. Furthermore, NHS England
resources (Goldstein et al., 2016; Howard et al., 2015). and individual NHS organizations undertake negotiations
The health-care systems currently face economic with manufacturers for discounts based on volume use
challenges due to several factors, but the most significant (The Lowdown, 2021).
one is the increase in the cost of new drugs. Anti-PD-L1 The FDA approves a new drug based on efficacy and
drugs like pembrolizumab have a particularly relevant safety data without considering cost. In the US, the cost
negative impact as they are introduced to the market with cannot be used as a criterion to limit patient access to
high prices and are approved for a variety of treatments, new drugs. In developing countries, such as India, the
including when used in combination with other therapies. treatment standards used in medical oncology are lower
In addition, patients usually use them for prolonged than those recommended in the guidelines established
periods. Since the regulatory approval of pembrolizumab by the US National Comprehensive Cancer Network
and its incorporation into cancer treatment, the issue of (NCCN) (Kerr et al., 2017). What changes from country to
cost has been continuously discussed in conferences and country is the regulatory process, the budget impact, and
scientific articles (Da Veiga et al., 2018; Tartari et al., 2016). the ability to negotiate with pharmaceutical companies.
The pricing of cancer drugs is a topic that is often The economic analysis of new drugs should be considered
discussed, and there are varying opinions on the best in the incorporation of technologies and used to shape
method for determining prices. Some believe that prices healthcare-related policies. Public concern over the high
should be determined based on the unique clinical cost of cancer drugs, pressure from health insurance to
benefits provided by these drugs. On the other hand, control costs, the challenge for policymakers to link drug
others argue that a variety of factors must be taken into costs to value-based pricing, and the legal and political
consideration, such as pharmacoeconomic studies, budget frameworks for drug approvals in different national
impact analysis, and negotiations with the pharmaceutical governmental frameworks are expected to influence
industry, to establish value-based prices. This process of market access for a new generation of cancer drugs (Da
considering multiple factors is particularly important for Veiga et al., 2018).
drugs that address unmet medical needs (Franken et al., The present study highlights the importance of
2016; Sleijfer & Verweij, 2016). understanding the eligible patient populations and
In Europe, there are significant regulatory differences associated costs for pembrolizumab and trastuzumab
among the countries of the European Union, which affect deruxtecan. However, it is essential to acknowledge
the way drugs that are evaluated and prices are set. A scale certain limitations and uncertainties inherent in the data
used by a European medical society measures the size of sources utilized, including clinical trials, epidemiological
the clinical benefits of therapeutic interventions but does sources, and regulatory documents. These limitations
not consider the cost of the intervention. Using this scale, may introduce variations and potential inaccuracies
a drug was considered to have high clinical benefits for in estimating the eligible patient populations and cost
patients with a certain condition but was rejected for those projections, particularly due to unaccounted variations
same clinical conditions in a cost-effectiveness assessment. in patient characteristics, treatment patterns, and disease
However, through a price discount, that same drug prevalence across different regions of Brazil.
combination was recommended for another condition Furthermore, it is crucial to recognize that the
(Sleijfer & Verweij, 2016; Tartari et al., 2016). analysis did not account for potential changes in clinical
The complex nature of drug pricing across markets can practice or treatment guidelines that may arise from the
make it difficult to compare prices. However, drug prices in expanded indications of pembrolizumab and trastuzumab
the United Kingdom (UK) are substantially lower than in deruxtecan. These changes in clinical practice patterns
the US and several other developed markets. One reason for could significantly impact the number of eligible patients
this is that the UK employs certain price control strategies, and the associated costs, thereby influencing the overall
such as centralized price negotiations. Companies often findings of the study. In addition, the study did not assess
request that the prices they negotiate with the government the comparative effectiveness or cost-effectiveness of the

Volume 1 Issue 1 (2023) 7 https://doi.org/10.36922/ghes.0994