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Global Health Econ Sustain Impact of new drug indications in Brazil

Table 2. Incremental indications for pembrolizumab Table 2. (Continued)
Year Pembrolizumab indications Year Pembrolizumab indications
2016 1. Advanced melanoma 2022 21. Triple-negative breast cancer, metastatic, as first-line
2017 2. Advanced non-small-cell lung cancer, as a single agent, treatment
after platinum-containing chemotherapy 22. Triple-negative breast cancer, early-stage
3. Urothelial carcinoma, locally advanced or (non-metastatic), in combination with chemotherapy as
metastatic, with progression during or following neoadjuvant treatment, and then continued as a single
platinum-containing chemotherapy agent as adjuvant treatment after surgery
2018 4. Urothelial carcinoma, locally advanced or metastatic, 23. Primary mediastinal large B-cell lymphoma, adult and
ineligible for platinum-containing chemotherapy pediatric, refractory or patient who have relapsed after
2 or more prior lines of therapy
5. Non-small-cell lung cancer, metastatic, in combination
with chemotherapy
6. Recurrent locally advanced or metastatic gastric or Pharmaceutical companies may prioritize the
gastroesophageal junction adenocarcinoma, patient who development and registration of drugs for cancer and rare
have disease progression on or after two or more prior diseases due to the potential for high demand and significant
systemic therapies profits. Cancer and rare diseases often have unmet medical
7. Renal cell carcinoma, combined with axitinib for needs, and there is usually a large population willing to
first-line treatment pay for effective treatments. In addition, the regulatory
2019 8. Adjuvant therapy for melanoma environment for drug approval for cancer and rare diseases
9. Metastatic squamous non-small-cell lung cancer, combined may be more favorable, with regulatory agencies often
with platinum- and taxane-containing chemotherapy considering drugs for these indications on an accelerated
10. Non-small-cell lung cancer, with an expression of basis (Bach & Saltz, 2017).
PD-L1≥1, first-line treatment, as a single agent
One reason pharmaceutical companies may initially
11. Hodgkin’s lymphoma, refractory or relapsed seek that approval for their drugs in limited populations is
12. Head-and-neck squamous cell carcinoma, recurrent, to gather additional data on the safety and efficacy of the
locally advanced, or metastatic with an expression of
PDL1≥1, first-line treatment, as a single agent drug in specific patient groups. By focusing on a specific
13. Head-and-neck squamous cell carcinoma, recurrent, population, companies can conduct clinical trials and
locally advanced, or metastatic, with progression on or collect the necessary data to support regulatory approval
after platinum-containing chemotherapy more easily. Another reason pharmaceutical companies
2020 14. Non-muscle invasive bladder cancer, unresponsive, may initially seek that approval for their drugs in limited
high-risk, in situ, patient who are ineligible for or have populations is to establish a market position. By obtaining
elected not to undergo cystectomy approval for a specific indication or patient population, a
15. Esophageal or gastroesophageal junction company can generate revenue from the sale of the drug,
adenocarcinoma, locally advanced or metastatic, which can help finance further research and development
unresectable, or HER2-positive, expression of efforts. In addition to these factors, the regulatory
PD-L1≥10, first-line treatment in combination with environment may also play a role in the decision to initially
platinum-containing chemotherapy seek approval for a drug in a limited population. In some
16. Esophageal or gastroesophageal junction cases, regulatory agencies may require additional data or
adenocarcinoma, locally advanced, or metastatic,
PD-L1≥10, second or prior lines be more willing to consider a drug for approval in a specific
2021 17. Colorectal cancer, first-line treatment, unresectable or population before considering it for other indications
metastatic, high microsatellite instability, or mismatch (Brewer, 2006; Gammie et al., 2015; Sharma et al., 2010).
repair deficient The incidence of cancer is increasing globally, but the
18. Endometrial carcinoma, in combination with lenvatinib overall mortality rate has decreased over the past two decades
for advanced cancer, shows progression after prior due to vaccination campaigns, advancements in surgical and
systemic therapy in any setting, and the patient is not a
candidate for curative surgery or radiotherapy radiation techniques, early diagnosis, and new therapies. At
19. Hodgkin’s lymphoma pediatric patients (>3 years old) present, there are over 700 pharmacological treatments in
with refractory classical Hodgkin’s lymphoma or have development for cancer, and advances in the understanding
relapsed after 2 or more lines of therapy of cancer biology offer increasingly promising therapeutic
20. Renal cell carcinoma, adjuvant treatment at intermediate-high possibilities (Ferlay et al., 2015; Yu, 2016).
or high risk of recurrence following nephrectomy While new cancer drugs have been developed, their
(Cont’d...) prices have risen faster than the benefits they offer,

Volume 1 Issue 1 (2023) 6 https://doi.org/10.36922/ghes.0994