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Background: The cost of cancer drugs presents a significant challenge to accessibility of treatment worldwide. Projections indicate that by 2040, two-thirds of cancer cases will occur in low- and middle- income countries. Paradoxically, despite this impending burden, LMICs command less than 5% share of global resources for treating cancer. Morocco, like many LMICs, faces significant obstacles in providing innovative cancer treatments to its population., Aim: Firstly, we aimed to conduct an original research investigating the availability and affordability of innovative cancer drugs in Morocco. Secondly, we sought to review the broader market dynamics, pricing, and reimbursement policies in the country., Methods: For the first objective, we identified a preliminary list of medicines approved for oncological indications in the Moroccan market based on resources from ANAM (National Agency for Health Insurance), pharmacy regulators, and online resources that compile information on approved medicines. For the second objective, we exhaustively reviewed the regulatory documents, legal texts and grey literature reports. All the informations were examined by pharma delegates and local experts., Results: As of January 2024, Morocco has 39 innovative anticancer medicines with market authorization. 30% of these drugs were approved after 2020. The majority of approved drugs were for breast, lung, colorectal, and prostate cancer. The period between FDA approval and entry into the Moroccan market ranges from 2 to 7 years, with a median of 3 years for breast cancer drugs and 7 years for more expensive drugs like Olaparib and Osimertinib. 22 out of the 39 drugs are not reimbursed, with an average reimbursement time of 4 years. Compared to prices in France, the most notable pricing disparities concern immunotherapy agents, priced 600 to 900 euros lower in France, while drugs like Pazopanib and Erlotinib cost 50% less in Morocco., Conclusion: Our study reveals significant disparities in the availability and affordability of innovative cancer drugs in Morocco. Regulatory hurdles, importation challenges, and pricing strategies contribute to this inequitable landscape. Addressing systemic barriers, fostering collaborations between stakeholders, and adopting a value-based pricing approach are imperative steps toward ensuring equitable access to high-quality interventions for patients, regardless of their geographical location., (© 2024. The Author(s).)

Introduction: Despite progress in the development of new cancer drugs, concerns about equity of access remain. This study aimed to examine the availability and timeliness of availability of new cancer drugs around the globe over the past three decades and their associations with country characteristics., Methods: From a pharmaceutical intelligence database we identified new cancer drugs launched between 1990 and 2022. We calculated the number of new drugs launched in each country and the delay in launches. Using a multivariable linear regression and a Cox regression model with shared frailty, we examined the associations of the country's Gross National Income (GNI) per capita, cancer incidence, number of physicians per population, and Gini index with the number of new cancer drug launches and launch delay in a country, respectively., Results: A total of 568 cancer drugs were launched for the first time globally between 1990 and 2022. Among these, 35% had been launched in only one country by 2022, 22% in 2-5 countries, 15% in 6-10 countries, and 28% in more than 10 countries. The number of new cancer drugs launched in a country in this period ranged from 0 to 345. The average delays from the first global launch to the second, third, fourth, and fifth launch were 18.0 months, 24.3 months, 32.5 months, and 39.4 months, respectively. Our multivariate models showed that higher GNI per capita and cancer incidence in a country were associated with more launches and shorter delays., Conclusion: This research reveals significant disparities in the availability and timeliness of availability of new cancer drugs across countries. These disparities are likely to have contributed to the poor cancer outcomes observed in many countries., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In a context of intensive clinical development and innovation in oncology, the French National Cancer Institute has developed a horizon scanning focused on emerging anticancer drugs since 2019. This tool aims to provide further insight to national authorities responsible of the access to medicines and policymakers., Methods: EMERGINCaRE is based on an annual cycle initiated by the identification of clinical developments of interest from a database, one to three years prior European marketing authorization. Clinical developments are ranked and prioritized using a scoring approach. Scores are based on public information about developments collected by the Institute and on the evaluation carried out by clinicians who were asked to analyse and identify the most impacting drugs. A national steering committee prioritizes several high-score developments each year., Results: Seventy-five developments were analysed during the 2023 cycle. Among these developments, 50 are related to drugs for solid tumors and 25 for hematological malignancies. At the end of this cycle, six developments, including two concerning Advanced Therapy Medicinal Products, were prioritized. Half of these prioritized developments evaluate a drug for a poor prognosis cancer., Discussion: Among the developments evaluated with a high clinical impact score, some drugs were finally approved for the clinical situation concerned. As first public Horizon Scanning in France, the methodology of EMERGINCaRE has been refined and deadlines have been optimized to provide annually the information generated by this system to interested public institutions., (Copyright © 2024. Published by Elsevier Masson SAS.)

Background: High clinical value national reimbursement anticancer medications (NRAMs) are pivotal treatments for patients with cancer. However, the availability of NRAMs in medical institutions is unknown. This study aimed to assess the availability of NRAMs in national and provincial medical institutions., Methods: This cross-sectional study utilized national health insurance data to access the availability of NRAMs in national and provincial medical institutions. Further statistical analyses and visualizations were conducted in terms of medical institution level and daily cost. Using the Spearman's rank correlation test (α = 0.05), we calculated the correlation between the availability rates of NRAMs and their negotiation access time, daily cost, per capita disposable income, provincial gross product, and number of policy releases., Results: Overall, 81 NRAMs, with an average availability rate of approximately 1.01% nationwide, were included. There were significant differences between provinces for each drug, and the availability of NRAMs gradually decreased in tertiary (13.41%), secondary (1.58%), and primary medical institutions (< 0.05%). Differences were also observed in the availability rate of NRAMs in various daily drug cost ranges. Among the factors examined, negotiation access time (r 1  = 0.425), daily cost (r 2  = - 0.326), per capita disposable income (r 3  = 0.645), provincial gross product (r4 = 0.433), and number of policy releases (r 5  = 0.461) were all correlated with the availability of NRAMs., Conclusions: The low availability of NRAMs in national and provincial medical institutions indicates that their willingness to equip NRAMs needs to be improved. All factors examined in this study affected the availability of NRAMs. Our findings can guide policymakers in improving relevant policies., (© 2024. The Author(s).)

Purpose: To evaluate the availability, cost, affordability of anti-cancer medicines in Nanjing, Jiangsu., Methods: A longitudinal tracking investigation study was performed to collect information about 24 essential anti-cancer medicines (EAMs) and 17 innovative anti-cancer medicines (IAMs) in 26 healthcare institutions in Nanjing from 2016 to 2020. The availability, cost, drug utilization and affordability of EAMs and IAMs were investigated., Results: The availability of EAMs showed no significant changes in Nanjing, but the availability of IAMs showed a significant increase in 2018 and 2019 and tended to stabilize in 2020. For EAMs, the DDDc(Defined Daily Dose cost) of LPGs (Lowest-Priced Generics) showed no significant changes, and the DDDc of OBs (Originator Brands) and IAMs significantly decreased. The DDDs(Defined Daily Doses) of EAMs (LPGs) showed a decreasing trend since 2016 and rose again in 2019. Overall, the DDDs of EAMs (LPGs) decreased by 25.18% between 2016 and 2020, but the proportion selected for clinical treatment remained at 67.35% in 2020. The DDDs of EAMs (OBs) and IAMs both showed an increasing trend year by year, with a proportional increase of 207.72% and 652.68%, respectively; but the proportion selected for clinical treatment was only 16.09% and 16.56% respectively in 2020. EAMs (LPGs) had good affordability for urban residents but poor affordability for rural residents; the affordability of EAMs (OBs) and IAMs was poor for both urban and rural residents., Conclusions: There were no significant changes in the availability and cost of EAMs (LPGs), whose lower prices showed better affordability. Although their relative change in drug utilization showed a decreasing trend, they still dominated clinical treatment. Driven by the national drug price negotiation (NDPN) policy, the availability of IAMs was on the rise. It is necessary to further develop and strengthen policies for essential medicines procurement assessment to improve the accessibility of EAMs., (© 2024. The Author(s).)

Gaps in access to quality essential medicines remain a major impediment to the effective care of children with cancer in low-and middle-income countries (LMICs). The World Health Organization reports that less than 30% of LMICs have consistent availability of childhood cancer medicines, compared to over 95% in high-income countries. Information provided within this policy brief is drawn from a review of the literature and a mixed-methods study published in the Lancet Oncology that analyzed determinants of cancer medicine access for children in Kenya, Tanzania, Uganda, and Rwanda. Three key policy options are presented to guide strategic policy direction and critical health system planning for strengthening access to cancer medicines for children: pooled procurement, evidence-based forecasting, and regional harmonization of regulatory processes. Enhancing regional pooled procurement to address fragmented markets and improve medicine supply, investing in health information systems for improved forecasting and planning of childhood cancer medicine needs, and promoting regulatory harmonization to streamline medicine approval and quality assurance across East Africa are recommended. This policy brief is intended for policymakers, clinicians, and health-system planners involved in the procurement, supply chain management, policy and financing of childhood cancer medicines., (© 2024. The Author(s).)

An oncology fellow shares her experience navigating a cancer drug shortage alongside her patient.

Purpose: There is an urgent need to improve access to cancer therapy globally. Several independent initiatives have been undertaken to improve access to cancer medicines, and additional new initiatives are in development. Improved sharing of experiences and increased collaboration are needed to achieve substantial improvements in global access to essential oncology medicines., Methods: The inaugural Access to Essential Cancer Medicines Stakeholder Meeting was organized by ASCO and convened at the June 2022 ASCO Annual Meeting in Chicago, IL, with two subsequent meetings, Union for International Cancer Control World Cancer Congress held in Geneva, Switzerland, in October 2022 and at the ASCO Annual Meeting in June of 2023. Invited stakeholders included representatives from cancer institutes, physicians, researchers, professional societies, the pharmaceutical industry, patient advocacy organizations, funders, cancer organizations and foundations, policy makers, and regulatory bodies. The session was moderated by ASCO. Past efforts and current and upcoming initiatives were initially discussed (2022), updates on progress were provided (2023), and broad agreement on resulting action steps was achieved with participants., Results: Summit participants recognized that while much work was ongoing to enhance access to cancer therapeutics globally, communication and synergy across projects and organizations could be enhanced by providing a platform for collaboration and shared expertise., Conclusion: The summit resulted in new cross-stakeholder insights and planned collaboration addressing barriers to accessing cancer medications. Specific actions and timelines for implementation and reporting were established.

Objectives: This study aimed to investigate the availability, price, and affordability of nationally negotiated innovative anticancer medicines in China., Design: Retrospective observational study based on data from a nationwide medical database., Data Sources/setting: Quarterly data about the use of innovative anticancer medicines from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. This study covered 895 public general hospitals in 30 provincial administrative regions in China. Of the total hospitals, 299 (33.41%) were secondary and 596 (66.59%) were tertiary., Main Outcome Measures: The adjusted WHO and Health Action International methodology was used to calculate the availability and affordability of 33 nationally negotiated innovative anticancer medicines in the investigated hospitals. Price is expressed as the defined daily dose cost., Results: On average, the total availability of 33 innovative anticancer medicines increased annually from 2020 to 2022. The median availability of all investigated medicines in tertiary hospitals from 2020 to 2022 was 24.04%, 33.60% and 37.61%, respectively, while the indicators in secondary hospitals were 4.90%, 12.54% and 16.48%, respectively. The adjusted prices of the medicines newly put in Medicare (in March 2021) decreased noticeably, with the decline rate ranging from 39.98% to 82.45% in 2021 compared with those in 2020. Most generic brands were priced much lower than the originator brands. The affordability of anticancer medicines has improved year by year from 2020 to 2022. In comparison, rural residents had lower affordability than urban residents., Conclusions: The overall accessibility of 33 nationally negotiated innovative anticancer medicines improved from 2020 to 2022. However, the overall availability of most anticancer medicines in China remained at a low level (less than 50%). Further efforts should be made to sufficiently and equally benefit patients with cancer., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Waiting time for chemotherapy infusion is a fundamental factor to measure quality of care. It has been shown that a prolonged waiting time is related to a higher incidence of anticipatory nausea and poor patient adherence to scheduled appointments and recommended oncology treatment programs. Some chemotherapy regimens can be prepared hours ahead-of-time, due to long stability. We aimed to study the effect of an informatic-led workflow redesign intervention, facilitating workflow changes in the Oncology Pharmacy, on patient waiting time. This intervention included changes on EHR processes and the chemotherapy CPOE. Their main effect was allowing ahead-of-time preparation of selected chemotherapy regimes. We conducted a cross sectional study, comparing waiting times pre and post intervention periods. A total of 4600 programmed chemotherapy episodes were included. We found a 26.5 % decrease in the mean wait time in the post intervention period (p > 0.02). We were able to show a decrease in waiting time and a measurable impact of the intervention. This evaluation produced valuable and actionable data for Oncology units and adds a valuable, Latin American experience to the literature.

Competing Interests: KNV declares grants or contracts from the Swiss National Science Foundation and Swiss Cancer Research Foundation (Krebsforschung Schweiz). KJ and MPL declare no competing interests.

Monoterpene indole alkaloids (MIAs) are a diverse family of complex plant secondary metabolites with many medicinal properties, including the essential anti-cancer therapeutics vinblastine and vincristine 1 . As MIAs are difficult to chemically synthesize, the world's supply chain for vinblastine relies on low-yielding extraction and purification of the precursors vindoline and catharanthine from the plant Catharanthus roseus, which is then followed by simple in vitro chemical coupling and reduction to form vinblastine at an industrial scale 2,3 . Here, we demonstrate the de novo microbial biosynthesis of vindoline and catharanthine using a highly engineered yeast, and in vitro chemical coupling to vinblastine. The study showcases a very long biosynthetic pathway refactored into a microbial cell factory, including 30 enzymatic steps beyond the yeast native metabolites geranyl pyrophosphate and tryptophan to catharanthine and vindoline. In total, 56 genetic edits were performed, including expression of 34 heterologous genes from plants, as well as deletions, knock-downs and overexpression of ten yeast genes to improve precursor supplies towards de novo production of catharanthine and vindoline, from which semisynthesis to vinblastine occurs. As the vinblastine pathway is one of the longest MIA biosynthetic pathways, this study positions yeast as a scalable platform to produce more than 3,000 natural MIAs and a virtually infinite number of new-to-nature analogues., (© 2022. The Author(s).)

Introduction: Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary authorization for use (ATU) and temporary recommendation for use (RTU)., Method: We describe here the decision-making processes that led to the non-publication of the decree on the funding of three RTU in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib, and we analyse the fate of these drugs in order to quantify the potential loss of chance., Results: On 03AUG2018, the French National Agency for Medicines and Health Product Safety (ANSM) published 3 RTU in order to give rapid access to major innovations in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib. These drugs have respectively demonstrated reductions in the risk of recurrence by 35 %, 43% and 55% for target populations of 2200, 1900 and 650 patients per year. Despite a favourable opinion on reimbursement from the French National Authority for Health (HAS), the decrees on reimbursement will never be published, prohibiting the use of these products before the marketing authorisation, and depriving many patients of a potential cure., Conclusion: Despite a favourable opinion from scientists and health agencies for the rapid availability of a drug, the French public health code does not systematically imply access to a therapeutic innovation. The reform of access to innovation implemented on 01JUL2021 may help tackle this issue., (Copyright © 2021 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Background: The WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. We aimed to investigate whether the cancer medicines in the EML are aligned with the priority medicines of frontline oncologists worldwide, and the extent to which these medicines are accessible in routine clinical practice., Methods: This international, cross-sectional survey was developed by investigators from a range of clinical practice settings across low-income to high-income countries, including members of the WHO Essential Medicines Cancer Working Group. A 28-question electronic survey was developed and disseminated to a global network of oncologists in 89 countries and regions by use of a hierarchical snowball method; each primary contact distributed the survey through their national and regional oncology associations or personal networks. The survey was open from Oct 15 to Dec 7, 2020. Fully qualified physicians who prescribe systemic anticancer therapy to adults were eligible to participate in the survey. The primary question asked respondents to select the ten cancer medicines that would provide the greatest public health benefit to their country; subsequent questions explored availability and cost of cancer medicines. Descriptive statistics were used to compare access to medicines between low-income and lower-middle-income countries, upper-middle-income countries, and high-income countries., Findings: 87 country-level contacts and two regional networks were invited to participate in the survey; 46 (52%) accepted the invitation and distributed the survey. 1697 respondents opened the survey link; 423 were excluded as they did not answer the primary study question and 326 were excluded because of ineligibility. 948 eligible oncologists from 82 countries completed the survey (165 [17%] in low-income and lower-middle-income countries, 165 [17%] in upper-middle-income countries, and 618 [65%] in high-income countries). The most commonly selected medicines were doxorubicin (by 499 [53%] of 948 respondents), cisplatin (by 470 [50%]), paclitaxel (by 423 [45%]), pembrolizumab (by 414 [44%]), trastuzumab (by 402 [42%]), carboplatin (by 390 [41%]), and 5-fluorouracil (by 386 [41%]). Of the 20 most frequently selected high-priority cancer medicines, 19 (95%) are currently on the WHO EML; 12 (60%) were cytotoxic agents and 13 (65%) were granted US Food and Drug Administration regulatory approval before 2000. The proportion of respondents indicating universal availability of each top 20 medication was 9-54% in low-income and lower-middle-income countries, 13-90% in upper-middle-income countries, and 68-94% in high-income countries. The risk of catastrophic expenditure (spending >40% of total consumption net of spending on food) was more common in low-income and lower-middle-income countries, with 13-68% of respondents indicating a substantial risk of catastrophic expenditures for each of the top 20 medications in lower-middle-income countries versus 2-41% of respondents in upper-middle-income countries and 0-9% in high-income countries., Interpretation: These data demonstrate major barriers in access to core cancer medicines worldwide. These findings challenge the feasibility of adding additional expensive cancer medicines to the EML. There is an urgent need for global and country-level policy action to ensure patients with cancer globally have access to high priority medicines., Funding: None., Competing Interests: Declaration of interests FR, LM, and AI are employees of WHO. MS, DL, LM, EGEDV, DT, FR, RS, BG, and CMB are members of the WHO Essential Medicines List Cancer Medicine Working Group. EGEDV reports institutional financial support for research from Amgen, Bayer, Crescendo Biologics, CytomX Therapeutics, G1 Therapeutics, Genentech, Regeneron, Roche, Servier, and Synthon, and institutional financial support for participation on data safety monitoring boards and advisory boards of Daiichi Sankyo, NSABP, and Crescendo Biologics. FR reports honoraria for lectures from Dr Reddy's and payments for participation on advisory boards from Boehringer-Ingelheim and MSD. BG reports consulting fees from Vivio Health. All other authors declare no competing interests., (© 2021 World Health Organization; licensee Elsevier. This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)

Competing Interests: We declare no competing interests.

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. Bacterial L-asparaginase has played an important role in ALL treatment for several decades; however, hypersensitivity reactions to Escherichia coli-derived asparaginases often preclude their use. Inability to receive asparaginase due to hypersensitivities is associated with poor patient outcomes. Erwinia chrysanthemi-derived asparaginase (ERW) is an effective, non-cross-reactive treatment option, but is limited in supply. Consequently, alternative asparaginase preparations are needed to ensure asparaginase availability for patients with hypersensitivities. Recombinant technology can potentially address this unmet need by programming cells to produce recombinant asparaginase. JZP-458, a recombinant Erwinia asparaginase derived from a novel Pseudomonas fluorescens expression platform with no immunologic cross-reactivity to E. coli-derived asparaginases, has the same primary amino acid sequence as ERW, with comparable activity based on in vitro measurements. The efficient manufacturing of JZP-458 would provide an additional asparaginase preparation for patients with hypersensitivities., (© 2021 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Introduction: The cancer incidence continues to rise worldwide. Medical innovation has a major impact on patient survival, but within drug development, it can take more than 10 years to obtain marketing authorisation (MA). The time required for access to therapeutic innovation remains critical, so France has developed a specific expanded access program named ATU, which allows the administration of drugs before the European Medicines Agency (EMA) approval. The purpose of this study is to put in perspective the average time to access antineoplastic drugs worldwide, taking into account ATU, US Food and Drug Administration (FDA) and EMA approvals., Methods: The ATU system allows the use of a medicine before its MA, under exceptional conditions. All antineoplastic drugs in oncology that have benefited from the ATU system are analysed in terms of tumour site, biomarkers and number of patients who have access to the drug., Results: Between 1st January 2007 and 31st December 2019, 36 of 64 drugs (56.2%) that received MA in oncology were assigned an ATU, to the benefit of 16,927 patients. Thanks to the ATU, 25 of 36 drugs (69.4%) were made available early, on average 203 d (95% CI, 76-330) before FDA approval and on average 428 d (95% CI, 272-583) before EMA approval. Only three of 36 drugs were approved by the EMA before the FDA, and the average time lapse between European MA and FDA approval for these 36 drugs was 216 d (95% CI, 140-293)., Conclusion: This article demonstrates that the ATU system allows patients to benefit from therapeutic innovations before MA in Europe and USA, with full coverage by the healthcare system., Competing Interests: Conflict of interest statement The authors declare that they have no conflict of interest., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

The pandemic period has generated major problems in the pharmacies of hospitals and local health care companies regarding the distribution of drugs to patients undergoing treatment with chronic drugs. This is because the patient, during the lockdown, was forced to leave the house and go several miles away to reach the place where the drug was dispensed. Moreover, very often, the place was placed in covid-19 hospitals, like the one in Perugia, and was also a risk for the patient himself. The logistical organization allows, in addition to the advantages of traceability, efficiency and savings, with the arrival of the drug at home, a very high patient compliance that also translates into greater security in a pandemic period. To the Usl Umbria 1 of Perugia (Italy) has been centralized the activity of warehouse for all the South area that includes three hospitals and four sanitary districts. Such warehouse, through computerized procedure, guarantees the direct distribution with sending of the medicines directly to the district of belonging of the patient. In this way the patient was not forced to make long and risky trips to continue their chronic therapies. Moreover, this logistic warehouse has also allowed to cope with the correct management of many medicinal specialties that have been used against the SARS-CoV-2 virus avoiding their temporary deficiency for patients already on therapy according to the normal therapeutic indications (anti-inflammatory, antiretroviral and immunomodulatory). This paper aims to demonstrate how logistical organization is of vital importance for a National Health System that has to face increasing costs, ensure the traceability of all processes and, last but not least, survive a worldwide pandemic period.

Objective : This study aims to provide an up-to-date analysis of the current state of patient access to new drugs in South Korea, focusing on the effect of new review pathways for reimbursement. Methods : We analyzed patients' access to new drugs, listing rate and lead time until listing from marketing authorization. New pathways were defined as 'price negotiation waiver,' 'risk-sharing agreements,' and 'pharmacoeconomic evaluation exemption.' Results : The listing rate for drugs increased after the introduction of the new pathways (93.7% vs. 77.9%, p < 0.001). Before the new pathways, the median lead time for listing was 21.0 months (95% CI: 16.9-25.0), while afterward it was shortened to 10.9 months (95% CI: 10.2-11.7) (p < 0.001). Conclusion : Although it has strengthened national health insurance coverage by positively impacting the rate and lead time, the lead time for the oncology and orphan drugs is substantially longer as compared to other drugs. Expanding the eligibility criteria to include non-life-threatening but rare or intractable diseases, and resolving the system's operational issues are still necessary.

Purpose: The Spanish Society of Medical Oncology (SEOM) has carried out a study to analyse the conditions of access to oncology drugs in clinical practice in Spain. For the first time, the access of predictive biomarkers has also been analyzed., Methods: A questionnaire was sent to 146 hospitals in Spain to collect information on the process of approval of 11 oncology drugs of an unquestionable clinical benefit and five predictive biomarkers of mandatory determination for specific treatments., Results: Results highlight the still existing differences in the access of oncology drugs, as well as the newly identified differences in the access to predictive biomarkers between Autonomous Communities (AACC) in Spain, as well as between different hospitals within the same Autonomous Community. Conclusions The SEOM considers it necessary to reduce the differences identified, increase homogeneity, and improve conditions of access to oncology drugs and biomarkers, and makes proposals to address these issues.

Background: The substantial increase in the use of expensive anticancer drugs has been accompanied by an increase in the amount of disposing residual liquid from drug preparations. Many Western countries, including the United States, have implemented drug vial optimization (DVO) to prevent the waste of anticancer drugs and have reported the reductions in the total drug costs. This study was designed to estimate the expected reduction in spending on anticancer drugs by Japanese cancer hospitals when DVO was implemented instead of individual preparations and to test the effectiveness of this approach., Methods: We investigated the doses of drugs used and quantity specifications for individually prepared vials for patients who received anticancer drug treatment in December 2017 at the Outpatient Treatment Center of the National Cancer Center Hospital East. Based on these findings, we calculated the total quantity of each drug used on a given day, and the minimum cost for preparation of the number of specified combinations corresponding to the total cost (DVO preparation). Based on the differences in these two costs, we estimated the economic impact of implementing DVO., Results: While the cost for anticancer drugs for the 1-month study period was US$3,305,595 (US$1 = \110) for individual preparations, the estimated cost for DVO preparations was US$3,092,955, equivalent to a reduction of US$212,640., Conclusions: Based on these study results, implementation of DVO-based preparation of injectable anticancer drugs in Japan in 2017 would have resulted in saving approximately US$460 million. This calculation revealed the need for the Japanese government to modify the methods employed to calculate drug costs in the insurance system and develop policies for the proper and optimal use of medical resources.

Purpose: Medication shortages in US hospitals are ongoing, widespread, and frequently involve antineoplastic and supportive medications used in cancer care. The ways shortages are managed and the ways provider-patient communication takes place are heterogeneous, but the related preferences of oncology patients are undefined. This study sought to qualitatively evaluate patient preferences., Methods: A cross-sectional, semi-structured interview study was conducted from January to June 2019. Participants were adult oncology inpatients who received primary cancer care at the University of Chicago, had undergone treatment within 2 years, and had 1 or more previous hospitalizations during that period. Participants (n = 54) were selected consecutively from alternating hematology and oncology services. The primary outcome was thematic saturation across the domains of awareness of medication shortages, principle preferences regarding decision makers, preferences regarding allocation of therapy drugs, and allocation-related communication., Results: Thematic saturation was reached after 39 participants completed the study procedures (mean age, 59.6 years [standard deviation, 14.5 years]; men made up 61.5% of the study population [mean age, 24 years]; response rate, 72.0%). In all, 18% of participants were aware of institutional medication shortages. Patients preferred having multiple decision makers for allocating medications in the event of a shortage. A majority of patients named oncologists (100%), ethicists (92%), non-oncology physicians (77%), and pharmacists (64%) as their preferred decision makers. Participants favored allocation of drugs based on their efficacy (normalized weighted average, 1.3), and they also favored prioritizing people who were already receiving treatment (1.8), younger patients (2.0), sicker patients (3.1), and those presenting first for treatment (5.3). Most participants preferred preferred disclosure of supportive care medication shortages (74%) and antineoplastic medication shortages (79%) for equivalent substitutions., Conclusion: In a tertiary-care center with medication shortages, few oncologic inpatients were aware of shortages. Participants preferred having multiple decision makers involved in principle-driven allocation of scarce medications. Disclosure was preferred when their usual medications needed to be substituted with equivalent alternatives. These preliminary data suggest that preferences do not align with current management practices for medication shortages.

Response, action, and adaptation of the way health services are delivered will impact our ability to provide optimized and continuity of care while acting within resource constraints imposed by COVID-19. Care for patients with cancer is particularly important given increased infection rates and worse outcomes from COVID-19 in this patient population, as well as potential adverse outcomes if treatment pathways need to be compromised. In this commentary, we provide a global oncology pharmacy perspective (including both developed and developing nations) on how COVID-19 has impacted access to and delivery of cancer therapies. This perspective was prepared by the International Society of Oncology Pharmacy Practitioners, with input from national and regional oncology pharmacy practice groups (42 practice leaders from 28 countries and regions) who contributed to a snapshot survey between 10 and 22 April 2020. Specifically, we highlight challenges related to safe handling of hazardous drugs and maintaining high-quality medication safety standards that have impacted various stakeholders.

Background: More alternatives have become available for the diagnosis and treatment of cancer in low- and middle-income countries. Because of increasing demands, governments are now facing a problem of limited affordability and availability of essential cancer medicines. Yet, precise information about the access to these medicines is limited, and the methodology is not very well developed. We assessed the availability and affordability of essential cancer medicines in Mexico, and compared their prices against those in other countries of the region., Methods: We surveyed 21 public hospitals and 19 private pharmacies in 8 states of Mexico. Data were collected on the availability and prices of 49 essential cancer medicines. Prices were compared against those in Chile, Peru, Brazil, Colombia and PAHO's Strategic Fund., Results: Of the various medicines, mean availability in public and private sector outlets was 61.2 and 67.5%, respectively. In the public sector, medicines covered by the public health insurance "People's Health Insurance" were more available. Only seven (public sector) and five (private sector) out of the 49 medicines were considered affordable. Public sector procurement prices were 41% lower than in other countries of the region., Conclusions: The availability of essential cancer medicines, in the public and private sector, falls below World Health Organization's 80% target. The affordability remains suboptimal as well. A national health insurance scheme could serve as a mechanism to improve access to cancer medicines in the public sector. Comprehensive pricing policies are warranted to improve the affordability of cancer medicines in the private sector.

Background: Currently, cancer is among the leading causes of morbidity and mortality in the world. Exposure to CDs may occur during drug preparation and mixing, during drug administration, during transport, and cleaning spills and waste disposal. Healthcare workers who prepare or administer antineoplastic drugs, or who work in areas where these drugs are used, can be exposed to these agents. This also affects the public around the exposed area if appropriate disposal system is not known. Several studies reported increased risks of leukemia and breast cancer among nurses handling CDs and not following safety guidelines. Because of the absence of studies in Ethiopia, the current study was conducted to determine the knowledge level of cytotoxic drug handling and associated factors among health professionals in the University of Gondar Comprehensive Specialized Hospital., Methods: The institutional-based cross-sectional study was conducted from June to August 2019. Epi info 7.1 was used for data entry and then exported into SPSS version 20 for computing, recording, and statistical analysis. Logistic regression was used to explain the relationship with independent variables., Results: Four hundred and twelve health professionals participated in the study with 53.4% males. The participants' mean age was 29.9 (± 5.43) years ranging from 20-60. Two hundred and twenty-three (54.1%) health professionals heard about cytotoxic drugs, and 52.7% (95% UI 47.8-57.8%) had good knowledge of cytotoxic drug handling. Being male sex (AOR = 1.84, 95% CI (1.13-3.00)), age of 29-31 (AOR = 1.99, 95% CI (1.03-3.84)), hearing information about cytotoxic drug handling (AOR = 2.53, 95% CI (1.43-4.47)), ever attended training on cytotoxic drug handling (AOR = 3.15, 95% CI (1.13-8.79)), ever taking courses related to cytotoxic drugs (AOR = 2.03, 95% CI (1.15-3.59)), and good practice (AOR = 3.24, 95% CI (1.95-5.37)) were significantly associated with knowledge towards cytotoxic drug handling. It is therefore imperative to train health professionals and to incorporate CDs handling related course contents while revising curricula to raise the knowledge of health professionals about proper cytotoxic drug handling., Conclusion: Above half of the study participants scored higher than the median of the cytotoxic drug handling knowledge questions. Sex, age, information about cytotoxic drug handling, training, taking courses related to cytotoxic drugs, and good practice were significantly associated with knowledge towards cytotoxic drugs handling.

The availability of Erwinia Asparaginase has been limited across the world due to manufacturing shortages or for some countries due to the high acquisition cost, putting patients at risk for inferior outcomes. This manuscript provides guidance on how to manage hypersensitivity reactions and utilize therapeutic drug monitoring (TDM) to conserve and limit Erwinia use. The clinical and financial impact of a multidisciplinary committee are also discussed. Faced with a global Erwinia shortage, a multidisciplinary asparaginase allergy committee was created to review all hypersensitivity reactions to asparaginase therapy, staff education was performed on the management of asparaginase hypersensitivity reactions, an institution-wide premedication policy was mandated, and standardized guidelines were created for TDM. This multidisciplinary approach reduced the PEG-asparaginase to Erwinia switch rate from 21% (35 of 163) to 7% (10 of 134) ( p  = .0035). A multifaceted approach can safely maintain patients on PEG-asparaginase and conserve Erwinia for patients who need it most.

Objectives : Timely access to novel anticancer drugs is challenging and value frameworks such as the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) could assist in drug prioritization. We assessed the overall time to access to novel anticancer drugs in Slovenia and its correlation with ESMO-MCBS scores. Methods : Anticancer drugs with European Medicines Agency marketing authorization (EMA MA), applying for national reimbursement approval (NRA) in the period 2008-2018 with assigned ESMO-MCBS score, were included. Publically available data from EMA and the Slovenian National Health Insurance Institute were used for time calculations. Results : Among 53 studied drugs; a majority (47) of them obtained reimbursement approval within the observed time. The median time to EMA MA was 397 (range 98-615) days with the NRA requiring additional 422 (range 154-892) days. Neither time to EMA MA nor NRA correlated with ESMO-MCBS substantial clinical benefit ( p = 0.332 and p = 0.965, respectively). Conclusions : In Slovenia, time to access to novel anticancer drugs exceeds two years and, more importantly, is equally long for drugs with or without substantial clinical benefit. Integration of the ESMO-MCBS into reimbursement deliberations could improve access to drugs with substantial clinical benefit.

Objectives: With the increasing incidence of cancer, poor access to affordable anticancer medicines has been a serious public health problem in China. To help address this issue, we assessed the availability, price and affordability of pharmacotherapy for cancer in public hospitals in the Jiangsu Province, China., Methods: In 2012 and 2016, anticancer medicine availability and price information in the capital and five other cities was collected. A total of six cancer care hospitals, 26 tertiary general hospitals and 28 secondary general hospitals were sampled, using an adaptation of the World Health Organization/Health Action International methodology. Data was collected for the anticancer medicines in stock at the time of the surveys. Prices were expressed as inflation-adjusted median unit prices (MUPs). Medicine was affordable if the overall cost of all the prescribed anticancer medicines was less than 20% of the household's capacity to pay. We used generalized estimating equations to estimate the significance of differences in availability from 2012 to 2016 and the Wilcoxon rank test to estimate the significance of differences in MUPs. Multivariate logistic regression was computed to measure predictors of affordability., Results: From 2012 to 2016 there was a significant decrease in the mean availability of originator brands (OBs) (from 7.79% to 5.71%, p = 0.012) and lowest-priced generics (LPGs) (36.29% to 32.67%, p = 0.009). The mean availability of anticancer medicines in secondary general hospitals was significantly lower than the cancer care, as well as in tertiary general hospitals. The MUPs of OBs (difference: -21.29%, p < 0.01) and their LPGs (-22.63%, p < 0.01) decreased significantly from 2012 to 2016. The OBs (16.67%) of all the anticancer medicines were found to be less affordable than LPGs (34.62% for urban residents and 30.77% for rural residents); their affordability varied among the different income regions. From 2012 to 2016, the proportion of LPGs with low availability and low affordability dropped from 30.77% to 19.23% in urban areas and 34.62% to 26.92% in rural areas, respectively. Generic substitution and medicine covered by basic medical insurance are factors facilitating affordability., Conclusion: There were concerning decreases in the availability of anticancer medicines in 2016 from already low availability in 2012. Anticancer medicines were more affordable for the patients in high-income regions than the patients in low-income regions. Governments should consider using their bargaining power to reduce procurement prices and abolish taxes on anticancer medicines. Policy should focus on the special health insurance plan for low-income patients with cancer. The goal of drug policy should ensure that first-line generic drugs are available for cancer patients and preferentially prescribed.

International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.

In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children's EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.

Prescription drug shortages began to increase markedly in the mid-2000s, including sterile injectable products such as chemotherapy drugs. Using Medicare claims linked to Surveillance Epidemiology and End Results (SEER), we examined outpatient chemotherapy use during shortage periods relative to the months before and after a shortage for newly diagnosed patients with breast, colorectal, leukemia, lung, lymphoma, ovarian, or pancreatic cancer (N = 182,470). For most drugs, we found little impact of shortages on either the fraction of patients receiving that drug or the quantity provided. In some cases, we found declines in utilization: 4% for doxorubicin and fluorouracil; 2.9% for oxaliplatin; and about 1% for cytarabine, dacarbazine, and leuprolide. Although shortages for a few drugs resulted in substantial reductions in use, in most cases, they resulted in little to no reduction. We discuss potential explanations for these counterintuitive findings, including potential limitations of current drug shortage reporting methods., (© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.)

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. This impressive statistic is largely the result of integrating research with clinical care. At the core of this endeavor are multiagent combination chemotherapy and supportive care agents (CASCA). Most CASCAs belong to the class of sterile injectable drugs, which make up the backbone of many proven and life-saving pediatric oncology regimens. There are few if any alternative agents available to treat most life-threatening childhood cancers. In the United States, shortages of CASCAs are now commonplace. The consequences of drug shortages are far reaching. Beyond the economic costs, these shortages directly affect patients' lives, and this is especially true for children with cancer. Drug shortages in general and shortages of CASCAs specifically result in increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths. One way to mitigate drug shortages is to adopt an essential medicines list and ensure that these medications remain in adequate supply at all times. We argue for creation of a CASCA-specific essential medicines list for childhood cancer and provide ethical and policy-based reasoning for this approach. We recognize that such a call has implications beyond pediatric cancer, in that children with other serious disease should have an equal claim to access to guaranteed evidence-based medicines. We provide these arguments as an example of what should be claimed for medical indications that are deemed essential to preserve life and function.

Background: One of the main contributors in low survival rate in LMIC is the lack of availability of cancer medications for curative, supportive and palliative care. In many developing countries access to cytotoxic medicine is a major challenge. The information about the availability of essential medicines for pediatric cancer in the country is not known. The main objective of this study was to determine whether the medications used during the treatment of pediatric cancer are available in Armenia. Methods: In summer 2016 we conducted a survey in the 3 main pharmacies in Yerevan, which import pediatric cancer medications to Armenia to evaluate whether medications used during cancer treatment are officially registered and available in the country. In addition, the information on official registration was cross-checked with the Ministry of Health of the Republic of Armenia (MOH). Simultaneously, detailed information about the drugs, on type of produced drug company, doses and price intervals was confined from the price lists of the national drug importer companies. Results: The survey included 64 agents in three classes of medication: anti-neoplastics, anti-microbials, and drugs used in supportive care. All of these medications were included in the recent version of the WHO model list of essential medicines. From 30 anti-neoplastic medications on the essential medicines list 22 (73%) were officially registered in Armenia; from 19 anti-microbial drugs all were registered except caspofungin and from 15 supportive care agents 13 (87%) were registered. From registered anti-neoplastic drugs 18% and from antimicrobial drugs 33% were not available in the drug stores. Conclusion: This study showed that not all the drugs from the SIOP PODC Essential Medication list for pediatric oncology are officially registered and available in Armenia, and effective drug regulation focusing on the childhood cancer care medicine is needed for improving the situation in the country., (Creative Commons Attribution License)

Purpose: Chemoradiotherapy is among the effective treatment modalities for head and neck cancer (HNC). We aimed to elucidate the factors affecting drug selection by describing the actual situation of chemoradiotherapy for HNC in Japan and the transition in treatment selection before and after the approval of cetuximab., Method: We used a claims database involving multiple hospitals nationwide. The study included patients diagnosed with HNC between April 2008 and August 2015 who underwent chemoradiotherapy. The anticancer drugs used were categorized into four groups, namely, cetuximab, cisplatin, other platinum agents, and other agents. After assessing patient background and transition in concomitant drugs, we performed multinomial logistic regression analysis to determine factors that affect patient drug selection., Results: This study analyzed 2777 patients whose median age was 66 years. A cisplatin-based regimen remained the most commonly used concomitant drug even after cetuximab approval. In multinomial logistic regression analysis, the odds ratio and 95% confidence interval (CI) in terms of age (66 y or older vs less than 65 y) relative to the cisplatin group were 3.01 (95% CI, 2.26-4.02) for the cetuximab group; 1.76 (95% CI, 1.22-2.48) for the other platinum agent group; and 3.09 (95% CI, 2.39-3.99) for the other agent group., Conclusion: This study showed the current practices in concomitant medication used in chemoradiotherapy for HNC patients in Japan, the transition in anticancer drugs used before and after cetuximab approval, and the factors affecting the selection of concomitant drugs., (© 2018 John Wiley & Sons, Ltd.)

Within the last two decades the therapeutic options for newly diagnosed multiple myeloma have changed dramatically. The implementation of high-dose chemotherapy with melphalan and subsequent autologous blood stem cell transplantation initially led to prolonged survival in younger, fit patients. Furthermore, recent data suggest that patients with high-risk disease seem to benefit most from tandem transplantation approaches. Therefore, risk stratification at initiation of first-line treatment is of great importance. With the advent and integration of the so-called novel agents, such as thalidomide, lenalidomide and bortezomib into first-line treatment, both transplant eligible and ineligble patients gained new therapeutic perspectives. In Germany, the combination of bortezomib with cyclophosphamide and dexamethasone is currently considered the standard of care as induction regimen before high-dose treatment and transplantation; however, the combination of lenalidomide, bortezomib and dexamethasone is increasingly being used, but is still not yet approved in Germany. For patients where high-dose therapy and stem cell transplantation are not feasible, bortezomib and lenalidomide are available as backbone agents of various combination regimens. Recently, the anti-CD38 antibody daratumumab has been approved in combination with bortezomib, melphalan and prednisone as primary treatment for newly diagnosed patients. An allogeneic stem cell transplantation can be considered for younger patients without relevant comorbidities and with high-risk disease or early relapse after autologous blood stem cell transplantation but should only be performed within controlled clinical trials and in specialized centers.

Objective: The Asia Pacific Advanced Prostate Cancer Consensus Conference (APAC APCCC 2018) brought together 20 experts from 15 APAC countries to discuss the real-world application of consensus statements from the second APCCC held in St Gallen in 2017 (APCCC 2017)., Findings: Differences in genetics, environment, lifestyle, diet and culture are all likely to influence the management of advanced prostate cancer in the APAC region when compared with the rest of the world. When considering the strong APCCC 2017 recommendation for the use of upfront docetaxel in metastatic castration-naïve prostate cancer, the panel noted possible increased toxicity in Asian men receiving docetaxel, which would affect this recommendation in the APAC region. Although androgen receptor-targeting agents appear to be well tolerated in Asian men with metastatic castration-resistant prostate cancer, access to these drugs is very limited for financial reasons across the region. The meeting highlighted that cost and access to contemporary treatments and technologies are key factors influencing therapeutic decision-making in the APAC region. Whilst lower cost/older treatments and technologies may be an option, issues of culture and patient or physician preference mean, these may not always be acceptable. Although generic products can reduce cost in some countries, costs may still be prohibitive for lower-income patients or communities. The panellists noted the opportunity for a coordinated approach across the APAC region to address issues of access and cost. Developments in technologies and treatments are presenting new opportunities for the diagnosis and treatment of advanced prostate cancer. Differences in genetics and epidemiology affect the side-effect profiles of some drugs and influence prescribing., Conclusions: As the field continues to evolve, collaboration across the APAC region will be important to facilitate relevant research and collection and appraisal of data relevant to APAC populations. In the meantime, the APAC APCCC 2018 meeting highlighted the critical importance of a multidisciplinary team-based approach to treatment planning and care, delivery of best-practice care by clinicians with appropriate expertise, and the importance of patient information and support for informed patient choice., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Background: A better understanding of the modulation of the immune system has resulted in the development of new classes of antitumor agents such as nivolumab and pembrolizumab. Despite the proven effectiveness and tolerability of these new drugs for specific types of cancer, the high cost of treatment has affected their accessibility., Objective: The aim of this study is to conduct a meta-narrative review of studies that have addressed the concerns that have been voiced regarding the cost of and access to nivolumab and pembrolizumab in oncology health care. This meta-narrative review attempts to answer the following questions: (1) which papers have considered this broad topic area?; (2) what are the main empirical/theoretical findings?; and (3) what insights can be drawn by combining and comparing findings from different papers?, Methods and Data Source: A meta-narrative review has been conducted in 5 research databases (Web of Science, Science Direct, Scopus, Embase and Pubmed) without time limitations up to January of 2017 to address concerns related to the cost of and access to nivolumab and pembrolizumab in oncology health care. From each research base, articles were selected that had a key word related to the theme of pharmacoeconomics and nivolumab or pembrolizumab in any field of scientific work. The research questions were analyzed through the application of a meta-narrative review approach and the use of a convergence-coding matrix to summarize similarities and differences directly related to the research topic between the different papers., Key Findings: The first contribution of this meta-narrative review is that it summarizes economic-based works on the use of nivolumab and pembrolizumab, particularly for three therapeutic indications: melanoma, NSCLC and RCC. In general, despite the clinical benefit of nivolumab and pembrolizumab being well accepted and proven by scientific works, the published studies show that there are contradictory results with regard to the cost-effectiveness of these anti-PD-1s. The regulatory, economic and epidemiological variations mean that healthcare costs for cancer patients vary greatly from country to country and according to the type of tumor. The second contribution has to do with the recommendations for the development of high quality process for pharmacoeconomic analyses, especially in the new field of immuno-oncology. Finally, the third contribution is with regard to recommendations for the sustainable use of immunotherapies., Conclusions: Given the revolution in cancer therapy in recent years, the efficient allocation of existing resources is essential for healthcare systems to meet the evolving needs of populations and remain sustainable in the long term. The application of high quality information that stems from scientific evidence and economic modeling can help considerably to make the healthcare system sustainable over time mainly due to a higher number of therapeutic indications or more countries giving regulatory approval for the use of new and expensive cancer drugs., (Copyright © 2018 Elsevier B.V. All rights reserved.)