Cancer remains the leading cause of death globally and a leading barrier to improving life expectancy. According to the data released by the International Agency for Research on Cancer (IARC) in 2021, there were 19.3 million new cancer cases and 10 million deaths worldwide in 2020, with approximately 4.57 million new cases in China alone. IARC further predicts that global cancer incidence will rise to 28.4 million new cases by 2040, with the most significant increase in cases expected in the low-and middle-income countries (1).

Tumor diseases have garnered global attention not only because of their high mortality rates but also due to their significant financial burden on patients. The availability and affordability of anticancer medicines are critical to successfully implementing prevention, screening and treatment programs, particularly in developing countries. However, factors such as the high price of anticancer medicines, imperfect supply systems and suboptimal treatment quality limit patients’ access to these life-saving therapies (2). According to the WHO Global Action Plan, the availability of anticancer medicines is set to reach 50% by 2025 (3). However, data from international sources reveal significant gaps in achieving this goal. A Mexican study showed that the mean availability of anticancer medicines in public hospitals and private pharmacies was 61.2 and 67.5%, respectively (4). Public hospitals achieve only 43% availability of essential anticancer drugs in Pakistan (5). The situation appears particularly concerning in China. Hubei Province reports availability rates of just 13.7 and 6.67% for originator brands (OBs) in tertiary and secondary hospitals, respectively, with lower-priced generics (LPGs) performing better at 62.83 and 42.92% (6). Our previous Study in Jiangsu Province (2012–2016) documented a worrying decline in availability for both OBs (7.79–5.71%) and LPGs (36.29–32.67%) among 40 essential anticancer medicines (7). Financial barriers compound these accessibility challenges. High out-of-pocket healthcare expenditures remain a systemic challenge, with unaffordable medication prices, particularly for innovative anticancer medicines (IAMs), representing the primary reason for treatment discontinuation. In 2016, China implemented its “National Drug Price Negotiation Policy” targeting patented and exclusively produced high-cost innovative therapeutics (including anticancer targeted agents and orphan drugs). Led by the National Healthcare Security Administration (NHSA), multidisciplinary negotiation teams comprising clinical specialists, pharmaceutical scientists, and health economists engaged in direct price negotiations with pharmaceutical manufacturers. These negotiations employed volume-based procurement strategies, leveraging therapeutic clinical value, international reference pricing, and patient population needs to secure price concessions. Successful negotiations resulted in inclusion in the National Reimbursement Drug List (NRDL), with select agents additionally qualifying for the National Essential Medicines List (NEML). Despite achieving an average 61.71% price reduction across 67 negotiated agents in 2021, numerous anticancer therapies remained unavailability in hospitals due to performance metrics, particularly drug expenditure-to-sales ratio restrictions and inventory management protocols. These policies restricted the procurement of National Negotiated Drugs. Therefore, China formally instituted the “National Negotiated Drug Dual-Channel Management Policy” in May 2021. This policy established a parallel distribution system including hospital and community pharmacy to ensure availability of anticancer medicines that remain excluded from hospital formularies. NHSA selected “designated retail community pharmacies” meeting stringent criteria—including cold-chain storage capacity and on-site pharmacist verification—as official supply points for negotiated drugs. Through this “dual-channel” framework, patients purchased negotiated drugs through these dual-channel community pharmacies receive identical medical insurance reimbursement policies as those obtaining the same medications via hospitals. Additionally, the NHSA regularly update the dual-channel drug directory and oversee the drug supply and service quality of these dual-channel community pharmacies.

There were several limitations in the existing literature on related researches. Only a limited number of anticancer medicines were evaluated independently of the values of accessibility and affordability. The accessibility of anticancer medicines in Eastern China, where the incidence of cancer diseases is highest among different regions, has remained unclear since 2016. The comparison between the accessibility and affordability of essential anticancer medicines (EAMs) and IAMs warrants further studies. The evaluation of the accessibility of anticancer medicines in community pharmacies has not yet been investigated in China. Most crucially, existing studies had not yet evaluated the impact of National Drug Price Negotiation policy and the Dual-channel policy on the availability, price, and affordability of anticancer medicines. We conducted a comprehensive survey using standardized WHO methodology to address these gaps.

In this study, we adopted the cross-sectional survey method, and the survey time was from July 2021 to November 2021. Based on the WHO/HAI methodological recommendations, we assessed the accessibility, pricing, and affordability of 24 EAMs and 17 IAMs across 45 hospitals and 45 community pharmacies in 9 prefecture-level cities throughout Jiangsu Province. The relevant information covers drug prices, specifications, manufacturers, dosage forms, availability, etc.

Using the WHO/HAI standardized survey methodology, this study evaluated the availability of anticancer medications across 45 healthcare facilities and 45 community pharmacies in nine municipal cities within Jiangsu Province, China. The main findings are summarized as follows.

First, the availability of anticancer drugs did not meet the targets set by the World Health Organization, with healthcare institutions serving as the primary channel for oncological treatment delivery. These results align with domestic studies examining the accessibility of essential anticancer medications in China (7). A cross-sectional study in Hubei Province reported a generic essential anticancer drug availability rate of 40.88%, compared to only 7.57% for originator products (6). The current study observed relatively higher availability rates for originator drugs, which can be attributed to the exclusion of 12 essential medications (e.g., methotrexate, tamoxifen, and hydroxyurea) whose originator formulations lacked regulatory approval in China—either never having been introduced or having been withdrawn from the market. Additionally, cross-sectional research involving 82 countries found that the median availability of the 20 most essential anticancer drugs in low- and middle-income countries (LMICs) ranged between 9 and 54% (15).

Although retail pharmacies serve as an important supplementary source of anticancer medications outside hospitals, healthcare institutions remain the primary cancer treatment providers, likely due to the specialized nature of oncology care. The study also identified significant regional disparities in drug availability across areas with differing levels of economic development. These variations may reflect inequalities in regional diagnostic and therapeutic capabilities (16), underscoring the need for policy interventions to address economic imbalances. Notably, no statistically significant regional differences were observed in the availability of novel anticancer agents in retail pharmacies, potentially due to the convenience and portability of oral dosage forms.

Second, the dosage form appears to be a critical factor influencing the availability of anticancer drugs in retail pharmacies. This study found significantly lower availability of essential medicines in retail pharmacies than in medical institutions. In contrast, novel anticancer drugs showed comparable availability between the two channels—a discrepancy that may be linked to differences in dosage forms. Among the 24 essential medicines assessed, 18 (75%) were injectable formulations, while only 4 out of 17 (23.5%) novel anticancer drugs were injectables. It is well established that intravenous infusions carry higher risks, with both long-established essential drugs and newly approved novel agents associated with infusion-related adverse reactions. According to 2020 national adverse drug reaction monitoring data, injections accounted for 56.7% of all reported adverse reactions (17). Furthermore, the July 2021 announcement by the Jiangsu Medical Insurance Bureau listed 100 dual-channel drugs, 37 of which were injectables (18), highlighting their importance in dual-channel recommended products. Due to the high-risk profile and complex clinical requirements of injectables, their availability through retail pharmacy supply chains remains limited. Therefore, improving the management system for “dual-channel” injectable drugs is crucial for enhancing the availability of injectable anticancer formulations. Pilot programs introducing day-care infusion centers have partially addressed this issue (19). For DTP (Direct-to-Patient) pharmacies, collaboration with medical institutions to establish day-care ward infusion centers represents a key strategy for overcoming infusion-related challenges in retail pharmacy supply models (20), thereby improving the availability of injectable formulations in community pharmacies.

Third, despite national reimbursement negotiations, the pricing and affordability of novel anticancer drugs continue to pose significant challenges. Between 2016 and 2020, 63 anticancer drugs were included in the national negotiated drug catalog, including 57 Western medicines with an average price reduction exceeding 44% (21). Among the 17 novel anticancer drugs assessed in this study, only lapatinib failed to renew its agreement in 2019; the remaining drugs were either included in the national negotiation catalog or directly incorporated into the standard reimbursement list. However, most novel anticancer drugs remain financially inaccessible to rural populations, necessitating further price adjustments aligned with China’s socioeconomic conditions to improve affordability.

Fourth, the suboptimal availability of negotiated drugs in medical institutions may be partially attributed to policy misalignment. Policy formulation should adequately consider stakeholder motivations and interests. This study’s relatively low availability of novel anticancer drugs appears closely associated with hospital performance evaluation metrics, including the assessment pressure on essential drug utilization rates. The introduction of novel anticancer drugs significantly impacts the quantity of essential medicines and financial proportion, particularly since most novel agents are high-cost drugs that substantially affect essential drug expenditure ratios. These pressures include public hospital performance evaluations, volume-based procurement targets, and drug expenditure control measures (22). Reimbursement policies also influence negotiated drug implementation. For example, using negotiated drugs may exceed Diagnosis-Related Group (DRG) payment limits, with hospitals bearing the financial overage. After incorporating novel anticancer drugs into reimbursement, further adjustments to insurance benefits should be made to reduce disparities between urban–rural resident insurance and urban employee insurance, improve cross-regional reimbursement policies, and provide appropriate support for cancer patients with high treatment costs but limited financial capacity. These measures are crucial for optimizing the inclusion of novel anticancer drugs in insurance coverage and implementing negotiated policies effectively (23). Additionally, reimbursement indication restrictions may play a role. As queried from the Jiangsu Medical Insurance Bureau website, the approved indications for negotiated drugs are strictly defined by insurance policies, creating higher utilization thresholds that further affect policy implementation. Policy coordination is equally critical for the efficient operation of DTP pharmacies (24). Performance evaluation targets across different departments require further alignment, particularly between healthcare insurance and health authorities. Establishing dedicated pathways for negotiated drug implementation and pre-publishing relevant evaluation standards could promote appropriate adoption and use in medical institutions. To address barriers related to evaluation metrics, incentive indicators such as negotiated drug adoption rates could be introduced. Additional measures could include excluding high-cost negotiated drugs from total insurance budgets, removing them from per-visit cost evaluations, and eliminating patient reimbursement caps to enhance policy coordination for negotiated drug implementation.

Fifth, the medication access model under the “Dual-Channel” policy remains inadequate. Jiangsu’s first Dual-Channel pharmacy catalog included only 225 designated pharmacies (25), compared to over 700 secondary and tertiary medical institutions (26). This limited pharmacy coverage affects patient access to negotiated drugs. Additional implementation barriers include external prescription processes, service and management capabilities, sales qualifications, and insurance coordination in retail pharmacies. As all negotiated anticancer drugs are prescription medications, the complex external prescription process creates significant inconvenience for patients and potential fraud risks, posing substantial regulatory challenges. Therefore, the government needs to optimize prescription access for patients purchasing medications at retail pharmacies, such as establishing dedicated third-party online consultation services for negotiated drugs where clinicians can conduct remote assessments and issue prescriptions directly to designated pharmacies. Alternatively, healthcare insurance and health authorities could designate qualified medical institutions to provide prescription services for patients requiring negotiated drugs, thereby improving coordination between inpatient and outpatient medication channels and streamlining purchasing processes. The study’s data collection period (July–November 2021) coincided with Jiangsu’s announcement of the Dual-Channel pharmacy catalog in August 2021, which may have contributed to the relatively low availability metrics observed.

The availability of anticancer drugs in Jiangsu remains suboptimal, with significant regional disparities observed across different economic zones, except for novel anticancer drugs in retail pharmacies. As an important supplement to medical institutions for medication supply, retail pharmacies generally demonstrate limited availability of anticancer drugs, particularly essential anticancer agents, likely due to their predominantly injectable formulations. For patients purchasing medications at DTP pharmacies, efficiently coordinating with medical institutions for intravenous administration presents a significant challenge. While national drug negotiations have substantially reduced prices for novel anticancer drugs, they remain financially burdensome for rural residents, necessitating further government-led price optimization to improve affordability. The dual-channel policy has partially alleviated pressure on negotiated drug adoption in medical institutions and increased market share. However, it requires further optimization in cross-departmental coordination and patient convenience.

This cross-sectional study conducted on-site investigations to evaluate anticancer drug availability across 45 medical institutions and 45 retail pharmacies in nine cities in Jiangsu Province. Compared to similar studies, this research innovatively included retail pharmacies as evaluation targets while assessing essential and novel anticancer drugs. The data collection period coincided with the initial implementation of Jiangsu’s Dual-Channel policy, potentially underestimating retail pharmacy availability. For most novel anticancer drugs lacking international reference prices, this study used median prices from 18 European countries; therefore, the calculated MPR values may not fully align with WHO/HAI standards. The affordability assessment only analyzed medication costs without including other treatment expenses, potentially overestimating patient capacity. For calculation purposes, the study assumed fixed reimbursement ratios (30% for rural and 15% for urban residents), which may not reflect actual reimbursement scenarios.