Access to essential medicines used in the management of noncommunicable diseases in Southern Ethiopia: Analysis using WHO/HAI methodology.

Objectives: This study aims to assess access to essential medicines used in the management of noncommunicable diseases through analysis of the availability, prices, and affordability of these essential medicines in Arba Minch town, Gamo Zone, Southern Ethiopia. Methods: A cross-sectional design was carried out using the World Health Organization/health action international methodology between 2 March and 2 May 2023, within public and private healthcare facilities located in Arba Minch town, Southern Ethiopia. The median price ratio served as a metric. Statistical tests like the Shapiro-Wilk and Kolmogorov-Smirnov were utilized to assess the normal distribution of price data. The Wilcoxon-Mann-Whitney U test was also employed to compare median buyer's prices (patient prices) between public and private healthcare institutions. Treatment affordability was determined by estimating the number of days' wages required by the lowest-paid government employee in Ethiopia to afford the prescribed medication regimen. Results: Among 23 health facilities surveyed, the pooled availability of essential medicine used in the management of noncommunicable diseases was 18.7% (range: 0%-30.1%), with the public and private facilities contributing 16.3% and 38.3%, respectively. The overall percentage of availability originator brand versions was 1.1% for overall health sectors, 0.6% for public sectors, and 1.2% for private sectors. The overall percent availability of lowest price generics was 36.2% (range: 0%-26.2%; public: 32.0%; private: 37.1%). Only seven lowest price generics satisfied the World Health Organization target of 80% and above. The overall median price of lowest price generic medicines in private was two times higher than in public sectors. The top five median price scorers were amlodipine, furosemide, insulin, beclomethasone, and salbutamol. The Mann-Whitney U test showed that 11.6% of lowest price generics medicines had a statistically significant median price disparity between the public and private sectors (p < 0.05). The overall percent of unaffordability was found to be 100.0%, (public: 70.4; private: 100.0%). Conclusions: This study revealed the limited availability and potential financial burdens on patients seeking essential noncommunicable disease medications. Limited availability suggests the need for better supply chain management and consistent stock availability. The price disparities and affordability challenges identified underscore the necessity for policy interventions such as price regulation and subsidized programs to ensure equitable access to essential noncommunicable disease medications in Arba Minch town, Southern Ethiopia.

"No room for error": A qualitative interview study of experiences with health insurance coverage loss and COVID-19 pandemic relief policies among people with asthma.

Objectives. The COVID-19 pandemic led to unemployment and associated health insurance loss, prompting an unprecedented adoption of emergency policies, including economic relief efforts and health insurance coverage expansion. We sought to understand pandemic-related challenges for people with asthma and how emergency policies served families facing both chronic disease management and health insurance loss.Study Design. Qualitative interview study.Methods. In 2021, we conducted semi-structured telephone interviews with 21 adults who had asthma and lost employment and employer-sponsored health insurance coverage during the COVID-19 pandemic. We used thematic analysis to assess how health and economic policies affected participants' ability to access care and manage their asthma.Results. Participants reported reduced access to care and worry about heightened susceptibility to COVID-19 due to their asthma. While insurance loss exacerbated these challenges, participants indicated that economic relief efforts, including direct stimulus payments, helped them afford needed asthma care. Participants were more critical of enhancements to existing coverage policies such as the Affordable Care Act (ACA) Marketplace and Consolidated Omnibus Budget Reconciliation Act (COBRA) due to difficulty understanding, accessing, and affording such coverage.Conclusions. Our findings underscore that people affected by asthma and health insurance loss benefit from policies that provide flexible and easy-to-use assistance, such as direct payments, for meeting the diverse challenges posed by living with a chronic disease. Although policies that expand health insurance coverage are critical, more attention is needed to assist people with medically vulnerable conditions access these programs in a timely way.

Connecting Female Entertainment Workers in Cambodia to Health Care Services Using mHealth: Economic Evaluation of Mobile Link.

BACKGROUND: Mobile Link is a mobile phone-based intervention to increase access to, and use of, health care services among female entertainment workers in Cambodia who face higher risks for specific diseases and gender-based violence. A multisite randomized controlled trial showed that Mobile Link connected female entertainment workers with outreach workers for information and escorted referrals after 6 months but did not lead to statistically significant improvements in HIV and sexually transmitted infection testing, contraceptive use, and condom use. OBJECTIVE: This study aims to conduct a 3-part economic evaluation of Mobile Link to understand its costs, value, and affordability. METHODS: We conducted cost, cost-effectiveness, and budget impact analyses of Mobile Link using cost and outcomes data from the Mobile Link trial and other sources. For the cost analysis, we estimated the total, per-person, and incremental costs of Mobile Link compared with usual care. Using probabilistic decision-analytic models, we estimated the 1-year cost-effectiveness of Mobile Link from payer and combined payer and patient perspectives by converting selected primary and secondary outcomes from the trial to disability-adjusted life years (DALYs) averted. Finally, we estimated the financial costs of scaling up Mobile Link's messaging and outreach services to 70% of female entertainment workers in 5 years. RESULTS: The incremental costs of Mobile Link were US $199 from a payer perspective and US $195 per person from a combined payer and patient perspective. With an average of 0.018 (95% predicted interval -0.088 to 0.126) DALYs averted, Mobile Link's cost-effectiveness was US $10,955 per DALY from a payer perspective (US $10,755 per DALY averted from a payer and patient perspective). The costs of Mobile Link would have to decrease by 85%, or its effectiveness would have to be 5.56 times higher, for the intervention to meet the upper limit of recommended cost-effectiveness thresholds in Cambodia (US $1671 per DALY averted). The 5-year cost of scaling Mobile Link to 34,790 female entertainment workers was estimated at US $1.64 million or US $46 per person per year. CONCLUSIONS: This study provided a comprehensive economic evaluation of Mobile Link. We found that Mobile Link is not likely to be cost-effective unless its costs decrease or its effectiveness increases. Scaling up Mobile Link to more female entertainment workers is estimated to cost less than the costs of the trial. Given the importance of linking female entertainment workers to essential services, future research should focus on enhancing the effectiveness of Mobile Link or developing new mobile health interventions for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03117842; https://clinicaltrials.gov/study/NCT03117842.

The Effects of the 2021 Child Tax Credit on Housing Affordability and the Living Arrangements of Families With Low Incomes.

Access to safe and stable housing is important for child and adult well-being. Yet many low-income households face severe challenges in maintaining stable housing. In this article, we examine the impact of the 2021 temporary expansion to the Child Tax Credit (CTC) on housing affordability and the living arrangements of families with low incomes. We employ a parameterized difference-in-differences method and leverage national data from a sample of parents who are receiving or recently received Supplemental Nutrition Assistance Program benefits (N = ∼20,500), many of whom became newly eligible for the CTC. We find that the monthly CTC reduced parents' past-due rent/mortgages (both amounts and incidence) and their reports of potential moves due to difficulties affording rent/mortgages. The CTC increased the likelihood that parents reported a change in their living arrangements and reduced their household size, both effects driven by fewer mothers living with a partner (and not a reduction in doubling up). We find some differences in effects by race and ethnicity and earnings. Our findings illustrate that the monthly credit improved low-income parents' ability to afford housing, gain residential independence from partners, and reduce the number of people residing in their household.

Availability and pricing of insulin and related diagnostics in South Africa.

Background: In South Africa (SA), most patients rely on the government for free healthcare. Some choose to subscribe to a medical insurance scheme. If insulin is unavailable in government or otherwise unaffordable, non-adherence may occur, which can increase complications of the disease. Methods: Data on availability and pricing of insulin and related diagnostics was collected from SA pharmacies via an online survey. Co-payments levied on insulin by the biggest medical aids were extracted from formularies. Affordability of these items was then assessed. An adapted methodology from the World Health Organization/Health Action International tool was used. Results: There was fairly high availability of insulin in the public sector, with the exception of long-acting insulin which respondents claimed was difficult to find; however, long-acting insulin glargine was available in most private sector pharmacies. Point-of-care (POC) blood glucose testing was free in the public sector but offered in only 31.25% of pharmacies. Patients pay a minimum of USD 40.4 (over 3 days' wages for the lowest paid government worker (LPGW)) for a months' supply of the cheapest insulin, needles and test strips. Insulin in SA was cheaper than 5 other countries, except Australia. Conclusion: Overall, there is a good availability of insulin and related diagnostics in SA. Even though insulin is cheaper than other countries, it is unaffordable to the LPGW. This highlights the importance of ensuring a constant availability of insulin in the free public sector. Whilst human insulins are cheaper than newer analogue insulins and SA faces cost constraints, important variables in favour of newer insulins, such as ease-of-use, long term outcomes and value should be considered when treatment guidelines are updated. Annual POC testing should be available and offered free to all patients to detect diabetes early.

Access to essential and innovative anti-cancer medicines: a longitudinal study in Nanjing, China.

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.

Gaps in Migrants' Access to Contraceptive Services: A Survey of Nepalese Women and Men in Japan.

While all modern contraceptive methods are available for free or at minimal cost in Nepal, contraceptive devices in Japan are mainly limited to condoms, requiring Nepalese migrant women to rely on their male partners for their use. Therefore, Nepalese migrants often seek contraceptive devices from Nepal or request friends or relatives to send them from their home country. This study aimed to identify the gaps and challenges associated with Nepalese migrants' needs for sexual and reproductive health services (SRHSs), particularly contraceptives, before and after their migration to Japan. A mixed-methods study was adopted, an explanatory sequential design (ESD) combining quantitative and qualitative approaches, and data were collected from 186 Nepalese migrants (80 females and 106 males) through an online survey and from two focus-group discussions (FGDs) conducted among 24 participants (14 females and 10 males). This study highlighted the obstacles faced by Nepalese migrants in accessing contraceptive services, such as limited options, language barriers, and high costs. The study also revealed the importance of pre-departure training in Nepal and organizing post-arrival training in Japan to increase Nepalese migrants' awareness of the SRHSs available in Japan, thereby helping to prevent SRH-related health problems, including unintended pregnancies and abortions, in Japan.

Measuring food access using least-cost diets: Results for global monitoring and targeting of interventions to improve food security, nutrition and health.

Benchmark diets using the most affordable locally available items to meet health and nutrition needs have long been used to guide food choice and nutrition assistance. This paper describes the result of recent innovations scaling up the use of such least-cost diets by UN agencies, the World Bank, and national governments for a different purpose, which is monitoring food environments and targeting systemic interventions to improve a population's access to sufficient food for an active and healthy life. Measuring food access using least-cost diets allows a clearer understanding of where poor diets are caused by unavailability or high prices for even the lowest-cost healthy foods, insufficient income or other resources to acquire those foods, or the use of other foods instead due to reasons such as time use and meal preparation costs, or cultural factors such as taste and aspirations. This paper reviews the data, methods and results that have led to official FAO and the World Bank adoption of cost and affordability metrics for global monitoring, and the parallel use of similar methods to guide interventions in country studies led by the World Food Programme with partner agencies across Africa, Asia and Latin America. We conclude by summarizing how increasing availability of food price data, matched to food composition and dietary requirements, allows analysts to use recently developed software tools for least-cost diet assessment to improve food access in a wide range of settings.

Enhancing affordability and profit in a non-cooperative, coordinated, hypothetical pediatric vaccine market via sequential optimization.

This study considers a hypothetical global pediatric vaccine market where multiple coordinating entities make optimal procurement decisions on behalf of countries with different purchasing power. Each entity aims to improve affordability for its countries while maintaining a profitable market for vaccine producers. This study analyzes the effect of several factors on affordability and profitability, including the number of non-cooperative coordinating entities making procuring decisions, the number of market segments in which countries are grouped for tiered pricing purposes, how producers recover fixed production costs, and the procuring order of the coordinating entities. The study relies on a framework where entities negotiate sequentially with vaccine producers using a three-stage optimization process that solves a MIP and two LP problems to determine the optimal procurement plans and prices per dose that maximize savings for the entities' countries and profit for the vaccine producers. The study's results challenge current vaccine market dynamics and contribute novel alternative strategies to orchestrate the interaction of buyers, producers, and coordinating entities for enhancing affordability in a non-cooperative market. Key results show that the order in which the coordinating entities negotiate with vaccine producers and how the latter recuperate their fixed cost investments can significantly affect profitability and affordability. Furthermore, low-income countries can meet their demands more affordably by procuring vaccines through tiered pricing via entities coordinating many market segments. In contrast, upper-middle and high-income countries increase their affordability by procuring through entities with fewer and more extensive market segments. A procurement order that prioritizes entities based on the descending income level of their countries offers higher opportunities to increase affordability and profit when producers offer volume discounts.

Male contraception: Focus on behavioral and barrier methods.

INTRODUCTION: Male contraception includes various methods designed to prevent pregnancy by focusing on the male's role in reproduction. RESULTS: Behavioral methods, such as withdrawal and periodic abstinence, offer non-invasive alternatives that require self-control and precise timing to avoid depositing sperm in the female reproductive tract during fertile periods. However, these methods generally have low effectiveness and rely heavily on user adherence and experience. The male condom, a barrier method, provides both contraception and protection against sexually transmitted infections. Its effectiveness relies on correct and consistent use. DISCUSSION: Access to comprehensive sexual education and medical counseling is essential to dispel the stigma surrounding contraceptive use and correct misconceptions, ensuring proper usage and ultimately contributing to better reproductive health outcomes.

A Randomized, Double-Blind, Phase III Study in India for Comparing Efficacy, Safety, and PK of ZRC-3277 (Pertuzumab Biosimilar) With Perjeta® in Patients With HER2-Positive Metastatic Breast Cancer.

INTRODUCTION: To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). PATIENTS AND METHODS: This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel. Of 268 enrolled patients, mITT population had 243 patients (119 and 124 in the ZRC-3277 and Perjeta® groups, respectively). The primary objective was to compare the between-group objective response rate (ORR) after 6 cycles of treatment. ORR was determined by evaluating scans of computed tomography or magnetic resonance imaging following Response Evaluation Criteria in Solid Tumor (RECIST 1.1). Two-sided 95% confidence interval (95% CI) for the difference in ORR was determined to evaluate the noninferiority of ZRC-3277 to Perjeta®. The secondary outcomes included the assessment of PK, immunogenicity, and safety between the 2 groups. RESULTS: In the mITT population, 104 (87.39%) and 114 (91.94%) participants achieved the ORR in the ZRC-3277 and Perjeta® groups, respectively. For predefined -15% noninferiority margin, obtained 2-sided 95% CIs (-12.19%, 3.11%) for the difference in ORR (-4.55%) between the 2 groups demonstrated the noninferiority of ZRC-3277 to Perjeta®. PK, immunogenicity, and safety were not significantly different between the 2 groups. CONCLUSION: Efficacy, PK, immunogenicity, and safety profiles of ZRC-3277 was found to be similar to those of Perjeta®.

Utilization and affordability of health insurance coverage for rare disease drugs in a first-tier city in Northeast China from 2018 to 2021: a study based on the health insurance claims database.

OBJECTIVE: The accessibility issue of orphan drugs in China is prominent. Based on real-world data from a tier-one city in Northeast China, this study aims to analyze the current usage and affordability of orphan drugs for rare diseases. METHODS: The data was sourced from the health insurance claims data of a certain city from 2018 to 2021, including a total of 16 orphan drugs. The utilization of orphan drugs is assessed using four indicators: frequency of medical insurance claims, medication cost, defined daily doses (DDDs), and defined daily drug cost (DDDc). Affordability is measured using the concept of catastrophic health expenditure (CHE). RESULTS: Between January 2018 and December 2021, there were a total of 2,851 medical insurance claims in the city, with a total medication costs of $3.08 million. Overall, during the study, there was a year-on-year increase in the utilization frequency of individual rare disease drugs in the city, with DDDs rising from 140.22 in 2018 to 3983.63 in 2021. Additionally, the annual medication costs of individual drugs showed a consistent upward trend, increasing from $10,953.53 in 2018 to $120,491.36 in 2021. However, the DDDc of individual drugs decreased from $398.12 in 2018 to $96.65 in 2021.The number of sales and the amount of sales for orphan drugs in community pharmacies have significantly increased. Prior to medical insurance coverage, out of the 16 orphan drugs, 9 drugs had annual treatment costs exceeding CHE for urban residents, and 15 drugs had annual treatment costs exceeding CHE for rural residents. After medical insurance coverage, there were no drugs with out-of-pocket costs exceeding CHE for urban residents, while 8 drugs had out-of-pocket costs exceeding CHE for rural residents. Furthermore, both before and after medical insurance coverage, the four treatment drugs for idiopathic pulmonary arterial hypertension were more affordable compared to the four treatment drugs for multiple sclerosis. CONCLUSION: The usage frequency of orphan drugs in a certain city increased gradually, but the disease burden remained heavy. More policy support should be provided to the priority rare disease populations, and the rare disease medical security and diagnosis and treatment systems should be improved.

A Review on Affordable Combinations in Type 2 Diabetes Care: Exploring the Cost-Effective Potential of Glipizide + Metformin and Glimepiride + Metformin + Pioglitazone.

Management of type 2 diabetes mellitus (T2DM) largely relies on medication adherence of individuals with diabetes to achieve optimal glycemic control. The economic burden of diabetes could impede adherence, leading to a reduction in treatment efficacy and increased risk of complications. Furthermore, monotherapy in diabetes is losing traction due to its ineffectiveness in achieving early and sustained optimal glycemic control in a significant proportion of the population. Hence, clinicians prefer combination treatment due to their improved efficacy and safety. Considering these factors, the current review highlights the safety and efficacy of the affordable combination therapies, a dual therapy, glipizide + metformin, and a triple-drug combination of glimepiride + metformin + pioglitazone and its applicability in the management of T2DM among individuals with diabetes in India.

Access to assisted reproductive technologies in sub-Saharan Africa: fertility professionals' views.

Across sub-Saharan Africa, there remains disagreement among local expert providers over the best ways to improve access to assisted reproduction in low-income contexts. Semi-structured qualitative interviews were conducted between 2021 and 2023 with 19 fertility specialists and 11 embryologists and one clinic manager from South Africa, Zimbabwe, Namibia, Kenya, Ethiopia and Uganda to explore issues surrounding access and potential low-cost IVF options. Lack of access to ART was variously conceptualised as a problem of high cost of treatment; lack of public funding for medical services and medication; poor policy awareness and prioritisation of fertility problems; a shortage of ART clinics and well-trained expert staff; the need for patients to travel long distances; and over-servicing within the largely privatised sector. All fertility specialists agreed that government funding for public sector assisted reproduction services was necessary to address access in the region. Other suggestions included: reduced medication costs by using mild stimulation protocols and oocyte retrievals under sedation instead of general anaesthetics. Insufficient data on low-cost interventions was cited as a barrier to their implementation. The lack of skilled embryologists on the continent was considered a major limitation to expanding ART services and the success of low-cost IVF systems. Very few specialists suggested that profits of pharmaceutical companies or ART clinics might be reduced to lessen the costs of treatments.

This is a qualitative study involving interviews conducted between 2021 and 2023 with 19 fertility specialists and 11 embryologists and one clinic manager from South Africa, Zimbabwe, Namibia, Kenya, Ethiopia and Uganda to explore issues surrounding access and potential low-cost IVF options. The study found that across sub-Saharan Africa, clinical providers disagree over the best ways to provide assisted reproduction to improve access and affordability while maintaining high standards of care in low-income contexts. The lack of political, human resource and professional support to succeed in sub-Saharan Africa inhibits the implementation of low-cost initiatives to improve access and affordability. The study affirms the importance of giving more attention to infertility care in sub-Saharan Africa and increasing access and affordability of ARTs in the public health sector; the further development of national policies and professional guidelines; the need for more studies to evaluate low-cost initiatives; clarification of existing controversies about these initiatives; and the need for more training for embryologists in SSA.

Preconditions for efficiency and affordability in competitive healthcare markets: Are they fulfilled in Belgium, Germany, Israel, the Netherlands and Switzerland? Ten years later.

From the mid-1990s several countries have introduced elements of the model of regulated competition in healthcare. In 2012 we assessed the extent to which in five countries ten important preconditions for achieving efficiency and affordability in competitive healthcare markets were fulfilled. In this paper we assess to what extent the fulfilment of these preconditions has changed ten years later. In 2022, as in 2012, in none of the five countries all preconditions are completely fulfilled. In the period 2012-2022 on balance there have been some improvements in the fulfillment of the preconditions, although to a different extent in the five countries. The only preconditions that were improved in most countries were 'consumer information and transparency' and 'cross-subsidies without incentives for risk selection'. On balance the Netherlands and Switzerland made most progress in the number of better fulfilled preconditions. For Belgium these preconditions no longer seem relevant because the idea of regulated competition has been completely abandoned. In Germany, Israel and Switzerland, the preconditions 'effective competition policy' and 'contestability of the markets' are not sufficiently fulfilled in 2022, just as in 2012. In Germany and Switzerland this also holds for the precondition 'freedom to contract and integrate'. Overall, the progress towards realizing the preconditions has been limited.

Global outlook on affordability of biotherapeutic drugs.

Although biotherapeutic drugs have the potential of transforming the management of many life-threatening diseases, their affordability and accessibility remain an issue. This study offers an overview of the global affordability of biotherapeutic products. For this, prices for 10 representative biotherapeutic products were examined in 40 countries, including high-income countries (HICs), upper middle-income countries (UMICs), lower middle-income countries (LMICs), and low-income countries (LICs). The affordability of these biotherapeutics was calculated based on the World Health Organization/Health Action International (WHO/HAI) method. As expected, affordability was found to be better in HICs, followed by UMICs, LMICs, and finally, LICs. Furthermore, based on the trend of per capita income, we predict that in UMICs and LMICs, the affordability of high molecular weight biologics will worsen by 1.5× and 2× by 2030, respectively, and further by 4× and 6× by 2040. On the other hand, affordability will stay nearly the same for people living in HICs in the coming decades. Our analysis suggests that it is imperative that measures be taken to make this class of products more affordable and accessible. Governments can contribute by creating conducive policies. Global institutions like the WHO can play a significant role as well. Finally, manufacturers need to invest in and implement manufacturing innovations.

Orphan drug policy analysis in China.

Rare diseases have various types, low incidence rates, complex conditions, and are often difficult to diagnose. Due to China's large population, there is a significant number of rare disease patients, but there is a shortage of orphan drugs. Consequently, these patients often find themselves in a situation where necessary medications are either unavailable or unaffordable. To address this urgent clinical need, China has implemented a series of orphan drug policies aimed at improving drug accessibility and affordability. In terms of drug accessibility, companies are encouraged to expedite drug development through the implementation of tax incentives, guidance for clinical research on rare diseases, and the provision of data protection periods of 6 years, along with market exclusivity periods limited to a maximum of 7 years. Moreover, exemptions for clinical trials, acceptance of overseas clinical trial data, and the creation of a list prioritizing clinically urgent new drugs from overseas have been introduced to expedite the drug registration application, review, inspection, and approval processes. In terms of drug affordability, the import value-added tax on rare disease drugs has been reduced by 3%, and various provinces and cities have established a representative rare disease protection model, which includes special funds, medical assistance programs, and serious disease insurance. The national medical insurance catalog has been adjusted to reduce the financial burden on rare disease patients, resulting in an increase in the number of orphan drugs covered by the catalog to 95 as of March 2024. By comparing orphan drug policies in the United States, the European Union, Japan, Australia, and other countries (or regions), we will provide relevant suggestions to further improve orphan drug policies in China, thus bringing more treatment options and hope to patients with rare diseases.

"I probably have access, but I can't afford it": expanding definitions of affordability in access to contraceptive services among people with low income in Georgia, USA.

BACKGROUND: Disparities in rates of contraceptive use are frequently attributed to unequal access to and affordability of care. There is a need to better understand whether common definitions of affordability that solely relate to cost or to insurance status capture the reality of individuals' lived experiences. We sought to better understand how individuals with low incomes and the capacity for pregnancy conceptualized one domain of contraceptive access-affordability --in terms of health system and individual access and how both shaped contraceptive care-seeking in the US South. METHOD: Between January 2019 to February 2020, we conducted twenty-five life-history interviews with low-income individuals who may become pregnant living in suburban counties in Georgia, USA. Interviews covered the ways individual and health system access factors influenced care-seeking for family planning over the life course. Interview transcripts were analyzed using a thematic analysis approach to identify experiences associated with individual and health system access. RESULTS: Affordability was identified as a major determinant of access, one tied to unique combinations of individual factors (e.g., financial status) and health system characteristics (e.g., cost of methods) that fluctuated over time. Navigating the process to attain affordable care was unpredictable and had important implications for care-seeking. A "poor fit" between individual and health system factors could lead to inequities in access and gaps in, or non-use of contraception. Participants also reported high levels of shame and stigma associated with being uninsured or on publicly funded insurance. CONCLUSIONS: Affordability is one domain of contraceptive access that is shaped by the interplay between individual factors and health system characteristics as well as by larger structural factors such as health and economic policies that influence both. Assessments of the affordability of contraceptive care must account for the dynamic interplay among multilevel influences. Despite the expansion of contraceptive coverage through the Affordable Care Act, low-income individuals still struggle with affordability and disparities persist.

Financial assistance and payment plans for underinsured patients shopping for "shoppable" hospital services.

Recent price transparency laws are designed to better inform patients as they compare hospital options and "shop" for health care services. In addition to prices, underinsured patients seeking care need information on financial assistance, discounts, payment plans, and upfront payment requirements to compare the affordability of care across hospitals. Little is known about the availability of this information and the experience of prospective patients seeking it. We contacted a random sample of 10% of general short-term hospitals across the United States in this "secret shopper" telephone study to assess financial options and navigation challenges faced by underinsured patients in need of a non-emergency procedure. The administrative friction was substantial. Most hospitals have 3 siloed offices for (1) financial assistance, (2) payment plans and discounts, and (3) upfront payment requirements. All relevant offices were unreachable in 3 attempted calls at 18.1% of hospitals. Among hospitals with available information, the majority have financial options for patients: 86.7% of hospitals offer financial assistance and 97.0% of hospitals offer payment plans to underinsured patients for non-emergency care. The length and terms of payments plans varied widely for hospital-administered and third-party financing arrangements. Upfront payments were sometimes required, potentially posing barriers for patients without cash or credit access.

Sunscreen use and affordability attitudes based on ethnicity, socioeconomic status, and Fitzpatrick skin type.

IMPORTANCE: One in five Americans will develop skin cancer during their lifetime. While use of sunscreen can help prevent the development cutaneous cancer, regular use remains low nationwide. OBJECTIVE: To assess and better understand health care consumer preferences for sun protection products and perceived product accessibility and availability based on socioeconomic factors, race, and ethnicity. DESIGN: This quantitative survey study was conducted March through June of 2023. SETTING: Participants were recruited from two university family medicine clinical sites in the Buffalo, New York area, one located in a low and one located in a middle-to-upper socioeconomic neighborhood. PARTICIPANTS: Eligible participants were 18 years or older, fluent in English, and residents of the Buffalo, New York area. Surveys and consent forms were distributed by scripted verbal invitation, inviting all clinic patients who met eligibility criteria to participate. Participants were asked to self-report their racial/ethnic group as well as other demographic information including age, gender identification, household income, and household size. Information regarding sun exposure behaviors, and affordability/access was obtained using a combination of multiple choice and yes/no questions. A total of 405 participants were recruited. After excluding 235 incomplete responses, 170 surveys were available for analysis. INTERVENTIONS: None. MAIN OUTCOMES AND MEASURES: Our study aim was to expose health care consumer preferences as well as barriers to access based on socioeconomic factors, race, and ethnicity. RESULTS: Using a 25-question anonymous survey, 405 participants from two university family medicine clinical sites representing low- and middle-to-high-income neighborhoods, participated in the survey. 170 participants completed the survey questions and were included for analysis. Of those, 61.8% identified as female, 37.6% as male, and 0.6% as other. 51.2% of participants identified as lower income, 38.2% as middle-income, and 10.6% as upper income. The results of the survey revealed disparities in sunscreen use and affordability perceptions across demographic groups. Compared with Hispanics, Caucasians exhibited higher rates of sunscreen use (85 Caucasians, 7 Hispanics; p = 0.0073), prioritized SPF (95 Caucasians, 10 Hispanics; p = 0.0178), and were more likely to perceive sunscreen as unaffordable (6 Caucasians, 4 Hispanics; p = 0.0269). Analysis by Fitzpatrick Skin Type demonstrated differences in sunscreen utilization, with Types I-III using more compared to Types IV-VI (70 Types I-III, 51 Types IV-VI; p = 0.0173); additionally, Type I-III individuals were significantly more likely to cite cost as barrier to sunscreen purchase (40 Type I-III, 65 Types IV-VI; p < 0.0001). Moreover, lower-income individuals were significantly more likely to perceive sunscreen as unaffordable (12 lower-income, 1 middle & upper income; p = 0.0025) and cited cost as a barrier to purchase (46 lower-income, 59 middle & upper income; p = 0.0146) compared to middle-to-upper income counterparts. Though statistical significance was not established, respondents from middle & upper income groups reported higher sunscreen usage rates compared with their lower-income peers. CONCLUSIONS AND RELEVANCE: These findings highlight the importance of socioeconomic factors and ethnicity on accessibility to sunscreen and the impact of disparities in utilization among different ethnic and socioeconomic groups.