Access Landscape Research Articles

Market Access Challenges and Solutions in Cell and Gene Therapy in The Netherlands.

With the increasing pipeline of cell and gene therapies (CGTs) and the expected surge in the number of approvals, understanding the market access landscape becomes crucial for timely patient access. This study evaluates the challenges Dutch stakeholders encounter in CGT market access, offering insights for improving time-to-patient access. A traditional literature review was conducted to identify market access challenges and solutions for CGTs. Based on the findings, participants for semi-structured interviews, designed using an interview guide adapted to the Dutch context, were selected to capture diverse perspectives on market access. This review included 124 relevant articles out of 2449, covering several aspects of market access of CGTs. Subsequently, interviews with 16 stakeholders from academia, patient advocacy groups, manufacturers, health insurers, payers, hospital pharmacists, healthcare practitioners, and the Association of Innovative Medicines were conducted. Stakeholders identified challenges and proposed solutions for reimbursement package management, clinical trials, health economics, payment models, and procedural and organisational aspects. Thematic analysis revealed unique country-specific challenges and solutions in the Netherlands. This research provides insights into these challenges and potential solutions, emphasising the need for collaborative efforts among stakeholders to develop practical and multidisciplinary measures to improve the market access landscape for CGTs in the country.

Socio-ecological influences on access to abortion care in Costa Rica: a qualitative analysis of key perspectives from clinical and policy stakeholders

Costa Rica prohibits abortion except under narrow circumstances to save the pregnant person’s life. The country boasts historically strong support for social policy and human rights, while also presenting a complex and restrictive abortion access landscape. From September 2021 to March 2022, we conducted 23 interviews with obstetrician-gynecologist (OB/GYN) physicians, OB/GYN medical residents, and policy stakeholders to explore the socio-ecological influences on abortion access in Costa Rica. We sampled clinicians and policy stakeholders from the Universidad de Ciencias Médicas listserv through snowball sampling and conducted semi-structured in-depth interviews in Spanish. We identified limited access to comprehensive sexual health education, lack of support from interpersonal networks, inadequate provider knowledge and training, financial and migratory status, and both provider and community stigma as substantial barriers to abortion access. This study addresses a gap in published research around the social determinants of abortion in Costa Rica and sheds light on the attitudes and opinions of the medical and policy stakeholder communities about abortion access. The results highlight the need for expanded access to comprehensive sexual health education, abortion-related training for healthcare providers, and increased programming efforts, such as funding, outreach, and implementation, to ensure comprehensive reproductive health services are available and accessible, especially for vulnerable populations in Costa Rica.

The impact of state Medicaid coverage of abortion on people accessing care in three states.

Medicaid is a major funder of reproductive health services, including family planning and pregnancy-related care, especially for people with limited income and people of color. Federal Medicaid funds cannot be used for abortion however 16 states allow state Medicaid funds to pay for abortion. In recent years, Illinois and Maine implemented, and West Virginia discontinued, state Medicaid coverage of abortion. With retrospective procedure- and patient-level data obtained from clinics in these three states, we used an interrupted time series design, multivariable regression models, and descriptive statistics to assess changes in procedure volume and patients' share of total procedure price (patient price). In Maine and Illinois, implementing state Medicaid coverage of abortion contributed to an immediate overall increase in abortion access (as seen by a rise in monthly procedure volume at the time of the policy's implementation), a decrease in patient price (by 36% in Maine and 44% in Illinois) after policy implementation as compared to pre-implementation, and overall improved access among people of color. Conversely, when West Virginia discontinued coverage, access to care decreased, patient price increased by 130%, and the share of abortion procedures among people of color decreased. In the fragmented abortion access landscape of the post-Roe era, our study provides new evidence that financial assistance offered through state Medicaid policies that cover abortion may be most helpful to those facing traditional structural inequities to access, while discontinuation of Medicaid coverage of abortion further burdens those already economically marginalized.

HPR108 The Patient Access Landscape for Rare Disease Medicines in Brazil: A Multi-Stakeholder Perspective

HPR108 The Patient Access Landscape for Rare Disease Medicines in Brazil: A Multi-Stakeholder Perspective

HTA101 Mapping Opportunities in the Access Landscape for a New Rare Disease Treatment Option in Multiple EU Countries

HTA101 Mapping Opportunities in the Access Landscape for a New Rare Disease Treatment Option in Multiple EU Countries

MT6 Companion Diagnostics’ Launch and Market Access Landscape: Who Are the Trend Setters and Late Adopters?

MT6 Companion Diagnostics’ Launch and Market Access Landscape: Who Are the Trend Setters and Late Adopters?

PP20 Vaccines market access pathways in Asia-Pacific (APAC) – analysis and recommendations for improvement

IntroductionImmunization is one of the most effective public health interventions, saving millions of lives annually. However, complex and heterogenous market access pathways can impact timely and equitable population access to vaccines. Focusing on five Asia-Pacific (APAC) countries, this study described the current vaccine market access landscape and analyzed the success factors for National Immunization Program (NIP) inclusion.MethodsThe study was conducted in two phases (i) pragmatic literature review to map current regulatory and funding pathways and identify information gaps in China, Japan, Korea, Taiwan and Australia (ii) targeted interviews with market access and policy experts in each market to identify drivers and barriers to NIP inclusion.ResultsRegulatory approval, driven by safety and efficacy data, followed by introduction in the private market was commonly observed in all markets. However, pathways to NIP inclusion varied within and between markets. In all markets expert panels such as National Immunization Technical Advisory Groups (NITAG) were identified to play a crucial role in providing advice to governments on NIP inclusion. Health technology assessment was increasingly used to inform decision making. However, the assessment frameworks utilized were typically designed for medicines, rather than the unique features of vaccines.Japan, Korea and Australia provided relatively consistent coverage via national programs, despite the different processes employed to review, recommend and reimburse vaccines. In some cases, the reimbursement timeframe varied significantly for different vaccines within the same market. China and Taiwan provided coverage at the regional level, which required engagement with multiple local authorities to enable access. The key barriers to patient access were budget limitations, long reimbursement timeframes and a lack of coverage consistency. Early stakeholder engagement, local epidemiology and cost-effectiveness evidence were the main success factors for NIP inclusion.ConclusionsFunding pathways for vaccines in APAC are heterogenous. Adopting the Asia-Pacific Economic Cooperation (APEC) Action Plan on Vaccination Across the Life Course could increase vaccine coverage through alignment, collaboration, and improvement of reimbursement pathways in APAC.

Diamond Open Access landscape in Croatia - preliminary DIAMAS survey results

Open access scholarly publishing is a diverse realm, involving numerous stakeholders and various organisational models (Fuchs and Sandoval, 2013). However, one facet that has often been overlooked is the publishing activities carried out by scientific institutions themselves. Given that these institutional initiatives play a vital role in preserving the social, linguistic, cultural, and epistemological diversity within the European research landscape, the primary objective of the Horizon Europe project, "Developing Institutional Open Access Publishing Models to Advance Scholarly Communication" (DIAMAS), is to establish a unified European standard for the currently fragmented institutional publishing landscape (Mounier and Aspaas, 2023). This initiative aims to enhance efficiency, quality, and the overall practices of publishing activities and services across the European Research Area (ERA).The DIAMAS survey targeted 252 Institutional Publishing Service Providers (IPSPs) in Croatia and achieved a robust response rate of 77%. Half of Croatian IPSPs are affiliated with universities, faculties, and learned societies. IPSPs in Croatia primarily handle academic journals, academic books, and conference outputs. However, their services extend to encompass other research outputs, media, digital products, and non-academic content. On average, a Croatian IPSP publishes 1-5 scholarly journals, 11-100 scholarly articles, 1-10 academic books, and 1-20 conference proceedings annually. Multilingualism is a notable feature among IPSPs, with 82% practising multilingual publishing to engage wider audiences. Despite linguistic complexities and the need for human translators, the scientific community's commitment to extensive outreach remains evident.
 Croatia's Commitment to Open AccessIn Croatia, the academic publishing landscape is significantly shaped by universities and learned societies, staunch proponents of the non-profit model and early adopters of open access (OA). This dedication, supported by a national HRČAK platform hosting over 400 active OA journals and government subsidies, underscores Croatia's unwavering commitment to unencumbered knowledge sharing. The country's preference for not resorting to "article processing charges" reflects strong support for the diamond OA model.While a comprehensive national OA/OS policy is still in progress in Croatia, support for OA exists through different national laws and strategies. The government mandates OA and inclusion in the HRČAK portal for subsidised journals and OA repositories for graduation and doctoral theses. 64% of respondents reference some form of OA/OS policy, indicating the integration of OA principles into scholarly publishing practices over decades.
 Funding, Income Streams and SustainabilityGovernment subsidies from the Ministry of Science and Education and other ministries are the primary sources for scholarly journals, with the average IPSP budget below €10,000. Voluntary efforts significantly influence Croatia's IPSP landscape, with 53% of respondents relying on unpaid staff, accentuating the country's unique and complex scholarly publishing ecosystem. The importance of voluntary work is underscored by IPSPs' reliance on in-kind support from parent organisations in terms of facilities, IT services, and staff salaries.Challenges to financial sustainability include the lack of funding continuity, irregularity, delays, and insufficient funding. Furthermore, changes in government funding eligibility without notice and price increases in printing and copy-editing pose challenges. Suggestions to address these issues include enhancing financial literacy, collaboration, and promotion of scholarly publishing.Editorial Quality, Technical Services, Visibility, Metrics and Equity, Diversity, Inclusion, and Belonging (EDIB)IPSPs actively participate in editorial management, with 71% involved in editorial board recruitment and other aspects. Regarding peer review, a double-anonymous peer review is preferred by 44%, followed by a single-anonymous peer review (15%). Some IPSPs have begun implementing open identities and open review reports. IPSPs predominantly offer editorial services voluntarily or as in-kind contributions. In contrast, production and IT services are mostly outsourced. Technical challenges arise from financial constraints, lack of human resources, expertise, and technical limitations.Croatian IPSPs aspire to have their journals indexed in WoSCC and Scopus databases. Other indexes such as DOAJ, DOAB, ERIH PLUS, PubMed, Google Scholar, Research Gate, Google Books, and OAPEN are also considered. While 44% of IPSPs are content with their current indexing status, some face challenges in meeting technical participation criteria.IPSPs utilise metrics such as submissions, acceptance and publication dates, visits, views, downloads, and Journal Impact Factor. EDIB measures are prioritised, with the main measures being a code of conduct and non-discrimination policies. Accessibility standards are often unknown, and 64% of IPSPs do not have accessibility policies. Gender Equality Plans (GEP) are implemented by 25% of IPSPs.In summary, the DIAMAS survey illuminates the intricate landscape of scholarly publishing in Croatia, revealing its commitment to diamond open access while highlighting challenges and opportunities for improvement.

Food access in Kalamazoo, Michigan: A spatial analysis

Healthy and affordable food is a universal human need. In the U.S., food access is often limited in low-income areas as opposed to medium- and high-income areas. To address disparities in the availability of healthy foods, the dispersion of food access points needs to be quantified and docu­mented. Nutritional quality and consistency of availability vary across different types of food access points, including permanent grocery stores, farmers markets, community gardens, food pan­tries, and convenience stores. Accessibility is also determined by the means of transportation avail­able or required to get to food access points (public transit, driving, or walking). In this geographic information systems (GIS)-based analysis, we iden­tify differences in accessibility to distinct types of food access points—reliable, seasonal, and lower quality—between low-income and higher-income tracts in the City of Kalamazoo, Michigan. We found that all full-service grocery stores are acces­sible via bus routes in the City of Kalamazoo; however, 11% of people reside in low-income areas with low access to these grocery stores—beyond the 0.25-mile walkable distance to bus routes. We then asked whether the addition of community gardens, food pantries, and farmers markets, on the “plus” side, or convenience and dollar stores, on the “minus” side, changes the food access landscape in this community. We found that the “positive” access points served areas that already had access to grocers, while “negative” access points filled the access gap in lower income areas. More than twice as many low-income residents had walkable access to convenience stores—which provide lower-quality and highly processed food—with 81% of them being located within low-income tracts. Geographical analysis of low food access and low-quality food access is important to identify structural patterns, but it needs to be paired with interview-based community assessments to ascertain how residents actually procure their food.

Midwives Safeguarding Abortion Access: Establishing Medication Abortion Services.

The abortion access landscape for patients has changed dramatically in the wake of the US Supreme Court Dobbs v. Jackson Women's Health Organization decision in June of 2022. In response, the Division of Midwifery at Baystate Medical Center in Springfield, Massachusetts, began a medication abortion service for both established patients and those who may seek care from out of state. This service increases access to abortion care now while also providing the clinical experience needed for student nurse-midwives to become future abortion providers. This article outlines the steps taken to implement a medication abortion service and ways it can be adopted by other midwifery practices. Strategies to address possible clinical, administrative, and logistical challenges are addressed. Finally, this article is a call to action because midwives are well qualified to provide high quality, safe, and comprehensive medication abortion within the midwifery model of care.

Abortion assistance fund staff and volunteers as patient navigators following an abortion ban in Texas.

Abortion assistance funds constitute an important part of the healthcare safety net by covering some of abortion patients' out-of-pocket costs. Few studies have examined the other ways abortion assistance fund staff and volunteers support callers who need help obtaining care. Between June and September 2020, we conducted in-depth interviews with 23 staff and volunteers at 11 local abortion assistance funds that helped Texans seeking abortion care following a March 2020 state executive order that prohibited most abortions. Interviewers explored respondents' experiences with callers whose appointments had been canceled or who traveled out of state and subsequent operational changes. We used both inductive and deductive codes in the thematic analysis. Abortion assistance fund staff and volunteers bridged callers' information gaps about the services and financial resources available and helped create plans to secure care that accounted for callers' specific needs. They provided emotional support so callers felt it was possible to overcome logistical hurdles to get an abortion, even if that required out-of-state travel. Respondents described greater collaboration between Texas-based abortion assistance funds and out-of-state organizations to support callers' more complex logistical needs and increased costs. Some callers who encountered multiple barriers to care, including interpersonal violence, were unable to obtain an abortion, even with additional supports. Local abortion assistance funds worked with Texas callers to co-create person-centered plans for care and expanded inter-organization collaborations. Initiatives that bolster local assistance funds' infrastructure and capacity will be needed as the abortion access landscape becomes further restricted and complex.

HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Cancer Treatments in Europe: A Patient Access Landscape Review

Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS “substantial benefit” (score of 4 or 5) vs “no substantial benefit” (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.

HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Cancer Treatments in Europe: A Patient Access Landscape Review.

Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS "substantial benefit" (score of 4 or 5) vs "no substantial benefit" (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.

HTA56 The Post-Brexit UK Access Landscape: Does Project Orbis Significantly Accelerate Patient Access for Oncology Drugs in the UK Versus Europe?

Following Brexit, the MHRA has become the standalone regulator for medicines in the UK (except Northern Ireland). To ensure timely access to innovative oncology products, the UK joined Project Orbis, an FDA-led review programme. This research compares UK reimbursement outcomes for medicines approved through Project Orbis with EU4.

The Role of Libraries and LIS Professionals in Changing the Open Access Landscape during COVID-19 Crisis

The Role of Libraries and LIS Professionals in Changing the Open Access Landscape during COVID-19 Crisis

427P Oncology combination therapies in Asia-Pacific markets: What are the current access challenges?

Combination therapies (CT) are increasingly being developed and used in oncology. They have clinical benefits over and above monotherapies but face challenges in their assessment and pricing, which can delay or prevent access for patients in Asia-Pacific (AP) markets, especially when CTs consist of multiple on-patent constituents with different manufacturers. OHE conducted a study to understand the access landscape for CTs in AP and current access challenges (if any).

What about access to birth control and emergency contraception now that abortion rights are overturned?

What about access to birth control and emergency contraception now that abortion rights are overturned?

STEM Librarians and the Future of Scholarly Publishing: Scholarly Communication Concepts that Researchers Need

This narrative reflection describes how five librarians developed a scholarly communication workshop intended for a specific conference with an audience of science researchers, then proceeded to modify it to fulfill different professional development opportunities. We explored themes around open access, the current and future landscape of scholarly publishing, and the deciding factors for researchers when choosing a journal to submit papers to. Identifying further venues for the workshop and submitting formal and informal proposals leveraged our knowledge of our own professional associations and what might appeal to those audiences.

Pretransplant Dialysis and Preemptive Transplant in Living Donor Kidney Recipients.

The optimal timing of dialysis access placement in individuals with stage 5 CKD is challenging to estimate. Preemptive living donor kidney transplant (LDKT) is the gold-standard treatment for ESKD due to superior graft survival and mortality, but dialysis initiation is often required. Among LDKT recipients, we sought to determine which clinical characteristics were associated with preemptive transplant. Among non-preemptive LDKT recipients, we sought to determine what dialysis access was used, and their duration of use before receipt of living donor transplant. We retrospectively extracted data on 569 LDKT recipients, >18 years old, who were transplanted between January 2014 and July 2019 at UCSF, including dialysis access type (arteriovenous fistula [AVF], arteriovenous graft [AVG], peritoneal dialysis catheter [PD], and venous catheter), duration of dialysis, and clinical characteristics. Preemptive LDKT recipients constituted 30% of our cohort and were older, more likely to be White, more likely to have ESKD from polycystic kidney disease, and less likely to have ESKD from type 2 diabetes. Of the non-preemptive patients, 26% used AVF, 0.5% used AVG, 32% used peritoneal catheter, 11% used venous catheter, and 31% used more than one access type. Median (IQR) time on dialysis for AVF/AVG use was 1.86 (0.85-3.32) years; for PD catheters, 1.12 (0.55-1.92) years; for venous catheters, 0.66 (0.23-1.69) years; and for multimodal access, 2.15 (1.37-3.72) years. We characterized the dialysis access landscape in LDKT recipients. Venous catheter and PD were the most popular modality in the first quartile of dialysis, and patients using these modalities had shorter times on dialysis compared with those with an AVF. Venous catheter or PD can be considered a viable bridge therapy in patients with living donor availability given their shorter waitlist times. Earlier referral of patients with living donor prospects might further minimize dialysis need.

OP10 Market Access Timelines to Innovation in Algeria

Innovative medicines can nowadays open new horizons for patients with life threatening diseases; but access to health innovation is a real headache for decision-makers. The therapeutic progress brought by these innovations is often linked to a heavy cost. This study aims to determine time to access in Algeria for innovative medicines. METHOD : a deep descriptive analysis of the algerian market access landscape in terms of registration, pricing, reimbursement and procurement was undertaken, then, to select the innovative medicines, a comparison between the HAS and the FDA was conducted, the registration and market access timelines were determined in Algeria and the performance against France and USA