At Clarivate, we are deeply committed to working with the research community to safeguard research integrity. We invest significant effort in ensuring that the Web of Science Core Collection only contains content from trustworthy sources and over the last few years, we’ve introduced a series of editorial policy changes that affect the Journal Citation Reports (JCR). These contribute to our efforts to promote transparency, to provide more data and help level the playing field. In doing so, we help protect the integrity of the scholarly record.

As we prepare for the release of the Journal Citation Reports for 2024, our commitment to enhancing transparency and trust in the scholarly record takes center stage. As announced in March 2023 and described in more detail in February 2024, we are moving from edition-specific Journal Impact Factor (JIF) category rankings to unified rankings. The following examples illustrate how this change will affect the 2023 dataset.

Trusted and reliable metrics for journal evaluation

This year’s JCR will introduce unified rankings across subject categories. This approach is designed to simplify the evaluation of journal performance by providing a more comprehensive view of each journal’s standing within its respective subject area.

Each subject category ranking will include journals assigned to that category regardless of edition, including the Emerging Sources Citation Index (ESCI). More than 7,200 journals will have new subject category rankings with full JIF metrics in the JCR 2024 release. Of those, around 7,000 are from ESCI and 200 from the Arts & Humanities Citation Index (AHCI). The creation of unified category rankings will provide a simpler and more complete category view for the evaluation of journal performance.

Although we initially intended to apply this change to all subject categories, after consulting with the research community, we’ve decided not to apply it to arts and humanities-only categories. A deep dive into the data revealed that this approach would create an unexpectedly large number of ties in rank which, in turn would skew the quartile distributions, making them difficult to interpret and of questionable value to the community. In the spirit of transparency, we shared our findings and our hesitation to introduce these rankings with a set of publishers and some other industry stakeholders. Together, we arrived at the consensus that the responsible thing to do would be not to publish rankings for these categories. A complete list of these omitted categories is provided at the end of this blog.

Category-first approach

The category-first approach simplifies journal performance assessment with a holistic view of all journals in each subject category. In the JCR 2023 release, there were 178 subject category rankings for the Science Citation Index Expanded (SCIE) and 58 subject category rankings for the Social Science Citation Index (SSCI), totaling 236. With this year’s release, there are 229 subject category rankings, reduced slightly where subject categories are shared in both SCIE and SSCI.

These shared subject categories will combine into a single subject category ranking. Journals covered in both SCIE and SSCI for that shared category had a ranking for each edition in prior years. Now those journals will receive a single ranking in that subject category going forward. This change will not be applied retrospectively to earlier JCR data years.

Figure 1: JCR subject category rankings from the 2023 release to 2024. 

Figure 2: Geology – SCIE ranking becomes Geology. 

Figure 3: Psychiatry with two separate rankings in SCIE and SSCI combines into one Psychiatry ranking. 

Exploring the impact of these changes

The inclusion of ESCI and AHCI journals in subject category rankings has led to an increase in category sizes, with SCIE subject categories seeing an average increase of ~30% and SSCI subject categories experiencing a larger average increase of ~85%. This reflects broader coverage of social science and arts and humanities journals in ESCI, and the inclusion of AHCI-only journals in social science shared categories for the first time. History is the category that grew most from AHCI journals, with ~36% of the increase coming from history journals only in AHCI.

Figure 4 – History now includes History journals in ESCI and History journals only in AHCI. 

The distribution within quartiles across all categories and the journals within the categories follows an expected pattern where journals in SCIE, SSCI and AHCI are more heavily represented in the higher-performing quartiles and the majority of ESCI in the lower-performing quartiles.

In general, ESCI journals have a lower JIF than journals in the science or the social science indices in the same category. That’s because to enter SCIE or SSCI, a journal needs to pass our four impact criteria, which are designed to select journals with the highest scholarly impact, in addition to our 24 quality criteria.

Some ESCI journals have a higher JIF than the science and social science journals in the same category, and there are several reasons for this. First, the distinction between ESCI, SCIE and SSCI is not solely based on a journal’s JIF at a specific point in time; rather it hinges upon whether a journal passes our four impact criteria. Additionally, in 2022 we paused our impact evaluations of indexed journals in order to put more effort into our quality evaluations of submitted and indexed journals. This prioritization exercise has enabled us to address the growing issue of pollution in the scholarly literature.

Quartile distribution 

Before

After

Science subject category example (SCIE+ESCI) 

Before

After

Social science category example (SSCI+ESCI) 

Before

After

We remain committed to providing the research community with trusted and reliable metrics for journal evaluation by working closely with and consulting our partners. This coming change to the JCR, which focuses on a category-first approach with more than 7,000 additional journals, ensures that members of the research community will have the most complete picture of journals covered in the Web of Science Core Collection, supporting their decision-making and academic endeavors.

This is the second in a series of updates on the Journal Citation Reports 2024 release. Bookmark this page and stay tuned for further details as we continue to advance transparency and integrity in journal assessment.

SCIE+SSCI shared subject categories

Subject categories moving from two separate rankings to one are: History Philosophy of Science; Green Sustainable Science Technology; Nursing; Psychiatry; Public Environmental Occupational Health; Rehabilitation; Substance Abuse.

AHCI-only subject categories

Arts and humanities categories that will not be ranked are: Architecture; Art; Asian Studies; Classics; Dance; Film, Radio, Television; Folklore; Humanities, Multidisciplinary; Literary Reviews; Literary Theory & Criticism; Literature; Literature, African, Australian, Canadian; Literature, American; Literature, British Isles; Literature, German, Dutch, Scandinavian; Literature, Romance; Literature, Slavic; Medieval & Renaissance Studies; Music; Philosophy; Poetry; Religion; Theater; Archaeology; Language & Linguistics.

The post Journal Citation Reports 2024 preview: Unified rankings for more inclusive journal assessment appeared first on Clarivate.

Overall survival: A trusted benchmark, but not always best

The preferred clinical endpoint in oncology clinical trials, OS serves as a trusted benchmark, offering wide ranging advantages over other endpoints^[1][2]. Defined as the time from randomization to death, OS is precise, objective, and relatively easy to measure. Given its clinical robustness and patient relevance, OS is universally accepted by regulators and health technology assessment (HTA) bodies alike^[2][3].

However, in some disease settings, OS is associated with important limitations^[2]. The need for long studies makes OS an unsuitable endpoint in the case of slowly progressing and early-stage cancers, for example. Measurement of OS is also susceptible to confounding, particularly when involving multiple lines of therapies, patient crossover, and the occurrence of non-cancer related deaths. Furthermore, OS does not capture the broader priorities of patients and physicians; for example, when quality of life is a priority over prolonging survival^[2]. For pharmaceutical companies, these limitations can translate into time and financial constraints.

Alternative oncology-relevant endpoints provide opportunities to address these concerns, allowing the collection of data at earlier time points than with OS (Figure 1)^[1]. Such endpoints allow measurement of outcomes before starting subsequent therapies, giving a more direct measure of treatment efficacy. Some endpoints also offer broader value to patients too – besides being surrogate endpoints for OS, non-OS endpoints can provide standalone information, including on symptoms, function, treatment burden, and quality of life^[4].

Figure 1: Alternative oncology-relevant endpoints

Source: Modified from Delgado and Guddati 2021^[1]
Abbreviations: EQ-5D, EuroQol 5-dimensions index; NSCLC-SAQ, Non-Small Cell Lung Cancer Symptom Assessment Questionnaire; PROs, patient reported outcomes.

Why aren’t alternative oncology-relevant endpoints used more widely?

Despite their potential value, alternative oncology-relevant endpoints remain underused in clinical trial design. In 2021, non-OS endpoints accounted for just 16% of primary endpoints in Phase II or Phase III oncology trials, with the most common being pathological complete response, relapse rate and disease-free survival^[5].

Major barriers to the broader adoption of alternative oncology-relevant endpoints in clinical trials include a lack of agreement on their value and the uncertainty among payers that they accurately capture treatment benefits for patients and healthcare systems^[4][6]. While regulators are generally more receptive towards non-OS endpoints, accepting measures that are reasonably likely to predict clinical benefit, HTA bodies typically require validation of surrogacy^[4][6]. In general, guidelines published by HTA bodies indicate a preference for OS data or consider surrogate endpoints only where validation studies demonstrate strong correlation with survival^[6]. From a payer perspective, this caution is arguably expected; several therapies approved on the basis of improvements in outcomes such as progression-free survival (PFS) have not demonstrated OS benefits^[2]. Despite this, few agencies provide detailed methodological guidance for surrogacy validation^[7].

This uncertainty is further confounded by differences in the willingness of national HTA bodies to evaluate even well-established alternative oncology-relevant endpoints such as PFS^[6]. The resulting complexity feeds a vicious cycle: a lack of standardized methodologies for evidence generation leads to insufficient evidence to quantify the long-term benefits of non-OS endpoints, deterring HTA bodies from giving due consideration to these outcomes in decision making^[6].

Moreover, while HTA bodies continue to place particular importance on mortality, patients and clinicians often consider outcomes such as the avoidance of surgery or pain equally or more important than OS in some treatment settings^[6]. HTA bodies and payers can perceive patient reported outcomes (PROs) as more subjective, a point of difference that is reflected in the regional variations in the way PRO evidence is reviewed and considered in global HTA decision-making^[6]. This lack of alignment contributes to a lack of clarity around PRO requirements, reinforcing uncertainty among stakeholders.

Towards stakeholder alignment on alternative oncology-relevant endpoints

Overcoming the uncertainties and inconsistencies limiting broader adoption of alternative oncology-relevant endpoints requires concerted efforts from all stakeholders and a more harmonized approach towards their use^[4][6]. There is growing consensus that, by working together, the oncology community can move closer towards establishing sets of appropriate endpoints for specific cancer types and stages that have wide buy-in from regulatory authorities, reimbursement bodies, pharmaceutical developers, and patients themselves.

A key step towards this goal will be agreeing upon the endpoints that matter most to patients, which will almost certainly differ by cancer type and stage^[4][6]. For example, while extending survival may remain a priority in treatment settings with poor prognoses, for cancers where prognosis is improving, disease progression and quality of life may prove more valuable. Once alignment is reached on which outcomes are most valuable to patients, appropriate endpoints and PROs should then be defined through consultation with clinicians and healthcare professionals^[6].

There also exists an opportunity for greater harmonization in the methodologies used to validate endpoints and generate data^[4][6]. This is particularly important for PROs where there is lack of standardization in data collection methods, analysis and interpretation. Alignment on the levels of uncertainty that are acceptable to regulatory and HTA decision-makers and other stakeholders is also important, requiring greater transparency on the evidence needed to support regulatory approval and reimbursement in specific treatment settings^[4][6]. Much work has already been undertaken to establish the surrogate and standalone value of alternative oncology-relevant endpoints. However, the use of real-world evidence and other health economics and outcomes research (HEOR) studies to evaluate the long-term clinical and economic impact of treatments may help accelerate efforts to bridge these gaps^[6].

Global HTA bodies and professional organizations are already taking steps towards a more harmonized approach to assessing the surrogate and standalone value of non-OS endpoints. For example, an ongoing collaboration between HTA bodies including the National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC) and Canadian Agency for Drugs and Technologies in Health (CADTH) is developing methodological guidance and a new joint scientific advice procedure on the use of surrogate outcomes for cost-effectiveness analysis^[8]. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has also established a taskforce to set good practices for surrogacy evaluation and validation of the relationships between outcomes informing HTA decisions^[9]. These initiatives run alongside broader efforts to harmonize HTA decision-making processes within the European Union under Joint Clinical Assessment, providing an opportunity to promote greater standardization around non-OS endpoints^[10][11].

By supporting more transparent and consistent approaches for the evaluation of alternative oncology-relevant endpoints, these programs have the potential to promote more predictable outcomes in HTA decision-making – a necessary step towards building confidence in the value and suitability of alternative endpoints in clinical trial design.

Looking beyond overall survival

Overall survival remains an important measure of the value of cancer therapies, yet there exists a growing role for oncology-relevant endpoints beyond this ‘gold standard’. By considering patients’ needs, addressing uncertainties, and building consensus around the best outcomes to use in specific treatment settings, oncology-relevant endpoints beyond OS have the potential to facilitate faster and more cost-efficient access to novel cancer treatments.

Clarivate has supported our clients bring the next generation of innovative oncology treatments to market, empowering early-stage R&D and robust clinical trial design, through to navigating regulatory and market access pathways. Within Clarivate’s Evidence, Value and Access consultancy, our reimbursement dossiers, value stories, and objection handlers have supported clients achieve their market access goals in breast cancer, bladder cancer, leukemia and beyond, and our team have expertise with novel technologies such as CAR-T therapies. To learn more about our capabilities and how we can support you, please get in touch here.

This post was written by Richard Massey, Director, Value Communication and Clara Ricci, Senior Medical Writer.

References

^[1]Delgado, A. and A.K. Guddati, Clinical endpoints in oncology – a primer. Am J Cancer Res, 2021. 11(4): p. 1121-1131.

^[2]Cimen, A., et al., Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across stakeholder groups to support oncology HTA decision-making. Journal of Clinical Oncology, 2023. 41(16_suppl): p. e13646-e13646.

^[3]McKee, A.E., et al., The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. Oncologist, 2010. 15 Suppl 1: p. 13-8.

^[4]Fameli, A., et al., Looking Beyond Survival Data: How Should We Assess Innovation in Oncology Reimbursement Decision Making. Values & Outcomes Spotlight, 2023. 9(5): p. S5.

^[5]IQVIA report, Evolving oncology endpoints – a new horizon for health outcomes 2021.

^[6]European Federation of Pharmaceutical Industries and Federations report, Improving the understanding, acceptance and use of oncology–relevant endpoints in HTA body / payer decision-making 2023

^[7]Grigore, B., et al., Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines. PharmacoEconomics, 2020. 38(10): p. 1055-1070.

^[8]NICE, International health technology assessment collaboration expands

^[9]ISPOR, Surrogate Endpoint Statistical Evaluation for HTA Decision Making

^[10]European Commission, Questions and Answers: Adoption of Regulation on Health Technology Assessment

^[11]European Commission, Health Technology Assessment

The post Beyond overall survival: Time to agree on the value of alternative oncology endpoints? appeared first on Clarivate.

At Clarivate^TM, we understand the transformative power of artificial intelligence (AI) in the academic realm and the imperative to introduce AI thoughtfully and responsibly into research, teaching and learning environments.

Over the past year we engaged in several research projects, working closely across our data science, engineering, content and user experience teams and customer community to learn first-hand about the potential and the limitations of generative AI (GenAI). This experience, alongside years of using AI and machine learning in our products, enabled us to shape our path forward for harnessing AI and tailoring it to the needs of research and education.

Today, we are excited to announce the launch of the Clarivate Academic AI Platform. The platform serves as a technology backbone, enabling accelerated and consistent deployment of AI capabilities across our Academia & Government portfolio of solutions. With Retrieval Augmented Generation (RAG) architecture, document insights and metadata capabilities at its core, the platform ensures that answers and insights provided by Clarivate solutions are grounded in our extensive collection of curated scholarly content, including Web of Science Core Collection^TM, ProQuest^TM full text resources, Ebook Central materials and the Ex Libris^TM Central Discovery Index.

The role of an AI Platform

The Clarivate Academic AI Platform is designed to tackle a range of challenges and help leverage opportunities across the academic spectrum. Here is how it transforms our offerings:

1. Unified approach
   Ensuring a common approach to how AI capabilities are deployed, scholarly content sources are used and how we safeguard security and privacy.
2. Accelerated innovation
   By leveraging platform infrastructure, product teams can develop AI-based features in days — rather than weeks or months — bringing new innovations to customers faster.
3. Consistent user experience
   Facilitating a common, intuitive user experience across Clarivate academic solutions, helping users easily navigate products, while preserving the unique characteristics of each product.
4. Integrity and quality
   Employing rigorous testing methodologies to validate results for accuracy, relevance and interpretability and reduce the risk of misinformation and bias.
5. Expertise and best practices
   The AI Platform team serves as a central hub of expertise, evangelizing the possibilities of AI and ensuring that our teams are at the forefront of AI developments.

Figure 1: The Clarivate Academic AI Platform

Technology backbone

The Clarivate Academic AI Platform leverages a suite of advanced technologies to enhance functionality and user experience:

• Semantic search infrastructure
  Semantic search enables more nuanced and context-aware discovery, helping understand the intent behind queries. Coupling semantic search and keyword search allows us to provide accurate and relevant results.
• Specialized APIs
  We offer internal, task-specific APIs tailored for distinct product needs. For instance, APIs designed for extracting insights from academic documents can add valuable information to our records, which enables researchers to uncover insights, trends and patterns more efficiently.
• Data integrity management
  Addressing possible issues of misinformation stemming from the training data, along with security and privacy, is crucial. A centralized approach ensures that these aspects are uniformly managed and facilitates easy deployment of new products, upholding high standards of data integrity and user trust.
• Centralized LLM gateway
  Managing Large Language Models (LLMs) becomes more streamlined with the AI Platform, allowing us to use the most appropriate model for specific needs and use cases. This targeted approach ensures optimal performance and relevance of solutions.
• Multi-Language support
  To cater to a global academic community, the platform supports translation of AI queries into various languages, ensuring broader accessibility and inclusivity.

The importance of a unified user experience

By adopting consistent interface designs, graphic elements and interactive elements, we ensure that users can quickly familiarize themselves with these powerful new tools across Clarivate products for academia and government. This unity in design is not merely about aesthetics — it’s about creating a user-centered environment that helps users complete their research tasks with speed and confidence.

Figure 2: Clarivate Research Assistants UX examples (Web of Science, Primo, ProQuest)

Products powered by the AI Platform

Our broad investment in GenAI research is helping us embed AI wide and deep across our academia and government portfolio, with a range of solutions that are coming out this year and will continue to grow over time:

Web of Science Research Assistant
Helping researchers at all levels explore the world’s most trusted citation index – leveraging over a century of research – with natural language discovery, guided tasks, and contextual visualizations.

ProQuest Research Assistant
Enabling users to navigate millions of full text academic works within ProQuest and easily obtain new insights for research and learning.

Alethea Academic Coach
Nurturing students’ learning skills and critical thinking by guiding students to the core of their course readings, helping them distill takeaways and prepare for class discussion.

Primo Research Assistant
Transforming library discovery, providing users a new way to find and explore materials through natural language search, article references and recommended queries to support research.

Over time, the platform will expand its capabilities to support the introduction of AI capabilities into additional products, including Alma^TM, Ebook Central, EndNote^TM and Leganto® as well as present backend efficiencies such as metadata creation and enrichment.

Looking ahead

The v1.0 release of the Clarivate Academic AI Platform is just the beginning. As we move forward, we plan to roll out continuous updates and enhancements, working closely with customers and our newly formed Academic AI Advisory Council, aligned with technology advancements.

This platform marks a significant milestone in our effort to empower the academic community with innovative AI tools and technologies. Our commitment is to ensure that AI is used to enhance academic work while adhering to academic principles and the highest standards of ethical practice.

Interested in our Academic AI solutions? Learn more here.

The post Introducing the Clarivate Academic AI Platform appeared first on Clarivate.

While the drug has been on the mainland China market since 2021, its recent success can be attributed to the growing enthusiasm towards GLP-1 drugs that offer promising weight loss benefits.

Mainland China is at the forefront of the GLP-1 revolution

Mainland China presents an enormous commercial opportunity for drug developers in this space, as the total number of people living with T2D and obesity is the highest anywhere in the world. Clarivate epidemiological forecasts forecast the total obese population in the country to exceed 500 million2 by 2033, suggesting a huge paradigm shift in the way the disease is currently dealt with. With only two3 GLP-1 drugs currently approved for weight loss—Huadong Medicine’s version of daily dosed liraglutide and thrice-a-day dosed beinaglutide from Benamae Pharma—the gap is substantial and leaves a solid market opportunity for weight loss drugs.

What’s leading to the boom in development of semaglutide biosimilars?

A nationwide obesity problem is at the heart of semaglutide biosimilar development in Mainland China. Hangzhou Jiuyuan Gene Engineering (owned by Huadong Medicine) is expected to be the first domestic manufacturer to secure approval for their version of the drug once semaglutide goes off-patent in 20264 in Mainland China. The company filed for marketing approval of their semaglutide biosimilar for the treatment of T2D with the National Medical Products Administration (NMPA) in April 2024, and this is expected to amplify clinical development of semaglutide biosimilars from domestic manufacturers in the next two to three years.

A crowded semaglutide biosimilars pipeline is shaping up in Mainland China

*Biosimilars of semaglutide include both T2D and obesity patient segments (April 2024)

Source: Clarivate Cortellis

In a three-way battle, will price beat innovation?

Competition is expected to intensify in the next few years as both Novo Nordisk and Eli Lilly plan to launch their respective weight-loss drugs in Mainland China. While Wegovy® (Novo Nordisk) carries the same chemical compound semaglutide for weight loss, Lilly is expected to gain market approval on tirzepatide (Mounjaro® for T2D / Zepbound® for obesity) soon. Innovent Biologics, a domestic manufacturer, is currently evaluating its anti-diabetic and weight-loss GLP-1 drug, mazdutide, in a phase 3 trial in Mainland China, backed by Eli Lilly. Robust clinical data around multiple cardiometabolic indicators supported by all three assets is poised to lead widespread adoption in Mainland China. However, availability of cost-effective biosimilars of semaglutide starting 2026 is likely to influence patient perception of the drug in a price-sensitive Chinese market, especially for obese patients in the absence of reimbursement for weight loss drugs.

Centralized drug procurement – will the NHSA challenge semaglutide’s status quo?

The last time Novo Nordisk went for centralized drug procurement to get its insulins included in round 6 of Mainland China’s Value Based Pricing regimen, most long-acting and rapid-acting insulins were given substantial price cuts, impacting the sales of a solid billion-dollar segment in Mainland China. With biosimilars of semaglutide lined up for approval and launch, and with Ozempic inching closer to achieving blockbuster status, the NHSA will endeavor to initiate centralized drug procurement for semaglutide biosimilars. While this would warrant a price cut for the manufacturers, patients will eventually get access to quality medicines at a reduced cost and with a guarantee of supply to the public medical institution network.
With the Mainland Chinese therapeutic market for weight loss drugs undergoing a significant expansion spearheaded both by multinationals and domestic manufacturers, many biopharmaceutical companies will seek to capitalize on this momentum to enter the market and compete for share. While domestic firms are well-positioned to succeed in their home territory, owing to lesser logistical challenges, multinationals developing and selling GLP-1 drugs continue to expand access in a market driven by brand loyalty and strong word of mouth, backed by superior clinical data.

References:

1. China In-Depth: Type 2 Diabetes
2. Clarivate Epidemiology
3. China In-Depth: Obesity / Overweight
4. Novo Nordisk 2023 annual report

For Clarivate in-depth analysis of Mainland China’s GLP-1 receptor agonists market, read our China In-Depth | Type 2 Diabetes and China In-Depth | Obesity / Overweight content. Contact us to learn more about the Mainland China healthcare market and disease-specific trends.

To learn more about key domestic and multinational company drugs launching into the Mainland China marketplace, please download our Drugs to Watch 2024 report.

The post What a string of semaglutide biosimilars could mean for Mainland China appeared first on Clarivate.

Medicaid and health insurance exchange enrollment is shifting dramatically across the U.S. following the end of the COVID-19 public health emergency, which lapsed in May 2023.

According to Clarivate’s latest enrollment data, as of January 2024, Medicaid enrollment had plummeted by nearly 9 million compared to six months prior. This drop was caused by the ending of the redetermination of eligibility process for Medicaid that was enacted under the government’s emergency declaration.

Medicaid enrollment fell with the end of COVID-19 emergency measures

Source: Clarivate enrollment data as of January for each year (January 2024 enrollment is projected)

The considerable enrollment loss in Medicaid has presented a growth opportunity for health exchange enrollment nationwide, with membership increasing by more than 4 million.

Clarivate’s new enrollment survey numbers, which are scheduled for release in June, shed light on the impact of Medicaid verification efforts in all 50 states and the District of Columbia. States have taken a wide variety of approaches to re-verifying eligibility.

Several states moved quickly to terminate enrolment of those that did not respond to mailed questionnaires, resulting in large numbers of families applying to be restored to coverage. News stories have reported these members saying they never received the state’s packet in the mail and only found out they had been cut off upon going to the pharmacy.

Medicaid’s managed care organizations have followed their states’ actions closely, using their own outreach to help their members reapply or find subsidized coverage through insurance exchanges established by the Affordable Care Act.

In its Q4 earnings call, Molina noted that roughly one-third of its members had been terminated early on, but that more than 70% were removed for “procedural” reasons, not because they were determined to be ineligible. “As a result, we are seeing nearly 30% of those termed being reconnected, and we expect these numbers to grow,” said Molina CEO Joseph Zubretsky. “Given the high number of procedural terminations and increasing state and CMS interventions, we expect reconnects will likely continue decreasing currently reported membership losses.”

Reconnection to coverage is also variable by state, with some states forcing families to re-apply for coverage, a process that can take weeks.

Insurance exchanges underwent their largest single-year enrollment growth since their inception in 2014, pushing exchange enrollment to yet another all-time high.

After staying relatively flat for several years, enrollment growth took off in 2021 after an expansion in federal subsidies for silver-level plans passed in the American Rescue Plan and was then renewed through 2025 in the Inflation Reduction Act. That supercharged exchange enrollment and made crossing from Medicaid to exchange coverage easier.

For 2024, 18% of enrollees were new to exchange coverage, according to the Centers for Medicare and Medicaid Services.

Several of the national for-profit insurers, including national exchange leader Centene and Elevance Health, mirror the trend, with exchange enrollment taking another big leap while Medicaid enrollment declined. Coverage for national carriers such as Elevance and UnitedHealth Group has extended to the group commercial market as well, an indication that Medicaid redeterminations have moved some losing Medicaid coverage back under group coverage.

The enhanced subsidies are a key factor in uninsured rates not spiking after so many Americans have lost Medicaid coverage. Astute insurers also worked to move people losing that coverage to exchange plans, where subsidies can defray most of the premium cost.

Many insurers use similar networks for Medicaid and exchange plans, so shifting to an exchange plan is less likely to cause a lapse in coverage or abandonment of prescription drugs or maintenance medications that control chronic conditions.

Medicaid expansion states

While much of the Medicaid news highlights significant decreases in enrollment, some states have recently expanded Medicaid eligibility or have programs in place to ensure their residents maintain insurance coverage.

One example is North Carolina, which launched its Medicaid expansion Dec. 1, 2023. Under the expansion, North Carolina now provides Medicaid for adults ages 19 to 64 even if they make too much money to qualify for traditional Medicaid but are below eligibility to receive subsidized private insurance. According to Clarivate data, the state’s Medicaid enrollment increased 10.6% to about 2.5 million between January 2023 and January 2024.

In April 2024, Mississippi lawmakers reached a tentative deal to expand Medicaid to include more than 200,000 additional low-income residents, although hurdles remain to finalize this expansion.

In March 2024, New York received approval for a five-year Medicaid expansion through April 1, 2028, extending eligibility to include individuals with incomes up to 250% of the federal poverty level (eligibility was previously capped at 200%).

New York and Minnesota are the only two states to provide the Basic Health Plan through a Section 1331 waiver since 2015. The program, called the Essential Plan in New York, was created under the Affordable Care Act as a health coverage program for low-income residents who are eligible to purchase coverage through the marketplace but whose income fluctuates above and below Medicaid and CHIP levels.

Texas, Massachusetts and Connecticut are among the numerous states approved for a Section 1115 waiver to ensure Medicaid coverage. The CoveredCT program, approved in December 2022, offers no-cost health and dental insurance to eligible residents between the ages of 19 and 64 who exceed the Medicaid income limit, but do not exceed 175 percent of FPL and are enrolled in Access Health CT, the state’s marketplace.

Key takeaways

Although growth in commercial and exchange enrollment will blunt some impacts, an increased uninsured rate will lead to increased uncompensated care, adding to cost pressures for health systems, especially safety-net hospitals that will see the highest volume of people cut from Medicaid. This may also lead to gaps in care, reduced drug adherence, increased emergency room visits and a decline in chronic care management.

With the latest surge in exchange enrollment, commercial payers that have avoided exchange marketplaces might have to reconsider that strategy as the exchange business has become entrenched as a critical component in coverage.

On the other hand, unprecedented exchange growth could be short-lived since the subsidy cliff that existed before the American Rescue Plan could return if the enhanced subsidies are not renewed in 2025. Depending on the results of the 2024 election, coverage and subsidies under the ACA may come under scrutiny again.

Learn more about Clarivate Managed Market Surveyor enrolled lives data and trends reports or get in touch with a Clarivate representative here.

This post was authored by: Bill Melville, Lead Healthcare Research and Data Analyst; Paula Wade, Lead Healthcare Research and Data Analyst; and Valerie E. Pillo, Senior Healthcare Research and Data Analyst.

The post The U.S. health insurance market is undergoing a post-pandemic sea change appeared first on Clarivate.

As a result, 2023 saw an upsurge in merger and acquisition (M&A) and deal activity. According to BioWorld, M&A values in 2023 jumped 80% over 2022, and deal values reached BioWorld’s highest level ever recorded.

Doubling down on strategic therapeutic areas

Pharma once again finds itself having to narrow its sights on partnerships that deliver the next blockbuster and enable differentiation from the competition—all while navigating increasing regulatory scrutiny and shifting patient and payer expectations.

A prime example of strategic spending is Merck & Co./MSD, which continued its spending spree to strengthen its oncology portfolio. Following high-dollar deals in 2022 for antibody drug conjugates (ADCs) in the oncology space with Mersana Therapeutics and Kelun-Biotech, Merck/MSD once again led biopartnering activity in 2023. This time, the company paid top dollar for ADCs targeting solid tumors from Daiichi Sankyo, with the value of this single deal equaling all of its 15 deals in 2022. Other oncology-related deals for Merck/MSD included its acquisitions of Image Biosciences Inc and Harpoon Therapeutics.

In the neuroscience space, Bristol Myers Squibb acquired Karuna Therapeutics to gain access to KarXT. Initially under regulatory review to treat schizophrenia, KarXT is also being investigated for Alzheimer’s disease psychosis, Alzheimer’s disease agitation and bipolar I disorder. The acquisition complements BMS’s existing programs tackling neurodegenerative and neuromuscular diseases, including 20 programs in the discovery space and five in the clinic. Contributions to these programs come from BMS’s partnership with Evotec SE for neurodegeneration therapies, which the company renewed for the second time in 2023 at a value that landed the deal in the top 10 for the year.

Extending revenue through biologics

Under the IRA, small molecule drugs become eligible for price negotiation after nine years, while biologics are granted a safe harbor of 13 years. This could further fuel interest in ADCs and other antibodies for companies looking to maximize revenue, and ADCs and polyspecific antibodies have featured in many of the recent top deals.

The top ADC deal was that between Merck/MSD and Daiichi Sankyo. Coming in second place, Bristol Myers Squibb bolstered its oncology pipeline, which previously consisted of only two acquired ADCs, through ADC-related deals with Mainland China-based SystImmune, a Sichuan Biokin Pharmaceutical Co Ltd subsidiary, and with Germany-based Tubulis. This represents the first partnership for Tubulis, moving its ADC technologies closer to clinical proof of concept and opening the doors for future collaborations.

Amsterdam-based Synaffix B.V., a Lonza company, had a busy 2023. It entered multiple partnerships to provide access to its clinical-stage antibody conjugation technology, GlycoConnect, and ADCs developed from the platform. Two of its five agreements, with MacroGenics Inc and Amgen, fell within the top-valued deals for 2023, and other lucrative deals occurred with SOTIO Biotech, Hummingbird Bioscience and ABL Bio Inc. These add to the company’s previous licensing agreements with Genmab A/S, Kyowa Kirin Co Ltd, ProfoundBio, Innovent Biologics Inc, ADC Therapeutics SA, Emergence Therapeutics AG and others.

With regulatory approvals of bispecific antibodies reaching double digits, biopharma is building on the ability of these therapies to overcome the limitations of monoclonal antibodies by continuing to innovate and partner in this space. Two of the top five polyspecific antibody deals in 2023 involved trispecific or tetraspecific antibodies — between Mainland China-based WuXi Biologics and GSK plc and between Celltrion Inc and Cyron Therapeutics Co Ltd, both for oncology targets.

Other partnerships of note include one for a couple of Shanghai-based Elpiscience Biopharma Ltd’s preclinical bispecific antibody assets, licensed by Tokyo-based Astellas Pharma Inc, with the option to license two more. Both products are based on Elpiscience’s Bispecific Macrophage Engager (BiME®) platform and will undergo collaborative early-stage research between the two companies. This continues work between the companies that started with a shared interest in the concept of macrophages and a desire to investigate Claudin18.2 as a target for the BiME platform.

In addition, BioNTech signed a deal with Biotheus Inc for exclusive options to a preclinical-stage bispecific antibody candidate for oncology. This adds to the multiple high-value ADC deals BioNTech signed in 2023 for oncology targets and aligns with its plans to diversify and grow its pipeline of oncology candidates to include ADCs, cancer vaccines, cell therapies and more.

Partnering at the heart of innovation

Pharmas rely on biotechs to fill gaps in expertise, technology and resources, which will continue to drive opportunities for biotechs to partner or pursue acquisition to further their assets and continue innovation. As pharmas are increasingly selective about how they spend their money, biotechs would benefit from aligning their strengths with pharma companies’ priorities.

For more on how pharmas and biotechs are navigating a challenging financing environment, please view our recent webinar, Raising money in uncertain times: How private life science companies can overcome fundraising challenges.

The post Pharma is placing bigger bets on fewer, more strategic assets and platforms appeared first on Clarivate.

Discover how the Web of Science Research Intelligence platform will revolutionize research evaluation by driving responsible innovation and demonstrating societal impact.

At Clarivate, we recognize the pivotal role that research plays in shaping the future. That’s why we’re excited to announce the development of Web of Science Research Intelligence, a next-generation software solution powered by AI that will empower researchers to accelerate breakthroughs and research institutions to better measure and showcase the impact of their research.

Empowering innovation in a changing landscape

In today’s rapidly evolving research landscape, institutions face increasingly complex challenges that demand innovative solutions and strategic approaches. Clarivate conducted extensive research throughout 2023 to better understand current priorities and pain points among university research office executives. In addition to the Research Offices of the Future report from Research Professional News, product teams also conducted a series of in-depth qualitative interviews with leaders around the world. From mounting pressures to secure research funding to an urgent imperative to demonstrate societal impact beyond publications, the hurdles are diverse and ever present. University leaders and researchers must navigate increasing cost pressures, adapt to new technologies such as AI, and maintain the integrity of research outputs to remain competitive and relevant. Web of Science Research Intelligence represents the next generation of tools designed to empower institutions to meet these challenges head-on.

Currently being developed in partnership with leading academic institutions, Web of Science Research Intelligence is an AI-native platform that embodies a vision centered on three pillars: unification, innovation and impact. It seamlessly integrates funding data with research outputs that include publications, patents, conference proceedings, books, policy documents and more. Based on these data, the platform identifies relevant funding opportunities within emerging research areas, equipping institutions and researchers to innovate.

• A conversational assistant powered by generative AI enables all users to gain insights and create qualitative narratives for more balanced impact assessment, from data scientists to those with limited analysis experience.
• Tailored recommendations for collaboration and funding help early career researchers build their networks and all researchers position themselves to win.
• A new framework for measuring societal impact beyond traditional citation metrics will empower researchers and institutions to showcase the broader impacts of their work.

Unlocking the societal benefit of research 

Research funders and policymakers are increasingly placing a premium on the societal benefits derived from research investments. This shift underscores the growing imperative for research institutions to deliver findings that not only meet rigorous academic standards but also yield tangible contributions to the public. The Institute for Scientific Information (ISI) recently discussed the challenges of assessing the societal impact of publicly funded research and announced the forthcoming release of our proposed framework. With Web of Science Research Intelligence, institutions gain the ability to unearth and spotlight their sociological, economic, environmental, political, technological and sustainability impact at various levels — be it at the organizational, departmental, or researcher level — and the flexibility to define their own impact. This capability not only enriches the research narrative but also strengthens the case for continued support and recognition in an increasingly competitive landscape.

Web of Science Research Intelligence isn’t only about driving innovation; it is also about enhancing institutional efficiency and effectiveness. Recent studies have underscored the inefficiencies inherent in traditional research management processes. Researchers and administrators spend countless hours re-keying publication and grant information into university systems, while only a fraction of institutions effectively utilize data for decision-making. By streamlining administrative tasks of collecting, unifying and tracking faculty research outputs, our platform reduces friction so that researchers and administrators can focus on advancing knowledge and driving change— a fundamental aspect of our mission.

Shaping the future together

As part of our commitment to innovation, we recognize the invaluable role of collaboration with the research community. That’s why our approach to developing Web of Science Research Intelligence is centered on partnerships with research institutions. This partnership not only fosters trust in the technology and its applications but also ensures that our solution remains relevant and impactful in meeting the evolving needs and addressing the most pressing challenges of the research community.

“The University of Manitoba looks forward to being a strategic partner in the development of next-generation methodologies for assessing global research performance and emerging trends.”

“We are pleased to partner with Clarivate and peer institutions in the development of a novel technological solution to harness the power of research intelligence. Web of Science Research Intelligence has the potential to transform the way we map, fund and measure research opportunities and societal impact. This collaboration is a strategic move to integrate our collective expertise to benefit the global research enterprise.”

As we continue to develop Web of Science Research Intelligence in collaboration with academic partners around the world, we’re excited about the impact it will have on the future of research. With our platform, institutions will not only enhance their funding prospects and global visibility but also cultivate stronger research teams and solidify their position as leaders in innovation and academia.

We invite you to join us in shaping the future of research with Web of Science Research Intelligence. Together, we can unlock new opportunities, drive responsible innovation and shape the future of research and research management.

Learn more about Web of Science Research Intelligence here. To become an early adopter, contact us at wosripartners@clarivate.com

The post Reimagining research impact: Introducing Web of Science Research Intelligence appeared first on Clarivate.

Compumark

France – Trademark applications

France is the largest national level trademark register in the EU, with nearly 1.4 million active trademark records. The French National Institute of Industrial Property (INPI) received just over 92,000 trademark applications in 2023. Volume has been falling in recent years, after a record high in 2021 of nearly 113,000 applications.

Source: CompuMark SAEGIS®

Source: CompuMark SAEGIS®

Germany – Trademark applications

Germany also has a large and highly active national trademark register, with over 920,000 active trademarks and around 75,000 new trademark applications filed each year. Like France, filing volume peaked in 2021 with over 87,000 new trademark applications filed. Although filing activity has fallen since 2021, it is still higher than pre-pandemic levels.

Source: CompuMark SAEGIS®

German applicants accounted for 92% of all new trademark applications filed at the German Patent and Trademark Office (DPMA) in 2023. Visionborn IP was the leading applicant, filing 5,525 trademark applications during the year. It would appear that a high proportion of these are speculative and are not taken further: Visionborn IP has filed over 12,000 trademark applications at the DPMA but currently only owns 85 registered trademarks in Germany.

Source: CompuMark SAEGIS®

Italy – Trademark applications

Italy has an unusual feature on their trademark register: when trademark registrations are renewed they receive a new official number. Removing renewals from the analysis reveals that the Italian registry (UIBM – Ufficio Italiano Brevetti e Marchi) has seen remarkably stable trademark filing volume in recent years at around 40,000 new applications each year. 2021 was the exception, with a record 48,742 new applications filed.

Source: CompuMark SAEGIS®

The Italian trademark register is dominated by domestic brands. In 2023, Italian applicants filed over 96% of all new trademark applications lodged at the UIBM. Among the leading filers were Ferrari, although they were behind the Italian National Lottery, the Franciacorta wine region consortium and Italian Post.

Source: CompuMark SAEGIS®

Spain – Trademark applications

Spain receives around 50,000 trademark applications a year and filing activity has been relatively stable in recent years. Unlike other registers, Spain did not see a major increase in 2021; however a significant fall in trademark filing volume took place in 2022. Filing volume recovered in 2023, increasing by 8%

Source: CompuMark SAEGIS®

Spanish representatives provide the attorney/individual name when a trademark application is filed at the Spanish trademark office (OEPM – Oficina Española de Patentes y Marcas), making it difficult to determine which law firm is the representative for a given application or how many applications are filed by major IP legal practices.

Source: CompuMark SAEGIS®

BENELUX – Trademark applications

Benelux is a trademark register covering three neighbouring countries. The Benelux Office of Intellectual Property (BOIP) provides trademark registration for Belgium, the Netherlands and Luxembourg and typically receives 20,000 applications each year.

Source: CompuMark SAEGIS®

The Benelux register receives applications predominantly from local brands – around 95% of applications are filed by applicants in the three member countries. Despite being the smallest of the five major national EU registers, the 2023 top filer list contains a number of well-known global brands: GSK, Merck Sharp & Dohme, Rigo Trading (Haribo), Unilever, Philips, Formula One, Karl Lagerfield.

Source: CompuMark SAEGIS®

Although a European Trademark (EUTM) provides a cost-effective way to register a trademark in 27 countries, for businesses operating in just a single European country a national trademark registration in their home country may offer better value. As a result, each national trademark office in the EU is still active and receiving trademark applications at a stable rate, mostly from domestic brand owners.

About SAEGIS®

SAEGIS® makes it easy to perform knock-out searches of proposed trademarks in jurisdictions worldwide—whether you want an automated search strategy or prefer to create your own. Contact us today to request a demo or speak to a trademark search specialist: https://clarivate.com/contact-us/sales-enquiries/

The post Top trademark applicants and representatives 2023 – Examining European trademark registers appeared first on Clarivate.

The meteoric rise in popularity of a class of drugs for diabetes and weight loss has been weighing on medtech stocks. GLP-1 drugs like semaglutide (Ozempic®/Wegovy®) and tirzepatide (Mounjaro®/Zepbound®) spooked investors who feared that these treatments could disrupt a number of medical technologies, including surgical obesity interventions and orthopedics. We took a look at these drugs’ impact on the medtech sector for our forthcoming report, Medtech Trends to Watch in 2024, and found a more nuanced picture. Here are some of the report’s key findings:

• Rapid adoption of GLP-1s for weight loss will impact obesity interventions like bariatric surgeries, but drug costs and reimbursement policies will be factors. GLP-1s will offer an attractive option to patients hesitant to undergo an invasive surgical procedure, and manufacturers like Medtronic and Johnson & Johnson anticipate a temporary dip in surgery volumes. However, the high cost associated with the drugs, along with spotty reimbursement and side effects, could prompt some patients to reconsider a surgical approach whose safety and efficacy are well understood.

  Device-based treatments for comorbidities associated with obesity will also see an impact. For example, sleep apnea is another possible indication for GLP-1 treatments, with tirzepatide in late-stage clinical trials for the condition.

• The impact of GLP-1s on the medtech aesthetics market is likely to be mixed, benefiting some segments while undercutting others. As with bariatric surgery, more invasive fat reduction procedures like liposuction could see reductions as some patients opt for an injectable option, and some aesthetic physicians have already seen fewer patients coming in for even noninvasive fat reduction procedures, per Clarivate physician surveys. On the other hand, rapid weight loss can lead to reduced skin elasticity, which could drive demand for aesthetic injectable treatments like dermal fillers and complementary cosmetic procedures like skin tightening and rejuvenation.
• Similarly, in the orthopedics space, use of GLP-1s could actually drive increased volumes of some procedures. Companies like Stryker and Smith & Nephew have acknowledged the potential of GLP-1s to impact the joint reconstructive implant market, but noted that the cost to patients of these drugs is likely to limit their reach. Meanwhile, the large joint reconstructive implant space could see an expanded pool of eligible patients as some who previously did not qualify for surgeries achieve the BMI levels necessary for surgery. These drugs could also enlarge the pool of candidates for major joint surgeries as patients become more physically active after achieving weight reductions, as Stryker has noted.

“The overall impact GLP-1 adoption will have on medical technologies is still a big question mark that will really hinge on long-term clinical data and coverage for the drugs, which so far has trended somewhat favorably. Device-based treatments will definitely be affected both directly, such as in the case of bariatric surgeries, and more downstream, in the case of treatments for conditions linked to obesity like heart disease and diabetes. However, weight loss in GLP-1 users also creates a bigger pool of patients eligible for certain surgeries who previously weren’t. Ultimately, all this points toward a shift in market dynamics rather than all-loss situation for medtech players.”

This and other key trends impacting the medtech industry are covered in a forthcoming Clarivate report, Medtech Trends to Watch in 2024, and will be discussed in a May 8 webinar, Medical Technologies to Watch 2024. You can register for the webinar here.

The post What GLP-1 drugs mean for medtech appeared first on Clarivate.

Last year, we announced our collaboration with the research community to bring a new generative-AI-powered capability to the Web of Science — the Web of Science Research Assistant. Since we released the beta to our development partners around the world, we have identified innovative ways to ensure the quality, strength and suitability of generative AI for academic researchers. We are excited to announce that our research assistant will be available from September 2024.

Harnessing AI to support researchers’ decisions

We are carefully considering how AI technology can be leveraged in a way that solves problems for researchers, and we see an opportunity for the Web of Science Research Assistant to provide much more than conversational search. In addition to streamlining discovery of content, the tool will encourage research skill-building and surface useful information on the underlying dynamics of a research field. By proactively serving up relevant, context-specific insights at the point of need, our assistant helps researchers make decisions about their next research step.

Our development partners have also shared positive feedback about the future of the research assistant. Juan P. Denzer, Engineering & Computer Science Librarian at Syracuse University, said “We’re excited about the AI features that Web of Science is developing. I think Web of Science Research Assistant will be far superior to the other genAI tools currently available to faculty and students at the moment.”

We are using AI to help researchers conduct research more efficiently, and we do that in two ways. First, improved search capabilities quickly lead researchers to relevant content. More importantly, we’ll also help researchers tackle complex and involved tasks, such as understanding a topic, finding a journal for a manuscript and completing a literature review. The Web of Science Research Assistant offers innovative functionality that complements our broader AI-assisted search experience. Our goal is to help researchers at all levels get more out of their interactions with the trusted publication and citation data in Web of Science Core Collection.

^{Figure 1: Web of Science Research Assistant interface}

As we further develop the research assistant, we are also improving the general search experience in the Web of Science in parallel. Natural language, semantic search provides users with more flexibility. Keyword suggestions and spelling corrections offer a smarter search experience. And restructuring our document and author search interfaces will make it simple to locate experts on a topic using our meticulously indexed data.

Key features surface deeper research insights

Web of Science Research Assistant takes the idea of an enhanced, simplified discovery experience even further.

• Multilingual searching creates a more efficient environment for users, where they can find content and explore its relevance in their own language.
• Commentaries of search results spanning over 120 years of research help users swiftly explore foundational and emerging topics.
• Contextual, timely prompts reveal additional ways to view and understand the data or refine the scope of a research question.
• Unique data visualizations bring the myriad connections between people, papers and concepts into focus.

The Web of Science Research Assistant delivers relevant information at the right time without requiring users to navigate search and visualization menus.

^{Figure 2: Co-citation map in Web of Science Research Assistant}

A user can approach the Web of Science Research Assistant with a broad range of question types or tasks in mind—a search for research articles only scratches the surface of what the tool can do.

For example, in addition to retrieving results and highlighting top cited papers, the research assistant can also reveal how and why researchers are citing a paper by leveraging enriched cited reference data. This additional context offers researchers a signpost so they can more adeptly explore the literature.

Or take the example of a researcher trying to find the best-fit journal for their manuscript. An author may take many factors into consideration when submitting a paper, and the research assistant guides the user to descriptive profiles of potential matches based on the title and abstract of a paper.

Partnering with the community to responsibly implement AI

By partnering with the community and leveraging our high-quality, reliable data and expertise, we are responsibly implementing cutting-edge technology in the Web of Science to improve research discovery and analytics. We strive to create an engaging, insightful researcher experience, and we are excited to continue that journey with the Web of Science Research Assistant.

Learn more about the Web of Science Research Assistant here and more about our approach to Academic AI here.

The post Beyond discovery: AI and the future of the Web of Science appeared first on Clarivate.