Negotiating pricing and payment terms for insurance covered mHealth apps: a qualitative content analysis and taxonomy development based on a German experience.

BACKGROUND: Germany was the first country worldwide to offer mobile digital health applications (mHealth apps, "DiGA") on prescription with full cost coverage by statutory health insurances. Especially statutory health insurances criticize the current pricing and payment regulations in Germany due to "free and non-transparent" pricing in the first year and lack of cost use evidence. The study consists of two parts: The first part evaluates interests of digital health application providers and statutory health insurances in Germany to identify overlaps and divergences of interests. The second part includes the development of a comprehensive pricing and payment taxonomy for reimbursable mHealth apps in general. METHODS: Both parts of the study used the input from 16 expert interviews with representatives of digital health application providers and statutory health insurances in Germany. In part one the authors conducted a qualitative content analysis and in part two they followed the taxonomy development process according to Nickerson et al. (2013). RESULTS: A value based care model is expected to bring the greatest benefit for patients while statutory health insurances welcome the idea of usage based pricing. The final pricing and payment taxonomy consists of four design and negotiation steps (price finding, payment prerequisites, payment modalities, composition of negotiation board). CONCLUSIONS: As healthcare resources are scarce and thus need to be optimally allocated, it is important to implement pricing and payment terms for reimbursable mHealth apps that result in the greatest benefit for patients. To the best of the authors' knowledge, there has been no structured study yet that examines alternative pricing strategies for reimbursable mHealth apps.The developed pricing and payment taxonomy for reimbursable mHealth apps serves as planning and decision basis for developers, health policy makers and payers internationally.

Escalating costs of innovative medicines: perspective and proposals.

Public healthcare systems are challenged by the soaring costs of medications that require increasing resources, often at the expense of other investments. The increasing pharmaceutical budget poses a threat to the allocation of funds for essential preventive and primary healthcare services while also raising concerns about equitable access, particularly in models where patients bear part of the costs out of their own pockets. Proposals on how to ensure ongoing and long-term accessibility, efficiency, and financial stability are required. The escalating costs of medicines may be explained in part by the mismatch between the traditional value-based pricing and reimbursement frameworks and the type of clinical development of targeted therapies and precision medicine in clinical practice. New appraisal methods and managed access strategies should be adapted to therapies targeting small populations and addressing increased uncertainty. Fair pricing strategies, transparent healthcare investments based on problems and outcomes, regulatory reforms, international cooperation, and critically examining the drug acquisition model are potential solutions. Transitioning from an industry-driven pricing approach to a health-driven payment model can help align the cost of treatments with actual health outcomes, establishing a foundation for a healthcare system that addresses immediate challenges and fosters long-term well-being. Acknowledging the lack of a universally applicable solution, the practical implementation of interventions requires a reframing of the pricing and access system and adaption to the targeted therapeutic approaches. Balancing innovation with financial sustainability necessitates a collaborative, adaptive, and transparent approach, as well as transitioning toward health-driven payment models, moving the focus from the cost of medications to the well-being of populations worldwide.

Dynamics of biological markets with multiple biosimilar competitors in the United States.

BACKGROUND: The dynamics of biological markets with multiple biosimilar competitors in the United States are poorly understood. Moreover, due to confidentiality issues, the relationship between originator biologic net prices, rebates, and biosimilar entry is largely unexplored. RESEARCH DESIGN AND METHODS: We conducted a review of the Food Drug Administration (FDA) purple book and manufacturer websites to identify all originator biologics with multiple competitors and their characteristics. We leveraged a novel data source to examine originator biologic net prices and rebates over time and used descriptive statistics and interrupted time-series analyses to assess their relationship with biosimilar entry. RESULTS: By December 2022, only five originator biologics had three or more available biosimilar competitors. Mean time between biosimilar approval and biosimilar launch was 9 months (SD = 7.04 months). By third biosimilar competitor, entry net prices for originator biologics had decreased by 9.34% to 50.93%, while rebates had increased by 25.35% to 89.71%. CONCLUSIONS: Very few originator biologics have multiple available biosimilar competitors. Barrier to biosimilar availability seems to be at the approval level as the time between approval and launch is relatively short. However, originator biologics respond quickly to biosimilar competition, mainly through an increase in rebates.

Indivisibilities in investment and the role of a capacity market.

The topic of pricing non-convexities in power markets has been explored vividly in the literature and among practitioners for the past twenty years. The debate has been focused on indivisibilities in short-term auctions, the computational tractability of some pricing proposals, and the economic analysis of their behavior. In this paper, we analyse a source of non-convexities that is not discussed as broadly: the indivisibilities in investment decisions. The absence of equilibrium that we are primarily concerned about is the long-term equilibrium. We derive a capacity expansion model with indivisibilities and we highlight the issues arising from it. We discuss its relevance and address one particular argument for neglecting indivisibilities in investment, namely market size. We investigate to what extent a capacity market that clears discrete offers can mitigate the lumpiness problem. We particularly introduce the novel concept of convex hull pricing for capacity auctions. We illustrate the main findings with a numerical experiment conducted on the capacity expansion model used by ENTSO-E to assess the adequacy of the entire European system. Supplementary Information: The online version contains supplementary material available at 10.1007/s11149-024-09473-6.

Cost-utility analysis and drug pricing of once-weekly insulin icodec versus once-daily insulin degludec for type 2 diabetes patients treated with basal insulin in China.

AIM: Insulin icodec is a first once-weekly administration basal insulin analogue for type 2 diabetes. This study aimed to investigate the price range of icodec for type 2 diabetes in the Chinese market, taking insulin degludec as reference. MATERIALS AND METHODS: Long-term health outcomes and costs for icodec and degludec were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model (version 2.1) over 40 years from the Chinese healthcare provider's perspective. The efficacy and safety data were obtained from the ONWARDS 2 trial (Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial). Cost-utility analysis and a binary search were used to investigate the price range of icodec. Sensitivity analyses were performed to verify the robustness of the base-case analysis results. RESULTS: After a 40-year simulation, the quality-adjusted life years (QALY) of icodec and degludec were 10.32 and 10.28 years, respectively. At the initial assumption of the same annual costs of icodec and degludec of $455.40, icodec was the dominant therapy compared with degludec, with higher QALYs and lower total cost. After the binary search, we observed that the annual cost range of icodec was $625.17-$855.25. This cost range was finally adjusted to be $597.66-$736.34 using one-way sensitivity analysis and confirmed using probabilistic sensitivity analysis and scenario analysis. The scenario analysis revealed that the annual cost range of icodec could be $506.70-$736.34 if the price of degludec decreased by 20% in the future. CONCLUSION: Insulin icodec appears to be more cost effective than degludec if the annual cost of icodec ranges from $597.66 to $736.34 for patients with type 2 diabetes in China.

Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price.

OBJECTIVE: This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. METHODS: We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000-2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response's relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. RESULTS: The median development time for breast cancer drugs was 7.8 years (95% CI 6.2-10.8). 26% of treatments were considered innovative ("first-in-indication") with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA's special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417-752) at 181 centers (IQR 142-223) across 19 countries (IQR 17-20). New drugs' HR were 0.78 for OS (95% CI 0.74-0.82) and 0.59 for PFS (95% CI 0.54-0.64) with a RR for tumor response of 1.61 (95% CI 1.46-1.76). Median improvements of OS were 2.8 months (IQR 1.8-5.8) and PFS were 4.4 months (IQR 2.2-7.1). In single-arm trials, the average ORR was 31% (95% CI 10-53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a 'high-value' ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097-17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840-86,062). CONCLUSIONS: Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life.

The improved integrated Exponential Smoothing based CNN-LSTM algorithm to forecast the day ahead electricity price.

The deregulation of electricity market has led to the development of the short-term electricity market. The power generators and consumers can sell and purchase the electricity in the day ahead terms. The market clearing electricity price varies throughout the day due to the increase in the consumers bidding for electricity. Forecasting of the electricity in the day ahead market is of significance for appropriate bidding. To predict the electricity price the modified method of Exponential Smoothing-CNN-LSTM is proposed based on the time series method of Exponential Smoothing and Deep Learning methods of Convolutional Neural Network (CNN) and Long Short-Term Memory (LSTM). The dataset used for assessment of the forecasting algorithms is collected from the day ahead electricity market at the Indian Energy Exchange (IEX). The forecasting results of the Exponential Smoothing-CNN-LSTM method evaluated in terms of Mean Absolute Error (MAE) as 0.11, Root Mean Squared Error (RMSE) as 0.17 and Mean Absolute Percentage Error (MAPE) as 1.53 % indicates improved performance. The proposed algorithm can be used to forecast the time series in other domains as finance, retail, healthcare, manufacturing.•The method of Exponential Smoothing-CNN-LSTM is proposed for forecasting the electricity price a day ahead for accurate bidding for the short-term electricity market participants.•The forecasting results indicate the better performance of the proposed method than the existing techniques of Exponential Smoothing, LSTM and CNN-LSTM due to the advantages of the Exponential Smoothing to extract the levels and seasonality and with the CNN-LSTM methods ability to model the complex spatial and temporal dependencies in the time series.

Pricing dynamics of anti-seizure medications in the U.S.

BACKGROUND: The median cost of anti-seizure medications (ASM) in the United States (U.S.) nearly doubled per person between 2006 and 2021. This increase, combined with shifts in ASM usage and the impact of the COVID-19 pandemic on drug supply chains amid rising inflation, underscored the urgent need to scrutinize ASM pricing dynamics. This study aimed to analyze the complex dynamics of ASM pricing in the U.S. over the past decade (2013-2023); this included how the entry of generic ASMs influenced the pricing of brand-name counterparts and what impacted price variations across different ASM formulations (e.g., significant inflation, the COVID-19 pandemic). METHODS: This study utilized National Average Drug Acquisition Cost (NADAC) data from November 2013 to July 2023. We adjusted ASM prices for inflation using the Consumer Price Index for Medicinal Drugs - Seasonally Adjusted (CPI-MDS). Statistical analyses included fixed effects regressions and multivariable regression analysis to evaluate the impact of inflation, the number of medication labelers, and the COVID-19 pandemic on ASM prices. RESULTS: Our study analyzed 23 ASMs approved by the U.S. Food and Drug Administration (FDA), which encompassed 223 oral formulations:112 brand-name and 111 generics. From 2013-2016 to 2020-2023, accounting for standard deviations (SD), the average price of brand-name ASMs increased from $8.71 (SD 5.9) to $15.43 (SD 10.7), while generic ASMs saw a slight decrease from $1.39 (SD 1.8) to $1.26 (SD 1.6). Consequently, the price gap between brand-name and generic ASMs surged from 1452.39 % to 3399.26 %. The proportion of matched brand-name and generic ASMs with a price difference of 1000 %-9999 % increased from 32.88 % (2013-2016) to 41.43 % (2020-2023), while those exceeding 10,000 % rose from 16.44 % to 20 % in the same period. Generic immediate-release (IR) formulations were significantly less expensive than extended-release (ER) or delayed-release (DR) counterparts, with cost differences reaching up to 7751.20 %. The number of medication labelers was inversely related to generic ASM prices, which decreased by 5.45 % (p = 0.001) with each additional generic labeler, while brand-name ASM prices increased by 2.46 % (p < 0.001) with each additional generic labeler. The COVID-19 pandemic led to a 24.4 % increase in brand-name ASM prices and a 23.1 % decrease in generic ASM prices. CONCLUSIONS: The findings reveal an expanding price disparity between brand-name and generic oral ASMs. An inverse relationship was observed between the number of medication labelers and generic ASM prices, with additional labelers driving down generic prices. However, introducing more generic labelers led to a significant increase in brand-name ASM prices. Furthermore, following patent expirations, brand-name ASM prices rose-a trend explained by the "generics paradox," where, contrary to expectations, brand prices do not decrease and may even increase when generics enter the market. These findings underscore the need for targeted interventions in drug pricing policies to manage the rising costs associated with epilepsy treatment. To ensure equitable access to ASMs, stakeholders must understand and address the factors driving these pricing dynamics.

Exposing the pitfalls of plastics mechanical recycling through cost calculation.

The plastic industry needs to match the recycling goals set by the EU. Next to technological hurdles, the cost of plastics mechanical recycling is an important modality in this transition. This paper reveals how business economic cost calculation can expose significant pitfalls in the recycling process, by unravelling limitations and boundary conditions, such as scale. By combining the business economic methodology with a Material Flow Analysis, this paper shows the influence of mass retention of products, the capacity of the processing lines, scaling of input capacity, and waste composition on the recycling process and associated costs. Two cases were investigated: (i) the Initial Sorting in a medium size Material Recovery Facility and (ii) an improved mechanical recycling process for flexibles - known as the Quality Recycling Process - consisting of Additional Sorting and Improved Recycling. Assessing the whole recycling chain gives a more holistic insight into the influences of choices and operating parameters on subsequent costs in other parts of the chain and results in a more accurate cost of recycled plastic products. This research concluded that the cost of Initial Sorting of flexibles is 110,08-122,53 EUR/t, while the cost of subsequent Additional Sorting and Improved Recycling ranges from 566,26 EUR/t for rPE Flex to 735,47 EUR/t for rPP Film, these insights can be used to determine a fair price for plastic products. For the Quality Recycling Process it was shown that rationalisation according to the identified pitfalls can reduce the cost per tonne of product by 15-26%.

Econometric analysis of factors influencing electricity consumption in Spain: Implications for policy and pricing strategies.

This study employs a comprehensive database of Spanish homes and econometric modeling to assess the factors influencing electricity consumption in Spain. Using panel data covering the period from 1998 to 2023, we analyzed the average yearly electricity usage across the 18 Spanish regions. Our findings reveal that fluctuations in electricity prices have remained the primary driver of consumption over this period. The price elasticity of demand has been exceptionally high, exceeding levels observed in earlier research and periods. Additionally, factors such as income, hours of sunlight, and temperature fluctuations positively influence electricity usage, albeit to a lesser extent than household and family characteristics (e.g., whether a single parent heads the household or if it includes foreign residents). There is no significant correlation between demand and factors such as the age or employment status of family members. Based on these findings, policy actions that target power pricing (e.g., price-based instruments) are likely to be the most effective in reducing electricity consumption.

The 340B Program and High-Risk Prescribing of Oral Targeted Therapies for Advanced Prostate Cancer.

INTRODUCTION: The use of expensive oral targeted agents for advanced prostate can be influenced by those who stand to gain from their use. The 340B drug pricing program allows eligible hospitals to purchase medications at steep discounts, generating millions of dollars in savings. The extent to which hospitals engage in higher-risk prescribing due to program incentives is unclear. METHODS: Medicare claims were used to perform a retrospective study of men with advanced prostate cancer. The primary outcome was targeted therapy use in men with high noncancer mortality risk. Secondary outcomes included androgen biosynthesis inhibitor use in men with cardiovascular history, androgen receptor inhibitor use in men with neurocognitive history, and therapy within 14 days of death. Proportional hazards models were used to assess time-to-event outcomes, while logistic regression was used for binary outcomes. RESULTS: In men with high noncancer mortality risk, targeted therapy use did not differ at 340B participating compared to nonparticipating hospitals (hazard ratio [HR] 1.1, 95% CI 0.67-1.5). There was no difference in androgen biosynthesis inhibitor use in men with a prior cardiac event (HR 0.96, 95% CI 0.70-1.3) or androgen receptor inhibitor use in men with a prior neurocognitive event (HR 1.5, 95% CI 0.65-3.4) in those treated at 340B participating compared to nonparticipating hospitals. Therapy use in the last 14 days of life did not vary by 340B participation (odds ratio 1.3, 95% CI 0.86-1.9). CONCLUSIONS: In men with advanced prostate cancer, high-risk prescribing and futility measures did not vary by participation in the 340B drug pricing program.

Informing the United States Medicare Drug Price Negotiation for Apixaban and Rivaroxaban: Methodological Considerations for Value Assessments Many Years After Launch.

OBJECTIVES: To demonstrate how health technology assessment methods can be used to support Medicare's price negotiations for apixaban and rivaroxaban. METHODS: Following the statutory outline of evidence that will be considered by Medicare, we conducted a systematic literature review, network meta-analyses, and decision analyses to evaluate the health outcomes and costs associated with apixaban and rivaroxaban compared with warfarin and dabigatran for patients with nonvalvular atrial fibrillation. Our methods inform discussions about the therapeutic impact of apixaban and rivaroxaban and suggest price premiums above their therapeutic alternatives over a range of cost-effectiveness thresholds. RESULTS: Network meta-analyses found apixaban resulted in a lower risk of major bleeding compared with warfarin and dabigatran and a lower risk of stroke/systemic embolism compared with warfarin but not compared with dabigatran. Rivaroxaban resulted in a lower risk of stroke/systemic embolism versus warfarin but not dabigatran, and there was no difference in major bleeding. Decision-analytic modeling of apixaban suggested annual price premiums up to $4350 above the price of warfarin and up to $530 above the price for dabigatran at cost-effectiveness thresholds up to $200 000 per equal value of life-years gained. Analyses of rivaroxaban showed an annual price premium of up to $3920 above warfarin and no premium above that paid for dabigatran. CONCLUSIONS: Although health technology assessment is typically performed near the time of regulatory approval, with modifications, we produced comparative clinical and relative cost-effectiveness findings to help guide negotiations on a "fair" price for drugs on the market for over a decade.

The impact of differential pricing subject on consumer behavior.

The escalating use of artificial intelligence in marketing significantly impacts all aspects of consumer life. This research, grounded in attribution theory and S-O-R theory, employs scenario-based experimental methods to simulate two distinct purchasing contexts. The aim is to investigate consumers' psychological and behavioral responses to AI-initiated pricing. Through SPSS analysis of variance and Bootstrap analysis, the mechanisms of influence of AI-initiated pricing on consumer behavior are tested, revealing the mediating variables of mind perception and consumer perceived ethicality, as well as the mediating variables of perceived enterprise control. Data were collected from Chinese customers to test the model of this study. A total of 841 valid questionnaires were analyzed using ANOVA and Bootstrap analysis with SPSS. The results show that: (1) Consumers exhibit higher repurchase and word-of-mouth recommendation behaviors and lower complaint and switching behaviors for AI-initiated pricing compared to marketers; (2) AI-initiated pricing leads to diminished mind perceptions and augmented ethical perceptions among consumers. Ethical perceptions serve as a complete mediator, while mind perceptions play a less significant mediating role; (3) Perceived enterprise control plays a moderating role in the impact of AI-initiated pricing on consumer behavior. That is, when consumers know that the enterprise can control pricing agents, AI-initiated pricing leads to lower repurchase and word-of-mouth recommendation behaviors, and higher instances of complaining and switching behaviors than humans.

Which factor reduces pharmaceutical expenditure, number of entrants or price variance? Updated generic drug markets in South Korea.

BACKGROUND: Introducing more generics has been a successful strategy for lowering pharmaceutical prices and expenditure. However, the effect of the strategy depends on the pricing schemes for generics. We aimed to update the South Korean generic markets in terms of effective competition, and to examine the effects of number of manufacturers and price variance on pharmaceutical expenditure. METHODS: We constructed balanced panel data provided by the Health Insurance Review and Assessment Service covering 726 reimbursed substances from 2019 to 2023. We developed original indicators to analyze the generic markets: the maximum-minimum price variance (MMPV) and the maximum-weighted price variance (MWPV). Panel regression with fixed and time-fixed effects was used. RESULTS: Over the study period, the number of manufacturers increased from 17.81 in 2019 to 20.98 in 2020 and then decreased to 18.70 in 2023. The MMPV increased from 204.70 in 2019 to 230.07 in 2022 and then decreased slightly to 225.34 in 2023. The MWPV increased from 59.70 in 2019 to 72.58 in 2023. Two types of segmented markets were noteworthy: low use of low-cost generics with sufficient manufacturers and high use of low-cost generics with insufficient manufacturers. In the fixed and time-fixed effects panel analyses, the MWPV presented a negative association with the number of manufacturers and a positive association with the MMPV. CONCLUSIONS: A newly introduced tiered pricing scheme, designed to differentiate generic prices, was associated with a decrease in the number of manufacturers and an increase in price dispersion. The pricing schemes for generics should be designed with price variance in mind and limit the number of too many generics in South Korea.

Commercial markups on pediatric oncology drugs at 340B pediatric hospitals.

Eligible pediatric hospitals can purchase clinician-administered drugs at discounted rates through the 340B Drug Pricing Program and charge payers prices exceeding drug acquisition costs, but the magnitude of these markups is not known. In a study of newly approved oncology drugs at pediatric 340B hospitals, median negotiated prices ranged from 102% (interquartile range [IQR]: 91%-156%) of average sales price (ASP) at Phoenix Children's Hospital to 630% (IQR: 526%-630%) at Driscoll Children's Hospital. Pediatric hospitals participating in the federal 340B Drug Pricing Program can extract steep payments on new drugs from commercial insurers, though with wide variation between and within hospitals.

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.

Challenges for novel antiretroviral development in an era of widespread TLD availability.

Over 80% of people living with HIV in low-and-middle-income countries (LMICs) take first-line TDF/XTC/DTG (TLD). Due to hard-fought activism, in >100 LMICs TLD now costs under $45pppy under Voluntary License. With final DTG patents expiring by 2029, generic TLD will soon be available globally. We identify seven critical benchmarks underpinning TLDs success which novel ART should now meet, and an eighth for which novel ART should aim. These are superior efficacy; a high genetic barrier to resistance; safety in hepatitis B coinfection; favourable drug-drug interaction profiles including with antimycobacterials; efficacy in HIV-2; safety in pregnancy, long-acting formulation availability and affordable pricing from the outset. We illustrate when generic TLD will become available worldwide and compare this with trial programmes and approval timelines for two case-study novel ART combinations: islatravir/doravirine and cabotegravir/rilpivirine. We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD.

Assessing carbon tax using a CGE model with firm heterogeneity: An application to Vietnam.

Vietnam's government is considering introducing a carbon market as part of its decarbonization strategy. The carbon tax is an option for the government to regulate greenhouse gas emissions. We evaluate the potential macroeconomic and climate impacts of carbon tax policy in Vietnam using a unique data set and simulation analysis with a multi-sector dynamic computable general equilibrium model. The model allows for firm heterogeneity: domestic firms and foreign-invested enterprises. The results show that with plausible tax rates, emissions can be reduced to levels 1.3-2.8 percent below the target value of emissions in 2030. The cost is a loss in GDP by 1.2-2.7 percent in 2030. The results also show that foreign-invested enterprises tend to increase emissions in the medium run even with a carbon tax while a carbon tax is more effective when applied to domestic firms. In addition, a substantial reduction in emissions from the energy sector and improvement in energy efficiency are keys to success in carbon abatement.

Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative.

National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry's internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration's potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape.