Price Negotiation Research Articles

Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016-2019 data.

To reduce Medicare prescription drug expenditures, the 2022 Inflation Reduction Act (IRA) allows the Centers for Medicare & Medicaid Services (CMS) to directly negotiate with drug manufacturers on Medicare prices of high-expenditure drugs (≥$200m annual spending) which meet certain eligibility criteria. However, it is unclear what proportion of high-expenditure drugs covered by Medicare, and attributable annual drug spending, would typically be eligible for CMS negotiations in a given year. We used historical Medicare drug spending data to determine how many high-expenditure drugs, and attributable drug spending, would have been eligible for CMS negotiations had the IRA been in effect from 2016-2019, while also determining which of the IRA's eligibility criteria is most restrictive. From 2016-2019, approximately one third (33.3% for Part B, 32.4% for Part D) of high-expenditure Medicare drugs would have been eligible for negotiation, with ineligible drugs accounting for 75.2% and 63.8% of spending on high-expenditure drugs in Medicare Part B and D, respectively. Most ineligible high-expenditure drugs were ineligible because they launched too recently. From 2016-2019, between 59 and 74 high-expenditure drugs were eligible per year, indicating that in some years there may not be enough eligible drugs for CMS to negotiate on the maximum number of drugs allowable by law. The IRA's current eligibility criteria may restrict CMS from being able to negotiate drug prices on approximately two-thirds of the high-expenditure drugs covered by Medicare and may not allow CMS to negotiate on the maximum number of drugs allowable by law. Congress could consider relaxing eligibility requirements for price negotiation, such as those pertaining to launch date recency, to ensure there are a sufficient number of high-expenditure drugs eligible for negotiation or make certain ineligible drugs contributing to significant annual Medicare spending eligible for negotiation on a case-by-case basis.

Post-approval indications and clinical trials for cardiovascular drugs: some implications of the US Inflation Reduction Act

Objective To describe the historical baseline landscape of cardiovascular drug post-approval activity, including the number and timing of post-approval clinical trials and approved indications. The US Inflation Reduction Act of 2022 (IRA) Drug Price Negotiation Program (DPNP) and its Maximum Fair Prices (MFPs) will affect incentives for investment in post-approval activity such as clinical trials for new indications. While three of the first ten drugs selected for the DPNP and MFP-setting are cardiovascular or antithrombotic drugs, limited attention has been paid to potential cardiovascular drug impacts, and to post-approval innovation. Methods For the 65 drugs originally approved by the FDA from 1995 through 2021 for a cardiovascular or antithrombotic indication (60 small molecules and 5 biologics), we develop a novel dataset of industry-sponsored, post-approval clinical trials and FDA-approved label changes for new indications. We analyze their number and timing relative to DPNP drug selection and MFP implementation dates, by drug approval-year cohort. Results We find 49% of indications were awarded and 76% of industry-funded clinical trials were completed post-approval, reaching 98% of trials for drugs in the earliest 1995–99 cohort. For the 60 small molecules, 76% of post-approval trials ended five years or more after original drug approval, 65% ended seven or more years after original drug approval (i.e. after potential DPNP selection), and 53% nine or more years after original drug approval (i.e. after potential MFP implementation). Conclusions Post-approval FDA indication approvals and clinical trial starts and primary completion dates often occurred after or near new DPNP selection and MFP implementation dates. This has economic consequences for future investment incentives. Post-approval trials for small molecules, longer-duration trials, and larger-enrollment trials, and post-approval indications focused on limited patient populations and older patients could face particular economic challenges.

The role of budget impact and its relationship with cost-effectiveness in reimbursement decisions on health technologies in the Netherlands

Health authorities using cost-effectiveness analysis (CEA) for informing reimbursement decisions on health technologies increasingly require economic evaluations encompassing both CEA and budget impact analysis (BIA). Good Research Practices advocate that the economic and clinical assumptions underlying these analyses are aligned and consistently applied. Nonetheless, CEAs and BIAs often are stand-alone analyses used in different stages of the decision-making process. This article used policy reports and Ministerial correspondence to discuss and elucidate the role of budget impact and its relationship with cost-effectiveness in reimbursement decisions in the Netherlands. The results indicate that CEAs and BIAs are both considered important for informing these decisions. While the requirements regarding CEAs—and application of the associated decision rule—are consistent across the different stages, the same does not hold for BIAs. Importantly, the definition of and evidence on budget impact differs between stages. Some important aspects (e.g. substitution and saving effects) typically are considered in the assessment and appraisal stages but are seemingly not considered in price negotiations and the final reimbursement decision. Further research is warranted to better understand why BIAs are not aligned with CEAs (e.g. in terms of underlying assumptions), vary in form and importance between stages, and do not have a clear relationship with the results of CEAs in the decision-making framework. Improving the understanding of the circumstances under which decision-makers attach a relatively larger or smaller weight to (different aspects of) budget impact may contribute to increasing the transparency, consistency, and optimality of reimbursement decisions in the Netherlands.

Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials.

The sodium glucose cotransporter-2 inhibitors are guideline-recommended to treat heart failure across the spectrum of left ventricular ejection fraction; however, economic evaluations of adding sodium glucose cotransporter-2 inhibitors to standard of care in chronic heart failure across a broad left ventricular ejection fraction range are lacking. We conducted a US-based cost-effectiveness analysis of dapagliflozin added to standard of care in a chronic heart failure population using pooled, participant data from the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trials. The 3-state Markov model used estimates of transitional probabilities, effectiveness of dapagliflozin, and utilities from the pooled trials. Costs estimates were obtained from published sources, including published rebates in dapagliflozin cost. Adding dapagliflozin to standard of care was estimated to produce an additional 0.53 quality-adjusted life years (QALYs) compared with standard of care alone. Incremental cost effectiveness ratios were $85 554/QALY when using the publicly reported full (undiscounted) Medicare cost ($515/month) and $40 081/QALY, at a published nearly 50% rebate ($263/month). The addition of dapagliflozin to standard of care would be of at least intermediate value (<$150 000/QALY) at a cost of <$872.58/month, of high value (<$50 000/QALY) at <$317.66/month, and cost saving at <$40.25/month. Dapagliflozin was of at least intermediate value in 92% of simulations when using the full (undiscounted) Medicare list cost in probabilistic sensitivity analyses. Cost effectiveness was most sensitive to the dapagliflozin cost and the effect on cardiovascular death. The addition of dapagliflozin to standard of care in patients with heart failure across the spectrum of ejection fraction was at least of intermediate value at the undiscounted Medicare cost and may be potentially of higher value on the basis of the level of discount, rebates, and price negotiations offered. URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01035255 & NCT01920711.

Medicare Part D Coverage of Drugs Selected for the Drug Price Negotiation Program

This cross-sectional study describes and historically benchmarks Medicare Part D coverage in 2019 and 2023 for the first 10 drugs selected for negotiation.

Managing Sales via Livestream Commerce: Implications of Price Negotiation and Consumer Price Search

Livestream commerce has become an important sales channel with billions of revenue potential. A major challenge that brands often face in managing livestream sales in practice is negotiating sales prices and commission rates with key opinion leaders (KOLs) who promote products in such sales. On the one hand, KOLs can increase consumer reach, enhance consumer valuation of a product, and improve profitability of a sale. On the other hand, KOLs—who typically promise low sales prices in livestream sales—are subject to reputation damage risks if their followers find cheaper prices of the same product elsewhere. As a result, KOLs often bargain for deep discounts, which lead to price reduction in negotiation and reduce brands’ profit margins. In this article, we examine this tradeoff based on a Nash bargaining game framework. We show that price reduction may not be the brand’s optimal negotiation strategy to mitigate the KOL’s reputation concern. Instead, increasing the commission rate to the KOL may be more effective especially when product availability in the livestream sale is low. We further show that the presence of consumer price search can either improve or undermine the profitability of a livestream sale depending on the competitive features of the sale. Our study indicates that the negotiation dynamics in livestream sales can have significant profit impact for the brand, and the brand should be mindful about the operational features of livestream sales and stakeholder incentives such as KOLs’ reputation concerns and consumer price search when developing the optimal negotiation strategy.

Orphan drugs approved in Canada: health technology assessment, price negotiation, and government formulary listing

ABSTRACT Background The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have incentives to stimulate the development and marketing of orphan drugs. Health Canada has none. Methods We identified 82 FDA and/or EMA-designated orphan drugs approved by one or both agencies between 2015 and 2020 that were also authorized in Canada. We tracked the drugs through health technology assessments (HTAs), price negotiations, and listing in government drug plans to assess the time required for these processes. Results Median times for HTAs and price negotiations suggest a delay of around a year, but the median wait time between marketing authorization and price negotiation completion was over 18 months. Conclusions Listing of orphan drugs in Canadian government drug plans is closely aligned with reimbursement recommendations and outcomes of price negotiations. Medicines with unsuccessful price negotiations are not listed. However, not all drugs with successful negotiations are listed by all provinces and listing does not guarantee patient access. Compared with Americans and some western Europeans, Canadians with rare disorders continue to suffer from a lack of timely and equitable access to innovative treatments. A comprehensive orphan drug policy would improve Canadians’ access to the innovative treatments on the research horizon.

Medicare price negotiation and pharmaceutical innovation following the Inflation Reduction Act.

The Inflation Reduction Act (IRA) requires Medicare to negotiate lower prices for some medicines with high Medicare spending. Using historical data from public and proprietary sources to apply the IRA's negotiation criteria retrospectively, we identify all drugs that met the eligibility criteria from 2012 to 2021 to classify drugs that would have had a negotiated price in effect in 2022 and to calculate associated decreases in industry revenues. Our results suggest that the IRA's reduction in overall industry revenue will be modest, will not affect most top-selling drugs and will not likely result in large-scale defunding of research and development. Changes in the net present value of drug-development projects will be concentrated in medicines where Medicare is a notable purchaser and where the ratio between expected revenue and development costs was only marginally positive before the IRA. Policymakers considering narrowing or expanding the scope of Medicare negotiation should carefully consider the tradeoffs across medicines with diverse characteristics.

A summit on amplifying voices of patients, caregivers, and people with disabilities in Inflation Reduction Act drug price negotiations.

On September 18, 2023, Cancer Support Community convened patient and caregiver advocates, health care providers, policy experts, and health care innovators and thought leaders for a roundtable discussion on the need to ensure that patients, people with disabilities, and caregivers have a voice in defining "clinical benefit" for the purpose of Medicare Part D drug price negotiations and future health care policies that impact patients. The meeting featured presentations from Lara Strawbridge, Deputy Director for Policy at the Medicare Drug Rebate and Negotiations Group in the Center for Medicare, regulatory expert, Dr Monique Nolan, Counsel at Arnold and Porter, LLP, and 3 panel discussions: IRA Implementation-What Matters to Patients, a discussion of policies expected to impact patients and caregivers who are likely to rely heavily on high-cost drugs or biologics to treat cancer or other chronic illnesses, as well as the future development of novel therapies; The Science of Measuring Patient Experience, a discussion of current science of measuring patient experience and how it should be incorporated into the definition of clinical benefit; and Developing an Infrastructure for External Feedback, a discussion of actions and goals for patient engagement, advocacy opportunities, and how to best coordinate such efforts. This article represents an analysis of relevant resources as well as highlights from these sessions and subsequent discussions. It also outlines principles for engaging patient and provider advocacy organizations, whether in policy, media, or online discussions, surrounding the implementation of the Medicare Drug Price Negotiation Program.

Striving for affordable medicine: Lessons in price negotiation learned from the United Kingdom.

In August 2022, the Centers for Medicare & Medicaid Services were granted unprecedented power to negotiate the price of some pharmaceuticals covered under Medicare Part D of the Inflation Reduction Act. Price negotiation was previously banned by Medicare Part D legislation but is not a new idea globally. For decades, nations like the United Kingdom have price set or negotiated the cost of medicine with manufacturers, fine-tuning their methodologies, with mixed success. The United States can learn from other countries' work to develop a methodology capable of achieving increased affordability and patient access to medicine. Secretary Xavier Becerra should consider the United Kingdom's policy approach, which facilitates early and transparent collaboration with key stakeholders like patient groups and industry but limits flexibility in evidence submission, to help the United States minimize unintended damage to patient access to new medicines and achieve the Inflation Reduction Act's goals.

Assessing clinical benefit in the Medicare Drug Price Negotiation Program: A 2-step approach for improving transparency, consistency, and meaningful patient engagement.

In early 2024, the Centers for Medicare & Medicaid Services (CMS) will send initial price offers to the manufacturers of the first 10 drugs selected for the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act. However, CMS has not specified exactly how it will adjust the starting point for an initial price offer based on assessment of a drug's clinical benefit. This article addresses unanswered questions relating to CMS' methods for assessing clinical benefit. Specifically, we address how CMS can weigh various measures of evidence, ensure transparency and consistency, meaningfully incorporate patient and other stakeholder perspectives, and support addressing evidence gaps. We propose a 2-step approach for assessing the overall clinical benefit of a selected drug compared with its therapeutic alternatives that builds on the framework outlined by CMS. In step 1, CMS would evaluate conventional clinical benefit, defined in terms of outcomes commonly used in clinical studies for the selected drug and indications. In step 2, CMS would evaluate other outcomes broadly related to patient experience that are not adequately represented in the clinical literature. Overall, our approach incorporates the advantages of both qualitative and quantitative approaches to value assessment and decision-making. We describe a set of loose decision rules to improve transparency and consistency, recommend incorporating ranks and weights to signal to researchers and manufacturers which elements of clinical benefit and sources of data are the most important, and center meaningful deliberation with clinical experts, patients, and caregivers.

From Indication-Based Pricing to Blended Approach: Evidence on the Price and Reimbursement Negotiation in Italy.

New indications for existing medicines are increasing over time. In most countries, drug pricing and reimbursement conditions are renegotiated every time a new indication is approved. There is a growing interest in the price negotiation model for new indications, specifically comparing an indication-based versus blended approach. However, little evidence currently exists regarding the complexity of these negotiations and their impact on actual prices. Italy has recently transitioned from an indication-based approach to a blended price model. This study aims to measure the impact of price and reimbursement negotiation of new indications on discounts (i.e. actual prices) and on the negotiation duration, used as a proxy of its complexity. We considered new indications approved through a European centralized procedure from January 2013 to March 2022 for which the price and reimbursement status was approved in Italy between January 2015 and March 2022, amounting to 52 new indications. Data on the timeframe of the Italian price and reimbursement process and its phases were obtained from publicly available sources. Discounts for the first indication and their subsequent increases for new indications were estimated by comparing ex-factory prices and tendered prices. To calculate p-values, we employed the Mann-Whitney test, and multiple regression models were utilized to examine correlations between negotiation time and the characteristics of the medicines. The mean time to reimbursement was 603 days, in contrast to 583 days for the first launch. Price negotiation took longer for rare diseases, cancer drugs, and in case of therapies with minor added therapeutic value. On average, the additional discount (on top of discounts for prior indications) was 13%, significantly lower than the mean discount for the first indications approved (24.9%). The discounts increment was lower, but negotiation took longer if a Managed Entry Agreement accompanied the final agreement. Additionally, discounts have increased over the years. The negotiation for new indications takes longer than the first one, and provides, on average, an additional discount of 13%. While our findings bear the potential for significant policy implications, they necessitate prudent interpretation due to a limited number of observations. The increasing trend in additional discounts over time applied to all indications in recent negotiations, may suggest a descending trend of value for new indications and a shift from an indication-based pricing approach to a blended model. Otherwise, budget impact considerations might have outweighed a value-based approach in the recent negotiations. If so, two potential options for restoring a value-based approach are returning to an indication-based pricing or giving explicit and higher weight to value within a blended model.

Non-cooperative game-based electricity pricing method for data centers

Data centers are characterized by high energy consumption, with operating costs being extremely sensitive to electricity prices. Therefore, modern data centers are often equipped with microgrids for power supply, which adjust their operational strategies based on the given electricity prices to minimize costs. However, existing research has overlooked the flexible pricing potential of electricity retailers, prompting this study to propose a non-cooperative game theory-based optimization method for data center electricity procurement negotiation. A two-layer optimization model is established for data center electricity pricing. The upper layer focuses on electricity price optimization, modeling price negotiation as a Stackelberg game and adopting a weighted average cost approach to describe the electricity procurement prices. The lower layer addresses data center operational optimization, formulated as a nonlinear programming problem. To enable rapid solution convergence, a hybrid problem-solving method combining a genetic algorithm and branch-and-cut algorithm is proposed. Finally, a simulation is conducted using a data center located in California, United States, to validate the proposed method. The results demonstrate that the proposed method can reduce data center operational costs by 3% and increase the revenue for electricity retailers by 17%, achieving a win–win outcome.

Price competition for service provision with different bargaining abilities

Price negotiation still has an important role in business-to-business trades. In the negotiations, the realized price depends on the bargaining power of each firm. Therefore, it is important for consumers to know which firm has weaker bargaining power. Simultaneously, some consumers do not negotiate at all. In the case, they buy goods at the price that firms publicly post. In the sense, two different pricing system, the negotiated price and posted price, consumers exist in trades. In our paper, we also consider that the consumers need to pay their transportation costs. In this setting, we analyze how consumers determine which firm each of them visit, and how the realized price is formed. Our results show that negotiated prices depends on their opponent bargaining powers, but independent from consumers’ transportation costs.

Health technology assessment of medicinal products in Greece: a 5-year (2018-2023) review of timelines and productivity.

To assess the health technology assessment (HTA) process in Greece from its establishment in 2018 until 2023 in terms of timeliness and productivity. Data were collected from the HTA Committee's database and other publicly available sources. The overall study timeframe was divided into three periods: (i) July 2018-January 2020, (ii) January 2020-July 2021, and (iii) July 2021-February 2023. During the study period, a total of 1,157 applications for medicinal products (MPs) (including 219 new active substances (NAS) and orphans) were submitted to the HTA Committee. The number of HTA recommendations increased from 60 (first period) to 641 (third period), while the backlog of MPs pending HTA and price negotiations decreased from 89 and 106 (January 2020) to 8 and 44 (February 2023), respectively. The median time intervals for all application types decreased significantly over time. In February 2023, the median time for clinical data assessment of NAS (excluding orphans) almost halved from 207days in the first period to 114days; median times for NAS and orphans from regulatory approval to HTA application were 420 and 457days, and from HTA application to reimbursement 228 and 417days, respectively. The performance of the HTA process in Greece improved significantly over time, with increased MP appraisals, backlog reduction, and decreased timelines. Delays in reimbursement of NAS were mainly caused by the long gap between regulatory approval and HTA application. Overall, HTA review times in Greece are now on par with that of well-established European HTA systems.

E-KATALOG: Langkah Strategis Pemerintah dalam Memerangi Fraud Pengadaan Barang dan Jasa

This research aims to investigate the effectiveness of e-catalogs as a strategic government initiative in combating fraud in the procurement of goods and services. E-catalogs represent an innovation in the procurement process expected to enhance transparency, speed, and reliability in the selection of suppliers by the government. The research employs a juridical normative approach, detailing references from books, regulations, and relevant literature. The findings of the research indicate that the use of e-catalogs has had a positive impact on clarity, process acceleration, and ease in selecting suppliers. However, the study also identifies potential security loopholes that need attention to enhance resilience against fraud within the system. While e-catalogs enable open access to prices, the research highlights the need for additional strategies to address the potential for high price negotiations. The implications of these findings can serve as a foundation for the government to continually develop and improve the security of e-catalogs as an effective tool in maintaining integrity and transparency in the procurement of goods and services.

Increasing supply network resilience by collaborative negotiation protocols

A necessary prerequisite in establishing agreements within a network of suppliers and customers is a negotiation process. Network parties seek a compromise and agreement about costs and pricing acceptable to each of them, respectively. Price negotiation processes are necessary for supply networks’ success; hidden information, however, is a common challenge during such negotiations. A new collaborative negotiation method, not addressed by previous research, is designed to mitigate the impact of the hidden information in supply networks and foster mutual trust among parties. The proposed method incents and motivates the sharing of information, about the supplier’s operation costs, by weighting the operations costs and the estimated profit within the auction bids during negotiations. This paper lays the groundwork for creating an agent-based collaborative negotiation protocol. The proposed collaborative negotiation approach results indicate overall savings and significant benefits for the collaborating bidding parties, consequently increasing trust and supply network resilience. The proposed protocol could support decision-makers in establishing a long-lasting, resilient collaborative supply network of benevolent parties.

Striving for Affordable Medicine: Lessons in Price Negotiation Learned from the United Kingdom.

In August 2022, the Centers for Medicaid and Medicare Services (CMS) were granted unprecedented power to negotiate the price of some pharmaceuticals covered under Medicare Part D of the Inflation Reduction Act (IRA). Price negotiation was previously banned by Medicare Part D legislation but is not a new idea globally. For decades, nations like the United Kingdom (UK) have price set or negotiated the cost of medicine with manufacturers, fine tuning their methodologies, with mixed success. The United States (US) can learn from other countries' work to develop a methodology capable of achieving increased affordability and patient access to medicine. Secretary Xavier Becerra should consider the UK's policy approach, which facilitates early and transparent collaboration with key stakeholders like patient groups and industry but limits flexibility in evidence submission, to help the US minimize unintended damage to patient access to new medicines and achieve the IRA's goals.

Sociodemographic and spending characteristics of Medicare beneficiaries taking prescription drugs subject to price negotiations.

The 2022 Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 drugs in 2026 and additional drugs thereafter. Understanding the sociodemographic and spending characteristics of beneficiaries taking these specific drugs could be important describing the impact of the legislation. To describe sociodemographic and spending characteristics of Medicare beneficiaries who use the 10 prescription drugs ("negotiated drugs") that will face Medicare drug price negotiations in 2026. A 20% sample of Medicare Part D beneficiaries from 2020 (n = 10,224,642) was used. Sociodemographic and spending characteristics were descriptively reported for beneficiaries taking the negotiated drugs, including subgroups by low-income subsidy (LIS) status and by drug, and for Part D beneficiaries not taking negotiated drugs. Part D beneficiaries taking a negotiated drug compared with Part D beneficiaries not taking a negotiated drug overall had similar sociodemographic characteristics, more comorbidities (3.9 vs 2.2) and higher mean [median] Medicare ($33,882 [$18,251] vs $12,366 [$3,429]) and out-of-pocket (OOP) spending ($813 [$307] vs $441 [$160]). There was variation in characteristics by LIS status. The mean age was highest among non-LIS beneficiaries taking a negotiated drug compared with LIS beneficiaries taking a negotiated drug and beneficiaries not taking a negotiated drug (76.2 vs 69.9 vs 71.4). Among beneficiaries using negotiated drugs, a higher percentage of LIS beneficiaries compared with non-LIS was female (59.7% vs 48.0%), was Black (20.9% vs 6.6%), and resided in lower-income areas (39.1% vs 20.3%). Mean [median] annual Part D OOP spending for negotiated drugs was $115 [$59] for beneficiaries with LIS and $1,475 [$1,204] for beneficiaries without LIS. There were also differences depending on which negotiated drug was used. Drugs for cancer and blood clots had the highest proportions of White users, whereas type 2 diabetes and heart failure drugs had the highest proportions of Black users and beneficiaries residing in lower-income areas. Annual Part D OOP costs were lowest for sitagliptin (LIS: $104 [$60], non-LIS: $1,391 [$1,153]) and highest for ibrutinib (LIS: $649 [$649], non-LIS: $6,449 [$6,867]). Among non-LIS beneficiaries, 24% (22% to 76%) had more than $2,000 in OOP costs. Inflation Reduction Act OOP spending caps and LIS expansion will lower prescription drug costs for beneficiaries with OOP costs exceeding $2,000 who are mostly White and live in higher-income areas, insulin users who are disproportionately Black with multiple chronic conditions, and beneficiaries with low incomes. However, these provisions will not impact the 76% of non-LIS beneficiaries using negotiated drugs who have OOP costs that are still substantial but below $2,000. Negotiations could reduce OOP costs through reduced coinsurance payments for this group, which is older and has more chronic conditions compared with beneficiaries not taking negotiated drugs. Part D plan design, spending, and utilization changes should be monitored after negotiation to determine if further solutions are needed to lower OOP costs for this group.

Using a patient-centered value assessment to optimize fair prices for Inflation Reduction Act's Medicare Drug Price Negotiation Program.

In the United States, various federal agencies, institutions, and foundations, including the Centers for Medicare & Medicaid Services (CMS), have supported the incorporation of patient perspective in health care decision-making. Despite a series of patient-focused listening sessions planned as part of the Inflation Reduction Act's Medicare Drug Price Negotiation Program, the details of these sessions in the guidance developed by CMS remain unclear. CMS has not specified how patients' inputs will be used to determine the maximum fair prices (MFPs) of selected drugs for the first round of the negotiations. In this Viewpoint article, we urge CMS to use patient-centered value assessment methods to optimize MFPs in the Medicare Drug Price Negotiation Program. We focused on a stated preference method, the discrete choice experiment, which has been increasingly used to determine patient preferences and patient's willingness to pay for drugs. We discussed an example using a discrete choice experiment as a patient-centered method to assess the value of Jardiance and optimize its MFP in the negotiation program.