Differential effect of China's Zero Markup Drug Policy on provider-induced demand in secondary and tertiary hospitals.

Following the marketization of China's health system in the 1980's, the government allowed public hospitals to markup the price of certain medications by 15% to compensate for reduced revenue from government subsidies. This incentivized clinicians to induce patient demand for drugs which resulted in higher patient out-of-pocket payments, higher overall medical expenditure, and poor health outcomes. In 2009, China introduced the Zero Markup Drug Policy (ZMDP) which eliminated the 15% markup. Using Shanghai as a case study, this paper analyzes emerging and existing evidence about the impact of ZMDP on hospital expenditure and revenue across secondary and tertiary public hospitals. We use data from 150 public hospitals across Shanghai to examine changes in hospital expenditure and revenue for various health services following the implementation of ZMDP. Our analysis suggests that, across both secondary and tertiary hospitals, the implementation of ZMDP reduced expenditure on drugs but increased expenditure on medical services, exams, and tests thereby increasing hospital revenue and keeping inpatient and outpatient costs unchanged. Moreover, our analysis suggests that tertiary facilities increased their revenue at a faster rate than secondary facilities, likely due to their ability to prescribe more advanced and, therefore, more costly procedures. While rigorous experimental designs are needed to confirm these findings, it appears that ZMDP has not reduced instances of medical expenditure provoked by provider-induced demand (PID) but rather shifted the effect of PID from one revenue source to another with differential effects in secondary vs. tertiary hospitals. Supplemental policies are likely needed to address PID and reduce patient costs.

Cost-effectiveness analysis of atezolizumab plus bevacizumab compared with sorafenib as first-line treatment in advanced hepatocellular carcinoma in Singapore.

OBJECTIVES: This study aims to explore the cost-effectiveness of atezolizumab plus bevacizumab against sorafenib for first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC) in Singapore. METHODS: A partitioned survival model was developed from a healthcare system perspective, with a 10-year lifetime horizon. Clinical inputs and utilities were obtained from the IMbrave150 trial. Healthcare resource use costs were obtained from published local sources; drug costs reflected the most recent public hospital selling prices. Outcomes included life years, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to assess the model's robustness. RESULTS: Atezolizumab plus bevacizumab offered an additional 1.42 life years and 1.09 QALYs, with an additional cost of S$111,847; the ICER was S$102,988/QALY. The World Health Organization considers interventions with ICERs <1 gross domestic product (GDP)/capita to be highly cost-effective. At a willingness-to-pay (WTP) threshold of S$114,165/QALY (Singapore's 2022 GDP/capita), atezolizumab plus bevacizumab is cost-effective compared with sorafenib. The ICER was most sensitive to variations in utilities, but all parameter variations had no significant impact on the model outcomes. CONCLUSION: At a WTP threshold of Singapore's GDP/capita, atezolizumab plus bevacizumab is cost-effective compared with sorafenib.

The Cost of Medications at a Student-Run Free Clinic in New Haven, Connecticut, 2021-2023.

Introduction: Haven is a student-run free clinic in New Haven, Connecticut, that serves more than 500 patients annually. Haven's pharmacy department helps patients obtain medications by providing discount coupons or medications from the clinic's in-house pharmacy, directly paying for medications at local pharmacies, and delivering medications to patients' homes. This study aimed to identify prescriptions that have the highest cost among Haven patients. Methods: Our sample consisted of all Haven patients who attended the clinic from March 2021 through March 2023. Patients were eligible to be seen at Haven if they were aged 18 to 65 years, lacked health insurance, and lived in New Haven. We determined the lowest cost of each medication prescribed to Haven patients by comparing prices among local pharmacies after applying a GoodRx discount. We defined expensive medication as more than $20 per prescription. We excluded medical supplies. Results: Of the 594 Haven patients in our sample, 64% (n = 378) required financial assistance and 22% (n = 129) were prescribed at least 1 expensive medication. Among 129 patients prescribed an expensive medication, the mean (SD) age was 45.0 (12.3) years; 65% were women, and 87% were Hispanic or Latino. Median (IQR) household annual income was $14,400 [$0-$24,000]. We identified 246 expensive medications; the median (IQR) price per prescription was $31.43 ($24.00-$52.02). The most frequently prescribed expensive medications were fluticasone propionate/salmeterol (accounting for 6% of all expensive medications), medroxyprogesterone acetate (6%), albuterol sulfate (5%), and rosuvastatin (5%). Conclusion: The average Haven patient has an income well below the federal poverty level, and many have chronic cardiovascular and respiratory conditions that require expensive medications. Future research should work toward making medications universally affordable.

Consequences of cost barriers to prescriptions: cohort study in Aotearoa New Zealand.

AIMS: A NZ$5 co-payment prescription charge was removed in July 2023 but may be reinstated. Here we quantify the health impact and cost of not being able to afford this charge. METHODS: We linked New Zealand Health Surveys (2013/2014-2018/2019) to hospitalisation data using data available in Integrated Data Infrastructure (IDI). Cox proportional-hazards models compared time to hospitalisation between those who had faced a cost barrier to collecting a prescription and those who had not. RESULTS: Of the 81,626 total survey respondents, 72,243 were available for analysis in IDI. A further 516 were excluded to give an analysis dataset of 71,502. Of these, 5,889 (8.2%) reported not collecting a prescription due to cost in the previous year. Among people who faced a cost barrier, 60.0% (95% confidence interval [CI] 58.7-61.2%) were admitted to hospital during the study period, compared to 43.9% (95% CI 43.6-44.3%) of those who did not. Having adjusted for socio-demographic variables, people who faced a cost barrier were 34% (hazard ratio 1.34; 95% CI 1.29-1.39) more likely to be admitted to hospital than those who did not. Annual avoidable hospitalisation costs-were prescription co-payments to remain free-are estimated at $32.4 million per year based on the assumption of a causal relationship between unmet need for prescription medicines and subsequent hospitalisation. CONCLUSIONS: The revenue to the health system from co-payments may be offset by the costs associated with avoidable hospitalisations.

The usage and costs of national drug price-negotiated anticancer medicines in a first-tier city in Northeast China: a study based on health insurance data.

BACKGROUND: The National Drug Price Negotiation (NDPN) policy has entered a normalisation stage, aiming to alleviate, to some extent, the disease-related and economic burdens experienced by cancer patients. This study analysed the use and subsequent burden of anticancer medicines among cancer patients in a first-tier city in northeast China. METHODS: We assessed the usage of 64 negotiated anticancer medicines using the data on the actual drug deployment situation, the frequency of medical insurance claims and actual medication costs. The affordability of these medicines was measured using the catastrophic health expenditure (CHE) incidence and intensity of occurrence. Finally, we used the defined daily doses (DDDs) and defined daily doses cost (DDDc) as indicators to evaluate the actual use of these medicines in the region. RESULTS: During the study period, 63 of the 64 medicines were readily available. From the perspective of drug usage, the frequency of medical insurance claims for negotiated anticancer medicines and medication costs showed an increasing trend from 2018 to 2021. Cancer patients typically sought medical treatment at tertiary hospitals and purchased medicines at community pharmacies. The overall quantity and cost of medications for patients covered by the Urban Employee Basic Medical Insurance (UEBMI) were five times higher than those covered by the Urban and Rural Resident Medical Insurance (URRMI). The frequency of medical insurance claims and medication costs were highest for lung and breast cancer patients. Furthermore, from 2018 to 2021, CHE incidence showed a decreasing trend (2.85-1.60%) under urban patients' payment capability level, but an increasing trend (11.94%-18.42) under rural patients' payment capability level. The average occurrence intensities for urban (0.55-1.26 times) and rural (1.27-1.74 times) patients showed an increasing trend. From the perspective of drug utilisation, the overall DDD of negotiated anticancer medicines showed an increasing trend, while the DDDc exhibited a decreasing trend. CONCLUSION: This study demonstrates that access to drugs for urban cancer patients has improved. However, patients' medical behaviours are affected by some factors such as hospital level and type of medical insurance. In the future, the Chinese Department of Health Insurance Management should further improve its work in promoting the fairness of medical resource distribution and strengthen its supervision of the nation's health insurance funds.

Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

Financial impact of integrated specialty pharmacy efforts to avoid oral anticancer medication waste.

BACKGROUND: The growing number of oral anticancer medications represents a significant portion of pharmacy spending and can be costly for patients. Patients taking oral anticancer medications may experience frequent treatment changes following necessary safety and effectiveness monitoring, often resulting in medication waste. Strategies to avoid medication waste could alleviate the financial burden of these costly therapies on the payer and the patient. OBJECTIVE: To evaluate the impact on waste and cost avoidance of reviewing the amount of medication patients have on hand and the presence of upcoming follow-up (ie, provider visit, laboratory testing, or imaging) before requesting a prescription refill renewal for patients taking oral anticancer medications through an integrated health system specialty pharmacy. METHODS: We performed a retrospective review of patients filling oral anticancer medications prescribed by a Vanderbilt University Medical Center provider and dispensed by Vanderbilt Specialty Pharmacy between January 1, 2020, and December 31, 2020. Specialty pharmacists received a system-generated refill renewal request for oral anticancer medications when the final prescription refill was dispensed, prompting the pharmacist to review the patient's medical record for continued therapy appropriateness and to request a new prescription. If the patient had a sufficient supply on hand to last until an upcoming follow-up (ie, provider visit, imaging, or laboratory assessment), the pharmacist postponed the renewal until after the scheduled follow-up. Patients were included in the analysis if the refill renewal request was postponed after review of the amount of medication on hand and the presence of an upcoming follow-up. Medication outcomes (ie, continued, dose changed, held, medication changed to a different oral anticancer medication, or discontinued) resulting from the follow-up were collected. Cost avoidance in US dollars was assigned based on the outcome of follow-up by calculating the price per unit times the number of units that would have been unused or in excess of what was needed if the medication had been dispensed before the scheduled follow-up. The average wholesale price minus 20% (AWP-20%) and wholesale acquisition cost (WAC) were used to report a range of costs avoided over 12 months. RESULTS: The total cost avoidance over 12 months associated with postponing refill renewal requests in a large academic health system with an integrated specialty pharmacy ranged from $549,187.03 using WAC pricing to $751,994.99 using AWP-20% pricing, with a median cost avoidance per fill of $366.04 (WAC) to $1,931.18 (AWP-20%). Refill renewal requests were postponed in 159 instances for 135 unique patients. After follow-up, medications were continued unchanged in only 2% of postponed renewals, 56% of follow-ups resulted in medication discontinuations, 32% in dose changes, 5% in medication changes, and 5% in medication holds. CONCLUSIONS: Integrated health system specialty pharmacist postponement of refill requests after review of the amount of medication on hand and upcoming follow-up proved effective in avoiding waste and unnecessary medication costs in patients treated with oral anticancer medications at a large academic health system.

The cost of influence: How gifts to physicians shape prescriptions and drug costs.

This paper investigates the influence of gifts - monetary and in-kind payments - from drug firms to US physicians on prescription behavior and drug costs. Using causal models and machine learning, we estimate physicians' heterogeneous responses to payments on antidiabetic prescriptions. We find that payments lead to increased prescription of brand drugs, resulting in a cost rise of $23 per dollar value of transfer received. Paid physicians show higher responses when they treat higher proportions of patients receiving a government-funded low-income subsidy that lowers out-of-pocket drug costs. We estimate that introducing a national gift ban would reduce diabetes drug costs by 2%.

Assessment of antibiotic prescribing pattern and cost for hospitalized patients: A study from Palestine.

BACKGROUND: One of the largest problems facing the world today is the morbidity and mortality caused by antibiotic resistance in bacterial infections. A major factor in antimicrobial resistance (AMR) is the irrational use of antibiotics. The objective of this study was to assess the prescribing pattern and cost of antibiotics in two major governmental hospitals in the West Bank of Palestine. METHODS: A retrospective cohort study was conducted on 428 inpatient prescriptions containing antibiotics from two major governmental hospitals, they were evaluated by some drug use indicators. The cost of antibiotics in these prescriptions was calculated based on the local cost. Descriptive statistics were performed using IBM-SPSS version 21. RESULTS: The mean ± SD number of drugs per prescription (NDPP) was 6.72 ± 4.37. Of these medicines, 38.9% were antibiotics. The mean ± SD number of antibiotics per prescription (NAPP) was 2.61 ± 1.54. The average ± SD cost per prescription (CPP) was 392 ± 744 USD. The average ± SD antibiotic cost per prescription (ACPP) was 276 ± 553 USD. The most commonly prescribed antibiotics were ceftriaxone (52.8%), metronidazole (24.8%), and vancomycin (21.0%). About 19% of the antibiotics were prescribed for intra-abdominal infections; followed by 16% used as prophylactics to prevent infections. Almost all antibiotics prescribed were administered intravenously (IV) 94.63%. In general, the average duration of antibiotic therapy was 7.33 ± 8.19 days. The study indicated that the number of antibiotics per prescription was statistically different between the hospitals (p = 0.022), and it was also affected by other variables like the diagnosis (p = 0.006), the duration of hospitalization (p < 0.001), and the NDPP (p < 0.001). The most commonly prescribed antibiotics and the cost of antibiotics per prescription were significantly different between the two hospitals (p < 0.001); The cost was much higher in the Palestinian Medical Complex. CONCLUSION: The practice of prescribing antibiotics in Palestine's public hospitals may be unnecessary and expensive. This has to be improved through education, adherence to recommendations, yearly immunization, and stewardship programs; intra-abdominal infections were the most commonly seen infection in inpatients and ceftriaxone was the most frequently administered antibiotic.

Explaining why increases in generic use outpace decreases in brand name medicine use in multisource markets and the role of regulation.

BACKGROUND: Healthcare systems worldwide face escalating pharmaceutical expenditures despite interventions targeting pricing and generic substitution. Existing studies often overlook unwarranted volume increases in multisource markets due to differential physician perceptions of brand name and generics. OBJECTIVE: This study aims to explain the outpacing of generic medicine use over brand name use in multisource markets and assess the regulatory role, specifically examining the impact of reference pricing on volume and intensity increases. METHODS: Analyzing German multisource prescription medicine markets from 2011 to 2014, we evaluate regulatory mechanisms and explore whether brand name and generic medicines constitute separate market segments. Using an Oaxaca-Blinder decomposition approach, we divide the differential in brand name versus generic medicine use rates into market structure and unobserved segment effects. RESULTS: Generic use rates surpass same-market brand name substitution by 3.87 prescriptions per physician and medicine, on average. Reference pricing mitigated volume increase, treatment intensity and expenditure. Disparities in quantity and expenditure dynamics between brand name and generic segments are partially explained by market structure and segment effects. CONCLUSION: Generic medicine use effectively reduces expenditures but contributes to increased net prescription rates. Reference pricing may control medicine use, but divergent physician perceptions of brand name and generics, revealed by identified segment effects, call for nuanced policy interventions.

New Anticancer Drugs: Reliably Assessing "Value" While Addressing High Prices.

Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. We need system-wide reform that will enable less expensive, faster drug development. The speed with which COVID-19 vaccines and AIDS therapies were developed indicates this is possible if governments prioritize it. Countries also differ in how they value drugs, and generally, those willing to pay more have better, faster access. Canada is used as an example to illustrate how "incremental cost-effectiveness ratios" (ICERs) based on measures such as gains in "quality-adjusted life-years" (QALYs) may be used to determine a drug's value but are often problematic, imprecise assessments. Generally, ICER/QALY estimates inadequately consider the impact of patient crossover or long post-progression survival, therapy benefits in distinct subpopulations, positive impacts of the therapy on other healthcare or societal costs, how much governments willingly might pay for other things, etc. Furthermore, a QALY value should be higher for a lethal or uncommon disease than for a common, nonlethal disease. Compared to international comparators, Canada is particularly ineffective in initiating public funding for essential new medications. Addressing these disparities demands urgent reform.

What is a fair price for a medicine? Establishing the main elements of a fair price based on the current policy debate.

OBJECTIVE: Unfair medicines prices have been discussed widely as an obstacle for patient access. This article aims to structure the discussion about fair pricing of medicines, analyses the elements for a fair price, and assesses its practical implications. METHODS: A systematic literature research has been undertaken and complemented by gray literature. Definitions and elements of a fair price have been extracted from the sample, categorized via a thematic and a quantitative analysis, and mirrored against the traditional framework of 'iustum pretium' (fair price). RESULTS: The most often attributes of a fair price mentioned were affordability (n = 30), followed by value and research and development (R&D) investment (n = 20). Other frequently mentioned attributes are profitability (n = 19), transparency of R&D costs (n = 18), cost-effectiveness (n = 17), and manufacturing (n = 14). Nearly all definitions present fair price as a balance between different objectives. CONCLUSIONS: Most publications stipulate that medicines are a common good and should be affordable. At the same time, most publications also propose a pricing approach based on covering costs for R&D and/or on value. Consequently, most of the attempts to clarify fair price result in a value-affordability dilemma, which does not necessarily warrant patient access. Many social health systems implement pricing regardless of the debate. This systematic review offers a set of attributes for fair price and helps refining the existing pricing and reimbursement regulations. Once complemented by empirical datapoints, it provides the basis for developing a framework for fair pricing.

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study.

BACKGROUND: The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. METHODS: We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. RESULTS: We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. INTERPRETATION: No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.

US Hospital Service Availability and New 340B Program Participation.

Importance: The US 340B Drug Pricing Program enables eligible hospitals to receive substantial discounts on outpatient drugs to improve hospitals' financial sustainability and maintain access to care for patients who have low income and/or are uninsured. However, it is unclear whether hospitals use program savings to subsidize access as intended. Objective: To evaluate whether the 340B program is associated with improvements in access to hospital-based services and to test whether the association varies by hospital ownership. Design, Setting, and Participants: Difference-in-differences and cohort analysis from 2010 to 2019. Never and newly participating 340B general, acute, nonfederal hospitals in the US using data from the American Hospital Association's Annual Survey of Hospitals merged with hospital and market characteristics. Data were analyzed from January 1, 2023, to January 31, 2024. Exposures: New enrollment in 340B between 2012 and 2018. Main Outcomes and Measures: Total number of unprofitable service lines, ie, substance use, psychiatric (inpatient and outpatient), burn clinic, and obstetrics services; and profitable services, ie, cardiac surgery and orthopedic, oncologic, neurologic, and neonatal intensive services. Results: The study sample comprised a total of 2152 hospitals, 1074 newly participating and 1078 not participating in the 340B program. Participating hospitals were more likely than nonparticipating hospitals to be critical access and teaching hospitals, have higher Medicaid shares, and be located in rural areas and in Medicaid expansion states. At public hospitals, participation in the 340B program was associated with a significant increase in total unprofitable services (0.21; 95% CI, 0.04 to 0.38; P = .02) and marginal increases in substance use (5.4 percentage points [pp]; 95% CI, -0.8 pp to 11.6 pp; P = .09) and inpatient psychiatric (6.5 pp; 95% CI, -0.7 pp to 13.7 pp; P = .09) services. Among nonprofit hospitals, there was no significant association between 340B and service offerings (profitable and unprofitable) except for an increase in oncologic services (2.5 pp; 95% CI, 0.0 pp to 5.0 pp; P = .05). Conclusions and Relevance: The finding of the cohort study indicate that participation in the 340B program was associated with an increase in unprofitable services among newly participating public hospitals. Nonprofit hospitals were largely unaffected. These findings suggest that public hospitals responded to 340B savings by improving patient access, whereas nonprofits did not. This heterogeneous response should be considered when evaluating the eligibility criteria for the 340B program and how it affects social welfare.

Economic implications of novel regimens for tuberculosis treatment in three high-burden countries: a modelling analysis.

BACKGROUND: With numerous trials investigating novel drug combinations to treat tuberculosis, we aimed to evaluate the extent to which future improvements in tuberculosis treatment regimens could offset potential increases in drug costs. METHODS: In this modelling analysis, we used an ingredients-based approach to estimate prices at which novel regimens for rifampin-susceptible and rifampin-resistant tuberculosis treatment would be cost-neutral or cost-effective compared with standards of care in India, the Philippines, and South Africa. We modelled regimens meeting targets set in the WHO's 2023 Target Regimen Profiles (TRPs). Our decision-analytical model tracked cohorts of adults initiating rifampin-susceptible or rifampin-resistant tuberculosis treatment, simulating their health outcomes and costs accumulated during and following treatment under standard-of-care and novel regimen scenarios. Price thresholds included short-term cost-neutrality (considering only savings accrued during treatment), medium-term cost-neutrality (additionally considering savings from averted retreatments and secondary cases), and cost-effectiveness (incorporating willingness-to-pay for improved health outcomes). FINDINGS: Total medium-term costs per person treated using standard-of-care regimens were estimated at US$450 (95% uncertainty interval 310-630) in India, $560 (350-860) in the Philippines, and $730 (530-1090) in South Africa for rifampin-susceptible tuberculosis (current drug costs $46) and $2100 (1590-2810) in India, $2610 (2090-3280) in the Philippines, and $3790 (3090-4630) in South Africa for rifampin-resistant tuberculosis (current drug costs $432). A rifampin-susceptible tuberculosis regimen meeting the optimal targets defined in the TRPs could be cost-neutral in the short term at drug costs of $140 (90-210) per full course in India, $230 (130-380) in the Philippines, and $280 (180-460) in South Africa. For rifampin-resistant tuberculosis, short-term cost-neutral thresholds were higher with $930 (720-1230) in India, $1180 (980-1430) in the Philippines, and $1480 (1230-1780) in South Africa. Medium-term cost-neutral prices were approximately $50-100 higher than short-term cost-neutral prices for rifampin-susceptible tuberculosis and $250-550 higher for rifampin-resistant tuberculosis. Health system cost-neutral prices that excluded patient-borne costs were 45-70% lower (rifampin-susceptible regimens) and 15-50% lower (rifampin-resistant regimens) than the cost-neutral prices that included patient costs. Cost-effective prices were substantially higher. Shorter duration was the most important driver of medium-term savings with novel regimens, followed by ease of adherence. INTERPRETATION: Improved tuberculosis regimens, particularly shorter regimens or those that facilitate better adherence, could reduce overall costs, potentially offsetting higher prices. FUNDING: WHO.

Role of Specialty Drugs in Rising Drug Prices for Medicare Part D.

Importance: Prices for brand-name drugs affect both federal spending and out-of-pocket liability for Medicare Part D enrollees. Objective: To examine how prices for brand-name drugs, net of rebates and discounts, have changed from 2010 to 2019 and to examine the role of specialty drugs in those changes. Design, Setting, and Participants: This study involved a descriptive analysis of prescription drug spending and prices between 2010 and 2019. The universe of prescription drug event data from those years were combined with confidential data from the Centers for Medicare & Medicaid Services on rebates and discounts that manufacturers and pharmacies pay to Medicare Part D plans to calculate rebate percentages, net spending, and net prices at the drug level. Specialty drugs were identified using information from IQVIA, allowing for a stratified analysis by specialty status. Data were analyzed from March 2019 to March 2024. Main Outcomes and Measures: Average prices (net of rebates and discounts in 2019 US dollars) and average annual price growth for brand-name prescription drugs, overall and separately for specialty and nonspecialty drugs. Results: Average net prices for brand-name drugs doubled from 2010 to 2019 (from $167 to $370). Growth in specialty drug prices was an underlying factor in those increases: average annual price growth was 13.2% for specialty drugs compared with 2.6% for nonspecialty drugs. Price growth for specialty drugs over the decade was smaller than what the Congressional Budget Office reported for the 2010 to 2015 period (increase of 22.3% per year vs 4.5% per year for nonspecialty drug prices), suggesting that price growth slowed after 2015. Drugs that treat hepatitis C contributed to that difference because prices for those drugs were initially high and then subsequently fell. Absent those drugs, price growth for specialty drugs averaged 18.1% in the first half of the decade and 6.9% in the second half. Conclusions and Relevance: Results of this study show that prices for specialty drugs have continued to increase over time in the Medicare Part D program, which contributes to high out-of-pocket liability for users of those drugs in addition to US federal budgetary expenditures.