Project description:IntroductionIn Germany, all new, innovative medicines are subject to an early benefit assessment by the German Federal Joint Committee with subsequent price negotiation and optional arbitration. The purpose of this study was to identify drivers of negotiated (including arbitrated) prices of new, non-orphan innovative medicines in Germany.MethodsThe analysis considered all non-orphan drugs that underwent a benefit appraisal between January 2011 and June 2016, and displayed a reimbursement price in the German Drug Directory (Lauer-Taxe®) in November 2017. Negotiated annual treatment costs were analyzed with respect to 11 explanatory variables in regression models.ResultsThe total sample included 106 non-orphan drugs. The analysis showed a significant and positive association of log-transformed negotiated annual treatment cost of new medicines with log-transformed annual treatment cost of its comparator(s), extent of added benefit, and log-transformed size of the target population. Analyzing the effects of specific endpoints instead of the overall added benefit revealed that the single endpoint with the largest impact on price is adverse events (AEs). Surprisingly, an increase in AEs significantly increased the price. Various subgroup and sensitivity analyses demonstrated the robustness of the results. The adjusted R squared for all models was above 80%.ConclusionsThe analysis was able to confirm that variables whose consideration is mandated by law are, in fact, the key drivers of negotiated prices. Somewhat puzzling, the analysis also found an increase in AEs to move prices significantly upward.

| S-EPMC7423852 | biostudies-literature

Payer Type and Emergency Department Visit Prices.

Project description: Not available

| S-EPMC10918506 | biostudies-literature

2021 American Thyroid Association Guidelines for Management of Patients with Anaplastic Thyroid Cancer.

Project description:Background: Anaplastic thyroid cancer (ATC) is a rare but highly lethal form of thyroid cancer. Since the guidelines for the management of ATC by the American Thyroid Association were first published in 2012, significant clinical and scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, and researchers on published evidence relating to the diagnosis and management of ATC. Methods: The specific clinical questions and topics addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of the Task Force members (authors of the guideline). Relevant literature was reviewed, including serial PubMed searches supplemented with additional articles. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations. Results: The guidelines include the diagnosis, initial evaluation, establishment of treatment goals, approaches to locoregional disease (surgery, radiotherapy, targeted/systemic therapy, supportive care during active therapy), approaches to advanced/metastatic disease, palliative care options, surveillance and long-term monitoring, and ethical issues, including end of life. The guidelines include 31 recommendations and 16 good practice statements. Conclusions: We have developed evidence-based recommendations to inform clinical decision-making in the management of ATC. While all care must be individualized, such recommendations provide, in our opinion, optimal care paradigms for patients with ATC.

| S-EPMC8349723 | biostudies-literature

Negotiated Rates for Surgical Cancer Care in the Era of Price Transparency-Prices Reflect Market Competition.

Project description:ObjectiveTo measure commercial price variation for cancer surgery within and across hospitals.BackgroundSurgical care for solid-organ tumors is costly, and negotiated commercial rates have been hidden from public view. The Hospital Price Transparency Rule, enacted in 2021, requires all hospitals to list their negotiated rates on their website, thus opening the door for an examination of pricing for cancer surgery.MethodsThis was a cross-sectional study using 2021 negotiated price data disclosed by US hospitals for the 10 most common cancers treated with surgery. Price variation was measured using within-hospital and across-hospital ratios. Commercial rates relative to cancer center designation and the Herfindahl-Hirschman Index at the facility level were evaluated with mixed effects linear regression with random intercepts per procedural code.ResultsIn all, 495,200 unique commercial rates from 2232 hospitals resulted for the 10 most common solid-organ tumor cancers. Gynecologic cancer operations had the highest median rates at $6035.8/operation compared with bladder cancer surgery at $3431.0/operation. Compared with competitive markets, moderately and highly concentrated markets were associated with significantly higher rates (HHI 1501, 2500, coefficient $513.6, 95% CI, $295.5, $731.7; HHI >2500, coefficient $1115.5, 95% CI, $913.7, $1317.2). National Cancer Institute designation was associated with higher rates, coefficient $3,451.9 (95% CI, $2853.2, $4050.7).ConclusionsCommercial payer-negotiated prices for the surgical management of 10 common, solid tumor malignancies varied widely both within and across hospitals. Higher rates were observed in less competitive markets. Future efforts should facilitate price competition and limit health market concentration.

| S-EPMC10840891 | biostudies-literature

The Reality of Commercial Payer-Negotiated Rates in Cleft Lip and Palate Repair.

Project description:BackgroundCommercial payer-negotiated rates for cleft lip and palate surgery have not been evaluated on a national scale. The aim of this study was to characterize commercial rates for cleft care, both in terms of nationwide variation and in relation to Medicaid rates.MethodsA cross-sectional analysis was performed of 2021 hospital pricing data from Turquoise Health, a data service platform that aggregates hospital price disclosures. The data were queried by CPT code to identify 20 cleft surgical services. Within- and across-hospital ratios were calculated per CPT code to quantify commercial rate variation. Generalized linear models were used to assess the relationship between median commercial rate and facility-level variables and between commercial and Medicaid rates.ResultsThere were 80,710 unique commercial rates from 792 hospitals. Within-hospital ratios for commercial rates ranged from 2.0 to 2.9 and across-hospital ratios ranged from 5.4 to 13.7. Median commercial rates per facility were higher than Medicaid rates for primary cleft lip and palate repair ($5492.20 versus $1739.00), secondary cleft lip and palate repair ($5429.10 versus $1917.00), and cleft rhinoplasty ($6001.00 versus $1917.00; P < 0.001). Lower commercial rates were associated with hospitals that were smaller ( P < 0.001), safety-net ( P < 0.001), and nonprofit ( P < 0.001). Medicaid rate was positively associated with commercial rate ( P < 0.001).ConclusionsCommercial rates for cleft surgical care demonstrated marked variation within and across hospitals, and were lower for small, safety-net, or nonprofit hospitals. Lower Medicaid rates were not associated with higher commercial rates, suggesting that hospitals did not use cost-shifting to compensate for budget shortfalls resulting from poor Medicaid reimbursement.

| S-EPMC11240862 | biostudies-literature

Prices and Clinical Benefit of National Price-Negotiated Anticancer Medicines in China.

Project description:BackgroundHigh prices of anticancer medicines have increased the economic burden for both patients and health insurance systems. Since 2017, China has implemented national price negotiations for medicines, relying on evidence from health technology assessments. We aim to assess the relation between negotiated price and value of anticancer medicines listed in China's National Reimbursement Drug List (NRDL).MethodsFor all price-negotiated anticancer medicines and corresponding indications listed in the latest NRDL between 2017 and 2020, we collected their clinical outcomes data, including overall survival (OS) and progression-free survival (PFS), in supporting trials. Pearson correlation coefficient was calculated to estimate the association between the daily cost and clinical benefit of each indication.ResultsIn total, 75 indications of 46 branded anticancer medicines were included for analysis. The median daily costs for the anticancer therapies that had gone through negotiation in 2017-2020 were US$87.6, US$71.8, US$58.9, and US$39.7, respectively. For indications supported by randomized trials, no correlation between daily costs and OS and PFS benefit of the price-negotiated cancer therapies was observed (N = 41, r = -0.05, and N = 49, r = 0.04, respectively). For cancer indications newly listed in NRDL in 2020, the association between their daily cost and OS benefit was -0.78 (N = 4, p = 0.221) and 0.01 (N = 8, p = 0.986) before and after the price negotiation.ConclusionThough the negotiation policy decreased prices of anticancer medicines in China, no statistically significant correlation was observed between their daily costs and clinical benefits. A more transparent and credible pricing approach needs to be established to promote value-based anticancer medicines and healthcare system efficiency.

| S-EPMC9270265 | biostudies-literature

Diagnosis and Management of Sitosterolemia 2021.

Project description:Sitosterolemia is an inherited metabolic disorder characterized by increased levels of plant sterols, such as sitosterol. This disease is caused by loss-of-function genetic mutations in ATP-binding cassette (ABC) subfamily G member 5 or member 8 (ABCG5 or ABCG8, respectively), both of which play important roles in selective excretion of plant sterols from the liver and intestine, leading to failure to prevent absorption of food plant sterols. This disorder has been considered to be extremely rare. However, accumulated clinical data as well as genetics suggest the possibility of a much higher prevalence. Its clinical manifestations resemble those observed in patients with familial hypercholesterolemia (FH), including tendon xanthomas, hyper LDL-cholesterolemia, and premature coronary atherosclerosis. We provide an overview of this recessive genetic disease, diagnostic as well as therapeutic tips, and the latest diagnostic criteria in Japan.

| S-EPMC8326170 | biostudies-literature

What if the federal government negotiated pharmaceutical prices for seniors? An estimate of national savings.

Project description:The government is prohibited from directly negotiating drug prices for Medicare Part D, resulting in substantial policy debate. However, the government has an established mechanism for setting prices with pharmaceutical manufacturers for certain other federal programs--the Federal Supply Schedule (FSS).To estimate how much could be saved nationwide if prices equivalent to the 2006 FSS were achieved for the top 200 drug formulations dispensed to seniors.Cross-sectional analysis of drug utilization patterns and costs from the nationally representative Medical Expenditure Panel Surveys (MEPS), 2003-2004, and the 2006 FSS.Seniors who filled a prescription for any of these common drugs (n = 6,135 individuals).Prescription expenditures were obtained from MEPS, and a price/unit was calculated in 2006 dollars. This price/unit was compared to the 2006 FSS, and a savings/unit was calculated and summed across the observed units dispensed in MEPS.The potential annual savings with FSS prices would be $21.9 billion [95% confidence interval (CI), $21.1 billion to $22.8 billion]. If FSS prices were substituted for only the top ten drugs, the annual savings would be $5.9 billion (95% CI, $5.7 billion, $6.1 billion).Extension of existing price setting mechanisms to Medicare could save tens of billions of dollars if prices similar to those already achieved by other federal programs could be reached. Whether or not this is a political or economic possibility, the magnitude of these savings cannot be ignored.

| S-EPMC2517993 | biostudies-other

Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.

Project description: Not available

| S-EPMC6902106 | biostudies-literature