Financial Toxicity of Withdrawn Poly (Adenosine Diphosphate Ribose) Polymerase Inhibitor Indications for Ovarian Cancer.

OBJECTIVES: We sought to quantify exposure to and financial impacts of poly (adenosine diphosphate ribose) polymerase inhibitor (PARPi) treatments for eventually withdrawn ovarian cancer indications. METHODS: We identified in Optum's deidentified Clinformatics® Data Mart database 1695 patients with ovarian cancer diagnoses who received olaparib, rucaparib, or niraparib between January 2015 and September 2021. We describe PARPi use and out-of-pocket, total healthcare, and PARPi spending among patients with ovarian cancer with 3 or more previous lines of therapy. RESULTS: Of the 1695 patients who received PARPi, 254 were estimated to have been heavily pretreated and exposed to eventually withdrawn indications. Cumulative total medical and pharmacy costs for these patients were $53 392 184; PARPi costs accounted for 34%. Median PARPi cost per patient was $43 347. Cumulative out-of-pocket costs totaled $533 281. CONCLUSIONS: Potential patient harm, including financial toxicity, might have been mitigated through more stringent drug approval requirements.

Comparison of health care costs following sleeve gastrectomy versus Roux-en-Y gastric bypass among patients with type 2 diabetes.

OBJECTIVE: The objective of this study was to compare the impact of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on overall and diabetes-specific health care costs among patients with type 2 diabetes. METHODS: This retrospective cohort study examined patients with type 2 diabetes after SG and RYGB using data from Optum's deidentified Clinformatics® Data Mart database. The matched study group included 9608 patients who underwent SG or RYGB and were enrolled between 2007 and 2019. The primary outcomes assessed were overall and diabetes-specific health care costs. RESULTS: Health care costs associated with type 2 diabetes declined substantially in the first few years following both SG and RYGB. RYGB was associated with a larger decrease in pharmacy costs, as well as type 2 diabetes-specific office and laboratory costs. SG was associated with lower total health care costs in the first three follow-up periods and lower acute care costs in the first 2 years after surgery. CONCLUSIONS: In this nationwide study, patients with type 2 diabetes at baseline undergoing RYGB appear to experience a reduced need for ambulatory type 2 diabetes monitoring and reduced requirements for antidiabetes medication but, despite this, did not experience an overall medical cost-benefit in the first few years after RYGB versus SG.

Acute Care Utilization and Costs Up to 4 Years After Index Sleeve Gastrectomy or Roux-en-Y Gastric Bypass: A National Claims-based Study.

OBJECTIVE: To compare acute care utilization and costs following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). SUMMARY BACKGROUND DATA: Comparing postbariatric emergency department (ED) and inpatient care use patterns could assist with procedure choice and provide insights about complication risk. METHODS: We used a national insurance claims database to identify adults undergoing SG and RYGB between 2008 and 2016. Patients were matched on age, sex, calendar-time, diabetes, and baseline acute care use. We used adjusted Cox proportional hazards to compare acute care utilization and 2-part logistic regression models to compare annual associated costs (odds of any cost, and odds of high costs, defined as ≥80th percentile), between SG and RYGB, overall and within several clinical categories. RESULTS: The matched cohort included 4263 SG and 4520 RYGB patients. Up to 4 years after surgery, SG patients had slightly lower risk of ED visits [adjusted hazard ratio (aHR): 0.90; 95% confidence interval (CI): 0.85,0.96] and inpatient stays (aHR: 0.80; 95% CI: 0.73,0.88), especially for events associated with digestive-system diagnoses (ED aHR: 0.68; 95% CI: 0.62,0.75; inpatient aHR: 0.61; 95% CI: 0.53,0.72). SG patients also had lower odds of high ED and high total acute costs (eg, year-1 acute costs adjusted odds ratio (aOR) 0.77; 95% CI: 0.66,0.90) in early follow-up. However, observed cost differences decreased by years 3 and 4 (eg, year-4 acute care costs aOR 1.10; 95% CI: 0.92,1.31). CONCLUSIONS: SG may have fewer complications requiring emergency care and hospitalization, especially as related to digestive system disease. However, any acute care cost advantages of SG may wane over time.

Comparison of Ambulatory Health Care Costs and Use Associated With Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy.

Importance: Studies comparing contemporary bariatric surgical types could facilitate procedure selection for patients interested in reducing their frequency of health care visits and reliance on prescription drugs. Objective: To compare the association of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) with ambulatory health care costs and use for as long as 4 years after surgery. Design, Setting, and Participants: This comparative effectiveness study, which included patients undergoing bariatric surgery who were aged 18 to 64 years with at least 24 months of enrollment data before surgery and 12 months of enrollment data after surgery, used a retrospective interrupted time series with a comparison group. Data represent insurance claims dated January 2006 to June 2017, with analyses completed in September 2021. Data were collected from US commercial and Medicare Advantage claims database. Cohorts were matched on characteristics including baseline body mass index category, diabetes status, baseline ambulatory care costs, region of the United States, and year of surgery. Exposures: SG or RYGB, based on procedure codes. Main Outcomes and Measures: Annual ambulatory health care costs, and subtypes of cost and use including prescriptions, office visits, laboratory encounters, and radiology. Results: Matched cohorts included 3049 patients who underwent SG and 3251 patients who underwent RYGB, with a mean (SD) age of 45.2 (10.0) years; 4820 (77%) were women. Full follow-up was 37% for SG (514 patients) and 38% for RYGB (643 patients) among those eligible for 4-year follow-up. There were no significant differences between SG and RYGB in total ambulatory costs, office visit costs, or radiology costs in all follow-up years. Patients who underwent SG had significantly higher prescription costs than those who underwent RYGB bypass in year 4 ($852.8 per patient per year; 95% CI: $395.6-$1310.0 per patient per year) with more cardiometabolic medication fills in each year (eg, year 4: 42.5%; 95% CI, 13.7%-71.2%). In contrast, early after surgery, patients who underwent SG had relatively fewer specialist visits (eg, year 1: -7.2%; 95% CI, -14.3% to -0.2%) and lower laboratory costs (eg, year 1: -$118.9 per patient per year; 95% CI, -$220.2 to -$17.5 per patient per year). Conclusions and Relevance: Despite clinical studies showing greater weight loss and comorbidity improvement with RYGB vs SG, this study found no difference in total ambulatory costs for as long as 4 years after SG and RYGB. These findings may reflect the trade-off between greater improvements in cardiometabolic health and additional surgery-related care among patients undergoing RYGB. Studies with longer follow-up time could determine whether greater sustained weight loss from RYGB eventually results in lower costs compared with SG.

Trends in Annual Surveillance Mammography Participation Among Breast Cancer Survivors From 2004 to 2016.

BACKGROUND: Annual mammography is recommended for breast cancer survivors; however, population-level temporal trends in surveillance mammography participation have not been described. Our objective was to characterize trends in annual surveillance mammography participation among women with a personal history of breast cancer over a 13-year period. METHODS: We examined annual surveillance mammography participation from 2004 to 2016 in a nationwide sample of commercially insured women with prior breast cancer. Rates were stratified by age group (40-49 vs 50-64 years), visit with a surgical/oncology specialist or primary care provider within the prior year, and sociodemographic characteristics. Joinpoint models were used to estimate annual percentage changes (APCs) in participation during the study period. RESULTS: Among 141,672 women, mammography rates declined from 74.1% in 2004 to 67.1% in 2016. Rates were stable from 2004 to 2009 (APC, 0.1%; 95% CI, -0.5% to 0.8%) but declined 1.5% annually from 2009 to 2016 (95% CI, -1.9% to -1.1%). For women aged 40 to 49 years, rates declined 2.8% annually (95% CI, -3.4% to -2.1%) after 2009 versus 1.4% annually in women aged 50 to 64 years (95% CI, -1.9% to -1.0%). Similar trends were observed in women who had seen a surgeon/oncologist (APC, -1.7%; 95% CI, -2.1% to -1.4%) or a primary care provider (APC, -1.6%; 95% CI, -2.1% to -1.2%) in the prior year. CONCLUSIONS: Surveillance mammography participation among breast cancer survivors declined from 2009 to 2016, most notably among women aged 40 to 49 years. These findings highlight a need for focused efforts to improve adherence to surveillance and prevent delays in detection of breast cancer recurrence and second cancers.

Use of Palliative Care Among Commercially Insured Patients With Metastatic Cancer Between 2001 and 2016.

PURPOSE: Early palliative care, concomitant with disease-directed treatments, is recommended for all patients with advanced cancer. This study assesses population-level trends in palliative care use among a large cohort of commercially insured patients with metastatic cancer, applying an expanded definition of palliative care services based on claims data. METHODS: Using nationally representative commercial insurance claims data, we identified patients with metastatic breast, colorectal, lung, bronchus, trachea, ovarian, esophageal, pancreatic, and liver cancers and melanoma between 2001 and 2016. We assessed the annual proportions of these patients who received services specified as, or indicative of, palliative care. Using Cox proportional hazard models, we assessed whether the time from diagnosis of metastatic cancer to first encounter of palliative care differed by demographic characteristics, socioeconomic factors, or region. RESULTS: In 2016, 36% of patients with very poor prognosis cancers received a service specified as, or indicative of, palliative care versus 18% of those with poor prognosis cancers. Being diagnosed in more recent years (2009-2016 v 2001-2008: hazard ratio [HR], 1.8; P < .001); a diagnosis of metastatic esophagus, liver, lung, or pancreatic cancer, or melanoma (v breast cancer, eg, esophagus HR, 1.89; P < .001); a greater number of comorbidities (American Hospital Formulary Service classes > 10 v 0: HR, 1.71; P < .001); and living in the Northeast (HR, 1.43; P < .001) or Midwest (v South: HR, 1.39; P < .001) were the strongest predictors of shorter time from diagnosis to palliative care. CONCLUSION: Use of palliative care among commercially insured patients with advanced cancers has increased since 2001. However, even with an expanded definition of services specified as, or indicative of, palliative care, < 40% of patients with advanced cancers received palliative care in 2016.

Financing Strategies to Facilitate Access to High-Cost Anticancer Drugs: A Systematic Review of the Literature.

BACKGROUND: Each country manages access to anticancer drugs differently due to variations in the structure and financing of the health system, but a summary of the various strategies used is absent. This study aimed to review and summarize financing strategies implemented across countries to facilitate access to high-cost anticancer drugs. METHODS: We conducted a systematic review of articles referenced in PubMed, Embase, and Web of Science through May 12, 2021. Articles published in the English language from 2000 that describe strategies implemented in different countries to facilitate access to high-cost anticancer drugs were included. Letters, news articles, and proposed strategies were excluded. Quality assessment was not performed as we aimed to summarize the strategies. Data were analyzed by thematic analysis. A review protocol was registered at PROSPERO (CRD42018068616). RESULTS: The review included 204 studies from 176 countries. Three themes of financing strategies were identified: (1) Basic pharmaceutical reimbursement and pricing policies, (2) Alternative funding strategies specific to high-cost drugs, and (3) Financial assistance for individual patients. Access in most countries depends mainly on basic pharmaceutical reimbursement policies (165 of 176 countries). Apart from that, high-income countries (HICs) tended to use funding strategies targeting high-cost drugs (72% of HICs vs 0%-24% of the rest), such as managed entry agreements (MEAs) or dedicated funds for high-cost drugs. In contrast, lower-income countries tended to implement financial assistance programs for cancer patients as a tool to increase access (32% of HICs vs 62%-79% of the rest). CONCLUSION: Many countries have implemented a combination of strategies to increase access to high-cost anticancer drugs. Most low- and middle-income countries utilized placement of anticancer drugs on a national list of essential medicines and patient assistance programs (PAPs) to facilitate access, while many HICs implemented a broader range of strategies.

Real-world Use of and Spending on New Oral Targeted Cancer Drugs in the US, 2011-2018.

Importance: Launch prices of new cancer drugs in the US have substantially increased in recent years despite growing concerns about the quantity and quality of evidence supporting their approval by the US Food and Drug Administration (FDA). Objective: To assess the use of and spending on new oral targeted cancer drugs among US residents with employer-sponsored insurance between 2011 and 2018, stratified by the strength of available evidence of benefit. Design, Setting, and Participants: In this cross-sectional study, dispensing claims for oral targeted cancer drugs first approved by the FDA between January 1, 2011, and December 31, 2018, were analyzed. The number of patients with drugs dispensed and the total payment for all claims were aggregated by calendar year, and these outcomes were arrayed according to evidence underlying FDA approvals, including pivotal study design (availability of randomized clinical trials) and overall survival (OS) benefit, as documented in drug labels. This study was conducted from July 17, 2019, to July 23, 2021. Main Outcomes and Measures: Annual and cumulative numbers of patients who had dispensing events, and annual and cumulative sums of payment for eligible drugs. Results: Of 37 348 patients who had at least 1 of the 44 new oral targeted drugs dispensed between 2011 and 2018, 21 324 were men (57.1%); mean (SD) age was 64.1 (13.1) years. Most individuals (36 246 [97.0%]) received drugs for which evidence from randomized clinical trials existed; however, a growing share of patients received drugs without documented OS benefit during the study period: from 12.7% in 2011 to 58.8% in 2018. Cumulative spending on all sample drugs totaled $3.5 billion by the end of 2018, of which 96.8% was spent on drugs that were approved based on a pivotal randomized clinical trial. Cumulative spending on drugs without documented OS benefit ($1.8 billion [51.6%]) surpassed that on drugs with documented OS benefit ($1.7 billion [48.4%]) by the end of 2018. Conclusions and Relevance: The findings of this cross-sectional study suggest that drugs used for treatment of cancer without documented OS benefits are adopted in the health system and account for substantial spending.

Comparative Effectiveness of Vertical Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Diabetes Treatment: A Claims-based Cohort Study.

OBJECTIVE: The aim of the study was to compare diabetes outcomes following vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB). BACKGROUND: There are few comparative studies on diabetes outcomes after VSG and RYGB. METHODS: We used a US-wide commercial insurance claims database to identify adults with diabetes undergoing VSG or RYGB in 2010 to 2016. We matched patients on baseline insulin use, total diabetes medication burden, age, presence of diabetes complications, and follow-up duration, and used adjusted Cox proportional hazards models to compare diabetes medication discontinuation between procedures. We used difference-in-differences analyses to compare changes in medication use intensity up to 2 years after surgery. RESULTS: The matched cohort included 1111 VSG and 922 RYGB patients: 16% were younger than 40 years, 11% were 60 years or older, 67% were women, 67% had a body mass index of 40 kg/m2 or higher, and 23% were on insulin at the time of surgery. Thirteen percent were lost to follow-up at 1 year, and 30% at 2 years after surgery. Patients with VSG were less likely than matched RYGB patients to discontinue all diabetes medications (hazard ratio 0.80, 95% confidence interval 0.72-0.88). Although both groups had substantial decreases in medication use after surgery, RYGB patients had an 86% (32%, 140%) lower total diabetes medication dose than VSG by the second half of postoperative year 2. CONCLUSIONS: In a large claims-based, nationwide cohort of bariatric patients with diabetes, those undergoing RYGB were more likely to come off all medications than those undergoing VSG. Patients with diabetes should consider this potential benefit of RYGB when making informed decisions about obesity treatments.

Intensity of End-of-Life Care in a Cohort of Commercially Insured Women With Metastatic Breast Cancer in the United States.

PURPOSE: There is limited evidence on the intensity of end-of-life (EOL) care for women < 65 years old, who account for about 40% of breast cancer deaths in the United States. Using established indicators, we estimated the intensity of EOL care among these women. METHODS: We used 2000-2014 claims data from a large US insurer to identify women with metastatic breast cancer who, in the last month of their lives, had more than one hospital admission, emergency department visit, or an intensive care unit (ICU) admission and/or used antineoplastic therapy in the last 14 days of life. Using multivariate logistic regression, we assessed whether intensity of EOL care differed by demographic characteristics, socioeconomic factors, or regions. RESULTS: Adjusted estimates show an increase in EOL ICU admissions between 2000-2003 and 2010-2014 from 14% (95% CI, 10% to 17%) to 23% (95% CI, 20% to 26%) and a small increase in emergency department visits from 10% (95% CI, 7% to 13%) to 12% (95% CI, 9% to 15%), both statistically significant. There was no statistically significant change in the proportions of women experiencing more than one EOL hospitalization (14% in 2010-2014; 95% CI, 11% to 17%) and of those receiving EOL antineoplastic treatment (24% in 2010-2014; 95% CI, 21% to 27%). Living in predominantly mixed, Hispanic, Black, or Asian neighborhoods correlated with more intense care (odds ratio, 1.39; 95% CI, 1.10 to 1.77 for ICU). CONCLUSION: Consistent with findings in the Medicare population, our results suggest an overall increase in the number of ICU admissions at the EOL over time. They also suggest that patients from non-White neighborhoods receive more intense acute care.

Concurrent hiatal hernia repair and bariatric surgery: outcomes after sleeve gastrectomy and Roux-en-Y gastric bypass.

BACKGROUND: Hiatal hernias are often repaired concurrently with bariatric surgery to reduce risk of gastroesophageal reflux disease-related complications. OBJECTIVES: To examine the association between concurrent hiatal hernia repair (HHR) and bariatric outcomes. SETTING: A 2010-2017 U.S. commercial insurance claims data set. METHODS: We conducted a retrospective cohort study. We identified adults who underwent sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) alone or had bariatric surgery concurrently with HHR. We matched patients with and without HHR and followed patients up to 3 years for incident abdominal operative interventions, bariatric revisions/conversions, and endoscopy. Time to first event for each outcome was compared using multivariable Cox proportional hazards modeling. RESULTS: We matched 1546 SG patients with HHR to 3170 SG patients without HHR, and we matched 457 RYGB patients with HHR to 1156 RYGB patients without HHR. A total of 73% had a full year of postoperative enrollment. Patients who underwent concurrent SG and HHR were more likely to have additional abdominal operations (adjusted hazard ratio [aHR], 2.1; 95% CI, 1.5-3.1) and endoscopies (aHR, 1.5; 95% CI, 1.2-1.8) but not bariatric revisions/conversions (aHR, 1.7; 95% CI, .6-4.6) by 1 year after surgery, a pattern maintained at 3 years of follow-up. Among RYGB patients, concurrent HHR was associated only with an increased risk of endoscopy (aHR, 1.4; 95% CI, 1.1-1.8)) at 1 year of follow-up, persisting at 3 years. CONCLUSIONS: Concurrent SG/HHR was associated with increased risk of some subsequent operative and nonoperative interventions, a pattern that was not consistently observed for RYGB. Additional studies could examine whether changes to concurrent HHR technique could reduce risk.

What are the volume and budget needs to provide chemotherapy to all children with acute lymphoblastic leukaemia in Thailand? Development and application of an estimation tool.

OBJECTIVE: Insufficient access to anticancer medicines may contribute to the wide survival differences of children with cancers across the globe. We developed a tool to estimate the volume of medicines and budget requirements to provide chemotherapy to children with acute lymphoblastic leukaemia (ALL). DESIGN: Development and application of an estimation tool. SETTING: Paediatric oncology hospital departments in Thailand. PARTICIPANTS: 318 children aged 0-14 years diagnosed with ALL and 215 children with undiagnosed ALL. INTERVENTIONS: Estimates of volume and budget requirements for administering a full course of chemotherapy for ALL and a further course for children who relapse, according to National Treatment Guidelines. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measures were the volume (mg) and cost (US$) of medicines needed to treat children with ALL. For medicines whose main indication is paediatric ALL (asparaginase and 6-mercaptopurine), we estimated the difference between volume needed and actual sales in 2017 (secondary outcome). RESULTS: Ten anticancer medicines and four chemoprotective agents are needed for the treatment of paediatric ALL according to the Thai treatment guidelines. Of these 14 medicines, 13 are included in the WHO essential medicines list for children. All are available as generics. We estimated that essential chemotherapy and chemoprotective agents to treat all children diagnosed with ALL in Thailand in 2017 would cost US$ 814 952 (US$ 1 365 422 for diagnosed and undiagnosed children), which corresponds to 0.005% (0.008%) of the country's total health expenditure. The volumes of asparaginase and 6-mercaptopurine available on the Thai market in 2017 were more than sufficient (2.3 and 1.5 times the amounts needed, respectively) to treat all children diagnosed with ALL. CONCLUSIONS: Procuring sufficient quantities of essential medicines to treat children with ALL requires relatively modest resources. Medicine cost should not be a major barrier to ALL treatment in similar settings.

Trends in screening breast magnetic resonance imaging use among US women, 2006 to 2016.

BACKGROUND: Supplemental breast cancer screening with breast magnetic resonance imaging (MRI) is recommended for women at high risk of breast cancer. To the authors' knowledge, recent national trends in breast MRI use are unknown. METHODS: The authors used claims data from a large national insurer to calculate screening breast MRI rates from 2006 to 2016 in a US cohort of 10 million women aged 20 to 64 years. Use was stratified by subgroups of women with a BRCA mutation, family history of breast cancer, and prior breast cancer history and stratified by age. Joinpoint regression evaluated annual changes in trends. RESULTS: The total sample included 37,447 screening breast MRI examinations in 25,617 women. Overall screening breast MRI rates were low and increased from 2.9 to 12.1 examinations per 10,000 women from 2006 to 2016. MRI use in women with a BRCA mutation increased by 21% on average annually from 210.8 per 10,000 women to 1562.0 per 10,000 women from 2006 to 2016. By 2016, women aged 50 to 64 years who had a BRCA mutation had the highest use of breast MRI (1669.6 MRI examinations per 10,000 women) compared with younger women (1198.4 MRI examinations per 10,000 women, 1519.1 MRI examinations per 10,000 women, and 1567.2 MRI examinations per 10,000 women, respectively, among women aged 20-29 years, 30-39 years, and 40-49 years). Women with a BRCA mutation comprised <1% of the current study population but received approximately 9% of screening breast MRI examinations. Breast MRI rates among women with a family history of breast cancer or prior breast cancer history initially increased from 2006 to 2008, but then stabilized or decreased. CONCLUSIONS: The increases in breast MRI use observed in the current study have indicated improvements in concordance with breast imaging guidelines. However, women with BRCA mutations remain underscreened, particularly younger women, thereby identifying a clear gap with which to enhance access.

Sales of anti-cancer medicines; China, Indonesia, Kazakhstan, Malaysia, Philippines and Thailand.

OBJECTIVE: To assess sales of anti-cancer medicines in the 2017 World Health Organization's WHO Model list of essential medicines in China, Indonesia, Kazakhstan, Malaysia, Philippines and Thailand from 2007 (2008 for Kazakhstan and Malaysia) to 2017. METHODS: We extracted sales volume data for 39 anti-cancer medicines from the IQVIA database. We divided the total quantity sold by the reference defined daily dose to estimate the total number of defined daily doses sold, per country per year, for three types of anti-cancer therapies (traditional chemotherapy, targeted therapy and endocrine therapy). We adjusted these data by the number of new cancer cases in each country for each year. FINDINGS: We observed an increase in sales across all types of anti-cancer therapies in all countries. The largest number of defined daily doses of traditional chemotherapy per new cancer case was sold in Thailand; however, the largest relative increase per new cancer case occurred in Indonesia (9.48-fold). The largest absolute and relative increases in sales of defined daily doses of targeted therapies per new cancer case occurred in Kazakhstan. Malaysia sold the largest number of adjusted defined daily doses of endocrine therapies in 2017, while China and Indonesia more than doubled their adjusted sales volumes between 2007 and 2017. CONCLUSION: The use of sales data can fill an important knowledge gap in the use of anti-cancer medicines, particularly during periods of insurance coverage expansion. Combined with other data, sales volume data can help to monitor efforts to improve equitable access to essential medicines.

Differences in reimbursement listing of anticancer therapies in China: an observational study.

OBJECTIVE: Access to highly priced anticancer medications usually requires insurance coverage. A first step towards coverage of such medications is their inclusion in reimbursement lists. We assessed listing for reimbursement in China between 2009 and 2018 of anticancer medications on the WHO's Essential Medicines List. SETTING AND STUDY DESIGN: Using publicly available data, we assessed which anticancer medications listed in the 20th WHO Model List of Essential Medicines (EML) were included in China's National Reimbursement Drug List (NRDL). For five targeted anticancer medications on the WHO EML, we also assessed inclusion in the 31 Chinese Provincial Reimbursement Drug Lists (PRDLs). Logistic regression was used to test whether inclusion of targeted anticancer medications was associated with provincial economic levels. PRIMARY OUTCOME MEASURES: Inclusion of five targeted anticancer medications in the NRDL and PRDLs before and after 2017. RESULTS: The 2017 NRDL included all anticancer medications on the WHO EML (except for one not approved in China at the time), and by 2018, all 31 PRDLs listed the targeted anticancer medications except for nilotinib; four provinces had covered all five targeted medications before the 2017 NRDL coverage mandate. Provincial economic level and regional incidence of specific cancers seemed unrelated to the inclusion of five targeted anticancer medications in PRDLs. CONCLUSION: Our findings suggest that by including medications in the national and provincial reimbursement lists, China has taken an important first step in promoting access to targeted anticancer medications. Further research is needed to determine whether inclusion in PRDLs improved the availability, appropriate use and affordability of highly priced targeted anticancer medications in China.

Risk of Operative and Nonoperative Interventions Up to 4 Years After Roux-en-Y Gastric Bypass vs Vertical Sleeve Gastrectomy in a Nationwide US Commercial Insurance Claims Database.

Importance: There are few nationwide studies comparing the risk of reintervention after contemporary bariatric procedures. Objective: To compare the risk of intervention after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). Design, Setting, and Participants: This cohort study used a nationwide US commercial insurance claims database. Adults aged 18 to 64 years who underwent a first RYGB or VSG procedure between January 1, 2010, and June 30, 2017, were matched on US region, year of surgery, most recent presurgery body mass index (BMI) category (based on diagnosis codes), and baseline type 2 diabetes. The prematch pool included 4496 patients undergoing RYGB and 8627 patients undergoing VSG, and the final weighted matched sample included 4476 patients undergoing RYGB and 8551 patients undergoing VSG. Exposures: Bariatric surgery procedure type (RYGB vs VSG). Main Outcomes and Measures: The primary outcome was any abdominal operative intervention after the index procedure. Secondary outcomes included the following subtypes of operative intervention: biliary procedures, abdominal wall hernia repair, bariatric conversion or revision, and other abdominal operations. Nonoperative outcomes included endoscopy and enteral access. Time to first event was compared using multivariable Cox proportional hazards regression modeling. Results: Among 13 027 patients, the mean (SD) age was 44.4 (10.3) years, and 74.1% were female; 13.7% had a preoperative BMI between 30 and 39.9, 45.8% had a preoperative BMI between 40 and 49.9, and 24.2% had a preoperative BMI of at least 50. Patients were followed up for up to 4 years after surgery (median, 1.6 years; interquartile range, 0.7-3.2 years), with 41.9% having at least 2 years of follow-up and 16.3% having at least 4 years of follow-up. Patients undergoing VSG were less likely to have any subsequent operative intervention than matched patients undergoing RYGB (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.72-0.89) and similarly were less likely to undergo biliary procedures (aHR, 0.77; 95% CI, 0.67-0.90), abdominal wall hernia repair (aHR, 0.60; 95% CI, 0.47-0.75), other abdominal operations (aHR, 0.71; 95% CI, 0.61-0.82), and endoscopy (aHR, 0.54; 95% CI, 0.49-0.59) or have enteral access placed (aHR, 0.58; 95% CI, 0.39-0.86). Patients undergoing VSG were more likely to undergo bariatric conversion or revision (aHR, 1.83; 95% CI, 1.19-2.80). Conclusions and Relevance: In this nationwide study, patients undergoing VSG appeared to be less likely than matched patients undergoing RYGB to experience subsequent abdominal operative interventions, except for bariatric conversion or revision procedures. Patients considering bariatric surgery should be aware of the increased risk of subsequent procedures associated with RYGB vs VSG as part of shared decision-making around procedure choice.

Influence of government price regulation and deregulation on the price of antineoplastic medications in China: a controlled interrupted time series study.

BACKGROUND: In October 2012, the Chinese government established maximum retail prices for specific products, including 30 antineoplastic medications. Three years later, in June 2015, the government abolished price regulation for most medications, including all antineoplastic medications. This study examined the impacts of regulation and subsequent deregulation of prices of antineoplastic medications in China. METHODS: Using hospital procurement data and an interrupted time series with comparison series design, we examined the impacts of the policy changes on relative purchase prices (Laspeyres price index) and volumes of and spending on 52 antineoplastic medications in 699 hospitals. We identified three policy periods: prior to the initial price regulation (October 2011 to September 2012); during price regulation (October 2012 to June 2015); and after price deregulation (July 2015 to June 2016). RESULTS: During government price regulation, compared with price-unregulated cancer medications (n=22, mostly newer targeted products), the relative price of price-regulated medications (n=30, mostly chemotherapeutic products) decreased significantly (ß=-0.081, p<0.001). After the government price deregulation, no significant price change occurred. Neither government price regulation nor deregulation had a significant impact on average volumes of or average spending on all antineoplastic medications immediately after the policy changes or in the longer term (p>0.05). CONCLUSION: Compared with unregulated antineoplastics, the prices of regulated antineoplastic medications decreased after setting price caps and did not increase after deregulation. To control the rapid growth of oncology medication expenditures, more effective measures than price regulation through price caps for traditional chemotherapy are needed.

Brazilian generics market change after Farmácia Popular program.

OBJECTIVE: To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS: This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS: Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS: Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

A systematic review of the effectiveness of strategies to improve health care provider performance in low- and middle-income countries: Methods and descriptive results.

BACKGROUND: Health care provider (HCP) performance in low- and middle-income countries (LMICs) is often inadequate. The Health Care Provider Performance Review (HCPPR) is a comprehensive systematic review of the effectiveness and cost of strategies to improve HCP performance in LMICs. We present the HCPPR's methods, describe methodological and contextual attributes of included studies, and examine time trends of study attributes. METHODS: The HCPPR includes studies from LMICs that quantitatively evaluated any strategy to improve HCP performance for any health condition, with no language restrictions. Eligible study designs were controlled trials and interrupted time series. In 2006, we searched 15 databases for published studies; in 2008 and 2010, we completed searches of 30 document inventories for unpublished studies. Data from eligible reports were double-abstracted and entered into a database, which is publicly available. The primary outcome measure was the strategy's effect size. We assessed time trends with logistic, Poisson, and negative binomial regression modeling. We were unable to register with PROSPERO (International Prospective Register of Systematic Reviews) because the protocol was developed prior to the PROSPERO launch. RESULTS: We screened 105,299 citations and included 824 reports from 499 studies of 161 intervention strategies. Most strategies had multiple components and were tested by only one study each. Studies were from 79 countries and had diverse methodologies, geographic settings, HCP types, work environments, and health conditions. Training, supervision, and patient and community supports were the most commonly evaluated strategy components. Only 33.6% of studies had a low or moderate risk of bias. From 1958-2003, the number of studies per year and study quality increased significantly over time, as did the proportion of studies from low-income countries. Only 36.3% of studies reported information on strategy cost or cost-effectiveness. CONCLUSIONS: Studies have reported on the efficacy of many strategies to improve HCP performance in LMICs. However, most studies have important methodological limitations. The HCPPR is a publicly accessible resource for decision-makers, researchers, and others interested in improving HCP performance.