Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.
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ABSTRACT:
SUBMITTER: Hwang TJ
PROVIDER: S-EPMC6649801 | biostudies-literature | 2018 Apr
REPOSITORIES: biostudies-literature
Publications
Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.
Hwang Thomas J TJ Kesselheim Aaron S AS Gyawali Bishal B
JNCI cancer spectrum 20180401 2
In response to the rising cost of cancer drugs, the National Comprehensive Cancer Network (NCCN) recently developed a value framework, known as "Evidence Blocks," to grade the efficacy, safety, evidence quality, evidence consistency, and affordability of treatments included in its clinical guidelines. The value scores were available for 55 of the 69 new cancer drugs approved by the US Food and Drug Administration from 2007 to 2016. Overall, the treatment costs for 95% of new cancer medicines in ...[more]
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Project description:BackgroundMalaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components.Methods and findingsThe methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector.ConclusionsThe free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.
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Project description:The clinical multifocal electroretinogram (mfERG) is an electrophysiological test of local retinal function. With this technique, many local ERG responses, typically 61 or 103, are recorded from the cone-driven retina under light-adapted conditions. This document specifies guidelines for performance of the test. It also provides detailed guidance on technical and practical issues, as well as on reporting test results. The main objective of the guidelines is to promote consistent quality of mfERG testing and reporting within and among centers. These 2007 guidelines, from the International Society for Clinical Electrophysiology of Vision (ISCEV: http://www.iscev.org ), replace the ISCEV guidelines for the mfERG published in 2003.
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Project description:BackgroundEssential medicines are those drugs that satisfy the priority health care needs of the population and help with functioning healthcare systems. Although many countries have formulated an essential medicine list, almost half of the global population still lack regular access to essential medicines. Research about the initiation of National Essential Medicines Policy in Chinese secondary and tertiary hospitals is inadequate, and the long-term effect on access after the reform is still unknown. This study's objective was to investigate the access to essential medicines in mainland China's secondary and tertiary hospitals.MethodsData on the access to 30 essential medicines from China's National Essential Medicine List were obtained from China Medicine Economic Information database covering 396 secondary hospitals and 763 tertiary hospitals. We improved the standard methodology developed by the World Health Organization and the Health Action International to measure the availability, median price ratio (MPR) and the incidence of catastrophic drug expenditure (CDE).ResultsFive essential medicines had > 50% availability and the nationwide availability kept steady; availability of drugs in eastern regions of China was significantly higher than the central and western regions. The median MPR of 30 drugs nationwide kept steady approximately 5; MPR of drugs in the eastern regions was significantly higher than the central and western regions and the ratio of MPR of innovator brands to generics increased from 3.66 to 6.32 during the study period. The incidence of CDE caused by essential medicines decreased from 2011 to 2014; brand name medicines were more likely to cause CDE than generics and rural patients have a greater tendency to fall into CDE.ConclusionsAfter the implementation of National Essential Medicines Policy, the MPR of essential medicines was well controlled and became more affordable in the context of steady availability. This has highlighted the problems associated with region disparity and inequity between rural and urban areas in the delivery of essential medicines and sustainable mechanisms are needed to deepen the National Essential Medicines Policy in mainland China.
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Project description:BackgroundWhether the high cost of cancer drugs is commensurate with their value to patients, which has become the focus of public concern. We aimed to assess the value of new cancer drugs approved for solid cancer in China and to explore the association between price and value of drugs.MethodsWe identified all new drugs for solid tumor that approved by the China's National Medical Products Administration (NMPA) between 2016 and 2020. The value of these drugs was assessed according to the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). We calculated Cohen's κ statistic to describe agreement between the two frameworks. Spearman's correlation coefficient was used to evaluate the correlation between price and value of drugs.ResultsBetween 2016 and 2020, 37 new drugs were approved by the NMPA for solid tumor and we could evaluate the value of 28 drugs (76%). Eight (29%) of drugs were approved for non-small-cell lung cancer and 6 (21%) for breast cancer. ASCO-VF scores had a range of -20 to 110.1, and the median score was 43.3 (inter-quartile range 27.1-58.35). Only seven drugs (25%) met the ASCO-VF cutoff score. By the ESMO-MCBS, 13 drugs showed a meaningful value. Agreement between these two frameworks thresholds was only fair (κ = 0.515, P < 0.05). We found no statistically significant correlation between launch price of drugs and clinical benefit according to both frameworks.ConclusionsNot all NMPA-approved new cancer drugs had meaningful value as measured by ASCO-VF or ESMO-MCBS. There was no significant correlation between drug price and the level of clinical benefit.
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Project description:ObjectiveUp to 70% of people living with epilepsy could become seizure-free with the appropriate use of antiseizure medicines. However, three quarters of people with epilepsy living in low-income countries do not get the treatment they need and also do not access antiseizure medicines. The purpose of this study was to assess the availability, price, and affordability of antiseizure medicines in Addis Ababa, Ethiopia.MethodsA cross-sectional study was done in selected pharmacies using a questioner developed after the modification of World Health Organization/Health Action International methodology. Data on the availability and price of lowest-priced generics and originator brand antiseizure medicines from essential medicines list in Ethiopia were collected from seven public sectors, five private sectors, and seven other sectors (five Kenema Public Community and two Red Cross Pharmacies) in Addis Ababa between 09 May and 31 2022. The data were analyzed using the modified World Health Organization/Health Action International workbook part I excel sheet. Descriptive results were reported in text and table format.ResultsThe overall availability of lowest-priced generics medication was 52%. The availability of lowest-priced generics was 62.86%, 30%, 55%, and 50% in public, private, Red Cross, and Kenema Public Community Pharmacies, respectively. The median price ratio in the public, private, Red Cross, and Kenema Public Community Pharmacy was 1.45, 3.72, 1.46, and 1.7, respectively. All the medications were unaffordable. Patients may be required to pay more than 6-month wage to purchase standard treatment for 1 month only.SignificanceThe overall availability of antiseizure medicines was lower than the WHO target for noncommunicable diseases. All the available medicines were unaffordable.
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Project description:BackgroundChina ranks first amongst the countries for the abuse of antibacterials. Essential antibacterials could help solve the problem. The aim of the work is to evaluate the availability, price and affordability of essential antibacterials in Hubei province, China.MethodThe standardized methodology developed by the World Health Organization and Health Action International was used to collect data on the availability and prices of 16 antibacterials in 5 cities of Hubei province, China.ResultsFirst, in total, the median availability of originator brands and lowest-priced generics for the essential antibacterials was low, 3.0% (0.0, 18.2%) and 33.3% (0.0, 87.9%) for each, respectively. Second, the median price ratio of originator brands for the antibacterials was 20.30 (4.71, 35.80), while for generics, it was 0.49 (0.07, 1.18). Third, the affordability of originator brands for the antibacterials was 28.14 (21.70, 41.90) times the daily wages of an unskilled government worker, while for generics, the affordability was 0.35 (0.04, 6.11). Finally, we found that in Hubei province, lowest-priced generics for essential antibacterials with (fairly) high availability and relatively low price included Amoxicillin/Clavulanic Acid, Ceftazidime, Metronidazole, Gentamicin Sulfate and Ceftriaxone.ConclusionThe prices of lowest-priced generics for essential antibacterials in Hubei province were reasonable, and in tertiary hospitals the availability was the highest, while in secondary and primary hospitals, it was relatively lower. Originator brands were not only extremely expensive but also difficult to obtain. Measures should be taken to improve the availability of essential antibacterials and the affordability of originator brands.
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Project description:ImportanceThe China National Drug Administration (NMPA) established the breakthrough therapy designation (BTD) in 2020 to encourage the accelerated development of drugs for the prevention and treatment of diseases that are life-threatening. However, the differences between BTD and non-BTD cancer drugs regarding clinical benefit, regulatory approval, and price are unclear.ObjectivesTo compare BTD and non-BTD cancer drugs in clinical benefit (defined as efficacy and safety), novelty, time to approval, and average monthly treatment price.Design, setting, and participantsThis cross-sectional study analyzes the original indication of BTD and non-BTD novel cancer drugs approved by the NMPA between July 8, 2020, and July 8, 2024. Data on efficacy, safety, regulatory approval, and price of cancer drugs were extracted from pivotal clinical trials based on review reports published by the NMPA, peer-reviewed articles or meeting reports, and winning bid prices for cancer drugs in the Chinese provincial-level centralized procurement process.Main outcomes and measuresThe main outcome was the efficacy and safety associated with BTD vs non-BTD cancer drugs, including progression-free survival (PFS), response rate (RR), duration of response, serious adverse events, grade 3 or higher adverse events, and treatment-related deaths. In addition, the time to approval, novelty, and initial and latest average monthly treatment prices were evaluated, as well as the average annual reduction rate (AARR; the sum of the reduction rates divided by the number of years for the monthly treatment price) for these cancer drugs.ResultsBetween July 2020 and July 2024, 18 BTD (36%) and 32 non-BTD (64%) cancer drugs were approved by the NMPA. The median (IQR) clinical development time for BTD drugs was significantly shorter than for non-BTD drugs (5.6 [95% CI, 4.3-7.3] vs 6.6 [95% CI, 6.0-8.5] years; P = .02). No significant differences were observed in PFS (HR, 0.44 [95% CI, 0.38-0.52] vs HR, 0.51 [95% CI, 0.40-0.65]; P = .20), PFS gained (median [IQR], 5.4 [3.9-7.0] vs 2.7 [2.6-5.9] months; P = .77), RR (58% [95% CI, 45%-74%] vs 59% [95% CI, 51%-69%]; P = .85), and duration of response (median [IQR], 18.0 [15.0-21.6] vs 11.1 [7.4-17.4] months; P = .09) between BTD and non-BTD drugs. The rates of serious adverse events (37% [95% CI, 26%-52%] vs 32% [95% CI, 27%-36%]; P = .45), adverse events grade 3 or higher (64% [95% CI, 53%-77%] vs 55% [95% CI, 45%-68%]; P = .31), and treatment-related deaths (2% [95% CI, 1%-4%] vs 1% [95% CI, 1%-2%]; P = .10) were similar between BTD and non-BTD drugs. BTD drugs are more likely to be first-in-class drugs (5 of 18 [28%] vs 1 of 32 [3%]; P = .02). Differences in the median (IQR) initial ($5665 [$3542-$9321] vs $3361 [$2604-$5474]; P = .06) and latest ($5665 [$1553-$9321] vs $2145 [$1318-$4276]; P = .18) average monthly treatment prices for BTD drugs and non-BTD drugs were not significant. The median (IQR) AARRs for BTD drugs and non-BTD drugs were 15.2% (0%-46.9%) and 19.8% (1.0%-42.9%), respectively.Conclusions and relevanceThe findings of this cross-sectional study suggest that BTD has facilitated faster time to market for cancer drugs and improved novelty, but the price of treatment is relatively higher. There was no significant difference on comparative efficacy and safety.
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Project description:ObjectiveThe aim of the study was to describe temporal trends in screening and outcomes for women, after changes in guidelines in Alberta, Canada, that raised starting age to 21 years, then to 25 years of age, and reduced frequency to 3 yearly.Materials and methodsCalgary Laboratory Information System data were used to examine screening rates, follow-up procedures, and cancer among women 10-29 years from 2007 to 2016 in the whole population of Calgary. Interrupted time-series analyses were used to assess changes in screening and subsequent diagnostic procedures over the 10-year period.ResultsAnnual screening rates dropped by approximately 10% at all ages older than 15 years after the 2009 Alberta cervical cancer screening guidelines, followed by a steady decrease. Further change continued subsequent to minimal apparent effect of the 2013 Canadian Task Force on Preventive Health Care guidelines. The rates of abnormal test results decreased in concert with decreased screening. No increases in cervical intraepithelial neoplasia 1, cervical intraepithelial neoplasia 2/3, or invasive cervical cancer rates were observed after reduced testing.ConclusionsThe largest decrease in screening and follow-up procedures occurred in the period immediately after implementation of 2009 Alberta screening guidelines. The number of consequent procedures also decreased in proportion to decreased screening, but there was no increase in cancer rates. Starting screening at the age of 25 years and reducing intervals seem to be safe.
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