Generic Drug Prices Research Articles

Analysis of cancer drug prices: a narrative review of literature

Abstract Objectives The objective of the literature review is to collect data on how cancer medication pricing affects affordability and availability around the world. Key findings A literature search was carried out between 12 October 2020 and 2 December 2020, articles were selected based on them being available as full texts online and written in English. The keywords used were: ‘cancer’, ‘medicines’, ‘drug’, ‘drugs’, ‘pharmaceuticals’, ‘price’, ‘prices’, ‘pricing’. The collective search produced a total of 10 725 articles. After a refining process, any articles considered unnecessary and potential duplications were eliminated, and 16 research articles were included in the final analysis. The results were included in the following categories: (a) high-income countries, (b) low- and middle-income countries (LMICs), (c) originator cancer drug prices, (d) generic drug prices, (e) breast and colorectal cancer drug pricing. The expensive pricing of oncology medications is typically expected to be an obstacle for developing nations; however, the soaring prices have been found increasingly challenging for high-income countries. Within Europe, variations exist between countries in government expenditure and cancer drug prices. Originator cancer drug prices tend to be most expensive in Sweden, Denmark, Switzerland and Germany whereas Greece, Spain, Portugal and the UK had among the lowest recorded prices. The high cost of cancer drugs coupled with low availability rates have resulted in restricted access for many LMICs as monthly medicinal costs are often greater than yearly incomes. Summary The literature has shown the increasing trend of cancer drug pricing. The synthesis has also shown that cancer treatments are unaffordable in many developing countries resulting in most cancer deaths occurring in LMICs. Furthermore, governments cannot effectively challenge patented drug prices until the expiry of the patent.

Physicians Against Drug Shortages (PADS): End Chronic Shortages & Skyrocketing Prices of Generic Drugs, Devices & Supplies, Repeal the 1987 Medicare Anti-Kickback “Safe Harbor” for Hospital Group Purchasing Organizations (GPOs)

Physicians Against Drug Shortages (PADS): End Chronic Shortages & Skyrocketing Prices of Generic Drugs, Devices & Supplies, Repeal the 1987 Medicare Anti-Kickback “Safe Harbor” for Hospital Group Purchasing Organizations (GPOs)

Trajectories of prices in generic drug markets: what can we infer from looking at trajectories rather than average prices?

BackgroundWell-functioning competitive markets are key to controlling generic drug prices. This is important since over 90% of all drugs sold in the US are generics. Recently, there have been examples of large price increases in the generic market.MethodsThis paper examines price trajectories for generic drugs using a group-based trajectory modelling approach (GBTM). We fit the model using quarterly price information in the IBM MarketScan claims database for the past decade.ResultsWe identify three dominant price trajectories for this period: rapid increase trajectories, slow decline and rapid decline. Most generic drugs show a slow or a rapid decline in price trajectories. However, around 17% of all generic drugs show rapid price increase trajectories.ConclusionsAs Congress is exploring an excise tax on drugs whose list price increases faster than the rate of inflation, we discuss what drugs would be most likely to be affected by this law.

National trends in post-launch cancer prescription drug prices and the impact of generic entry, 2014-2020.

6598 Background: The high prices of branded ‘on patent’ cancer prescription drugs and the impact of competition on them is of importance to patients, physicians, payers and policymakers. The objective of this study is to quantify trends in the prices of all currently approved cancer drugs and to evaluate the impact of loss of exclusivity and generic entry on prices using national and contemporaneous data. Methods: Observational study of cancer drug prices from the IQVIA National Sales Perspectives from January 2014 to December 2020. The compound annual growth rate (CAGR) of drug prices was calculated for branded and generic drugs by therapeutic class (chemotherapy, targeted therapy, and supportive therapy). An event study empirical strategy and ordinary least squares regression was used to determine the relationship between the natural logarithm of prices and loss of exclusivity and generic entry. Results: The study cohort included 184 cancer drugs (37% chemotherapy, 51% targeted therapy, and 12% supportive therapy), of which 105 were always branded, 18 were always generic and 18 underwent loss of exclusivity and generic entry during the study period. Prices of branded chemotherapies and targeted therapies increased by 2.24% (0.79% CPI-adjusted) and 2.83% (1.07% CPI-adjusted) annually, whereas generics decreased by 12.63% (-14.14% CPI-adjusted) and 20.15% (-21.57% CPI-adjusted), respectively. Prices of branded supportive therapies decreased by 0.73% (-2.40% CPI-adjusted), while generics increased by 1.28% but decreased with CPI-adjustment (-0.45). Loss of exclusivity and generic entry was associated with statistically significant decreases in generic drug prices, but increases in branded drug prices after CPI-adjustment; these effects are concentrated in chemotherapies and targeted therapies. Conclusions: We found that cancer drug prices increased, after adjusting for inflation, particularly among branded chemotherapies and targeted therapies. Generic entry mitigates these price increases, but only a handful of cancer drugs experienced competition in the study period. Drug prices are key determinants of cancer-related spending, and many cancer patients remain underinsured. Although this data reflects net prices before discounts to providers and pharmacies, patient out-of-pocket costs are based on the list price. Our findings are critical to informing current efforts to improve cancer treatment affordability.

Trends and determinants of retail prescription drug costs.

To characterize price trends and variation for US generic and branded drugs at the retail level as they relate to pharmacy acquisition costs and local market factors. Drug pricing data consisting of US pharmacy claims from 2014 to 2019 collected and licensed by GoodRx, an online tool for comparing drug prices. Time trends of median drug prices and coefficients of variation were measured for generic and branded drugs, including subgroups based on clinical condition (i.e., diabetes and cancer). Pharmacy competition was measured using the Herfindahl-Hirschman Index (HHI) at the zip-code level. Multivariable linear regression analysis assessed the impact of local market-level factors on drug prices and variation. US drug pricing data consisting of claims filled through a mix of public and private insurance at 58,332 chain and independent pharmacies across 14,421 zip codes in all 50 states. From 2014 to 2019, pharmacy retail markets trended towards greater competition: average HHI by zip code decreased by 15.0% (p < 0.001). Median cash price increased significantly for both generic (6.58%, p < 0.001) and branded (84.10%, p < 0.001) drugs. When normalized to acquisition costs, cash prices for generic drugs rose 22.03% (p < 0.001) while those of branded drugs decreased by 2.31% (p < 0.001). Diabetes drugs showed higher baseline overall markup of cash prices relative to acquisition costs (10.54, Interquartile range (IQR) 3.28-18.43) than cancer drugs (1.88, IQR 1.36-3.08). Neither local pharmacy competition nor median income significantly predicted drug price or variation. Measures of generic drug price and price variation are high despite decreased costs earlier in the pharmaceutical supply chain, defying expectations of what would happen in a competitive market. Efforts to bypass the pharmacy benefit model for generic drugs may offer consumers an opportunity for substantial savings.

Does Reference Pricing Drive Out Generic Competition in Pharmaceutical Markets? Evidence from a Policy Reform

In this paper we study the impact of reference pricing (RP) on entry of generic firms in the pharmaceutical market. For given prices, RP increases generic firms' expected profit, but since RP also stimulates price competition, the impact on generic entry is theoretically ambiguous. In order to empirically test the effects of RP, we exploit a policy reform in Norway in 2005 that exposed a subset of drugs to RP. Having detailed product-level data for a wide set of substances from 2003 to 2013, we find that RP increased the number of generic drugs. We also find that RP increased market shares of generic drugs, reduced the prices of both branded and generic drugs, and led to a (weakly significant) decrease in total drug expenditures. The reduction in total expenditures was relatively smaller than the reduction in average prices, reflecting the fact that lower prices stimulated total demand.

Effect of Competition on Generic Drug Prices.

Promoting substitution of lower priced generics for brand drugs once the market exclusivity period for the latter expires is a key component of the US strategy for achieving value in prescription drugs. This study examines the effect of generic competition on drug prices by estimating the effect of entry of generic drugs, following a brand's loss-of-exclusivity (LOE), on the average price of competing drugs. Using the Medicare Part D drug event (PDE) data from 2007 to 2018, we utilize both fixed effects and random effects at the drug level to estimate the relationship of competitors and prices within each drug while controlling for factors across drugs. We follow a drug 24 months and 36 months after first generic entry to examine whether the relationship between number of suppliers and price would change over time. We also test the hypothesis that drugs with more recent LOE might face less competition than those with earlier LOE. We find that drug prices fall with increasing number of competitors. Prices decline by 20% in markets with about three competitors (the expected price ratio of current generic to pre-generic entry brand average prices is 80%). Prices continue to decline by 80% relative to the pre-generic entry price in markets of ten or more competitors (the expected price ratio is about 30% following 2 years after entry, dropping to 20% following 3 years after entry). We also find that the impact of competition on relative prices is similar for generic drugs first entering the market in either 2007-11 or 2012-15. Promoting generic entry and maintaining effective provider competition are effective methods for containing drug prices.

Cost-Effectiveness of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: An Economic Evaluation Based on Network Meta-Analysis

ObjectivesTo assess the cost-effectiveness of systemic treatments for metastatic castration-sensitive prostate cancer from the US healthcare sector perspective with a lifetime horizon. MethodsWe built a partitioned survival model based on a network meta-analysis of 7 clinical trials with 7287 patients aged 36 to 94 years between 2004 and 2018 to predict patient health trajectories by treatment. We tested parameter uncertainties with probabilistic sensitivity analyses. We estimated drug acquisition costs using the Federal Supply Schedule and adopted generic drug prices when available. We measured cost-effectiveness by an incremental cost-effectiveness ratio (ICER). ResultsThe mean costs were approximately $392 000 with androgen deprivation therapy (ADT) alone and approximately $415 000, $464 000, $597 000, and $959 000 with docetaxel, abiraterone acetate, enzalutamide, and apalutamide, added to ADT, respectively. The mean quality-adjusted life-years (QALYs) were 3.38 with ADT alone and 3.92, 4.76, 3.92, and 5.01 with docetaxel, abiraterone acetate, enzalutamide, and apalutamide, added to ADT, respectively. As add-on therapy to ADT, docetaxel had an ICER of $42 069 per QALY over ADT alone; abiraterone acetate had an ICER of $58 814 per QALY over docetaxel; apalutamide had an ICER of $1 979 676 per QALY over abiraterone acetate; enzalutamide was dominated. At a willingness to pay below $50 000 per QALY, docetaxel plus ADT is likely the most cost-effective treatment; at any willingness to pay between $50 000 and $200 000 per QALY, abiraterone acetate plus ADT is likely the most cost-effective treatment. ConclusionsThese findings underscore the value of abiraterone acetate plus ADT given its relative cost-effectiveness to other systemic treatments for metastatic castration-sensitive prostate cancer.

Are drug prices subject to creative destruction? Evidence from the US, 1997-2017.

There are several types of pharmaceutical competition. In addition to competition among producers of the same chemical substance ("within-substance competition"), there may be competition among producers of different chemical substances in the same chemical subgroup ("between-substance competition"). There have been numerous econometric studies of the effect of within-substance competition on drug prices, but empirical evidence about the effect of between-substance competition is far more limited. The primary objective of this study is to assess the impact of the entry of new drugs in a drug's therapeutic class on branded drug prices, generic drug prices, and the generic market share, using publicly-available US data for the period 1997-2017. Two methods are used to estimate the effects of between-substance and within-substance competition on those variables. The first method is standard 2-way fixed effects estimation based on aggregate data. The second method, based on micro data, is estimation using the DID_MULTIPLEGT procedure developed by de Chaisemartin etal.(2021), which does not rely on, and allows us to test for, "parallel trends." Between-substance competition does not appear to have any effect on brand-name drug prices, although our inability to fully account for rebates may bias the estimates towards zero. (There is also little evidence for an effect of within-substance competition on brand-name drug prices.) However, between-substance competition has a significant negative effect on generic drug prices. We estimate that the 1985-2005 increase in the number of substances ever registered in a drug's ATC4 chemical subgroup reduced the 2017 price of generic drugs by 42%. (The ratio of the generic-price reduction attributable to rising between-substance competition to the generic-price reduction attributable to rising within-substance competition also happens to be 42%.) A striking finding is that the entry of imitators has no effect on the prices of brand-name drugs, but the entry of innovators has a significant negative effect on the prices of generic drugs in the same ATC4 chemical subgroup. In addition, between-substance competition has a significant positive effect on the generic market share: the 1985-2005 increase in the number of substances ever registered in a drug's ATC4 chemical subgroup increased the 2017 generic market share by 15.0 percentage points. Due to its effects on generic drug prices and the generic market share, the 1985-2005 increase in between-substance competition reduced the average 2017 price of drugs that were already sold in 1997 by 35%. We estimate that 36% of 2017 expenditure on drugs that were first registered during 1986-2005 was offset by reduced 2017 expenditure on drugs that were sold in both 1997 and 2017.

Markups and Fixed Costs in Generic and Off-Patent Pharmaceutical Markets

Abstract There is wide dispersion in pharmaceutical prices across countries with comparable quality standards. Under monopoly, off-patent and generic drug prices are at least four times higher in the United States than in comparable Englishspeaking high income countries. With five or more competitors, off-patent drug prices are similar or lower. Our analysis shows that differential US markups are largely driven by the market power of drug suppliers and not due to wholesale intermediaries or pharmacies. Furthermore, we show that the traditional mechanism of reducing market power – free entry – is limited because implied entry costs are substantially higher in the US.

The Impact of Tiered-Pricing Framework on Generic Entry in Canada

Background: Generic drug prices have been capped at specified percentages of the interchangeable branded drug’s price by the Canadian provincial public drug plans since 1993. The Pan-Canadian Pharmaceutical Alliance, formed as a coalition by the provinces/territories in Canada, implemented an alternative approach, a tiered-pricing framework (TPF) for new generic drugs on April 1, 2014, under which the percentage varies with the number of generic firms in each market. We evaluate the impact of the TPF on generic entry, ie, listing in public drug plans in Canada. Methods: Our study compared the pre-TPF period (01/01/2012-03/31/2014) with the TPF period (04/01/2014- 06/30/2016). Prescription drugs from nine provincial public drug plans were grouped into a "market" if they had the same active ingredient and strength, route of administration, and dosage form. Each "market" was contestable by generics and met the eligibility criteria for TPF. At the "market" level, Cox proportional-hazards models with time-varying covariates were used to measure the impact of the TPF on the first generic listing in any provincial public drug plan in Canada relative to the first launch date worldwide. Results: A total of 189 markets in Canada were selected for the analyses. Generic drugs in small markets were more likely to be listed in Canada during the TPF period compared to the pre-TPF period (hazard ratio [HR], 95% CI: 3.81, 1.51-9.62). There was no significant difference in generic drug listings in large markets between the two policy periods.Conclusion: TPF speeds up generic entry in small markets and generates the benefits of generic competition while avoiding the pitfalls of the previously employed price-cap regulations.

Assessment of financial impact of anti-cancer drug wastage for pediatric hematologic malignancies as a result of inappropriate dosage forms

Background: Considering the high-cost nature of cancer especially in developing countries and pediatrics, it is this vulnerable group and their families who will be burdened with drug wastage costs more. The main aim of this study is to evaluate the financial impact of anticancer drug wastage for pediatric hematologic malignancies because of inappropriate vial sizes. Methods: This is a descriptive-analytical study that has been performed in two university-affiliated hospitals between April2019-March2020 in Iran. First, parenteral chemotherapy drugs which prescribed for pediatrics with hematological cancers were identified. Patients’ demographics and chemotherapy regimen were recorded during saturation point sampling. In second step vial size availability, price and drug stability were recorded. To calculate costs, the weighted average price of branded and generic drugs available in the market were used. Wastage was calculated for each drug by subtraction of prescribed drug dose from the total content of consumed vial(s) during third step. Sensitivity analyses were performed for a range of (±20% and ±SD) the main influential variables. Results: Twelve drugs administered (88 times) were analyzed. The average proportion of drug wastage was 34.4% (0.0-70.0%). Drug waste expenditure was estimated to be 1,739 US$/cycle. Performing sensitivity analysis by a change of ±20% in variables, BSA, weight and drug price were the most effective factors and by a change of ±SD drug price occupied first place. Conclusion: The financial impact of anticancer drug wastage in pediatrics with hematologic malignancies in Iran was estimated in range of 19,402-278,103 US$ annually which is 0.14%-1.98% of Iran revenue from these drugs. Therefore, the prescribed dose and vial sizes mismatch can cause wastage and increase in chemotherapy indirect costs.

From Competition to Conspiracy: Accessing the Federal Trade Commission’s Merger Policy in the Pharmaceutical Sector

Prescription drugs safeguard Americans from numerous life-threatening maladies. Competition in pharmaceutical R&D, and for generic entry, produces essential drugs and ensures that medications are accessible and affordable. That promise is fading. There is mounting evidence that connects high market concentration and high drug prices. Price gouging for important drugs, conspiracies to fix generic drug prices, and ever more innovative schemes by branded drug manufacturers to keep generic rivals out of the market put merger control at center stage.The AAI White Paper “From Competition to Conspiracy: Accessing the Federal Trade Commission’s Merger Policy in the Pharmaceutical Sector” examines a major root of this problem—the Federal Trade Commission’s (FTC’s) policy of settling virtually all challenged horizontal pharmaceutical mergers with consent orders requiring divestitures. This stands in contrast to agency decisions to seek injunctions to stop highly concentrative, harmful mergers—arguably the most effective remedy for fully restoring competition. AAI’s macro-analysis of pharmaceutical mergers challenged by the FTC between 1994-2020 (to date) reveals that many drug makers engaged in serial mergers and/or repeatedly went to the till to purchase divestiture assets in other challenged mergers. Many of these firms were subsequently acquired by other pharmaceutical manufacturers, sometimes shortly after purchasing divestiture assets.The effect of the FTC’s policy has been the swapping of assets within a relatively small group of large and increasingly powerful firms. Just under 20% of all unique branded and generic firms that engaged in repeated mergers and acquisitions (M&A) and/or purchases of divestiture assets account for almost 45% of pharmaceutical assets “changing hands” from 1994-2020. Many of the very firms that were the most active in M&A, and as purchasers of divestiture assets, appear as defendants in private, state, and federal non-merger antitrust litigations and in federal criminal indictments. These accumulating lawsuits serve as powerful evidence that something has gone awry with merger policy in the pharmaceutical sector, leading to the exercise of market power by dominant firms and oligopolies.The FTC’s role in managing the allocation and ownership of important pharmaceutical assets through its extraordinary approach toward merger control has unduly involved it in shaping the industry. This resembles a form of “industrial planning” rather than antitrust law enforcement, which is designed to deter future anticompetitive conduct and relies on market forces to determine market structures. The FTC’s policy has also deprived the antitrust community and public of important transparency. Because no challenged merger between 1994-2020 was litigated in federal court, there is no judicial record detailing how highly concentrative mergers were likely to have survived a presumption of illegality. There is thus no way to evaluate claims that pharmaceutical mergers were likely to have delivered lower prices through claimed cost savings or consumer benefits due to improved quality and innovation.This White Paper begins with background on drug pricing and competition in the pharmaceutical supply chain. It then turns to the drug mergers themselves and the asset divestitures required in FTC consent orders. Next is an assessment of private, state, and federal antitrust cases against the companies involved in M&A and as buyers of divestiture assets. It concludes with policy recommendations on reframing competition policy in the pharmaceutical sector. The FTC, which has devoted considerable resources and expertise to understanding the pharmaceutical sector, should take the lead in reforming its own policy on merger control.Competition problems in pharmaceuticals now rise to the level a public policy concern, addressable only through a coordinated policy response, of which stronger antitrust enforcement and legislative reform should be central components. The imperative for wholesale change in the FTC’s merger policy in the pharmaceutical sector is more pressing than ever. Only robust competition among drug makers will result in the availability and affordability of drugs more generally, but also essential drug therapies and vaccines relating to the COVID-19 pandemic.

Is greater generic competition also linked to lower drug prices in South Korea?

BackgroundAlthough the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and market competitiveness in South Korea.MethodsA list of originator drugs approved by the national authority from 2000 to 2019 and their corresponding generic drugs were grouped along with the baseline information. The market was categorized into four groups based on the number of manufacturers: duopoly (2 manufacturers); low- (3–25 manufacturers); medium- (26–75 manufacturers); and high-competition (more than 76 manufacturers) markets. Price variance, calculated as the difference between the maximum price and minimum price divided by the maximum price, was obtained. A multivariate regression model was applied to regress price variance on the characteristics of market competitiveness, controlling for the characteristics of the originator drugs and their price level in the market.ResultsA total of 986 originator drugs were identified and then divided into duopoly (31%), low- (56%), medium- (9%), and high-competition (4%) markets; the median of the price variance for these markets was 0.013, 0.077, 0.200, and 0.228, respectively. In a multivariate regression model, price variance was associated with the characteristics of the originator drug, including the Anatomical Therapeutic Chemical classification, the route of administration, and the approval year. Controlling for the characteristics of the originator drugs, market competitiveness was positively associated with price variance.ConclusionsThe positive association between price variance and market competitiveness is still consistent in South Korea, where rare price competition among a large number of generic manufacturers has been reported. However, no significant price variance was observed between medium- and high-competition markets. These findings support policies for managing a large number of generic manufacturers in South Korea.

Gross profits of Canadian pharmacies: A changing policy regime.

Recently, both the Canadian and provincial governments have instituted policies to reduce manufacturers' prices for generic ($250 million sales annually) and brand name ($1,300 million sales annually) drugs. Both government groups made estimates of the financial magnitude of changes in drug prices, but neither has estimated the impact on retail pharmacies. We used a Cost-Volume-Profit model combined with operational data collected nationally to estimate the national impact of the pricing policy changes on pharmacy gross profits. Results show the average value of gross profits per pharmacy per year was approximately $440,000. It is estimated that the policy changes will lead to a 6.8% reduction in gross profits. Adding reductions in rebates for generic drugs, the pharmacies' reductions in gross profits will be 7.2%. In conclusion, policy-makers often ignore how their pricing changes influence the financial position of pharmacies, even though the impact can be substantial.

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.

Increasing generic drug price competition by facilitating abbreviated new drug applications (ANDA) submission may help patients have access to affordable care. This study examined factors associated with first ANDA submission for the brand drug to be copied [the "reference listed drug" (RLD)]. This study used several data sources from 1/1/2011 to 12/31/2017, including FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), internal ANDA submission data, FDA's Product-Specific Guidances (PSGs), National Drug Code, and IQVIA National Sales Perspectives. Two Cox proportional hazard models were separately performed to determine factors associated with first ANDA submissions for groups of ANDAs for RLDs with "new chemical entity" (NCE) exclusivity that were submitted on the first lawfully permissible date NCE ANDAs, and non-NCE ANDA groups. For NCE group, annual market sales were the only factor associated with increased likelihood of first ANDA submission. Specifically, adjusted hazard ratio (HR) for RLDs with annual sales > $250 million was nearly 5 times higher than those with annual sales < $10 million (HR 4.74; Confidence Interval [CI] 1.85-12.13) suggesting RLDs with higher sales are more likely to have ANDA submissions. For the non-NCE group, annual market sales (HR 2.40; CI 1.09-5.25, sales > $100-250 million compared with sales < $10 million) and PSG availability were associated with increased likelihood of first ANDA submission. Being an ANDA for a complex drug product was associated with decreased likelihood of submission for both NCE (HR 0.51; CI 0.26-0.99) and non-NCE groups (HR 0.62; CI 0.39-0.98). Given the impact of regulatory-related factors, particularly PSG availability prior to ANDA submission, the findings provide opportunities to address high drug prices with specific FDA actions. Specifically, timely development of PSGs, including those for complex generics, and research prioritizing complex generics may facilitate ANDA submission; and thus, promote drug price competition.

The Price to Consumers of Generic Pharmaceuticals: Beyond the Headlines.

Generic drug prices have received a great deal of attention in the past few years. Many agencies have conducted investigations into the pricing patterns for generic drugs. Price spikes for several specific generic drugs have also been widely reported in the media. Today, 90% of all retail prescriptions sold in the United States are generic drugs. Thus, these prices affect affordability of prescription drugs. We construct two Laspeyres chained price indexes for generic prescription drugs. The first reflects direct out-of-pocket payments by consumers to pharmacies for dispensing generic prescription drugs. The second measures the total price received by the pharmacy (the direct out-of-pocket payment plus the price paid to the pharmacy by the insurer). The chained direct out-of-pocket consumer price index we construct shows a roughly 50% decline for generic prescription drugs between 2007 and 2016. The total consumer price index for generic prescription drugs fell by nearly 80%.

PMH16 DRUG EXPENDITURE, PRICE, AND UTILIZATION IN THE U.S. MEDICAID PROGRAM: AN EMPIRICAL TREND ANALYSIS FOR SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) AND SEROTONIN-NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIS) ANTIDEPRESSANTS FROM 1991 TO 2018

To assess the trends of drug expenditure, utilization and price of SSRIs and SNRIs antidepressants in the U.S. Medicaid program, and to highlight the market share of SSRI and SNRI and the effect of generic drug entry on Medicaid drug expenditure. A retrospective descriptive data analysis was conducted for this study. A national pharmacy summary data for study brand and generic drugs were retrieved from the Medicaid State Outpatient Drug Utilization Data collected by the U.S. Center of Medicaid/Medicare Services. The study covered the period between 1991 and 2018. Study drugs include 12 different SSRI and SNRI brands and their generics available in the market, such as Citalopram, Escitalopram, Paroxetine, Fluoxetine, Sertraline, Venlafaxine, Desvenlafaxine, Duloxetine, and Levomilnacipran. Data were analyzed annually and categorized by total prescriptions (utilization), total reimbursement (spending) and cost per prescription as the proxy of price for each drug. From 1991 to 2018, total prescription of SSRI and SNRI drugs rose by 3001%. Total Medicaid spending on SSRIs & SNRIs increased from $64.5 million to $2 billion in 2004, then decreased steadily until reached $755 million in 2018. SSRIs average utilization market share was 87% compared to 13% of SNRIs’ utilization market share. About 72% of total Medicaid spending on the two groups goes to SSRIs, remaining 28% for SNRIs. SSRI and SNRI brands’ prices increased overtime. On the contrary, generics price was steadily decreased overtime. SSRIs' and SNRIs' utilization increased dramatically over the last 30 years. The utilization shifted from brand to generic drugs resulting in less spending but high utilization due to their low generic drug price. SSRI generics captured most of the prescription market in Medicaid programs in the past 10 years. Generic substitution demonstrated to be a meaningful cost-containment policy for Medicaid programs.

Ultra-low price of generic agents in China may weaken patients' drug recognition and compliance.

Drug quantity purchase in China has reshaped the pattern of drug market with lower price of generic drugs and relatively higher price of original brand-name drugs. However, most Chinese people do not trust the safety and efficacy of the generic drugs that sold at a very low price. Ultra-low price of generic agents may weaken patients' drug recognition and compliance, and affect the implementation of drug quantity purchase policy.

Marketing and Pricing Strategies of Blockbuster Drugs in the South Korean Market: A 15-Year Retrospective Cohort Study for Choline Alfoscerate.

IntroductionUnderstanding marketing strategies and price competition among manufacturers is essential to manage health care expenditures, particularly those related to blockbuster drugs.ObjectivesTo assess marketing and pricing strategies of blockbuster drugs in South Korea.MethodsBaseline information on manufacturers who were granted marketing approval for choline alfoscerate in various forms was retrieved. Accumulation of manufacturers in the market was also identified, and manufacturers were categorized into first movers and latecomers based on their marketing time. Then, an event history analysis and a regression analysis were applied to estimate the duration of marketing and their price competition.ResultsCurrently, 109, 83, and 26 manufacturers produce choline alfoscerate in capsule, tablet, or syrup form, respectively, indicating that many manufacturers have marketed generics and the majority of the generics are categorized as latecomers. The size of the manufacturer was a significant factor in marketing new medicines, while the variable was not related to the marketing of modified drugs. Furthermore, price competition in the market was rare and only a few major firms initiated price competition.ConclusionThe Korean market appears to be an example of perfect competition when we focus on the number of manufacturers. However, the market is near-monopolistic when examining the price of generic drugs. While product competition between different forms of drugs is effective in lowering price, product competition within the same form of a drug does not exist in the market.