Impact Of Generic Entry Research Articles

EE159 Price, Spending, and Utilization of Second-Generation Antipsychotics and the Impact of Generic Entry on Market Shares: Trend Analysis of Medicaid Database From 1991 to 2022

EE159 Price, Spending, and Utilization of Second-Generation Antipsychotics and the Impact of Generic Entry on Market Shares: Trend Analysis of Medicaid Database From 1991 to 2022

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.

Impact of Generic Entry on Hospital Antimicrobial Use: A Retrospective Quasi-Experimental Interrupted Time Series Analysis

Background: The impact of antimicrobials generic entry (GE) is controversial. Their introduction could provide an economic benefit yet may also increase their consumption, leading to a higher risk of resistance. Our aim was to analyze the impact of GE on trends of antimicrobial consumption in an acute-care hospital. Methods: A retrospective quasi-experimental interrupted time series analysis was conducted at a 400-bed tertiary hospital in Barcelona, Spain. All antimicrobials for systemic use for which a generic product entered the hospital from January 2000 to December 2019 were included. Antimicrobial consumption was expressed as DDD/100 bed days. Results: After GE, the consumption of cefotaxime (0.09, p < 0.001), meropenem (0.54, p < 0.001), and piperacillin-tazobactam (0.13, p < 0.001) increased, whereas the use of clindamycin (−0.03, p < 0.001) and itraconazole (−0.02, p = 0.01) was reduced. An alarming rise in cefepime (0.004), daptomycin (1.02), and cloxacillin (0.05) prescriptions was observed, despite not achieving statistical significance. On the contrary, the use of amoxicillin (−0.07), ampicillin (−0.02), cefixime (−0.06), fluconazole (−0.13), imipenem–cilastatin (−0.50) and levofloxacin (−0.35) decreased. These effects were noticed beyond the first year post GE. Conclusions: GE led to an increase in the consumption of broad-spectrum molecules. The potential economic benefit of generic antibiotics could be diluted by an increase in resistance. Antimicrobial stewardship should continue to monitor these molecules despite GE.

One Year after the Launch of the First U.S. Biosimilar Drug: Lessons for the Future?

In September 2015, the first biosimilar drug, Zarxio, was launched on the U.S. market. While the impact of generic entry on the small molecule branded market in the U.S. is well-understood, the impact of biosimilar entry on the large molecule biologic market has only been studied in Europe and results suggest that the nature of competition depends greatly on country-specific features of the health care market. In this article, we examine Zarxio’s performance in the first year since its launch and evaluate to what extent that performance can be informative of future biologic-biosimilar competition in the U.S. Since many of the market mechanisms driving fast penetration of small molecule generic drugs in the U.S. are absent in the case of biosimilar drugs, biosimilar penetration is expected to be slower. Indeed, the penetration for Zarxio has so far been much more modest than the average for small molecule drugs: 22% by the end of the first year compared to 88% for small molecule generic drugs. We identify several reasons why Zarxio’s performance may understate the rigor of future U.S. biologic-biosimilar competition.

Impact of generic entry to off-patent branded medicines in Japanese pharmaceutical market

The Japanese pharmaceutical market is known for having a relatively low market penetration of generic medicines. However, the velocity of generic penetration varies among medicines. Looking at current sales and share of off-patent branded medicines and generic medicines in Japanese pharmaceutical market, our main aim is to identify the factors associated with sales reductions of off-patent medicines and price competition caused by generic entry in the Japanese pharmaceutical market. We showed as one result that an increase in the number of generic maker entries significantly increases both price competition and sales reductions of off-patent branded medicines. As a second factor of note, we found that being subject to “NHI Drug Price Premium for Promoting the Creation of New Drugs and the Elimination of Off-label Use” before generic entry is related to maintaining sales of off-patent branded medicines after generic entry. The importance of generic medicines is increasing in association with the hypertrophy of health care expenditures in Japan. Efficient polices and corporate strategies reflecting market principles are strongly needed. Detailed results of this study on what determines whether sales and prices of off-patent medicines significantly decrease after generic entry in the Japanese pharmaceutical market should be useful for this purpose.

The impact of generic entry and price competition in Jordanian public health sector

Objectives Generics as widely considered a major tool to control escalating drugs' expenditures. The objectives of this study were to evaluate the impact of generic participation on the bidding prices of originators participated in annual tenders in Jordan (2009–2011) and role of local generics in reducing pharmaceutical expenditures. Methods Data were collected from the Jordan Joint Procurement Department (JPD) website. The difference between bidding prices of originators before and after generics participation was estimated. All prices evaluated in this study were postpatent price. Savings associated with local Jordanian generics was estimated by comparing the price of originators competing against winning local Jordanian generics. Results A total of 17 tenders were reviewed between June 2009 till July 2011. Generic participation in the tendering process lowered the bidding prices of the originators. This contributed to saving of 77 million JDs in 2010 and 15 million JDs in 2011. The bidding prices of originators on average reduced by 11% when competed with generics. Local generics contributed to significant reduction in pharmaceutical expenditures, this contributed to savings of 25 million JDs in 2009–2010. Conclusions Generics entrant resulted in almost 10% reduction in originator competitors, the substantial savings contributed by local generics leads focus on adapting generic substitution and switching private sector purchases to higher generic uptake recommending that policy makers and local manufactures to maintain high production quality, increase confidence in generics and promote their acceptance by professionals and patients.