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    3 Comments for this article
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    Controlling prescription drug prices
    Frederick Rivara, MD, MPH | University of Washington
    This study puts figures on common concerns shared by many- the rising costs of prescription drugs. A nearly 10% annual increase in prices combined with highly synchronized costs changes indicates that policy changes are clearly needed. I hope that policy makers will read this study.
    CONFLICT OF INTEREST: Editor in Chief, JAMA Network Open.
    YES, we need to address increase in ALL healthcare expenditures in the US, not just Rx drugs
    Robert Popovian, PharmD, MS | Pfizer Inc
    Interesting study, unfortunately, authors take some liberties with data and conclusions. For example, study claims to have used data from Jan 2012-Dec 2017 and highlights Lipitor as one of the culprits for drug pricing growth; what the study fails to mention is that Lipitor went generic, Nov 2011 and most if not all of the utilization was quickly switched to the generic equivalent. Study claims to have used SSR Health proprietary data to evaluate net prices, so in other words, we can pull off any numbers out of thin air and claim it is the correct number and call it based on proprietary data. Why didn't the authors reference data recently released by several biopharma companies depicting retail and net price growth for those products? It's not all about rebates; the Pew Charitable Trust study recently released demonstrated how rebates have remained flat for the past several years while fees collected by PBMs (and often not passed on to the plan sponsor such as BCBS) have increased. Why didn't the authors correlate the increase in overall spending increase regarding biopharmaceuticals to physician and hospital spending increases? Which by the way have outpaced prescription spending for the past several years. Perhaps conflict of interest! YES, the system needs to be reformed and YES, we need transparency across the supply chain as well as the entire healthcare system for the consumers to make appropriate choices. After all, healthcare is NOT all about prescription spending. Might I remind you that based data from the California Department of Managed Healthcare, only 13.1% of premium dollars are spent on prescription drugs while the rest is spent on professional services and hospital expenditures!
    CONFLICT OF INTEREST: Shareholder at Pfizer and other healthcare companies
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    Addressing the Rising Costs of Drugs in the United States
    Evyan Durham, MPH | George Washington University
    In “Trends in Prices of Popular Brand-Name Prescription Drugs in the United States,” authors highlight how prices of brand-name drugs have increased over the years, causing concern among consumers. In this commentary, I aim to address the issues raised by the authors concerning price transparency and government-protected market exclusivity.

    Although brand-name drug prices have consistently increased over the years, I challenge the observation that more robust policy changes which promote pharmaceutical innovation have not been implemented to combat rising prices (Wineinger et al., 2019). The Hatch-Waxmen Act promoted the growth of generic drugs in the United States through
    earlier and less costly FDA approval, thus, promoting innovation as well as increasing patient access to these pharmaceuticals. In fact, once generic drugs enter the market this typically causes prices to decrease rapidly. The introduction of generic drugs into the United States market between 2002 and 2014, resulted in a 51% reduction of drug prices within the first year of entry (Gupta et al., 2019).

    Admittedly, patents granted to brand-name drugs present a unique challenge in combating increasing drug prices. These patents protect brand-name drugs from generic drug competition for a period that lasts 20 years while exclusivity rights also enable these entities to enjoy market exclusivity for extended periods of time. It is during this time period that prices can be set at the whim of brand-name manufacturers, thus, leading to increased brand-name pricing. A concerted effort to introduce generic drugs into the market to reduce prices is slowed by these patents and market exclusivity periods, but generic drug manufacturers are able to challenge patents which show evidence of being invalid.

    Inter partes reviews are utilized by generic drug manufacturers to challenge Orange Book-listed patents. The Orange Book is a publication provided by the FDA containing drugs which serve as a reference for generic drug substitutions for brand-name drugs. Generic drug manufacturers have utilized inter partes reviews and succeeded in overturning challenged claims in 43% of patents targeted dating back to 2011. These overturned claims ensure that invalid patents do not hinder the timely availability of generic drugs (Darrow et al., 2018).

    In conclusion, the authors have raised concerns about important issues with the pricing of brand-name drugs which should continue to be discussed among the pharmaceutical community, states, and public health community. There is reason to be optimistic about drug prices moving forward due to the improved policies which have allowed generic drugs to enter the market with more feasibility.
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    Health Policy
    May 31, 2019

    Trends in Prices of Popular Brand-Name Prescription Drugs in the United States

    Author Affiliations
    • 1Translational Institute, Scripps Research, La Jolla, California
    JAMA Netw Open. 2019;2(5):e194791. doi:10.1001/jamanetworkopen.2019.4791
    Key Points español 中文 (chinese)

    Question  What are the prices of top-selling brand-name prescription drugs in the United States, and how have these prices changed in recent years?

    Findings  In this economic evaluation of 49 common top-selling brand-name drugs, 78% of the drugs that have been available since 2012 have seen an increase in insurer and out-of-pocket costs by more than 50%, and 44% have more than doubled in price.

    Meaning  Prices of brand-name drugs in the United States are likely to continue to increase, which warrants greater price transparency.

    Abstract

    Importance  High and continually increasing pharmaceutical drug spending is a major health and health policy concern in the United States.

    Objective  To demonstrate trends in prices among popular brand-name prescription drugs.

    Design, Setting, and Participants  This economic evaluation of drug prices focuses on 49 top-selling brand-name medications in the United States. Pharmacy claims data from January 1, 2012, through December 31, 2017, were obtained from Blue Cross Blue Shield Axis, a database that includes data from more than 35 million individuals with private pharmaceutical insurance. Drugs that exceeded $500 million in US sales or $1 billion in worldwide sales were examined.

    Main Outcomes and Measures  The median sum of out-of-pocket and insurance costs paid by patients or insurers for common prescriptions, presented annually and monthly, was the primary outcome.

    Results  In total, 132 brand-name prescription drugs were identified in 2017 that met the inclusion criteria. Of this total, the study focused on 49 top-selling drugs that exceeded 100 000 pharmacy claims. Substantial cost increases among these drugs was near universal, with a 76% median cost increase from January 2012 through December 2017, and almost all drugs (48 [98%]) displaying regular annual or biannual price increases. Of the 36 drugs that have been available since 2012, 28 (78%) have seen an increase in insurer and out-of-pocket costs by more than 50%, and 16 (44%) have more than doubled in price. Insulins (ie, Novolog, Humalog, and Lantus) and tumor necrosis factor inhibitors (ie, Humira and Enbrel) demonstrated highly correlated price increases, coinciding with some of the largest growth in drug costs. Relative price changes did not differ between drugs that entered the market in the past 3 to 6 years and those that have been on the market longer (number of drugs, 13 vs 36; median, 29% increase from January 2015 through December 2017; P = .81) nor between drugs with or without a Food and Drug Administration–approved therapeutic equivalent (number of drugs, 17 vs 32; median, 79% vs 73%; P = .21). Changes in prices paid were highly correlated with third-party estimates of changes in drug net prices (ρ = 0.55; P = 3.8 × 10−5), suggesting that the current rebate system, which incentivizes high list prices and greater reliance on rebates, increases overall costs.

    Conclusions and Relevance  The growth of drug spending in the United States associated with government-protected market exclusivity is likely to continue; greater price transparency is warranted.

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