The patent for branded capecitabine expired on December 14, 2013, and the first observed prescription fill of generic capecitabine was in March 2014.
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Cole AL, Sanoff HK, Dusetzina SB. Possible Insufficiency of Generic Price Competition to Contain Prices for Orally Administered Anticancer Therapies. JAMA Intern Med. 2017;177(11):1679–1680. doi:10.1001/jamainternmed.2017.2788
Generic price competition is viewed as an important way to contain prices and increase patient access to prescription medications.1,2 Following the introduction of generic options, substantial decreases have been observed in prices for infused anticancer therapies. However, it is unclear whether such declines will be observed for orally administered anticancer drugs.3 Capecitabine is one of the first high-priced orally administered anticancer drugs to lose patent protection in the United States, making it a useful case study for understanding how generic entry may affect orally administered anticancer drug prices.
We used the Truven Health MarketScan Commercial Database to estimate changes in capecitabine list price and patient out-of-pocket costs from 2002 through 2016, including the 3 years after patent expiration. We included 156 508 outpatient pharmacy claims for brand or generic capecitabine, filled by adults (age 18-64 years) with colorectal or breast cancer diagnoses. To compare values over time, we standardized prices to represent the median quantity dispensed per prescription fill (42 000 mg). We used generalized estimating equations with log links and Poisson distributions to estimate mean per-fill prices associated with generic entry, combining fills across generic manufacturers. We used 2002-2012 prices to estimate expected 2014-2016 branded prices in the absence of generic availability.
We estimated generic market penetration per month as the proportion of all capecitabine fills where generic capecitabine was dispensed. Per-fill out-of-pocket costs (deductible + copayment + coinsurance) were summarized by year, and relative risks (RRs) for paying $0, more than $100, and more than $500 for generic vs branded capecitabine were estimated. We inflation-adjusted all dollars to 2016 US dollars.
Between 2002 and 2013, list prices for branded capecitabine increased from $1367 (95% CI, $1346-$1388) to $2858 (95% CI, $2836-$2881) (Figure 1). In 2014, the list price for generic capecitabine was 17% lower than the projected branded price (mean generic price, $2598; 95% CI, $2570-$2625) and dropped to 36% from the projected branded price in 2016 (mean generic price, $2328; 95% CI, $2289-$2367). In March 2014, generic capecitabine accounted for 34% of capecitabine prescription fills, increasing to 90% by October 2014 and 93% by December 2015. Of 5 approved Abbreviated New Drug Applicants, we observed 4 generic entrants.
In the 3 years before generic entry, approximately 40% of patients paid $50 or more out of pocket for their capecitabine prescription fill compared with fewer than 20% of patients in the 3 years after generic entry (Figure 2). Compared with the 3 years before generic entry, patients in the 3 years afterwards were 61% more likely to pay nothing out of pocket for generic capecitabine (RR,1.61; 95% CI, 1.52-1.71) and were less likely to pay over $100 (RR, 0.59; 95% CI, 0.55-0.64) or over $500 (RR, 0.65; 95% CI, 0.57-0.74).
Despite rapid uptake of generic capecitabine, the observed decrease in list price was smaller than expected for a product with 4 generic entrants (36% vs 61%).1 While it is possible that prices may decrease further with additional manufacturers, recent work suggests that few novel oncology drugs have sufficient competition, possibly owing to smaller patient populations and limited potential profit.3 Furthermore, given the previously documented price increases at launch and for existing products,4,5 the modest price reductions for capecitabine are concerning.
Analyses of out-of-pocket costs should be interpreted with caution owing to factors like time-varying plan characteristics and copayment assistance not reflected on branded claims. Although list prices do not reflect rebates or discounts to payers, they represent the basis for calculating patient cost-sharing for the growing number of plans requiring deductibles and coinsurance.6
Generic competition has historically been an important means of cost containment for pharmaceutical products.1,2 While it is unclear whether capecitabine’s generic entry can be generalized to other orally administered anticancer therapies, if similar modest price decreases are observed for other orally administered anticancer drugs following generic entry, generic competition alone may not be sufficient to curb oncology spending. It will be important for future studies to evaluate how generic competition affects spending on other anticancer medications.
Corresponding Author: Stacie B. Dusetzina, PhD, Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina, 2203 Kerr Hall, Chapel Hill, NC 27599 (email@example.com).
Accepted for Publication: May 11, 2017.
Published Online: September 11, 2017. doi:10.1001/jamainternmed.2017.2788
Author Contributions: Ms Cole had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Cole.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Cole, Dusetzina.
Administrative, technical, or material support: Cole.
Conflict of Interest Disclosures: Ms Cole is an employee of Truven Health Analytics, an IBM Company. Dr Dusetzina serves on the National Academy of Sciences, Engineering, and Medicine Committee “Ensuring Patient Access to Affordable Drug Therapies,” and she is supported by Research Scholar Grant RSGI-14-030-01-CPHPS from the American Cancer Society (Dusetzina). Dr Sanoff has received research funding paid to the University of North Carolina from Bayer, Immunomedics, Merck, Novartis, Precision Biologics. No other disclosures are reported.
Funding/Support: This project was not supported by any external grants or funds. Access to the Truven Health MarketScan Research Databases were provided by Truven Health Analytics, an IBM Company.
Role of the Funder/Sponsor: No funder had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
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