Cost reduction for generic versions of capecitabine (Xeloda, Hoffman-La Roche), one of the first orally administered chemotherapies, has been less than expected, which is a blow to the idea that oral generics can help substantially control runaway oncology spending, according to the authors of a new study.
The cost for one fill of the generic form of capecitabine was $2328 in 2016. That price was 36% lower than the projected branded drug price in 2016. But that percentage is a “modest” savings compared to reductions seen with other generic drugs, say the authors, led by Stacie Dusetzina, PhD, a pharmacist at the Lineberger Comprehensive Cancer Center of the University of North Carolina, Chapel Hill.
Their research letter was published online September 11 in JAMA Internal Medicine.
“For this oral cancer treatment, we don’t see the level of price reduction that we would expect for generic drug entry,” said Dr Dusetzina in statement.
For infused chemotherapies that turn generic, the average prices are 38% to 46% lower than the prices of the former brand drugs, Dr Dusetzina told Medscape Medical News. Sometimes the price drops are much bigger. For example, the Medicare price of the infused chemotherapy irinotecan dropped by about 85% after the branded patent expired, she said.
Another expert concurred that the price drop appears slight.
“For a generic drug marketplace with four manufacturers (as was the case with capecitabine), we would expect to see a 61% reduction from brand-name prices compared to the 36% that the authors found,” said Chintan Dave, PharmD, citing historical data.
He is a research fellow in the Division of Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School and Brigham and Women’s Hospital, Boston, Massachusetts, and was not involved in the new study.
However, Dr Dave said that other variables, such as the size of the patient population, are at play and have to be considered.
“Prices for generic drugs that serve a smaller patient population are likely to be higher,” he said, adding that capecitabine’s market is relatively small compared to that of, for example, a lipid-lowering agent. “Accordingly, for these agents, we should expect to see modest price reductions in the initial off-patent years,” he told Medscape Medical News.
Prices for generic drugs that serve a smaller patient population are likely to be higher.
Capecitabine was one of the first high-priced chemotherapies to lose patent protection in the United States. It is indicated for use in colorectal and breast cancers. Thus, it provides a “useful case study” for how the pricing of generic oral cancer drugs may play out, say the study authors.
The North Carolina researchers used a commercial insurance claims database to estimate prescription prices for branded and generic capecitabine between 2002 and 2016. Capecitabine lost patent protection in 2013. First fill for the generic alternative was in early 2014. The authors found four different generic versions of capecitabine.
The price of a standard 1-month supply of generic capecitabine averaged $2598 in 2014, which was only 17% below the projected branded drug price. By 2016, the average generic price dropped to $2328, which was 36% below the projected branded drug price.
Overall, this is disappointing because, outside of cancer treatment, generic oral medications boast price reductions of about 90% within 30 months of generic competition, added Dr Dusetzina, citing IMS Health data.
During the study period, there was a rapid uptake of generic capecitabine. By 2014, 93% of all prescriptions for the drug were for a generic version.
The study authors also found that the brand-name drug price increased over time.
Between 2002 and 2013, the list price for branded capecitabine increased from $1367 to $2858. However, in 2014, the mean list price for the generic version of the drug was $2598.
What that means is that “patients are still paying more for their [generic] treatment than they would have paid when initially approved [as a branded product],” said Dr Dusetzina.
Dr Dusetzina said competition from generic drugs generally has been an important factor in curbing medical costs and expanding treatment access.
In the current study, most patients had lower out-of-pocket costs after generic entry. However, about 10% of patients still paid more than $100 for one fill of capecitabine.
More research needs to be done on other cancer drugs as they come off patent to see whether generic competition can help contain costs, conclude the authors.
Dr Dusetzina and Dr Dave have no disclosed no relevant financial relationships. One coauthor of the study is an employee of Truven Health Analytics, which is associated with the commercial database used in the study. Another coauthor has financial ties with Bayer, Immunomedics, Merck, Novartis, and Precision Biologics.
JAMA Intern Med. Published online September 11, 2017. Abstract
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