Use Patents, Carve-Outs, and Incentives — A New Battle in the Drug-Patent Wars

Arti, K.

doi:10.1056/nejmp1206573

Cited by 14 publications

(10 citation statements)

References 2 publications

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“…Many factors influence when generic drugs will come to market. [32][33][34] We modeled 28 December 2026, the date of the earliest expiration of an ibrutinib use patent, 35 as the time when a generic competitor would come to market and the cost of ibrutinib would drop from 64% of AWP to 27% of AWP. The base case treatment start date was December 2017.…”

Section: Sensitivity Analysismentioning

confidence: 99%

Cost-effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia in older adults without deletion 17p

Barnes

Divi²,

Begaye

et al. 2018

Blood Advances

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Ibrutinib is a novel oral therapy that has shown significant efficacy as initial treatment of chronic lymphocytic leukemia (CLL). It is a high-cost continuous therapy differing from other regimens that are given for much shorter courses. Our objective was to evaluate the cost-effectiveness of ibrutinib for first-line treatment of CLL in patients older than age 65 years without a 17p deletion. We developed a semi-Markov model to analyze the cost-effectiveness of ibrutinib vs a comparator therapy from a US Medicare perspective. No direct comparison between ibrutinib and the best available treatment alternative, obinutuzumab plus chlorambucil (chemoimmunotherapy), exists. Therefore, we compared ibrutinib to a theoretical treatment alternative, which was modeled to confer the effectiveness of an inferior treatment (chlorambucil alone) and the costs and adverse events of chemoimmunotherapy, which would provide ibrutinib with the best chance of being cost-effective. Even so, the incremental cost-effectiveness ratio of ibrutinib vs the modeled comparator was $189 000 per quality-adjusted life-year (QALY) gained. To reach a willingness-to-pay threshold (WTP) of $150 000 per QALY, the monthly cost of ibrutinib would have to be at most $6800, $1700 less than the modeled cost of $8500 per month (a reduction of $20 400 per year). When the comparator efficacy is increased to more closely match that seen in trials evaluating chemoimmunotherapy, ibrutinib costs more than $262 000 per QALY gained, and the monthly cost of ibrutinib would need to be lowered to less than $5000 per month to be cost-effective. Ibrutinib is not cost-effective as initial therapy at a WTP threshold of $150 000 per QALY gained.

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Section: Sensitivity Analysismentioning

confidence: 99%

Cost-effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia in older adults without deletion 17p

Barnes

Divi²,

Begaye

et al. 2018

Blood Advances

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“…We have already discussed patent life extension strategies such as patenting new indications, active enantiomers, new formulations, and fixed dose combinations. These approaches have met with mixed success in litigation proceedings, and generic companies have learned to carve out 63 newly patented indications from their ANDA applications and rely on off-label prescribing to support sales of the generic. In Part 1 of this series, we also discussed the pay for delay strategy whereby owners of branded drug owners pay generic companies to delay their ANDA applications.…”

Section: ■ Fierce Generic Competitionmentioning

confidence: 99%

Discovery of Innovative Therapeutics: Today’s Realities and Tomorrow’s Vision. 2. Pharma’s Challenges and Their Commitment to Innovation

Abou‐Gharbia

Childers

2014

J. Med. Chem.

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The pharmaceutical industry is facing enormous challenges, including reduced efficiency, stagnant success rate, patent expirations for key drugs, fierce price competition from generics, high regulatory hurdles, and the industry's perceived tarnished image. Pharma has responded by embarking on a range of initiatives. Other sectors, including NIH, have also responded. Academic drug discovery groups have appeared to support the transition of innovative academic discoveries and ideas into attractive drug discovery opportunities. Part 1 of this two-part series discussed the criticisms that have been leveled at the pharmaceutical industry over the past 3 decades and summarized the supporting data for and against these criticisms. This second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses, focusing on the industry's changing perspective and new business models for coping with the loss of talent and declining clinical pipelines as well as presenting some examples of recent drug discovery successes.

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“…For example, in f scal year 2010, FDA approved 11 generic drugs with skinny labeling. Indeed, three of the f ve top-selling brand-name drugs that "went generic" that year did so as a consequence of skinny labeling (2). Despite this reality, f rms that seek patents on uses that represent a fairly small improvement on prior uses are vulnerable to the charge of attempting to unduly extend patent life.…”

Section: Current Skepticismmentioning

confidence: 99%

“…T e U.S. Food and Drug Administration (FDA) does not prohibit physicians from prescribing the generic drug (or any other drug, for that matter) of -label for other uses, including patented uses. Moreover, the high standards for proving patent infringement make it dif cult to bring a legal claim that generic f rms are inducing physicians and patients to infringe use patents (2). Still, despite the apparently limited commercial power of use patents, pharmaceutical f rms do seek them, even on relatively small improvements.…”

mentioning

confidence: 99%