Drug patent expirations and the speed of generic entry.

OBJECTIVE: Using recent data, to analyze the generic drug entry phenomenon to determine the factors that influence the speed and likelihood of generic drug entries. DATA SOURCES: Data for 81 drugs that have lost patent between 1987 and 1994. Patent and exclusive marketing rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates: FDA Drug and Device Product Approvals (Jan. 1987-Dec. 1994). Numbers of pending generic applications: FDA Office of Generic Drugs Quantitative Report-ANDAs and AADAs (Nov. 1990-Jan. 1993). Sales revenue: Pharmaceutical Data Services, Walsh-America. STUDY DESIGN: This study appropriately recognizes generic entry as a survival problem, and uses a proportional hazard method for analysis. PRINCIPAL FINDINGS: (1) There is a negative relationship between an innovative drug's sales revenue and the time to generic entry. (2) Entries of generics tend to be slower for drugs that have either very few or a very large number of competing brands in the marketplace. (3) The time to generic entry increased overall between 1987 and 1994. (4) Drugs that primarily treat chronic symptoms tend to enter faster than the types of drugs that primarily treat acute illnesses. CONCLUSIONS: The analysis shows that the generic industry is targeting large-revenue products and chronic drug markets. Entry of a generic drug is influenced by the existing branded substitutes in the marketplace. Surprisingly, the generic drug entry process has slowed despite many changes that would facilitate entry.     

Nonlinear Pricing in Drug Benefits and Medication Use: The Case of Statin Compliance in Medicare Part D

ObjectiveTo examine how enrollees'' statin compliance responds to expected prices in Medicare Part D, which features a nonlinear price schedule due to a coverage gap.ConclusionThe presence of a coverage gap decreases statin compliance prior to the gap, suggesting that incorporating expected future prices is important to assess the full impact of cost sharing on drug compliance under nonlinear price schedules.     

Tax and Medicare aspects of hospital malpractice insurance. Part 1.

This first part of a two-part article on how tax laws and Medicare regulations affect hospital malpractice insurance discusses self-insurance mechanisms, particularly trust funds. Relationships among tax exemptions, Medicare and other intermediaries' reimbursements, investment income from such funds, and payments to and from the funds are examined.     

药品不同准入价格对医保基金及个人可负担性的影响——以部分抗肿瘤靶向药物为例

目的:分析抗肿瘤靶向药物不同准入价格下,武汉市新农合基金和个人的可负担性,为制定医保准入价格提供依据。方法:选择肺癌靶向药物凯美纳和乳癌靶向药物赫赛汀,分析2012—2014年武汉市新农合数据、湖北省2011—2015年肿瘤监测数据;咨询临床专家形成专家共识价,参考江苏省准入价及国家谈判价,探讨不同价格下,两药医保准入后武汉市新农合基金结余情况及个人的可负担性。结果:凯美纳以国家谈判价准入后,2016—2018年武汉市新农合基本账户结余分别为-1 194.8万元、251.3万元和8 295.5万元。赫赛汀以国家谈判价医保准入后,2016—2018年基本账户结余分别为-2 690.1万元、-3 596.2万元和1 754.2万元。凯美纳和赫赛汀以国家谈判价准入前后致贫率分别由45.85%和46.00%下降到33.40%和45.42%。结论:两药以国家谈判价医保准入后武汉市新农合基金基本可负担,赫赛汀在此价格下个人可负担性较差。