近日，美国约翰霍普金斯大学研究团队分析了独立的慈善患者援助项目的财务资格标准和药物覆盖范围。这一研究成果发表在2019年8月6日出版的国际学术期刊《美国医学会杂志》上。

人们对该计划的设计、患者资格或药物覆盖范围知之甚少。在这项对2018年274个病人援助项目的6个独立慈善组织的横断面研究中，97%的项目排除了未参保的病人，最常见的收入资格上限是联邦收入贫困水平的500%。在药物水平分析中，2016年联邦医疗保险D部分(Medicare Part D)的受益人均药物支出中值为1157美元，而未涵盖的药物支出中值为367美元。2018年，由6家独立慈善基金会运营的274个患者救助项目中，绝大多数没有为未参保患者提供医疗保险。病人援助计划涵盖的药物通常比没有涵盖的要贵。

据悉，尽管独立的慈善机构患者援助项目改善了患者获得昂贵处方药的途径，但最近的联邦调查对这些项目增加药品支出和违反联邦反回扣法规的可能性提出了质疑。
 

附：英文原文

Author: So-Yeon Kang, Aditi Sen, Ge Bai，Gerard F. Anderson, Gerard F. Anderson

Issue&Volume:Vol 322, No.5

Abstract: 

Importance Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage.

Objective To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them.

Design, Setting, and Participants Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10?000 in Medicare spending per beneficiary in 2016.

Exposures Support by independent charity patient assistance programs.

Main Outcomes and Measures The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs.

Results Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment–related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10?000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs.

Conclusions and Relevance In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

DOI: 10.1001/jama.2019.9943

Source: https://jamanetwork.com/journals/jama/article-abstract/2740721