Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.
Carey Business School, Johns Hopkins University, Baltimore, Maryland.
JAMA. 2019 Aug 6;322(5):422-429. doi: 10.1001/jama.2019.9943.
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.
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.
Support by independent charity patient assistance programs.
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.
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.
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.
尽管独立慈善机构患者援助计划提高了患者获得昂贵处方药的机会，但最近的联邦调查提出了一些问题，即这些计划可能会增加药品支出，并违反联邦反回扣法规。人们对这些计划的设计、患者资格或药物覆盖范围知之甚少。
研究独立慈善机构患者援助计划的资格标准以及这些计划涵盖的药物。
设计、设置和参与者：对 2018 年为包括但不限于 Medicare 受益人的患者提供患者援助计划的 6 家最大的独立慈善机构进行描述性横断面研究。这些慈善机构提供了 274 种不同的疾病特异性患者援助计划。对亚组分析中报告有 Medicare Part D 支出仪表板上使用的任何药物和 2016 年每个受益人 Medicare 支出超过 10000 美元的任何专利过期品牌药物的药物进行了识别。
独立慈善机构患者援助计划的支持。
主要结果是患者援助计划的特征，包括援助类型、保险覆盖（与未保险相比）和收入资格。次要结果是患者援助计划涵盖的药物的成本以及昂贵的专利过期品牌药物与可替代的通用药物的覆盖范围。
在分析中包括的 6 家独立慈善基金会中，其 2017 年的总收入范围为 2400 万美元至 5.32 亿美元，患者援助计划的支出范围为 2400 万美元至 3.53 亿美元，平均占其收入的 86%。这些组织提供的 274 个患者援助计划中，有 168 个（61%）仅提供共付援助，覆盖的最常见治疗领域是癌症或癌症治疗相关症状（113 个患者援助计划；41%）。共有 267 个计划（97%）要求保险覆盖作为资格标准（即排除未参保患者）。最常见的收入资格限制是联邦贫困线的 500%。计划覆盖的每个受益人的药物年度中位成本为 1157 美元（四分位距，247-5609 美元），而非覆盖药物的中位成本为 367 美元（四分位距，100-1500 美元）。专利过期的品牌药物（成本：>10000 美元）由平均 3.1（标准差，2.0）个患者援助计划覆盖，而其通用等效药物由平均 1.2（标准差，1.0）个患者援助计划覆盖。
2018 年，在 6 家独立慈善基金会运营的 274 个患者援助计划中，大多数计划并未为未参保患者提供保障。援助计划涵盖的药物通常比未涵盖的药物更昂贵。
