Financial conflicts of interest between the drug and device industry and physicians have long been recognized, but the frequency and scope of such conflicts between industry and patient advocacy organizations (PAOs) are less understood.
Last month, the American Dental Association (ADA) announced a new policy on opioid prescription. This is the latest in a series of statements issued by the ADA in response to the prominent role of dentistry in the opioid epidemic.
Engaging patients, families, and independent experts in policymaking is a laudable goal, but the process of doing so isn’t necessarily straightforward. If efforts to introduce patient and public perspectives also introduce bias, they may do more harm than good. A recent study raises concerns about bias in public engagement, finding that public engagement efforts by the Food and Drug Administration (FDA) may attract speakers with significant conflicts of interest (COI), which are frequently undisclosed.
Spending on cancer drugs in the United States has nearly doubled in the past five years and continues to grow, imposing substantial financial burden on patients with cancer. One of the biggest drivers of this growth is targeted cancer drugs – small molecules, monoclonal antibodies, and other therapies for cancer that target specific genomic aberrations. Now, a group led by the Abramson Cancer Center of the University of Pennsylvania has proposed three solutions to maximize the clinical benefit and affordability of targeted cancer drugs.
Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers
A comprehensive review of prior authorization (PA) requirements for a new class of expensive cholesterol-lowering drugs known as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors has found unusually complex and burdensome demands across public and private insurance plans in the United States. These findings raise concerns that current policies may create undue barriers to care even in medically appropriate patients, particularly since requirements were just as stringent for patients with a genetic condition that creates more clear-cut eligibility for PCSK9 inhibitor treatment.
In American Economic Journal: Applied Economics, Hans-Peter Kohler and Victoria Baranov study the impact of antiretroviral therapy (ART), a treatment for AIDS, on savings and human capital investment in Malawi. In particular, they use spatial and temporal differences in ART availability to evaluate the impact of ART provision on cash savings, education expenditures, and children’s schooling.
The authors find that ART availability increases savings, expenditures on education, and children’s schooling significantly, even amongst those who are HIV-negative and thus, do not...
Association of Patient Out-of-Pocket Costs With Prescription Abandonment and Delay in Fills of Novel Oral Anticancer Agents
High out-of-pocket (OOP) costs may limit access to novel oral cancer medications. In a retrospective study, nearly one third of patients whose OOP costs were $100 to $500 and nearly half of patients whose OOP costs were more than $2,000 failed to pick up their new prescription for an oral cancer medication, compared to 10% of patients who were required to pay less than $10 at the time of purchase. Delays in picking up prescriptions were also more frequent among patients facing higher OOP costs.
In August 2017, the US Senate passed The Right to Try Act, which would limit the Food and Drug Administration’s (FDA’s) oversight of the use of unapproved drugs in life-threatening situations. It now awaits a vote in the US House of Representatives.
Association of high cost sharing and targeted therapy initiation among elderly Medicare patients with metastatic renal cell carcinoma
In Cancer Medicine, Pengxiang (Alex) Li and colleagues, including Jalpa Doshi, explore whether high out-of-pocket costs limit access to oral therapies for Medicare patients newly diagnosed with metastatic renal cell carcinoma. Using 2011–2013 Medicare claims, the investigators identified 1,721 patients newly diagnosed with metastases in the liver, lung, or bone. They compared low-income Medicare Part D beneficiaries (who had low out-of-pocket costs due to...