Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Spending and Utilization on Drugs Prescribed by Otolaryngologists to Medicare Beneficiaries, 2013 to 2017

Objectives: The significant and rising cost of prescription drugs is a pressing concern for patients and payers. However, little is known about spending on and utilization of drugs prescribed by otolaryngologists. Methods: Utilizing publicly available Medicare Part D Prescriber Public Use data, we conducted a retrospective cross-sectional analysis of 34 small-molecule drugs commonly prescribed by otolaryngologists (defined as 2017 Medicare Part D spending ≥$500 000) to Medicare beneficiaries. Prescription data was characterized by drug type (brand name vs generic). Primary outcomes for each prescription drug included the total annual cost and the total annual number of days supplied. Results: From 2013 to 2017, spending on drugs prescribed by otolaryngologists to Medicare beneficiaries decreased by $32.1 million ($131.7–$99.5 million; relative decrease 24.4%; compound annual growth rate [CAGR] −5.4%), while total utilization increased by 24.9 million days supplied (74.6–99.5 million; relative increase 33.3%; CAGR 5.9%). For brand name drugs, there was a decrease in spending ($71.1–$26.7 million; relative decrease −62.4%; CAGR −17.8%) and utilization (11.2–3.1 million days supplied; relative decrease −72.5%; CAGR −22.8%). In contrast, generic drugs demonstrated increased spending ($60.6–$72.8 million; relative increase 20.2%; CAGR 3.7%) and utilization (63.5–96.4 million days supplied; relative increase 51.9%; CAGR 8.7%). Conclusions: Spending on drugs prescribed by otolaryngologists to Medicare Part D beneficiaries declined between 2013 and 2017 in part due to a transition from brand name drugs to lower-cost generic equivalents.

Regulating Conflicts of Interest in Medicine Through Public Disclosure: Evidence from a Physician Payments Sunshine Law

Hospital and healthcare administrators name high prescription drug costs as one of their largest problems. A significant body of research demonstrates that meals and honoraria from pharmaceutical firms to physicians leads to higher prescribing of expensive, brand name drugs, despite little difference in efficacy. Some administrators and scholars have advocated for mandatory disclosure of these payments in order to reduce this conflict of interest, but many practitioners believe disclosure has little effect on prescribing, and the empirical evidence is mixed. This paper uses a quasi-experiment of a 2009 payment disclosure policy in Massachusetts to estimate the causal impact of public disclosure on prescribing. The comprehensive data set includes all retail prescriptions for 262 drugs in nine drug classes written by 5,730 physicians in five states over 48 months. We show a significant postdisclosure reduction in brand name drug prescriptions by Massachusetts physicians, relative to control physicians in other states. These effects are driven by heavy prescribers of brand name drugs in the prepolicy period, particularly for drugs with large prepolicy sales forces. Effects are also detected before the first data were released, implying that the effects are not because patients or administrators responded to the disclosed payments. Instead, some physicians may have changed their payments and prescriptions behavior to avoid appearing biased. Taken in tandem with the many studies showing that pharmaceutical industry payments influence prescribing, this study suggests a strong role for mandatory public disclosure in reducing conflicts of interest in medicine and costly prescribing of brand name drugs. This paper was accepted by Stefan Scholtes, healthcare management.

A Model for Pricing the License of Brand-Name Drugs Using Cooperative Game Theory

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A Model for Pricing the License of Brand-Name Drugs Using Cooperative Game Theory

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