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Pharmaceutical industry payments and delivery of non-recommended and low value cancer drugs: population based cohort study

BMJ 2023; 383 doi: https://doi.org/10.1136/bmj-2023-075512 (Published 25 October 2023) Cite this as: BMJ 2023;383:e075512
  1. Aaron P Mitchell, assistant attending12,
  2. Stacie B Dusetzina, professor of health policy, Ingram professor of cancer research3,
  3. Akriti Mishra Meza, research biostatistician1,
  4. Niti U Trivedi, medical affairs data analyst4,
  5. Peter B Bach, chief medical officer4,
  6. Aaron N Winn, associate professor5
  1. 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY 10017, USA
  2. 2Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA
  3. 3Department of Health Policy and Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA
  4. 4Delfi Diagnostics, Baltimore, MD, USA
  5. 5University of Illinois Chicago, Chicago, IL, USA
  1. Correspondence to: A P Mitchell mitchea2{at}mskcc.org (or @TheWonkologist on Twitter)
  • Accepted 20 September 2023

Abstract

Objective To estimate the association between oncologists’ receipt of payments from the pharmaceutical industry and delivery of non-recommended or low value interventions among their patients.

Design Cohort study.

Setting Fee-for-service Medicare claims.

Participants Medicare beneficiaries with a diagnosis of incident cancer (new occurrence of a cancer diagnosis code in proximity to claims for cancer treatment, and no such diagnosis codes during a ≥1 year washout period) during 2014-19, who met additional requirements identifying them as at risk for one of four non-recommended or low value interventions: denosumab for castration sensitive prostate cancer, granulocyte colony stimulating factors (GCSF) for patients at low risk for neutropenic fever, nab-paclitaxel for cancers with no evidence of superiority over paclitaxel, and a branded drug in settings where a generic or biosimilar version was available.

Main outcome measures Receipt of the non-recommended or low value drug for which the patient was at risk. The primary association of interest was the assigned oncologist’s receipt of any general payments from the manufacturer of the corresponding non-recommended or low value drug (measured in Open Payments) within 365 days before the patient’s index cancer date. The two modeling approaches used were general linear model controlling for patients’ characteristics and calendar year, and general linear model with physician level indicator variables.

Results Oncologists were in receipt of industry payments for 2962 of 9799 patients (30.2%) at risk for non-recommended denosumab (median $63), 76 747 of 271 485 patients (28.3%) at risk for GCSF (median $60); 18 491 of 86 394 patients (21.4%) at risk for nab-paclitaxel (median $89), and 4170 of 13 386 patients (31.2%) at risk for branded drugs (median $156). The unadjusted proportion of patients who received non-recommended denosumab was 31.4% for those whose oncologist had not received payment and 49.5% for those whose oncologist had (prevalence difference 18.0%); the corresponding values for GCSF were 26.6% v 32.1% (5.5%), for nab-paclitaxel were 7.3% v 15.1% (7.8%), and for branded drugs were 88.3% v 83.5% (−4.8%). Controlling for patients’ characteristics and calendar year, payments from industry were associated with increased use of denosumab (17.5% (95% confidence interval 15.3% to 19.7%)), GCSF (5.8% (5.4% to 6.1%)), and nab-paclitaxel (7.6% (7.1% to 8.1%)), but lower use of branded drugs (−4.6% (−5.8% to −3.3%)). In physician level indicator models, payments from industry were associated with increased use of denosumab (7.4% (2.5% to 12.2%)) and nab-paclitaxel (1.7% (0.9% to 2.5%)), but not with GCSF (0.4% (−0.3% to 1.1%)) or branded drugs (1.2% (−6.0 to 8.5%)).

Conclusions Within some clinical scenarios, industry payments to physicians are associated with non-recommended and low value drugs. These findings raise quality of care concerns about the financial relationships between physicians and industry.

Footnotes

  • Contributors: All authors contributed to the interpretation of the data and preparation, review, and approval of the manuscript. APM is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: APM is supported by the National Cancer Institute (R37CA264563), National Institute of Health Care Management (GC260700), and Memorial Sloan Kettering Cancer Center, National Cancer Institute (support grant P30 CA008748). No funder had any involvement in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Cancer Institute and Institute of Health Care management; no support from any organization for the submitted work for the submitted work. AMM declares stock ownership in DNA and Teladoc Health. NT declares employment and stock options at Delfi Diagnostics. PB declares consulting/advisory role at EQRx, leadership roles at Delfi Diagnostics and Oncology Analytics, travel expenses paid by Oncology Analytics, stock ownership at EQRx, Oncology Analytics, and Delfi Diagnostics, and research funding by Kaiser Permanente and Arnold Ventures. ANW declares consulting with Takeda and CorMedix.

  • The lead author (APM) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.

  • Dissemination to participants and related patient and public communities: The results of this work will be disseminated to the public through institutional press release, ensuing news articles, social media, and an opinion piece authored by the study’s authors that describe the study’s findings for the public.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

Data availability statement

Data analysis was conducted under contract agreement with FAIR Health, a Centers for Medicare and Medicaid Services qualified entity. The authors are solely responsible for the research and conclusions reflected in this paper. FAIR Health is not responsible for the conduct of the research or for any of the opinions expressed in this paper. APM had full access to all of the aggregated, deidentified datasets used in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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