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Ensuring Access to Injectable Generic Drugs — The Case of Intravesical BCG for Bladder Cancer
by
Hwang, Thomas J
, Davies, Benjamin J
, Kesselheim, Aaron S
in
Administration, Intravesical
/ Antineoplastic Agents - economics
/ Antineoplastic Agents - supply & distribution
/ Antineoplastic Agents - therapeutic use
/ Bacillus Calmette-Guerin vaccine
/ BCG
/ BCG Vaccine - supply & distribution
/ BCG Vaccine - therapeutic use
/ Bladder cancer
/ Cancer
/ Drug Approval
/ Drug Costs - trends
/ Drugs, Generic - supply & distribution
/ Drugs, Generic - therapeutic use
/ Generic drugs
/ Health Care Costs
/ Health Services Accessibility
/ Humans
/ Invasiveness
/ Manufacturing
/ Medicare
/ Shortages
/ United States
/ United States Food and Drug Administration
/ Urinary Bladder Neoplasms - drug therapy
2017
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Ensuring Access to Injectable Generic Drugs — The Case of Intravesical BCG for Bladder Cancer
by
Hwang, Thomas J
, Davies, Benjamin J
, Kesselheim, Aaron S
in
Administration, Intravesical
/ Antineoplastic Agents - economics
/ Antineoplastic Agents - supply & distribution
/ Antineoplastic Agents - therapeutic use
/ Bacillus Calmette-Guerin vaccine
/ BCG
/ BCG Vaccine - supply & distribution
/ BCG Vaccine - therapeutic use
/ Bladder cancer
/ Cancer
/ Drug Approval
/ Drug Costs - trends
/ Drugs, Generic - supply & distribution
/ Drugs, Generic - therapeutic use
/ Generic drugs
/ Health Care Costs
/ Health Services Accessibility
/ Humans
/ Invasiveness
/ Manufacturing
/ Medicare
/ Shortages
/ United States
/ United States Food and Drug Administration
/ Urinary Bladder Neoplasms - drug therapy
2017
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Ensuring Access to Injectable Generic Drugs — The Case of Intravesical BCG for Bladder Cancer
by
Hwang, Thomas J
, Davies, Benjamin J
, Kesselheim, Aaron S
in
Administration, Intravesical
/ Antineoplastic Agents - economics
/ Antineoplastic Agents - supply & distribution
/ Antineoplastic Agents - therapeutic use
/ Bacillus Calmette-Guerin vaccine
/ BCG
/ BCG Vaccine - supply & distribution
/ BCG Vaccine - therapeutic use
/ Bladder cancer
/ Cancer
/ Drug Approval
/ Drug Costs - trends
/ Drugs, Generic - supply & distribution
/ Drugs, Generic - therapeutic use
/ Generic drugs
/ Health Care Costs
/ Health Services Accessibility
/ Humans
/ Invasiveness
/ Manufacturing
/ Medicare
/ Shortages
/ United States
/ United States Food and Drug Administration
/ Urinary Bladder Neoplasms - drug therapy
2017
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Ensuring Access to Injectable Generic Drugs — The Case of Intravesical BCG for Bladder Cancer
Journal Article
Ensuring Access to Injectable Generic Drugs — The Case of Intravesical BCG for Bladder Cancer
2017
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Overview
Limits on access to injectable generic drugs force providers to use potentially less effective alternatives, current patients to discontinue therapy, and some new patients to receive more invasive interventions. Yet shortages of important generic drugs remain frequent.
In November 2016, one of the two manufacturers of bacille Calmette–Guérin (BCG) informed health care providers that it planned to exit the market in mid-2017.
1
Intravesical immunotherapy with BCG is the standard of treatment for preventing recurrence and disease progression in high-risk patients with non–muscle-invasive bladder cancer, who account for a substantial minority of patients with newly diagnosed bladder cancer.
2
Yet the past few years have seen intermittent disruptions of the BCG supply. The most recent disruption occurred in 2014, after a plant was temporarily closed because of manufacturing quality issues. The November announcement raises the prospect of a sustained . . .
Publisher
Massachusetts Medical Society
Subject
/ Antineoplastic Agents - economics
/ Antineoplastic Agents - supply & distribution
/ Antineoplastic Agents - therapeutic use
/ Bacillus Calmette-Guerin vaccine
/ BCG
/ BCG Vaccine - supply & distribution
/ BCG Vaccine - therapeutic use
/ Cancer
/ Drugs, Generic - supply & distribution
/ Drugs, Generic - therapeutic use
/ Health Services Accessibility
/ Humans
/ Medicare
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