RESUMEN
Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.
Asunto(s)
Aprobación de Drogas , Costos de los Medicamentos , Oncología Médica/ética , Antineoplásicos/economía , Antineoplásicos/uso terapéutico , Sesgo , COVID-19/epidemiología , Control de Costos/ética , Control de Costos/organización & administración , Control de Costos/normas , Evolución Cultural , Aprobación de Drogas/economía , Aprobación de Drogas/legislación & jurisprudencia , Aprobación de Drogas/organización & administración , Costos de los Medicamentos/ética , Costos de los Medicamentos/legislación & jurisprudencia , Humanos , Oncología Médica/economía , Oncología Médica/organización & administración , Oncología Médica/normas , Neoplasias/tratamiento farmacológico , Neoplasias/economía , Neoplasias/mortalidad , Innovación Organizacional , PandemiasAsunto(s)
Países Desarrollados/economía , Países Desarrollados/estadística & datos numéricos , Salud Global/ética , Disparidades en Atención de Salud/ética , Disparidades en Atención de Salud/estadística & datos numéricos , Vacunas Virales/economía , Vacunas Virales/provisión & distribución , Vacunas contra la COVID-19 , Ensayos Clínicos Fase III como Asunto , Confidencialidad , Infecciones por Coronavirus/economía , Infecciones por Coronavirus/prevención & control , Aprobación de Drogas , Costos de los Medicamentos/ética , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Salud Global/estadística & datos numéricos , Acaparamiento/economía , Humanos , Subtipo H1N1 del Virus de la Influenza A/inmunología , Cooperación Internacional , Evaluación de Necesidades/ética , Factores de Tiempo , Vacunas Virales/biosíntesis , Vacunas Virales/síntesis químicaRESUMEN
Early reports of potential treatment for coronavirus disease (COVID-19) have raised concerns related to pharmaceutical distribution. Despite the lack of high-quality evidence, the mere hope of effectiveness of potential treatments, such as hydroxychloroquine, has led to surges in demand for these products, and many pharmacists are already informally reporting shortages through social channels. As manufacturers and wholesale distributors struggle to fulfill orders for drugs such as hydroxychloroquine, short-term price increases may seem reasonable in a free market when demand increases. However, any price increases by manufacturers, wholesale distributors, and pharmacies might be seen as exploitive gouging of consumers during a declared emergency. In addition to concerns of price gouging, increases in prescription drug utilization during the pandemic may lead to increases in spending for all payers as members may be treated for COVID-19. This article explores pharmaceutical supply chain and drug pricing nuances that may cause problems for payers and pharmacies as the country battles this global pandemic. DISCLOSURES: No funding supported the writing of this article. Mattingly reports unrelated consulting fees from the National Health Council, Bristol Myers Squibb, G&W Laboratories, Allergy and Asthma Foundation of American, and the Massachusetts Health Policy Commission. Hogue has nothing to disclose.