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There is an increasing demand for a therapy that usually faces shortages. ACR provides suggestions for how to approach this and other issues related to hydroxychloroquine and COVID-19.
In response to the overwhelming demand for hydroxychloroquine during the coronavirus disease 2019 (COVID-19) pandemic, the American College of Rheumatology (ACR) released guiding principles regarding the allocation of the drug.
Along with the need to allocate the medication for particular patients, controlled clinical trials are needed to test the efficacy of hydroxychloroquine, ACR suggested.
Hydroxychloroquine is typically an essential medication for patients with lupus or erythematosus, and a mainstay of therapy for patients with rheumatoid arthritis. The medication, along with chloroquine, have demonstrated antiviral activity against SARS-CoV-2 in tissue culture. Due to such findings and the tolerability of hydroxychloroquine in patients who take it for FDA-approved indications, there was more interest in using the agents as potential therapeutics for COVID-19.
What’s more, findings of a report by Philippe Gautret, MD, PhD, of Aix-Marseille University in France, and investigators led President Donald Trump and government officials to say the combination of hydroxychloroquine and azithromycin can be a therapeutic option for treatment of coronavirus.
Despite what Trump and others said, flaws in the methodology and interpretation of the data were publicized.
Still, the drug has few regular manufacturers and a history of shortages, therefore, ACR recommended the need to ensure an adequate supply of hydroxychloroquine for patients who actually need it. There should also be increased production and distribution of the medication for rheumatology patients and those with COVID-19 where indicated. Even more, enough hydroxychloroquine supplies should be allocated for patients with erythematosus—especially for patients who are pregnant.
Allocation decisions should be made locally and with the help of recommendations from rheumatologists and rheumatology health professionals. Rheumatologists could reduce hydroxychloroquine doses in patients and extend dosing intervals tailored to a patient’s need when shortages occur.
It would also be reasonable to put a 30-day limit on refills of the drug for patients prescribed the hydroxychloroquine before the pandemic.
For COVID-19, adequate amounts of hydroxychloroquine should be prioritized to support clinical trials testing the efficacy of the therapy as pre-exposure prophylaxis, post-exposure prophylaxis, and therapy in mild-to-moderate and severe cases of the virus.
Controlled human trials should also be expedited, ACR suggested. The organization wrote that despite data in the Gautret study not providing scientific justification for allocation of the drug, pre-clinical data which demonstrate antiviral activity of hydroxychloroquine in tissue culture combined with the need for effective therapy against SARS-CoV-2 justified the need.
The trials must be conducted by experienced investigators who can generate and interpret results and ensure patient safety. Adverse events for critically ill patients with COVID-19 demand the need for the trials to occur in a controlled setting.
During shortages, ACR recommended that insurers exempt rheumatology patients from prior authorization, step therapy protocols, and other utilization management practices so they can more readily get access to alternatives.
The organization also recommended several things be avoided when making decisions about hydroxychloroquine for patients with and without COVID-19 during the pandemic.
It was suggested that it was inappropriate to support the use of unrestricted access to the drug for coronavirus prophylaxis in the absence of trial data. It was also deemed inappropriate to put pharmacy-level restrictions on new starts of hydroxychloroquine for patients with erythematosus.
Regulatory bodies should also “vigorously oppose” predatory price increases or cost-sharing requirements during the pandemic.