ACR Recommendations for Hydroxychloroquine Management During the COVID-19 Pandemic

Based on current knowledge and circumstances, the American College of Rheumatology (ACR) developed and released recommendations for the allocation of hydroxychloroquine (HCQ) during the coronavirus disease 19 (COVID-19) pandemic. The report is published on the ACR website.¹

Hydroxychloroquine, a medication that has been shown to be essential in reducing flares and preventing organ damage in patients with systemic lupus erythematosus (SLE),² along with the antimalarial chloroquine, has demonstrated antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to findings from some research.^3,4 In addition, a study by Gautret P and colleagues indicated the association between HCQ and azithromycin treatment and reduction in viral load in patients with coronavirus disease 2019 (COVID-19), which the ACR stated had “serious flaws in the methodology and interpretation of the data.”^1,5

However, the consideration of HCQ as a potential treatment option for COVID-19 has resulted in shortages and price spikes of this drug. Therefore, to ensure that patients with SLE have access to this medication and the medical care that they need, ACR developed guiding principles for scarce resource (HCQ) allocation during the COVID-19 pandemic.¹

Recommendations for HCQ Management

Production & Distribution

• Efforts must be made to ensure HCQ for all patients who need it. The production and distribution of HCQ, including all aspects of the supply chain, for patients with both rheumatologic conditions and COVID-19 should be supported.
• Adequate supplies of HCQ should be especially allocated to pregnant women with systemic lupus erythematosus and to patients who are most at risk for flares of the disease as a result of brief cessation of their usual regimen.
• Decisions for HCQ allocation should take into consideration local conditions and circumstances. When possible, decisions for HCQ allocation should be based on recommendations by rheumatologists or rheumatology professionals who have experience in the management of HCQ for rheumatologic conditions. Ad hoc decisions for allocation of HCQ should not be made by individual dispensing pharmacies that may be acting in isolation.
• The ACR recommends that importation restrictions on HCQ be relaxed to create alternative avenues for its distribution in the United States.

Clinical Trials

• Adequate supplies of HCQ should be prioritized, but not limited, to support the testing of the drug for pre-exposure and post-exposure prophylaxis and therapy for mild to moderate and severe COVID-19. However, the guidelines do not recommend unrestricted access to HCQ for COVID-19 prophylaxis without supporting clinical trial data on its appropriate use.
• Clinical trials focused on the use of HCQ as effective therapy against SARS-CoV-2 should be conducted by experienced investigators who are equipped to generate and interpret results while maintaining patient safety and informed consent.
• Because of the risk for adverse events, including QT prolongation, in critically ill patients with COVID-19 receiving HCQ along with other drugs, clinical trials involving HCQ need to be conducted in controlled settings.

Dosing

• Rheumatologists and rheumatology professionals may pursue reasonable HCQ dose reductions and extend dosing intervals based on individual patient needs. ACR recommends a maximum of 30 days of HCQ refills for patients who were prescribed HCQ before the pandemic, if deemed reasonable based on local circumstances.
• Restricting the start of new doses of HCQ in outpatient settings may be reasonable based on approval by rheumatologists or rheumatology professionals. However, depending on the type of manifestation of SLE (eg, cutaneous), respective specialist health professionals should be allowed to approve new HCQ prescriptions.
• The ACR recommends against pharmacy-level restrictions on starting new doses of HCQ.

Pricing

• The recommendations suggest that insurance companies exempt patients with rheumatologic conditions from prior authorization, step therapy protocols, and other utilization management practices. This guidance was added to ensure that patients gain access to HCQ alternatives as suggested by their rheumatologists or rheumatology health professionals.
• During the course of the COVID-19 pandemic, predatory price increases or cost-sharing requirements should be vigorously opposed by regulatory bodies.

References

1. American College of Rheumatology. Guiding principles from the American College of Rheumatology for scarce resource allocation during the COVID-19 pandemic: the case of hydroxychloroquine. Updated March 26, 2020. Accessed March 30, 2020. https://www.rheumatology.org/Portals/0/Files/Guiding-Principles-Scarce-Resource-Allocation-During-Covid-19.pdf

2. Ponticelli C. Hydroxychloroquine in systemic lupus erythematosus (SLE). Expert Opin Drug Saf. 2017;16(3):411-419.

3. Yao X, Ye F, Zhang M, et al. In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [published online March 9, 2020]. Clin Infect Dis. doi:10.1093/cid/ciaa237

4. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-271.

5. Gautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial [published online March 20, 2020]. Int J Antimicrob Agents. doi:10.1016/j.ijantimicag.2020.105949