The following is a letter sent to governors, lieutenant governors, insurance commissioners, and pharmacy boards this week:
The American College of Rheumatology and the undersigned organizations represent rheumatology providers and patients across the United States. We routinely weigh in on policy matters that impact the practice of rheumatology and rheumatology patients. Our providers have extensive experience with the antimalarials, hydroxychloroquine (HCQ) and chloroquine, which are under investigation as potential treatments for the novel coronavirus. Both medications have been successfully used to treat lupus (SLE) and rheumatoid arthritis for decades. SLE, rheumatoid arthritis, and malaria are currently the only conditions for which HCQ has been approved by the Food and Drug Administration (FDA). There are currently limited data to support the use of HCQ in treating COVID-19.
While we remain hopeful that these drugs will be proven effective against the scourge of COVID-19, we also need to ensure that rheumatology patients who depend on these medications have access to them during this crisis. HCQ is critical to many rheumatology patients and, in the case of SLE, the only drug proven to reduce mortality. Specifically, we urge you to:
- Make every effort to ensure an adequate supply of HCQ for all patients who need it. Efforts to increase production and distribution of HCQ for rheumatology patients, as well as patients with COVID-19 where indicated, should be supported. Protections on the supply of HCQ should include all aspects of the supply chain from manufacturer to wholesaler, wholesaler to pharmacy and final distribution to patients.
- Ensure the allocated supply of HCQ for COVID-19 is prioritized (but not limited) to support clinical trials designed to test the efficacy of HCQ as preexposure prophylaxis, post-exposure prophylaxis, and therapy both in mild-to-moderate as well as severe cases of COVID-19.
- Work with the state board of pharmacy to ensure that HCQ prescriptions are filled when prescribed by a rheumatologist, a rheumatology professional, or for a patient with COVID-19 when the patient’s use of the drug is initiated and managed by an appropriate specialist.
- Relax importation restrictions on HCQ during the COVID-19 pandemic to create alternative avenues for distribution of HCQ in your state.
- Encourage decisions about the allocation of HCQ to be made locally, with input from experts, based on local conditions and calibrated over time as circumstances evolve. Decisions around allocation should not be made ad hoc by individual dispensing pharmacies acting in isolation.
- Prevent unreasonable price increases or cost sharing increases for these drugs.
- Consider limiting HCQ refills to 30 days for patients prescribed HCQ prior to the COVID-19 pandemic if local circumstances necessitate such action.
- Request that insurers exempt rheumatology patients from prior authorization, step therapy protocols, and other utilization management practices during HCQ shortages so that they may more readily gain access to appropriate alternatives as determined by their rheumatologist or rheumatology health professional.
- Communicate to the public, healthcare professionals, and other stakeholders accurate and up-to-date information about these drugs, their critical role in treatment for the current indications and the status of their use for COVID-19, including clinical trials underway and what is known or not known about the safety and efficacy of these drugs in COVID-19.
- Prevent unrestricted access to HCQ for pre-exposure prophylaxis in the absence of clinical trial data supporting its use.
- Prevent pharmacy-level restrictions on new starts of HCQ for patients with SLE.
We are in the midst of a public health crisis that is unprecedented in our lifetime. We understand the desire to find effective treatments as rapidly as possible. As members of the broader health community, we share the same desire, but those desires are tempered by the concern we have for rheumatology patients and our overall commitment to ensure that the drugs used to treat any disease are safe and effective.
We are happy to work with you and offer any assistance that we can during this difficult time. Thank you for your consideration of our concerns. If you have any questions, please contact Joseph Cantrell, Senior Manager of State Affairs, at jcantrell@rheumatology.org.
Sincerely,
American College of Rheumatology
Arthritis Foundation
Association for Women in Rheumatology
Coalition of State Rheumatology Organizations
Global Healthy Living Foundation
International Foundation for Autoimmune and Autoinflammatory Arthritis
Lupus and Allied Diseases Association
Lupus Foundation of America
Lupus Research Alliance
National Organization of Rheumatology Managers
Rheumatology Nurses Society
Sjogren’s Foundation
Alabama Society for the Rheumatic Diseases
Arizona United Rheumatology Alliance
Arkansas Rheumatology Association
Association of Idaho Rheumatologists
California Rheumatology Alliance
Colorado Rheumatology Association
Florida Society of Rheumatology
Georgia Society of Rheumatology
Hawaii Rheumatology Society
Kentuckiana Rheumatology Alliance
Looms for Lupus
Lupus Alliance of Upstate New York
Lupus Foundation New England
Lupus Foundation of Northern California
Lupus LA
Lupus Society of Illinois
Maryland Society for Rheumatic Diseases
Massachusetts, Maine, and New Hampshire Rheumatology Association
Michigan Lupus Foundation
Michigan Rheumatism Society
MidWest Rheumatology Society
Mississippi Arthritis and Rheumatism Society
More Than Lupus Foundation
Nebraska Rheumatology Society
New York State Rheumatology Society
North Carolina Rheumatology Association
Ohio Association of Rheumatology
Oregon Rheumatology Alliance
Pennsylvania Rheumatology Society
Rheumatology Alliance of Louisiana
Rheumatology Association of Iowa
Rheumatology Association of Minnesota and the Dakotas
Rheumatology Association of Nevada
Sjogren’s and Lupus Foundation of Hawaii
South Carolina Rheumatism Society
State of Texas Association of Rheumatology
State of West Virginia Rheumatology Society
Tennessee Rheumatology Society
Virginia Society of Rheumatologists
Washington State Rheumatology Alliance
Wisconsin Rheumatology Association
CC: Lt. Governor
Insurance Commissioner
Pharmacy Board