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Patients Using DMARDs for Autoimmune Diseases May Encounter Access Challenges

Summary

As COVID-19 deaths increase, the FDA is evaluating and considering approval of treatments more quickly, but the rush to find treatment options is creating new access considerations for patients and providers.

Hydroxychloroquine and chloroquine are disease-modifying anti-rheumatic drugs (DMARDs) that are commonly prescribed for patients with various autoimmune diseases. Currently, Food and Drug Administration (FDA)-approved indications across both drugs include rheumatoid arthritis (RA) and lupus. Patients with these chronic conditions often take chloroquine or hydroxychloroquine in combination with biologic therapies or when other treatments have failed to control disease symptoms. There may be limited or no alternatives to chloroquine and hydroxychloroquine for many of these patients, making access to these drugs critical.

States Are Taking Early Action on Cholorquine and Hydroxychloroquine Supply

Chloroquine and hydroxychloroquine are considered potential treatment options for COVID-19. While these drugs are currently undergoing clinical trials to assess their effectiveness, some states have proactively taken steps to preserve availability of these medications through dispensing restrictions on duration of supply and refills. Arizona, Idaho, Kentucky, New York, Nevada, North Carolina, Ohio, and Texas have already implemented restrictions. Several of these states limit prescriptions to a 14-day supply, except for patients who are previously established on the medication, who are limited to a 30-day supply. New York’s restrictions are more stringent and limit all prescriptions to 1 14-day supply with no refills.

While these restrictions could help with supply shortages and facilitate access to chloroquine and hydroxychloroquine for clinical trials and COVID-19 patients if they are proven to be effective, they also have the potential to limit access for patients who currently rely on these drugs to treat their chronic conditions. In an effort to prevent access issues for non-COVID-19 related prescriptions, Oregon and Mississippi have taken action to preserve supplies of choloroquine and hydroxycloroquine by limiting dispensing for treatment or prevention of COVID-19 to hospitalized patients with a documented infection only.

Patients Commonly Take These Medications on a Chronic Basis

Avalere conducted an analysis of 2018 Medicare fee-for-service (FFS) prescription and medical claims data to determine how many beneficiaries regularly use chloroquine or hydroxychloroquine and could therefore be affected by potential access challenges. The analysis found that over 200,000 Medicare FFS beneficiaries use chloroquine or hydroxychloroquine, with 75% of these patients having a diagnosis of RA or lupus, representing 21% of the total Medicare FFS population with a diagnosis of RA or lupus. Moreover, the prescription utilization data clearly indicates that Medicare beneficiaries use these drugs to manage their chronic conditions on a long-term basis, with over 50% filling at least 270 days of supply of chloroquine or hydroxychloroquine and 70% filling at least 180 days of supply.

Figure 1. Medicare FFS Chloroquine and Hydroxychloroquine Users by Diagnosis, 2018
Figure 1. Medicare FFS Chloroquine and Hydroxychloroquine Users by Diagnosis, 2018

In addition to the beneficiaries included in this analysis, patients with other forms of insurance coverage also currently use these drugs for autoimmune diseases. For these patients, some state dispensing restrictions could also disrupt access to their ongoing treatments. While the medical community continues to pursue the application of hydroxychloroquine and chloroquine to treat COVID-19, stakeholders should consider how to ensure access to these drugs for patients who rely on them to manage chronic conditions. Additional analysis of downstream medical complications associated with changes in prescription drug use could be important to understand how the focus on the use of hydroxychloroquine and chloroquine for treatment of COVID-19 could impact patients with RA and lupus long term.

Methodology

Avalere analyzed 2018 Medicare data, specifically 100% Part D prescription drug event (PDE) data and FFS Part B claims under a research data use agreement with CMS. We analyzed a cohort of beneficiaries representing less than 20% of the total Medicare population. This cohort included FFS beneficiaries enrolled in Medicare for the full 12 months in 2018 who received prescriptions for hydroxychloroquine (generic and its brand version, Plaquenil) or chloroquine (only generic, brand not available). For each beneficiary, Avalere identified prescription information, including days supply in the PDE data and their medical diagnoses in the Part B claims data for services provided in the physician’s office and hospital outpatient department.

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