PBMs and the Run on Hydroxychloroquine

Leading pharmacy benefit managers (PBMs) say the initial flood of demand for the antimalarial drug hydroxychloroquine, sparked by suggestions from the White House that it was an effective treatment for COVID-19, finally is showing some signs of easing. This has lessened pressures on supplies of the drug for FDA-approved indications, such as lupus and rheumatoid arthritis.

Prime Therapeutics’ ongoing monitoring of utilization trends for hydroxychloroquine showed a rapid spike between March 17 and 25, which caused many community pharmacies to scramble to maintain adequate supplies for the FDA-approved uses, as noted above.

“During this time, we did receive a few escalated member inquiries regarding drug supply issues. This was primarily due to local/regional supply chain inventory adjustments,” said David Lassen, MD, Prime’s chief clinical officer. “We assisted these members by redirecting to pharmacies with known inventory. We also took measures to limit quantities of prescriptions for new COVID-19 users to prevent further drug shortage concerns and/or potential stockpiling.”

Between late April and early May, after new reports suggested that the drug did not help hospitalized COVID-19 patients and the FDA warned against the use of hydroxychloroquine outside of the hospital setting or a clinical trial due to risk for heart rhythm problems (bit.ly/2WFOEog), Prime saw its utilization of the drug return to pre-baseline levels. This suggests that there is no longer a high demand for the product as a COVID-19 treatment in the outpatient setting, “which is consistent with the evolving clinical trial data suggesting that the risks (cardiovascular) may outweigh any benefits for this drug in the treatment of COVID-19,” Dr. Lassen said.

The Florida and Puerto Rico–based PBM Abarca also observed intermittent shortages of hydroxychloroquine during the mid-March utilization spike. “During that time, we continually monitored shortages and recommended strategies to our payors to prevent and address drug shortages to protect high-risk patients who depend on hydroxychloroquine for the treatment of their rheumatoid arthritis and lupus erythematosus disease states,” said VP of PBM Operations, Lissette Lorenzo, PharmD, adding that the company also has seen a return to pre-pandemic demand in the past few weeks. “Despite the sharp drop-off in utilization, our clinicians continue to monitor access to hydroxychloroquine. At this point, we have not received any complaints of patients who cannot obtain their medication supplies due to shortages caused the pandemic,” she said.

CVS Health reports that its retail, mail service and specialty pharmacies have adequate supply of hydroxychloroquine and are taking all necessary steps to maintain supply. “Very early on, we implemented quantity limits (with client consent) to help meet the needs of patients with conditions such as lupus,” said spokesperson Trey Hollern. “We continue to balance the growing interest in off-label use of certain prescription medications to treat COVID-19 pneumonia (like hydroxychloroquine) with the ongoing needs of patients and members who are prescribed these drugs to help manage chronic conditions, such as lupus.”

Increased demand for other medications being prescribed to treat COVID-19 and its complications has led to some temporary shortages, Mr. Hollern added. Besides hydroxychloroquine, these medications include azithromycin, which often is given in combination with hydroxychloroquine in COVID-19 patients, as well as albuterol inhalers, which are approved for treatment of lupus, bacterial infections, HIV, rheumatoid arthritis and asthma but often are used adjunctively in COVID-19. “In addition to standard processes at the pharmacy level,” he said, “CVS Health implemented new measures across our enterprise for these medications, such as adhering to state-level dispensing guidelines in our retail pharmacies and, as a PBM, setting coverage limits on quantity for pharmacies in our network.”

On May 7, an observational Columbia University study of more than 1,400 hospitalized patients—the largest study of hydroxychloroquine to date in COVID-19—found that the drug was not associated with either a greatly lowered or an increased risk for the composite end point of intubation or death (N Engl J Med, 2020 May 7. [Epub ahead of print]. doi: 10.1056/NEJMoa2012410).

ASHP Site Shows a Mixed Bag
Underscoring the moving target of hydroxychloroquine and azithromycin shortages, both drugs were still listed as being in short supply by the ASHP’s drug shortages website in early May. But a slightly deeper dive into the listings shows that the drugs can be obtained, albeit in a limited range of formulations and strengths.

According to ASHP’s “Current Drug Shortages” list, Concordia and Milan both had hydroxychloroquine available in 100-count/200-mg dosages, while several other suppliers had the drug on allocation to current customers and contracted wholesalers for approved indications. As for azithromycin, three suppliers—Athenex, Fresenius Kabi and Slate Run Pharmaceuticals—were listed as having IV lyophilized -powder for injection available in 10-count packages of 500-mg vials.

This article was written by Gina Shaw and originally published in Specialty Pharmacy Continuum.

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