April 24, 2020
On March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for two anti-malarial drugs (hydroxychloroquine sulfate and chloroquine phosphate) in oral formulations, which are also used on a maintenance basis for the treatment of Lupus, Rheumatoid Arthritis, and other autoimmune diseases, to treat COVID-19. The authorization comes with strict requirements for the use of these medications—which are not yet clinically proven to effectively treat patients who have COVID-19. In part, the EUA was established to protect patients who need these medications to treat other health conditions as well as to define how the drugs were to be used for patients with the COVID-19 virus. As of April 24, 2020, the FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.
Demand for these drugs has since increased substantially. Even though the treatment has not been proven effective and is to be reserved for people who have already been diagnosed with a confirmed case of COVID-19, increased demand is being driven by those who want to have a supply on hand in case it is subsequently proven effective. This has led to concern over possible shortages for people who have an established clinical need for the drug(s).
Protocol for Prescribing Hydroxychloroquine and Cholorquine
Under the EUA, hydroxychloroquine sulfate and chloroquine phosphate obtained from the Strategic National Stockpile can be used to treat adult and adolescent patients who weigh 50kg (110lbs.) or more and are hospitalized with COVID-19. In addition, a health care provider must administer the prescription(s). However, doctors outside of hospital settings appear to be prescribing these medications for patients who have tested positive for COVID-19 even though they are not hospitalized as well as for those who may not have received a positive test result.
In order to control the use of these drugs in the retail setting, a recent emergency order was issued from the NJ Attorney General’s office that requires that no prescriptions for hydroxychloroquine and/or chloroquine be dispensed without a diagnosis of a positive COVID-19 test result documented on the prescription. The prescription must be limited to a 14-day supply, with no refills permitted, and must be written within the prescriber’s appropriate scope of practice.
Patients taking hydroxychloroquine and chloroquine for maintenance of a pre-existing conditions, such as lupus or other autoimmune diseases, can continue to obtain their medication without being restricted to a 14-day supply. However, new prescriptions for a pre-existing condition must include a diagnosis or a diagnostic code, which supports continued dispensing with refills. Further, treating patients with that diagnosis must be within the prescriber’s appropriate scope of practice as determined by the dispensing pharmacist.
Other states are issuing or have issued administrative orders similar to New Jersey’s, which are applicable to patients who are not hospitalized or who have access to treatment through a clinical trial.
What is Benecard Doing?
To help ensure the appropriate use of these medications, Benecard has instituted expedited clinical reviews for prior authorization on all hydroxychloroquine and chloroquine prescriptions to confirm their use meets the guidelines set forth by the FDA and applicable state’s administrative orders. The clinical review requirements include:
- Patient has documentation of a positive COVID-19 test result.
- Adult or adolescent patient must weigh at least 110 lbs. (50 kg).
If the requirements are met, a non-refillable 14-day supply will be approved.
Benecard’s actions are being taken to help protect the supply of these medications for those patients who need them as defined by federal and state guidelines. While we hope that these medications will be proven effective in the treatment of COVID-19, it is important to recognize that all medications have side effects and the potential to interact with medications already being taken for other purposes. As of now, there is no proof that these drugs make it more difficult to become infected by the virus and no more than anecdotal evidence that they are effective once a person is already infected.
As of April 24, 2020, the FDA has issued a reminder to physicians and the public that hydroxychloroquine and chloroquine can cause serious heart rhythm problems, often in combination with azithromycin and other QT prolonging medicines. They are recommending an initial evaluation and monitoring for patients with COVID-19 who are prescribed these drugs when under the EUA or in clinical trials. Click here to read the full release.
We will continue to communicate with you as this situation evolves and are here if you have any questions.
For answers to frequently asked questions on COVID-19, please visit the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/faq.html.