MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (September 16)

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Expanding Pharmacy Access to COVID 19 Therapeutics

On September 9, 2021 the U.S. Department of Health and Human Services issued a declaration under the PREP Act authorizing pharmacists “to order and administer,” and qualified pharmacy technicians and interns “to administer” select COVID-19 therapeutics to patient populations authorized by the FDA. The most immediate application of this authorization is the ordering and administration of REGEN-COV™, a monoclonal antibody combination. The FDA has issued an emergency use authorization (EUA) for REGEN-COV™ (casirivimab and imdevimab) to be administered subcutaneously to certain patients age 12 or older, and who weigh at least 40 kg, to treat COVID-19 or to provide post-exposure prophylaxis. Complete details on patient selection, dosing, administration, adverse event reporting, and other information are contained in the EUA Fact Sheet for Health Providers.

If your pharmacies are ordering and administering REGEN-COV™, let MarkeTouch assist you in the scheduling monoclonal antibody patient appointments.  Trust MarkeTouch’s decade plus of experience in patient scheduling. The MarkeTouch Health and Wellness Scheduler is a time and load test proven system capable of managing millions of daily appointment inquiries.

Combo COVID-19 + Flu Vaccine Trial Begins

Novavax announced on Monday, September 6, 2021 that its combined influenza and COVID-19 vaccine produced working antibodies against both viruses in a preclinical study. The NanoFlu/NVX-CoV2373 vaccine elicited strong responses to both influenza A and B and protected against the SARS-CoV-2 virus. Test animals who received the combo vaccine showed increased levels of COVID-19 antibodies two weeks after their first immunization. Antibodies also increased significantly after administration of a second dose. Novavax said it expects to start clinical studies of the combined vaccine by the end of 2021.

COVID Vaccine Boosters – Will They Happen? If So, When?

The likelihood of COVID-19 booster shots for the general population is appearing to be less likely to happen in the US, in the near future. Scientists across the globe have petitioned that the general public does not need boosters at this time, given the continued protection that the current vaccines appear to provide against severe illness, hospitalization, and death.  The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting on 9/17 to discuss “booster doses” for individuals 16+.  CDC’s ACIP has scheduled a meeting for 9/27, however COVID boosters are NOT on the agenda as of now.  Stay tuned.

Vaccine Tracker

According to the CDC, as of 9/14/2021, 456 million doses of COVID-19 vaccine have been delivered. 381 million doses of vaccine have been administered.

This accounts for the following percentages of fully vaccinated people in the U.S.:

  • Total pop. = 53.9%
  • 12+ years = 63.1%
  • 18+ years = 65.0%
  • 65+ years = 82.5%

NCPDP Releases New Information About Additional Doses/Booster Claims Processing

When a patient requires an additional dose/booster of a specific Product/Service ID (407-D7), an additional identifier within the claim request may be necessary to specify the additional dose situation. (Full NCPDP guidance below.)

NCPDP recommends the use of the following Submission Clarification Codes (SCC) for dose identification. 

  • SCC 7 (Medically Necessary): Additional dose for targeted population, where days between additional dose and last dose of series is no less than the dose series time period.
  • SCC 10 (Meets Plan Limitations): Booster dose for broader population with waning immunity
  • If payers can’t immediately support SCC 10, NCPDP recommends an interim solution where both SCC 7 and 10 would be used. This would allow SCC 7 to trigger existing logic and SCC 10 could be used to support any additional override logic for reporting to identify a booster. 

First In-human Clinical Trial For A Vaccine To Treat Opioid Use Disorders 

A vaccine is currently being tested to study a therapeutic vaccine for opioid use disorder.  The trial will evaluate the safety and potential efficacy of a vaccine that is designed to selectively prevent the euphoric and toxic effects, specifically, of oxycodone. The vaccine works by stimulating the body’s immune system to produce antibodies to oxycodone. If someone who has been vaccinated takes oxycodone, those antibodies would bind to the drug molecule, preventing the oxycodone from entering the brain and, thus, stopping any euphoria or “high” effect produced by the drug.

Because of its selectivity for oxycodone, the vaccine will not interfere with FDA-approved medications, including methadone, buprenorphine, naltrexone and naloxone.  The vaccine offers the possibility of a safe, long-lasting and cost-effective opioid use disorder treatment alternative that could be used along with standard medical treatment for opioid use disorders.

The long-term goal of the expanded research program is to develop a series of opioid vaccines that target other commonly used opioids, such as heroin and fentanyl.

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