Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 17
September 1, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Clinical Pharmacy Update
U.S. Public Health Experts Recommend COVID-19 Booster Shots
On August 18, 2021, the U.S. Department of Health and Human Services (HHS) released a statement on their plan for COVID-19 booster shots. Current data suggests that protection against mild and moderate COVID-19 infection decreases slightly over time (91.7% to 79.8%), in individuals vaccinated with the Moderna or Pfizer vaccines, due to waning immunity. And although the vaccine remains protective against the worst outcomes of COVID-19 (severe disease, hospitalization, and death), there is concern that the reduction in immunity will continue to worsen and may be further complicated by new strains of concern, such as the delta variant. The recommendation is for a third “booster” shot to be administered 8 months after the second dose of the Pfizer/BioNTech and Moderna vaccinations mRNA vaccines and may take effect as early as September 20, 2021. The additional dose will produce an increase in the number of protective antibodies that a person has against COVID-19. The CDC advisory committee on immunization practices will not make a formal recommendation on mRNA vaccine booster shots until an independent evaluation of safety and effectiveness is conducted by the U.S. Food and Drug Administration (FDA). These booster shot recommendations are being made in addition to the expansion of the FDA emergency use authorization (EUA) for the mRNA vaccines that was made on August 12, 2021. The EUA was updated to allow for an additional dose of vaccine in certain immunocompromised patients who are potentially unable to mount an adequate immune response with just two doses. The additional dose can be given 28 days after administration of the second dose and although it is preferred to receive the same brand of medication, the mRNA vaccines can be mixed if one is unavailable. While the initial booster shot recommendations are being made for the mRNA based vaccines, data is being evaluated to determine if those who initially received the Johnson & Johnson vaccine will need an additional dose as well.
Compliance Update
New Frequently Asked Questions Released
On Friday, August 20, 2021, the Departments of Labor (DOL), Health and Human Services (HHS) and the Treasury (collectively the Departments) released new Frequently Asked Questions (FAQs). The FAQs provide guidance related to certain provisions of the Affordable Care Act (ACA), the No Surprises Act, the Consolidated Appropriations Act (CAA) and Transparency in Coverage Final Rules.
The FAQs address several topics, an overview of some topics applicable to prescription plans are listed below:
- Transparency in Coverage (TiC) Final Rules for Machine Readable Files (MRFs)
- The prescription drug MRF requirement has been deferred pending further rule making. The deferment was due to concerns over these requirements conflicting and being duplicative with the prescription drug reporting requirements from the No Surprises Act under the CAA. The TiC requirement will be considered through future notice-and-comment rulemaking as to whether or not prescription MRFs are still appropriate.
- Price Comparison Tools
- Price comparison requirements under the CAA for online and telephonic price comparisons effective January 01, 2022, are being postponed to align them with the price comparison online tool from TiC Final Rule initial 500 items effective January 01, 2023. The prescription comparison requirements are not required until January 01, 2024.
- Transparency in ID Cards
- There will be no additional regulations issued prior to the effective date January 01, 2022, but the Departments intend to engage in future rule making addressing implementation. The Departments expect good faith reasonable interpretation until additional regulation has been issued.
- Grandfathered Health Plans
- The FAQs have clarified the provisions of the CAA apply to grandfathered plans, there are no exceptions for grandfathered plans like there are with the ACA.
- Prescription Drug Reporting under the CAA
- The Departments recognize there are significant challenges and short timeframes for completing the requirements of these regulations. The Departments will defer the first deadline, December 27, 2021 and the second deadline, June 06, 2022 pending additional regulations or further guidance. Plans are strongly encouraged to start now and be ready to begin reporting for plan years 2020 & 2021 by December 27, 2022.
To review the full FAQs from the Departments.
From the Pharmaceutical Industry
REGEN-COV Gains Emergency Use Authorization (EUA) for Post-Exposure Prophylaxis for COVID-19
On August 10, 2021, the FDA revised the EUA for Regeneron’s COVID-19 antibody combination product, REGEN-COV (casirivimab and imdevimab), for use as prevention of COVID-19 after initial exposure to the virus. REGEN-COV was previously authorized for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients at least 12 years old and weighing at least 40kg (approximately 88 pounds) that are considered at high risk for progression to severe COVID-19 disease, hospitalization, or death. The authorization allows the medication to be used in this same population if the patient is not fully vaccinated or not expected to mount an adequate immune response even with vaccination (i.e., immunocompromised). In addition, the authorization allows these patients to be administered the medication if they are in the same institutional setting as an infected person, such as a prison or nursing home. The expanded authorization comes after results from a trial including over 1,500 patients who had come into contact with a household member diagnosed with COVID-19, showed that symptomatic COVID-19 developed in 7.8% of patients in the placebo group and in only 1.5% of patients in the treatment group. This prophylactic combination is intended to complement vaccination in high-risk individuals. It is not meant to be a replacement for vaccination and the medication is not authorized for use as pre-exposure prophylaxis in those individuals not exposed to COVID-19.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Nexviazyme® (avalglucosidase alfa-ngpt)
Intravenous infusion approved for the treatment of patients 1 year and older with late-onset Pompe disease, which is a rare, inherited disorder caused by the buildup of a complex sugar called glycogen within the cells of the body and results in muscle weakness. [08/06/21 – Orphan Drug – GENZYME CORP]
New Generics
New Generic Medications Entering the Marketplace*
Ansyr™ Plastic Syringes (atropine sulfate)
Indication: Bradycardia (slow heart rate)
Dosage Form/Strength: 0.05 MG/ML, and 0.1 MG/ML injectable solution
Average Wholesale Price (AWP): Generic = $13-$40 | Brand = $13-$40