23-695sum Summary Update: Medication Trend Updates and Formulary - 3rd Quarter 2023
Date: 08/02/23
Know what’s changed or changing and plan accordingly
This summary update includes information regarding the following:
- Patent expiration for commonly used brand-name medication.
- FDA withdrawal of brand Makena and its generics.
- FDA approved over-the-counter Narcan® nasal spray.
- Changes to the Health Net* commercial Formulary, Medi-Cal Preferred Drug List (PDL) and Medicare Part D Formulary for the third quarter of 2023.
To obtain a comprehensive description of the above topics, the complete update, 23-695 Medication Trend Updates and Formulary Changes – 3rd Quarter 2023 (PDF). Providers who do not have access to the Internet may request a print copy of update 23-695 by contacting the Health Net Provider Communications Department by email.
Patent expiration for commonly used brand-name medication
Patents are granted by the United States Patent and Trademark Office along the development lifeline of a medication. Patents expire 20 years from the date of filing. Many factors can affect the duration of a patent. When a brand-name medication loses its patent, lower-priced generics enter the market. U.S. Food and Drug Administration (FDA)-approved generic drugs are made under the same rigorous standards as their brand-name counterparts and are bioequivalent, delivering the same amount of active ingredients into a patient's bloodstream in the same amount of time as their brand-name product. During the upcoming year, the key medications listed in the complete update, 23-695, are anticipated to be available as generic equivalents.
FDA withdrawal of brand Makena and its generics for prevention of preterm birth
On April 6, 2023, the FDA formalized its decision to withdraw approval for Makena and its generics (17-alpha hydroxyprogesterone caproate, 17-OHPC) for the prevention of preterm birth. Makena previously gained FDA approval under the organization’s Accelerated Approval Program, whereby the sponsor was required to conduct a postmarket clinical trial to verify the medication’s benefit on reducing preterm births. This confirmational study failed to show that the medication reduced the risk of preterm births or resulted in neonatal clinical benefits. As a result, the FDA made the decision to withdraw approval of Makena and its generics.
While the approvals of Makena and its generics have been withdrawn, the FDA has advised patients to talk to their health care provider while recognizing that there is a supply of Makena and its generics that has already been distributed. Covis Pharma, maker of Makena, recommends that health care providers consider the FDA’s conclusion on the withdrawal of Makena because Makena and its generics are no longer shown to be effective. Its benefits do not outweigh the risks for the indication for which they were approved. Select link for additional information from the FDA on Makena.
The FDA approved the first over-the-counter (OTC) Narcan nasal spray
On March 29, 2023, the FDA approved Narcan, 4 milligram naloxone nasal spray, for OTC without a prescription. Narcan is a potentially lifesaving medication designed to help reverse the effects of an opioid in minutes. Drug overdose persists as a major public health issue in the United States, primarily driven by synthetic opioids. With the approval of OTC naloxone nasal spray, this will help improve access to naloxone and reduce opioid overdose deaths throughout the country.
The nasal spray will come in a package of two 4-milligram doses in case the person overdosing does not respond to the first dose. The product could be given to known or suspected opioid overdose in adults and children. Emergent BioSolutions, maker of OTC Narcan, expects the product to be for sale in big-box chains, supermarkets, convenience stores, gas stations and online retailers by late summer.
Changes to the Commercial Formulary, Medi-Cal PDL and Medicare Part D Formulary/ Drug benefit changes
Each quarter, the Health Net Pharmacy and Therapeutics (P&T) Committee reviews medications on the Formulary for commercial members, the PDL for Medi-Cal members, and the Medicare Part D Formulary for Medicare members to determine which medications remain on the same tier and which are moved. Refer to the complete update, 23-695 for a listing of some recent changes.
Pharmacy help line
For more information regarding changes to the Health Net Commercial Formulary, Medi-Cal drug benefits, or Medicare Part D Formulary, contact the proper pharmacy phone numbers listed below.
Product | Phone number | Fax number |
|---|---|---|
Pharmacy Benefit (Medi-Cal Rx) | 800-869-4325 | |
Medical Benefit Drugs (Medi-Cal) | 833-953-3436 | |
Commercial Pharmacy Services | 800-548-5524, option #3 | 866-399-0929 |
Medicare Pharmacy Service Center | 800-977-8226 |
Additional information
If you have questions regarding the information contained in this update, contact the Health Net Provider Services Center by email, by phone or through the Health Net provider portal.
This information applies to Physicians and Participating Physician Groups (PPGs).
For Medi-Cal, this information applies to Kern, Los Angeles, Riverside, Sacramento, San Bernardino, San Diego, San Joaquin, Stanislaus, and Tulare counties.