23-1179 Medication Trend Updates and Formulary Changes - 4th Quarter 2023
Date: 10/16/23
Review formulary changes and medication safety issues
Stay up to date with information about:
- FDA approved the second over-the-counter naloxone nasal spray.
- Preferred biosimilar medications.
- Changes to the California Health & Wellness Plan (CHWP) commercial Formulary, Medi-Cal Preferred Drug List (PDL) and Medicare Part D Formulary for the fourth quarter of 2023.
FDA approved the second over-the-counter (OTC) naloxone nasal spray, RiVive™
On July 28, 2023, the U.S. Food and Drug Administration (FDA) approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for OTC use. Naloxone is a nonprescription drug and is used for the emergency treatment of known or suspected opioid overdose. The first OTC naloxone product was Narcan® nasal spray which was approved back in March 2023.
Naloxone is a potential 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 RiVive as the second OTC naloxone nasal spray product, this will help increase consumer access to naloxone and reduce opioid overdose deaths throughout the country.
The approval of RiVive nasal spray for nonprescription use was supported by data from a study submitted by the manufacturer that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug has been demonstrated to be safe and effective for use as directed on its label.
The nasal spray will come in a package of two 3-milligram doses in case the person overdosing does not respond to the first dose. RiVive will be available in early 2024 primarily to the United States harm reduction organizations and state governments for costs lower than other opioid antagonist nasal sprays.
CHWP prefers biosimilar medications
Biosimilars are FDA approved safe and effective medicines that are similar to existing biologic medicines. The FDA regulates biosimilar manufacturing to ensure that they scientifically demonstrate safety and effectiveness while showing no clinically meaningful differences. Biosimilars cost less than their brand name counterparts which indicate they can help lower the overall cost of care for members while still providing quality care.
Effective September 1, 2020, CHWP began preferring the following biosimilar medications over their brand (or reference product) counterparts for Medi-Cal members. For those who have not tried a biosimilar, the patient must try and fail (or have a contraindication to) the preferred biosimilar(s) before the brand name or reference product will be approved.
Prior authorization guidelines can be found on CHWP’s provider portal.
Medications | |
|---|---|
Reference brand | Preferred products |
Bevacizumab agents (Avastin) (only applies to non-ophthalmology) | Mvasi, Zirabev |
Erythropoiesis-stimulating agents (Epogen, Procrit, Aranesp) | Retacrit |
Filgrastim agents (Neupogen) | Zarxio followed by Nivestym |
Infliximab agents (Remicade) 1 | Inflectra, Renflexis, Avsola |
Pegfilgrastim agents (Neulasta) | Ziextenzo, Udenyca |
Rituximab agents (Rituxan) 1 | Ruxience, Truxima |
Trastuzumab agents (Herceptin) 1 | Kanjinti, Ogivri, Trazimera |
1 Must try all preferred products prior to nonpreferred approval
- Preferred biosimilars are required in lieu of branded drugs.
- Authorized by CHWP Pharmacy Department.
- Must try all preferred products. Please refer to the drug specific policy for complete list of preferred products.
Drug benefit changes
The CHWP Pharmacy and Therapeutics (P&T) Committee reviews the Drug Benefit Changes quarterly to determine placement of medications on the drug list and any limitations to coverage. The P&T Committee consists of practicing physicians, pharmacists and other health care professionals.
Changes to the CHWP drug benefits
Medication | Status | Formulary alternative(s) | Comments |
|---|
Oral preparation
Skyclarys™ (omaveloxolone) capsule | Carved out to State |
| Treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. |
Injectable preparation
Lamzede® (velmanase alfa-tycv) injection | Medical Benefit2 |
| A recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. |
Intravitreal preparation
Syfovre™ (pegcetacoplan) injection | Medical Benefit2 |
| A complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). |
Note: The information above is subject to change. Please refer to provider portal for the most up-to-date formulary status.
2 Prior authorization (PA) is required to verify that the member is eligible and satisfies clinical protocols to ensure appropriate use of the medication.
Additional information
Providers are encouraged to access CHWP’s provider portal for real-time information, including eligibility verification, claims status, prior authorization status, plan summaries, and more.
If you have questions regarding the information contained in this update, contact CHWP at 877 658 0305.
This information applies to Physicians and Independent Practice Associations (IPAs).