24-283m Medication Trend Updates and Formulary Changes - Second Quarter 2024
Date: 03/29/24
Review formulary changes and medication safety issues
Stay up to date with information about:
- FDA warns of rare but serious drug reaction to antiseizure medicines (clobazam, levetiracetam)
- Changes to the Medi-Cal Preferred Drug List (PDL) for the second quarter of 2024.
FDA warns of rare but serious drug reaction to antiseizure medicines (clobazam, levetiracetam)
On November 28, the Food and Drug Administration (FDA) issued a safety alert about levetiracetam and clobazam causing a rare but serious reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life threatening if not diagnosed and treated quickly.
Levetiracetam is marketed under the brand names Keppra®, Keppra XR® and Spritam® for the treatment of partial-onset seizures, myoclonic seizures, or tonic-clonic seizures. Clobazam is the active ingredient in Onfi® and Sympazan® and is used to treat Lennox-Gastaut syndrome.
The drug reaction known as DRESS is a rare and severe drug allergy. Symptoms can include fever, rash, facial swelling, enlarged lymph nodes and kidney or liver injury. Patients with DRESS have a large number of abnormal eosinophils.
A search of the FDA Adverse Event Reporting System and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam and 10 patients treated with clobazam. Two patients treated with levetiracetam died. Most patients in these cases were hospitalized, and, in the majority of cases for which the FDA had information, DRESS symptoms improved when the medicines were discontinued.
As a result of these cases, the FDA announced that warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines. Patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.
Changes to the Medi-Cal PDL
The Health Net Pharmacy and Therapeutics (P&T) Committee includes practicing physicians, pharmacists and other health care professionals. Each quarter, the P&T Committee reviews medications on the PDL for Medi-Cal members to determine which medications remain on the same tier and which are moved. A table below listing some recent changes. The list contains brand-name prescription medications, status, other medication choices, and comments for the second quarter of 2024.
The complete Medi-Cal PDL is available on the provider portal.
Pharmacy help line
For more information regarding changes to the Medi-Cal Preferred Drug List, contact the proper pharmacy phone number listed.
Product | Phone number | Fax number |
|---|---|---|
Pharmacy Benefit (Medi-Cal Rx) | 800-869-4325 | |
Medical Benefit Drugs (Medi-Cal) | 833-953-3436 |
Changes to the CalViva Health Medi-Cal Preferred Drug benefits
Medication | Status | Formulary Alternative(s) | Comments |
|---|---|---|---|
Oral preparation | |||
Trulance® (plecanatide) tablet | Carve out to state | N/A | N/A |
saxagliptin (Onglyza®) tablet | Carve out to state | N/A | N/A |
saxagliptin-metformin (Kombiglyze® XR) tablet | Carve out to state | N/A | N/A |
Additional information
Providers are encouraged to access the 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 CalViva Health at 888-893-1569.
This information applies to Physicians and Participating Physician Groups (PPGs).
This information applies to Medi-Cal in Fresno, Kings and Madera counties.