Medication Trends and Formulary Changes – 4th Quarter 2018
Date: 11/02/18
Review information for the CURES mandate, new fluoroquinolones label warnings and quarterly preferred drug list changes
This update includes information regarding the mandatory use of California’s Controlled Substance Utilization Review and Evaluation System (CURES), updated label warnings for fluoroquinolones antibiotics and changes to the California Health & Wellness Plan (CHWP) Preferred Drug List (PDL) for the fourth quarter of 2018.
CURES CONSULTATION MANDATE
To improve opioid prescribing practices and reduce the risk of opioid use disorders (OUD), mandatory consultation of CURES became effective October 2, 2018. This mandate applies to the following:
· Any health care practitioner with both a Drug Enforcement Administration (DEA) Controlled Substance Registration Certificate and a California licensure as any one of the following:
- Dentist, physician, naturopathic doctor, optometrist, osteopathic doctor, physician assistant, podiatrist, registered certified nurse midwife (furnishing), and registered nurse practitioner (furnishing).
· This requirement does not apply to veterinarians or pharmacists.
Health care practitioners must consult the CURES database to review a patient’s controlled substance history before prescribing, ordering, administering, or furnishing a Schedule II–IV controlled substance for the first time and at least once every four months when the controlled substance is part of a continued treatment plan.
For more information and exemptions, refer to https://oag.ca.gov/cures or contact the CURES Program at CURES@doj.ca.gov or (916) 210-3187.
FLUOROQUINOLONES LABEL WARNING UPDATES
In July 2018, the U.S. Food and Drug Administration (FDA) required new safety labeling changes for a class of antibiotics called fluoroquinolones based on a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature. The labeling changes are to increase awareness about the risks of mental health side effects, serious blood sugar disturbances, and to make the warnings on labels more consistent for all fluoroquinolones taken by mouth or given by injection.1
· Labeling changes of the fluoroquinolone class require listing mental health side effects separately from other central nervous system side effects. These side effects include disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.
· The potential risk of coma with hypoglycemia must now be included on the fluoroquinolone class labeling under the Blood Glucose Disturbances subsection due to instances found among users.
1 U.S. Food & Drug Administration at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm612995.htm.
Health care providers and patients should consider all risks and benefits of fluoroquinolones and make an informed decision about their use. Remind patients to read the Medication Guide insert that comes with each fluoroquinolone prescription describing the safety issues associated with these medicines.
PREFERRED DRUG LIST CHANGES
The California Health & Wellness Pharmacy and Therapeutics (P&T) Committee reviews the PDL 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.
The following changes to the PDL are effective immediately, unless otherwise noted. | ||
Drug Name | PDL Status | Comments |
Oral Medications | ||
Benznidazole tablet | NF |
|
Solosec™ (secnidazole) oral granules | NF | Vaginal preparations: clindamycin (Cleocin®), metronidazole (MetroGel Vaginal,® Vandazole®), Clindesse®
Oral preparations: metronidazole (Flagyl®) |
Steglatro™ (ertugliflozin) tablet | F QL, EST | metformin, glyburide, glipizide, Jardiance,®** Invokana®** |
Symdeko® (tezacaftor/ ivacaftor; ivacaftor) tablet | F *, ** | Orkambi® *, ** |
Tavalisse™ (fostamatinib) tablet | NF | dexamethasone, prednisone |
Ophthalmic Preparations | ||
Rhopressa® (netarsudil) ophthalmic solution | NF | latanoprost (Xalatan®), timolol (Timoptic®), brimonidine (Alphagan® P), dorzolamide (Trusopt®) |
Injectable Preparations | ||
Crysvita® (burosumab) single-dose vial | Medical benefit * | calcitriol (Rocaltrol®), oral phosphate agent (K-Phos,® K-Phos Neutral®) |
*Prior authorization (PA) is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of medication.
**CCS = California Children’s Services: refer to www.dhs.ca.gov for the local telephone number to determine member’s coverage eligibility.
· F indicates formulary.
· NF indicates nonformulary. These medications require member-specific medical reasons why formulary medications cannot be considered. Requests are reviewed via CHWP's prior authorization process.
· QL indicates quantity limit.
· EST indicates electronic step therapy.
ADDITIONAL INFORMATION
Providers are encouraged to access CHWP’s provider portal online at www.cahealthwellness.com 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 your Provider Relations representative or call 1-877-658-0305.