21-108 Medication Trend Updates and Preferred Drug List Changes - 1st Quarter 2021
Date: 02/05/21
Review changes that improve patient safety and encourage medication adherence
Stay up-to-date with information about:
- U.S. Food and Drug Administration (FDA) proposes withdrawal of approval for Makena® and its generic from the market
- New prescribing and Controlled Substance Utilization Review and Evaluation System (CURES) reporting rules for controlled substances effective January 1, 2021
- Changes to the California Health & Wellness Plan (CHWP) Preferred Drug List (formulary) for the first quarter of 2021
FDA seeks withdrawal of Makena and its generic from the market
In October 2020, the FDA’s Center for Drug Evaluation and Research (CDER) proposed to withdraw approval of Makena (hydroxyprogesterone caproate injection) and its generic equivalents from the market based on a postmarketing study that failed to verify clinical benefit.
Makena received accelerated approval in 2011 to lower the risk of preterm birth among women with at least one prior spontaneous delivery before 37 weeks’ gestation. Because of its accelerated approval, the FDA required a postmarketing trial. The trial failed to show that Makena reduced the risk of preterm birth or improved the health of babies born to women with a history of unexplained preterm birth.
Makena and its approved generic equivalents will remain on the market until the manufacturers decide to remove the drugs or the FDA Commissioner mandates their removal. AMAG Pharmaceuticals, the maker of Makena, disagrees with the FDA’s proposal for removal. At this time, Makena’s approval and product label remain unchanged. The product continues to remain available to patients and prescribers.
In the meantime, the FDA recommends that health care professionals discuss Makena’s benefits, risks and uncertainties with women deciding whether to use it until a final decision is made about the drug’s marketing status.
Reference: CDER proposes withdrawal of approval for Makena on the FDA website.
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 1-877-658-0305.
New prescribing and CURES reporting rules for controlled substances
Effective January 1, 2021, prescribers of controlled substances must use the new security prescription form requirements based on California Assembly Bill 149 (AB 149). Except for limited emergency situations, pharmacists will be unable to fill a prescription for a controlled substance that is not on a compliant form. For more information, refer to the Joint Statement Re: AB 149 - New Requirements for Controlled Substances Prescription Forms (pdf). It is an informational document with frequently asked questions (FAQs) developed by the Board of Pharmacy, the Medical Board of California and the California Department of Justice.
In addition, beginning January 1, 2021, the dispensing of a controlled substance (Schedules II, III, IV and V drugs) must be reported to CURES within one working day (previously seven days) after the medication is dispensed.
Preferred Drug List changes
The CHWP Pharmacy and Therapeutics (P&T) Committee reviews the Preferred Drug List (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.
Oral medications
Medication | Status | Formulary alternative(s) | Comments |
|---|---|---|---|
Dayvigo™ (lemborexant) tablet | NF* | estazolam, temazepam, triazolam, zolpidem IR | Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance |
Fintepla® (fenfluramine) oral solution | NF* | valproic acid**, topiramate**, levetiracetam** | Treatment of seizures associated with Dravet syndrome (DS) in patients ages 2 and older |
Koselugo™ (selumetinib) capsule | NF* |
| Treatment of pediatric patients ages 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
Nexletol™ (bempedoic acid) tablet | NF* | atorvastatin, rosuvastatin | For use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) |
Nurtec® ODT (rimegepant) disintegrating tablet | NF* | almotriptan, naratriptan, rizatriptan, sumatriptan | Acute treatment of migraine with or without aura in adults |
Ongentys® (opicapone) capsule | NF*
| COMT inhibitor: entacapone
Dopamine agonist: ropinirole, ropinirole ER, pramipexole | Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes MAO-B: monoamine oxidase-B COMT: catechol-O-methyltransferase Quantity limit is one capsule per day |
Pemazyre™ (pemigatinib) tablet | NF* | capecitabine** | Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test Quantity limit is one tablet per day |
Qinlock™ (ripretinib) tablet | NF* | imatinib*,**, Sutent*,**, Stivarga*,** | Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib |
Retevmo™ (selpercatinib) capsule | NF* |
| Treatment of: Advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
RET-mutant medullary thyroid cancer (MTC)
RET fusion-positive thyroid cancer
|
Tabrecta™ (capmatinib) tablet | NF* |
| Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test |
Tukysa™ (tucatinib) tablet | NF* | Herceptin*,**, Perjeta*,**, Kadcyla*,** | For use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting |
Ubrelvy™ (ubrogepant) tablet | NF* | almotriptan, naratriptan, rizatriptan, sumatriptan | Acute treatment of migraine with or without aura in adults |
Xcopri® (cenobamate) tablet | NF* | carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine IR, levetiracetam IR, oxcarbazepine IR, phenobarbital, phenytoin, tiagabine (Gabitril), topiramate IR, valproic acid, zonisamide | Treatment of partial-onset seizures in adult patients
|
Zeposia® (ozanimod) capsule | NF* | Agents used for CIS and RRMS: Avonex*,**, Betaseron*,**, Rebif®, *,**, Plegridy®, *,**, glatiramer, *,** Agents used for RRMS: Aubagio*,**, Tecfidera*,**, Gilenya*,** | Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS), in adults |
Installation preparation
Medication | Status | Formulary alternative(s) | Comments |
|---|---|---|---|
Jelmyto™ (mitomycin for pyelocalyceal solution) single-dose vial | Medical benefit* |
| Treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC) |
Injectable preparations
Medication | Status | Formulary alternative(s) | Comments |
|---|---|---|---|
Jelmyto™ (mitomycin for pyelocalyceal solution) single-dose vial | Medical benefit* |
| Treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC) |
Evenity™ (romosozumab-aqqg) prefilled syringe | Medical benefit* | alendronate, risedronate* zoledronic acid (Reclast)*,** | Treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy |
Givlaari® (givosiran) single-dose vial | Medical benefit* |
| Treatment of adults with acute hepatic porphyria (AHP) |
Neulasta® (pegfilgrastim) single-dose prefilled syringe | NF* | Zarxio*, ** | Nonpreferred. Use Ziextenzo*
|
Tecartus™ (brexucabtagene autoleucel) single-dose unit infusion bag | Medical benefit* | Anthracycline: doxorubicin* Bruton tyrosine kinase (BTK) inhibitor: | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
|
Tepezza™ (teprotumumab) single-dose vial | Medical benefit* | methylprednisolone, prednisone | Treatment of thyroid eye disease (TED) |
Vyepti™ (eptinezumab-jjmr) single-dose vial | Medical benefit* | Aimovig* Antiepileptic drugs**: divalproex sodium, sodium valproate, topiramate Beta-blockers: metoprolol, propranolol, timolol Antidepressants:amitriptyline, venlafaxine | Preventive treatment of migraine in adults |
Vyondys 53™ (golodirsen) single-dose vial | Medical benefit* | prednisone | Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping |
Ziextenzo™ (pegfilgrastim-bmez) single-dose prefilled syringe | NF* | Zarxio*, ** | Preferred biosimilar to Neulasta* Approval of Ziextenzo requires Zarxio® step requirement |
*Prior authorization (PA) is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of the medication.
**CCS = California Children’s Services: refer to www.dhcs.gov for the local telephone number to determine member’s coverage eligibility.
NF indicates nonformulary. These medications require member-specific medical reasons why formulary medications cannot be considered. Requests are reviewed via the plan’s prior authorization process.