21-107 Medication Trend Updates and Preferred Drug List Changes - 1st Quarter 2021
Date: 02/05/21
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.
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 Health Net of California, Inc., Health Net Community Solutions, Inc. and Health Net Life Insurance Company, Inc. commercial Formulary, Medi-Cal Preferred Drug List (PDL) and Medicare Part D 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.
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.
Changes to the commercial Formulary, Medi-Cal PDL and Medicare Part D Formulary
The Health Net Pharmacy and Therapeutics (P&T) Committee, which includes practicing physicians, pharmacists and other health care professionals, reviews medications on the Formulary for commercial members, PDL for Medi-Cal members and the Medicare Part D Formulary for Medicare members each quarter to determine medications to stay on or be moved to a different tier. A list of some recent changes is provided in a table below. The list contains brand-name prescription medications, status, other medication choices, and comments for the first quarter of 2021.
Complete lists of the commercial Formularies, Medi-Cal PDLs and Medicare Part D Formularies are available on the Health Net provider website as listed below under Pharmacy Information.
Pharmacy help line
For more information regarding changes to the Health Net commercial Formulary, Health Net Medi-Cal PDL or Medicare Part D Formulary, contact the proper pharmacy telephone numbers below:
Pharmacy Services (commercial): 1-800-548-5524, option #3; fax 1-800-314-6223
Pharmacy Services Center (Medi-Cal, Medicare and Cal MediConnect): 1-800-867-6564; fax 1-800-977-8226
Health Net Clinical Pharmacy Line (clinical programs): 1-800-782-2221
Additional information
If you have questions regarding the information contained in this update, contact the applicable Health Net Provider Services Center within 60 days at:
Line of Business | Telephone Number | Provider Portal | Email Address |
|---|---|---|---|
EnhancedCare PPO (IFP) | 1-844-463-8188 | ||
EnhancedCare PPO (SBG) | 1-844-463-8188 | provider_services@healthnet.com | |
Health Net Employer Group HMO, POS, HSP, PPO, & EPO | 1-800-641-7761 | provider_services@healthnet.com | |
IFP (CommunityCare HMO, PPO, PureCare HSP, PureCare One EPO) | 1-888-926-2164 | provider_services@healthnet.com | |
Medicare (individual) | 1-800-929-9224 | provider_services@healthnet.com | |
Medicare (employer group) | 1-800-929-9224 | provider_services@healthnet.com | |
Medi-Cal | 1-800-675-6110 | N/A |
Health Net Commercial Formulary, Medi-Cal PDL and Medicare Part D Formulary Changes
Oral medications
| Medication | Status: Commercial 3-Tier Plan (4-Tier Plan) | Status: Medicare Part D Value1 | Status: Medi-Cal | Health Net Formulary Alternative(s): Commercial | Health Net Formulary Alternative(s): Medicare | Health Net Formulary Alternative(s): Medi-Cal | Comments |
|---|---|---|---|---|---|---|---|
Dayvigo™ (lemborexant) tablet | NF (NF) | NF
| NF*
| estazolam, eszopiclone, ramelteon (Rozerem®), temazepam, triazolam, zaleplon, zolpidem IR, Belsomra® | temazepam, zolpidem IR, Belsomra | 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 (NF) | Tier 5 (* for new start only) | NF*
| valproic acid, topiramate, levetiracetam | clobazam***, valproic acid, topiramate, levetiracetam, Epidiolex® *** | valproic acid**, topiramate**, levetiracetam** | Treatment of seizures associated with Dravet syndrome (DS) in patients age 2 and older |
Koselugo™ (selumetinib) capsule | F* (SP*) | NF | NF* | Treatment of pediatric patients age 2 and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) | |||
Nexletol™ (bempedoic acid) tablet | NF (NF) | NF | NF* | atorvastatin, rosuvastatin, Repatha® (*under Tier 4 plan) | atorvastatin, rosuvastatin, | 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 QL (NF QL) | NF | NF* | almotriptan, naratriptan, rizatriptan, sumatriptan, | naratriptan, rizatriptan, sumatriptan | almotriptan, naratriptan, rizatriptan, sumatriptan | Acute treatment of migraine with or without aura in adults Quantity limit is 15 tablets per month for commercial. |
Ongentys® (opicapone) capsule | NF QL (NF QL) | NF | NF* | COMT inhibitor: entacapone (under Tier 3 plan) MAO-B inhibitor: rasagiline Dopamine agonist: ropinirole, ropinirole ER (under Tier 3 plan), pramipexole
| COMT inhibitor: entacapone,
Dopamine agonist: ropinirole, ropinirole ER, pramipexole, pramipexole ER
Apokyn® *, Neupro® | 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 | Tier 3* QL (SP* QL) | Tier 5 (*for new start only) | NF*
| capecitabine (under Tier 3 plan) | cisplatin (BvD), Gemzar® * | 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 | Tier 3* (SP*) | Tier 5 (*for new start only) | NF*
| under Tier 3 plan: imatinib, Sutent® * | imatinib***, Sutent***, Stivarga® *** | 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 | Tier 3* (SP*) | Tier 5 (*for new start only)
| 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 | Tier 3* (SP*) | Tier 5 (*for new start only) | 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 | Tier 3* (SP*) | Tier 5 (*for new start only) | NF*
| Herceptin®***, Kadcyla®(BvD) | 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 QL (NF QL) | NF | NF* | almotriptan, naratriptan, rizatriptan, sumatriptan | naratriptan, rizatriptan, sumatriptan | almotriptan, naratriptan, rizatriptan, sumatriptan | Acute treatment of migraine with or without aura in adults Quantity limit is 16 tablets per month for commercial |
| Xcopri®(cenobamate) tablet | NF QL (NF QL) | 12.5-25MG is Tier 4, all other strengths are Tier 5, QL | NF* | carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine IR, levetiracetam, oxcarbazepine IR, phenobarbital, phenytoin, pregabalin IR (Lyrica®), topiramate IR, valproic acid, zonisamide | carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine IR, phenobarbital***, phenytoin, pregabalin IR (Lyrica), tiagabine (Gabitril®), topiramate IR, valproic acid, zonisamide, Aptiom® | 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 Quantity limit is two tablets per day for commercial. Quantity limit for Medicare is as follows:
|
Zeposia®(ozanimod) capsule | NF (NF) | NF
| NF* | Agents used for CIS and RRMS* (under Tier 4 plan): glatiramer, Copaxone®, Glatopa®
| Agents used for CIS and RRMS: Betaseron® ***, Copaxone***
Tecfidera® ***, Gilenya® *** | 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: Commercial 3-Tier Plan (4-Tier Plan) | Status: Medicare Part D Value1 | Status: Medi-Cal | Health Net Formulary Alternative(s): Commercial | Health Net Formulary Alternative(s): Medicare | Health Net Formulary Alternative(s): Medi-Cal | Comments |
|---|---|---|---|---|---|---|---|
Jelmyto™ (mitomycin for pyelocalyceal solution) single-dose vial | Medical benefit* | Medical benefit | Medical benefit* | Treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC) |
Injectable preparations
| Medication | Status: Commercial 3-Tier Plan (4-Tier Plan) | Status: Medicare Part D Value1 | Status: Medi-Cal | Health Net Formulary Alternative(s): Commercial | Health Net Formulary Alternative(s): Medicare | Health Net Formulary Alternative(s): Medi-Cal | Comments |
|---|---|---|---|---|---|---|---|
Evenity™ (romosozumab-aqqg) prefilled syringe | Medical benefit* | Medical benefit* | Medical benefit* | alendronate, ibandronate | alendronate, risedronate, ibandronate (BvD), zoledronic acid (BvD) (Reclast®)*, Prolia® | 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* | NF | Medical benefit* | Treatment of adults with acute hepatic porphyria (AHP) | |||
Neulasta® (pegfilgrastim) single-dose prefilled syringe | Medical benefit* (NF) | NF | NF* | Zarxio® * | Zarxio*, ** | Nonpreferred. Use Ziextenzo* | |
Tecartus™ (brexucabtagene autoleucel) single-dose unit infusion bag | Medical benefit* | Medical benefit* | Medical benefit* | Anthracycline: bendamustine
| Anthracycline: doxorubicin (BvD), bendamustine (BvD) Anti-CD20 monoclonal antibody: Ruxience™*** Bruton tyrosine kinase (BTK) inhibitor: Imbruvica***, Calquence® ***, Brukinsa™ *** | Anthracycline: doxorubicin*
Bruton tyrosine kinase (BTK) inhibitor: Imbruvica*,**, Calquence*,** | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
|
Tepezza™ (teprotumumab) single-dose vial | Medical benefit* | NF | Medical benefit* | methylprednisolone, prednisone | methylprednisolone, prednisone | methylprednisolone, prednisone | Treatment of thyroid eye disease (TED) |
Vyepti™ (eptinezumab-jjmr) single-dose vial | Medical benefit*
| NF
| Medical benefit* | Aimovig®, Emgality®(*under Tier 4 plan)
Antiepileptic drugs: divalproex sodium, sodium valproate, topiramate
Beta-blockers: metoprolol, propranolol, timolol
Antidepressants: amitriptyline, venlafaxine | Aimovig*
Antiepileptic drugs: divalproex sodium, topiramate
Beta-blockers: metoprolol, propranolol
Antidepressants:amitriptyline, venlafaxine | 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* | Medical benefit* | Medical benefit* | prednisone | prednisone | 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 | Medical benefit* (Tier 4*) | NF | NF* | Zarxio* | Zarxio*, ** | Preferred biosimilar to Neulasta* Approval of Ziextenzo requires Zarxio® step requirement |
1Medicare Part D = Health Net Gold Select (HMO), Health Net Healthy Heart (HMO), Health Net Jade (HMO C-SNP), Health Net Ruby (HMO), Health Net Ruby Select (HMO), Health Net Sapphire (HMO), Health Net Violet 1 (PPO), Health Net Violet 2 (PPO), Health Net Violet 3 (PPO), Health Net Violet 4 (PPO)
*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.dhs.ca.gov for the local telephone number to determine member’s coverage eligibility.
***Prior authorization (PA) for new start only is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of the medication.
- F indicates formulary.
- NF indicates nonformulary; NP indicates nonpreferred. These medications require member-specific medical reasons why formulary medications cannot be considered. Requests are reviewed via Health Net's prior authorization process.
- SP indicates specialty tier.
- AL indicated age limit.
- EST indicated electronic step therapy.
- IR indicated immediate release
- ER indicated extended release
- BvD indicates this drug requires a coverage determination for Medicare Part B versus D