20-582 Stay Up to Date with Medication Trend Updates and Preferred Drug List Changes - 3rd Quarter 2020
Date: 07/30/20
Review changes for oral, topical and injectable drugs
Stay up to date with information about:
- Weight-loss drugs Belviq® and Belviq XR® (lorcaserin) withdrawn from the market due to cancer risk
- Changes to the California Health & Wellness Plan (CHWP) Preferred Drug List (formulary) for the third quarter of 2020.
Weight-loss drugs Belviq and Belviq XR withdrawn from the market due to cancer risk
On February 13, 2020, the U.S. Food and Drug Administration (FDA) requested that Eisai Inc., the maker of Belviq and Belviq XR (lorcaserin), withdraw the drug from the U.S. market because a safety clinical trial showed an increased risk of cancer. Eisai Inc. has submitted a request to voluntarily withdraw the drug.
Lorcaserin was first approved by the FDA in 2012 as an add-on therapy to help aid weight loss, along with diet and exercise, in people who were obese or overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).
When the FDA approved lorcaserin in 2012, the FDA required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular problems. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal and lung. On January 15, 2020, the FDA announced that Belviq might have links to cancer and concluded that the potential risks of lorcaserin outweigh its benefit. FDA’s analysis found that about 7.7% of Belviq patients had cancer diagnoses, compared with 7.1% of patients who received a placebo.
Health professionals should stop prescribing and dispensing lorcaserin to patients. Inform the patients currently taking lorcaserin of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. They should discuss alternative weight-loss medicines or strategies with their patients.
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.
The following changes to the PDL are effective immediately, unless otherwise noted.
Preferred Drug List changes
Medication | Status | Formulary alternative(s) | Comments |
Oral medications
Ayvakit™ (avapritinib) tablet | NF | imatinib (Gleevec®)** | Treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
Brukinsa® (zanubrutinib) capsule | NF | Calquence®*,** Imbruvica®*,** | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
Caplyta® (lumateperone) capsule | Bill Medi-Cal fee for service directly |
| Treatment of schizophrenia in adults |
Oxbryta™ (voxelotor) tablet | NF | hydroxyurea** | Treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older |
Palforzia™ (peanut allergen powder-dnfp) capsule or sachets | NF |
| Mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients ages 4 through 17. Up-dosing and maintenance may be continued in patients ages 4 and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. |
Reyvow™ (lasmiditan) tablet | NF | almotriptan, naratriptan, sumatriptan | Acute treatment of migraine with or without aura in adults Limitation(s) of use: Reyvow is not indicated for the preventive treatment of migraine. |
Rinvoq™ (upadacitinib) extended-release tablet | NF | DMARDs: methotrexate**, hydrochloroquine, leflunomide, sulfasalazine Biologic DMARDs*: Humira®**, Enbrel®**, Xeljanz®, Xeljanz® XR, Orencia®**, Remicade®**, Simponi Aria®** | Treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate |
Tazverik™ (tazemetostat) tablet | NF | doxorubicin* | Treatment of adults and pediatric patients ages 16 and older with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection |
Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablet | Bill Medi-Cal fee for service directly |
| In combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. |
Topical preparations
Aklief® (trifarotene) cream | NF | adapalene, tazarotene, tretinoin | Topical treatment of Acne vulgaris in patients ages 9 and older |
Injectable preparations
Adakveo® (crizanlizumab-tmca) single-dose vial | Medical benefit* | hydroxyurea** | To reduce the frequency of vaso-occlusive crises (VOC) in adults and pediatric patients ages 16 and older with sickle cell disease (SCD) |
Reblozyl® (luspatercept-aamt) single-dose vial | Medical benefit* |
| Treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions |
Scenesse® (afamelanotide) implant | Medical benefit* |
| To increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) |
Skyrizi™ (risankizumab-rzaa) prefilled syringe | NF | methotrexate**, cyclosporine** Biologic DMARDs*: Humira**, Enbrel**, Otezla®, Cosentyx®, Remicade**, Simponi Aria** | Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
*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.