Preferred Drug List Changes – 3rd Quarter 2018
Date: 08/23/18
This update includes information regarding the potential risk of neural tube birth defects associated with the active ingredient dolutegravir in Juluca,® Tivicay® and Triumeq,® and changes to the California Health & Wellness Plan (CHWP) Preferred Drug List (PDL) for the third quarter of 2018.
POTENTIAL RISK OF NEURAL TUBE BIRTH DEFECTS ASSOCIATED WITH ACTIVE INGREDIENT DOLUTEGRAVIR IN JULUCA, TIVICAY AND TRIUMEQ
Serious cases of neural tube birth defects involving the brain, spine and spinal cord have been reported in babies born to women treated with dolutegravir used to treat HIV. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain and related structures do not form properly. Approved in 2013, dolutegravir has been on the market for five years and is available as a single ingredient product under the brand name Tivicay and as a fixed dose combination tablet with other HIV medications under the brand names Juluca and Triumeq.
Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. The U.S. Food and Drug Administration (FDA) is investigating this new safety issue and will update the public when more information is available.
Patients should not stop taking dolutegravir without first talking to their health care professionals (HCPs). HCPs should weigh benefits and risks of the drug and inform women of childbearing age about the potential risk of neural tube defects when a dolutegravir-containing regimen is used at the time of conception and early in pregnancy. Alternative antiretroviral medications should be considered. If women of childbearing age continue to use dolutegravir, HCPs should reinforce the consistent use of effective birth control. Pregnancy testing should be performed before initiating a dolutegravir-containing regimen in women of childbearing age to exclude pregnancy.
For further information, visit the FDA’s safety alerts page at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm.
CHANGES TO THE CALIFORNIA HEALTH & WELLNESS PLAN PREFERRED DRUG LIST
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 |
Bevyxxa® (betrixaban) capsule | F, prior authorization (PA) required | Prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
Quantity limit is 42 capsules per 42 days. For Medicare, quantity limit is 1 capsule per day |
Calquence® (acalabrutinib) capsule | F, PA required | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
Erleada™ (apalutamide) tablet | F, PA required | Treatment of patients with non-metastatic castration-resistant prostate cancer (CRPC) |
Prevymis™ (letermovir) tablet | NF | Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
Verzenio® (abemaciclib) tablet | NF | In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting |
Vyzulta® (latanoprostene bunod) ophthalmic solution | NF | Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
Fasenra™ (benralizumab) prefilled syringe | Medical benefit, PA required | Add-on maintenance treatment of patients with severe asthma ages 12 and older, and with an eosinophilic phenotype
Limitation(s) of use: - Fasenra is not indicated for treatment of other eosinophilic conditions - Fasenra is not indicated for the relief of acute bronchospasm or status asthmaticus |
Drug Name | PDL Status | Comments |
Hemlibra® (emicizumab-kxwh) vial | Medical benefit, PA required | Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors |
Mepsevii™ (vestronidase alfa-vjbk) vial | Bill Medi-Cal Fee for Service directly | Treatment of mucopolysaccharidosis VII (MPS VII, Sly syndrome) in pediatric and adult patients
Limitation(s) of use: The effect of Mepsevii on the central nervous system manifestations of MPS VII has not been determined |
Ozempic® (semaglutide) prefilled pen | NF | An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
Prevymis (letermovir) single-dose vial | Bill Medi-Cal Fee for Service directly | Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
Ciprofloxacin-dexamethasone 0.3-0.1% suspension (Ciprodex®) | F | Quantity limit = 7.5 ml per claim and 1 claim per 30 days |
Sumatriptan succinate 6mg/0.5ml vial (Imitrex®) | Quantity limit change | Quantity limit increased to 2.5 ml per 30 days. Vials can come in a box of up to 2.5 ml. This will prevent breaking a box |
The following changes to the PDL are effective as of November 1, 2018. | ||
Admelog® | F | Admelog is currently on the PDL; however it will be the preferred rapid-acting insulin for CHWP, effective as of November 1, 2018 |
Humalog® | NF | Removed from PDL. Admelog is the preferred rapid-acting insulin |
NovoLog® | NF | Removed from PDL. Admelog is the preferred rapid-acting insulin |
Apidra® | NF | Removed from PDL. Admelog is the preferred rapid-acting insulin |
Esterified estrogens & methyltestosterone 0.625-1.25 mg and 1.25-2.5 mg tablet (Estratest®) | NF | Drug Efficacy Study Implementation (DESI) 5 drugs are excluded from coverage |
Pseudoephedrine with codeine 30-10-100 mg/5 ml solution | NF | Desi 5 drugs are excluded from coverage |
Hyoscyamine sulfate 0.125 mg tablet, 0.125 mg sublingual (SL) tablet, 0.125 mg/5ml elixir, 0.125 mg/ml solution, 0.125mg dispersible tablet (Levsin®) | NF | Desi 5 drugs are excluded from coverage |
Drug Name | PDL Status | Comments |
The following changes to the PDL are effective as of November 1, 2018. | ||
Phenobarbital-Hyoscyamine-atropine-scopolamine 16.2-0.1037-0.0194-0; Phenobarbital-Hyoscyamine-atropine-scopolamine 16.2-0.1037-0.0194-0.0065mg/5ml elixir (Donnatal®) | NF | Desi 5 drugs are excluded from coverage |
Sodium citrate and citric acid 500-334 mg/5 ml solution [Shohl’s Solution (Modified)] | NF | Desi 5 Drugs are excluded from coverage |
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.