VIRGINIA MEDICAID DUR QUARTERLY NEWSLETTER Virginia Medicaid DUR Quarterly Newsletter VOLUME 1, NUMBER 14 MARCH 2019 Introduction CONTACT INFORMATION In this issue of the quarterly Drug Utilization Review (DUR) newsletter we look at the focused guideline update for AFib, the new FDA fluoroquinolone warning, and the DHHS guidance on naloxone. Virginia Department of Medical Assistance Services (DMAS) Pharmacy Department FOCUSED GUIDELINE UPDATE FOR AFib http://www.dmas.virginia.gov/ The American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) released a focused update of the Magellan Pharmacy Support Center 2014 Guideline on the Management of Patients with Atrial Fibrillation (AF). Key Service Authorizations: 1-800-932-6648 modifications include addition of the novel oral anticoagulant (NOAC) edoxaban Service Authorization Fax : 1-800-932-6651 Website: (Savaysa®; a factor Xa inhibitor) as an option for stroke prevention. All NOACs https://www.virginiamedicaidpharmacyservices.c (dabigatran [Pradaxa®], apixaban [Eliquis®], edoxaban, rivaroxaban [Xarelto®]) om/default.asp are now preferred over warfarin in NOAC-eligible patients with AF. In NOAC- eligible patients, NOACs were at least noninferior to warfarin in preventing DUR BOARD MEETINGS stroke and systemic embolism and have a lower risk of bleeding. Apixaban is June 13, 2019 September 12, 2019 preferred in patients with end-stage renal disease or on dialysis; remaining December 12, 2019 NOACs are not recommended in this population due to lack of evidence. The anticoagulant reversal agents idarucizumab (Praxbind®; reversal for dabigatran) P&T COMMITTEE MEETINGS and andexanet alfa (Andexxa®; reversal for rivaroxaban and apixaban) are March 29, 2019 recommended in the event of life-threatening bleeding or an urgent procedure. September 19, 2019 An oral anticoagulant, aspirin, plus a P2Y12 inhibitor are recommended in EDITORIAL STAFF patients with AF after percutaneous coronary intervention (PCI) with stent Rachel Cain, Pharm.D placement who are at increased risk of stroke (CHA2DS2-VASc risk score ≥ 2) and DMAS for whom triple therapy is prescribed. Clopidogrel is preferred over prasugrel (Effient®) in this setting. A transition to dual therapy (oral anticoagulant plus Nancy Eldin, Pharm.D Magellan Rx Management P2Y12 inhibitor) may be considered after 4 to 6 weeks. Dual therapy with dose- ©2019 Magellan Rx Management, All rights reserved. VIRGINIA MEDICAID DUR QUARTERLY NEWSLETTER | Issue 14 2 adjusted warfarin plus either clopidogrel, ticagrelor (Brilinta®), or dabigatran is also a reasonable option to reduce the risk of bleeding. Furthermore, new data demonstrates that weight loss provides additional benefit over risk factor modification alone in overweight and obese patients in reducing AF symptoms and severity, as well as the number and cumulative duration of AF episodes. The extent of improvement is directly related to the degree of weight loss. FDA FLUOROQUINOLONE WARNING The United States (US) Food and Drug Administration (FDA) issued a Safety Alert on the increased risk of rare, but serious, aortic ruptures associated with systemic fluoroquinolone (FQ) antibiotics in select patients. The alert is based on case reports submitted to the FDA Adverse Event Reporting System (FAERS) and 4 published observational studies. While the exact cause is unknown, patients treated with an oral or injectable FQ who had a history of blockages or aneurysm of blood vessels, including the aorta, hypertension, select genetic disorders (e.g., Marfan syndrome, Ehlers-Danlos syndrome), and advanced age were twice as likely to experience aortic aneurysm or dissection. The FDA is advising clinicians to avoid prescribing FQs in these patient populations, if possible. FQ treatment should be stopped immediately if symptoms of aortic aneurysm or dissection occur. DHHS GUIDANCE ON NALOXONE The Centers for Disease Control and Prevention (CDC) reported 47,600 opioid-related deaths in 2017. In an effort to increase access to naloxone that can reverse the life-threatening respiratory depression associated with opioid overdose, the US Department of Health and Human Services (DHHS) released a statement on its use. To ensure that naloxone is at the right place at the right time, the DHHS recommends clinicians to coprescribe naloxone to patients who are at risk of opioid overdose. This includes patients (1) receiving ≥ 50 morphine milligram equivalents (MME) per day, (2) with respiratory illness, (3) also prescribed a benzodiazepine, or (4) with a non-opioid substance use disorder (e.g., alcohol). Naloxone should also be prescribed to individuals at high risk of experiencing or responding to an opioid overdose, such as a family member or friend of a person with an opioid use disorder, including those who have decreased opioid tolerance (e.g., after release from incarceration or other controlled setting). The statement by the DHHS reinforces and expands upon prior CDC guidelines and the Surgeon General’s call to increase naloxone access. Naloxone comes in a variety of user-friendly formulations, including nasal spray and injection. Narcan® nasal spray and the naloxone syringe and vials are covered and preferred on the Virginia Medicaid’s Preferred Drug List, the Common Core Formulary. PRIOR AUTHORIZATION CONSENSUS STATEMENT At the December 2018 DUR Board meeting, Dr. Wendy Nash presented a review of the Prior Authorization Consensus Statement which came out at the beginning of 2018 by the American Hospital Association, America’s Health Insurance Plans, American Medical Association, American Pharmacists Association, BlueCross BlueShield Association and the Medical Group Management Association. They partnered together to identify opportunities to improve the prior authorization process. DMAS has always had an ongoing systematic review of all the service authorizations in place. In reference to transparency and communication regarding service authorizations, DMAS communicates all new information and updates in a very timely manner to the providers. With the move towards Medicaid Expansion and the Common Core Formulary, DMAS has provided a lot of communication to the providers and includes this information on the DMAS website. ©2019 Magellan Rx Management, All rights reserved. VIRGINIA MEDICAID DUR QUARTERLY NEWSLETTER | Issue 14 3 In addition, all service authorization fax form requests require a response back within 24 hours. This metric is in compliance 100% of the time. There are pharmacists and contracted physicians available 24 hours a day/ 7 days a week to meet this metric. DMAS also protects continuity of care during transitions to avoid disruptions in therapy. For example, if a member has an active service authorization in Anthem and moves to Aetna, that service authorization will follow the member. With members moving from Fee-For-Service (FFS) to a Managed Care Organization (MCO) or vice versa, there is a 30 day continuity of care requirement. March DUR Board Summary The Board reviewed 9 new medications - Copiktra™, Daurismo™, Libtayo®, Lorbrena®, Panzyga®, Talzenna™, Vitrakvi®, Vizimpro® and Xospata®. The Board also reviewed 2 physician administered drugs - Crysvita® and Ilumya™. Approved service authorization criteria are listed at the end of this newsletter. Additionally, the Board reviewed the results of several utilization analyses: compounded prescriptions, adult and pediatric narcotic utilization, concurrent use of opioids and benzodiazepines, naloxone utilization and antipsychotic duplication. The next DUR Board meeting is scheduled for June 13, 2019. The minutes from the March 2019 meeting can be found at: https://www.virginiamedicaidpharmacyservices.com/provider/drug-utilization-review New Clinical Service Authorizations – effective date April 25, 2019 Brand Name Generic Name Indication Copiktra™ duvelisib A kinase inhibitor indicated for the treatment of adult patients with: • Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. • Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Daurismo™ glasdegib A hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. Libtayo® cemiplimab-rwlc A programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Lorbrena® lorlatinib A kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on • crizotinib and at least one other ALK inhibitor for metastatic disease; or • alectinib as the first ALK inhibitor therapy for metastatic disease; or • ceritinib as the first ALK inhibitor therapy for metastatic disease. ©2019 Magellan Rx Management, All rights reserved. VIRGINIA MEDICAID DUR QUARTERLY NEWSLETTER | Issue 14 4 Talzenna™ talazoparib • A poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Vitrakvi® larotrectinib