Oral Oncology Agents. August 2017 Update. SGLT-2 Category Update. Removal of Medical Foods

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1 SUPPORTING OUR PROVIDER PARTNERS THROUGH COMMUNICATION AND COLLABORATION. DATE SEPTEMBER 2017 ISSUE 4 HELPFUL NUMBERS FOR PROVIDERS CVS: Primary: Secondary Commercial: Secondary Part D: Passport Advantage BIN: PCN: MEDDAVDV HELPFUL NUMBERS FOR MEMBERS Passport Health Plan WEBSITE NEW IN THIS ISSUE Oral Oncology Agents SGLT-2 Category Update Removal of Medical Foods Lock-In Reject Messaging New Generics Reviewed Medications and Quantity Limit Updates August P&T Committee Meeting Recent FDA Safety Advisories Oral Oncology Agents August 2017 Update Oral oncology agents were approved to move to a preferred status on the formulary. Please note that oral oncology agents which do not yet have a drug specific policy will be taken to the November 2017 P&T meeting for review prior to moving to a preferred status. SGLT-2 Category Update Jardiance (empagliflozin) will be moved to a preferred status after careful consideration of its new FDA-approved indication. As of December 2016, the FDA updated the indications for Jardiance to include reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Jardiance will now be subject to the same utilization management strategy as its drug class counterpart, Invokana (canagliflozin). Both medications will require step therapy with a prior trial of metformin. This decision was discussed with and deemed clinically appropriate by providers serving Passport s member population. Removal of Medical Foods Effective 10/16/17, medical food products that are not subject to a federal rebate will be removed. Examples of removals are below. Please note, this is not an all-inclusive list. Xyzbac Mebolic Deplin Vayarin Enlyte Foltanx RF Folbic RF L-Methylfolate (ONLY Virtus manufacturer is covered) 2017 PASSPORT HEALTH PLAN

2 Lock-In Reject Messaging Clarification Please note the following information regarding rejection messaging pertaining to the Passport Health Plan Lock-In criteria. These rejections are NOT a result of an error with the actual identification number for the prescriber or pharmacy. Reject 71 Prescriber Is Not Covered/ Member Prescriber Override Exclusion - Refers to prescriber lock-in, where the member is locked in with a different prescriber. Reject 50 Non-Matched Pharmacy Number - Refers to pharmacy lock-in, where the member is locked in with a different pharmacy. New Generics BRAND NAME BRAND NAME AVAILABLE FORMULARY STATUS Fluticasone/Salmeterol AirDuo Respiclick 4/24/2017 Do Not Add Ezetimibe/Simvastatin Vytorin 5/1/2017 $0 tier with PA Atomoxetine Strattera 6/1/2017 $0 tier with PA Olopatadine Pataday 6/12/2017 $0 tier Doxycycline Hyclate Acticlate 6/16/2017 $0 tier with ST Sevelamer Carbonate Renvela 6/16/2017 $0 tier Melphalan Alkeran 6/27/2017 $0 tier Testosterone Axiron 6/30/2017 $0 tier Moxifloxacin Vigamox 7/6/2017 $0 tier with ST Mesalamine Lialda 7/24/2017 $0 tier Eletriptan HBr Relpax 7/25/2017 $0 tier Adapalene/Benzoyl Peroxide Epiduo 7/31/2017 $0 tier with ST Scopolamine Transderm-Scop 8/1/2017 $0 tier *Generic drugs will have a $0 co-pay. However, some generic drugs may still be subject to prior authorization or step therapy requirements, and certain quantity limits. For details, please refer to the drug formulary on Passport Health Plan website www. passporthealthplan.com 2

3 The Passport Health Plan Pharmacy and Therapeutics Committee Reviewed the Following Medications and Quantity Limits in August 2017* BRAND NAME GENERIC NAME INDICATIONS FORMULARY ALTERNATIVES Noctiva Desmopressin acetate Nasal spray Austedo Deutetrabenazine Oral tablet Ingrezza Valbenazine Oral capsule Indicated for treatment of nocturia due to nocturnal prophylaxis in adults who awaken at least 2 times per night to void Indicated for treatment of chorea associated with Huntington s disease Indicated for treatment of adults with tardive dyskinesia DDAVP Bumetanide Furosemide Xenaxine Ingrezza Xenazine Austedo PASSPORT HEALTH PLAN STATUS Non-preferred with PA Non-preferred with PA Non-preferred with PA Rydapt Midostaurin Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML), FLT3-positive (as detected by an approved test), in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy Treatment of adult patients with mast cell leukemia (MCL), aggressive systemic mastocytosis (ASM), or systemic mastocytosis with associated hematological neoplasm (SM-AHN) Tymlos Abaloparatide Subcutaneous Injection Indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Alunbrig Brigatinib Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori (crizotinib) Imatinib Forteo Alecensa Xalkori Zykadia 3

4 BRAND NAME GENERIC NAME INDICATIONS FORMULARY ALTERNATIVES Haegarda Rituxan Hycela C1 esterase inhibitor subcutaneous [Human] Rituximab and hyaluronidase human Subcutaneous Injection Indicated for routine prophylaxis against angioedema attacks in adolescents >12 years of age and adult patients with Hereditary Angioedema (HAE) Subcutaneous Injection Indicated for treatment of: Follicular lymphoma for adult patients Diffuse large B-cell lymphoma for adults Chronic lymphocytic leukemia for adults Cinryze Rituxan PASSPORT HEALTH PLAN STATUS Preferred with QL *The Pharmacy and Therapeutics committee also reviewed updates to quantity limits, prior-authorization durations, and other clinical criteria requirements. For specific questions about the clinical criteria please visit or call Quantity Limit Updates Gralise, Horizant, and Neurontin branded products remain as non-preferred. PRODUCT CURRENT QUANTITY LIMIT NEW QUANTITY LIMIT Adlyxin Pen-Injector N/A 2 pens/30 Starter Pack N/A 1 per lifetime Horizant (gabapentin ER tablet) 300 mg N/A 60/ mg N/A 60/30 Gralise (gabapentin tablet) 300 mg N/A 30/ mg N/A 90/30 Starter Pack N/A 1 per lifetime Neurontin (gabapentin capsules) 100 mg N/A 1080/ mg N/A 360/ mg N/A 270/30 Neurontin (gabapentin tablets) 600 mg N/A 180/ mg N/A 120/30 4

5 Recent U.S. Food and Drug Administration (FDA) Drug Safety Advisories Affecting Network Pharmacies and Providers 4/20/17 FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. The FDA is restricting the use of codeine and tramadol medications in children. Singleingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. The following prescribing practices are now Contraindicated by the FDA: using codeine to treat pain or cough in children younger than 12 years of age; using tramadol to treat pain in children younger than 12 years of age; and using tramadol to treat pain after surgery to remove the tonsils and/or adenoids in children younger than 18 years of age. There has also been a new Warning recommending against the use of codeine and tramadol in adolescents between 12 and 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems. Finally, there is also now a Strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medications due to risk of serious adverse reactions in breastfed infants. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain factors such as obesity or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary. 4/27/17 FDA approves label changes for use of general anesthetic and sedation drugs in young children (*may not be applicable to retail pharmacy*). The FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include a new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years of age. It also includes the addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can result in long-term negative effects on the animals behavior or learning. The FDA does not advise delaying or avoiding surgeries or procedures for pregnant women and children under 3 years of age if medically necessary and will continue to monitor the use of these drugs in these patient populations. 5/16/17 FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medication canagliflozin (Invokana, Invokamet, Invokamet XR ) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including a Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. The CANVAS and CANVAS-R studies showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo. Before starting canagliflozin health care professionals should consider factors that may predispose patients to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Patients receiving canagliflozin should be monitored for any signs and symptoms of pain, tenderness, sores, ulcers, or infections in their legs or feet, and canagliflozin should be discontinued if these complications occur. 5

6 5/22/17 FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue (*may not be applicable to retail pharmacy*). An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues; however, because the FDA has identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, is harmful, restricting GBCA use is not warranted at this time. Health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. 9/6/17 FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs. The FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as any other medications taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medications. This will decrease the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, the FDA recommends separating the dosing of sodium polystyrene sulfonate from other orally administered drugs by at least 3 hours. When prescribing sodium polystyrene sulfonate, health care professionals should advise patients to separate dosing by at least 3 hours before and 3 hours after any other oral medication. That time should be increased to 6 hours for patients with gastroparesis or other conditions resulting in delayed emptying of food from the stomach into the small intestine. 6