3Mar
STATE OF EMERGENCY IN TENNESSEE DUE TO TORNADO

STATE OF EMERGENCY IN TENNESSEE DUE TO TORNADO

The Governor of Tennessee has issued a state of emergency for the following counties due to tornado: Benton, Davidson, Knox, Putnam, Shelby and Wilson. Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of March 3, 2020, and expiration date of April 4, 2020.

 
2Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Nexlizet Approved by the FDA
On February 26, 2020, the U.S Food and Drug Administration (FDA) approved Esperion’s Nexlizet™ (bempedoic acid and ezetimibe) tablets. Nexlizet is the first once-daily, non-statin, LDL cholesterol lowering combination. It is indicated for use in adults who have heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) and who are on a statin, but who require further lowering of LDL cholesterol (LDL-C). Nexlizet contains bempedoic acid and ezetimibe. Bempedoic acid, an ATP Citrate Lysase (ACL) inhibitor, was approved as a single drug earlier in February under the trade name Nexletol™. Ezetimibe, available as a generic, works by blocking absorption of cholesterol in the small intestine. Compared to placebo, Nexlizet lowered LDL-C by an average of 38% in clinical trials. Although Nexlizet does not carry a boxed warning, its label does caution that a few patients experienced high serum uric acid levels that led to gout and a few patients suffered tendon ruptures. Notable drug interactions include simvastatin in daily doses of 20mg or higher and pravastatin at 40mg or more. Patients should be monitored when taking cyclosporine, which could affect blood levels of both drugs, and fibrates, which could cause gallstones if taken together. Nexlizet is planned for launch in July 2020. Express Scripts currently is investigating the data around Nexlizet for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information can be found here.

Vyepti Approved for Migraine Prevention
Lundbeck’s Vyepti™ (eptinezumab-jjmr) was approved by the U.S Food and Drug Administration (FDA) on February 21, 2020, as the first intravenous (IV) prevention treatment for migraine in adult patients. Vyepti, a humanized monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), is given by IV infusion at a recommended dose of 100mg over 30 minutes once every three months. Some patients may need to increase the dose to 300mg, if relief is not adequate. In clinical trials that involved over 2,000 individuals, significantly more patients receiving Vyepti showed improvement on the first day after infusion compared to those given a placebo. Actively treated patients had fewer migraines over the following week, as well. Vyepti does not carry a black box warning but its label does advise about some relatively mild hypersensitivity reactions that still led to discontinuation of treatment by a few patients. To be introduced in April 2020, Vyepti, which does require dilution before administration, will be available in 100mg/mL single use vials. Lundbeck has not disclosed any plans for cost. Express Scripts currently is investigating the data around Vyepti for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. For full prescribing information, click here.

Nurtec ODT Approved for Acute Migraine
An oral CGRP antagonist, Nurtec™ ODT (rimegepant orally-disintegrating tablets), was approved by the U.S Food and Drug Administration (FDA) on February 27, 2020. It is indicated to treat adults who have acute migraine headaches, but not to prevent migraines. The recommended dose is one 75mg tablet, dissolve on or under the tongue, once a headache starts or once the patients has signs that a migraine is about to begin. Only one tablet should be used per day and using more than 15 tablets per month has not been proven safe. In the clinical studies of its use, Nurtec ODT moderated pain to tolerable levels within two hours for most patients. Relief generally lasted for 48 hours or longer for the majority of patients and 86% of them did not need to use another pain reliever for at least 24 hours after they took Nurtec ODT. Beginning next month, the manufacturer, Biohaven Pharmaceuticals, will market cartons containing eight blister-packed tablets, but the WAC has not been released, yet. Express Scripts currently is investigating the data around Nurtec ODT for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. For full prescribing information, click here.

Barhemsys Receives FDA Approval
Acacia Pharma Group was granted U.S Food and Drug Administration (FDA) approval on February 26, 2020, for Barhemsys ® (amisulpride) injection. Known as a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, it is an IV antiemetic indicated to prevent post-operative nausea and vomiting (PONV) either alone or along with another anti-nausea drug, such as ondansetron. The recommended dose to prevent nausea and vomiting before a surgical procedure is 5mg infused over one to two minutes. The dose is 10mg, administered over one to two minutes, for the treatment of PONV. Barhemsys is not approved for use in pediatric patients. Beginning in the second half of 2020, it will be available as single-dose vials containing 5mg/2mL. Pricing has not yet been announced. Barhemsys will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information can be found here.

FDA Approves ArmonAir Digihaler
Teva’s ArmonAir ® Digihaler™ (fluticasone propionate) inhalation powder was U.S Food and Drug Administration (FDA) approved on February 24, 2020. Administered as one inhalation twice each day, ArmonAir Digihaler is indicated for use as a maintenance therapy of asthma in patients at least 12 years of age. It should not be used as rescue treatment for acute bronchospasms, however. Each digihaler includes digital components that can transmit information to an app for keeping track of usage or sharing with a health professional. ArmonAir Digihaler will be marketed in 55mcg, 113mcg and 232mcg strengths. The manufacturer, Teva Respiratory, has not disclosed any plans for launch or cost. Express Scripts currently is investigating the data around ArmonAir Digihaler for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Check here for complete prescribing information.

Fluad Quadrivalent Approved
On February 21, 2020, the U.S Food and Drug Administration (FDA) approved Fluad ® Quadrivalent (influenza vaccine, adjuvanted - Seqirus) to prevent flu for patients who are 65 years old and older. Although Fluad has been available in a trivalent version for several years, the new form is the first version to be active against four strains of flu viruses. In addition, Fluad Quadrivalent contains an adjuvant (an immune booster) that not only improves its effectiveness, but prolongs it, as well. Like most other flu vaccines currently on the market, Fluad Quadrivalent will be given as one dose of 0.5mL in an intramuscular (IM) injection, ideally by the start of each year’s flu season. For its full prescribing information, click here.

Expanded indication for Trulicity
Trulicity ® (dulaglutide), Eli Lilly and Company’s long-acting glucagon-like peptide-1 (GLP-1) agonist, got a new indication from the U.S Food and Drug Administration (FDA) on February 21, 2020. Self-administered once-weekly as a subcutaneous (SC) injection, Trulicity originally was FDA approved in 2014 for use along with diet and exercise to manage blood sugar levels for adults who have type 2 diabetes. It now can be used to decrease the likelihood of cardiovascular (CV) events, such as heart attacks and strokes, in adult patients with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. All GLP-1 drugs carry a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have occurred among laboratory rodents treated with some GLP-1 receptor agonists in preclinical studies. However, whether or not humans using them develop thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), is not yet known. Patients who have MCT, individuals with close family members who have thyroid C-cell tumors and patients who have Multiple Endocrine Neoplasia syndrome type 2 (tumors in more than one gland) should not use Trulicity. For complete prescribing information, click here.

Riomet ER Launched
Following its U.S Food and Drug Administration (FDA) approval in August 2019, Sun Pharma’s Riomet ER™ (metformin for extended-release oral suspension) now is available in the U.S. Like immediate-release Riomet ® (metformin) oral solution, which needs to be taken two or three times a day, Riomet ER is indicated along with diet and exercise for treating patients at least 10 years old who have type 2 diabetes. Sun estimates that around 40% of the approximately 24 million American adults age 45 years and older who have type 2 diabetes also have some degree of difficulty swallowing tablets or capsules. Many small children also are more receptive to a liquid drug than to a solid dose form. Dispensed in 16-ounce bottles that are either grape or cherry flavored, Riomet ER has an initial recommended dose of 500mg once daily, which can be increased to as much as 2000mg once a day, if needed. It is taken along with the last meal of the day. All medications that contain metformin have a boxed warning that taking it may cause lactic acidosis, the buildup of excessive acid in the blood. Express Scripts currently is investigating the data around Riomet ER for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information can be found here.

Esperion’s Nexletol™ FDA Approved
On February 21, 2020, the U.S. Food and Drug Administration (FDA) approved Esperion’s Nexletol™ (bempedoic acid) tablets. The first drug in a new class, adenosine triphosphate (ATP) citrate lyase (ACL) inhibitors, it is used along with a diet and the highest dose of an HMG-CoA reductase inhibitor (statin) to treat adults who have heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) and who are already taking a statin but who require additional lowering of LDL cholesterol (LDL-C). The recommended dose is 180mg (one tablet) once a day. Launch is planned for March 30, 2020, at a wholesale acquisition cost of about $3,650 per year of therapy. Full prescribing information may be found here.

FDA Approval for Teva’s ProAir® 
On February 24, 2020, the U.S. Food and Drug Administration (FDA) approved Perrigo Pharmaceuticals’ AB-rated generic to Teva’s ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. Similar to the brand, Perrigo’s generic is indicated to prevent and treat bronchospasms for patients who are at least four years old and who have reversible obstructive airway disease. It also is approved to prevent exercise-induced bronchospasms (EIB) for patients aged four years and older. Perrigo and its manufacturing partner, Catalent Pharma Solutions, already have launched a small supply of albuterol inhalation aerosol and they plan to increase production to full capacity by the fourth quarter of 2020. Wholesale acquisition cost (WAC) is not yet available. According to Teva’s 2019 annual report, North American sales of the ProAir franchise (including two other brands, but not including the authorized generic [AG]) were $274 million. However, IQVIA estimated that total global sales for the last 12 months amounted to $1.4 billion.

Coronavirus Update
The Coronavirus disease 2019 (COVID-19) is a new respiratory virus that has healthcare professionals on alert. Since the outbreak was first associated with the Huanan seafood and live animal wholesale market in the city of Wuhan, China, on Dec. 31, 2019, the disease has spread internationally — mostly due to travel from the infected area. The first U.S. case of the virus was reported on Jan. 20, 2020 and several more have appeared around the country. The Centers for Disease Control and Prevention (CDC) is monitoring COVID-19, closely, as it works to keep health providers and the public informed. For additional information about COVID-19, click here.
 

 
24Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Contraceptive Patch Approved
Agile Therapeutics received U.S. Food and Drug Administration (FDA) approval on February 14, 2020, for Twirla ® (levonorgestrel/ethinyl estradiol) transdermal system. Each Twirla patch releases a low daily dose of an estrogen and a progestin to provide contraception. One patch is applied to clean, dry skin of the abdomen, back, buttocks or lower chest once each week for three weeks and then no patch is needed for the fourth week. Twirla is not approved for women who have a body mass index (BMI) over 30kg/m2 and its effectiveness may be limited for women whose BMI is between 25kg/m2 and 30kg/m2. An additional boxed warning specifies that its risk of causing blood clots means it should not be used by women who are older than 35 years of age and who smoke. Agile plans to begin distributing Twirla in the fourth quarter of 2020, but its price has not yet been disclosed. Express Scripts currently is investigating the data around Twirla for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Click here for its prescribing information.

FDA Approves Anjeso
Anjeso™ (meloxicam injection – Baudax Bio) was U.S. Food and Drug Administration (FDA) approved on February 20, 2020. It is a non-steroidal anti-inflammatory drug (NSAID) indicated to treat moderate-to-severe pain for adults. Patients in the clinical trials that lead to its approval had had surgeries ranging from bunion removal to major abdominal procedures. Although oral formulations of meloxicam have been available in the U.S. for about 20 years, Anjeso is the first injectable form to be FDA approved. It can be used by itself, but it does not begin to work immediately, so it also is approved for use with short-term pain relievers that are not in the NSAID class. Dosage is one vial (30mg) given as an intravenous (IV) bolus push per day. It should be used only as long as the patient needs relief for severe pain. Baudax plans to market Anjeso late in April or early in May. Its cost is not yet available. Express Scripts currently is investigating the data around Anjeso for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For its complete prescribing information, click here.

Additional Biosimilar to Herceptin Launched
Trazimera™ (trastuzumab-qyyp), a biosimilar for Herceptin® (trastuzumab - Genentech) was launched by Pfizer on February 15, 2020. It is used to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress the HER2 gene (HER2+). Mainly given as 30-minute IV infusions after an initial 90-minute infusion, doses vary on schedules that also differ according to the type of the cancer being treated. At $80.74 for 10mg ($3,671.64 for each 420mg vial), the wholesale acquisition cost (WAC) for Trazimera is 22% less than the WAC for Herceptin. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. In addition to sharing the market with Herceptin, Trazimera will compete with Kanjinti™ (trastuzumab-anns – Amgen/Allergan), the first Herceptin biosimilar to be released in the United States in June 2019, and with Ogivri™ (trastuzumab-dkst – Mylan/Biocon), introduced last December. None of the biosimilars is interchangeable with Herceptin or with each other. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for Trazimera can be found here.

New Dosage Form Approved for Procysbi
Procysbi ® (cysteamine bitartrate – Horizon Therapeutics) delayed-release oral granules was approved by the U.S. Food and Drug Administration (FDA) on February 14, 2020. Procysbi is a cystine-depleting agent used for treating patients who have nephropathic cystinosis, an orphan condition affecting only around 500 U.S. patients. Originally FDA approved in 2013 for adults and children six years and older, Procysbi’s indications later were extended to include patients as young as one year old. A hereditary metabolic lysosomal storage disorder, nephropathic cystinosis causes a protein, cystine, to accumulate in all body cells. Eventually, cystine buildups in organs can result in blindness, kidney failure, muscle wasting and premature death. If untreated, few patients who have it survive into their teens. Procysbi is taken once every 12 hours on a weight-based dosage scale beginning with amounts as small as 25mg each and gradually increasing over four to six weeks to maintenance doses of as much as 1,000mg each. Previously, Procysbi was available only as 25mg and 75mg oral capsules, which can be swallowed whole or their contents can be sprinkled onto soft foods or into small amounts of a drink and consumed right away. The granules are available in packets containing 75mg or 300mg, which may be easier to transport and open for patients, especially those taking higher doses of Procysbi. While taking it, patients should not drink grapefruit juice or alcoholic beverages. Launch for the granules is planned before the end of June. Revised prescribing information for Procysbi is here.

Three Products Switched to Non-Prescription Status
On February 14, 2020, the U.S. Food and Drug Administration (FDA) granted the manufacturers of three prescription drug products permission to sell the drugs without prescriptions (over-the-counter/OTC). All were shown to be safe for patients to use without diagnosis or supervision from a health professional. Because the products no longer will be available as prescription drugs, patients presently using one of them should discuss possible changes in therapy with their physicians. These products will be evaluated by the Value Assessment Committee (VAC) once they enter the drug file for inclusion in the Standard OTC Equivalents lists.

GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac) topical gel, 1% is an NSAID indicated for adults. Rubbed onto the skin, it helps to lessen joint pain caused by arthritis. Its full effectiveness may not be felt for up to a week, however; and it is not intended for other types of pain, such as sprains. Directions are to apply it four times a day, keeping total daily doses to 32gm or less. Patients should not use it for more than three weeks at a time. Although the risks may not be as great with a topical product as with the oral forms, a boxed warning on all NSAIDs cautions that using them may increase the risk of cardiovascular (CV) events, such as heart attacks, and/or gastrointestinal (GI) side effects, such as stomach ulcers. The OTC product is expected to be in stores in the spring of 2020.

Also switched to OTCs were Pataday Twice Daily Relief ® (olopatadine ophthalmic solution, 0.1%) and Pataday Once Daily Relief ® (olopatadine ophthalmic solution, 0.2%), made by Alcon. Both eye drops contain a mast cell stabilizer that helps to control allergy symptoms in the eyes. They can be used by patients two years old and older to reduce itching due to allergies. The twice-daily formulation (known as
Patanol ® in the prescription-only form) also reduces eye redness. Doses of it should be separated by six to eight hours. Patients should be careful not to touch the eye dropper tips or to use the eye drops while wearing contact lenses. Alcon has set a national launch date of March 2, 2020, for both products.

 
21Feb
Message About Coronavirus

Message About Coronavirus

With 34 confirmed cases in the United states and over 75,000 globally, people are understandably concerned about the Novel Coronavirus strain of the respiratory virus better known as COVID-19.

While most strains of the Coronavirus are relatively benign, causing mild respiratory symptoms that may resolve on their own, COVID-19 evolved to include more serious symptoms, and in some cases may even cause death.

The virus can be airborne, spread through coughing or sneezing, and by contact with an infected surface or human. The Center for Disease Control recommends washing your hands often and avoiding touching your eyes, nose or people you think may be unwell. Additionally, the Chinese Center for Disease Control and Prevention suggests boiling water before its consumption.

If you suspect you may have contracted COVID-19, CDC also recommends avoiding public places and using over-the-counter cold medicine to treat associated fever, congestion and cough. For more severe cases, it is suggested that you see your local healthcare provider as oxygen may need to be administered.

For more information in the U.S., please visit the Center for Disease Control and Prevention's website. International members may visit World Health Organization’s website.

If you have travel-related questions, please view the Department of State’s regularly-updated Travel Advisories.

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21Feb
State of Emergency expanded in Kentucky due to flooding

State of Emergency expanded in Kentucky due to flooding

The Governor of Kentucky has expanded the state of emergency to include the following counties due to flooding: Lawrence and McCreary. All counties now impacted include: Bell, Clay, Harlan, Knox, Lawrence, Leslie, Letcher, McCreary, Perry and Whitley. Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Feb. 20, 2020, and expiration date of March 21, 2020.

 
19Feb
State of Emergency issued in Alabama due to flooding

State of Emergency issued in Alabama due to flooding

The Governor of Alabama has issued a state of emergency for all counties due to flooding. Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Feb. 18, 2020, and expiration date of March 19, 2020.