Specialty Pharmacy Continuum (July / August 2020) by McMahon Group

Serving managed care, health-system and specialty decision makers Volume 9 • Number 4 • July/August 2020 • specialtypharmacycontinuum.com

One plan’s proactive strategy

CLINICAL Early SP check-in with myelofibrosis patients pays off ...................................

The ‘rare pharmacy’ model for orphan diseases ..................................

Gene Therapy Doesn’t Have to Break the Bank

OPERATIONS & MGMT Adherence help: the case for compliance consultants ............................ Health systems, payors duel over specialty access .............

OPINION A call for more drug pricing stability ................ Rx preapproval process: a failure to communicate? .............

Role of Specialty Pharmacists in Treating Patients With HIV See page 12.

hanges that are taking place during the COVID-19 pandemic could persist and significantly reshape the specialty pharmacy industry, experts believe. “This is an interesting time, and the question is, how much of the changes we’re seeing now are going to last?” said Adam Fein, PhD, the CEO of the Drug Channels Institute, a subsidiary of Pembroke Consulting Inc., during a recent webinar hosted by his firm. One possible realignment of the iindustry could come from an increase in sspecialty prescriptions, Dr. Fein said. As patients have had to stay at home, many p physicians have moved from prescribing p

Tempering the cold chain during COVID-19 ............. 22

REVIEW ARTICLE

Continued on page 20

POLICY Generics ‘wall’ a billiondollar problem ..................

Will COVID-19 Reconfigure The SP Industry?

y the time a member of Blue Cross and Blue Shield hield of Kansas inquired about covering a new prescripscription gene therapy for spinal muscular atrophy (SMA) MA) last spring, the pharmacy management team had been well ll prepared. d In fact, the team had been planning for gene therapy requests since late 2017 with the approval of voretigene neparvovec-rzyl (Luxturna, Spark), said Kenneth Mishler, PharmD, MBA, the insurer’s chief pharmacist, even though they had no members with retinal eye disease at the time. Anticipating a wave of gene therapies, Dr. Mishler and others at the payor built a work group to handle requests for the potentially high-cost treatment. The team included the company’s medical director and chief medical officer, as well as representatives from provider relations, sales and marketing, actuary, risk management, and customer service. Their eyes were on the 2019 expected approval of onasemnogene abeparvovec-xioi (Zolgensma, AveXis), a prescription gene therapy for young children with SMA, because they already had four members on nusinersen (Spinraza, Biogen), another therapy for the condition. One member was younger than 24 months old. “As small plans, we’re going to have to get this right the first time, because we might only have one patient [in need], and unless one is born into our plan, we may Continued on page 18

New Approval First CAR T-cell therapy okayed for MCL. See story, page 21.

M Multipronged S Strategies Boost R Rx Compliance

n 2012, avoidable U.S. health care costs related to inefficient or inappropriate medication use amounted to a staggering $475 billion, according Doug Long, MBA, the vice president of industry relations at IQVIA, a global health information company. By far, the biggest contributor to that nearly half-trillion dollars in lost savings opportunities was medication nonadherence, Mr. Long noted during a recent AMCP virtual meeting. Patients’ failure to take prescribed medicines, he said, accounted for 57%, or $269 billion, of those avoidable costs, Continued on page 8

Simplist Morphine MicroVault packaging supports diversion deterrence ®

Simplist MicroVault Packaging ®

Saves space with slimmer packaging taking up less room than a blister pack

INDICATIONS AND USAGE MORPHINE SULFATE INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia. IMPORTANT SAFETY INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS • Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1) • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2) • Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3) • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.4, 7)

NDC 76045-005-11

Supports secure dispensing and diversion deterrence with hard plastic packaging and tamper evident seal

NDC 76045-004-10

Makes narcotic inventory management easier with 5-pack bundling and 10-pack cartons

MORPHINE SULFATE INJECTION is contraindicated in patients with: significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days, known or suspected gastrointestinal obstruction, including paralytic ileus, and hypersensitivity to morphine. Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. Common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176 option 5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Overdosage: Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. This important safety information does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information, including Boxed Warning, for MORPHINE SULFATE INJECTION at www.simplist-us.com. Please see Brief Summary of Prescribing Information on the following page.

Ready-to-administer prefilled syringes

www.simplist-us.com | 1.888.386.1300

Morphine Sulfate Injection, USP CII Simplist for intravenous or intramuscular use. ®

BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information for MORPHINE SULFATE INJECTION, including BOXED WARNING, is available at www.simplist-us.com. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing. Neonatal Opioid Withdrawal Syndrome Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. • Reserve concomitant prescribing of Morphine Sulfate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. INDICATIONS AND USAGE Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., nonopioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

CONTRAINDICATIONS Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression. • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. • Known or suspected gastrointestinal obstruction, including paralytic ileus. • Hypersensitivity to morphine.

Other possible adverse reactions include: euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation, constipation, biliary tract spasm, tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, oliguria and urinary retention, pruritus, urticaria, skin rashes, opioid-induced histamine release (flushing of the face, diaphoresis, pruritus, and wheals and urticaria at the site of injection), androgen deficiency, anaphylaxis, serotonin syndrome, and adrenal insufficiency.

WARNINGS AND PRECAUTIONS (also see BOXED WARNING) • Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. • Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper. • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. • Risks of Use in Patients with Gastrointestinal Conditions: Morphine Sulfate Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. • Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients with a history of seizure disorders for worsened seizure control. • Withdrawal: Use of mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms. • Central Nervous System Toxicity: Dysphoric reactions may occur after any size dose and toxic psychoses have been reported. • Exposure, Hypothermia, Immersion and Shock: Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock, since impaired perfusion may prevent complete absorption; if repeated injections are administered, an excessive amount may be suddenly absorbed if normal circulation is re-established. • Risks of Driving and Operating Machinery: Morphine Sulfate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Morphine Sulfate Injection and know how they will react to the medication.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ADVERSE REACTIONS Serious adverse reactions (see BOXED WARNING and WARNING AND PRECAUTIONS) associated with Morphine Sulfate Injection included, addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with benzodiazepines or other CNS depressants, cardiac instability, adrenal insufficiency, severe hypotension, gastrointestinal adverse reactions, seizures, withdrawal, respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions included sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis.

USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm (see BOXED WARNING for neonatal opioid withdrawal syndrome). • Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Naloxone must be available for reversal for reversal of opioidinduced respiratory depression. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. • Lactation: Present in breast milk. Lactation studies have not been conducted and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Monitor infants for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of opioid analgesic is stopped, or when breast-feeding is stopped. • Females and Males of Reproductive Potential: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. • Pediatric Use: The safety and effectiveness of DILAUDID INJECTION in pediatric patients has not been established. • Geriatric Use: Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. Monitor for signs of central nervous system and respiratory depression. Start at the low end of the dosing range, titrate the dosage slowly and monitor for signs of CNS and respiratory depression. • Hepatic and Renal Impairment: Start these patients with a lower than normal dosage and monitor for signs of respiratory depression, sedation, and hypotension. DRUG INTERACTIONS Clinically significant drug interactions with Morphine Sulfate Injection: benzodiazepines and other central nervous system (CNS) depressants; serotonergic drugs; monoamine oxidase inhibitors (MAOIs); mixed agonist/antagonist and partial agonist opioid analgesics; muscle relaxants; cimetidine; diuretics; anticholinergic drugs; and Oral P2Y12 Inhibitors. OVERDOSAGE Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Injection, carefully monitor the patient until spontaneous respiration is reliably reestablished.

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

Early SP Check-ins a Must for Myelofibrosis A North Carolina–based health system has added a novel, nonprescription service to help monitor symptoms and perform risk assessments for its specialty pharmacy patients who have myelofibrosis, a bone marrow disorder. In a yearlong pilot program that began in March, pharmacists with the specialty pharmacy service at Atrium Health added a consult service to check in with myelofibrosis patients a few days before their appointments, asking questions from two standardized assessments that providers use to guide their treatment decisions. The Myeloproliferative Neoplasm Symptom Assessment Form total symptom score assesses 11 symptoms including fatigue, itching and bone pain, while the Dynamic International Prognostic Scoring System Plus assesses five risk factors, including white blood cell count, hemoglobin and platelets, to predict survival. Providers with Atrium Health’s Levine Cancer Institute use both assessments—part of the National Comprehensive Cancer Center (NCCN) guidelines, and internal treatment pathways—to identify when patients may need therapy changes and/or become a viable candidate for bone marrow transplantation. The idea for the project, described in a poster (abstract 168) presented at the American College of Clinical Pharmacy’s 2020 virtual poster symposium, came about in spring 2019, when leukemia specialists found it difficult to fit the assessments into patient appointment times, and turned to the specialty pharmacy for help, said Kristyn Yemm DiSogra, PharmD, BCOP. The service is designed to optimize provider workflow, help streamline patient care, and improve

adherence to NCCN and internal paththways, she said. “We saw this as a good opportunity to work closely with our leukemia pro-viders to do something that was not necessarily prescription-based but could have implications for patients who do have prescriptions with us, and with treatment decisions,” added Justin Arnall, PharmD, BCOP, another clinical pharmacist with Atrium Health. “Ultimately, what we’re trying to do is improve compli-ance with performing these assessments ts and to do that before clinic appointments, ments, so the providers have the results these surveys provide to talk with their patients.”

over assessments. Results are sent to the physician through the electronic health record, and patients are rescheduled for another telehealth call about three months later. Operationally, pharmacists reach can’tt reach them, out to patients three times; if they can they send a note through the electronic record so the

Telehealth Helps With Follow-Up Up Now, providers refer myelofibrosis is patients to the specialty pharmacy for a consult ult through a process integrated with the institution-wide on-wide standardized clinical pathways. Pharmacy cy technicians receive the consult referral and add d the patient to the roster. Next, pharmacists schedule hedule a telehealth call with the patient about 10 0 days before the next clinic appointment, to check eck in and go

EDITORIAL BOARD

Craig Wilson, Sales Associate, Classified Advertising cwilson@mcmahonmed.com

HOME INFUSION

ART/PRODUCTION STAFF

Jay Bryant-Wimp, RPh Owner/CEO Accurate Rx Pharmacy Columbia, MO

Michele McMahon Velle, Creative Director, MAX Graphics Frank Tagarello, Senior Art Director/Managing Director, MAX Graphics

Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH

James O’Neill, Senior Systems Manager

Volume 9 • Number 4 • July/August 2020

specialtypharmacycontinuum.com

PBMs

Marty Barbieri, Director of Production Leona Smith, Production Associate Rob Sinclair, Circulation Manager

Jason Borschow President & CEO Abarca Health Florida and Puerto Rico

SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA Consultant Specialty Pharmacy Rocky Hill, CT

Michael Sicilian President, Managed Health Care Associates Inc. Florham Park, NJ

EDITORIAL STAFF

Donald J. Vidic, RPh, MBA Vice President of Operations and Pharmacy Services Walgreens Specialty Pharmacy Carnegie, PA

Marie Rosenthal, Senior Editor mrosenthal@mcmahonmed.com

Matthew McMahon, General Manager, Partner

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

Lauren McMahon Smith, Michael McMahon, Michele McMahon Velle, Partners

Burt Zweigenhaft Managing Partner Upstream, a BioPharma Partners Company New York, NY

Kevin Horty, Don Pizzi, Adam Marcus, Contributing Editors

HEALTH-SYSTEM PHARMACY Ernest R. Anderson Jr., MS, RPh Brockton, MA

Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL

JoAnn Stubbings, PharmD Specialty Pharmacy Director, UIC Specialty Pharmacy Chicago, IL

Rina Shah, PharmD Vice President, Pharmacy Operations Walgreens Chicago, IL

WANT TO SUBSCRIBE? CHANGE YOUR ADDRESS? HERE’S HOW Selected U.S. hospital pharmacists and health care personnel receive Specialty Pharmacy Continuum free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address or make your address change directly with

David Bronstein, Editorial Director davidb@mcmahonmed.com

James Prudden, Group Editorial Director Elizabeth Zhong, Senior Copy Editor Kristin Jannacone, Copy Editor

SALES David Kaplan, Group Publication Director dkaplan@mcmahonmed.com

McMAHON PUBLISHING Van Velle, President, Partner

Ray and Rosanne McMahon, Co-founders

THE McMAHON GROUP, LLC McMAHON PUBLISHING McMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036 Telephone: (212) 957-5300 CT Office: 83 Peaceable Street, Redding, CT 06896.

REIMBURSEMENT

Joe Malichio, Director, Medical Education jmalichio@mcmahonmed.com

Bonnie Kirschenbaum, MS Breckenridge, CO

Sarah Rezvani, Account Manager srezvani@mcmahonmed.com

Copyright © 2020 McMahon Publishing, New York, NY 10036. All rights reserved. Specialty Pharmacy Continuum is published bimonthly by McMahon Publishing. POSTMASTER: Send address changes to Specialty Pharmacy Continuum, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

Specialty Pharmacy Continuum, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (815) 366–8297, or send it via email, circulation@mcmahonmed.com. If you are not a hospital pharmacist but would like to receive Specialty Pharmacy Continuum, please send a check for $70.00 (U.S.) or $90.00 (outside U.S.) for a year’s subscription payable to Specialty Pharmacy Continuum to McMahon Publish-

ing, 545 West 45th St., 8th Floor, New York, NY 10036. Please allow 8 to 12 weeks for delivery of the first issue. Individual issues are $9.00 (U.S.) or $12.00 (outside U.S.). McMahon Publishing is a 47-year-old, family-owned medical publisher of clinical newspapers and specialty periodicals, and creates compelling medical education programs and custom publications. As the second largest publisher of medical newspapers, McMahon produces

Anesthesiology News, Gastroenterology & Endoscopy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News, Pharmacy Practice News and Specialty Pharmacy Continuum. Opinions and statements published in Specialty Pharmacy Continuum are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

provider knows and can revert to previously standard practices of performing assessments in the clinic. So far, 33 patients seen at the main cancer center location, in Charlotte, N.C., have been enrolled in the service, Dr. DiSogra said. “It’s been very well received by providers,” she said. rece “Even when we were propos“E iing it to the physicians, they were concerned that after w the yearlong study period, we would stop performing these wo assessments, and we hadn’t ass even sstarted yet.” physician reported that she One p appreciated the pharmacists would apprecia provide an unbiased assessment, whereas she always hoped for good results on o the surveys to show the treatments she recommended were treatmen effective. To that end, the Atrium Health team tea hopes to study the impact on clinical and treatof their service se ment outcomes. outco Depending on how the pilot results Dependi look, this sservice could be expanded to myelofibrosis patients treated at other myelofibro or a similar non–prescriptionlocations, o consult service can be expanded based cons to other sservice lines such as hemophilia, HIV and hepatitis patients, Dr. said. DiSogra sa is “a very good start,” The program pro commented Leah Wolfe, RPh, BCOP, commente BScPharm, a registered hematology/ BS Ph oncology pharmacist and pharmacy consultant in Ohio. The goal in myelofibrosis is to downregulate the upregulated pathway, Ms. Wolfe said. “This decreases cytokines and disease symptoms, and possibly increases survival,” she explained, adding that timely performance of the assessments can help physicians make the best treatment decisions for their patients.

group than the placebo group for both intermediate- and high-risk patients (N Engl J Med 2012;366[9]:799-807). As for fedratinib, its approval was based in part on clinical data from the JAKARTA trials, in which the primary end points—spleen and myelofibrosis symptom responses—were met in approximately 35% to 40% of patients (JAKARTA) and 25% to 30% of patients (JAKARTA-2), respectively (Blood Adv 2020;4[8]:1792-1800). The fedratinib approval came with a boxed warning about the risk for serious and fatal

encephalopathy, including Wernicke encephalopathy. The agency ultimately determined that there was no evidence that fedratinib directly induced this encephalopathy in the 1.8% of patients who developed the syndrome, but the warning was still included due to the association seen in the clinical trial (Blood Adv 2020;4[8]:1792-1800).

The sources reported no relevant financial relationships.

For an overview of myeloproliferative neoplasms, the latest data on treatment safety and efficacy, diagnostic tools, clinical trial summaries and other resources, visit the MPN Connect website at www.mpnconnect.com.

Medi-Dose

EPS ...THE RIGHT PRESCRIPTION FOR PHARMACISTS

EPS

High quality, safe and effective products for medication administration, preparation and dispensing...in stock for fast shipment worldwide.

Unit Do s Bar Co e, ding, Pharm a Nursin cy & g Supp ly Expert s!

Priced low and ready to go! U Medi-Dose® Solid Oral Unit Dose Packaging U TampAlerT ® Liquid Unit Dose Packaging U MILT ® Software for Medication Identiﬁcation and Bar Coding U LiquiDose® Labels U IV Additive Disposable Accessories U Steri-Dropper ® Sterile Ophthalmic Dropper Bottles U Compounding Products U Cleanroom Supplies U Ophthalmic Practice Accessories U Resealable and Ultraviolet Inhibitant Bags U Tamper-Evident Products U Bottles, Vials and Containers U Operating and Procedure Room Accessories U ShrinkSafe® Bands and Safety Products U Tapes and Labels U Maternity and Laboratory Products U Record Keeping and Identiﬁcation Products U Storage and Transport Products

2 Approved Drugs As important as nonprescription therapy management is, providers also need to be familiar with prescription treatments. The FDA approved two drugs for myelofibrosis: ruxolitinib (Jakafi, Incyte) in November 2011, and fedratinib (Inrebic, Bristol-Myers Squibb) in August 2019. Both are oral kinase inhibitors and have first-line treatment status for certain patients with the malignancy, according to current NCCN guidelines (bit.ly/3g38jqz). Given the earlier approval of ruxolitinib, this drug has more follow-up data. In a five-year update of the COMFORT-1 clinical trial, there were 69 deaths from all causes among patients randomized to ruxolitinib (n=155) and 82 deaths among those receiving placebo (n=154). In a subgroup analysis based on risk status, there was a nonsignificant trend toward longer overall survival in the ruxolitinib

—Karen Blum

More Resources

Visit our website for our EZ order system!

EPS

Exceptional Products and Service A Member of The Medi-Dose® Group

800.523.8966

MediDose.com

® ®

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

‘Rare pharmacies’

The Next Wave in Orphan Disease Management As more treatments for orphan and rare diseases enter the marketplace, there will be a need for a subset of specialty pharmacy focused exclusively on rare diseases, according to a 2020 white paper by PANTHERx Rare Pharmacy. “While new treatments are transforming patients’ lives, they come at a very high cost and with a multitude of challenges for patients and the health care system,” the report stated. Rare pharmacies can play a leading role in

development of drugs for rare pediatric diseases, many more orphan drugs joined the FDA pipeline and market, Dr. Vanscoy noted. Only 7% of patients have an available therapy, so there are fewer patients typically with these

tions of the disease and promoting medication adherence. PANTHERx Rare also attributes its success to its ability to create “flawless” distribution models—a critical element because orphan drugs typically are lifesaving, Dr. Vanscoy emphasized.

Accreditation on the Map PANTHERx Rare has worked with the Accreditation Commission for Health Care to develop the first accreditation for rare pharmacy, and last fall became the first pharmacy nationwide to receive that distinction. The health care accreditation authority URAC created its own Rare Disease Pharmacy Center of Excellence designation in

waste. Because the product is refrigerated, they developed a precise system for shipping, he said, selecting special coolers and adjusting shipping dates, taking into consideration potential disruptive weather patterns. The pharmacy provides patients with refrigerators that have embedded flat-screen technology software with the ability to check injection sites. Radiofrequency identification tags on the medicine help the pharmacy see how much inventory is in the fridge. On the service side, nurses and dedicated teams are available to help patients with questions, reimbursement concerns or other needs. “When a patient with hypophosphatasia calls in, they get right to that

One ultrarare condition that PANTHERx has developed expertise in is hypophosphatasia, an inherited disorder that weakens and softens the bones, causing skeletal abnormalities.

providing optimized care for patients through robust disease state management programs; expertise in patient financial assistance; and focused educational training for patients, physicians and payors. By 2024, orphan drugs are expected to account for more than one-third of total drug pipeline sales, the paper found. The authors discussed the evolution of rare pharmacy, providing information on rare disease medication development, the challenges and impact of rare diseases, and rare pharmacy solutions. “The white paper is intended to encourage a standard of practice that is required to manage patients with rare and devastating disorders,” said co-author Gordon J. Vanscoy, PharmD, MBA, the founding chair and CEO of PANTHERx Rare, in Pittsburgh. “It’s a really unique population that is growing very quickly. The characteristics around how you manage not only the patient but also the payors, providers and biopharma partners [are] very different [from what] you typically would see in specialty pharmacy.” In 2012, with the presidential approval of the Pediatric Rare Disease Voucher Program that encouraged the

disease states, he said; half are pediatric patients and about 80% have a genetic underpinning. Rare pharmacy includes a much more intensive focus on the patient and the disease state, he said. Because some of the diseases are so few, there may be just one or a very small network of pharmacies managing the patient population. The drugs may be lifesaving, with very delicate distribution mechanisms. Some products have Risk Evaluation and Mitigation Strategies associated with them. “It takes a significant investment in the patient journey,” Dr. Vanscoy said. “We have to understand each one of these individual disease states as well as a larger specialty pharmacy understands diabetes, HIV or transplant patients.” Dedicated services provided by rare pharmacies include: • adverse drug reaction monitoring programs; • financial assistance to help patients obtain their medicines through insurance, copay cards or philanthropic organizations; • experts who help with the prior authorization process; and • pharmacists and nurses dedicated to understanding the clinical manifesta-

‘The individuals who most need specialty pharmacies are our most vulnerable— patients who are poor, living alone, or very early in their journey with a child who has major medical needs.’ —Kimberly Haugstad, MBA February, as an add-on to the specialty pharmacy accreditation. PANTHERx also has developed expertise in hypophosphatasia, an inherited disorder that weakens and softens the bones, causing skeletal abnormalities, said Richard Faris, PhD, RPh, the senior vice president and head of pharmacy for PANTHERx Rare. A self-injected treatment, asfotase alfa (Strensiq, Alexion), was approved by the FDA in 2015. The drug dose is based on weight, so as children grow, it needs to increase, Dr. Faris said. Therefore, the pharmacy developed dosing calculators. PANTHERx Rare also worked with physicians to ensure the proper vial size is prescribed for each patient, reducing

RxARECARE team,” Dr. Faris said, referring to the company’s dedicated patient care teams. “They don’t have to go through some phone tree. Often, they talk to the same person time after time.”

How Rare Is ‘Rare’? Most conditions managed by specialty pharmacies could fit into the “rare” definition, said Mary Dorholt, PharmD, the senior director and clinical practice lead, Specialty, for Express Scripts, in Minneapolis-St. Paul. Even cancer, which covers a large population, can be looked at as a collection of individual diagnoses affecting smaller groups of people, she said. “We would absolutely agree that a

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

focus on rare conditions is critical for adequate patient care,” Dr. Dorholt said. “As one would not see a general practitioner for treatment of cancer, pharmacy care should be delivered similarly. However, all specialty pharmacies may not be structured in a way, or have the scale in given areas of therapy, to provide this kind of specialized, dedicated care.” Accredo, Express Scripts’ specialty pharmacy arm, has 15 Therapeutic Resource Centers dedicated to the treatment of specialty disorders such as cancer, multiple sclerosis, pulmonary arterial hypertension and hemophilia, Dr. Dorholt said. “These can be thought of as virtual pharmacies that are focused only on one rare disease state or therapy area.” Even within these centers, the company often creates subteams focused on even narrower patient populations. For example, the Rare Disorders TRC comprises teams that may work only with individual medications or disorders. “The role of specialty pharmacies will continue to evolve and be critically important in this space,” Dr. Dorholt said. As more gene therapies are approved, they will often be used in rare patient populations. “The highly complex clinical, handling, shipping and reimbursement requirements of gene therapies will necessitate similar types of specialized models demonstrated to support rare populations.”

or representatives who personally deliver products to patients and can obtain a glimpse of their home environment, providing a level of care beyond typical pharmacy services, she said. At one of Ms. Haugstad’s former jobs, her organization received a call from a specialty pharmacy representative who reported concerns that a patient’s oven door was falling off and he couldn’t afford a new stove. Ms. Haugstad’s employer helped him purchase a replacement. “This was a gentleman living completely alone,” she said. “No one else

would have ever known he would have been without any type of cooking apparatus.”

A ‘Most Rewarding’ Area Of Pharmacy Rare pharmacy is “a fascinating area and, quite frankly, one of the most rewarding areas of pharmacy to be part of,” Dr. Vanscoy said. As recently as 10 to 20 years ago, patients were more likely to be isolated and undiagnosed, he said. Now, through the internet and increased medical knowledge, they

have patient groups. Some patients have lifesaving or life-improving therapies that they never thought were possible. “When you can bring that kind of hope to patients, it’s pretty remarkable.” For more information or to download the white paper, visit prx.pantherxrare. com/rarepharmacywhitepaper. —Karen Blum The sources reported no relevant financial relationships beyond their places of employment.

Check Out Our

Tech Website

Making a Difference In many instances, a specialty pharmacy is the only avenue for patients with rare diseases to obtain medications, said Kimberly Haugstad, MBA, the CEO of Global Genes, a nonprofit advocacy organization for people with rare and genetic diseases. These pharmacies provide a level of care and compassion that can make a huge difference in patients’ lives, Ms. Haugstad said. “The individuals who most need specialty pharmacies are our most vulnerable—patients who are poor, living alone, or very early in their journey with a child who has major medical needs.” Often these pharmacies have nurses

www.pharmacytechnologyreport.com A Rare Resource Managing patients with rare and orphan diseases can be a daunting task. For help with patient assistance programs, educational resources for patients and providers, and other guidance, visit the National Organization for Rare Diseases at bit.ly/336HEFL.

Best practices in automation, informatics and patient safety

Specialty Pharmacy Continuum • July/August 2020

OPERATIONS & MANAGEMENT

Rx Compliance Tips continued from page 1

the associate director of specialty pharmacy services at the University of Illinois at Chicago (UIC) College of Pharmacy. “That goal is even more important now. We need to make sure our patients are getting their medications and managing their therapies and diseases better than ever, so they don’t have those flares and emergencies that bring them back to the hospital.” To accomplish that goal, said Dr. Rim, who recently joined UIC from the University of Utah Health, “our specialty pharmacy team here [in Chicago] or in Utah will call patients every month. We try to make it seamless,” he

key objective of CVS Specialty. Prem Shah, PharmD, the executive vice president of Specialty Pharmacy and Product Innovation at CVS Health, said the company’s specialty pharmacy arm has “adapted our processes to ensure service continuity and to make sure patients have an adequate supply of their specialty medications, so they can continue to receive the care they need safely and at home.” Free home delivery of medications is one way the company has strived to ensure adherence. Dr. Shah said CVS Specialty also had leveraged its existing technology infrastructure “to make it easier for patients to access specialty pharmacy care. “We’ve seen great success with CVS Specialty’s two-way secure messaging capabilities that puts a nurse or pharmacist at patients’ fingertips to help those who are navigating new care challenges as a result of the COVID-19 landscape,” Dr. Shah said. In March, he added, the messaging platform saw a nearly 30% increase in encounter volume, as CVS Specialty representatives helped patients manage their medications. Dr. Shah said the company is using other technology to help patients get answers to disease or medication-related questions. “We have enabled our interactive voice recording technology to deliver relevant outbound health messages to patients and are also posting pertinent COVID-19 updates on the CVS Specialty website and mobile app. Patients can also use the online portal and mobile app to track orders, order refills and make payments.”

“It’s also important to look at patients’ clearly outstripping the combined total of all other medication practice fail- overall medication regimen,” said ures, including delays in evidence-based Dr. Skiermont, who joined Prime treatments ($62 billion), antibiotic mis- Therapeutics in May following nearly use ($54 billion), medication errors ($42 two decades at Fairview Health Services, billion), suboptimal generic use ($30 the last four as the chief operating officer. billion) and mismanaged polypharmacy He noted there might be a once-daily in elderly patients ($18 billion) (Figure). alternative to that multidose medication, Providers, pharmacists and managed or for patients on multiple medications, care stakeholders have struggled for “trying to work with them to find strateyears to address the multiple triggers of gies that can fit medication taking into nonadherence, including unaffordable their daily routines.” medications, intolerable side effects, ‘[During COVID-19], we don’t want spotty patient monitoring, and misconnections among prescribers, dispensing any of our patients coming back to pharmacies and patients. Mr. Long said the hospital due to medication-related the abandonment of new prescriptions due to rising patient out-of-pocket issues, especially those who are taking expenses has become a growing probspecialty drugs that make them immunolem for adherence. Disease severity also plays a part, he said. Adherence is compromised.’ greatest in patients with cancer, HIV —Matthew Rim, PharmD infection and rheumatoid arthritis, for said, and “we make sure patients are whom the consequences of not taking Multiple Touch Points taking their medication on time every a medication can be dire, and less so During COVID-19 in those with pulmonary conditions, Specialty pharmacies have been par- month and address any concerns and diabetes and sleep disorders. ticularly active in implementing multi- issues remotely.” The pharmacists who call always ask Dosing complexity adds another obsta- ple touch points to ensure patients with cle. Mr. Long pointed out that a once- serious and complex diseases remain if patients have any medication quesdaily dosing regimen results in a 72% adherent to often high-cost therapies. tions or whether they’re experiencing adherence rate, whereas four daily doses These multiple connection points have side effects, Dr. Rim said. “If you ask drags that percentage down to 51%. become even more crucial now, with anyone at a health system, they’ll tell A host of solutions have been put into specialty patients staying at home dur- you that specialty pharmacy is pretty much the gold standard for adherence service. Mr. Long cited medication syn- ing the COVID-19 crisis. chronization, an ambulatory pharmacy “We don’t want any of our patients because we make sure everything is innovation that combines a patient’s total coming back to the hospital due to done properly at all times.” therapies for pickup during the same medication-related issues, especially visit, and compliance packaging, which those who are taking specialty drugs CVS Specialty’s Approach offers pills in convenient blister packs that make them immunocomproKeeping patients safe at home and Walgreens Embraces Virtual clearly marked for time of day to be taken. mised,” said Matthew Rim, PharmD, adherent to their therapies also is a Consults Another important apThe COVID-19 pandemic proach has been what Kyle also has transformed the steps Skiermont, PharmD, the that Walgreens’ Specialty Medication senior vice president of spePharmacy at Baptist MD 57% 269 nonadherence ciality and home delivery at Anderson Cancer Center, in Prime Therapeutics, called Jacksonville, Fla., takes to frequent “connect points” ensure its vulnerable patients 13% 62 Delayed evidence-based treatment practice with patients, involving regremain safe and adherent to ular telephone calls or text their medication therapies. reminders. The messages, he “A lot of specialty pharma11% 54 Antibiotic misuse said, can be “as simple as cies like ours are located in ‘How are you feeling today?’ health care facilities,” said or ‘Did you take your mediSydney Beliles, PharmD, the 9% 42 Medication errors cation today?’ clinic manager of the Jack“One other thing that pharsonville pharmacy, one of Suboptimal generic use macies—and in particular, spenearly 190 Walgreens phar6% 30 ciality pharmacies—can do,” macies located within health Dr. Skiermont said, “is to help systems or hospitals. “We’re Mismanaged polyphar4% 18 with mitigation strategies for not a closed-door pharmamacy in elderly patients side effects”: helping a patient cy. We’re used to seeing our understand, for example, that patients every day. We welthe upset stomach, trouble come patients to come in.” Total avoidable costs 100% 475 sleeping or other side effect However, the threat of that come with certain mediCOVID-19 infection has Figure. Estimated 2012 avoidable costs, in billions. cations will often lessen over kept most patients at Source: IQVIA. time if they can just make it home, and the pharmacy through the first week or two. has had to transition from

Specialty Pharmacy Continuum • July/August 2020

OPERATIONS & MANAGEMENT

nerve-wracking to start chemotherapy, particularly when your face-to-face visits with your provider are decreasing.” The pharmacy also provides services such as injection training coordination, medication side effect management and financial assistance coordination. Because of these efforts, Dr. Beliles said, “we’ve been successful in helping our patients obtain their medications in about two days—far below the industry standard of seven to 10 days.”

Owning the ‘Middleman’ Role A Walgreens-operated, health-system–based specialty pharmacy recently installed plexiglass barriers to protect the handful of patients who come to the pharmacy and the pharmacy’s staff, which includes two pharmacists, one pharmacy technician and one specialty billing technician. A small waiting room has only three chairs, placed to ensure social distancing.

face-to-face patient visits to virtual consultations by telephone. “That’s been the hardest part,” Dr. Beliles said, “changing the way we’ve been doing business.” The physical appearance of the pharmacy also has changed. Located on the second floor of the recently opened cancer facility, it features an open,

glass-encased look. But plexiglass barriers have been installed to protect the handful of patients who come to the pharmacy and the pharmacy’s staff: two pharmacists, one pharmacy technician and one specialty billing technician. A small waiting room has only three chairs, placed to ensure social distancing.

Dr. Beliles said a major focus of the pharmacy team has been on overcoming barriers to specialty drug treatment. Offering free home delivery is one way; speeding the prior authorization process is another. “We’re helping to get those medications authorized more quickly, especially right now with newly diagnosed patients,” she said. “It’s really

Adherence Help Is at Hand T

he goal of totally eliminating medication nonadherence may never be realized, but managed care and other health insurers are pushing hard against the barriers to get as close as possible. Pharmacy consultant groups that work hand in hand with plan sponsors and pharmacy benefit managers (PBMs) support these efforts to devise strategies to close the gap. The stakes are high. Increased adherence can mean better patient outcomes and fewer complications that result in costly hospitalizations and greater morbidity and mortality. Although adherence rates may be higher in the specialty space than in ambulatory pharmacy, the adverse consequences of nonadherence can be just as severe, or even worse. Consulting organizations supply the analytical tools that can drill down into mountains of prescription claims and “slice and dice the data” to identify nonadherent plan members and why they’re not taking their prescribed medications, said Wendy Weingart, MS, RPh, Visante’s senior vice president of Managed Care Services. “They certainly may have monetary issues, and that can create access barriers that contribute to nonadherence in addition to other factors. We work with plans to provide reviews of individuals who may not pick up their first fill or even a subsequent fill based on a higher-than-anticipated cost of the medication or other reasons.” Or it can be identifying members who use multiple pharmacies and prescribers, she added, “which increases the risk for medication misuse, nonadherence, therapeutic duplication and/or medicationrelated problems because of the complexity of their medication regimens. “If there’s a cost-prohibitive factor,” Ms. Weingart said, “there may be lower cost formulary alternatives available, or assistance programs” that can be accessed, “and through targeted case management these members can have greater access to programs that can help reduce their cost.” Sorting through the adjudication system to analyze claims rejections and prior authorization (PA) denials

is another service the company provides. “Adherence is all intertwined with the backstory of those claims being rejected,” she said,” and whether or not there are subsequent paid claims.” Have these efforts helped to improve adherence rates? “Although the degree of improved adherence can vary based on the types of intervention pathways and other factors,” Ms. Weingart said, “the interventions absolutely do make a difference.”

Another Approach Pharmacy management consultant groups offer many different paths to improving medication adherence. At Point-of-Care Partners (POCP), a health information technology firm based in Hollywood, Fla., one of the most effective ways is to help clients develop and implement electronic transaction strategies that can quickly overcome bottlenecks such as PAs or patient benefit issues that delay or even deny needed therapy—particularly in the specialty space. “We work with our clients to better understand what’s causing the issues around medication adherence,” said Pooja Babbrah, MBA, a senior consultant at POCP and the firm’s pharmacy benefit management lead. “Then we determine technology solutions that are available and transactions that can be automated to address those issues.” “The No. 1 reason for nonadherence is cost,” Ms. Babbrah said. “Physicians may not even be aware that patients aren’t taking their medication as prescribed—that they either stopped taking it or they never picked it up in the first place because of cost.” One solution, Ms. Babbrah said, is a real-time benefit check that lets a prescribing physician connect electronically to a PBM to determine a patient’s outof-pocket cost for a medication and learn whether a less expensive alternative is available. “There’s also the ‘patient-facing’ real-time benefit check transaction that we’ve been involved in pushing forward with industry,” she added, explaining that the strategy allows patients to use an electronic

Overall, Dr. Beliles said, “we’ve really been owning a new role as that middleman between the patients and providers in our facility. We’re acting as a hub to triage patients for side effects, adherence issues and staying connected with our physicians, whether via electronic medical record, email or telephone.” She added: “We’re just trying to get used to our new normal.” —Bruce Buckley The sources reported no relevant financial relationships.

Resource Box These consultant companies offer a wide range of medication adherence services: Aardex Group: bit.ly/30m0qHn Adhere Tech: www.adheretech.com Mango Health: www.mangohealth. com/partners.html Omada Health: bit.ly/2EIJp1H Point-of-Care Partners: ww.pocp.com PQS: www.pharmacyquality.com Visante Inc.: www.visanteinc.com

device, such as a smartphone, to compare out-ofpocket costs at their regular pharmacy with what other area pharmacies charge. “We have clients that come to us looking to implement a real-time benefit check transaction within their workflow,” Ms. Babbrah said. Or they may be seeking to implement electronic PAs or automate their specialty pharmacy transactions. POCP’s client base spans the entire stakeholder spectrum, Ms. Babbrah said. It includes health systems and hospitals, physician groups, managed care organizations, PBMs, and life science companies. “We also work with a lot of technology companies that are looking to get into the market.” —B.B. The sources reported no relevant financial relationships.

Specialty Pharmacy Continuum • July/August 2020

OPERATIONS & MANAGEMENT

‘There are no bad guys here’

Health Systems Versus Payors: A Duel for SP Care Dueling misperceptions among health plans and payors about the value each brings to patient care can make it difficult for them to forge effective partnerships, according to a recent survey of the stakeholders from Trellis Rx. To create the report, Trellis Rx partnered with third-party firm Reckner/ Blueberry to conduct 60-minute blinded

telephone interviews with 10 hospital pharmacy leaders (i.e., directors, vice presidents, chief or specialty pharmacy managers) and 10 health plan leaders (i.e., medical directors, pharmacy directors, directors of pharmacy contracting), as well as nine subject matter experts: industry consultants and health-system pharmacy executives.

Many of the responses underscored the wide gulf that exists between these key market players. “Health-system specialty pharmacies are expensive providers of a commodity service that cannot match the scale or level of service of large national specialty pharmacies, and have little incentive to reduce drug charges or improve existing inefficiencies,” one

respondent noted. Another countered, “Health plans ... prioritize profit and market ownership over patient care, and are unwilling to grant network access to health-system specialty pharmacies.” Those comments were not an outlier: The survey found that most health plans don’t recognize the potential value that health-system specialty pharmacies can

demonstrate your commitment to quality pharmacy Achieving ACHC Accreditation reﬂects a pharmacy’s dedication and commitment to meeting standards that demonstrate a higher level of performance and patient care. Our team of industry experts developed relevant standards with providers’ needs in mind.

pharmacy accreditation services: Ambulatory Infusion Center

Infusion Pharmacy

Long-Term Care Pharmacy

Specialty Pharmacy

Mail Order Pharmacy new !

With DMEPOS

Infusion Nursing

Without DMEPOS

PCAB Accreditation Non-Sterile Compounding (Ref. USP <795>) Sterile Compounding (Ref. USP <797>)

experience the achc difference:

Distinction Among Competition

Industry-Expert Surveyors

Payor Recognition

To ﬁnd out more, call (855) 937-2242 or visit achc.org

create. In their view, many health systems have not invested in the necessary specialty pharmacy capabilities and infrastructure required to deliver that value. As a result, the two parties are often adversarial rather than cooperative. “To capitalize on the value of these partnerships, health plans and health systems must engage in purposeful dialogue and meaningful change must happen now,” wrote Andy Pulvermacher, the principal consultant for the Blue Fin Group, in the report’s foreword. “Longstanding misconceptions on both sides of the bargaining table have resulted in mistrust as leaders talk past one another instead of finding ways to collaborate on behalf of patients.”

‘Zero Reasons’ to Work With Health-System SPs? The report paints a picture of two entities with a fraught relationship: working on the same side, theoretically toward the same purpose, but each struggling to understand the other and skeptical of the other’s approaches. “Health systems think payors prioritize profit and market ownership over patient care, and perceive talking to them as almost a futile effort,” said Jerry Buller, DPh, MMHC, the chief pharmacy officer for Trellis Rx, in a separate interview with Specialty Pharmacy Continuum. “Health plans see the health-system approach as

Specialty Pharmacy Continuum • July/August 2020

OPERATIONS & MANAGEMENT

just too expensive, with a higher cost than other specialty pharmacy options.” In the health plan view, “a pharmacy is a pharmacy is a pharmacy.” Further, “they all have the ability to order a product. They all have the ability to dispense a product. There is absolutely no difference” between health-system specialty pharmacies and others, said one pharmacy director of a health plan in the Northeast that covers 5 million patients. “Our specialty pharmacy does everything I believe a health-system pharmacy would do just as well,” concurred anoth-

er pharmacy director of a national health plan covering 3 million patients, who saw “zero reasons” for health plans to work with hospital specialty pharmacies. The general perception among payors was that because specialty pharmacy is not a health system’s primary focus, it is just a “line extension” to them. Overall, payors believed health systems to have limited geographic and population impacts, limited 24/7 call center access and relatively limited access to pharmacists with specialized, disease state expertise. “Some payors might have a misperception that health-system specialty pharmacies don’t measure up to their aligned pharmacies,” said Troy Polan, the acting CEO at Excelera, a national network of health systems. “For example, manufacturers often avoid contracting with health systems because of their size, so when considering negotiating a contract with a health-system specialty pharmacy, insurers might also question if a health system has sufficient patient volume within a therapeutic category to merit going through the contracting process. Many payors could also question if a healthsystem specialty pharmacy can deliver the full complement of core capabilities to care for a specific patient population.”

‘I Can’t Even Play’ Health systems, for their part, saw health plans as dictating their access to

‘If you want a payor to work with you, you need to build a bonafide, clinically integrated specialty pharmacy that has the ability to drive better outcomes—not just for surrogate markers like turnaround times, time to therapy and reduced abandonment, but for real clinical markers like adherence, lab values, quality of life, reduced ER visits.’ —Jerry Buller, DPh, MMHC the market—and in some cases, questioned whether health plans’ focus on cost comes at the detriment of care quality. Health-system respondents characterized the relationship with health plans using terms such as “lack of communication,” “adversarial,” “conflicting interest” and “disconnected,” and noted that their systems are under increasing pressure from a confluence of forces, including rising drug costs, reduced reimbursement and risk-based contracts that require greater control over medical and pharmacy care for health systems to be successful. “Without a doubt, access to health plan networks is my biggest challenge,” said Dustin Lewis, the specialty pharmacy manager at Nationwide Children’s Hospital, in Columbus, Ohio. “I know that I can only fill prescriptions for about a third of the patients who come through our doors. And it’s not for lack of willingness to negotiate; it’s that we cannot even get a meeting with a payor or talk to an actual person about obtaining a contract. It’s not like I’ve been playing hardball with the payors; it’s that I can’t even play. I don’t even have a baseball glove.”

The Search for Lifetime Value As costs also shift to providers, health systems are focusing on reducing costs through models that prioritize optimal patient outcomes, lower long-term costs and provide lifetime value, Mr. Polan said. “However, long-term cost reduction can benefit other risk-bearing entities besides the current payor; insurers tend to focus on short-term gains in terms of market share, revenue and patient experience. That is why value-based care is so important, because it rewards shared risk between stakeholders and promotes better patient outcomes using a common set of metrics based on quality of care and care management. Integrated care models position health-system specialty pharmacies at the center of the value equation, where long-term cost reduction can be managed through higher quality of

care and care management.” Fortunately, said Mr. Buller, the report found some common ground. “Both parties agree that the rising cost of drugs is unsustainable; that patients are paying unfairly for a broken health care system; and that the patients and employer sponsors suffer.” They also agree, the report noted, that the focus must shift from fee-for-service to quality and innovation, with health systems pursuing risk-based agreements and health plans giving health systems the control they need to execute on those agreements successfully. “The health plan needs to know that if a health system says they have a specialty pharmacy, they’ll be able to deliver on their promises,” Mr. Buller said. “If you want a payor to work with you, you need to build a bonafide, clinically integrated specialty pharmacy that has the ability to drive better

outcomes—not just for surrogate markers like turnaround times, time to therapy and reduced abandonment, but for real clinical markers like adherence, lab values, quality of life, reduced ER visits. At the end of the day, real value equals better care at reduced cost.”

More Dialogue Mr. Buller said Trellis Rx plans to bring together stakeholders for more dialogue and conversation over the next 12 months, to work toward solutions in an environment where both sides can be candid without fear of retribution. “Both sides are health care professionals trying to create value for their customers,” he said. “There are no bad guys here.” —Gina Shaw The sources reported no relevant financial relationships other than their stated employment.

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

Role of Specialty Pharmacists in

Treating Patients With HIV JAMES ZHANG, PHARMD, CSP Clinical Program Manager Clinical Services AllianceRx Walgreens Prime Frisco, Texas

n February 5, 2019, in the State of the Union Address, President Donald Trump announced a goal to end the HIV

epidemic in the United States within 10 years.1

The Ending the HIV Epidemic: A Plan for America initiative was created with the goal of reducing new HIV infections in the United States by 75% in 5 years and 90% by 2030. Collaboration among federal, state, and local health departments, and health care providers is needed to reach this target. Specialty pharmacists also have a role to play to help ensure that goal is reached, starting with understanding HIV guidelines and how specialty pharmacists can facilitate and optimize the care of HIV patients.

Table 1. TDF Combinations and Corresponding TAF Productsa

TDF Regimen

TAF Regimen

Emtricitabine-TDF (Truvada)

Emtricitabine-TAF (Descovy)

Cobicistat-elvitegravir-emtricitabine-TDF (Stribild)

Cobicistat-elvitegravir-emtricitabine-TAF (Genvoya)

Emtricitabine-rilpivirine hydrochloride-TDF (Complera)

Emtricitabine-rilpivirine hydrochloride-TAF (Odefsey)

All products are marketed by Gilead.

TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate

Treatment Guideline Recommendations First-Line Antiretroviral Treatment (ART) for Treatment-Naive Adults and Adolescents2 • Bictegravir-emtricitabine-tenofovir alafenamide (BIC/FTC/TAF; Biktarvy, Gilead) • Abacavir (ABC), dolutegravir (DTG), lamivudine (3TC) (only if patient is HLA-B*5701-negative and does not have chronic hepatitis B virus [HBV] coinfection) – Available in 3-drug combination (Triumeq, ViiV Healthcare) or separately • DTG plus 3TC (except for those with more than 500,000 copies/mL of HIV RNA, no HBV coinfection, or in whom ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available) – Available in combination (Dovato, ViiV) or separately • DTG plus (FTC or 3TC) plus TAF or tenofovir disoproxil fumarate (TDF) • Raltegravir (RAL) plus FTC or 3TC, plus TAF or TDF • Generally, HIV guidelines recommend 1 integrase strand inhibitor (INSTI) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination as first-line therapy. – Other regimens, such as 1 boosted protease inhibitor (PI) plus 2 NRTIs or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI) plus 2 NRTIs, could be preferred in certain

situations, such as in females of childbearing potential, and may be patient specific. One boosted PI regimen, a darunavir (DRV)based regimen, may be used if resistance testing is not available or delayed and treatment must be started immediately, because it is associated with a low likelihood of resistance. – See AIDSinfo Clinical Guidelines for more details.2 Treatment-Experienced Patients2 • Drug resistance testing is recommended for a patient on a failing regimen or within 4 weeks of discontinuation. • Use of 2 to 3 active agents with uncompromised activity based on ART history or drug resistance test results, possibly with new mechanism of action, is recommended. • Adding a single agent to a current regimen generally is not recommended. • For highly ART-experienced patients, continue treatment with a regimen that will minimize adverse effects (AEs) while maintaining CD4 counts to delay disease progression. Patients With Coinfections2 • Hepatitis C virus (HCV) infection2,3 – Screen all HIV patients for HCV. – ART may help preserve liver function and

should be started immediately, regardless of CD4 count. – Prescribers should collaborate to prevent drug interactions between HCV and HIV regimens. * If HCV treatment is not being implemented, start HIV ART as recommended for patients without HCV. – See HCV guidelines for more details.3 • HBV infection2 – Screen all HIV patients for HBV. – FTC, TAF, TDF, and 3TC have dual activity against HBV and HIV and are recommended. – Certain HBV regimens may not be recommended due to potential HIV resistance. – Discontinuation of dual-activity HIV/HBV drugs increases risks for liver damage and HBV reactivation and should be avoided if possible. If these agents are discontinued, patients should have frequent liver function tests and take entecavir to prevent flare-ups. • Tuberculosis (TB)2 – Due to the risk for drug interactions, ART regimens should be carefully evaluated. – All patients with active TB and HIV (especially those who have CD4 counts <50 cells/mm3 and/or who are pregnant) should

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

Table 2. Selected Recently Approved HIV Drugs

start ART as soon as possible. – See HIV guidelines for more recommendations.

Pre-Exposure Prophylaxis The FDA has approved 2 drugs for pre-exposure prophylaxis (PrEP): FTC/TDF (Truvada, Gilead) and FTC/TAF (Descovy, Gilead). FTC/ TDF is indicated to prevent HIV in people at risk through sexual activity or injection drug use. FTC/ TAF is recommended for people at risk through sex but not those at risk through receptive vaginal sex. There have been insufficient studies supporting HIV prevention in those engaging in receptive vaginal sex. When taken daily, PrEP has been shown to decrease the risk for contracting HIV via sex by approximately 99% and via injecting drugs by approximately 74%.4 Gilead announced in May 2019 that a generic version of FTC/TDF would be available in September 2020, 1 year earlier than expected.5 Gilead had previously reached an agreement with Teva to allow early launch of a generic. The release of a generic generally allows for lower pricing of the drug, but there are concerns related to affordability associated with having only 1 generic manufacturer. Teva will have approximately 1 year of exclusivity until the patent on FTC/TDF expires in September 2021. As with many other diseases and conditions, prevention and education are the preferred methods of controlling spread. As specialty pharmacists, we can educate patients about who is at risk for contracting HIV and about recommendations for starting PrEP, as necessary.

Generic Name(s) (Brand name, Manufacturer)

Drug Class(es)

Fostemsavir (Rukobia, Viiv)

gp120 attachment inhibitor

FDA Approval Date

Significance

7/2/20

• First drug in class • Indicated for use in combination with other ART in HTE adults with multi-drug resistant HIV-1 • Granted FDA Fast Track, Priority Review, and Orphan Drug Designations

Doravirine-lamivudine-TDF (Delstrigo, Merck)

NNRTI/ NRTI

8/30/2018

• New NNRTI-based combination

Darunavir-cobicistatemtricitabine-TAF (Symtuza, Janssen)

PI/NRTI

7/17/2018

• First and only darunavir-based, single-tablet regimen

Dolutegravir-lamivudine (Dovato, ViiV)

INSTI/NRTI

4/8/2019

• First single-tablet, 2-drug regimen approved for treatment-naive adults

Bictegravir-emtricitabine-TAF (Biktarvy, Gilead)

INSTI/NRTI

2/7/2018

• First and only complete 3-drug, INSTI-based, single-tablet regimen

Ibalizumab-uiyk (Trogarzo, Theratechnologies)

Postattachment inhibitor

3/6/2018

• First drug approved in new drug class

• Favorable lipid profile and less neuropsychiatric adverse effects (sleep disorders/disturbances, dizziness, and altered sensorium) compared with efavirenzemtricitabine-TDF (Atripla, Gilead)

• IV administration and treats patients with multidrug resistance • Granted FDA Fast Track, Priority Review, and Orphan Drug Designations

ART, antiretroviral therapy; HTE, heavily treatment experienced; INSTI, integrase strand inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil Based on reference 2.

PrEP for Men Who Have Sex With Men (MSM)4 • For adult HIV-negative men, who have had any male sex partners in the past 6 months, are not in a monogamous partnership with a recently tested, HIV-negative man, and for whom at least 1 of the following is true: – They have had any anal sex without condoms (receptive or insertive) in the past 6 months. – They have had a bacterial sexually transmitted infection (STI) (syphilis, gonorrhea, chlamydia) diagnosed or reported in the past 6 months. PrEP for Heterosexually Active Adults4 • For HIV-negative adults, who have had any sex with opposite sex partners in the past 6 months, are not in a monogamous partnership with a recently tested HIV-negative partner, and for whom at least 1 of the following is true: – They are behaviorally bisexual (see MSM guidelines). – They infrequently use condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk for HIV infection. – They are in an ongoing sexual relationship with an HIV-positive partner. – They have had a bacterial STI (syphilis, gonorrhea, chlamydia) diagnosed or reported in past 6 months. 4

PrEP for People Who Inject Drugs • For adults without acute or established HIV infection who have injected any drugs not

prescribed by a clinician in the past 6 months for whom at least 1 of the following is true: – They have shared injection or drug preparation equipment in the past 6 months. – They are at risk for sexual acquisition. (See above guidelines and MSM guidelines.)

Trends in Prescribing TAF in Place of TDF TDF has a risk for nephrotoxicity.11 Dose adjustments are recommended in patients with a creatinine clearance (CrCl) of less than 50 mL/min, which can be challenging for a fixed combination tablet. TAF does not require dose adjustments at a CrCl less than 50 mL/min, although neither product is recommended for a CrCl less than 30 mL/min. In a pooled analysis of 26 clinical trials, TAF caused fewer renal events and had an overall more favorable renal profile than TDF.12 A total of 5 combination products containing TAF have come on the market since TAF was initially released in 2015. Three of these products use TAF in place of TDF in combination products (Table 1), whereas the other 2—cobicistat-DRV/FTC/TAF (Symtuza, Janssen) and BIC/FTC/TAF—are novel TAF combinations. 2 Given TAF’s proven better renal and bone safety profile, more prescribers are switching to TAF-containing regimens over TDF-containing regimens.11-13

Single-Tablet Regimens Another trend is higher prescribing of singletablet regimens. As more people are diagnosed with HIV, having more options to improve adherence is always better for the patient. Most new HIV drugs released to the market are new combinations of already FDA-approved medications or combinations of new drugs. A retrospective study in 2018 showed that single-tablet regimens led to higher rates of retention in care and favorable virologic outcomes.14 Another meta-analysis from 2015 showed that the odds for adherence among patients on a single-tablet regimen was 2.37 times higher than among those on a multiple-tablet regimen.15

On the Horizon Looking ahead at the pipeline, cabotegravirrilpivirine (ViiV) is a long-acting injectable that shows promise. This once-monthly intramuscular injectable combination drug has completed phase 3 trials and is awaiting FDA approval. If approved, it would be the first and only oncemonthly, long-acting regimen for treatment of HIV-1. It received approval for use in Canada on March 20, 2020, as Cabenuva.16

Role of the Specialty Pharmacist Reviewing Regimens It is important for specialty pharmacists to help ensure patients receive complete and see HIV, page 14

Specialty Pharmacy Continuum • July/August 2020

CLINICAL

HIV continued from page 13

recommended regimens. With new drugs often coming to the market, it is important to stay up-to-date with new drugs and guideline recommendations. Guidelines generally are updated annually and include revisions based on new drug releases or studies. Table 2 lists selected HIV drugs approved since 2018 that have significantly improved HIV treatment. Facilitating Adherence Adherence is the most important factor in achieving viral suppression.17 The job of a specialty pharmacist is to help ensure new fills or refills are processed in a timely manner and any processing issues are resolved to avoid missed doses. Adherence levels of at least 95% generally are accepted benchmark standards for achieving successful virologic outcomes, although some studies show a more lenient range.18 Understanding the importance of patient adherence will allow specialty pharmacists to educate patients about not missing doses. A study on pharmacist adherence interventions showed that a pharmacist-led adherence clinic helped HIV-infected patients achieve viral suppression, significant prevention of HIV transmission to secondary partners, and cost savings of nearly $3 for each dollar spent on adherence intervention.19 The interventions include monitoring refills and reaching out to patients and doctors’ offices to provide additional education as needed. Not all specialty pharmacies have adherence programs, but the study showed there is value in pharmacist intervention to improve adherence of HIV patients.19 If patients are taking multiple drugs for HIV, it is also important that they receive their complete regimen and not a partial regimen because that may lead to drug resistance.2 A partial regimen can occur if 1 of the drugs is out of stock or is rejected by a payor. Pharmacists can work with the prescriber to determine an appropriate course of action and follow up with the patient so they can receive a complete therapeutic regimen. Managing Drug Costs With high drug costs for HIV treatment, the specialty pharmacy should explore all options to find affordable care for patients. This search includes reaching out to various drug foundations or copay assistance programs and assisting patients through enrollment processes. If a prior authorization is required, diligent efforts to initiate the process and educate the patient on next steps will allow for a smoother process. Many specialty pharmacies offer resources for patients to use to explore various patient assistance programs.

or mail-order pharmacy. Specialty pharmacists can refer to HIV guidelines for complete listing of drug– drug interactions or use drug databases, such as Clinical Pharmacology or LexiComp, to verify.2 Managing Adverse Effects It is important to counsel patients at the time of their initial dispense and as necessary afterward. Helping patients set expectations about potential AEs, and providing counseling and guidance when they occur, will greatly improve adherence and virologic outcomes.19 Managing Therapy Interruptions If a patient misses doses or has an upcoming medical procedure, it is important to be aware of guidelines on managing therapy interruptions. Notifying the prescriber should be the first course of action, but it also is important to educate the patient. Planned short-term interruptions can last up to 2 weeks.2 Drugs that have similar half-lives should be stopped at the same time. All drugs that are part of a regimen should be stopped if the interruption will only be for 1 or 2 days, regardless of half-life.2 NNRTIs may have longer half-lives; thus, it is recommended that they be stopped earlier, but there are no clear guidelines stating so. Specialty pharmacists can play a large role in achieving the goal of ending the HIV epidemic by 2030. Whether it is reaching out to a patient who consistently refills late, taking extra time to review HIV guidelines, or helping a patient find copay assistance to start their regimen, all these activities help create better outcomes for those patients. Specialty pharmacists helping patients one by one is how we can help achieve this goal.

References 1.

Department of Health and Human Services. What is ‘Ending the HIV epidemic: a plan for America’? HIV. gov. Updated February 26, 2020. www.hiv.gov/federalresponse/ending-the-hiv-epidemic/overview. Accessed June 29, 2020.

2. Department of Health and Human Services, Clinical Guidelines. AIDSinfo. Updated April 7, 2020. aidsinfo.nih. gov/guidelines. Accessed June 29, 2020. 3. American Association for the Study of Liver Diseases/ Infectious Diseases Society of America. HCV guidance: recommendations for testing, managing and treating hepatitis C. Patients with HIV/HCV coinfection. Updated November 6, 2019. www.hcvguidelines.org/uniquepopulations/hiv-hcv. Accessed June 29, 2020. 4. CDC. HIV basics. www.cdc.gov/hiv/basics/index.html. Accessed June 29, 2020. 5. Fitzsimons T. Generic HIV prevention drug coming in 2020, Gilead says. NBC News. May 8, 2019. www.nbcnews.com/ feature/nbc-out/generic-hiv-prevention-drug-coming2020-gilead-says-n1003391. Accessed June 29, 2020.

Monitoring Drug Interactions

6. Merck. FDA approves Merck’s DELSTRIGO (doravirine/ lamivudine/tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and PIFELTRO (doravirine), an NNRTI, both for the treatment of HIV-1 in appropriate patients. August 30, 2018. bit.ly/3eMflhZ. Accessed July 20, 2020.

It is important to maintain current medical profiles of allergies, medications, and conditions. Many HIV drugs have interactions with other medications that a patient may be getting from a retail

7. Janssen Global. Janssen announces U.S. FDA approval of SYMTUZA (D/C/F/TAF), the first and only complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection. July 17, 2018. bit.ly/2OEthAb. Accessed July 20, 2020.

8. ViiV Healthcare. US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, singletablet, two-drug regimen for treatment-naïve HIV-1 adults. April 8, 2019. bit.ly/2ZIK0IT. Accessed July 20, 2020. 9. Gilead. U.S. Food and Drug Administration approves Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection. February 7, 2018. bit.ly/3eQcp3P. Accessed July 20, 2020. 10. FDA. FDA approves new HIV treatment for patients who have limited treatment options. March 6, 2018. www.fda. gov/news-events/press-announcements/fda-approvesnew-hiv-treatment-patients-who-have-limited-treatmentoptions. Accessed July 21, 2020. 11. Venter WDF, Fabian J, Feldman C. An overview of tenofovir and renal disease for the HIV-treating clinician. South African J HIV Med. 2018;19(1):817. doi. 10.4102/sajhivmed. v19i1.817. Accessed June 29, 2020. 12. Gupta SK, Post FA, Arribas JR, et al. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate, a pooled analysis of 26 clinical trials. AIDS. 2019;33(9):14551465. doi. 10.1097/QAD.0000000000002223. Accessed June 29, 2020. 13. Surial B, Cavassini M, Calmy A, et al. Rates and predictors of switching to tenofovir alafenamide-containing ART in a nationwide cohort. BMC Infect Dis. 2019;19:834. doi. 10.1186%2Fs12879-019-4454-9. Accessed June 29, 2020. 14. Hemmige V, Flash CA, Carter J, et al. Single tablet HIV regimens facilitate virologic suppression and retention in care among treatment naïve patients. AIDS Care. 2018;30(8):1017-1024. doi. 10.1080/09540121.2018.1442554. Accessed June 29, 2020. 15. Clay PG, Nag S, Graham CM, et al. Meta-analysis of studies comparing single and multi-tablet fixed dose combination HIV treatment regimens. Medicine. 2015;94(42):e1677. doi. 10.1097/MD.0000000000001677. Accessed June 29, 2020. 16. Johnson & Johnson. Janssen announces Health Canada approval of CABENUVA, the first long-acting regimen for the treatment of HIV. March 20, 2020. www.jnj.com/ janssen-announces-health-canada-approval-of-cabenuvathe-first-long-acting-regimen-for-the-treatment-of-hiv. Accessed June 29, 2020. 17. Machtinger EL, Bangsberg DR. Adherence to HIV antiretroviral therapy. HIV InSite. Published May 2005. Updated January 2006. http://hivinsite.ucsf.edu/ InSite?page=kb-03-02-09. Accessed June 29, 2020. 18. Bezabhe WM, Chalmers L, Bereznicki LR, et al. Adherence to antiretroviral therapy and virologic failure: a meta-analysis. Medicine. 2016;95(15):e3361. doi. 10.1097%2FMD.0000000000003361. Accessed June 29, 2020. 19. Dilworth TJ, Klein PW, Mercier RC, et al. Clinical and economic effects of a pharmacist-administered antiretroviral therapy adherence clinic for patients living with HIV. J Manag Care Spec Pharm. 2018;24(2):165-172. doi. 10.18553/jmcp.2018.24.2.165. Accessed June 29, 2020.

Want More Reviews From SPC? Visit www.specialtypharmacy continuum.com and click on Review Articles under the Section tab. You’ll get the latest updates on inflammatory bowel disease, rheumatoid arthritis, schizophrenia, and more.

Order your copy of NHIFâ&#x20AC;&#x2122;s Infusion Industry Trends report Your guide to the latest data on the home & specialty infusion market

Published by NHIF, Infusion Industry Trends is the first of its kind in more than a decade. Learn more on therapy mix, payer trends, growth rates, reimbursement models, and more.

Get insight on this $19 billion industry, including: Provider characteristics and services Patient characteristics Payer sources Referral sources Revenue Operations

ON SALE NOW Order your copy now at https://bit.ly/3bt7RzH

Thanks to our sponsor for their generous support

Specialty Pharmacy Continuum • July/August 2020

OPINION

Elevating Pharmacists Through Rx Pricing Stability By Matthew Gibbs, PharmD

Prescription abandonment rate, %

I worked as a pharmacy intern and technician for six years in a large retail chain pharmacy. I admired the relationship the pharmacist I worked under, let’s call her Mary, had with her patients and the unbelievable amount of trust they put in her advice. Mary’s acuity with patients underscored the value that pharmacists—the highest-educated health care professionals on medication topics—bring to the health care team. Indeed, they are uniquely trained to help providers and patients deal with complex issues involving medication management.

PBM practices. The financial model of most PBMs is based on discounts and rebates rather than driving optimal financial and clinical outcomes. As a result, most PBMs use average wholesale price (AWP), a pricing benchmark that lacks predictability and often is subject to arbitrary inflation because the PBM charges the pharmacy significantly higher prices for drugs than their actual cost, which jeopardizes independent pharmacies. Many of these same PBMs use a spread pricing model whereby the PBM charges

A Shift to Value There is good news: As I shifted my career from the clinical side to management and eventually to being part of a nontraditional PBM, health care has begun to shift from a reimbursement structure based on volume toward one based on value. From my vantage point, having experienced both sides of the equation, I believe pharmacists have an

80 70 60

Actual data

Model

40 30 20 10 0

100

200

300

400

500

Out-of-pocket costs, $

Figure. Prescription abandonment increases 0.6% for each out-of-pocket dollar by the patient. Source: CoverMyMeds 2020 Medication Access Report (prn.to/3f6nz5P). Data points (blue) adapted from IQVIA analysis of brand-name prescription abandonment by new patients as out-of-pocket costs increase.

I aspired to be a respected resource for my community when I entered pharmacy school, but by the time I graduated in the late 1990s, a major shift in the industry already had taken hold. I noticed Mary and other pharmacists scrambling on the phone with insurance carriers, calling doctors’ offices to get prescriptions changed to comply with their patients’ formulary. I saw Mary’s relationship with her patients turn from a helpful exchange of medical information to managing copay charges and trying to explain why the price of a medication kept changing each time they went to refill. Mary is not alone. Pharmacists are reporting higher workloads, more stress and less overall job satisfaction, as a recent survey showed (bit.ly/2ZKgQb8). Compounding this issue, the largest pharmacy benefit managers (PBMs) now exclude hundreds of products. Brand-name medications are particularly prone to such exclusions: Their

‘I believe pharmacists have an opportunity to be leaders in accountable care by taking specific steps to advocate for price stability and performancebased pay.’ removal increased by as much as 63% in 2020, according to CoverMyMeds’ 2020 Medication Access Report (prn. to/3f6nz5P). Moreover, nearly 70% of patients report having made personal or financial sacrifices to afford prescriptions, and 30% say they’ve had to abandon a prescription due to cost, the CoverMyMeds report noted. That abandonment rate is even higher when out-of-pocket costs exceed $100 (Figure). Additionally, formulary exclusions of brand-name medications continue to increase. These barriers to care impede a pharmacist’s ability to play the role they are trained for and limit where they can effect meaningful change. These problems exist in part due to

a payor more than it reimburses the pharmacy for a certain drug and retains the difference. It is often unclear how much of the payment the PBMs give to pharmacies and how much they pocket. This is all taking place at a time when pharmacies are fighting for survival by means of fair reimbursement and living under the expectation that they will fill as many prescriptions as possible below cost. These actions reduce the role of the pharmacist from an integral player in evidence-based medicine delivery and patient advocacy, to a role mired in administrative burden. Pharmacists are not given the time or resources to realize their full professional potential and rise in their organizations.

opportunity to be leaders in accountable care by taking specific steps to advocate for price stability and performance-based pay. To address inconsistent pricing, pharmacists can choose PBMs that use the National Average Drug Acquisition Cost (NADAC) database as the source for drug prices (bit.ly/38lNbJ1). NADAC data are maintained by the Centers for Medicare & Medicaid Services and align drug prices with average actual pharmacy drug costs rather than manufacturer list prices, so they are not subject to the inflationary tendencies of AWP. One example where this is put into practice is CortexRx Wellness Pharmacy, in La Jolla, Calif., which continues to embrace alternate pricing models such as NADAC-based pricing to ensure they receive the fairest reimbursement possible. Using NADAC-based pricing as a reimbursement source enables their pharmacists to spend less time managing cost concerns and more time focusing on adding value over volume when it comes to patient care. A transparent pricing model gives pharmacies the data to negotiate more effectively. Because NADAC is stable, auditable and publicly available, this benchmark allows pharmacists the resources and incentives to excel at their clinical services. By demanding to be paid transparently and based on the value they provide, pharmacists can thrive. Mr. Gibbs is the president of commercial markets, Capital Rx, a pharmacy benefit manager that services prescription benefit plans on behalf of employers, unions and other members.

Specialty Pharmacy Continuum • July/August 2020

OPINION

Getting Patients the Medications They Need By Susan A. Cantrell, RPh, CAE

ed i ci nes t ha t m i g ht a i d i n the fight against COVID-19 are flooding our newsfeeds. As health care researchers around the world seek treatments and vaccines, the health care system must be ready to identify those therapies that demonstrate the greatest value and expedite them to patients as quickly as possible. To do this, we must effectively share data on promising products with the health plans and other payor organizations that provide health care coverage for hundreds of millions of Americans.

canceled its order. (In mid-June, the FDA revoked emergency use authorization for hydroxychloroquine due to a lack of efficacy and known safety concerns.) These examples highlight the need to examine drugs’ evidence early. Such an approach is inherent in a process called pharmaceutical information exchange (PIE). PIE gives manufacturers and HCDMs the ability to proactively share certain nonpromotional health care economic and scientific information on products “ahead of” FDA approval, including for both initial and subsequent indications. PIE has the potential to accelerate patient access to emerging pharmaceuticals and devices, including those granted breakthrough designation by the FDA, by expediting coverage decisions.

Sign up @ SpecialtyPharmacyContinuum.com/eNews Get the latest news from the most widely read specialty pharmacy publication in the United States, including multimedia and web-only content, delivered directly to your inbox!

‘Given the current global pandemic, it is even more critical to urge Congress to introduce and pass bipartisan legislation that allows manufacturers and HCDMs to exchange preapproval information.’

These organizations rely on health care decision makers (HCDMs), experts in formulary development and benefit design, who have the unique know-how to examine new drugs and consider their efficacy, safety and cost-effectiveness. HCDMs’ ultimate goal is to get patients the medications they need at costs they can afford—health systems and patients expect that. The process includes working with formulary committees to make timely recommendations about new medications and treatments. Therefore, HCDMs require access to clinical and economic information “before” new products are approved for marketing or expanded indications. The current situation with COVID-19 offers a clear example of why sharing early information on medications in the pipeline is so important: Payors need new treatment data from manufacturers as early as possible. For example, the FDA recently authorized the emergency use of remdesivir, which early evidence shows may reduce recovery times in patients with the coronavirus. Another example is Utah’s move to spend $800,000 to build a stockpile of chloroquine and hydroxychloroquine without rigorous evidence that the therapies helped patients recover faster from COVID-19. The state later

Given the current global pandemic, it is even more critical to urge Congress to introduce and pass bipartisan legislation that allows manufacturers and HCDMs to exchange preapproval information. While the FDA has guidance regarding PIE, writing it into law provides a firm and clear basis that will ensure manufacturers that they can lawfully share truthful and non-misleading clinical and economic information about medications in their development pipelines, as well as new uses of approved products, prior to FDA approval. To be clear, PIE is not to be used for promotional communications about unapproved products, which is prohibited by the FDA. Rather, it is designed specifically for HCDMs to obtain the information they need to evaluate medical products and make population-based coverage and reimbursement decisions quickly and effectively. Patients are waiting for lifesaving drugs to combat COVID-19. Passing legislation and providing valuable tools that enable and facilitate PIE can help. Ms. Cantrell is the CEO of AMCP, a professional association that advocates for access to high-quality, cost-effective medications and other therapies.

Serving managed care health-system and specialty pharmacy decision makers SpecialtyPharmContinuum

@SpecialtyPharm

Specialty Pharmacy Continuum • July/August 2020

POLICY

‘[Gene … therapies will] continue to push up drug spend, but they’re a small contributor to the entire system. It’s just a really big deal if you’re a medium-sized health plan or an employer group that has one, two or three of these claims.’ —Brett Sahli, PharmD

The Gene Rx Cost Cliff continued from page 1

never go back and visit a [gene therapy] administration again,” Dr. Mishler said during an AMCP webinar. The group took several steps to prepare. First, they reviewed clinical trial data to adopt the FDA-approved criteria for onasemnogene abeparvovec-xioi. They also worked with Prime Therapeutics, their pharmacy benefit manager, to seek out value-based outcome contract opportunities and make the terms more favorable. When the first

Drugs for rare and orphan conditions cost hundreds of thousands of dollars per year, and new gene therapies are pushing over

$1 million per year in annual costs. inquiry for coverage of the therapy was received by the payor’s customer service specialists June 4, 2019, the team was notified in hours. The Blue Cross team reached out to their employer group and started discussing how to cover the drug, as well as to one of the two specialty pharmacies that would be distributing the gene therapy. As it turned out, a vice president at the company knew the Blue Cross team from a former job with an infusion company, and spoke to the payor to offer assistance. They worked out a strategy

to direct bill the plan forr the drug, and ship the therapy to the provider. From there, more steps ensued. The committee’s provider relations ns talked to the physician who planned to administer onasemnogene abeparvovec-xioi in her office, and waited for her to become authorized to administer the gene therapy by the manufacturer. The doctor was relieved that Blue Cross was going to manage payment of the treatment, but the clinic’s chief financial officer wanted to buy and bill for the therapy instead. The insurer’s provider relations manager knew this CFO, and initiated a phone conversation appealing to the goal of getting the child treated without looking for means to profit. The CFO agreed. Then, a few days before the planned administration of the therapy, the local hospital got involved and wanted to offer the therapy in its outpatient infusion suite. A representative from the insurer’s institutional relations department, who knew the hospital’s CFO, stepped in, sending an email describing how everything was already set in place. Finally, everything went off as planned, and a local TV station even did a human interest story on the girl receiving treatment. Health plans should understand that no two gene therapies are going to be the same, especially for smaller plans with limited exposure to any one therapy that comes out, Dr. Mishler said. It also takes a village, he said: “You have to rely on those people who have the expertise and to

grease the skids to make sure things go well. Don’t underestimate those in your organization that already have relationships with providers.” One area of concern is who will track value-based contract outcomes, and what happens if the company is due a reimbursement for a member who has since moved to another health plan, he said.

$1 Million Treatment Gene and cell therapies can be considered new “drugs,” used in the diagnosis, cure, mitigation, treatment or prevention of disease, said Brett Sahli, PharmD, the senior director of value and health outcomes for Prime Therapeutics. The cost of these therapies needs to be on the radar of managed care stakeholders, Dr. Sahli stressed. Drugs for rare and orphan conditions cost hundreds of thousands of dollars per year, including chimeric antigen receptor T-cell/gene therapy, which runs more than $500,000 per treatment (JAMA Oncol 2018;4[7]:994-996). In fact, some new gene therapies cost more than $1 million per year, Dr. Sahli said during the webinar, citing in-house data from 2019. By 2025, the FDA may be approving 10 to 20 cell and gene therapy products annually, he added. These high-cost therapies can be likened to a monster truck on the

highway, Dr. Sahli said. “It’s really big on an individual basis—it’s the th new supersize. Gene and cell therapies are going to c continue to push up drug c spend, but they’re a small s contributor to the entire c system. It’s just a really big s deal d if you’re a medium-sized health plan or an employer group that has one, two or three of these claims. Then it’s not spread out anymore.” They’re also like monster trucks in that they’re not something you use every day, being made for one-time administration, Dr. Sahli said. And they present several challenges for health plans, beyond how to pay for and cover them. For example, will a member’s other health care costs be lowered by receiving the high-priced drug? Moreover, how will the treatment affect patients’ out-of-pocket costs or their need to travel for therapy? Among the approaches to managing gene therapy costs are annuities that spread payments out two or more years; milestone-based contracting (an annuity payment contingent on a positive outcome or a rebate based on performance failure); and risk pooling (paying into a pool so plans won’t have to bear the full cost), Dr. Sahli said. Longer term, he hopes to see portable patient registries that track members who switch plans. —Karen Blum The speakers were scheduled to present at AMCP’s Managed Care & Specialty Pharmacy annual meeting, which was canceled because of the COVID-19 pandemic. The organization made the information available via a webinar instead. Other than their employment, the sources reported no relevant financial relationships.

Specialty Pharmacy Continuum • July/August 2020

POLICY

Medicaid takes the hit

Generics ‘Wall’ Costs Near $1B in Lost Savings W

hen the market entry of generic drugs is delayed due to patent fights and other factors, the price tag for lost savings opportunities approaches more than $100 million annually (Health Aff 2020;39[6]:1011-1017). Among 69 brand-name drugs studied that were expected to lose patent exclusivity in 2010 to 2016, generic entry occurred before or within a quarter-year of the expected date for just 38 products (55%), the investigators found. Market entry for generics was delayed by more than a

spending for patients, it raises costs for the health care system.” Dr. Kesselheim and his colleagues reviewed patent term restoration data from the U.S. Patent and Trademark Office to identify a cohort of drugs with key patents expiring in 2010 to 2015, adding six months to the exclusivity period in cases for which the manufacturer was asked to conduct pediatric clinical trials. They also studied Medicaid State Drug Utilization files to tally use of these products by National Drug

respectively, and were associated with estimated excess Medicaid spending of $126 million, $62 million and $100 million. GENERIC PRESCRIPTIONS Because Medicaid serves only FILLED IN 2018 23% of the total U.S.-insured population, and commercial insurers and Medicare plans typically have much lower brandname rebates, excess spending OF GENERIC PRESCRIPTIONS ARE in other parts of the health care FILLED AT $20 OR LESS system are likely much higher, said. Dr. Kesselheim sa AVERAGE AVERAGE BRANDthan one reason Often, more th GENERIC COPAY: NAME COPAY: was associated with delays to market entry entr for the top 15 brand-n brand-name products Medicaid spending, by Medic Source: IQVIA 2019. researchers found. For 12 researcher (80%), patent litproducts (8 igation was the most common reason; nine of the 12 cases in market ready to go at the time when which litigation was a contributor were exclusivity is expiring.” court. Ten products (67%) settled out of co also had a ci citizen petition filed with Patent Is the Key the FDA that th might have delayed There are sometimes legal delays in approval of the generic. new generics being released, but generregulatory ap For example, generic manufactur- ally once a patent’s time is up, a generers of bosentan (Tracleer, Actelion) ic product is approved, said Howard obtaining brand-name Wild, BSPharm, RPh, the vice president cited issues in o bioequivalence testing. of generic strategies at MedImpact, a samples for b over patents for atorvas- pharmacy benefit manager. He noted Disputes ov tatin (Lip (Lipitor, Pfizer) and piogli- that the data used in this study were tazone (Actos, Takeda) were several years old. Dr. Kesselheim said settled out of court after his team wanted to allow enough time delaying generic entry by between the end of the study and present delay approximately 1.75 and day to calculate spending. app 1.5 years, respectively. Another tactic that manufacturers 1. The study authors use is to work with a specific generic pointed out some pol- drugmaker to release an authorized p icy recommendations generic identical to the brand-name that could overcome these issues. One product earlier and at a higher cost of the most important aspects is having than other generics scheduled for clear expected generic entry dates for release, Mr. Wild said. This strategy brand-name products, Dr. Kesselheim allows the manufacturer to share in the said, which could be used to alert revenue, and often limits the release of authorities—such as the Federal Trade other generic versions due to the size Commission or FDA—to investigate of the market. when a generic alternative does not hit Some hurdles faced by generic manuthe market. Because reasons for delays facturers include sourcing of raw mateoften include litigation over patents on rials, conducting bioequivalence studthe brand-name drug, he also advocat- ies, production capability and quality ed for better systems of ensuring that control in the manufacturing plant, Mr. “frivolous or otherwise inappropriately Wild said. Another factor that could granted patents are not granted or are drive increased Medicaid spending is easier to overturn. that while pharmacy benefit managers “There are a lot of different strate- and others initiate maximum allowable gies to try to fix this problem, because cost (or MAC) pricing within days of there [is] a multitude of strategies the release of a new generic, governmanufacturers use to delay generic ment programs might not list a generic entry,” Dr. Kesselheim said. He recom- for months, he said. mended more funding at the FDA level —Karen Blum “to provide guidance as to the types of studies needed to get generics on The sources reported no relevant financial relationships. the market so we have a competitive

4 Billion

95%

$5.63

quarter for 20 products (29%) and did not occur for 11 products (16%). For the 31 products that had delayed or no generic entry, Medicaid spent an estimated $761 million more over seven years, or $109 million annually. Patent litigation was cited as the most common reason for the delays. “Delaying generic entry is one of the key strategies that pharmaceutical manufacturers use to maintain their high revenue streams,” said Aaron Kesselheim, MD, JD, MPH, a professor of medicine at Harvard Medical School and the director of the Program On Regulation, Therapeutics And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacogenomics at Brigham and Women’s Hospital, in Boston. “That’s a big problem because it raises costs for patients, which reduces patient adherence to important medications. For Medicaid, which provides drug coverage with limited out-of-pocket

Code identifiers to find when generic entry actually did happen. For each drug, they estimated the difference between the expected and actual quarter-year of generic drug entry, defined as the first appearance of a prescription for a generic equivalent in Medicaid. The researchers then searched broadly to identify reasons for delay, including press reports and other industry patent databases. The study identified darunavir (Prezista, Janssen) as the product associated with the highest share of excess Medicaid spending due to delays in generic entry. Although a generic was expected by the first quarter of 2015, none was detected during the study period, yielding an estimated excess spending of $137 million. Generic versions of paliperidone (Invega, Janssen), atorvastatin (Lipitor, Pfizer), and olopatadine (Pataday, Alcon) were delayed for three, 1.75 and 4.5 years,

$40.65

Specialty Pharmacy Continuum • July/August 2020

POLICY

COVID-19: What’s Next? continued from page 1

office- or clinic-administered IV medications to oral agents, self-administered injectables or home infusions. “Some of this is a short-term reaction to the lockdown, but I think a lot of patients will get used to the convenience of these formulations and specialty pharmacies could see a growth in prescriptions,” Dr. Fein said.

Losses, Gains With Mass Shift To Medicaid Dr. Fein anticipates a large-scale shift in Medicaid enrollment. As of June 3, roughly 42.5 million Americans had filed unemployment claims since lockdowns began in March, and many have now lost employer-sponsored insurance. “With an estimated 8 [million] to 20 million people expected to enroll in Medicaid, there will be some very big impacts on the pharmacy industry,” Dr. Fein said, noting the 2008-2009 recession also was followed by a spike in Medicaid enrollment (Figure). For example, retail pharmacies located in states operating under a Medicaid fee-for-service (FFS) model will benefit, since Medicaid tends to reimburse more for dispensing fees under an FFS model than do commercial plans or Medicaid managed care organizations. On the other hand, drugs are

reimbursed at their acquisition cost under Medicaid FFS, whereas Medicaid managed care organizations provide drug reimbursement at the published benchmark price, which can be higher than the acquisition cost, Dr. Fein noted. “More Medicaid fee-for-service dispensing will mean losses for the 25,000 340B contract pharmacy locations across the country that can earn substantial fees from 340B-covered entities,” because they acquire drugs at lower costs, Dr. Fein said.

specialty pharmacies in],” he explained. Chris Simpson, PharmD, the CEO of VitalRx, in Pelham, Ala., did not share that optimism, instead noting that smaller specialty pharmacies such as his are seeing a decrease in new prescriptions as fewer patients visit their physicians during the COVID-19 pandemic. He said he was concerned that large PBMs would try to increase their specialty pharmacy market share by merging with or acquiring these distressed pharmacies, or would seek to shut them down entirely. “It’s a fight to maintain a positive margin,

the relaxation of historically strict rules for refill quantities and prior authorization (PA) requirements, Dr. Fein said. “Commercial insurers have given lots of leeway in filling 90-day prescriptions, and under the CARES Act [the coronavirus relief bill], Medicare has also allowed reimbursement for 90-day scripts at retail pharmacies, which is not something you normally see in Medicare Part D plans,” he explained. Dr. Fein noted that the Centers for

and that’s the reality of the situation currently and in the foreseeable future,” Dr. Simpson said.

Medicare & Medicaid Services (CMS) also is allowing reimbursement for out-of-network pharmacies and home deliveries. Furthermore, CMS has relaxed—and in some cases, waived—PA requirements. “The interesting question is what happens when patients and providers start getting used to these relaxed scenarios,” he said. “When you squeeze the toothpaste out of the tube, it’s very hard to put it back in.” Caroline Carney, MD, the chief medical officer at Magellan Rx Management, the pharmacy segment of Magellan Health, headquartered in Phoenix, said her company has loosened its 90-day fill criteria and PA requirements for many conditions. However, whether the changes will be kept in the long term depends on federal, state and client guidance, as well as other factors. “It is an option to provide 90-day refills to patients who are on established long-term therapy that is effective and safe, particularly if the prescribing physician is comfortable with this,” Dr. Carney said. “But a 90-day fill for a patient just starting a new treatment could result in waste if it isn’t effective or leads to intolerable side effects.” Magellan Rx Management will decide whether to permanently relax PA requirements “diagnostic area by diagnostic area,” Dr. Carney said, adding that any permanent change would have to meet evidence-based guidelines for patient safety and cost-effectiveness.

More Opportunities for Smaller Specialty Pharmacies? Small- to-mid-sized specialty pharmacies that currently operate in the shadows of monoliths, such as CVS Specialty or OptumRx, could benefit from the ascent of Medicaid as a more dominant payor, Dr. Fein said, pointing to Medicaid’s preference for open distribution networks, which increase access to medications. “Manufacturers generally limit their distribution networks to their PBM [pharmacy benefit manager] partners, but if the government takes a larger role in creating distribution networks, manufacturers could have to potentially loosen up those networks [and allow smaller

The Future of Changes To Benefit Design One change that is taking place during the pandemic and that might persist is

‘Manufacturers generally limit their distribution networks to their PBM partners, but if the government takes a larger role in creating distribution networks, manufacturers could have to potentially loosen up those networks [and allow smaller specialty pharmacies in].’ —Adam Fein, PhD

Figure. Medicaid enrollment. Source: Drug Channels Institute analysis of National Health Expenditure Accounts, Office of the Actuary in the Centers for Medicare & Medicaid Services. Figure for 2019 reflects CMS projection. Figure for 2020 reflects estimates by Health Management Associates.

—David Wild The sources reported no relevant financial relationships other than their stated employment.

Specialty Pharmacy Continuum • July/August 2020

POLICY

First CAR T-Cell Therapy Approved for MCL The FDA approved the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (Tecartus, Kite) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). “The availability of [brexucabtagene autoleucel] as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90% and early clinical evidence suggesting durable remissions in later lines of

appear within the first one to two weeks after treatment, but some may occur later. During the ZUMA-2 trial, the most common (occurring in ≥10% of patients) grade 3 or higher AEs were anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy,

leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection, pneumonia, hypocalcemia and lymphopenia. The brexucabtagene autoleucel label (bit.ly/39F1tFo) carries a boxed warning for potentially fatal cytokine release syndrome (CRS) and neurologic toxicities. Of the 82 patients evaluable for safety during ZUMA-2, 18% of patients experienced grade 3 or higher CRS and 37% experienced neurologic AEs.

Because of these safety issues, brexucabtagene autoleucel is approved with a Risk Evaluation and Mitigation Strategy (REMS). The REMS is combined with the REMS for axicabtagene ciloleucel (Yescarta, Kite) (www.YescartaTecartusREMS.com). The FDA also is requiring the manufacturer to conduct a postmarketing study of the drug. —PPN Staff

Free CE now available! NNRTIs as a Drug Class: Improving Care, Improving Adherence RELEASE DATE: JULY 1, 2019

EXPIRATION DATE: SEPTEMBER 1, 2020

At a CAR T-enabled clinical center, patients undergo a short chemotherapy conditioning regimen prior to infusion of CAR T cells. Once infused, the CAR T cells replicate in vivo and attack cancer cells. Source: Kite.

therapy,” said Michael Wang, MD, the lead investigator on the ZUMA-2 trial that led to the approval. Brexucabtagene autoleucel, an autologous anti-CD19 CAR T-cell therapy, is custom-prepared using a manufacturing process that includes T-cell enrichment. During the ZUMA-2 trial, investigators assessed the treatment in 74 adults with relapsed or refractory MCL who had previously received anthracyclineor bendamustine-containing chemotherapy, anti-CD20 antibody therapy, and a Bruton tyrosine kinase inhibitor (ibrutinib [Imbruvica, Pharmacyclics] or acalabrutinib [Calquence, AstraZeneca]). The primary end point was objective response rate per the Lugano classification (2014), defined as the combined rate of a complete response (CR) and partial responses, as assessed by an independent radiology review committee. In the study, among 60 evaluable patients, 87% responded to a single infusion of brexucabtagene autoleucel, including 62% who achieved a CR. The most common adverse effects (AEs) related to brexucabtagene autoleucel include serious infections, low blood cell counts and a weakened immune system. AEs related to treatment usually

Faculty Jason J. Schafer, PharmD, MPH, BCPS AQ-ID, BCIDP, AAHIVP (Program Chair) Associate Professor Department of Pharmacy Practice Jefferson College of Pharmacy Thomas Jefferson University Philadelphia, Pennsylvania

This activity is jointly provided by Postgraduate Institute for Medicine and Miller Medical Communications, LLC. This activity is supported by an independent educational grant from Merck. This activity is distributed by CMEZone.com.

Melissa E. Badowski, PharmD, MPH, FCCP, BCIDP, BCPS, AAHIVP Clinical Associate Professor Section of Infectious Diseases Pharmacotherapy Department of Pharmacy Practice University of Illinois at Chicago, College of Pharmacy Chicago, Illinois Credits: 1.0 contact hour (0.1 CEU) ACPE UAN: JA4008162-9999-19-828-H02-P

Access today at www.cmezone.com/MM193

Specialty Pharmacy Continuum • July/August 2020

POLICY

Keeping the Cold Chain Strong During COVID-19 Pharmaceutical manufacturers and accreditors will scrutinize cold-chain packaging and processes more closely in the COVID-19 and post-COVID eras, according to Jon Pritchett, PharmD, the pharmacy program director at the Accreditation Commission for Health Care (ACHC), in Cary, N.C. Some manufacturers already go so far as to show specialty pharmacies the precise package materials and packout configurations they’ve validated to optimize temperature integrity of highvalue medications and ensure patient safety, Dr. Pritchett added. “They even state the size of cooling packs and how to layer them in the box to maintain temperature for specific medications for set time periods,” he told Specialty Pharmacy Continuum. COVID-19 has added further pressure to pack out and ship or courier properly because insurers now approve 90-day prescriptions for patients sheltering at home. The 90-day extension is being applied to refrigerated nonspecialty items such as insulin, and patients want their medications dropped off at their doorstep while carriers struggle to meet delivery demand for all kinds of merchandise.

More Cold Chain Rigors Specialty pharmacies address this added complexity in different ways, even as some ship beyond their geography due to the demands of limited and sole distribution networks. “Packages that go from, say, New York to Arizona or Alaska, for example, must thermally protect medication efficacy under widely diverse environmental conditions year round,” Dr. Pritchett explained. Accreditors are on top of this. The Utilization Review Accreditation Commission (URAC), in Washington, D.C., raised its Performance Qualification testing standards last October to twice a year from once for all medications— refrigerated, frozen and room temperature—for each packout size and shipment method. ACHC is “waiting to see how finalization of USP [Chapters] <800>, <797> and <795> standards flesh out before we issue a more prescriptive standard for cold chain,” Dr. Pritchett said. Until that happens, pharmacies must do as much as they can to ensure they are following optimal cold chain strategies, he stressed. “If a medication doesn’t work, you want to know that it’s a pharmacological issue with the drug rather than it went out of temperature in transport.”

UIC’s Approach To comply with the new URAC standards, the specialty pharmacy at University of Illinois Hospital, in Chicago (UIC), has validated a room temperature

medication packout for the 55° to 105° F temperature range, using room temperature ice packs instead of refrigerated and frozen ice packs, and less insulating material—in their case, bubble wrap, explained Lisa Kumor, PharmD, the accreditation coordinator for UIC’s specialty pharmacy services. “We’re still working on the proper amount of insulation for room temperature packouts less than 55° F, and we need to educate patients not to refrigerate room temperature medications despite our new packouts,” Dr. Kumor said. Room temperature packouts “will be a hurdle for specialty pharmacies overall because they generally haven’t yet done extensive testing to make sure they’re maintaining controlled room temperature requirements,” said Katie Kraverath, a senior business development manager at Temptime. “There will be an increase in mail-order medications in light of COVID-19, and guidelines will continue to tighten to make sure they’re protected.”

Hospital-Based Specialty Pharmacies Innovate “The COVID crisis sheds light on our need to be very local and patient-specific,” said JoAnn Stubbings, BSPharm, a clinical associate professor of pharmacy practice at UIC College of Pharmacy, referring to the UIC specialty pharmacy where she recently retired from the post of associate director. “Our concierge-style courier service has served us phenomenally well during this crisis.” The pharmacy, she noted, “experienced zero disruption to timely deliveries” while maintaining temperature integrity. Ms. Stubbings added that “it was almost overkill when we set up this service in 2016. But when COVID-19 hit, nothing changed in our ability to serve patients.” Part of that success was due to the use of a refrigerated van, which helped ensure no wasteful packouts at the pharmacy. Fast forward to the pandemic, with social distancing and a “no-touch” approach to cold chain management, and adjustments were needed, such as full cold chain packs. The pharmacy also monitors the van’s temperature in real time while en route, Ms. Stubbings noted. Mike Gannon, PharmD, a business coordinator of specialty pharmacy services at UIC, pointed to another key driver of cold chain success, one that may well be unique to health systems: the fact that

such facilities have medical centers near its patients. That type off structure, he noted, adds ds “value when you consider der [their specialty] pharmacy’s cy’s ability to integrate with h the medical record, which expedites prior authorizations ns and allows for better communication nication across health care providers.” ers.” Successful cold chain manage management also requires dedicated partners, and for UIC, one was the local courier Webber Logistics, which averaged about 20 daily deliveries to specialty pharmacy patients in southwestern Chicago in March 2020. Courier owner Bryant Webber said the average delivery time was three hours, 44 minutes. But speed is not the only service goal, he stressed. It’s also important to take a few extra customer service steps, such as calling or texting patients when a delivery is imminent. That way, Mr. Webber noted, patients can be ready to retrieve and store their medications properly upon no-contact delivery.

The Pandemic Effect “If COVID and sheltering at home continue to scale, the need for people to receive medication deliveries will increase,” said Stephen F. Eckel, PharmD, the associate dean of global engagement and a clinical associate professor at the University of North Carolina Eshelman School of Pharmacy, in Chapel Hill. “Specialty pharmacies need to educate patients to treat them like their perishable groceries, something they could easily relate to.” About 30% of the 800 to 1,200 prescriptions mailed every day by the UNC Shared Services Center Specialty Pharmacy, also in Chapel Hill, require cold chain packaging, according to director of pharmacy Jeff Reichard, PharmD. The pharmacy attaches a temperature tag to each product so patients can see if it deviated from “normal” conditions by 2° to 8° C; a color change on the tag would indicate a short, moderate or extended excursion period. The pharmacy also uses advanced tracking services to “rescue” packages at risk for being exposed to suboptimal conditions—for example, refrigerated items not delivered within 24 hours of their packout, Dr. Reichard said.

Top Priorities Specialty pharmacies that are able to comply with evolving thermal protection standards, save on shipping space and labor and materials costs on packouts, and keep the environment safer would come out on top while keeping pace in an era of increasing medication shipments.

‘If a medication doesn’t work, you want to know that it’s a pharmacological issue with the drug rather than it went out of temperature in transport.’ —Jon Pritchett, PharmD To this end, both Dr. Eckel and Ms. Stubbings said they would welcome clearer packout guidelines from pharmaceutical manufacturers, and more feasible, affordable solutions to show temperature variations from suppliers. Approaches by some vendors, among them two distinctive paths toward sustainability and shipping efficiencies, are being made. Jed Dutton, the vice president of marketing at TemperPack, in Richmond, Va., pointed to one key trend in cold chain materials and policy. “Styrofoam bans exist in many parts of the country. The National Institutes of Health has said styrene is a probable carcinogen to humans [Mutagenesis 2011;26(5):583-584]. Shipping lifesaving drugs in 70-year-old technology associated with cancer puts pharmaceutical makers and pharmacies in an uncomfortable position,” Mr. Dutton said. The company’s ClimaCell box liners, made largely of starch and paper, are a recyclable alternative. Additionally, TemperPack’s thermal transport lab, which he said is certified by the International Safe Transit Association, emulates external shipping conditions, which enables it to test and qualify packaging solutions that meet temperature range and shipping specifications for each user. Meanwhile, the shipper reclamation system by Coldchain Technology Services (CTS), in Spring Branch, Texas, allows pharmaceutical manufacturers to pay a variable cost for boxes as they use them, rather than purchasing and storing them. Specialty pharmacies with multiple sites “can use our pre-engineered systems to establish a uniform shipping and packout protocol across their organization, which decreases risk, improves product security and helps with accreditations,” said Scott Bullard, the company’s director of business development. KabaFusion, a Cerritos, Cal.–based chain of 28 URACand ACHC-accredited home infusion specialty pharmacies across the nation, “plans to deploy” the CTS shipping solution this summer, said Frank Esposito, RPh, the vice president of operations. —Al Heller The sources reported no relevant financial relationships other than their stated employment.

Read Specialty Pharmacy Continuum Anywhere, Anytime!

www.specialtypharmacycontinuum.com

When you need it on time every time,

count on McKesson Home infusion therapy patients don’t have time for missing shipments or wrong orders. Count on McKesson to deliver the products you need to keep providing the highest levels of care.

• Find what you need with access to industry-leading product selection • Get it fast with 99% order accuracy • Connect to patients with smart technology • Be supported by a team willing to go the distance

To learn more about our home infusion therapy solutions, visit

Specialty Pharmacy Continuum (July / August 2020)

Articles inside

TECHNOLOGY

Time is now for nonopioid pain modalities

Patient support programs keeping up despite COVID-19

Will COVID-19 clog generics, biologics pipeline?