10
18 OPERATIONS & MGMT 3 ways to think smarter amid disruptionhealthcare 3 POLICY Time is now to prepare for USP Chapter updates on compounding 4 CLINICAL Where’s the urgency on social determinants of health? 16 Navigating treatment choices in cGVHD disease 20 TECHNOLOGY High-quality research possible in busy specialty practice 22 REVIEW DuchenneTreatmentsEmergingARTICLEforMuscularDystrophy Access by choosing Review Articles in the Sections tab specialtypharmacycontinuum.comat Serving managed care, health-system and specialty decision makers Volume 11 • Number 4 • July/August 2022 • specialtypharmacycontinuum.com Atopic
While living in Chicago, Mr. Wake had his first cerebral infarction related to SCD. The event was a “silent” stroke that affected the part of his brain controlling speech. Strokes, manifesting as both cognitive impairment or overt infarcts, are a common complication of SCD (Pediatr Neurol 2019;95:34-41). ACCREDITATION, page see pagesee CELL STRUGGLE, page Dermatitis
SICKLE
5
Magellan
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Millions in Savings From Onc Biosimilars
BIOSIMILARS SAVINGS,
URAC, JC, ACHC Detail What’s New In SP Accrediting By Karen Blum PHOENIX—The specialty pharmacy accreditation field is heating up this year, highlighted by three new elements of performance and a new way to review pharmacy services that reaches beyond traditional drug dispensing, representatives from the major accrediting bodies reported during the 2022 ASHP Summer Meetings and Exhibition. Any healthcare provider trying to enter the specialty pharmacy market knows that getting some form of accreditation is essential for gaining access to payor and pharmacy benefit manager networks or limited distribution drugs. That’s why it is critical to keep up with Rx Reports
By Karen Blum CHICAGO—Biosimilars for oncology are gaining ground, with more payors implementing strategies to cover them and large projected savings for health plans, health systems and patients, speakers said during a panel discussion at the AMCP 2022 annual meeting. Biosimilars are defined as biologic products approved by the FDA that are highly similar to an FDA-approved biologic product, also known as the reference product, said YuQian Liu, PharmD, RPh, the director of specialty clinical solutions at Magellan Rx Management, Inadequate pain relief rampant
Patient–specialty pharmacy interaction fundamental
For Sickle Cell Patients, The Struggle Continues By Marie Rosenthal CHICAGO— Kevin Wake understands all too well the disparities in healthcare that prevail in the United States, especially for patients with sickle cell diseaseThose(SCD).inequities almost killed him, he told attendees at the AMCP 2022 annual meeting.
see SP
in the continuity of care See page 12.
1. Health and Human Services, Federal Drug Administration, 510(k) Clearance Letter, July 24, 2015. 2. Ergonomics: The Study of Work. U.S. Department of Labor Occupational Safety and Health Administration. OSHA 3125 2000 (Revised). 3. Internal study, data on file. 4. Internal study, data on file. HALO® is a registered trademark of Corvida Medical, Inc. ©2022 Fresenius Kabi USA, LLC. All Rights 2395-HALO-05-01/22Reserved. True containment. True comfort. Right in the palm of your hand. True drug containment that offers comfort and peace of mind, HALO® CSTD is your complete solution for hazardous drug preparation and administration. • Airtight and leak-proof 1 • Ergonomically designed for hand comfort 2 • Strong and secure attachment 3 • No internal filter to maximize vial extraction4 Make the HALO system your standard of care for enhanced protection of patients and caregivers. To request a demonstration or to order the HALO System, call 1-888-386-1300 or visit us at www.HALO-CSTD.com Your Containment and Protection Ally
1. There is no digital disruption, just digital delivery. All organizations have adapted to new work patterns and methods of engaging with patients and distributors, Mr. Walsh said. Digital disruption and transformation are now the price of staying in business, he said, and the way that today’s youth—who have grown up with interactive technologies, such as tablets—are going to expect to be treated as patients and co-workers is going to be “radically different than any generation before.”
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 Copyright © 2022 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. We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication. 11 • Number 4 • July/August 2022 specialtypharmacycontinuum.com
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LAS VEGAS—Healthcare companies must design new work cultures and leverage technology to continually evolve and be successful going forward, a speaker said during the 2022 Managed Health Care Associations Inc. (MHA) Business Summit. “This is more than just a period of recovery,” said futurist Mike Walsh, the CEO of Tomorrow, a consultancy on designing companies for the 21st century, referring to the aftermath of the peak COVID-19 pandemic. “This is the dawn of a new world, one that’s going to run on a very new set of rules. … There’s no going back to the way things were.”
A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers or semiannual Special Editions.
3 Ways to Think Smarter Amid Healthcare Disruption
Technology Won’t Provide All the Answers
The sources reported no relevant financial disclosures.
David Bronstein, Editorial davidb@mcmahonmed.comDirector
By Karen Blum
and several annual
2. There is no remote work, just work. What made the radical shift to remote or hybrid work schedules during the pandemic difficult for some wasn’t the technology as much as a change in corporate culture, Mr. Walsh said. Successful organizations embrace more than casual Fridays or picnics to define culture by how their employees communicate, collaborate and make decisions.
Mr. Walsh suggested three themes that healthcare organizations should embrace in this era of rapid change:
• Automate and elevate (how to upskill people for the new age) those people in your organization who have natural abilities that can be remapped.
Kate Baggaley, Associate kbaggaley@mcmahonmed.comEditor
EDITORIAL BOARD HOME INFUSION Jay Bryant-Wimp, RPh AccurateOwner/CEORx Pharmacy Columbia, MO Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH PBMs Jason Borschow President & CEO Abarca Health Florida and Puerto Rico
• Embrace uncertainty; this is not something that’s going to go away, Mr. Walsh said. Uncertainty must be faced head-on.
3. AI will not destroy jobs, but it will change them. In all industries, including healthcare, automation and robotics, will be a bigger part of the future, Mr. Walsh said. As these technologies become more adopted and integrated into the workspace, traditional jobs as we know them will have to adapt to new roles managing the technologies or supplementing them with different skill sets. Businesses will need a deeper understanding of human complexity and how to motivate people toward a great patient experience, balanced with how to get better at using data and leveraging automation to augment our own capabilities, he said. The following principles should be considered:
Michael Sicilian President, Managed Health Care Associates Inc. Florham Park, NJ Donald J. Vidic, RPh, MBA Vice President of Operations and Pharmacy Services Walgreens Specialty Pharmacy Carnegie, PA Burt Zweigenhaft Managing Partner Upstream, a BioPharma Partners Company New York, NY HEALTH-SYSTEM PHARMACY Ernest R. Anderson Jr., MS, RPh Brockton, MA JoAnn Stubbings, PharmD Specialty Pharmacy Director, UIC Specialty Pharmacy Chicago, IL REIMBURSEMENT Bonnie Kirschenbaum, MS Breckenridge, CO
SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA RockySpecialtyConsultantPharmacyHill,CT Cindy Kunzendorf, PharmD General Elmhurst,Accredo/CCSManagerLocationsIL
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• Don’t work, design work—think of how to design a better way of doing things. Should any human be doing a particular job, or is there a better method?
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Think about how technology can help change the underlying patient experience and drive better outcomes, Mr. Walsh said. Modern organizations are thinking about how to use data and technology to continuously refine the customer experience. This could apply to areas such as medication adherence or patient equity, he said. There also is a strong focus on how to employ technology such as artificial intelligence or algorithms to automate processes or address vexing problems.
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Audience members appreciated understanding that disruption isn’t just about implementing new technology but also about people and processes, commented Tom Hermey, MHA’s executive vice president for technology and operations. For example, many pharmacies have been focused on being lean, Mr. Hermey said: “While I don’t think they might change their minds on being a lean organization, I think the use of AI and becoming more adaptable, like getting outside the box, really resonated withOnethem.”pointthat stuck out to Mr. Hermey was the notion that some jobs need to evolve and be remapped to respond to the post-pandemic environment and staffing challenges that face pharmacies today: “The impetus for these changes are all things that we’re going through now, and it presents a unique opportunity for pharmacies or businesses that are going to really succeed and thrive.”
By Karen Blum PHOENIX As the pharmacy community awaits impending updates to USP General Chapters <795> and <797>, it would be wise to start adjusting compounding policies and procedures accordingly and to be aware of state requirements, speakers said at the 2022 ASHP Summer Meetings and Exhibition. Revisions to Chapters <795> and <797> were proposed in 2021 and are still being reviewed, said Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety at Cardinal Health. This means the 2014 version of <795> and the 2008 version of <797> are official. Chapter <800>, published in 2016, and <825> for radiopharmaceuticals, published in 2019, also are current. “These standards as written by USP are minimum standards,” Ms. Kienle noted. Sterile-to-sterile compounding will undergo some nomenclature changes in the proposed revisions, to represent the areas where materials are prepared rather than ingredients. Low risk will be Category 1, for materials prepared in the segregated compounding area. Medium risk will be Category 2, for those prepared in cleanroom suites. A proposed Category 3 will cover materials prepared in the cleanroom suites using extended beyond-use dates (BUDs). Common questions arise regarding repackaging, Ms. Kienle said. This area of practice is not covered in <795> but rather, in an FDA guidance document, she noted (bit.ly/3xAzTpe). Even so, the requirements listed are enforceable by regulations in many states. Chapter <797> covers repackaging for drugs, diluents, containers and closures, while <800> covers repackaging regarding protections to workers from hazardous drug contamination.Whenitcomes to nonsterile compounding, Chapter <795> is the standard, but it should be recognized that every state board has regulations on compounding that can vary, Ms. Kienle said. She cited the following examples:
• Ensure no other activities are happening when compounding is occurring.
General Chapters <795>, <797> and <800> use the term “designated person” as the individual to oversee training competence and compliance with policies and procedures. The proposed revisions also describe an “assigned trainer,” or someone responsible to the designated person to oversee training. Compounding facilities may want to begin incorporating that component, Ms. Kienle said, encouraging pharmacy leaders to look at the proposed revisions. Training also comes into play when ensuring compliance with USP revisions that include a list of necessary core skills, including proper hand hygiene, garbing, measuring and mixing, and the cleaning process, Ms. Kienle noted. Inspectors from state boards of pharmacy or surveyors from accrediting organizations that come in may ask for this information, she said. So, it’s a good idea to keep a continuing checklist of how you train pharmacy staff in these skills. If your organization does anything in an unusual manner, be prepared to explain it, she added, especially if it’s something that a surveyor or inspector might not have seen before. Training needs to be conducted for everyone who enters the compounding area, Ms. Kienle stressed, not just for compounding staff. Consider what policies and procedures you’ll need for other pharmacists who may enter orders but are not involved with compounding; visiting inspectors and surveyors; students who observe; maintenance workers who may need to touch some surfaces or materials when making repairs; and environmental services personnel who clean the rooms. As an example, Ms. Kienle mentioned an environmental services worker she observed at a facility, who rolled up a mat placed in front of a compounding preparation area and put it under the hood while cleaning the floor, unaware of the potential hazard. —K.B. Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee.
Keeping an eye on state board regulations also key Time Is Now to Prepare for USP Chapter Updates
PHOENIX—Training and competency are the linchpin of safe sterile compounding—and a key to USP compliance, according to Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety at Cardinal Health. “We can have all the greatest facilities; we can have all the greatest policies and procedures; but if we don’t have folks who are adequately trained and competent in what they’re doing, that’s a problem,” Ms. Kienle said. “They need to know not only what they need to do, but where things are starting to look suspicious and that need to be escalated. This is absolutely the most important part” of training, she noted.
The comments in this article are her own.
POLICY 4 Specialty Pharmacy Continuum • July/August 2022
Don’t Go It Alone Relying too heavily on one in-house “expert” for USP compliance is not a recipe for success, noted Caryn Belisle, RPh, MBA, the director of pharmacy regulatory compliance, quality and safety at Brigham and Women’s Hospital, in Boston. “Having dedicated staff focused on cleanroom compliance is imperative nowadays,” said Ms. Belisle, who was not part of the ASHP session. “You can’t expect your cleanroom manager to do it all. You need someone outside the cleanroom’s day-to-day operations who is focused on quality and compliance. First, it’s just too much for one person to have to keep their eye on, and second, it’s always good practice to have your staff separate your quality from your operations when you are compounding significant amounts of product, either patient-specific or batch.” Internal audits are also highly beneficial, Ms. Belisle added. “You can observe your trends in environmental monitoring, but you need to also get out of your chair and watch the staff gown and garb, and see how they’re behaving in the cleanroom. At Brigham, we perform monthly quality rounds” to ensure such quality control steps are being followed, she noted.
• If you have a containment ventilated enclosure, it needs to be certified at least once a year.
Ms. Belisle reported no relevant financial disclosures. Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee. The comments in this article are her own.
The proposed revision also states that training and documentation of competency should be done for personnel doing the compounding. Additionally, whereas gloves are required for nonsterile compounding, Ms. Kienle also recommended using face masks and hair covers. The sources of your components should be known, too. If there are chemicals or other components in your cabinets that are undated or have been there for years, they should be discarded appropriately. Water used should be purified or better. Many pharmacies use sterile water for irrigation, which is fine; however, she said, accreditors may question bottles of sterile water because they are intended for single use. From a best-practice perspective, consider adding a sticker that indicates the bottle is for nonsterile compounding only and establish a policy including when it must be discarded. The proposed revisions of <795> and <797> discuss activities related to water use because of a risk for microbial contamination. Managers should review the revisions for the types of dosage forms considered aqueous or not for a guideline of what to consider in their preparations, Ms. Kienle Compoundingadvised.allergenic extracts is covered in Chapter <797> because they are sterile preparations. They can be prepared in a cleanroom or segregated compounding area. Do not prepare them in the regular IV room, Ms. Kienle said, because that could introduce contaminants such as dander or mold. Chapter <797> revisions also state they can be prepared in an allergenic extracts compounding area, which is a designated space with a visible perimeter. For sterile best practices, consider that BUDs in <797> are not defaults, Ms. Kienle said. Not all preparations can use the maximum BUDs; there may be stability issues that would require a shorter time. Furthermore, moving compounds from one storage temperature to another will change the BUD. Another area to watch is surface sampling, Ms. Kienle said. The current <797> chapter requires this action periodically, and it is usually done by a certifier. But the proposed revision requires monthly sampling, and it will affect all classified areas and pass-throughs opening into the classified areas. Make sure that’s included in your surface sampling plan, she said. Pharmacies will need instruction, media, an incubator and microbiology support.
Training a Key Component of USP Compliance
• Avoid carpeting.
POLICY
in Middletown, R.I. Legislation enacted in 2010 created a regulatory pathway for FDA approval of biosimilars, but patent litigations prevented most biosimilars from entering the market immediately, she said. In 2018, biosimilars accounted for less than 2% of the total biologic market, according to Dr. Liu. But in 2019, there was a “drastic increase” in both FDA approvals and utilization of biosimilars. Three oncology biosimilars launched in 2019 achieved “significant uptake in their first year,” she said, with bevacizumab biosimilars leading at 42%, followed by trastuzumab at 30% and rituximab at 20%. These biosimilars were trending toward nearly 60% market share by the end of their first two years on the market, Dr. Liu explained. In the oncology space, there are 17 biosimilars on the market, including seven for the oncology-support agents epoetin alfa, filgrastim and pegfilgrastim, and 10 for the cancer treatments bevacizumab, rituximab andWhentrastuzumab.thefirst oncology biosimilar, filgrastim-sndz (Zarxio, Sandoz), was approved in March 2015, “there was a lot of hesitation [and] provider pushback. It was just very difficult to get patients to shift to a biosimilar,” she said. But from 2017 to 2019, there were many new entrants and more uptake, “making the space now very competitive,” Dr. Liu said. The projected savings over the next five years from biosimilars is estimated to be more than $100 billion, she predicted. As biosimilars enter the market, they create competition for the reference product. Biosimilars are launching with at least a 15% discount, which can be made higher with additional rebates and discounts, Dr. Liu said. In 2019, the reduction in average sales price for biosimilars over reference products was between 15% and 45%. Bevacizumab, rituximab and trastuzumab biosimilars saw an average sales price reduction of $500 to $2,000 for a standard course of treatment. Savings trickle down to patient out-of-pocket costs to the point that a patient, on average, will pay 12% to 45% less than someone taking a reference product. At this time, no oncology biosimilars have been designated by the FDA as interchangeable, meaning they cannot be automatically substituted for the reference product at the point of sale, Dr. Liu cautioned. Interchangeable products must demonstrate they can produce the same clinical results in any patient, and that switching between products would not reduce efficacy or increase toxicity. Meanwhile, managed care organizations and healthcare systems have adopted a practice to designate therapeutic substitutions, she said. The pharmacy and therapeutics committee declares a product to be therapeutically equivalent to the reference product, yielding similar outcomes or adverse effects. This protocol gives the pharmacy or managed care organization permission to substitute the drug based on a predefined protocol, without provider consent. Rules for this vary by state. In a survey of 41 payors by the Magellan Rx Management 2020 Medical Pharmacy Trend Report, 76% reported having a strategy in place for approving and covering biosimilars. Fifty-nine percent said they implemented strategies for oncology biosimilars, Dr. Liu noted. In the same survey, half of payors said they are reimbursing based on the Medicare rate, which is the standard average sales price plus 6%. Payor strategy often consists of utilization management with step therapy, Dr. Liu said. Payors select a few preferred biosimilar products and require that those products be tried first, typically in new-start patients. They make decisions following a clinical and financial review of products, as well as consultation with large, in-network provider groups, among other factors. “The goal is to drive utilization toward the least costly alternative product,” she said.
Dr. Jensen and colleagues faced several barriers when first implementing a biosimilar strategy at Mayo Clinic. Providers needed to understand what the products were. The health system manages its own health plan and has providers in four states with different payor mixes. Dr. Jensen’s team also had to tackle issues with workflow and electronic health record build to facilitate biosimilar adoption; explain to providers why biosimilars were important; and handle payor-specific demands for certain products. “We had been discussing biosimilars coming to market with our task forces for many years, especially within the hematology-oncology setting, where these providers are very well aware of financial toxicity to patients,” Dr. Jensen said. Her team’s strategy included contracting for preferred agents (either a biosimilar or innovator) for the health system with a focus on the lowest-net-cost product; making all biosimilars available in clinics and infusion centers for insurance plans that mandate specific products; and developing a streamlined process for providers allowing therapeutic substitution. In addition, they built preferred products into the electronic health record as the default, when possible. They also educated pharmacy and pharmacy technician staff to avoid selection of the wrong product and charges being denied, and informed pharmacy procurement teams to anticipate purchasing fewer reference products as biosimilar adoptionFormularyincreased.team members made sure to have an updated document available to prior authorization and nursing leadership teams listing the formularypreferred and non-preferred biosimilars within each therapeutic class, and their corresponding codes for billing. Payor coverage was listed on a separate tab. Updated lists were sent as contracting or payor demands changed. Six months after implementing these changes, use of formulary-preferred biosimilars was 94.8% for rituximab, 87.2% for trastuzumab and 83.8% for bevacizumab within the hematology and oncology practices, Dr. Jensen said (Mayo Clin Proc 2022; in press). The strategy overall achieved $23 million in drug expenditure savings in the first year after implementation, which was a 24.3% reduction in pharmaceutical line item expenses over the previous year, she said. The sources reported no relevant financial disclosures other than their stated employment.
Source: Internal Magellan data for 16 million covered lives.
Biosimilars Savings
Pitfalls Still Present
continued from page 1 Specialty Pharmacy Continuum • July/August 2022 5
The prevalence of biosimilars and clear cost-savings potential do not ensure a smooth implementation process for health systems, cautioned Chelsee Jensen, PharmD, RPh, a pharmaceutical formulary manager for Mayo Clinic in Rochester, Minn.
Use of trastuzumabincreasedbiosimilarsfrom 11% to 87% in one year, yielding an estimated $45 million in net savings independent of rebates and discounts.
Internal Magellan data for 16 million covered lives showed significant savings from using biosimilars versus reference products over a yearlong period from fourth quarter 2020 through third quarter 2021. For example, use of trastuzumab biosimilars increased from 11% to 87% in this period and provided an estimated $45 million in net savings independent of rebates and discounts.
INDICATION REZUROCK® (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions • Embryo-Fetal Toxicity: administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose Adverse Reactions ••• Drug Interactions • Strong CYP3A Inducers: coadministered with strong CYP3A inducers • Proton Pump Inhibitors: coadministered with proton pump inhibitors • Pregnancy: administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to the fetus An innovative way to treat cGVHD 1-3 ROCK ON
IMPORTANT SAFETY INFORMATION (cont)
References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. Zanin-Zhorov A, Weiss JM, Nyuydzefe MS, et al. Selective oral ROCK2 inhibitor down-regulates IL-21 and IL-17 secretion in human T cells via STAT3dependent mechanism. Proc Natl Acad Sci USA. 2014;111(47):16814-16819. doi:10.1073/pnas.1414189111 3. Flynn R, Paz K, Du J, et al. Targeted Rho-associated kinase 2 inhibition suppresses murine and human chronic GVHD through a Stat3-dependent mechanism. Blood. 2016;127(17):2144-2154. doi:10.1182/blood-2015-10-678706 4. 5. Cutler CS, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021 6. 7. Lee SJ, Cook EF, Soiffer R, Antin JH. Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2002;8(8):444-452. doi:10.1053/bbmt.2002.v8.pm12234170
aProportion
• Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe renal You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.
• Pediatric Use: The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established
• Geriatric Use: clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients
The ROCKstar study was an open-label phase 2 study comparing REZUROCK 200 mg once daily (n=66) with REZUROCK 200 mg •• There was no death or new systemic therapy initiation in 62% d • Clinically meaningful improvements in QOL were reported by 52% of patientse • CS and CNI dose reductions • across 2 clinical studies © 2022 Kadmon Pharmaceuticals, LLC. All Rights Reserved. MAT-US-2202849-v1.0-06/2022
• Lactation: There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the
cb g gdefDenominator excludes patients with unknown status.1 VISIT REZUROCKhcp.com TO LEARN MORE real-world demographicc Enroll your patients by calling 1-844-KADMON1KadmonAssist.com(523-6661) ASSIST ™ 75% P ORR PRIMARY END POINT1
Please see Brief Summary of Prescribing Information on adjacent pages. AE, adverse event; aGVHD, acute graft-versus-host disease; cGVHD, chronic graft-versus-host disease; CNI, calcineurin inhibitor; CR, complete response; CS, corticosteroid; ECP, extracorporeal photopheresis; FDA, US Food and Drug Administration; LSS, Lee Symptom Scale; NIH, National Institutes of Health; ORR, overall response rate; PPI, proton pump inhibitor; PR, partial response; QOL, quality of life; ROCK2, rho-associated coiled-coil–containing protein kinase-2. of patients who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria in the 200-mg once-daily arm.
Treatment with REZUROCK has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with REZUROCK [see Clinical Pharmacology (12.3) in the full prescribing information]
Grade 3 AST
2 DOSAGE AND ADMINISTRATION
2.2 Dose Modifications for Adverse Reactions Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly. Modify the REZUROCK dosage for adverse reactions as per Table 1
• If a dose of REZUROCK is missed, instruct the patient to not take extra doses to make up the missed dose.
6
4 CONTRAINDICATIONS None.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice. Chronic Graft versus Host Disease In two clinical trials (Study KD025-213 and Study KD025-208), 83 adult patients with chronic GVHD were treated with REZUROCK 200 mg once daily [see Clinical Studies (14.1) in the full prescribing information]. The median duration of treatment was 9.2 months (range 0.5 to 44.7 months). Fatal adverse reaction was reported in one patient with severe nausea, vomiting, diarrhea and multi-organ failure. Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia, dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia, edema, and renal failure with (2% each). The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.
7 DRUG INTERACTIONS 7.1 Effect of Other Drugs on REZUROCK Strong CYP3A CoadministrationInducersofREZUROCK with strong CYP3A inducers decreases belumosudil exposure [see Clinical Pharmacology (12.3) in the full prescribing information], which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK when coadministered with strong CYP3A inducers [see Dosage and Administration (2.3)] Proton Pump CoadministrationInhibitorsofREZUROCK with proton pump inhibitors decreases belumosudil exposure [see Clinical Pharmacology (12.3) in the full prescribing information], which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK when coadministered with proton pump inhibitors [see Dosage and Administration (2.3)] Nonlaboratory Adverse Reactions in ≥ 10% Patients with Chronic GVHD Treated with acute upper respiratory conjunctivitis, sinusitis, respiratory tract infection, bronchitis, sepsis, septic shock. b includes influenza, rhinovirus infection, gastroenteritis viral, viral upper respiratory tract infection, bronchitis viral, Epstein-Barr viremia, Epstein-Barr virus infection, parainfluenzae virus infection, Varicella zoster virus infection, viral infection. c includes cellulitis, Helicobacter infection, Staphylococcal bacteremia, catheter site cellulitis, Clostridium difficile colitis, Escherichia urinary tract infection, gastroenteritis Escherichia coli, Pseudomonas infection, urinary tract infection bacterial. d includes fatigue, asthenia, malaise. e includes edema peripheral, generalized edema, face edema, localized edema, edema. f includes nausea, vomiting. g includes abdominal pain, abdominal pain upper, abdominal pain lower. h includes dyspnea, dyspnea exertional, apnea, orthopnea, sleep apnea syndrome. i includes cough, productive cough. j includes contusion, hematoma, epistaxis, increased tendency to bruise, conjunctival hemorrhage, hematochezia, mouth hemorrhage, catheter site hemorrhage, hematuria, hemothorax, purpura. k includes pain in extremity, back pain, flank pain, limb discomfort, musculoskeletal chest pain, neck pain, musculoskeletal pain. l includes headache, migraine. m includes rash, rash maculo-papular, rash erythematous, rash generalized, dermatitis exfoliative. n includes pruritus, pruritus generalized.
sinusitis, device related infection, ear infection, folliculitis, gastroenteritis, gastrointestinal infection, hordeolum, infectious colitis, lung infection, skin infection, tooth infection, urinary tract infection, wound infection,
Table 2:
tract infection, pneumonia,
Adverse ReactionSeverity*REZUROCK Dosage Modifications
REZUROCK® (belumosudil) tablets, for oral use Initial U.S. Approval: 2021 Brief Summary of Prescribing Information. 1 INDICATIONS AND USAGE REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
5.1 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of belumosudil to pregnant rats and rabbits during the period organogenesis caused adverse developmental outcomes including embryo-fetal mortality and malformations at maternal exposures (AUC) less than those in patients at the recommended dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1) in the full prescribing information] ADVERSE REACTIONS
Strong CYP3A Inducers Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with strong CYP3A inducers [see Drug Interactions (7.1)] Proton Pump Inhibitors Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors [see Drug Interactions (7.1)]
The recommended dose of REZUROCK is 200 mg given orally once daily until progression of chronic GVHD that requires new systemic therapy. Instruct the patient on the following: • Swallow REZUROCK tablets whole. Do not cut, crush, or chew tablets.
2.1 Recommended Dosage
Table 2 summarizes the nonlaboratory adverse reactions. Table 3 summarizes the laboratory abnormalities in REZUROCK.
Hepatotoxicity [see Adverse Reactions (6.1)]
or ALT (5x to 20x ULN) or Grade 2 bilirubin (1.5x to 3x ULN) Hold REZUROCK until recovery of bilirubin, AST and ALT to Grade 0-1, then resume REZUROCK at the recommended dose. Grade 4 AST or ALT (more than 20x ULN) or Grade ≥ 3 bilirubin (more than 3x ULN) Discontinue REZUROCK permanently. Other adverse reactions [see Adverse Reactions (6.1)] Grade 3 Hold REZUROCK until recovery to Grade 0-1, then resume REZUROCK at the recommended dose level. Grade 4 Discontinue REZUROCK permanently. *Based on CTCAE v 4.03 Table 3: Selected Laboratory Abnormalities in Patients with Chronic GVHD Treated with REZUROCK 200REZUROCKmgoncedaily Grade Baseline0-1 Grade 2-4 Max Post Grade 3-4 Max Post Parameter (N) (%) (%) Chemistry Phosphate Decreased 76 28 7 Gamma Glutamyl Transferase Increased 47 21 11 Calcium Decreased 82 12 1 Alkaline Phosphatase Increased 80 9 0 Potassium Increased 82 7 1 Alanine Aminotransferase Increased 83 7 2 Creatinine Increased 83 4 0 Hematology Lymphocytes Decreased 62 29 13 Hemoglobin Decreased 79 11 1 Platelets Decreased 82 10 5 Neutrophil Count Decreased 83 8 4
2.3 Dosage Modification Due to Drug Interactions
5 WARNINGS AND PRECAUTIONS
REZUROCK Adverse Reaction 200REZUROCKmgoncedaily(N=83) All Grades (%)Grades 3-4 (%) Infections and infestations Infection (pathogen not specified)a 5316 Viral infectionb 194 Bacterial infectionc 164 General disorders and administration site conditions Astheniad 464 Edemae Pyrexia181271 Table 2: Nonlaboratory Adverse Reactions in ≥ 10% Patients with Chronic GVHD Treated with REZUROCK (continued)AdverseReaction 200REZUROCKmgoncedaily(N=83) All Grades (%)Grades 3-4 (%) Gastrointestinal Nauseaf AbdominalDiarrhea355424pain g Dysphagia160221 Respiratory, thoracic and mediastinal Dyspneah 335 Coughi 300 Nasal congestion120 Vascular Hemorrhagej Hypertension217235 Musculoskeletal and connective tissue Musculoskeletal paink 224 Muscle Arthralgia152spasm170 Nervous system Headachel 210 Metabolism and nutrition Decreased appetite171 Skin and subcutaneous Rashm 120 Pruritusn 110 a infection with an unspecified pathogen includes
Table 1: Recommended Dosage Modifications for REZUROCK for Adverse Reactions
• Take REZUROCK with a meal at approximately the same time each day [see Clinical Pharmacology (12.3) in the full prescribing information]
from animal studies and the mechanism of action [see Clinical Pharmacology (12.1) in the full information], REZUROCK can cause fetal harm when administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, administration of belumosudil to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including alterations to growth, embryo-fetal mortality, and embryo-fetal malformations at maternal exposures (AUC) approximately ≥ 3- (rat) and ≥ 0.07 (rabbit) times the human exposure (AUC) at the recommended dose (see Animal Data). Advise pregnant women and females of reproductive potential of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
prescribing
8.2 Lactation Risk
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk BasedSummaryonfindings
ThereSummaryarenodata available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with REZUROCK and for at least one week after the last dose.
8.5 Geriatric Use Of the 186 patients with chronic GVHD in clinical studies of REZUROCK, 26% were 65 years and older. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients.
The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. Use of REZUROCK in this age group is supported by evidence from adequate and well-controlled studies of REZUROCK in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the pharmacokinetics of drug substance, that the exposure of drug substance is expected to be similar between adults and pediatric patients age 12 years and older, and that the course of disease is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients.
8.3 Females and Males of Reproductive Potential REZUROCK can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]
The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established.
8.4 Pediatric Use
In an embryo-fetal developmental study in rabbits, pregnant animals administered oral doses of belumosudil at 50, 125, and 225 mg/kg/day during the period of organogenesis resulted in maternal toxicity and embryo-fetal developmental effects. Maternal toxicity (body weight loss and mortality) was observed at doses ≥ 125 mg/kg/day. Embryo-fetal effects were observed at doses ≥ 50 mg/kg/day and included spontaneous abortion, increased post-implantation loss, decreased percentage of live fetuses, malformations, and decreased fetal body weight. Malformations included those in the tail (short), ribs (branched, fused or deformed), sternebrae (fused), and neural arches (fused, misaligned, and deformed). The exposure (AUC) at 50 mg/kg/day in rabbits is approximately 0.07 times the human exposure at the recommended dose of 200 mg.
Males Advise males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose of REZUROCK.
Data Animal Data
Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating treatment with REZUROCK.
Embryo-fetal development studies were conducted in rats with administration of belumosudil to pregnant animals during the period of organogenesis at oral doses of 25, 50, 150, and 300 mg/kg/day in a pilot study and doses of 15, 50, and 150 mg/kg/day in a pivotal study. In the pilot study, maternal toxicity and embryo-fetal developmental effects were observed. Maternal toxicity (reduced body weight gain) occurred at 150 and 300 mg/kg/day doses. Increased post-implantation loss occurred at 50 and 300 mg/kg/day. Fetal-malformations were observed at ≥ 50 mg/kg/day and included absence of anus and tail, omphalocele, and dome shaped head. The exposure (AUC) at 50 mg/kg/day in rats is approximately 3 times the human exposure at the recommended dose of 200 mg.
Contraception Females Advise females of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose of REZUROCK. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.
Infertility Females Based on findings from rats, REZUROCK may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology (13.1) in the full prescribing information] Males Based on findings from rats and dogs, REZUROCK may impair male fertility. The effects on fertility are reversible [see Nonclinical Toxicology (13.1) in the full prescribing information]
Active ingredient made in India. Distributed and marketed by: Kadmon Pharmaceuticals, LLC Warrendale, PA REZUROCK1-877-377-786215086®isaregistered trademark of Kadmon Pharmaceuticals, LLC. © 2022 Kadmon Pharmaceuticals, LLC, Warrendale, PA 15086. All rights reserved.MAT-US-2202849-v1.0-06/2022
any new wrinkles to the specialty pharmacy accrediting process, the speakers noted during an ASHP session on accreditation.
More than 500 organizations have achieved specialty pharmacy accreditation through URAC, which launched its program in 2008, Dr. Richards said. URAC works with many different practice models, she noted, from hospital and health-system specialty pharmacies (the fastest-growing segment for new accreditations) to independent and chain pharmacies. The organization is working on a revision of its accrediting standards for specialty pharmacy and anticipates releasing its new requirements by the fourth quarter of 2022. In addition, specialty physician practice dispensing standards are under review.
The Joint Commission, founded in 1951, evaluates and accredits more than 22,000 healthcare organizations and programs in the United States, said Robert Campbell, PharmD, BCSCP, the clinical director of the organization’s Standards Interpretation Group, and director of medication management for the organization. Specialty pharmacy Table. ACHC center pharmacy USP USP <797>)
3
AccreditationPharmacyPharmacyservices • Ambulatory infusion
URAC’s Wide Range URAC, founded in 1990 as a nonprofit, independent organization validating healthcare quality practices, has several programs for pharmacy accreditation in specialty pharmacy, infusion pharmacy, mail-order pharmacy, pharmacy services and others, as well as supplemental designations for expertise in rare diseases, opioid stewardship, measurement-based care, integrated behavioral health and transitions of care, said Jenn Richards, PharmD, JD, CSP, a product development principal for the organization.
<795>) • Non-sterile compounding (Reference:
URAC’s current pharmacy accreditation requirements look at foundational skills such as operations and infrastructure, performance monitoring and improvement, as well as five focus areas specific to specialty pharmacy programs, Dr. Richards said. These areas are pharmacy operations, product handling and security, patient service and communication, reporting performance measures, and patient management. This year, URAC launched a new pharmacy services accreditation to recognize services offered beyond traditional dispensing, she said. This program offers four modules: vaccine administration, community practice, drug therapy management and pointof-care testing. Specialty pharmacies seeking this accreditation must choose at least one module to start. To become accredited, candidates must upload an application. From there, URAC will conduct a desktop review of a pharmacy’s policies, processes and more, and then conduct a validation review to ensure those procedures occur in practice. Next, all information is presented to an accreditation committee for review. Once accreditation is awarded, URAC has an ongoing monitoring process, Dr. Richards said. New Elements From TJC
• Long-term care pharmacy • Mail-order pharmacy • Specialty pharmacy (with or without DMEPOS) • PCAB Accreditation • Non-sterile compounding (Reference:
Pharmacy distinctionsa in: • Hazardous drug handling • Infectious disease specific to HIV • Nutrition support • Oncology • Rare diseases and orphan drugs a The provider must be accredited with ACHC to be eligible for a distinction service. DMEPOS, durable medical equipment, prosthetics, orthotics and supplies; PCAB, Pharmacy Compounding Accreditation Board. POLICY SP Accreditation continued from page 1 Free CE/CME now available! Safe Opioid Prescribing A Patient-Centered Approach to the FDA Blueprint A 3-Part Series RELEASE DATE: OCTOBER 27, 2021 EXPIRATION DATE: DECEMBER 31, 2022 CharlesCHAIR E. Argoff, MD YvonneFACULTYM.D’Arcy, CRNP, CNS Marc R. Gerber, MD Courtney M. Kominek, PharmD, BCPS, CPE Bill H. McCarberg, MD, FABM INDEPENDENT REVIEWER Michael Clark This activity is jointly provided by Global Education Group and Applied Clinical Education. These activities are supported by an independent educational grant from the Opioid Analgesic REMS Program Companies. Please see https://opioidanalgesicrems.com/Resources/Docs/List_of_RPC_Companies.pdfforalistingofREMSProgramCompanies. This activity is intended to be fully compliant with the Opioid Analgesic REMS education requirements issued by the U.S. Food and Drug Administration (FDA). Distributed by CMEZone.com 1.0 AMA PRA Category 1 Credit ™1.0 AANP credit1.0 ACPE credit1.0 ANCC credit Access today at www.cmezone.com/SY212 10 Specialty Pharmacy Continuum • July/August 2022
• Infusion nursing • Infusion
The sources re POLICY The sources reported no relevant financial disclosures. Web Only ASHP’s Lynnae Mahaney, BSPharm, MBA, offers her take on the keys to success.accreditationAccess specialtypharmacycontinuum.comat Lynnae Mahaney, BSPharm, MBA 800.523.8966MediDose.com EPS ® Exceptional Products and Service A Member of The Medi-Dose® Group Unit Dose,Bar NursingPharmacyCoding,&SupplyExperts! ® ® Medi-Dose EPSEPS ®...THE FORPRESCRIPTIONRIGHTPHARMACISTSPriced low and ready to go! Medi-Dose® Solid Oral Unit Dose Packaging TampAlerT ® Liquid Unit Dose Packaging MILT ® Software for Medication Identification and Bar IVLiquiDoseCoding®LabelsAdditiveDisposable Accessories Steri-Dropper ® Sterile Ophthalmic Dropper ResealableOphthalmicCleanroomCompoundingBottlesProductsSuppliesPracticeAccessoriesandUltravioletInhibitant Bags Tamper-Evident Products Bottles, Vials and Containers Operating and Procedure Room Accessories ShrinkSafe® Bands and Safety Products Tapes and Labels Maternity and Laboratory Products Record Keeping and Identification Products Storage and Transport Products Visit our website for our EZ order system! High quality, safe and effective products for medication administration, preparation and dispensing...in stock for fast shipment worldwide. Specialty Pharmacy Continuum • July/August 2022 11
The Accreditation Commission for Health Care (ACHC) has more than 30 years of experience as a nonprofit accreditor, said Timothy Safley, MBA, an ACHC program director. More than 1,000 providers carry the ACHC specialty pharmacy accreditation. ACHC pharmacy accreditations cover ambulatory infusion centers, infusion nursing and pharmacy, long-term care pharmacy, mail-order pharmacy and specialty pharmacy with or without durable medical equipment, prosthetics, orthotics and supplies, as well as accreditation for non-sterile and sterile compounding from the Pharmacy Compounding Accreditation Board, Mr. Safley said (Table). The organization also offers pharmacy distinctions for accredited organizations in hazardous drug handling, rare diseases and orphan drugs, oncology, HIV, and other areas of focus for specialty pharmacies. To meet the range of specialty pharmacy practice models, ACHC has accredited licensed providers, including community-based pharmacies, physician-based dispensing pharmacies and hospital pharmacies, he said. The organization reviews its standards annually and releases updates every February based on industry dynamics, customer feedback and expert review, Mr. Safley said. The 2022 updates for specialty pharmacy were minimal, he noted, removing the requirement for preemployment drug testing and clarifying a requirement for temperature-sensing devices to be verified and calibrated with the standards of the National Institute of Standards and Technology. To obtain ACHC accreditation, organizations should start by reading the standards and conducting an internal audit involving key personnel to create buy-in for the process. Help in preparation is available through ACHC directly, through educational workshops and other resources available from ACHCU, the accreditor’s educational arm, or through consultants. Collaborat One of the tion was for their ResourceBSPharm,programMofpharmacyDetionsmentionaccreditorstandnuancescesses.“ItwfirsthandandnotingthatAitsownspeci“Accreditatsheadded.advancemen
accreditation currently lies within the home care accreditation program, but the organization is evaluating that for the future, Dr. Campbell said. The Joint Commission has one manual using the base standards for dispensing pharmacies. It contains an applicability grid through which pharmacies can determine which standards apply based on their type. Overall, the organization looks at factors such as staff training, infection control practices and records of care, he said. It recently added three new elements of performance: two related to data collection of adherence rates, turnaround time for patient delivery of medications and associated products, and billing and coding errors; and one record of care requirement related to documentation of patient education on medication instructions and use.
• The patient care process, which covers onboarding patients, maintaining care, receipt of medications and patient satisfaction.
• Medication care, which covers medication storage, packaging and preparation, safe and secure shipping, and proper medication destruction. Regarding survey structure, the Joint Commission sends one pharmacist surveyor for one to two days, Dr. Campbell said. They review patient medical records on-site and evaluate care for patients. They do not conduct home visits but will call patients to ask questions. The Joint Commission survey also will look at medication management, emergency management and competency assessments for staff. Additionally, they talk to specialty pharmacy leadership to ask about policy/procedure development, the culture of safety and more. Surveyors will take a pharmacy tour and also review documents related to policies and procedures, information for new patients, and pharmacy licenses for those shipping across state lines, he noted. ACHC Casts a Wide Net
The organization’s survey process consists of two categories:
The most common form of eczema, AD is an inflammatory skin condition that causes dry skin (also known as xerosis or xeroderma) and itching, known as pruritus. These 2 conditions often result in scaly patches, rashes, blisters, and skin infections.1 One in 10 Americans is affected by AD. Although the condition typically develops by 5 years of age, it can start as early as birth and continue through life.2 In some children, AD symptoms may fade as they grow up, while other children will have disease flares into adulthood.3 Although the exact etiology of AD is not fully understood, new research confirms that it is related to disruptions in immune regulation, epidermal gene mutations, and other environmental factors RENEE BAIANO, PHARMD, CSP Clinical Program Manager AllianceRx Walgreens Pharmacy Pittsburgh, Pennsylvania
Patient–specialty pharmacy interaction is fundamental in the continuity of care
Atopic Dermatitis: More Than an Itch
CLINICAL
12 Specialty Pharmacy Continuum • July/August 2022
Moreover, children with AD can experience sleep disturbances, which predispose them to developing attention-deficit/hyperactivity disorder and headaches.5
Home Therapies Sometimes AD can be managed effectively with nonpharmacologic treatments and over-the-counter (OTC) topical therapies. Lukewarm baths with a mild, fragrance-free cleanser can help relieve
that disrupt the outermost layer of the skin.4 The chronic itch sensation creates a vicious cycle whereby scratching the itch only further damages the skin and leads to more itching.
Although AD is an inflammatory condition, it is commonly associated with other conditions, such as food allergy, allergic rhinitis, and asthma. There are 2 proposed theories to explain the relationship between AD and these other conditions. The first is called the inside-out theory, which suggests that dysregulation in the immune system leads to epidermal barrier dysfunction (skin breakdown). The other theory is the outside-in theory, which proposes that AD starts with an impaired skin barrier, leading to dysregulation of the immune system.7
The complex nature of atopic dermatitis (AD) and evolution of new medications for moderate and severe forms of the disease allow a specialty pharmacist to play a key role in helping patients understand why they should follow the prescribed treatment plan. By educating patients on their condition and counseling them on medication administration, adverse events, and disease activity, a specialty pharmacist can help providers and patients achieve the best clinical outcomes.
Source: National Eczema Association.
The diagnosis of AD considers 4 main factors: pruritus, dermatitis in infants or adults, chronic or relapsing dermatitis, and personal or family history. Three of these 4 major factors must be met for an AD diagnosis. Once a provider evaluates family history and rules out other conditions, such as seborrheic dermatitis, irritant contact dermatitis, allergic contact dermatitis, or plaque psoriasis,8 he or she will discuss treatment options, taking into consideration severity of disease, patient preferences, and effect on quality of life.
A survey in the United States found that 91% of patients with eczema experienced itching on a daily basis, which impairs mental health, as evidenced by studies showing that approximately 1 in 3 adults with AD reported symptoms of depression and suicide ideation. These adverse mental health effects may be partly due to embarrassment about altered appearance and lower self-esteem.5,6
Diagnosis
Atopic Dermatitis
The skin structure is disrupted in patients with atopic dermatitis (AD), leading to the release of toextremelysymptomsthatthethethewhichtothenthespinalsensationofpropagatemediatorsinflammatorythatmessagesanitchingthroughthecordanduptobrain.Thebrainsignalsthehandsstartscratching,canactivaterewardcentersofbrain,leadingtoitch/scratchcyclecanincreaseADandbedisruptivequalityoflife.
CLINICAL see ATOPIC DERMATITIS, page 14 Table. Targeted Therapy Options Approved for Atopic Dermatitis ofMechanismactionMedication Route administrationAvailableof formsIndication and dosage inhibitorkinaseJanus (Cibinqo,AbrocitinibPfizer) OralTablet• 100 mg orally once daily
• Maintenance: 300 mg every other week Patients ≥6 y: • Weight ≥60 kg: 600 mg initially, followed by 300 mg 2 wk later, then 300 mg every other week
• Weight 30 to <60 kg: 400 mg initially, followed by 200 mg 2 wk later, then 200 mg every other week
• 200 mg orally once daily is recommended for patients who are not responding to 100 mg once daily after 12 wk (Rinvoq,UpadacitinibAbbVie) OralTablet • Pediatric patients ages 12 y and older, weighing ≥40 kg, and adults >65 y: Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily
Specialty pharmacists can help educate patients on adverse events, warnings and precautions, and contraindications associated with medications. Notably, there were recent label updates to JAK inhibitors based on postmarketing trial data. Tofacitinib (Xeljanz, Pfizer), for example, had a label update in February 2021, and in September 2021, the label update was expanded to other drugs in this class. An FDA review of a large, randomized clinical trial of safety found an increased risk for serious heart-related events, such as heart attack or stroke, cancer, blood clots, and death with the JAK inhibitor medications used to treat inflammatory conditions.18 Specialty pharmacists can educate patients on side effects to watch for, what they can do about them, and when to call their physician. Additionally, these medications can cause an increased risk for developing serious infections that could lead to hospitalization. Some people have died from these infections.16,17 Pharmacists can ensure patients are screened for infections, including tuberculosis, before starting therapy, and monitor them for signs of infection throughout treatment.
• Adults ≥65 y: Recommended dosage is 15 mg once daily (Dupixent,Dupilumab Sanofi and Regeneron) SubcutaneousPre-filled syringe, pre-filled pen Adults • Induction: 600 mg initially, followed by 300 mg 2 wk later
Conventional Treatment Options
• Weight 5 to <15 kg: 200 mg every 4 wk
antagonistIL-13 (Adbry,Tralokinumab-ldrmLEOPharma) SubcutaneousPre-filled syringe• Induction: 600 mg followed by 300 mg 2 wk later
A Specialty Pharmacist’s Role: Support Improving Quality of Life
antagonist(IL)-4Interleukinalpha
• Dosage of 300 mg every 4 wk may be considered for patients with body weight <100 kg who achieve clear or almost clear skin after 16 wk of treatment discomfort.9 In addition, moisturizers and topical corticosteroids are safe and effective ways to treat AD, and are best if applied after the bath.10 Identification and management of triggering exposures is also an important part of treating AD. Triggers may include factors such as stress, viral infections, and fragrances. Changes in weather or temperature extremes can often trigger AD symptoms and lead to sweating or dryness. Environmental allergens, such as dust mites, pollens, molds, and cigarette smoke, as well as food allergens, can exacerbate symptoms.5 Although these OTC treatment options can be effective for managing AD symptoms at home, more severe disease most likely will need prescription interventions.
In the United States, AD has been estimated to cost more than $5 billion annually. These costs
Advances in Treating AD
In March 2017, the FDA approved subcutaneous dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of adult patients with moderate to severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable (Table). This interleukin (IL)-4 inhibitor marked the first biologic therapy the FDA approved for adult patients with AD. The agency later expanded the label to include children and adolescents ages 6 years and older, giving the pediatric population a new treatment option.14 On June 7, 2022, dupilumab was approved for the treatment of children ages 6 months to 5 years with moderate to severe AD whose disease does not respond to topical prescription therapies or when these therapies are not advisable. This approval makes dupilumab now the first and only biologic medicine approved to treat AD from infancy through adulthood.14
• Maintenance: 300 mg every other week
For some AD patients, stronger medications may be required for disease control. These agents include prescription topicals, prescription oral medications, and phototherapy. Topical calcineurin inhibitors (TCIs) work by regulating the immune system and help prevent inflammation and redness. Tacrolimus ointment and pimecrolimus cream are 2 TCIs available by prescription. Another FDA-approved topical medication, crisaborole (Eucrisa, Pfizer), is approved for adults and children ages 3 months and older with mild to moderate AD. It works by inhibiting an enzyme, phosphodiesterase 4, that causes inflammation.5,11Lighttherapy, or phototherapy, can be prescribed to treat AD in adults and children, and helps to reduce itch and inflammation.12 Immunosuppressive medications such as methotrexate, azathioprine, cyclosporine, and mycophenolate mofetil are sometimes used off-label.13 Biologics are indicated for patients with moderately to severely active disease. Typically, providers prescribe biologics to patients who have failed to respond to conventional therapies; however, some situations warrant earlier usage.8
JAK inhibitors should be researched by brand for any black box warnings. A specialty-trained pharmacist can assist in guiding the best treatment options, such as oral versus injectable medications, for patients with unique situations.
• Weight 15 to <30 kg: 600 mg initially, followed by 300 mg 4 wk later, then 300 mg every 4 wk Patients 6 mo to 5 y: • Weight 15 to <30 kg: 300 mg every 4 wk
In the past year, there have been numerous treatment advances and new FDA approvals for AD. Approved specialty medications target various cytokines, such as Janus kinases (JAKs) and interleukins. In December 2021, the FDA approved tralokinumab-ldrm (Adbry, LEO Pharma),the first biologic product that specifically binds to and inhibits the IL-13 cytokine, for subcutaneous use in adults with AD.15 Two oral JAK inhibitors, upadacitinib (Rinvoq, AbbVie) and abrocitinib (Cibinqo, Pfizer), received FDA approval to treat AD in January 2022. Upadacitinib, which originally received approval in 2019 for rheumatoid arthritis, was approved to treat adults and children 12 years of age and older.16 Abrocitinib is now approved for the treatment of adults.17 Both drugs are indicated for the treatment of refractory, moderate to severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of these therapies is inadvisable.16,17
Specialty Pharmacy Continuum • July/August 2022 13
Managing Medication Risks
3. National Eczema Association. Atopic dermatitis. Accessed June 29, 2022. of-eczema/atopic-dermatitishttps://nationaleczema.org/eczema/types-
14. Dupixent [prescribing information]. Regeneron Pharmaceuticals, Inc. Accessed June 29, www.regeneron.com/downloads/dupixent_fpi.pdf2022.
19. Adamson AS. Adv Exp Med Biol. 2017;1027:79-92.
21. Tymms K, et al. Arthritis Care Res. 2014;66(5):190-196. Note: For full prescribing information and warnings for any of these medicines, visit the manufacturer websites or dailymed.nlm.nih.gov.
12. Sidbury R, et al. J Am Acad Dermatol. 2014;7(2):327-349.
CLINICAL
4. Frazier W, et al. Am Fam Physician. 2020;101(10):590-598.
10. American Academy of Dermatology. Eczema treatment: corticosteroids applied to the skin. Accessed June 29, corticosteroids-applied-to-skinwww.aad.org/public/diseases/eczema/childhood/treating/2022.
5. Avena-Woods C. Am J Manag Care. 2017;23(8 suppl): S115-S123.
References 1. National Eczema Association. What is eczema? Accessed June 29, 2022. https://nationaleczema.org/eczema
7. Silverberg NB, et al. Cutis. 2015;96(6):359-361.
2. American Academy of Dermatology. Eczema types: atopic dermatitis overview. Accessed June 29, 2022. aad.org/public/diseases/eczema/types/atopic-dermatitishttps://www.
11. National Eczema Association. Prescription topicals. Accessed June 29, 2022. nationaleczema.org/eczema/ treatment/topicals
15. Adbry [prescribing information]. LEO Pharma. Accessed June 29, 2022. bit.ly/3ufWsP5 16. Rinvoq [prescribing information]. AbbVie. Accessed June 29, 2022. www.rxabbvie.com/pdf/rinvoq_pi.pdf
For years, YT was prescribed a series of medications to prevent and manage exacerbations, including methotrexate, several courses of corticosteroids, and topical therapies. Over time, this treatment became less effective. She also takes over-the-counter cetirizine to manage seasonal allergies. Relentless itching keeps YT awake most nights. Her lack of good-quality sleep, and self-isolation due to her rashes, led to development of symptoms of Duringdepression.thepatient’s recent followup dermatology appointment, she explained to her physician that she was at her wits’ end. She felt that her AD symptoms prevented her from focusing on anything, and she couldn’t continue like this anymore. She explained that she always could sense that people were looking at her rashes. Her physician referred her to a psychologist for counseling. She also wanted YT to begin a new medication to treat her AD. After discussing treatment options and YT’s preference for avoiding a daily medication, her physician prescribed dupilumab, an interleukinWheninhibitor.AllianceRx Walgreens Pharmacy received YT’s prescription for dupilumab, her health insurance required a prior authorization. Insurance specialists at AllianceRx Walgreens Pharmacy reached out to her physician to assist with this process. Once the medication was approved, YT began to receive it, and her insurance copay (ie, the patient’s financial responsibility) was more than $450 per fill. At the initiation of dupilumab therapy with AllianceRx Walgreens Pharmacy, the pharmacy’s insurance team researched several options to assist YT with her financial responsibility. Since YT had a commercial insurance plan, she qualified for the manufacturersponsored copay assistance program. The program reduced YT’s financial responsibility to $0 per dispense. During the first telephone call to YT, the pharmacist counseled her on how to take her medication and things she could do to help manage flares. Before each prescription refill, an AllianceRx Walgreens Pharmacy patient care advocate (PCA) proactively contacted YT. During the patient outreach process, the PCA used AllianceRx Walgreens Pharmacy’s disease management application, Connected Care, to obtain information from YT related to any missed doses, disease flares or decline in disease activity in the last 30 days, and any adverse events. These scheduled patient interactions promoted medication adherence and facilitated patient-specific disease management.Afteridentification of any issues or concerns based on the Connected Care algorithm, the patient received a consultation from an AllianceRx Walgreens Pharmacy specialty-trained pharmacist. As an example, during a recent call, YT reported missing several doses of her medication. When the PCA asked about this, YT said she experienced painful injections. The Connected Care algorithm prompted the PCA to transfer YT to an AllianceRx Walgreens Pharmacy pharmacist. The pharmacist provided YT with options on how to reduce injection site reactions, such as allowing the medication to reach room temperature prior to injecting. Monitoring how YT was doing on her medication allowed the pharmacist to provide an important intervention and helped ensure YT was using her medication as prescribed. Before initiating dupilumab, YT reported that she was experiencing severe discomfort related to her AD. Since starting therapy at AllianceRx Walgreens Pharmacy 3 months ago, YT reported that she already had a significant improvement in her skin rash and she was able to sleep through the night. Supporting patients like YT through pharmacist interventions and proactive refill calls offers the patient a better opportunity to have positive outcomes.Thiscase study demonstrates the key roles that a specialty pharmacy can have in assisting AD patients in managing their treatment.
Conclusion The continual interaction between the patient and specialty pharmacy is fundamental in the continuity of care for AD patients. The pharmacist must stay up-to-date on the new and alternative treatment options to educate patients as they manage their therapy. Specialty pharmacists can improve the quality of life of these patients by providing expert advice and support of treatment regimens, as well as encouraging medication adherence. Dr Baiano reported no relevant financial disclosures.
ATOPIC DERMATITIS continued from page 13 include direct costs, such as prescriptions, hospitalizations, and visits to health care providers, as well as indirect costs, including missed days or lost productivity at work or school and reduced quality of life.19 A specialty pharmacist can play a key role in identifying other opportunities for intervention with patients, including adherence. Research suggests that poor medication adherence is a significant problem in the management of AD.20 Low adherence rates can result in adverse clinical outcomes, including increased disease activity, higher healthcare costs, and possibly poor quality of life. When discussing adherence with patients, it is important for specialty pharmacists to be mindful of potential barriers patients can face. It is common for patients to have improved symptoms and misinterpret this as meaning they no longer need medication. This type of patient-driven undertreatment is one of the most common causes of nonadherence in various chronic inflammatory conditions. Patients tend to be concerned with the current state of their disease rather than future disease control.21 Other common reasons for nonadherence include financial barriers, fear of side effects, and complexity of the treatment plan. Identifying obstacles to adherence and educating patients on the importance of taking their medication can increase the patient’s chance of disease improvement. Whether it is helping patients take their medication the right way or notifying their prescriber about new adverse events, a specialty pharmacist plays a vital role in helping patients to manage their condition. AllianceRx Walgreens Pharmacy offers education on specialty disease states and medications in the form of pharmacist counseling and educational materials. At AllianceRx Walgreens Pharmacy, our team of specialty-trained pharmacists takes a proactive approach to encourage medication adherence. After initiation of therapy, pharmacists schedule consultations with AD patients. Before each subsequent refill, they conduct outreach assessments to follow up with patients and schedule delivery of their refilled medication. During these proactive interactions, AllianceRx Walgreens Pharmacy team members, using a proprietary patient management platform, assess the patient for missed doses, medication adverse events, and worsening of disease symptoms. Any patient concern or identified issue leads to a clinical escalation. The pharmacist counsels the patient and provides education and support with follow-up notification to the patient’s prescriber, as needed. By identifying nonadherence and other concerns, the specialtytrained pharmacist can provide the patient with the required patient-specific, supportive care.
17. Cibinqo [prescribing information]. Pfizer. Accessed June 29, 2022. https://labeling.pfizer.com/ShowLabeling. aspx?id=16652
13. National Eczema Association. Prescription orals. Accessed June 29, 2022. childhood/treating/strong-medicinewww.aad.org/public/diseases/eczema/
18. FDA. New FDA Drug Safety Communication on Tofacitinib (Xeljanz, Xeljanz XR), Baricitinib (Olumiant), and Upadacitinib (Rinvoq) - Drug Information Update [Sept 1, 2021]. Accessed June 29, 2022. accounts/USFDA/bulletins/2ef5ee3content.govdelivery.com/
6. Yu SH, et al. Dermatology. 2015;135(12):3183-3186.
20. Krejci-Manwaring J, et al. J Am Acad Dermatol. 2007;56: 211-216.
14 Specialty Pharmacy Continuum • July/August 2022
8. Fleming P, et al. J Am Board Fam Med. 2020;33(4):626-635.
9. American Academy of Dermatology. How to bathe a child who has eczema. Accessed June 29, 2022. public/diseases/eczema/childhood/itch-relief/bathe-childwww.aad.org/
Patient Case YT is a 34-year-old woman who was originally diagnosed with atopic dermatitis (AD) when she was 2 years old.
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80% of respondents to a payor survey reported that racial and ethnic disparities had a moderately significant impact on medication access and utilization.
Source: ICON Market Access.
ISO
The survey evaluated how payors gather and track social determinants of health (SDOH), their high-priority disease states, what they believe they need to address disparities, their perceived impact of disparities on medication access and utilization, and their current and planned efforts in this area, said Renee Rizzo Fleming, RPh, MBA, the president of PRN Managed Care Consulting Services, in East Amherst, N.Y. Payors typically review data from claims, case manager screenings and more, and use that information to match members to programs that meet their SDOH needs, such as access to care, housing or transportation help, Ms. Fleming said. Payors also track needs through Z codes: additional codes provided in the International Classification of Diseases, Tenth Revision to report nonmedical factors influencing health status. For example, code Z63 would indicate difficulty with a patient’s family/support, such as alcoholism or drug addiction. Approximately 71% of payors in the ICON report used Z codes to monitor SDOH; however, they said less than 20% of submitted claims included these codes. As more clinicians become aware of and use Z codes, payors can increasingly match patients to appropriate programs and resources, Ms. Fleming said. Diabetes, maternal health, heart disease and psychiatric disorders were among the conditions that payors reported were of highest priority to them, she said. Payors also reported that additional budgets and personnel are essential to implement programs to address racial and ethnic disparities, along with more technology and data acquisition.
By Karen Blum CHICAGO—Less than 20% of providers submitted claims using a type of payment code that could help identify and address health disparities that adversely affect patient outcomes, according to a new ICON Market Access report. The results come amid a growing call for payors and pharmaceutical manufacturers to work together to better address racial and ethnic health inequalities, speakers said during the AMCP 2022 annual meeting.
80% of respondents to a payor survey reported that racial and ethnic disparities had a moderately significant (855) 937-2242 x458 achc.org customerservice@achc.org 9001:2015 CERTIFIED.
Such health disparities exist in nearly all U.S. states, said Jessica Cherian, PharmD, RPh, the vice president of content and strategic services for ICON Market Access, citing a 2021 Commonwealth Report, In 2021, her company surveyed 32 payor executives for their perceptions regarding health disparities in racial and ethnic groups, with a targeted focus on medication access and utilization.
MORE EXPERIENCED YOUR TRUSTED PARTNER IN PHARMACY ACCREDITATION FOR OVER 20 YEARS Cost-EffectiveSolutionsCustomerExceptionalService SurveyEducationalApproach 16 Specialty Pharmacy Continuum • July/August 2022
CLINICAL
Tools for Addressing SDOH Underused
Payors believe their organizations could have a positive impact on lack of patient education and transportation, but were less likely to think they could affect a lack of insurance coverage or prescribing bias, she said. However, over the next one to three years, payors reported having more confidence that initiatives they undertake to address racial and ethnic health disparities will have a positive impact on access and medication use. More respondents have been partnering with community and local organizations, government bodies, and patient/caregiver advocacy organizations to address disparities in medication access and use, but there are additional opportunities to build relationships with technology companies, pharmaceutical manufacturers and disease management organizations, Ms. Fleming said.
The sources
Manufacturer Response Some pharmaceutical manufacturers such as Genentech are actively studying health equity and its effects on patient care. Early disease detection and education, and education about medication adherence, are areas that potentially can be culturally sensitive and dependent to a degree on health literacy, noted Juny Simpson, the health equity director for the company. “This is meant to close those educational gaps that we know exist across all patient demographics,” she said.
When proposing partnerships among payors and manufacturers to address disparities, questions should consider potential shared goals within a therapeutic area, ICON Market Access’s Dr. Cherian said. It is also important, she noted, to consider opportunities for intervention along the patient journey and how the impact of potential solutions could be measured. reported no relevant financial disclosures than their stated employment.
The company has been focusing on initiatives to diversify its workforce and clinical trials, and cultivating partnerships to advance diversity and inclusion across healthcare communities. A health equity study funded by the company in 2020 and 2021 that surveyed more than 2,000 U.S. adults, including 1,206 who identified as medically disenfranchised, found that 52% of those patients believed the healthcare system was flawed, or rigged against them. Half stopped seeking care or didn’t ask questions for fear of being misunderstood or thought to be unintelligent, Ms. Simpson noted.
other
Overall, 80% of respondents reported that racial and ethnic disparities had a moderately significant impact on medication access and utilization, Ms. Fleming said. A lack of medication adherence and affordability were two of the key factors payors reported to have the greatest impact in this arena, followed by deficits in health literacy, medication persistence and transportation.
CLINICAL More on the Web Manufacturers address SDOH. Access specialtypharmacycontinuum.comat TODAYREGISTER 2October-29September WASHINGTON D.C. Gaylord National Resort & Convention Center Ig-NS.org/IgNS2022 IgNS 2022 11th National Conference Use Code PPN20 to Get 20% DISCOUNT Scan the Code to Register!213 The IgNS 2022 Conference is around the corner. Let’s get started with 3 easy steps to attend! Choose the pre-conference course that’s right for you Register for the IgNS 2022 BookConferenceyourroom - we’re almost sold out Immunoglobulin | Biologics | Plasma Therapies Specialty Pharmacy Continuum • July/August 2022 17
12. Are there population-specific differences in pharmacodynamics/pharmacokinetics?
Unfortunately, Mr. Wake’s experiences are commonplace among patients with SCD, agreed Emily G. Tsiao, PharmD, a clinical pharmacist at Premera Blue Cross, the largest health plan in the Pacific Northwest, who shared the platform with Mr. Wake at the meeting. “The pandemic highlighted that we have a lot of health disparities in our healthcare system,” Dr. Tsiao said. “In the sickle cell community, that disparity and inequality are well documented and go back decades.”
Resolving the healthcare disparities that exist for patients with sickle cell disease (SCD) was a priority for Premera Blue Cross because they were impeding the provision of care for its members with SCD, said Emily G. Tsiao, PharmD, a clinical pharmacist at Premera, the largest health plan in the Pacific Northwest. The insurer focused on formulary utilization management (UM) strategies to enable SCD patients to gain access to opioids for chronic pain and vaso-occlusive crisis related to ApproximatelySCD.2million members receive their medical benefit, with roughly half also receiving their pharmacy coverage through Premera, which serves people mainly in two states: Washington and Alaska. Approximately 11% of pharmacy benefit members used an opioid at some point in 2021, and about 2% of them required a long-acting opioid, according to Dr. Tsiao. “Premera has a long history of promoting safe and lawful use of opioids. We have prior authorization [PA] requirements for members for requesting a greater than seven-day supply of an opioid, when they have not been treated with an opioid recently, and a PA for long-acting opioids as well. We also have a quantity check for patients being treated with opioids.”
“My case was called in to the hospital as an early 30s, Black male with drug overdose or intoxication,” Mr. Wake said. “They never once considered that I had sickle cell or some other condition. It was only after being in the hospital that I was able to flag down a nurse and write down with my nondominant hand, three words—sickle cell stroke—and that probably saved my life because my triage changed.”
Mr. Wake cited several statistics showing that the problem is indeed endemic. A multicenter study compared research and funding for two conditions: SCD, which mainly affects Black people, and cystic fibrosis (CF), which occurs primarily in white individuals (JAMA Netw Open 2020;3[3]:e201737). According to the study, the National Institutes of Health spent 11 times more for CF research than for SCD research, and the study found similar funding disparities from national foundations.
—M.R. 7 Formulary
13. What barriers to accessing this treatment could patients face? How can we help?
Among its members, 142 people with SCD used the pharmacy benefit in 2021, and about 61 (43%) required an opioid that year; 80% used long-acting opioids, according to Dr. Tsiao. The UM guidelines were put in place after the 2016 release of the CDC’s “Guideline for Prescribing Opioids for Chronic Pain.” Unfortunately, legitimate pain patients, such as those with SCD, who were on existing opioid regimens—and in many cases benefiting from them—were tapered to lower doses or taken off the medications entirely by physicians after those guidelines were released, David Dickerson, MD, the section chief for pain medicine at the NorthShore University HealthSystem, in Chicago, told our sister publication Pain Medicine News (bit.ly/3PJN136-SPC).
15. What challenges does SCD pose in a patient’s daily life? How will the drug help overcome them?
16. What socioeconomic, logistical or geographic factors might hinder successful therapy?
14. What education do providers need to ensure optimal use of the drug?
CLINICAL Sickle
Perceived Drug Seeking a Common Mistake
Premera began to exclude SCD members from opioid UM requirements in April 2020, after the CDC said its original guideline for prescribing opioids was not intended to deny clinically appropriate opioid regimens. The insurer said its decision also was based on information gleaned from a report by the Institute for Clinical and Economic Review (ICER) that highlighted the challenges SCD patients faced in obtaining opioids, as well as a Medicare recommendation that beneficiaries with SCD be excluded from real-time opioid safety edits (bit.ly/3BmJYts-SPC; bit.ly/3cGoXiY-SPC; go.cms.gov/3JjKTNm). The ICER report really struck Dr. Tsiao. “That report aligned with my experiences supporting sickle cell patients in the hospital. ICER can really be an important resource to help manage organizations as they address any health disparities that exist for a certain area.”
continued from page 1 18 Specialty Pharmacy Continuum • July/August 2022 C LINI C AL
“Cystic fibrosis actually receives more than 440 times the national funding than sickle cell disease patients,” Mr. Wake said, adding that there are almost twice as many papers about CF than SCD in the peer-reviewed literature.Heunderscored the racial demographics of both disorders when considering those research and funding disparities. About 35,000 people, mostly white, have CF in the United States. In contrast, for SCD, “we’re How Premera Addressed SCD Coverage Inequities
11. Will the SCD drug be used in an underserved population? How can we identify the patients?
To accomplish this exemption, Dr. Tsiao and her colleagues met with internal stakeholders, including those from the pharmacy and therapeutics committee and medical policy committee, about the exemption. The insurer also issued an update to providers and members and made sure that case managers and customer service personnel also were aware of the policy. The team also took steps to ensure that prompts in the electronic prior authorization (e-PA) software asked about SCD. “Our goal was to ensure that providers and patients knew that members with sickle cell disease are exempt from our utilization management criteria,” she said. “We also allow member IDs associated with a sickle cell disease by diagnosis code with a claim for an opioid to bypass that hard stop at the pharmacy when a patient goes to fill an opioid prescription.”Dr.Tsiaoand her colleagues documented modest increases in the number of members with SCD using opioids after the exemption went into effect. About 43% of Premera’s members with SCD used an opioid in 2021 versus 41% in 2019, and about 8% of members with SCD used a long-acting opioid in 2021 versus 7% in 2019. They also saw a modest increase in the percentage of members with SCD who have more than 90 morphine milligram equivalents per day (14% from 2020 to 2021), and also a modest increase in the number of members with SCD who were using an opioid long term and a high-risk drug, such as a muscle relaxant, from about 29.1% in 2020 to 29.4% in “Taking2021. advantage of e-PA and UM capabilities when excluding SCD members from opioid UM requirements will decrease the administrative burden for SCD members and their providers,” Dr. Tsiao said. “When it comes to addressing disparities specifically in formulary development, there is a need for the pharmacy team to really take charge and bring these considerations to the forefront for our decision makers in meetings like our independent committee, the internal medical policy committee and other forums.” Review
17. What cultural factors (e.g., distrust of healthcare) might hinder drug therapy? Cell Struggle
People with SCD, an inherited disorder, have intermittent episodes of sudden, severe pain that lasts hours to days, which is caused when the sickled red blood cells occlude the small blood vessels. The treatment is opioids—often required at a higher dose than the patient takes for chronic, noncrisis pain (Eur J Haematol 2020;105[3]:237-246). However, that legitimate need for increased opioids often is horribly misconstrued in emergency departments (EDs), as evidenced by another visit to the hospital that Mr. Wake related. He described sitting in the ED for six hours in sickle cell crisis, waiting to be seen. It took this long, he said, not because there was a huge backup, gun violence or any number of other situations that can delay care in a busy ED. He was ignored because the ED staff assumed he was seeking drugs. When he finally convinced them he was having a vaso-occlusive crisis related to SCD, he left with the same opioid dose he takes for his daily pain, not the amount he needed while in crisis. “I’ve been labeled a drug seeker on multiple occasions when I seek care for a sickle cell crisis. I go the extra mile now to carry identification with me and update my patient portal, so that there’s no question that I have sickle cell disease,” said Mr. Wake, who is the president of the Uriel E. Owens Sickle Cell Disease Association of the Midwest, in Kansas City, Kan. He stressed that his experience is not uncommon. “Patients with sickle cell wait up to 50% times longer than those patients who show up in the ER with longbone fractures, even though evidence has shown that aggressive pain treatment can reduce the duration the sickle cell patient is in pain. It can reduce complications and irreversible tissue damage,” Mr. Wake explained, citing data from a published study (Am J Emerg Med 2013;31[4]:651-656).
Questions
There are more than 130 comprehensive care centers for hemophilia, which affects about 20,000 people, but very few for SCD, especially in low-income and rural communities, according to Mr. Wake. “Barriers also exist within the urgent care centers, where many patients receive their care for sickle cell pain crisis. Patients are often labeled as drug seeking, and their pain severity is questioned. Patients often feel the need to get dressed, do their hair and makeup, and put on their best ‘face,’ so that they give the best first impressions when they meet the staff at the hospital,” Mr. Wake said. Another barrier is recognizing coping mechanisms, he said. Tuning into their cellphones and playing videos or listening to music is a coping mechanism, especially for children and adolescents. Yet, this behavior leads to more questions about whether people are “really in crisis and at the pain level that they say.”
‘The CDC clarified that their guidance on opioids for chronic pain was not intended to deny clinically appropriate opioid therapy to any patients who suffer from acute or chronic pain for having sickle cell disease.’
Hematology Hematology PrimaryCare Maybe Coordinator NurseCare Team PainM CanagementPare r imary CounselorGenetic WorkerSocial Services P s ychiatric OpticalCDentalNardiac euro. Neph.
10 Tips for Breaking Down SCD Rx Barriers Here are 10 tips for removing barriers to care, addressing social determinants of health and improving outcomes for patients with sickle cell disease (SCD), from Kevin Wake, the president of the Uriel E. Owens Sickle Cell Disease Association of the Midwest, in Kansas City, Kan.
Children with SCD receive comprehensive care, which has greatly decreased mortality. They lose that support network when they transition to adult care.
7. Increase access to disease-modifying therapies.
Proactive Approach Many of the above strategies are based “on being proactive versus reactive,” Mr. Wake said. He reiterated the importance of creating and encouraging “preventive health payment programs that focus on self-care.” Such an approach is critical “for improving health outcomes for all patients, not just pediatric patients.” The strategies for ensuring widespread access to SCD care, including disease-modifying therapies, also are key, Mr. Wake stressed. In the process, “we need to look at what the issues are that are preventing patients from getting access to theseWhenmedicines.”implementing improvements, don’t forget the patient, he added. Patients should provide input into any programs for them to be truly meaningful and useful to them. “We need to make sure we have a seat at the table, because if we don’t have a place at the table, we often wind up being left off the menu.” —M.R.
5. Improve the transition from pediatric care to adult care. 6. Improve insurance coverage for SCD that includes preventive care.
Specialty Pharmacy Continuum • July/August 2022 19
9. Overcome the shortage of specialists in SCD and work toward attracting specialists by providing mentoring programs.
1. Highlight the importance of patients keeping regular appointments, promoting self-care and treatment programs, as well as mental healthcare.
CLINICAL
—Emily G. Tsiao, PharmD
Pediatric SCD care, however, has improved greatly, with children receiving complete and comprehensive care. These efforts have significantly decreased mortality—95% of children with SCD now survive to adulthood (MMWR Morb Mortal Wkly Rep 2017;66[46]:1269-1271). But when they transition to adult care, they lose that supportive network that helps them navigate a complex healthcare system. “In the U.S., we love our pediatric patients,” Mr. Wake explained. “They [benefit from] a multidisciplinary approach to caring for patients [Figure]. They receive care not only from their hematologist and their primary care provider, but they also [have a care coordinator who helps manage treatments from] all specialists, including vision care, dental care, dietary specialists and even mental health specialists.”
10. Improve funding for SCD research.
8. Develop a national or statewide system to keep track of SCD patients, and ensure they receive needed care.
A recent study (JAMA Netw Open 2019;2[5]:e194410) highlighted the attitudes of some physicians as a particular problem. The 15 patients in the study reported that: • they faced increased barriers to the use of opioids for pain management; • their physicians exclusively focused on opioid dosage without establishing a multimodal pain management plan; and • they lacked access to nonopioid therapies. Dr. Tsiao agreed that opioid therapy for SCD can be overly restricted, even though the 2016 CDC “Guideline for Prescribing Opioids for Chronic Pain” specifically excludes patients with SCD from its opioidciariesDr.acutepriatechronicline.html).(www.cdc.gov/opioids/providers/prescribing/restrictionsguide-“TheCDCclarifiedthattheirguidanceonopioidsforpainwasnotintendedtodenyclinicallyappro-opioidtherapytoanypatientswhosufferfromorchronicpainforhavingsicklecelldisease,”Tsiaosaid.Infact,“CDCrecommendedthatbenefi-withsicklediseasebeexcludedfromreal-timesafetyedits.”
Next Steps Mr. Wake underscored that these kinds of provider misconceptions about SCD, coupled with continuing access issues, are “negatively impacting patients’ health, their psychological well-being and ultimately disease outcomes.” However, those outcomes can be improved if strategies are implemented that help patients navigate the complex healthcare system and enable them to advocate for themselves, as Mr. Wake was taught early by his mother, who was a nurse. “It is important to improve access to care for people with SCD, enhance the patient–provider relationships, and teach providers about SCD and pain management,” Mr. Wake said. The sources reported no relevent financial disclosures.
2. Improve access to care, especially in rural and underserved areas. Many primary care providers do not accept SCD patients because they “can be difficult,” and their care is complicated.
3. Build more comprehensive care centers for SCD. 4. Teach providers at urgent care centers about SCD pain and how to recognize coping mechanisms.
Lack of Training Another Impediment Besides the inequalities in care, many healthcare providers lack training in pain management for SCD, and are overly influenced by the opioid crisis when they prescribe treatment, even though studies have shown that SCD patients are not at higher risk for opioid overdose and death ( Blood 2008;111[3]:997-1003). Although Mr. Wake said SCD patients are regularly discriminated against by providers, the healthcare system and third-party payors, the situation has become worse since the opioid crisis.
looking at 100,000 patients, and more than 90% of those patients are African American.”
For years, therapeutic options for graft-versus-host disease (GVHD) had been limited. Although several recent approvals have helped, clinicians will need to determine how the new agents fit into the armamentarium for this challenging condition.
This activity is jointly provided by Global Education
PaulFacultyE.Sax, MD Clinical Director, Division of Infectious Diseases Professor of Medicine, Harvard Medical School Brigham and Women’s Hospital Boston, Massachusetts Julia Garcia-Diaz, MD, MSc, FACP, FIDSA, CPI Director Clinical Infectious Diseases Research Director Medical Student Research Associate Professor, University of Queensland Brisbane, DepartmentAustraliaInfectious Diseases Ochsner Health System New Orleans, Louisiana Group Applied from ViiV Healthcare and Merck & Co., Inc.
Distributed by Infectious Disease Special Edition and CMEZone.com 1.0 AMA PRA Category 1 Credit ™ Access today at www.cmezone.com/CU213 20 Specialty Pharmacy Continuum • July/August 2022
By Bob Kirsch
“Having three FDA-approved therapies for patients with chronic GVHD [cGVHD], a debilitating condition, is truly remarkable, given that just over five years ago there was not a single FDA-approved therapy available to these patients,” said Amin M. Alousi, MD, the director of the GVHD Clinic and Research Program, and a professor of stem cell transplantation at The University of Texas MD Anderson Cancer Center, in Houston.
Clinical Education. This activity is supported by an educational grant
Ruxolitinib (Jakafi, Incyte) received an indication in September 2021, both for the treatment of steroid-refractory acute GVHD (aGVHD) in adults and children who are 12 years of age and older and for treatment of cGVHD after failure of one or two lines of systemic therapy.“Akinase inhibitor, ruxolitinib affects the signaling of various cytokines and growth factors while also altering signaling pathways connected to the development, proliferation and activation of multiple immune cell types relevant in GVHD,” Dr. Alousi explained. Belumosudil (Rezurock, Kadmon/ Sanofi) was approved in July 2021 to treat patients who are 12 years of age and older with cGVHD, after failure of at least two prior lines of systemic therapy. “This novel drug inhibits a protein believed pivotal for both skewing T cells toward an inflammatory phenotype, [and it] plays a role in multiple fibrotic pathways that are aberrant in patients with chronic GVHD,” Dr. Alousi said. These medications have a pediatric indication, “whereas ibrutinib [Imbruvica, Pharmacyclics/Janssen] is only approved for adult patients,” observed Doris M. Ponce, MD, a hematologic oncologist at Memorial Sloan Kettering Cancer Center, in New York City, and the lead author of the 2021 Guidelines for the Prevention and Management of Graft-Versus-Host Disease After Cord Blood Transplantation of the American Society for Transplantation and Cellular Therapy Cord Blood Special Interest Group Abatacept (Orencia, Bristol Myers Squibb) received an indication in December 2021 for the prophylaxis of aGVHD, with a calcineurin inhibitor and methotrexate, in adults and children who are 24 months of age and older undergoing hematopoietic stem cell transplantation from a matched or one allele–mismatched unrelated donor. Abatacept is a selective T-cell co-stimulation modulator that works by inhibiting a signal needed for T-cell activation.
and
CLINICAL Between 20% and 70% of patients who receive an allogeneic stem cell transplant as a part of their cancer treatment will develop at least a mild case of GVHD.
New Approvals for GVHD Expand Treatment Options
Free CE/CME now available! Managing HIV Multidrug Resistance: A Persistent Challenge RELEASE DATE: DECEMBER 1, 2021 EXPIRATION DATE: DECEMBER 31, 2022
CLINICAL ‘Having three FDA-approved therapies for patients with chronic GVHD, a debilitating condition, is truly remarkable, given that just over five years ago there was not a single FDA-approved therapy available to these patients.’
efficacy, high percentage of patients having improvement in symptom burden, novel mechanism of action and high safety profile have “driven enthusiasm for this therapy.”
GVHD.”Thedemonstrated
—Amin M. Alousi, MDAmin M. Alousi, MD
Abatacept’s indication is for prophylaxis of aGVHD, Dr. Alousi pointed out. “It is important to note that this therapy is the first—and to date only— drug approved in the United States for prevention of GVHD.”
The pharmacists’ role in treating cGVHD is not limited to clinical recommendations and monitoring. They can be important conduits of information between doctors, patients and insurance companies, according to Nancy M. Nix, PharmD, a pharmacy oncology clinical coordinator at Ballad Health, in Johnson City, Tenn. “Patients will view the relationship with their pharmacist differently from the relationship with their oncologist,” Dr. Nix said. “They will tell you things about their medication that they won’t tell the doctor because they think doctors [focus primarily on] their physical care, and so they choose to tell the pharmacist about their drug care. But the physician really needs to know all this information before he or she makes a choice of treatment, and due to our role, we can relate this information to physicians.”
Abatacept The standard prophylaxis for GVHD consists of a calcineurin inhibitor [tacrolimus/cyclosporine] with methotrexate or mycophenolate, and although there are a number of additional approaches, they are off-label, Dr. Alousi explained. These approaches may involve in vivo or ex vivo depletion of T cells. Recently, there has been a marked increase in the use of cyclophosphamide, which “when administered on the third and fourth day following the transplant, has been highly effective in reducing not only acute but also severe forms of chronic GVHD,” he said. “I think it is very unlikely that abatacept will be widely used for GVHD prophylaxis when compared with more affordable and generally accepted forms of GVHD prophylaxis, such as cyclophosphamide-based regimens,” heDiscussingsaid. the trials upon which abatacept approval was founded, Dr. Alousi pointed to “a number of limitations of these trial results that will limit widespread use of the drug for GVHDAmongprevention.”thelimitations, the control group did not receive any of the commonly used and available strategies to mitigate the well-detailed increased rates of aGVHD and diminished survival resulting from use of a mismatched unrelated donor, and the growing use of cyclophosphamide-based GVHD prophylaxis strategies across the world. Published results from prospective and retrospective studies have shown “significant reductions in severe acute and severe chronic GVHD across various donor types: matched, mismatched, half-matched family, etc. How abatacept would measure up against this commonly employed GVHD mitigation strategy was not studied in the trial leading to approval.” So, what does the clinician do? Especially for cGVHD, “I do not think the relevant question is when would a prescribing provider chose therapy X over therapy Y,” Dr. Alousi said. “Given that very few patients with steroid-refractory chronic GVHD will have a complete response to any therapy, it is likely that the majority of patients with this disease” will receive several different medications throughout their lives, both indicated and offlabel medications, he added. “A more likely question will be one of affordability, given the price of these drugs and chronic nature of the disease,” he explained.
—Additional reporting by Myles Starr Dr. Alousi reported serving as an advisory board member for Incyte and Kadmon Corp. and has received research funding from Incyte. Dr. Nix reported no relevant financial disclosures. Dr. Ponce reported serving as an advisory board member for CareDx, Ceramedx, Evive Biotechnology (Shanghai) Ltd., Incyte and Kadmon Corp., and has accepted researchfromfundingIncyte.
Specialty Pharmacy Continuum • July/August 2022 21
In regard to the pivotal belumosudil study, he noted that “the impressive results with a 75% response rate and 60% improvement in symptom burden are even more significant when considering the study population had very advanced and heavily treated chronic
The recent approvals address a large unmet need for patients who have undergone a allogeneic stem cell transplant, according to Dr. Ponce. During the autumn of 2020, “I was using off-label treatments for patients who had progressed or not responded to the only drug the FDA had approved at that time, ibrutinib,” she added. Dr. Alousi noted that “enthusiasm for the first approved therapy, ibrutinib, has been limited,” due to concerns that the phase 2 trial included too few patients (n=42); that the study population poorly reflected real-world patients (most had one or two organs involved and were relatively early in the course of the disease); and that the toxicity (fatigue, diarrhea and infections) seen with the study dose was not insignificant. Ruxolitinib Ruxolitinib, in contrast, “has broad appeal,” Dr. Alousi said, “because there has been considerable experience with this drug in chronic GVHD, even prior to its FDA Hematologists’approval.”experience with this drug date back to its 2011 approval for patients with myelofibrosis. Although anemia, neutropenia and thrombocytopenia can be seen when using ruxolitinib in the cGVHD setting, this is less of a consideration with aGVHD patients, and “can generally be managed through dose reductions or holding the drug,” Dr. Alousi said. Cytopenias are common in the setting of aGVHD, which at times can make continuation of this drug challenging. Further, the randomized trial “failed to show a reduction in non-relapse mortality, with roughly half the patients in both arms experiencing non-relapse death by 18 months post-enrollment.” Of note, “the fact that it has demonstrated efficacy when compared headto-head with other therapies also gives weight to the data,” he said.
Belumosudil Features High Response Rate Describing belumosudil as “the popular new kid on the block,” Dr. Alousi explained that its “unique mechanism of action with potential to halt the fibrotic process common to chronic GVHD contributes to its appeal. Further, the high response rates in the ROCKstar study that were seen in such a high-risk, heavily treated study population along with the 60% of patients who had clinically meaningful improvement in symptom burden supports the enthusiasm for this drug” (Blood 2021;138:2278-2289).
By David Bronstein
The Vanderbilt team, led by specialty pharmacist Amanda Kibbons, PharmD, considered this research approach “about three years ago, when we wanted to evaluate our adherence rates and any opportunities to improve them,” Dr. Zuckerman said. Their initial investigations showed they had more than 1,000 patients with a proportion of days covered (PDC) of less than 80%, versus a baseline overall rate of 95%. So, the next question was how to identify the key drivers of nonadherence in that cohort, as well as strategies to address them, in a way that worked with the demanding schedule of pharmacists tasked with performing the prospective research. A Tale of 2 Databases
The sources reported no relevant financial disclosures.
‘Pragmatic study design’ lauded Research Tool Ups Adherence for SP Therapies
One key piece of this puzzle was to engage with a health information technology partner within the medical center to build a connection between the pharmacy software system and Vanderbilt’s Research Electronic Data Capture (REDCap) system. “REDCap is actually external to our electronic health record, but it allowed us to efficiently perform randomization and collect patient and intervention data,” Dr. Zuckerman said. “We then developed a daily report of patients who met our inclusion criteria, which was securely transferred to a server. An API [Application Programming Interface] was built between the server and REDCap, such that we had automatic importing of the data into REDCap each evening.” When the pharmacist who was assigned to the research project had dedicated time to devote to it, “she would review the newly imported patients for reasons for nonadherence,” Dr. Zuckerman explained. “If they had no appropriate gaps in treatment, she would randomize them within REDCap.” But the effort wasn’t only about numbers: “We also engaged patients in the process by asking them about the main medication adherence barriers they were facing,” she emphasized.
The prospective study that emerged focused on patients who had more than four fills of the same specialty medication in the previous 12 months and a PDC of less than 90%. A total of 439 patients were included in the final analysis, with an even split between patients given usual care and those who received pharmacist interventions to address key drivers of medication noncompliance.
Diving a bit deeper into the data, median PDC at six months was 0.95 versus 0.90 for patients in the intervention and usual care arms, respectively (P=0.003); at eight months, 0.94 versus 0.88 (P<0.001); and at 12 months, 0.93 versus 0.87 (P<0.001).
TECHNOLOGY
Dr. Stubbings, a member of the advisory board for Pharmacy Practice News and Specialty Pharmacy Continuum, also lauded the research approach taken by the Vanderbilt team. “I like the prospective study design with a control group and the PDC measures taken after a reasonable time—four months for baseline and eight months for intervention,” she said. “The Vanderbilt group demonstrated that monitoring adherence and targeted interventions such as memory aids can significantly improve adherence in the long run. We can all put these findings into action to improve patient outcomes.”
Vanderbilt’s health information technology partner helped build a connection between Vanderbilt’s pharmacy software and its Research Electronic Data Capture (REDCap) system.
22 Specialty Pharmacy Continuum • July/August 2022
—Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP
Overcoming Challenges The pragmatic study design approach taken by the Vanderbilt team allowed for several invaluable tweaks, Dr. Zuckerman noted. For example, “we found that reviewing patients when they showed up on the nonadherence report was burdensome and required significant manpower,” she said. “So, we enlisted an additional floater pharmacist to help with patient review.”
“There is so much about this study design that excites me,” commented JoAnn Stubbings, BSPharm, MHCA, a clinical associate professor emerita in the Department of Pharmacy Practice, University of Illinois Chicago College of Pharmacy, and one of the founding members of UIC’s Specialty Pharmacy program. “The interface between the pharmacy software system and REDCap was innovative and efficient.”
As for when to consider employing a pragmatic study design in clinical practice, “if you’re planning to develop a new service or change services, maybe this is how you assess its effectiveness,” Dr. Zuckerman said. She also stressed the benefits of involving your IT department in the process. “By all means, engage health IT and your research experts. They are likely at your institution, so the good news is that you don’t have to necessarily reinvent the wheel.”Finally, when doing any type of research, it’s important not to lose sight of the importance of providing high-quality care amid all of the data crunching, Dr. Zuckerman noted. “We certainly don’t want to reduce the care we’re providing,” she said. “Rather, we want to optimize it by identifying an add-on service or a better method for providing patient care.”
PHOENIX—Using a research tool known as pragmatic study design, investigators at Vanderbilt Specialty Pharmacy identified a large cohort of patients who were nonadherent to their medications and developed several targeted interventions that significantly improved compliance. But it was the value of the methodology, as much as the study results, that Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP, the director of Health Outcomes and Research at Vanderbilt Specialty Pharmacy, in Nashville, Tenn., emphasized. “Contrary to a controlled clinical trial, pragmatic studies must fit into normal workflow and allow for variation in practice,” Dr. Zuckerman said during a Specialty Pearls session at the 2022 ASHP Summer Meetings and Exhibition. “This is important for those of us integrating research into practice, because it takes into account the challenges, intricacies and behaviors of patients and clinicians in a nonclinical trial setting.”
The most common interventions were related to memory (27% of all reasons for nonadherence), which included setting up memory aids on patients phones or sending pill boxes. Additionally, for patients who were unreachable to schedule a refill (20%), the pharmacist attempted to contact them via phone, patient portal, and finally mail, Dr. Zuckerman noted. “Our primary outcome was PDC at eight months, post-enrollment,” she said. “We found that at that time point, intervention patients were 1.8 times more likely to have a higher PDC than usual care, illustrating the effectiveness of the interventions.”
Excited by Study Design
‘Contrary to a controlled clinical trial, pragmatic studies must fit into normal workflow and allow for variation in practice.’
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