Emerging pediatric technologiesPediatric Technology Watch | 2019 Volume 4

2Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Table of contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Market watch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Increases seen in the cost of pediatric hospital stays 3

Doctors recommend decreasing the use of cough and cold medicines

among children 3

Economic watch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Price projections affecting the pediatric market 4

Technology watch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Innovative medical devices in the pediatric pipeline 5

Currently available products 6

Products in development or investment phase 6

Supplier watch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Sarstedt 7

DandleLion Medical 7

Translite LLC 8

Seca 8

Pharmaceutical watch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Novel drug approvals, and new indications and formulations 9

New drug approvals 9

New indications 10

New formulations 11

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Disclaimer: Vizient® staff attend clinical sessions at important scientific meetings throughout the year. The staff meet with suppliers, review new technologies and monitor data from pertinent clinical trials. The information is consolidated into this overview of product and practice trends in the various pediatric segments. This document is intended to educate nonclinical hospital staff by offering insights into new and innovative technologies. Vizient staff members have no personal financial connections with the suppliers and no conflicts of interest in the development of this document. The products and trends presented are for educational purposes. Vizient does not endorse any of the products described in this document.

3Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Introduction Children require specialized, compassionate and comprehensive care. The Vizient Pediatric Technology Watch is intended to educate and provide insights into new and innovative technologies that support delivery of the highest-quality pediatric care. This issue highlights

the latest products and pharmaceuticals available in the market, as well as emerging technologies. It also features Vizient pricing projections for both products and pharmaceuticals.

Market watch

Increases seen in the cost of pediatric hospital stays According to a recent brief released by the Agency for Healthcare Research and Quality, "Healthcare Cost and Utilization Project Statistical Brief #250: Costs of Pediatric Hospital Stays, 2016,"1 the cost of pediatric stays is on the rise, as indicated by the distribution of aggregate hospital costs and hospital stays in 2016 by type of stay and patient age. The brief highlights that in 2016, the average hospital cost for pediatric non-birth stays was $13,400 — 68.9% more compared to $8,900 for complicated births and $1,200 for uncomplicated birth stays. The average hospital cost for inpatient stays for complicated births was over seven times higher than the average cost for stays for uncomplicated births in 2016.

Five diagnostic categories constituted 67.7% of aggregate hospital costs among pediatric stays in 2016:

• Newborns and other neonates: 39.8%

• Respiratory system: 9.0%

• Circulatory system: 7.3%

• Nervous system: 6.0%

• Musculoskeletal system: 5.6%

A recent research article in Health Affairs2 discussed quality improvement efforts that aimed to reduce high hospitalization rates in children by focusing on social determinants of health. The study used population health improvement initiatives to develop and refine a method focused on narrowing equity gaps across broader geographic areas. Interventions included the optimization of chronic disease management; transitions in care; mitigation of social risk; and use of actionable, real-time data. The results showed the inpatient bed-day rate for two target neighborhoods decreased by 18% from baseline (July 2012-June 2015) to the improvement phase (July 2015-June 2018). In addition, hospitalizations decreased by 20%.

Doctors recommend decreasing the use of cough and cold medicines among childrenIn 2008, the US Food & Drug Administration (FDA) recommended that over-the-counter cough and cold medicines not be administered to children younger than 2 years, due to concerns about efficacy and safety as well as the deaths of three infants with high levels of pseudoephedrine in their systems. Soon thereafter, manufacturers voluntarily modified their cough and cold medicine product labels to state that they should only be used in children 4 years and older, and the American Academy of Pediatrics recommended that cough and cold

medicines not be administered to children younger than 6 years. Subsequent national US utilization studies through 2010 showed equivocal effects on pediatric cough and cold medicine use. A recent study published in JAMA Pediatrics3 found that for children under 2 years old, prescriptions for nonopioid cough and cold medicines decreased by 70%; for children under 6 years old, prescriptions dropped by 90%. Overall, a decrease in recommending cough and cold medicines was seen due to serious potentially fatal side effects among younger children.

4Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Table 1 shows the national price inflation projection over the next 18 to 24 months. Vizient expects overall market prices for supplies to increase to 1.8% in late 2019 and 2020. Table 2 shows projected changes in drug prices over the next 18 months.

Table 1 Projected supply price changes over the next 18 to 24 months

Product categoryNational price inflation

projection (%)

Cardiology (overall) 1.4

Cardiac rhythm management -0.5

Drug-eluting stents -1.1

Orthopedic (overall) 0.6

Orthopedic supplies 0.5

Joint implant -1.7

Spinal -0.1

Trauma 1

Neurosurgical 2.2

IV solutions 3

Medical/surgical supplies 0.9

Medical equipment 1.2

Imaging equipment -1.3

Laboratory equipment 0.3

Laboratory consumables 1.1

Medical gases 5.4

Purchased services 2.1

IT hardware -2.1

IT software -1.3

IT services 1

Commercial printing 2

Office supplies 2.6

Product categoryNational price inflation

projection (%)

Furniture 3.2

Water 3.5

Electricity 1.2

Natural gas 2.2

Telephone (wireless) -2.1

Internet 0.5

Food overall 3

Overall projected price change 1 8

Source: Vizient Budget Impact Projections Report, Q2 2019. Abbreviations: IT = information technology; IV = intravenous.

Table 2 Projected drug price changes

Product group

Estimated price change weighted by Vizient

purchases (%)

Contract purchases 1.22

Noncontract purchases 3.35

Total weighted average drug price inflation estimate

4.57

Children’s Hospital Association inflation

Contract purchases 1.19

Noncontract purchases 2.16

Total weighted average drug price inflation estimate

3.35

Source: Vizient Drug Price Forecast, July 2019. The July 2019 Drug Price Forecast is our best estimate of the change in the cost of pharmaceuticals that participants in the Vizient Pharmacy Program will be purchasing between Jan. 1, 2020, and Dec. 31, 2020. The forecast focuses on pharmaceutical products used across multiple health system settings, including inpatient and non-acute environments, and provides a year-over-year estimate of the expected price change. Vizient market price projections are forecasts, not predictions. Forecasts are point-in-time estimates of price changes and are subject to changes in market conditions.

Economic watch

Price projections affecting the pediatric market

5Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Technology watch

Innovative medical devices in the pediatric pipelinePediatric device approvals peaked in fiscal year 2017, according to data included in an annual report to Congress posted by the FDA (Figure 1). Still, the 16 premarket approvals (PMAs) and two humanitarian device exemptions the agency authorized for young patients accounted for only 27% of all the devices it approved that year.4 According to the FDA, over the last 10 years the average pediatric device approval rate per year has been about 24%.4 A quarter of the 16 PMAs granted in 2017 focused on diabetes; these included continuous glucose monitoring and insulin pump systems from Dexcom, Abbott, Tandem and former Johnson & Johnson insulin pump manufacturer Animas.

The list also included three laser systems, two defibrillators, two diagnostic tests, a sinus implant, a transcatheter pulmonary valve and an occluder for patients with patent foramen ovale, a hole in the heart that can lead to stroke. Just two of the devices — a vagus nerve stimulation system and a ventricular assist device — were designed first and foremost with children in mind, which, under section 738(a)(2)(B)(i) of the Federal Food, Drug and Cosmetic Act, allowed the manufacturers of those devices to forego application fees.

Figure 1 Number of FDA-approved pediatric devices, 2008-2017

Source: US Department of Health and Human Services. Annual report: Premarket approval of pediatric uses of devices, FY 2017. US Food & Drug Administration website. https://www.fda.gov/media/128659/download?utm_campaign=2019-07-10%20CDRH%20New&utm_medium=email&utm_source=Eloqua. Accessed October 1, 2019.

Abbreviation: FDA = US Food & Drug Administration.

02468

101214161820

Num

ber

of a

ppro

ved

devi

ces

Fiscal year

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Neonates (birth to 28 days) Infants (29 days to < 2 years)

Children (2 to < 12 years) Adolescents (12 through 21 years)

6Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Currently available products

LifeBubble Umbilical Catheter Securement System (Novonate)

Designed for neonates in intensive care, LifeBubble secures and protects the umbilical catheter insertion site, preventing the transmission of infection from caregivers and parents.

Status: LifeBubble is a commercial product that is registered with the FDA and available to neonatal intensive care units in the US.

Products in development or investment phase

AlgometRx Rapid Drug Test (AlgometRx, Inc )

The AlgometRx Rapid Drug Test is used to detect and monitor neonatal abstinence syndrome, enabling the physiological stress of opioid withdrawal to be evaluated and addressed earlier.

Status: In development

Epilog Seizure Monitoring (Epitel)

Epilog is an inexpensive, discrete and disposable electroencephalogram machine that provides real-time monitoring of neonates suspected of having hypoxic-ischemic encephalopathy, revolutionizing the way they are cared for at community hospitals.

Status: In development

Raydiant Oximetry Sensing Systems (Raydiant Oximetry, Inc )

The Raydiant Oximetry Sensing System is a novel, noninvasive technology that more accurately detects fetal distress during labor and delivery, reducing medically unnecessary cesarean deliveries and the number of newborns suffering from metabolic acidosis.

Status: FDA Breakthrough Medical Device, approval requested

Rhaeos FlowSense monitoring device (Rhaeos, Inc )

FlowSense is a wearable device that noninvasively monitors ventricular shunt function in patients who have hydrocephalus, obviating the need for imaging and unnecessary hospital visits and admissions.

Status: Investment phase

Aucutus Surgical Tethering System (Aucutus Surgical, Inc )

Aucutus has begun development on a dynamic surgical tethering system for non-fusion growth modulation in the pediatric population. The system uses a magnetically driven nonsurgical adjustment mechanism activated by an external controller.

Status: Intellectual property patent filed

AmnioBed incubator (Amnion Life LLC)

AmnioBed is a fluid-filled incubator with 13 subsystems, creating a warm and safe environment that promotes the growth and development of preterm infants. It incorporates synthetic amniotic fluid in a self-regulating, sterile submersion bath incubator system that improves thermoregulation, reduces water loss and reestablishes the natural fluid environment.

Status: Investment phase

7Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Supplier watch

Sarstedt

Company overview

Sarstedt has been developing, producing and selling medical devices and consumables since 1961, and has an extensive product portfolio of blood collection systems for neonates, infants, toddlers and children. Sarstedt’s pediatric-specific technology ensures its Micro-Needle and Safety-Heel systems— both of which have been designed for the neonate population — are safe and gentle.

S-Monovette

The S-Monovette is an innovative enclosed blood collection system that enables the user to minimize the filling volume

of each collection to keep the diagnostic blood loss for pediatric patients as low as possible. In addition, its small size and low nominal volumes help keep patient discomfort to a minimum. The dual collection system does not require sample transfers, which improves specimen quality, with studies showing that it reduces overall hemolysis fifteen fold and practically eliminates subsequent rejection compared to vacuum tube collection. This innovative enclosed blood collection technology eliminates the 90-minute diagnostic delay that typically occurs with each rejected sample, saving up to $300,000 per year in re-collections and increasing ED turnover.

DandleLion Medical

Company overview

DandleLion Medical provides evidence-based products that promote neuroprotective care for babies. All of its products are created at the suggestion of clinicians or with an advisory team of clinicians.

Crown Cradle

The Crown Cradle is a noninvasive, nonrestrictive adjustable orthotic device that supports the development of a hospitalized infant’s natural head shape. The Crown Cradle relieves pressure on the occiput, allowing cranial development without the impact of negative external forces. The two-part system includes a specialized mattress with removable foam inserts, both of which comfortably cradle the head and help promote proper

alignment of the head, neck and spine at a 4-degree incline. The foam layer is easily removed and replaced with a plug for prone positioning. Deformational plagiocephaly (DP), characterized by cranial flattening, ear misalignment, frontal bossing and facial asymmetry, can occur as a result of limited positioning options on a bed surface that is often too firm. DP can have negative short- and long-term effects on hospitalized infants, contributing to altered parental attachment, neurobehavioral problems and social isolation. Studies have also linked DP with gross and fine motor delays, communication deficits, and vision and hearing problems. Studies have shown that the Crown Cradle may reduce the potential impact to the infant’s head by redistributing contact pressure, supporting the cranium and providing a pathway for more symmetrical skull growth.

8Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Translite LLC

Company overview

Translite LLC designs, manufactures and sells medical devices that help reduce pain and trauma to patients during venous access and treatment of varicose veins. In 1999, it revolutionized vein imaging and access with the introduction of the Veinlite. Translite continues to launch new, best-in-class portable vein access devices.

Veinlite Pedi and Neo

Although peripheral intravenous catheter intervention is frequently used in pediatric emergency departments, it is still regarded as a difficult task, as pediatric patients have smaller blood vessels that are often surrounded by subcutaneous tissue and that can be difficult to see superficially. The Veinlite Pedi and Neo are transillumination

devices used to improve vein access in neonates, infants and children, and have been clinically proven to improve vein access success rates. Studies5 have shown that transilluminators improve first-attempt cannulation while near-infrared devices do not impact the first-attempt success rate. The Veinlite Pedi facilitates through-the-body illumination, and is specifically designed for infants and neonates, while the Veinlite Neo is a revolutionary new transillumination device designed to detect both veins and arteries in neonates. A recent randomized control trial6 compared the use of Veinlite Pedi with the medical standard of care (SoC) in 112 children. The primary outcome measure was the first-attempt success rate, which was significantly higher in the Veinlite group compared with the SoC group (92.9% vs. 72.2%).

Seca

Company overview

Since 1840, Seca has been developing innovative, practical weighing technologies and has become the world's market leader in the field of medical measuring and weighing. Its measuring systems and scales, which are sold by 16 branch offices and exported to 110 countries, are no longer regarded as isolated devices but are instead becoming integral parts of networked systems. Seca devices can identify patients and transmit their measured values directly into an electronic patient record.

It’s vital that pediatric patient data be entered accurately, without the hassle of manual data entry or risk of errors. That’s why Seca has designed a line of baby scales focused on optimizing processes, saving time, reducing costs and improving patient safety. Seca supports integration solutions with a wide range of electronic medical record (EMR) systems including Epic, Allscripts, Athenahealth, Philips and many others. In addition, it is the only provider of medical scales that is validated by the Cerner CareAware VitalsLink platform.

Seca 333 i

The precise Seca 333 i baby scale is equipped to meet diverse pediatric demands and features an optional digital measuring rod. The EMR-certified connectivity transmits weight and length directly into the EMR, eliminating manual

transcription errors. With routine work simplified by its integrated Wi-Fi technology, the digital measuring rod and an optional bar code scanner for patient identification, medical staff have more time to care for their little patients.

Seca 374

The Seca 374 EMR-validated baby scale is ergonomic, convenient and saves time. The scale transmits weight and length measurements directly into an EMR system with the press of a button, and its extra-large weighing tray can easily weigh a seated toddler up to 44 pounds.

Seca 727

The Seca 727 embodies precision, and features an EMR-validated scale with fine 1 gram graduation for detecting even the slightest weight changes. The scale is ideal for use in a neonatal intensive care unit and the wireless transmission of measurements eliminates manual entry errors. An advanced integrated damping system together with an Auto-Hold function provide quick, precise weighing even if the baby is restless. The backlit LCD display ensures that digits can be easily read, even in rooms with dim lighting.

9Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

Pharmaceutical watch

Novel drug approvals, and new indications and formulationsThe projected drug inflation rate through December 2020 is predicted to be 4.57% weighted by Vizient member purchases, while the pediatric drug inflation rate is predicted to be 3.35%. Nearly one-third of the overall spend for vaccines is associated with Prevnar (Pfizer) and Gardasil 9 (Merck). A preferential recommendation by the Centers for Disease Control and Prevention for Shingrix (GlaxoSmithKline) over zoster vaccine live has resulted in a Shingrix shortage, but overall spend is expected to rise when more product is released. In a review of more than 6,000 hospitals across the US, it’s estimated that drug shortages are costing facilities at least $359 million per year in additional spend on labor alone.7 Table 3 shows the top 10 drugs based on total expenditures among self-governed children’s hospitals.

Table 3 Top 10 drugs based on children’s hospital spenda

Dinutuximab (Unituxin; United Therapeutics)

Pegaspargase (Oncaspar; Baxalta)

lnfliximab (Remicade; Janssen Biotech)

Asparaginase (Erwinaze; Jazz Pharmaceuticals)

Eculizumab (Solaris; Alexion)

Sildenafil (Revatio; Pfizer)

Palivizumab (Synagis; AstraZeneca)

Pneumococcal 13-valent conjugate vaccine (Prevnar-13; Pfizer)

Dornase alfa (Pulmozyme; Genentech)

Pegfilgrastim (Neulasta; Amgen) a Based on overall spend among Vizient members for April 1, 2018, through March 31, 2019.

New drug approvals

Triclabendazole (Egaten) tablet for oral use (Novartis Pharmaceuticals Corporation)

Triclabendazole is the only drug that is FDA approved and recommended by the World Health Organization for the treatment of fascioliasis (liver fluke infestation), which is estimated to infect 2.4 million people globally. The recommended dosage is two doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older.

Immune globulin intravenous human-slra (Asceniv) injection (ADMA Biologics, Inc )

Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes — such as bacteria and viruses — and prevent against infection and disease. Ascensiv is indicated for the treatment of primary humoral immunodeficiency in adults and adolescents 12 to 17 years of age. It prevented serious bacterial infection among 59 patients treated for 12 months during a pivotal investigation.

Dengue tetravalent vaccine, live (Dengvaxia) suspension for subcutaneous injection (Sanofi Pasteur, Inc.)

Dengue disease, a mosquito-borne viral infection, is endemic in the US territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands. Dengue tetravalent vaccine is the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes in patients aged 9 through 16 years.

Onasemnogene abeparvovec-xioi (Zolgensma) suspension for intravenous infusion (AveXis)

Onasemnogene abeparvovec-xioi is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 gene. Onasemnogene abeparvovec-xioi joins nusinersen (Spinraza) as the second treatment for children with SMA.

10Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

New indications

Dupilumab (Dupixent) injection for subcutaneous use (Regeneron Pharmaceuticals)

Dupilumab is indicated for the treatment of patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies. The approval also represents the first FDA-approved biologic treatment option for adolescents with moderate to severe AD. In adolescents, the recommended dose is based on weight.

Belimumab (Benlysta) injection for subcutaneous and injection for intravenous use (GlaxoSmithKline)

Belimumab is the first drug approved for the treatment of pediatric systemic lupus erythematosus (SLE). This approval extends the current indication in adults to patients aged 5 years and older with SLE.

Glecaprevir/pibrentasvir (Mavyret) tablet for oral use (AbbVie, Inc )

Glecaprevir/pibrentasvir is the first pangenotypic hepatitis C virus (HCV) treatment approved in pediatric patients. This approval extends the current indication in adults to patients aged 12 years and older infected with any of the six identified HCV genotypes. A boxed warning states that there is a risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.

Ivacaftor (Kalydeco) granules and tablet for oral use (Vertex Pharmaceuticals, Inc )

Ivacaftor is the first cystic fibrosis transmembrane conductance regulator (CFTR) modulator to treat infants with cystic fibrosis (CF) as young as 6 months. This approval extends the current indication in pediatric patients aged 12 months and older to pediatric patients aged 6 months to less than 12 months.

Avelumab (Bavencio) injection for intravenous use (EMD Serono, Inc )

Avelumab is an immunotherapy that may help the immune system fight Merkel cell carcinoma, a skin cancer, and urothelial cancer, a cancer in the bladder or urinary tract. It is also indicated for first-line treatment in combination with axitinib (Inlyta) of patients with advanced renal cell carcinoma (RCC). This combination joins pembrolizumab plus axitinib as the second immunotherapy combination regimen for the treatment of advanced RCC.

Ruxolitinib (Jakafi) tablet for oral use (Incyte Corporation)

Ruxolitinib is a kinase inhibitor indicated for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adults and pediatric patients 12 years and older. It is a targeted treatment that helps keep the production of blood cells under control. Ruxolitinib is the first FDA-approved treatment for steroid-refractory GVHD.

Infliximab-abda (Renflexis) injection for intravenous use (Merck Sharp & Dohme)

Infliximab-abda is a biosimilar for Remicade. It is a tumor necrosis factor blocker indicated for reducing the signs and symptoms of moderately to severely active ulcerative colitis, as well as inducing and maintaining clinical remission in pediatric patients who have had an inadequate response to conventional therapy. It is also used to treat autoimmune diseases.

Liraglutide recombinant (Victoza) injection for subcutaneous use (Novo Nordisk)

This new indication represents the first FDA approval of a noninsulin drug for the treatment of type 2 diabetes in pediatric patients in 19 years. It is indicated as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus.

OnabotulinumtoxinA (Botox) injection for intramuscular use (Allergan)

This supplemental approval expands the use of Botox for treatment of upper limb spasticity due to cerebral palsy or stroke to pediatric patients age 2 to 17 years.

Tezacaftor/ivacaftor and ivacaftor (Symdeko) tablet for oral use (Vertex Pharmaceuticals Incorporated)

Indicated for the treatment of CF in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.

11Emerging pediatric technologies — Pediatric Technology Watch | 2019 Volume 4© 2019 Vizient, Inc. All rights reserved.

New formulations

Amifampridine (Ruzurgi) tablet for oral use (Jacobus Pharmaceutical Company, Inc )

Amifampridine is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome, a disease in which the immune system attacks the body's own tissues, in patients 6 to less than 17 years of age. Ruzurgi is the second FDA-approved formulation of amifampridine.

Midazolam (Nayzilam) nasal spray (UCB)

Midazolam is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters and acute repetitive seizures) that don’t follow a typical seizure pattern in epilepsy patients 12 years of age and older. This is the second FDA-approved rescue therapy for seizures; the first was rectal diazepam (Diastat).

Thiola EC (tiopronin) – delayed release tablets for oral use (Mission Pharmacal)

This medication is used in combination with high fluid intake, alkali and diet modification to prevent kidney stones in people with cystinuria, an inherited disorder. It prevents cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria who are resistant to changes in diet and high fluid intake.

Amlodipine (Katerzia) oral suspension for oral use (Azurity Pharmaceuticals)

Katerzia is the first and only FDA-approved amlodipine oral solution. It is a calcium channel blocker indicated for the treatment of hypertension in adults and children 6 years and older, and for the treatment of coronary artery disease including chronic stable angina, vasospastic angina and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%.

Glucagon (Baqsimi) nasal powder for intranasal use (Eli Lilly and Company)

This approval represents the first emergency treatment for severe hypoglycemia that does not have to be administered by an injection in patients with diabetes 4 years of age and older.

References1 Moore BJ, Freeman WJ, Jiang HJ. Costs of pediatric hospital stays, 2016:

statistical brief #250. Healthcare Cost and Utilization Project (HCUP) website. https://hcup-us.ahrq.gov/reports/statbriefs/sb250-Pediatric-Stays-Costs-2016.pdf. Published August 2019. Accessed September 26, 2019.

2 Beck AF, Anderson KL, Rich K, et al. Cooling the hot spots where child hospitalizations rates are high: A neighborhood approach to population health. Health Affairs website. https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2018.05496. Published September 2019. Accessed September 26, 2019.

3 Horton DB, Gerhard T, Strom BL. Trends in cough and cold medicine recommendations for children in the United States, 2002-2015. JAMA Network website. https://jamanetwork.com/journals/jamapediatrics/article-abstract/2740225. Published July 29, 2019. Accessed September 26, 2019.

4 US Department of Health and Human Services. Annual report: Premarket approval of pediatric uses of devices FY 2017. US Food & Drug Administration website. https://www.fda.gov/media/128659/download?utm_campaign=2019-07-10%20CDRH%20New&utm_medium=email&utm_source=Eloqua. Accessed October 17, 2019.

5 Heinrichs J, Fritze Z, Klassen T, Curtis S. A systematic review and meta-analysis of new interventions for peripheral intravenous cannulation of children. PubMed.gov website. https://www.ncbi.nlm.nih.gov/pubmed/23823270. Published July 2013. Accessed September 26, 2019.

6 Gümüs M, Bąbakkal Z. Efficacy of Veinlite PEDI in pediatric peripheral intravenous access: A randomized controlled trial. TransLite LLC website. https://www.veinlite.com/media/downloads/pedi-randomized-controlled-trial.pdf. Published 2018. Accessed September 26, 2019.

7 Vizient Drug Price Forecast. Vizient website. https://www.vizientinc.com/drug-price-forecast. Published July 2019. Accessed October 17, 2019.

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