IFICTRA TNI - BIOSUPPLY TRENDS QUARTERLY
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
FALL 2 0 18
Artific
cial
Intelligence
gence
ce
ENHANCING DIAGN
NOSTICS AND TREAT
TMMENT
CHA
ANGING LIVES WIITH
Cordd Blood Trraansplantss
UNDERSTA
ANDING
Migrraines
TREEAT
TING CHRO
ONIC
PA
AIN WIITH
Medical Marijuana
SCIIG fooor
The Groowthh of Biosimilars
rs: CIID
DP Maainteenance
NEW THERAP
PEUTIC OPTIONS Therapyy p. 46
8 Critical Sttep
eps
Purchasing
R
TURE
FAC
NU
MA
At FFF, we only purchase products from thhe manufacturer–never from
another distributor or source. This means the integrity of our products
is never in question from tampering or mishandling.
Storage
We store and transpoort viable protein compounds that are sensitive
to temperature variattions. Temperature controlled, monitored 24/7,
and supported with bbackup generators in the event of power loss.
Speciialty Packaging
WHXVHRQO\FHUWLƓHG,TXDOLƓHG, environmentally-friendly
packaging, taking extra precautions for frozen and
refrigerated
a products.
Interactive Allocation
Assures responsible, demand-based distribution of critical-care
products in challenging market conditions. Reduces potential for
gray-market purchasing to accommodate critical demand issues.
To Guarannteed
Channel Integrity ™
D
Delivery
We deliver only to facilities with a state-issued license, and onnly to the
adddress on the license. We make no exceptions. It is our comm mitment
too do everything in our power too prevent products from enterring a
seecondary distribution channel..
0HWKRGVRf'HOLYHU\
Monitoring aand adjusting for extreme weather
a conditions
allows time-ssensitive delivery to ensure product integrity.
VHULƓFDWLRQ
In compliance with DSCSA requuirements, every product shippedped
froom FFF is accompanied by a packing
acking slip that includes information
rmation
reegarding the manufacturer andd presentation, as well as the three T's:
Transaction Information, Transaction
ction History and Transaction Statement.
TrDFNLQJ
To meet DSCSA requirements, FFF providess product traceability
information on all packing slips. In addition, Lot-Track®
electronically captures and permanently stores each product lot
number, matched to customer informationn, for every vial of drug we supply.
y
Our commitment to a secure pharmaceutical supply chain
is demonstrated by our flawless safe
ety record.
More than 29 counterfeit-free years
Since 1988
FALL 2018 | Special Focus: INNOVATION
Features
16 Artificial Intelligence and
Big Data — A Crossroads
BioSources
54 BioResources
of Interoperability Literature for the
biopharmaceuticals
and Capability industry
By Amy Scanlin, MS
20 55 BioResearch
20 The Future of Cord Blood
By Ronale Tucker Rhodes, MS
Cutting-edge
biopharmaceuticals research
32
56 BioDashboard
28 Biosimilars: From
Concept to Reality
Product availability, average
wholesale prices and
reimbursement rates
By Trudie Mitschang
32 Medical Marijuana
and the Opioid Crisis About BioSupply Trends Quarterly
BioSupply Trends Quarterly is the definitive source for industry
By Diane L.M. Cook trends, news and information for healthcare professionals in the
biopharmaceuticals marketplace.
36 Update on Migraines
By Jim Trageser
BioSupply Trends Quarterly (ISSN 1948-2620) is a national
publication, with quarterly themed issues.
36 Publisher: FFF Enterprises, Inc., 44000 Winchester Road,
Temecula, CA 92590
41 Myths and Facts: Complex
Regional Pain Syndrome
Subscriptions to BioSupply Trends Quarterly are complimentary.
Readers may subscribe by calling (800) 843-7477 x1351.
By Ronale Tucker Rhodes, MS The opinions expressed in BioSupply Trends Quarterly are
those of the authors alone and do not represent the opinions,
policies or positions of FFF Enterprises, the Board of
Directors, the BioSupply Trends Quarterly Advisory Board
or editorial staff. This material is provided for general
Up Front BioFocus information only. FFF Enterprises does not give medical
advice or engage in the practice of medicine.
5 Publisher’s Corner 46 Industry Insight BioSupply Trends Quarterly accepts manuscript submissions
Exciting Advancements in Subcutaneous Immune Globulin in MS Word between 600 and 2,500 words in length.
Disease Diagnosis and Treatment Maintenance Therapy for CIDP: Email manuscripts to or request submission guidelines
By Patrick M. Schmidt An Idea Whose Time Has Come at editor@BSTQuarterly.com. BioSupply Trends Quarterly
By Keith Berman, MPH, MBA retains the right to edit submissions. The contents of each
submission and their accuracy are the responsibility of the
author(s) and must be original work that has not been,
BioTrends Watch 52 Patient Profile nor will be, published elsewhere, without the written
Medical Marijuana: permission of BioSupply Trends Quarterly. A copyright
6 Washington Report A Patient’s Perspective agreement attesting to this and transferring copyright to
Healthcare legislation By Trudie Mitschang FFF Enterprises will be required.
and policy updates Advertising in BioSupply Trends Quarterly
BioSupply Trends Quarterly has a circulation of 40,000,
8 Reimbursement FAQs 53 Physician Profile with an approximate readership of more than 100,000
Medical Marijuana: decision-makers who are comprised of general practice
Proposed 2019 OPPS Rules A Physician’s Perspective physicians, hospital and clinic chiefs of staff and buyers,
By Bonnie Kirschenbaum, MS, FASHP, FCSHP By Trudie Mitschang pharmacy managers and buyers, specialist physicians and
other healthcare professionals.
10 Industry News
Research, science and For information about advertising in BioSupply Trends Quarterly,
manufacturer updates you may request a media kit from Ronale Tucker Rhodes
at (800) 843-7477 x1362, rrhodes@bstquarterly.com.
4 BIOSUPPLY TRENDS QUARTERLY | Fall 2018
UP FRONT Publisher’s Corner
Exciting Advancements in
Disease Diagnosis and Treatment
LOOKING BACK AT the history of medicine underscores just
how far we have come — from making diagnoses “based on what
ancient physicians could observe with their eyes and ears,” to the
development of the microscope that “revealed not only the cellular
structure of human tissues, but also the organisms that cause disease,” to the establishment of
the clinical laboratory and the development of new biological treatments in the 20th century.1
Today, modern methods of diagnosing and treating diseases continue to make exciting
advances, several of which we highlight in this issue.
Some tout artificial intelligence (AI) as the future of medicine. As we explore in our article
“Artificial Intelligence and Big Data — A Crossroads of Interoperability and Capability,” there
are different forefronts of AI. One, known as “deep learning,” provides the potential for
machines to learn via repetition to detect diseases far more accurately and faster than could ever
be possible by humans. Another, known as the “deep patient,” allows machines to sift through
vast amounts of data and link comparative trends to help humans make decisions that will
develop better roadmaps to care. But AI also comes with many unknowns — especially when
looking at its capabilities for altering genes. Clearly, as AI moves forward, it will be necessary
to scrutinize its ethical and legal ramifications.
Another area of treatment predicted to radically transform medical strategies over the next few
decades is the use of cord blood in transplants. While cord blood was once considered a useless
byproduct, it is now known to contain stem cells that can be harvested, stored and used to save
the lives of people with more than 80 different diseases. In our article “The Future of Cord
Blood,” we explain the importance of cord blood for hematopoietic stem cell transplants. We
also delve into cord blood’s advantages and limitations, because while there is no denying it is
lifesaving, especially for those with blood and immune system disorders and for ethnic
minorities who are limited in locating potential bone marrow donors, its benefit in transplants
for adults is hampered due to the small volume of stem cells collected in one cord blood unit.
As such, considerable research is being conducted to expand the usefulness of cord blood
transplants, as well as to assess its ability to treat a host of other diseases.
On another front, while not as favorable as generics in reducing the cost of drugs, biosimilars
will undoubtedly have an impact, with many predicting a reduction in price by about one-third
or more. Biosimilars have been widely available in Europe for more than a decade, and finally,
the number of approvals in the U.S. is starting to make headway. Even so, manufacturers of
biosimilars in the U.S. face many challenges, as we explain in our article “Biosimilars: From
Concept to Reality.” These include patient satisfaction and safety, demonstrating interchange-
ability and extrapolating indications. Nevertheless, biosimilars have support from payers and
regulators, so it will be essential to create policy frameworks to ensure their continued approval.
As always, we hope you enjoy this issue of BioSupply Trends Quarterly, and find it both
relevant and helpful to your practice.
Helping Healthcare Care,
Patrick M. Schmidt
Publisher
1. Berger D. A Brief History of Medical Diagnosis and the Birth of the Clinical Laboratory. MLO, July 1999. Accessed at www.academia.dk/Blog/wp-
content/uploads/KlinLab-Hist/LabHistory1.pdf.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 5
BIOTRENDS WATCH Washington Report
CMS Launches New HHS Loosens Restrictions on
Voluntary Bundled Short-Term Health Plans
Payment Model
A final rule issued by the U.S.
In a continued move toward value- Department of Health and Human
based care that shifts to information Services (HHS) allows insurers to once
technologies that better manage care, again sell short-term health insurance for
risk and cost, the Centers for Medicare up to 12 months, as well as makes the
and Medicaid Services (CMS) has plans renewable for up to three years. The
launched a new voluntary bundled rule overturns an Obama administration
payment model that qualifies as an directive that limited these plans to 90
advanced alternative payment model days. Short-term plans differ from other
(APM) under its quality payment Affordable Care Act (ACA) plans because
program (QPP). The new model, they can bar people with preexisting
called Bundled Payments for Care health conditions, limit coverage, set
Improvement (BPCI) Advanced, is annual and lifetime caps on benefits,
part of the BPCI initiative developed and cover fewer prescription drugs. in 2018. Factors driving the increase
by the Centers for Medicare and Most exclude benefits for maternity include medical inflation, but CBO also
Medicaid Innovation to test innovative care, preventive care, mental health services cited the administration’s decision last fall
payment and service delivery models or substance abuse treatment. to drop payments to insurers for lowering
that could reduce Medicare, Medicaid Administration officials estimate short- deductibles for certain low-income policy-
and Children’s Health Insurance term plan premiums could be half the holders. The same report expects premi-
Program expenses while preserving or cost of the more comprehensive ACA ums for ACA plans to increase 15 percent
enhancing the quality of care for bene- plans, and predict approximately 600,000 in 2019, partly due to consumers being less
ficiaries. Participants will receive pay- people will enroll in the plans in 2019, likely to purchase coverage without the
ments for performance on 32 different with 100,000 to 200,000 of those threat of a tax penalty. v
clinical episodes such as major joint dropping ACA coverage to do so. Just
replacement of the lower extremity over 14 million people are enrolled in Appleby J. Trump Administration Loosens Restrictions on Short-Term
Health Plans. Kaiser Health News, Aug. 1, 2018. Accessed at
(inpatient) and percutaneous coronary ACA plans this year. According to a khn.org/news/trump-administration-loosens-restrictions-on-short-
term-health-plans/?utm_campaign=KHN%3A%20Daily%20Health
intervention (inpatient or outpatient). recent Congressional Budget Office %20Policy%20Report&utm_source=hs_email&utm_medium=email
“BPCI Advanced builds on the earlier (CBO) report, premiums for the average &utm_content=64888976&_hsenc=p2ANqtz--5OhM5pXfdCB2BV-
jYegaOtWozm4M6Quvtf9Sb6_rHveBb3vzZsSWdswS9QrDs326c6
success of bundled payment models benchmark ACA plan rose by 34 percent Dyk9Rxy3m1ggLf-HlnVUNQxZQ&_hsmi=64888976.
and is an important step in the move
away from fee-for-service and toward
paying for value,” said CMS
Administrator Seema Verma. “In CMS Restores Risk Adjustment Program
BPCI Advanced, participants will be
expected to redesign care delivery to After a brief suspension of the Centers rule will restore operation of the risk-
keep Medicare expenditures within a for Medicare and Medicaid Service’s adjustment program and mitigate some of
defined budget while maintaining or (CMS) risk-adjustment program, the the uncertainty caused by the New Mexico
improving performance on specialty agency adopted an interim final rule to litigation,” said CMS Administrator
quality measures. Participants bear restore $10.4 billion in funding to insurers Seema Verma.
financial risk, have payments under the to help them provide coverage to sick and The risk-adjustment program is not
model tied to quality performance and costly enrollees. The final rule makes no funded by taxpayer dollars; rather, it is
are required to use Certified Electronic changes to the program other than restor- collected from insurers that have healthier
Health Record Technology.” v ing it. CMS cited its reason for stopping enrollees overall and then given to insurers
payments was a court ruling from a federal with sicker, more expensive enrollees to
help cover their costs. v
Slabodkin G. CMS Launches New Voluntary Bundled Payment
Model. Health Data Management, Jan. 10, 2018. Accessed at judge in New Mexico who found the
www.healthdatamanagement.com/news/cms-launches-new-
voluntary-bundled-payment-model. administration had not fully justified its Weixel N. Trump Admin Restarts Key ObamaCare Payments. MSN News,
July 25, 2018. Accessed at www.msn.com/en-us/news/politics/trump-
formula for dispensing the funds. “This admin-restarts-key-obamacare-payments/ar-AAAnnCw.
6 BIOSUPPLY TRENDS QUARTERLY | Fall 2018
Washington Report
FDA Introduces Biosimilar Action Plan
On July 18, the U.S. Food and Drug comparator products;
Administration (FDA) introduced its • Establishing an Office of Therapeutic
Biosimilar Action Plan (BAP) to help Biologics and Biosimilars;
speed up approvals to enhance access to • Continuing to provide education to
lower-cost biologics. With biologics rep- healthcare professionals about biosimilar
resenting 40 percent of all prescription and interchangeable products;
drug spending, FDA says it is trying to • Publishing guidance on biosimilar
better manage review and licensure product labeling;
pathways to facilitate competition and • Providing additional clarity on
modernize policies to make review more demonstrating interchangeability;
efficient. According to Scott Gottlieb, • Providing additional support to product
FDA’s commissioner, the BAP seeks to developers regarding product quality and
preserve the “balance between innovation • Developing and implementing new manufacturing processes; and
and competition [through] efficient, pre- FDA review tools such as standardized • Engaging in public dialogue about the
dictable and science-based pathways for review templates for biosimilar and inter- biosimilar program.
drug review.” changeable products; Additionally, FDA has committed to
Specifically, the BAP focuses on four • Creating information resources and holding public meetings and hearings, as well
areas: efficiency of development and development tools for biosimilar sponsors; as prioritizing the development of guidance
approval; scientific and regulatory clarity; • Enhancing the Purple Book to make it on various aspects of the Biologics Price
effective communication; and reducing more useful; Competition and Innovation Act. v
gaming of FDA requirements or other • Exploring data-sharing agreements Koblitz SW. Biosimilar Action Plan Introduced to Kick-Start the
delays in competition. As part of the with foreign regulatory authorities to facil- Biosimilar Market. U.S. Food and Drug Administration Law Blog, July
20, 2018. Accessed at www.fdalawblog.net/2018/07/biosimilar-action-
BAP, FDA is: itate increased use of non-U.S.-licensed plan-introduced-to-kick-starting-the-biosimilar-market.
CMS Proposes Paying for Telehealth
and Overhauling Medicare Billing
The Centers for Medicare and Medicaid With current Medicare billing standards,
Services (CMS) is proposing a plan to pay doctors bill Medicare for patient visits
doctors for virtual visits and overhaul using a set of codes that distinguish level of
Medicare billing standards put in place in complexity and site of care. Instead, CMS
the 1990s. is proposing allowing practitioners to
For telehealth, doctors would be paid designate the level of a patient’s care needs
for their time spent reaching out to benefi- using their medical decisionmaking or
ciaries via telephone or other telecommu- time spent with the patient rather than
nications devices to decide whether an applying the coding. In addition, CMS
office visit or other service is needed, as seeks to eliminate the requirement to justify a statement. “Physicians tell us they con-
well as when they review a video or image the medical necessity of a home visit in lieu tinue to struggle with excessive regulatory
sent by a patient seeking care or diagnosis. of an office visit, and is considering requirements and unnecessary paper-
“This is a big issue for [the] elderly and eliminating a policy that prevents pay- work that steal time from patient care.
disabled population for which transporta- ment for same-day visits with multiple This administration has listened and is
tion can be a barrier to care,” said CMS practitioners in the same specialty within a taking action.” v
Administrator Seema Verma. “We’re not group practice. “Today’s proposals deliver
intending to replace office visits, but on the pledge to put patients over paper- Dickson V. CMS Proposes to Overhaul Medicare Billing Standards, Pay
rather to augment them and create new work by enabling doctors to spend more for Telehealth. MTelehealth, July 12, 2018. Accessed at www.mtele
health.com/cms-proposes-to-overhaul-medicare-billing-standards-
access points for patients.” time with their patients,” Verma said in pay-for-telehealth.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 7
BIOTRENDS WATCH Reimbursement FAQs
Proposed 2019 OPPS Rules
By Bonnie Kirschenbaum, MS, FASHP, FCSHP
The long-awaiTed proposed 3) Specified covered outpatient drugs payable) or SI N (items and services
2019 Outpatient Prospective Payment (SI K) packaged into ambulatory payment
System (OPPS) rules have been pub- In the second category (not separately classification [APC] rates). For 2019,
lished in the Federal Register and will take payable) (SI N), these include: new drugs and biologicals will be paid
effect on Jan. 1. As anticipated, the focus 4) Lower-cost packaged products cost- at wholesale acquisition cost (WAC)
is on a patient-driven healthcare system ing (proposed) less than $125 per day (up plus 3 percent (rather than WAC plus 6
with reimbursement across the episodic from $120 in 2018) percent) before ASP is available. If WAC
care journey rather than on single 5) Regardless of cost, products used in is not available, CMS will continue to
encounters in a healthcare facility. The policy packaged services. pay 95 percent of average wholesale
proposed payment rule set has several Payment for all packaged drugs, biolog- price (AWP). Proposed provisions
prominent themes for the pharmacy icals and radiopharmaceuticals is included reducing transitional pass-through
sector: 1) simplify electronic health in the services and procedures with which payments for policy-packaged drugs,
record requirements, reporting and they are reported. These include: biologicals and radiopharmaceuticals to
regulations, 2) cut costs and save money • All diagnostic radiopharmaceuticals offset costs packaged into APC groups
and 3) address the opioid crisis. • All contrast agents is being developed for diagnostics and
• Anesthesia drugs skin substitutes, and will be published
Paying for Part B Drugs • Implantable biologicals that are by CMS as decisions are made.
Under OPPS surgically inserted or implanted into the Drugs and biologicals: The threshold for
Part B drugs are those used in an outpa- body through a surgical incision or natural drugs and biologicals that are separately
tient setting pursuant to a physician’s orifice payable has increased to $125 per day
order and are usually injectables. The • Drugs, biologicals and radiopharma- based on ASP, an increase of $5 over this
Centers for Medicare and Medicaid ceuticals that function as supplies when year. These will continue to be paid at
Services (CMS) pays for Part B drugs in used in a diagnostic test or procedure ASP plus 6 percent (minus 2 percent
five different ways divided into two cate- • Drugs and biologicals that function as sequestration) under the statutory default
gories: 1) separately payable with line-item supplies or implantable devices in a surgical payment policy adopted in 2013. CMS
reimbursement and 2) not separately procedure will pay all non-pass-through separately
payable without line-item reimbursement Average sales price (ASP) for these drugs payable therapeutic radiopharmaceuticals
(since they’re paid as part of a bundle/ can vary from one quarter to another, and at ASP plus 6 percent (minus 2 percent
package). Regardless of where the drug this year, CMS is proposing to change SIs sequestration) as well. However, radio-
falls in these categories, it’s essential to bill to reflect a shift from SI K to SI N and pharmaceutical manufacturers are not
for each and every drug. CMS uses claims back again as needed. required to submit ASP (although some
information to set rates in future years and manufacturers do voluntarily submit data,
makes them available to big data pools for OPPS 2019 Proposed Payment and CMS will use if for a patient-ready
analytic purposes. Any missing or erro- Transitional pass-through status: Non- dose). If ASP data are not available, CMS
neous data skews the accuracy of the pools pass-through separately payable drugs will will base payment on mean unit cost from
and leads to faulty pathway development continue to be paid for at ASP plus 6 its claims data.
or decision-making. percent (minus 2 percent sequestration). To respond to these changes, pharmacy
In the first category (separately payable), Some of these will expire in the quarter providers should ensure all drugs with SIs
these include: that is as close to three full years as possible G, K and N are billed regardless of
1) New drugs not yet assigned a unique after the products were first covered with whether they are separately payable. The
Healthcare Common Procedure Coding pass-through payment status. The proposed updated addendum B (a voluminous Excel
System code rule lists 45 drugs with new/continuing spreadsheet that is updated quarterly
2) New pass-through drugs, biologicals pass-through status and 23 that lose pass- throughout the year) will be published
and radiopharmaceuticals (status indicator through payment status and move from SI later this fall and will indicate the status
[SI] G) G (pass-through) to SI K (separately indicators of Part B drugs and their
8 BIOSUPPLY TRENDS QUARTERLY | Fall 2018
Reimbursement FAQs
payment rates. One of the simplest ways pocket or through secondary insurance. Exparel as an example. In other rules,
to use it is to sort the SI column and look When payment rates decrease, this positively CMS is proposing getting rid of pain-
only at SI G, K and N drugs. In addition, affects patients by lowering their costs. management questions from Hospital
pharmacy providers should prepare for Biosimilar products in 2019: There are Consumer Assessment of Healthcare
changes in their list of waste billing drugs by no proposed changes to the 2018 CMS Providers and Systems in response to the
determining which on the current list have revised payment policy for biosimilar opioid epidemic.
moved from K to N status and will no longer
be eligible for waste billing as of Jan. 1.
“
Payment rate changes for certain Medicare
Part B drugs purchased by hospitals through
340B: Understanding what is proposed is The proposed 2019 OPPS rules retain
essential before working on any statistics or
predictions. First and foremost, this is not the 2018 rates that cut reimbursement for
a Health Resources and Services
Administration rule change, although 340B facilities, as well as the modifier
many administrative changes to the 340B
program are anticipated in the new year. requirement that is the trigger to
”
These OPPS changes apply only to Medicare
patients treated in an OPPS setting. identify drugs with rate cuts.
The proposed 2019 OPPS rules retain
the 2018 rates that cut reimbursement for
340B facilities, as well as the modifier
requirement that is the trigger to identify products that established separate coding Also of interest to pharmacies are the
drugs with rate cuts. Products acquired and a separate payment rate for each proposed site-neutral payments under
under 340B and used in an outpatient set- biosimilar product, even if they have the which hospital clinic visits will be reim-
ting for Medicare-eligible patients will same biological reference product as bursed at the same rate as physician
continue to be paid at ASP minus 22.5 another biosimilar product. All biosimilar offices and other ambulatory facilities.
percent, WAC minus 22.5 percent or biological products are eligible for pass- The PFS rule proposes telehealth/virtual
69.46 percent of AWP, as applicable. through status, not just the first biosimilar care reimbursement that will offer many
Remember that OPPS reimburses in five for a reference product. Biosimilar prod- new opportunities. v
different ways (pass-through before and ucts purchased under 340B also are subject
after ASP is established, separately payable, to the payment cuts.
and bundled or packaged either due to cost bonnie kirschenbaum, MS, FASHP,
or statute). Only separately payable drugs Responding to the Opioid Crisis FCSHP, is a freelance healthcare consultant with
(SI K) are affected; drugs on pass-through In response to recommendations from senior management experience in both the pharma-
status (SI G) and vaccines continue to be ceutical industry and the pharmacy section of large
the President’s Commission on Combating
corporate healthcare organizations and teaching
excluded. Nonexcepted, off-campus hospital Drug Addiction and the Opioid Crisis, the
hospitals. She has an interest in reimbursement
departments defined as outpatient facilities proposed rule set contains extensive discus- issues and in using technology to solve them.
located away from the hospital’s main sions of practice changes that could be Kirschenbaum is a recognized industry leader
facility paid under physician fee service beneficial. For example, CMS is proposing in forging effective alliances among hospitals,
(PFS) will also be subject to the reduction to unpackage and pay separately for the physicians, pharmaceutical companies and
in 2019 and will be paid ASP minus 22.5 cost of non-opioid pain management distributors and has written and spoken
percent for drugs acquired through the drugs that function as surgical supplies extensively in these areas.
340B program. This is a change from this when they are furnished in the ambulatory
year when they were the exception to the surgery center setting in 2019. An equi- Sources
1. CMS Proposes Medicare Hospital Outpatient Prospective Payment
payment cut rule. Also remember that table payment adjustment in the form of System and Ambulatory Surgical Center Payment System Changes for
2019 (CMS-1695-P). Accessed at www.cms.gov/Newsroom/
CMS covers 80 percent of the payment an add-on payment for APCs that use a MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-
with the remaining 20 percent the non-opioid pain management drug, device 07-25.html.
2. Billing Code 4120-01-P. Accessed at s3.amazonaws.com/public-
patient’s responsibility, either out of or service is also being discussed, with inspection.federalregister.gov/2018-15958.pdf.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 9
BIOTRENDS WATCH Industry News
Guidelines
Flu Vaccine Recommendations Updated by CDC and AAP
use of seasonal influenza (flu) vaccines and In addition, the American Academy of
guidance for vaccine providers about the Pediatrics (AAP) issued its annual flu rec-
use of flu vaccines for the 2018-19 season. ommendations that state all children ages 6
These include: months and older should receive the
1) The vaccine virus composition for influenza vaccine as soon as it becomes
2018-19 U.S. seasonal influenza vaccines; available. With 179 flu-related deaths in
2) A recommendation for the 2018-19 the 2017-18 season, AAP said the vaccine
season that the live-attenuated influenza “significantly reduces a child’s risk of
vaccine is an option for flu vaccination of severe influenza and death.” “The flu virus
persons for whom it is appropriate; is common and unpredictable,” said Flor
3) A recommendation that persons with M. Munoz, MD, FAAB, member of the
a history of egg allergy may receive any AAP Committee on Infectious Diseases.
licensed, recommended and age-appropriate “Being immunized reduces the risk of a
influenza vaccine; and child being hospitalized due to flu.” v
4) Recent regulatory actions, including
new vaccine licensures and labeling Prevention and Control of Seasonal Influenza with Vaccines:
Recommendations of the Advisory Committee on Immunization
changes for previously licensed vaccines. Practices — United States, 2018–19 Influenza Season. Centers for
Disease Control and Prevention, Aug. 24, 2018 Accessed at
The Centers for Disease Control and The complete set of recommendations www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm?s_cid=rr6703
Prevention’s (CDC) Advisory Committee can be viewed at www.cdc.gov/mmwr/ a1_e.
AAP Issues Flu Vaccine Recommendations for 2018-2019. American
on Immunization Practices has updated its volumes/67/rr/rr6703a1.htm?s_cid=rr Academy of Pediatrics press release, Sept. 3, 2018. Accessed at
www.aap.org/en-us/about-the-aap/aap-press-room/Pages/AAP-
2017-18 recommendations regarding the 6703a1_e. Issues-Flu-Vaccine-Recommendations-for-2018-2019.aspx.
Influenza
FDA Chooses Influenza Vaccine Strains for the 2018-19 Season
In March, the U.S. Food and Drug months to 8 years. The vaccine was 67
Administration’s (FDA) Vaccines and percent effective against A(H1N1)pdm09,
Related Biological Products Advisory and 42 percent effective against influenza B
Committee chose the Northern Hemisphere’s (mostly B/Yamagata, not in inactivated
2018-19 influenza (flu) vaccine strains influenza vaccine, trivalent).
based on the World Health Organization’s “In terms of last year’s vaccine … even
recommendations. For the trivalent vaccine, though we’ve had a bad flu year, the strains
the committee voted unanimously to that were selected … were really good selec-
include an A/Michigan/45/2015 (H1N1) tions,” said Jack Bennink, PhD, a tempo-
pdm09-like virus and an A/Singapore/ rary voting member on the committee and
INFIMH-16-0019/2016 (H3N2)-like virus, senior managing epidemiologist at the
the latter of which is a change from the National Institute of Allergy and Infectious
2017-18 vaccine. And, the committee Diseases. “They were as good as one could
voted 11-1 to include a B/Colorado/ guess and make at the time. I don’t think
06/2017-like virus (B/Victoria/2/87 line- we could’ve done any better, and I’m
age), which is also a change from the For the 2017-18 season, interim results encouraged by the fact that particularly [in
2017-18 vaccine. The committee also show the vaccine lowered the number of children aged 6 months] to 8 years old, it’s
voted unanimously to include a B/Phuket/ cases of medically attended flu illness by 36 almost 60 percent effective.” v
3073/2013-like virus (B/Yamagata/16/88 percent. Vaccine effectiveness against
lineage) as the second influenza B strain in influenza A(H3N2) was 25 percent for all Brown T. FDA Committee Recommends 2018-2019 Influenza Vaccine
Strains. Medscape, March 1, 2018. Accessed at www.medscape.com/
the quadrivalent vaccine. ages and 51 percent for children aged 6 viewarticle/893314.
10 BIOSUPPLY TRENDS QUARTERLY | Fall 2018Industry News
Research
Heart Failure Death Risk Drops 50% in Those Who Receive Flu Vaccine
A new study shows people with heart in the risk of being hospitalized for cardio-
failure who receive a seasonal influenza vascular problems.
(flu) vaccine have a 50 percent drop in the “It is well-known that influenza infection
risk of death during flu season and a 20 is associated with increased risk of mortality
percent drop in the risk of death during the in heart failure patients,” said Hidekatsu
rest of the year. In the meta-analysis, Fukuta, MD, a cardiologist at Nagoya City
researchers analyzed six studies conducted University Graduate School of Medical
in the U.S., Europe and Asia that included Sciences in Nagoya, Japan, and the study’s
data for more than 78,000 patients with lead author. “Given the high mortality rate
heart failure. Five of the studies were obser- and the relative low influenza vaccination
vational and one was a retrospective analy- rates in heart failure patients worldwide, Fukuta, “Randomized controlled studies
sis of clinical trial results. They found get- our study supports a wider use of influenza should be planned to confirm our observed
ting the flu vaccine reduced the risk of vaccination in heart failure patients.” potential survival benefit of influenza
dying (from any cause) by about half dur- The study’s authors caution, however, vaccination in these patients.” v
ing flu season and by about one-fifth dur- that while observational studies can show Getting Influenza Vaccine Linked to 50% Drop in Risk of Death for Heart
ing the rest of the year. Vaccination was associations, they do not necessarily prove Failure Patients. News Medical, March 1, 2018. Accessed at www.news-
medical.net/news/20180301/Getting-influenza-vaccine-linked-to-
also associated with a 22 percent reduction cause and effect. Therefore, said Dr. 5025-drop-in-risk-of-death-for-heart-failure-patients.aspx.
Research Vaccines
Cell-Based and CDC OKs FluMist for 2018-19 Influenza Season
Recombinant Vaccines AstraZeneca, manufacturer of FluMist,
More Effective in that addressed a possible root cause of poor
effectiveness against the influenza AH1N1
2017-18 Flu Season virus and a potential solution to address it,
New data shows cell-based and recombinant which includes using a different type of
vaccines were more effective in the 2017-18 influenza AH1N1 virus in the vaccine.
influenza (flu) season, according to U.S. Food Specifically, AstraZeneca presented posi-
and Drug Administration (FDA) commissioner tive results from a U.S. study in children
Scott Gottlieb, MD. “The data aren’t final yet, ages 2 years to 4 years that evaluated their
but I’m comfortable saying that I think it’s going responses to the H1N1 strain in the
to be about 20 percent improved efficacy for quadrivalent formula of the spray, which
the cell-based vaccine relative to the egg-based protects against four different influenza
vaccines,” said Dr. Gottlieb. “As we consider viruses. Results showed the H1N1 strain in
greater investment in alternative vaccine The Centers for Disease Control and the 2017-18 vaccine performed signifi-
development processes, it’s important to note, Prevention's advisory committee has voted cantly better than the H1N1 strain in the
however, that there are also challenges with these 12-2 to recommend FluMist, the nasal 2015-16 vaccine.
newer cell-based approaches. To help address spray version of the influenza vaccine, be Even though FluMist has not been rec-
these challenges, the FDA is working to help used during the 2018-19 influenza (flu) ommended for the past two flu seasons,
develop more effective cell lines that can be season. FluMist is a live attenuated the U.S. Food and Drug Administration
better scaled through continuous manufacturing. influenza vaccine licensed for use in other- (FDA) has still approved it. The availability
We’re also looking at how we develop a wise healthy, nonpregnant people ages 2 of FluMist in the U.S. for the 2018-19
more robust recombinant vaccine manu- years through 49 years. For the past two flu influenza season is pending annual strain
facturing process to increase yield while seasons, FluMist has not been recom- approval from FDA. v
reducing cost.” v mended because of poor performance
Keet E. FDA Says Cell-Based Flu Vaccine May Be 20% More Effective Than Egg-Based compared with the flu vaccine. Scutti S. FluMist Set to Return for Next Flu Season. CNN, Feb. 21, 2018.
Vaccine. Contagion Live, March 28, 2018. Accessed at www.contagionlive.com/ Accessed at www.cnn.com/2018/02/21/health/flumist-returns-cdc-
news/fda-says-cell-based-flu-vaccine-may-be-20-more-effective-than-egg-based-vaccine. The decision was based on data from bn/index.html.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 11BIOTRENDS WATCH Industry News
Research Research
Study Finds Asthma Mumps Vaccine Protection Wanes Over Time,
Treatments for Kids According to Meta-Analysis
More Likely to Fail A recent meta-analysis of six studies of immunity to mumps played a major role
Without Flu Shot mumps vaccine effectiveness conducted in the recent reemergence of mumps
in the U.S. found protection against among young adults. The findings suggest
mumps lasts an average of 27 years after that in addition to the recommended two
the last dose of the vaccine. In addition, doses of mumps vaccine in childhood,
researchers estimated 25 percent of adding a third dose or booster shot at age
Americans who were vaccinated against 18 could help maintain protection. v
mumps as children may lose protection
within about eight years, 50 percent Mumps Vaccine Protection May Be Waning, Driving Rise in U.S. Cases.
within 19 years and 75 percent within United Press International, March 21, 2018. Accessed at www.upi.com/
Health_News/2018/03/21/Mumps-vaccine-protection-may-be-
38 years. They also found weakening waning-driving-rise-in-US-cases/2411521663206.
New research shows an annual influenza
(flu) shot is crucial for children with asthma.
In the study, researchers examined approxi-
mately 1,000 children treated for moderate
Vaccines
or severe asthma attacks in emergency rooms Researchers Find Vaccines Don’t
at five Canadian hospitals. In addition, they Weaken Babies’ Immune Systems
analyzed nose swabs taken from those kids to
determine if they also had the flu or another In response to concerns from parents from birth through age 23 months.
respiratory virus. Of the nearly two-thirds about whether multiple vaccines in early Among the 944 participants (mean age
tested positive for a viral infection, 19 per- childhood could weaken their children’s 32.5 months; 45 percent female), the esti-
cent who were given the standard treatments immune system, researchers conducted a mated mean cumulative vaccine antigen
for an asthma attack (including oral cortico- study that examined whether the vaccine exposure was 240.6 for cases and 242.9 for
steroids and inhaled bronchodilators) didn’t schedule was associated with an increased risk controls, with a between-group difference
respond to their medications. They found of infections not targeted by vaccines for estimated cumulative antigen exposure
that those with influenza or parainflunza had (referred to as “nontargeted infections”). -2.3. The researchers concluded that
a 37 percent higher chance of not respond- They found no statistically significant differ- “among children from 24 through 47
ing to asthma treatments compared to 13 ences in estimated cumulative vaccine antigen months of age with emergency department
percent without the virus. Asthma treat- exposure through the first 23 months of life. and inpatient visits for infectious disease
ments were also more likely to fail among The nested case-control study examined not targeted by vaccines, compared with
children with respiratory sincytial virus. 193 children with nonvaccine-targeted infec- children without such visits, there was no
However, human rhinoviruses (the usual tions and 751 controls without nonvaccine- significant difference in estimated cumula-
cause of common colds) did not reduce the targeted infections in six U.S. healthcare tive vaccine antigen exposure through the
effectiveness of asthma treatments. organizations participating in the Vaccine first 23 months of life.” v
According to Francine Ducharme, MD, Safety Datalink. Participants were children
Glanz JM, Newcomer SR, Daley MF, et al. Association Between Estimated
a pediatrician and co-author of the study, ages 24 months through 47 months born Cumulative Vaccine Antigen Exposure Through the First 23 Months of
Life and Non-Vaccine-Targeted Infections From 24 Through 47 Months
“We now know that if these kids get the flu, between Jan. 1, 2003, and Sept. 31, 2013, of Age. JAMA, 2018;319(9):906-913. Accessed at jamanetwork.com/
the risks are very high that emergency treat- who were followed until Dec. 31, 2015. journals/jama/article-abstract/2673970?redirect=true.
ment for an asthma attack will fail. Instead Cases of nonvaccine-targeted infection were
of having an 18 percent risk of treatment matched to controls by age, sex, healthcare
failure, with flu, the risk rises to 40 percent. organization site and chronic
These kids should get their flu shot and they disease status. Cumulative
should get it systemically; it’s worth it.” vaccine antigen exposure
The study was published in the June 4 was estimated by
issue of Pediatrics. v adding the number
Dallas ME. Kids with Asthma Need a Flu Shot: Study. WebMD, June 4, of antigens in each
2018. Accessed at www.webmd.com/asthma/news/20180604/kids-
with-asthma-need-a-flu-shot-study. vaccine dose received
12 BIOSUPPLY TRENDS QUARTERLY | Fall 2018Industry News
Guidelines
Updated C. Diff Guidelines Reflect New
Treatment Options and Recommendations
The Infectious Diseases Society of metronidazole. They also rec-
America (IDSA) and Society for Healthcare ommend both drugs for a first
Epidemiology of America (SHEA) have and second recurrence of C.
updated guidelines for diagnosis and man- diff. But, for patients who have
agement of Clostridium difficile (C. diff), had several bouts and have
which has become the leading cause of failed all appropriate antibiotic
diarrhea in hospital patients and one of the treatments, the guidelines recommend testing be limited to
most common healthcare-associated infec- fecal microbiota transplantation (FMT), those patients with more
tions that sickens nearly 500,000 Americans a procedure that involves the transfer of stool than three episodes of new-onset
and is associated with 15,000 to 30,000 from a healthy donor into the colon of an diarrhea within 24 hours, specifically
deaths annually. The last IDSA/SHEA infected patient. FMT is still considered an patients whose symptoms aren’t attributable
guidelines for C. diff were issued in 2010. investigational treatment by the U.S. Food to underlying conditions or use of laxatives.
And, while many of the recommendations and Drug Administration, but it has pro- In addition, it is recommended molecular
remain the same, the updated guidelines duced strong results in anecdotal reports and tests, which have become increasingly popu-
reflect new treatment options and recom- in randomized clinical trials. “An important lar in recent years due to their high sensitiv-
mendations for who should be tested and aspect of susceptibility to C. difficile, if not ity and quick diagnosis, be used on their own
which diagnostic tests are most appropriate. the majority of susceptibility, is due to dis- only when hospitals have established criteria
The previous guidelines recommended ruption of the microbiota by antibiotics,” for patients who are most likely to be at risk
metronidazole as first-line therapy for initial said Clifford McDonald, MD, senior advi- for C. diff. When the criteria don’t exist, a
cases of mild-to-moderate C. diff and van- sor with the Centers for Disease Control and two- to three-step process that includes a
comycin for more severe cases. But, the Prevention. “These patients can have multi- toxin immunoassay plus a molecular test
updated guidelines recommend either van- ple recurrent C. diff, they’re failing over and and/or an antigen test are recommended. v
comycin or fidaxomicin as the drug of choice over again, and that’s where FMT is now Dall C. New C Diff Guidelines Incorporate Fecal Transplant. Center for
for all initial episodes based on high-quality another tool in the toolbox.” Infectious Disease Research and Policy, Feb. 16, 2018. Accessed at
www.cidrap.umn.edu/news-perspective/2018/02/new-c-diff-guide-
evidence that both drugs are superior to The new guidelines also recommend lines-incorporate-fecal-transplant.
Guidelines
Zika Virus Blood Screening Guidelines Revised by FDA
The U.S. Food and Drug Admini- unknown course of the epidemic and the
stration (FDA) has revised its recommen- observed severe effects from the disease
dations for testing blood donations for the indicated that individual donor testing was
Zika virus, allowing for pooled testing of needed to ensure the continued safety of
donations using a screening test it has the blood supply,” explained Marks.
licensed. The revised guidance replaces “Now, given the significant decrease in
guidance announced in August 2016 that cases of Zika virus infection in the U.S.
recommended universal nucleic acid test- and its territories, we are moving away
ing for Zika virus of individual units of from testing each individual donation to
blood donated in U.S. states and territo- testing pooled donations. [However, FDA]
ries. Roche’s cobas Zika test for use on the plasma specimens from individual human will continue to monitor the situation
cobas 6800 and 8800 PCR systems enables blood donors. According to Peter Marks, closely, and as appropriate, reconsider
streamlined screening of multiple individ- director of FDA’s Center for Biologics what measures are needed to maintain the
ual blood or plasma donations that have Evaluation and Research, the new safety of the blood supply.” v
been pooled together. The test is a qualita- approach is usually more cost-effective and FDA Revises Zika Virus Screen Guidance, Recommends Pooled Testing
tive in vitro nucleic acid screening test for less burdensome for blood establishments. of Blood. Genomeweb, July 6, 2018. Accessed at www.genomeweb.
com/regulatory-news/fda-revises-zika-virus-screening-guidance-
the direct detection of Zika virus DNA in “When Zika virus first emerged, the recommends-pooled-testing-blood#.W0SuniOZM1g.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 13BIOTRENDS WATCH Industry News
Medicines
CDC Expects Shortage of New Shingles Vaccines
The Centers for Disease Control and percent of the time. This is 97 percent of and causes a painful blistering rash along
Prevention (CDC) is warning about a the time. And, remember, over a third of with possible complications, including
shortage of Shringrix, the newest shingles the population will get shingles, so this is searing nerve pain and pneumonia.
vaccine recommended for individ- something for everybody over Individuals are encouraged to get on the
uals 50 years and older, due the age of 50,” said David list to receive it. “Every week, [the compa-
to greater-than-expected Agus, MD. “Even peo- ny is] releasing more of [the vaccine], so
demand. “It’s a really ple who have the old get on the list. Figure out where it is. It’s
potent, excellent vac- vaccine need to get not a critical shortage, but it’s a shortage,”
cine. I got it myself. the new vaccine.” said Dr. Agus. v
And this is a vaccine Shingles is
where the old vac- triggered by the CDC Warns of Shingles Vaccine Shortage. CBS News, June 29, 2018.
Accessed at www.cbsnews.com/news/cdc-warns-of-shingles-vaccine-
cine worked 30, 40 chicken pox virus shortage-shingrix.
Medicines Research
FDA Approves First Current Pertussis Vaccine Mounts a Weaker
Treatment for High- Recall Response with Booster Shots
Risk Prostate Cancer Researchers at the La Jolla Institute for bacteria that came with unwanted side effects)
The U.S. Food and Drug Admini- Allergy and Immunology have found individ- or the acellular pertussis (aP) vaccine (the new
stration (FDA) has approved Erleada (apa- uals who had been inoculated with the newer vaccine that relies on purified bacterial pro-
lutamide) to treat men with prostate cancer pertussis (whooping cough) vaccine as part of teins to induce immunity) in infancy and
that has not yet spread but has a quickly their initial series of shots mount a weaker administered booster vaccinations with aP in
rising PSA level while on treatment with recall response when receiving booster shots middle and high school and as adults, and
hormone therapy, which causes concern later on. Specifically, the study found the new analyzed their immune response at regular
for cancer growth and spread. This is the vaccine, which replaced the original vaccine in intervals. Their results showed that priming in
first FDA-approved treatment for this 1996, fell short of generating a robust T cell the first few months after birth with the aP or
high-risk type of prostate cancer known as response, which provides the long-term wP vaccines induces different T-cell responses.
nonmetastatic castration-resistant prostate memory that allows the immune system to And, while both are initially capable of gener-
cancer. Erleada works by blocking the mount a rapid response if exposed to the ating protective immunity, differences evolve
effects of androgens, a type of hormone, on pathogen. “Ideally, you should engage both over more than 15 years. In addition, T cells
the tumor. Androgens such as testosterone arms of a protective response against originally primed with aP gradually lose the
can help tumors grow. pathogens — B cells that produce antibodies ability to respond to booster vaccination.
Approval under FDA’s priority review and T cells that generate long-term memory,” “These cells just sit there and do nothing
program was based on a randomized clini- said Ricardo Antunes, PhD, a postdoctoral while T cells primed with wP respond with a
cal trial of 1,207 men with high-risk researcher and first author of the study. “But, pronounced boost,” said Dr. Antunes.
nonmetastatic castration-resistant prostate apparently, the new vaccine fails to generate The study was conducted because the birth
cancer that measured the amount of time an adequate T cell response. Although B cells years of the teenagers and young adults most
patients’ tumors did not spread (metasta- are a very important component of vaccine affected by the sudden increase in pertussis
size). All men in the trial received hormone efficacy, the important role of T cells is being cases coincided with the nationwide switch
therapy, but only some also received more and more appreciated and the key from the wP to the aP vaccine. According to
Erleada. Those who received Erleada had point of our study is to show that there are the researchers, unraveling the differences
no metastasis for an average 40.5 months striking differences in the T-cell response to between the two vaccines is key to understand-
compared to 16.2 months for men who did the two different vaccines.” ing how to better prevent whooping cough
not receive the drug. v In the study, researchers recruited 114 and may also provide important lessons on
FDA Approves Erleada (Apalutamide) for Some Prostate Cancers.
healthy adults who had been originally vacci- vaccine efficacy in general. v
American Cancer Society, Feb. 15, 2018. Accessed at www.cancer.org/ nated with the whole pertussis (wP) vaccine Whooping Cough Vaccine: The Power of First Impressions. La Jolla Institute for
latest-news/fda-approves-erleada-apalutamide-for-some-prostate- Allergy and Immunology, July 9, 2018. Accessed at www.sciencedaily.
cancers.html. (the original vaccine crafted from dead com/releases/2018/07/180709143912.htm.
14 BIOSUPPLY TRENDS QUARTERLY | Fall 2018Industry News
Research Guidelines
Immune System WHO Recommends Typhoid Vaccine
Response Discovery in in Children in Endemic Countries
Newborns Could Lead The World Health Organization (WHO)
to Earlier Vaccine is recommending a single dose of the
Administration typhoid conjugate vaccine (Typbar-TCV)
for use in infants and children older than
Researchers at the TCD School of 6 months and a catch-up vaccine in
Medicine and the National Children’s children up to 15 years in countries where
Research Centre (NCRC) in Ireland have the infection is endemic. The recommen-
discovered a distinct immune response in dation is a result of a review of the vaccine
newborns that could lead to both earlier by WHO’s Strategic Advisory Group of
vaccine administration and reduced need Experts on Immunization in October vaccines,” said Adwoa Bentsi-Enchill,
for multiple booster shots. According to 2017 that considered data on vaccine MD, medical officer of the Department of
the researchers, their discovery is a “class safety, efficacy, feasibility and afford- Immunization, Vaccines and Biologicals
of danger signals” that are highly efficient ability, as well as growing rates of drug- at WHO. “The recommendation for the
at triggering an immune response in resistant typhoid. The Typbar-TCV vaccine typhoid conjugate vaccine to be included
young infants. provides longer-lasting protection and in routine immunization programs will
The discovery was made after scientists fewer doses than previous vaccines. help pave the way for national authorities
theorized newborns may retain a more “Studies have shown that TCV is safe, to introduce this vaccine in countries
robust immune response to viruses and effective and can provide protection for where they are needed most.” v
found a class of adjuvants (one of two key infants and children under 2 years of age, First Typhoid Conjugate Vaccine Recommended by WHO. Contagion
Live, April 3, 2018. Accessed at www.contagionlive.com/news/first-
components in vaccines) that activate spe- unlike the previous available typhoid typhoid-conjugate-vaccine-recommended-by-who.
cialized sensors that drove a very strong
immune response in newborns where other
microbial infections arise. “These sensors Research
are normally activated in response to viral Tuberculosis Vaccine May Reverse Type 1 Diabetes
infection and direct the immune system to
clear up viral infections,” said Sarah Doyle, them below the cutoff point for a clinical
MD, of the NCRC. “Harnessing these effi- diagnosis. And, after being followed for an
cient antiviral immune responses will help additional eight years, most retained the
in the design of targeted adjuvants for reduction. In contrast, those who received
pediatric vaccines by directly activating a placebo and followed normal diabetic
immune responses that are fully functional management saw their blood sugar
in neonates and infants.” measurement rise by a few percentage
“Many adjuvants used in vaccines today points during the same periods. All
were developed in adults; however, babies study participants continued to use
and children are not simply little adults, insulin during the study period.
and because of this, a child’s immune A recent study shows two injections of “Nobody thought you could inter-
system responds differently than an the bacillus Calmette-Guérin (BCG) vene with an immunotherapy in people
adult’s immune system does,” said Kiva vaccine (used to prevent tuberculosis) a 10, 20 years out,” said the study’s prin-
Brennan, MD, at TCD School of few weeks apart may reverse the causes of cipal director Denise Faustman, MD,
Medicine and lead author of the study. type 1 diabetes over several years. In the director of the Massachusetts General
As a result, the key to improving vaccine study of 52 participants, nine received the Hospital Immunobiology Laboratory.
efficacy is the design of adjuvants that injections and three received a placebo. “To have data showing durability for
specifically target and kick the newborn Those who received the injections had a eight years, without revaccination, is
immune response into action.” v substantial reduction in the blood-sugar remarkable.” v
O’Sullivan K. Irish Scientists Find Distinct Immune System in Newborn
marker HbA1c used to diagnose diabetes: Fleishman G. Tuberculosis Vaccine Could Reverse Type 1 Diabetes,
Babies. The Irish Times, July 16, 2018. Accessed at www.irishtimes. a 10 percent reduction after three years Study Shows. Fortune, June 21, 2018. Accessed at fortune.com/
com/news/health/irish-scientists-find-distinct-immune-system-in- 2018/06/21/tuberculosis-vaccine-reverse-juvenile-diabetes-
newborn-babies-1.3566105. and 18 percent after four years, bringing study-shows.
BIOSUPPLY TRENDS QUARTERLY | Fall 2018 15You can also read
