Axway’s Healthcare OnDemand
February, 2010
Agenda
•
Introductions
•
Legislation review
•
Healthcare on Demand Overview
•
Partnering Discussion
•
Wrap up and Next Steps
2
2
© 2010 Axway Confidential and proprietary. All rights reserved.
Compliance – State ePedigree
Legislation
2010 HDMA Map of State Pedigree Legislation/Regulations
As of January 1, 2010
WA
ME
ND
MT
MN
OR
ID
NH
WI
SD
WY
IA
NE
NV
UT
CA
AZ
PA
IL
CO
KS
OK
NM
NY
MI
MO
AR
VA
NC
TN
RI
NJ
DE
MD
SC
AL
MA
CT
WV
KY
MS
TX
IN
OH
VT
GA
LA
HI
FL
AK
18
4
No Legislation
or Regulations
3
Proposed
Legislation
9
Enacted
Legislation
5
Enacted
Legislation,
Rules In
Development
15
Final Rules Adopted
© 2010 Axway Confidential and proprietary. All rights reserved.
ePedigree Legislation – State Level
Summary of Recent Legislative Activity (2009)
Mar
PA
SB 555
Introduced pedigree/licensure bill to assembly
NY
AB 6546
No “normal” distribution provisions. Proposed electronic pedigree effective
dates: Jan 1, 2016 (mfg); July 1, 2016 (WS); July 1, 2017 (pharmacies).
ID
SB 1066
Clean up bill for 2007 ePed legislation
Apr
MA
HB 3915
Bill introduced titled “An Act regulating wholesale prescription drugs” Similar
to last year’s
May
TX
HB 1504
Bill to amend the states definition of normal distribution
Jun
TX
SB 1645
Amendment signed into law
Summary of Recent Regulatory Activity – CO, NM, OR, and FL
CO
Effective date changed to Jan 1, 2017 from Jan 1, 2010 for products outside normal distribution.
In-transit proposed language deleted
NM
Criminal background checks, drug screens, periodic assessments of security provisions on all
wholesaler common carriers. Monitor high-risk deliveries.
Expected 2010 Activity
5
Legislation
FL, MA, MD, NY and PA
Regulatory
FL, IL (Dec.), KS, MS, ND (Jan.), SD and TX
© 2010 Axway Confidential and proprietary. All rights reserved.
ePedigree Legislation – State Level (Cont.)
Florida
Rule development in progress to address changes resulting from House Bill 7049.
Manufacturer issues include:
•
•
•
•
“limited amounts” of API’s allowed into the state without pedigree for purposes of R & D
Dept of Health attempting to define a manufacturer’s “distribution point” as contained within
the definition of “manufacturer”. New mfg definition – effective Oct 1st.
Rx included in kits no longer need Pedigree, only the kit
Problems with Authentication rules regarding:
• Certificate Authority requirement, use of unique ref #, and corporate certificates
Maryland
In 2008, SB 759 recommends the following implementation dates for electronic track
and trace technology across the supply chain:
•
•
•
Manufacturers: Jan 1, 2016 (first 50% of products) & Jan 1, 2017 (last 50%);
Distributors: July 1, 2017;
Pharmacies: July 1, 2018
California
In 2008, SB 1307 recommends the following implementation dates for electronic track
and trace technology across the supply chain:
•
•
•
•
6
Manufacturers (generic and brand) must pedigree:
• 50 percent of their products by 2015, the remaining 50 percent by 2016
Wholesalers and repackagers must accept and pass pedigrees by July 2016
Pharmacies and pharmacy warehouses must accept pedigrees by July 2017
Percentages can be based upon:
• Unit volume, Product package (SKU) type, Drug product family
© 2010 Axway Confidential and proprietary. All rights reserved.
E-pedigree Studies & Deadlines
• States that were required to do a study by July 1, 2009
(and have yet to do so):
– Georgia, Idaho, Illinois, Nebraska, North Dakota, South
Dakota
• Oklahoma , Texas, Wisconsin - After January 1, 2011 –
Boards “studying” and can require e-pedigree “outside
normal channel”
• California – 2015 for manufacturers (50%) - target for
industry partners working toward compliance.
7
© 2010 Axway Confidential and proprietary. All rights reserved.
Compliance - FDA
Federal Bill Activity
Overall Federal Pedigree Goals
–
–
–
–
–
–
–
Uniformity
Preservation of safety, efficiency and cost-effectiveness
Serialization at the unit level
Flexibility to allow for technology development
Practicality – from an operations perspective
Stakeholder consensus
Congressional and State support
H.R. 5839 – Matheson (D-UT) and Buyer (R-IN) Federal Pedigree
Legislation
– Introduced legislation (HR 5839) in April 2008 – no action taken
– Released discussion draft (based on HR 5839 with modifications) in Nov
2008
• Modified normal distribution in the interim
• Serialization and track-and-trace implementation and timelines similar to
California law
H.R. 759 – FDA Globalization Act – a.k.a “Import Safety”
S. 525 – Importation Legislation – Senators Dorgan (D-ND)
and Snowe (R-ME)
9
© 2010 Axway Confidential and proprietary. All rights reserved.
Federal Bill Activity – Cont…
S. 1232 – “Pharmaceutical Market Access and Drug Safety Act of 2009” –
Importation Bill – enactment 1/1/2012
– FDA approved importation by registered exporter, or by groups of
pharmacies or wholesalers who are registered importers
• Cannot import several drug classes including controlled substances,
biologics, infused drugs, injected drugs, etc.
– All prescription drugs will be tracked & traced and ADR exemption is
eliminated
– Requires the use of anti-counterfeit and track & trace technologies at the
pallet and case level by Jan 1, 2013
– Unique identifier must be applied at package level by July 1, 2013
– Placed on calendar under General Orders – Calendar No. 73
H.R. 2726 – “Counterfeit Drug Enforcement Act of 2009,” also known as
“Tim Fagan’s Law” – Federal Pedigree
– Increased criminal penalties for knowingly selling adulterated or
misbranded pharmaceuticals
– Eliminates authorized distributors of record (ADR) and requires a pedigree
on all prescription products within 90 days of enactment
– Empowers HHS to establish track & trace standards
– Bill is in Committee
10
© 2010 Axway Confidential and proprietary. All rights reserved.
Current Landscape – Industry
• Current activity amongst large
manufacturers is toward business solutions
that bring real ROI as well as international
regulatory requirements.
– Returns
– Product authentication
– Cold Chain
– ASN Reconciliation
– Turkey, Brazil Compliance
11 |
11
11
© 2010 Axway | All rights reserved.
© 2010 Axway Confidential and proprietary. All rights reserved.
Axway HealthCare On Demand
12
© 2010 Axway Confidential and proprietary. All rights reserved.
ePedigree On Demand
McKesson - Largest single pedigree
implementation in the US powered by Axway
Over 50,000 pedigrees delivered daily
HDMA iBusiness award winner
Comprehensive archiving,
in 2007.
reporting and alerting
33 States have enacted and/or
EPC Global certified.
Store and access ePedigrees
passed legislation
HDMACompliance
Dec, 2009
with all state and
federal
Leader
with 60+ pedigree
requirements
customers – mfg, wholesalers
and retailers.
AZ, Mylan, Apotex, Watson, PSS,
Harvard, etc implemented within
weeks along with an investment in
the Axway platform
13
© 2010 Axway Confidential and proprietary. All rights reserved.
ePedigree On Demand
Complete item
level
information
Reference
data includes
invoice#,
PO#,
shipment#
Chain of
custody
tracking
14
© 2010 Axway Confidential and proprietary. All rights reserved.
CSOS On Demand
McKesson, Cardinal and ABC
all use Axway CSOS
Anda grew C2 business over
400% in the first 18 months
Largest CSOS award winning
solution provider in the market
with thousands of pharmacies
Convert all paper 222 forms to validated
connected
electronic e222 documents
“sell-side” functionality enabling
manufacturers to comply with major
distributor and retailer mandates/requests
to process
Watson, UPS
recentlye222 orders
implemented Axway CSOS
Save $250K per 10000
annual e222 documents
15
© 2010 Axway Confidential and proprietary. All rights reserved.
CSOS Orders Validated
All line level data
visible to users in
a standard style
sheet
DEA Registrant
number
16
© 2010 Axway Confidential and proprietary. All rights reserved.
EDI On Demand
McKesson, Cardinal and ABC
all use Axway EDI for all of
their EDI transactions
Full lifecycle and order to cash
visibility by trading partners
Receive, send and track EDI
documents over various protocols via
the internet
Common data feed can be
Pre-defined
utilized for other
Axway Ondocument translation for
thee.g.
major
wholesalers
Demand solutions
RxASN
for ePedigree
Save money by eliminating
VANs
17
© 2010 Axway Confidential and proprietary. All rights reserved.
EDI On Demand
Provides users with complete
lifecycle
Standard
dashboards
visibility for all pertinent events
and
showing
multiple
EDI documents.
metrics
Events can be logical or alert based.
All EDI documents can be viewed
when selected
18
© 2010 Axway Confidential and proprietary. All rights reserved.
Clinical Trials On Demand
Abbott Labs has recently
implemented Axway’s
Clinical Trials solution
NIH best practices in
clinical trial data collection
merged with Axway’s
industry
leading enterprise
Hosted software platform for
managing
single or multi-site clinical researchMFT solutions
studies
Real-time visibility and
Facilitates protocol configuration and
dashboards
easy submission of case report forms
(eCRFs) with guaranteed secure file
transfers
Supports HIPAA/HITECH
and other regulatory
guidelines and architected
as a standards-based
platform
19
© 2010 Axway Confidential and proprietary. All rights reserved.
eSubmissions On Demand
JnJ, Merck, Schering
Plough and all of the
Track, monitor, and report
other leading
Hosted offering
onyour
submissions activity for
manufacturers
have to automate
to the FDA, EMEA end-to-end
and MHLW process
enhancedsubmissions
revenue by
securely
visibility
avoiding
latency
Secure, Compliant, and Validated
regulatory documents in any format via
any industry-standard protocol
Compliance with CFR Part 11
validation
20
Ensure the privacy and
security of your electronic
submissions
© 2010 Axway Confidential and proprietary. All rights reserved.
Review all eSubmissions
Search for all
your submissions
through the
portal
See the details
of each
payload
21
© 2010 Axway Confidential and proprietary. All rights reserved.
Channel Analytics On Demand
Focus is on:
Inventory - Cash Management
& Revenue Management
BI, DDN, GSK
use Axway’s
Downstream Sales/Returns Channel
Batches of reports for each
Core
New
Product Intros
Analytics
Enterprise on a Weekly, Monthly and
and Returns
Quarterly basis - 23 core Chargebacks
reports are
included in the package Forecasting
No customer UI, scorecards,
user
DataorReconciliation
administration required
Date Stamped Reports
22
© 2010 Axway Confidential and proprietary. All rights reserved.
Channel Analytics on Demand
You can select
the type of chart
you would like to
see on the report
Every Report is
date stamped
23
See detailed
calculations for
each report
© 2010 Axway Confidential and proprietary. All rights reserved.
Track and Trace On Demand
Securely captures,
retrieves, transfers and
manages key product and
serialized event data
Astra Zeneca, Genzyme,
JnJ, BMS, Schering
Plough
Axway Track
& Trace with an EPCIS
compliant
Event Repository with product
all use Axway’s
EPCIS
authentication
compliant Track
& Trace and serial number
management
Customer has access to a serialization
Modules available:
pilot for 1 SKU, 1 DC and 1 Packaging Line
Real-time life cycle views
24
Diversion detection
Global regulatory compliance
Anti-counterfeiting
© 2010 Axway Confidential and proprietary. All rights reserved.
Track and Trace On Demand
Product Serial number
PAI
Enterprise
can be
entered and
authenticated
Positive Authentication
Negative Authentication
results with product
results will block the
information will appear on
serial number
this screen
See the detailed
information for
every product
25
© 2010 Axway Confidential and proprietary. All rights reserved.
Partnering Opportunities
• ABSG can offer these solutions to your customer
base
• Increase competitive “stickiness”
• Additional Revenue
• Viewed more and just a 3PL
• Consultative Selling
26
© 2010 Axway Confidential and proprietary. All rights reserved.