cardinal health specialty solutions · distribution to sites of care, including hospitals,...

Cardinal Health Specialty SolutionsAt the nexus of health and care

To ensure all those interactions go smoothly, to maximize your therapy’s chance of success, you need a partner who is fully engaged in the healthcare system. One who works with all the other stakeholders in patient care. One with a thorough understanding of the processes, procedures and organizations that make up modern medicine. You need a partner like Cardinal Health Specialty Solutions.

The biopharmaceutical industry is responsible for many everyday miracles — therapies that save and change lives. But the healthcare system you are a part of is nearly as complex as the human body itself. To heal people, to ensure the right therapy gets to the right patient at the right time, the whole system has to work together.

Even your role alone is incredibly complex. From development through approval, and from prescription to reimbursement, you work with every other part of the system.

Connect with the company that already does.

To connect to patients who need your therapies, you have to connect with their providers and payers.

Research and discovery

Clinical development Launch Maturity Sunset

Solutions for the full lifecycle of your product

Product development

Distribution and related services

Reimbursement and patient support and access

Product commercialization

Data and analytics

Therapy decision support

Cardinal Health Specialty Solutions is uniquely focused on the role of pharmaceuticals, biologics and medical devices in patient therapy. Our deep involvement in every aspect of healthcare provides us insights into the events that drive healthcare today — and those that will affect it tomorrow.

Innovative programs and technology

Clinical Pathways: the first evidence-based clinical pathways program in oncology to operate across networks of payers

PathWare® Decision Support Solutions: Web-based tool to provide real-time decision support at the time of care

KEW Group: state-of-the-art diagnostic services for community oncologists

Cardinal Health Specialty Solutions turns expertise and insights into action.

Want to use real-world data and analytics to inform your go-to-market strategy and help patients achieve better outcomes?

Talk to us.

Through our ongoing quest to improve, innovate and collaborate, we have developed a unique understanding of the challenges you face.

Unsure how to navigate the ever-changing, complex world of regulatory requirements?

We can guide you.

Have questions about how to provide the appropriate treatment and services necessary for the smaller target patient populations that proliferate healthcare today?

We can answer them.

Concerned about the financial issues related to patient access and authorization, reimbursement or supply chain management?

We can help.

Wonder whether there is a better way to manage the clinical and financial impact of complex dosing regimens upon patient compliance and adherence?

We can show you how.

KEW GroupAnticipating the increased use of molecular diagnostics in patient care, Cardinal Health Specialty Solutions recently became a minority investor in KEW Group.

KEW Group This state-of-the-art molecular diagnostics laboratory and oncology services company provides next generation technology to enable precision cancer care in community hospitals and clinics. KEW seeks to enable community oncologists to deliver the same level of evidence-based care as specialists at larger research hospitals. Through this collaboration, oncologists are provided with action-oriented solutions and emerging therapies to help guide treatment decisions and advance patient care.

Offerings include:

• KEW CancerPlexSM: a comprehensive gene testing panel to evaluate genetic changes in a patient’s tumor

• KEW Molecular Diagnostics: cutting-edge, cost-effective MDx testing and interpretation services

• KEW Treatment Pathways: genetics-intensive, evidence-based pathways for the community setting

• KEW Oncology Network: alignment of these tools to advance personalized care in community practices

The partnership with KEW Group is just one way Cardinal Health Specialty Solutions has evolved beyond its focus on specialty pharmaceuticals to remain on the forefront of macro-trends in patient care. The co-marketing and data-sharing relationships currently under development through this partnership ensure that both companies will continue to lead innovation in healthcare.

Working with biopharmaceutical developers and manufacturers on the next generation of therapies, Cardinal Health Specialty Solutions draws upon both our regulatory expertise and knowledge of the entire lifecycle of a therapy.

Product d

evelopm

ent

Develop scientific and regulatory strategies designed to meet global requirements

Prepare regulatory documentation for investigational and marketing applications

Compile electronic regulatory submissions according to the eCTD guidelines

Prepare post-approval submissions and required state licenses

Product development

Regulatory SciencesCardinal Health Regulatory Sciences guides pharmaceutical, biotechnology and medical device companies throughout the product development and regulatory approval processes.

We work with you to mitigate and streamline the development continuum, devise the best regulatory strategy for your therapy, prepare documentation and navigate the approval and licensing processes. We will help you maximize your return on investment by creating and implementing efficient global scientific and regulatory strategies within the U.S., European, Canadian and rest-of-world markets.

Solutions

• Worldwide regulatory development strategies

• Chemistry, manufacturing and controls

• Nonclinical development

• Clinical development

• Medical writing

• Regulatory publishing services

• Compliance services

• Launch and post- approval services

• Training services

Areas of expertise

• Synthesis development and optimization

• Formulation development and analysis

• Analytical development

• Nonclinical and clinical study design and protocol creation

• Product labeling and investigator brochure

• Contractor (CRO/CMO) management

• Preparation, review and publishing of regulatory submissions

• Investigational applications (INDs, IDEs, CTAs, etc.)

• Marketing applications (NDAs, BLAs, PMAs, ANDAs, biosimilar 351(k)s, MAAs, etc.)

38years of global experience

100+regulatory scientists on staff

One of the more complex aspects of the healthcare system is the distribution and delivery of therapies. We will work with you to develop and execute the optimal commercialization and distribution strategy for your therapy.

Distrib

ution an

d related

services


99.9percent on-time, accurate shipping

• A leading distributor of fractionated blood derivatives and specialty pharmaceuticals

• Supplies hospitals, community-based physicians, clinics and alternate care sites and providers

• Emergency Drug Response Program for healthcare facilities in key geographical regions

• Exclusive distribution contracts and flexible, customized programs

Specialty Pharmaceutical DistributionSpecialty Pharmaceutical Distribution helps our customers deliver therapies for specialized patient care and helps increase sales through contracts with our group purchasing organizations (GPOs). Decades of experience managing plasma (IVIG and albumin) allocation databases for a number of large GPOs has given us the depth and scope to successfully manage all the details associated with these markets.

Web-based software

• RxID and RFID consignment technology

• Seamless electronic ordering

• Real-time buying with accurate pricing and product search

• Alerts, recall and transfer notifications

• Inventory use and return capture

• Multiple storage location monitoring

• Support for multi-user hospital networks

• Transfer, track and trace capabilities

• Flexible, customizable reporting via analysis tools

• Access from smartphones, tablets and laptops

2-3

Emergency Drug Response Program reaches 90 percent of hospitals in

hours


Pharmaceutical DistributionFrom retail to hospital to mail-order facilities, the Pharmaceutical Distribution service at Cardinal Health leads the industry in pharmaceutical logistics. We work with customers throughout the U.S., Puerto Rico and China, distributing products to retail and specialty pharmacies, hospitals, community practices, imaging centers, mail-order facilities and alternate care sites — even directly to patients for free drug distribution.

Services

• Pharmaceutical repackaging

• Telesales

• Generic sales services

• Brand-to-generic conversions

* Gartner Inc. ranked Cardinal Health No. 1 on its fifth annual Healthcare Supply Chain Top 25 for a third consecutive year

Ranked number 13 years in a row*

Successfully getting your products into customers’ and patients’ hands requires a comprehensive commercialization solution, and Cardinal Health Specialty Solutions 3PL Services delivers the optimal combination of services to ensure your product reaches the end-customer quickly, efficiently and reliably. Add to that our unmatched regulatory expertise and healthcare industry knowledge and it is clear — Cardinal Health 3PL Services isn’t just a logistics solution — it’s a total business solution.

• Solutions that exceed regulatory and quality assurance requirements

• Cold chain expertise

• Order-to-cash management expertise


Cardinal Health Specialty Solutions 3PL Services

Services

• Quality assurance and regulatory consulting

• Order-to-cash

• EDI, FTP, real-time reporting and data analytics

• Distribution and warehousing

• Returns management

• Sample distribution

• End-to-end transportation management

30-40 percent transportation savings

Exclusive Pharmaceutical Transportation Network (EPTN)

The nation’s only pharmaceutical-specific network, EPTN covers 70 percent of all trade volume shipped for pharmaceutical products. Our one-touch approach to handling products virtually eliminates damages during shipment as well as the added cost of labor and cold chain packaging.

• Temperature-controlled trailers

• Minimal third-party touches

• Cardinal Health contracted rates

• Reduced expedited shipping expenses

$14B+

product flow-through

Sonexus Health®, now a Cardinal Health Specialty Solutions company, offers a compelling distribution option for high-cost or specialty therapies, including orphan and ultra-orphan products, with direct distribution to sites of care, including hospitals, practices and specialty pharmacies.

Integrated with access and patient support services, these customized solutions and compliant facilities were designed for high-volume, small-parcel shipments, enhancing cost efficiency, product security and control of the product. With better control and a shorter supply chain, biopharmaceutical manufacturers can more readily manage the complexities they face on a daily basis such as product security, serialization, REMS and managing 340B entities.


Sonexus Health®

All of these services are integrated into a robust technology platform that gives companies a real-time view of their product from point of dispense to point of reimbursement.

OneSource portal for

360-degree product view

Direct distribution services

• Warehousing and fulfillment

• Invoicing and accounts receivable management

• Customer service

• Inventory management

• FDA-licensed relabeling

Direct-to-patient services

• Help qualifying patients with patient assistance programs (PAP)

• Rapid therapy initiation for patients waiting on prior authorizations or appeals

• Bridge programs for those facing a temporary lapse in coverage

• Comparator or ancillary study medications for clinical study product programs


A group purchasing organization (GPO) for community-based physician practices, VitalSource® GPO has a deep focus on oncology and urology products, and therapies for rheumatoid arthritis. It offers its members solutions to deliver financial, clinical and operational results.

VitalSource® GPO

Provider services

• Practice analytics

• Regimen analyzer

• GPO contract performance dashboards

• Remittance and claims management

• Practice assessment services

• Education and publications

Flexible, turnkey solutions for oral dispensing

• OncoSourceRx central fill model

• Physician dispensing program

• Licensed pharmacy

• Consignment program

For our pharmaceutical manufacturing partners, VitalSource® GPO offers a comprehensive portfolio of services to engage with key healthcare professionals and prescribers in member practices. These targeted services are designed to achieve strategic brand initiatives through driving awareness, clinical conviction and changing prescribing behavior.

Services

• Digital

- Banner advertising

- Email marketing

- Digital advertising

- Data offerings

• Print

- Direct mail

- Print media

• Personal

- Targeted practice interactions

- Practice manager interactions

- Physician interactions


VitalSource® GPO continued

$1B+ annualized member pharmaceutical sales

Fastest growingGPO in oncology

Largest GPOin urology

Our Specialty Pharmacy division partners with biopharmaceutical manufacturers in the exclusive and limited distribution of specialty therapies. An important part of this work involves efforts to improve patient compliance and adherence with these medications, which requires high-touch, personalized patient interactions.

At the core of our patient-centric model is OncoSourceRx. Offering true concierge service, all of our customer service staff are registered pharmacy technicians or pharmacists and can address any clinical questions, side effect management, therapy management inquiries or financial issues.

Services

• Customized support for high-touch product launches

• Proprietary adherence, intervention and outcome process

• Prior-authorization and benefits investigation

• Patient assistance program/copay support

• Compliance and persistency programs

• Refill reminders

• Forecasting tools and ongoing assessments

• End-of-therapy discharge assessments

• Clinical care and validation process

• Risk assessment tools including QoL assessments and productivity

• Clinical management of:

- Oncology

- Rheumatoid arthritis

- Inflammatory disease

- Hepatitis C

- Multiple sclerosis

Packaging solutions

• Partial fill “Quick Start” program with 7-14 days of product

• Optimal Therapy Adherence Packaging with individualized doses and pre-packaged ancillary drugs

• Dose titration for optimal therapy adherence


Specialty Pharmacy

“Your staff is incredible. With all of the other medications I have to orchestrate on behalf of my family, this is one I don’t have to worry about! You all make it so easy. Thank you.”

OncoSourceRx customer

“They make sure to call me and order my medicine a shot ahead just in case something was to happen, that I have my medicine. They are very nice and respectful on the phone.”

OncoSourceRx customer


Specialty Pharmacy continued

Areas of expertise

• Industry leading time to first fill

• Maximizing days on therapy

• Customizable data and reporting analytics

• Customized biopharma programs

• The highest measured medication possession ratio in the industry


Nuclear Pharmacy Services The leader in its field, Cardinal Health Nuclear Pharmacy Services provides reliable access to a comprehensive portfolio of imaging agents, and helps provide more efficient processes and safer environments for staff and patients alike. We offer a broad range of FDA-approved diagnostic and therapeutic radiopharmaceuticals, as well as pharmacologic stress agents, radioactive quality control sources, functional imaging drugs and ancillary medical supplies.

• Nearly 135 nuclear pharmacies

• 35 Positron Emission Tomography (PET) biomarker sites

10M radiopharmaceutical doses each year

Nearly

Our patient services support optimal clinical outcomes and cost savings in patient care by identifying target populations, reporting outcomes and facilitating patient access and reimbursement.

Reimb

ursement an

d p

atient supp

ort and

access

Specialty products are unique. That is why, through integrated access and patient support services, we deliver flexible capabilities that enable biopharmaceutical manufacturers to provide personalized service and creative solutions to patients and healthcare providers.

These solutions provide real-time reporting, analysis and payer insight, and remove barriers related to treatment approval hurdles, financial issues and clinical trial transitions. Integrated with direct distribution of the product to sites of care, our services allow providers to prescribe products with confidence, and patients rapidly obtain and cost-effectively complete prescribed therapies.

Reimbursement and patient support and access

Sonexus Health®

Diagnosis

Renew therapy(Renewal enrollment)

Your team• Specialty pharmacy

• Program support

• MD

Begin treatment• Dispense

• Program enrollmentPatient services and support• Enrollment and access

• Financial assistance

• Resource center

• Psych/social support

Tracking your progress• Mobile app

• Portal journaling

• Referrals to inform therapy providersCommunity• Social media websites

• Patient journaling

• Advocacy and resources

• Support groups

Continued case management• Nursing support

Patient journey

The ConnectMyCare mobile app lets patients coordinate management of their therapy and disease state through a smartphone or tablet.

Financial solutions

Distribution and pharmacy services

Access and patient support

Data reporting and analytics

Reimbursement services

• Benefit verification

• Prior authorization

• Denials and appeals

• Billing and coding information

• Claims tracking

Patient access programs

• Copay assistance

• Eligibility verification

• Alternate coverage research and triage

• Rapid therapy initiation

• Continuity of care

• Premium assistance

Clinical services

• Adherence programs

• REMS programs

• Medical information and pharmacovigilance

• MSL program services

• Injection training program services

• Psych/social support

Product com

mercialization

In today’s dynamic market, maintaining patient access and market share can present significant challenges. Our commercialization solutions use real-world data, analysis and payer insights to help you meet and overcome these challenges.

Custom and standard kits for all procedural areas

• Operating room

• Cath lab

• Interventional radiology lab

• Endoscopy and GI suite

• Emergency room

• Labor and delivery

• Nursing floors


Kits help clinicians focus on patient care

• Aligned with latest care standards

• Consistent quality

• Predictable pricing and inventory

• Cost effective

Packaging services help increase patient access

• Unsurpassed product availability

• High-volume items monitored for sell-through to patients

• Complies with FDA Good Manufacturing Practices

• Original manufacturers’ package inserts included

• The largest repackaging program in the industry

• 180+ branded items, 27 controlled drugs and six CII items

Packaging and kittingCardinal Health provides an essential link between biopharmaceutical and medical supply companies and the pharmacies and healthcare facilities that use their products through our packaging and kitting services.

180+branded items


ParMed™ Pharmaceuticals

10,000+ customers

• Independent pharmacies

• Chain drug stores

• Food stores

• Home health

• Managed care

• Respiratory inhalation

• Specialty oncology

• Rheumatology

• Veterinary

ParMed™ Pharmaceuticals, a Cardinal Health company, supplies generic pharmaceuticals and supports key brand products and product launches. Its robust outbound and inbound sales capabilities and high-touch model provide measurable results for its customers.

40,000high-touchesper week

Outbound and inbound sales

• Account management

• Customer service

• Call metrics and tracking

• Customer relations

• Customer survey/interviews

• Cold calling

• Campaign marketing

• Lead generation/ appointment setting

• New account set up

• Pre-booking campaigns

• Product sales and detailing

• Product launches

• Program overview and compliance

• Website support

Promotional services

• Summit lectures

• National dinner programs

• Web conferences

• On-demand webcasts

• eBlasts


Marketing communications In today’s increasingly targeted market, reaching the

patients who will benefit most from your therapy requires

equally targeted communications. At Cardinal Health

Specialty Solutions, our comprehensive data resources

enable us to help customers identify patients, understand

physician behavior and reach everyone involved in

treatment decision-making.

Consulting services

Geographic InsightsOur proprietary platform can provide information on

patient population and treatments to the ZIP code or

physician-level across a variety of parameters to inform

your communications.

Treatment trendsThis program allows us to review the clinical evidence,

identify gaps in physician perceptions and publish the

resulting learnings and best practices.

Mock pathwaysThis service provides a unique understanding of the

clinical pathway development process, clinical treatment

algorithms and clinical climate.

Case insightsAn hour-long case study discussion with physicians,

nurses and pharmacists, these interactive sessions provide

feedback on providers’ thinking and current treatments.

Advisory meetingsFrom identifying relevant participants to content

development and moderation, our experts use our

knowledge and connections to get the most out of

your meetings.

Inform Position

InfluenceEducate

Promotional programs

Digital marketing services

Direct-to-patient initiatives

Market research

Consulting services

eBlast database of

community oncology providers

20,000hospital pharmacists and

16,000+

One of our greatest strengths lies in the deep relationships we have with all the stakeholders in healthcare. The unparalleled data gained through these relationships provides insights we use to optimize strategic decisions and messaging.

Data an

d an

alytics

100M+unique lives in payer database

Data and analytics

Outcomes research

Combining provider, payer and pharmaceutical experience with research-based services to model outcomes from treatment effectiveness to budgetary impact

• Comparative effectiveness research

• Economic value analysis

• Market assessment

• Resource utilization

• Clinical benefits

BioPharma Analytics Our analytical proficiency — paired with some of the industry’s most comprehensive and complete data sets — allows us to deliver much more than analyses and reports. We provide recommendations that move you toward success.

Market insights

Robust research capabilities and experience providing in-depth market intelligence and turning that intelligence into insights

• Predictive analytics

• Evidence insights

• Market expansion

• Payer insights

• Provider insights

Our advantage

• Large, diverse and fast-growing databases

- 100M+ lives payer claims

- 1.7M lives urology EMR

- 2.5M lives oncology EMR

- 5.6M integrated lives EHR/claims

• Knowing healthcare systems and the evidence and insight needed to influence change

• Insights into patients, providers and payers

• A history of working with — and collecting data from — physicians, hospitals, pharmacies, labs and payers

• A commitment to add new sources of valuable data

Cost of care reports leverage comparative effectiveness research and value analysis to help inform therapy decisions.

Figure 1. Treatment patterns by line and age group

100%

Prop

orti

on o

f pat

ient

s (%

)

9 0%

8 0%

70%

6 0%

50%

4 0%

30%

20%

10%

0%First-line,

Age <65First-line,

Age ≥65First-line,

TotalRelapsed,Age <65

Relapsed,Age ≥65

Relapsed,Total

6% 3% 4% 11% 11% 11%

2% 1% 1% 4% 4% 4%

9% 11% 10% 2% 6% 5%

11% 11% 11% 17% 14% 15%

17% 18% 18% 24% 27% 26%

20% 29% 27% 17% 21% 20%

37%

Other combinations

Alemtuzumab-based

Chlorambucil-based

Cyclophospamide-based

Bendamustine-based

Rituximab monotherapy

Fludarabine-based 26% 29% 26% 18% 20%

Oncology EMR• Community-based

oncology practices

• 2.5M patients

• 1,200+ oncologists

• Labs

• Staging

• Chart access

• KOL partnering

Urology EMR• Community-based

urology practices

• 1.7M patients

• 1,500+ urologists

• 330 practices

• Gleason scores

• PSA levels

• KOL partnering

Payer claims• 100M+ patient lives; multiple TAs

• 5.8M+ cancer patients

• Data from 2000

• 90-day lag time

• Commercial, Medicaid and Medicare (A, B, D)

• Integrated labs (25 percent)

• Medical and pharmacy

• Formulary benefit detail

To ensure that we can provide the most incisive insights, we have assembled some of the industry’s most comprehensive and complete data sets — drawing from electronic medical records, payer databases, claims and remittance information and more.

Real-world data to inform your go-to-market strategy

Integrated EHR/claims• Payer claim data set with links

to EHR

• 5.6M linked patients

• Community and hospitalized patients

• Labs

• Pharmacy/medical claims

• Based on 130M payer claims

• Based on 28M EHR patients

Laboratory• Largest clinical lab data

repository in U.S.

• 2005 to present

• 150 patient encounters

• Broad coverage of labs from chronic, oncology, infectious disease and toxicology

• ICD9 diagnosis and patient demographics

• Mobile app and patient engagement/ compliance solutions

Point of care claims• Proprietary claims remit data

• 200+ practices

• 1,300 oncologists

• Tumor distribution by drug

• Reimbursement details and denials by plan type

• Use of drug by indication

• Provider and administrator access

As treatment options and cost increase, so does the need for evidence-based decision making. In response, we have expanded our treatment pathways and decision support tools to encompass more disease areas and protocols.

Therap

y decision

supp

ort

15 percent reduction in the overall cost of cancer care1

Therapy decision support

Clinical Pathways and PathWare® Decision Support SolutionsPatient diagnosis

Regimen selection

Benefit verification

Multiple pathways management

The first evidence-based clinical pathways program operating across payer

networks, our Clinical Pathways program was established to provide clinically

proven, evidence-based treatment protocols that promote the delivery of high-

quality, cost-efficient patient care. PathWare® is also a key practice management

tool to administer multiple pathways.

Clinical pathways

• Oncology

• Inflammatory diseases

- Rheumatology

- GI

PathWare® Decision Support Solutions software

• Clinical informatics and decision support trees

• Automated therapeutic algorithms

• Real-time specialty pharmacy orders

• Seamless real-time workflow

• Multiple pathways management

• Quick selection of appropriate treatment regimens

• Access to real-time physician and practice compliance

Goals

• Reduce treatment variation

• Improve patient outcomes

• Direct site of care

• Save healthcare costs

1. Feinberg B, Milligan S, Cooper J, et al. Third-party validation of observed savings from an oncology pathways program. Am J Manag Care. 2013;19(4).

Together, Clinical Pathways and PathWare® offer

a new care delivery paradigm in which patients have

better outcomes, payers are able to lower their costs and

providers are supported with higher and aligned reimbursement.

Partner with Cardinal Health Specialty Solutions to:• Solve complex regulatory puzzles

• Provide evidence of better patient care outcomes

• Access a unique level of expertise, agility and customer service

• Get assistance at any — or all — stages of a product’s lifecycle

• Lower costs, streamline patient care and enable better outcomes

• Work with well-educated, well-trained professionals, including teams of on-staff physicians, PhD-level scientists, clinicians, analysts and health economists

• Drive product uptake and provide your business with market decisions informed by real-world data

We provide actionable information to help you take on any

challenge you may face. As your strategic business partner, we

can maximize your product’s potential throughout its lifecycle.

© 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, VitalSource, PathWare, ParMed, Sonexus Health and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other trademarks are the properties of their respective owners. Lit. No. 1SS14-16110 (08/14)

cardinalhealth.com/specialtysolutions

Cardinal Health7000 Cardinal PlaceDublin, Ohio 43017

913.451.3955

Cardinal HealthSpecialty Solutions

cardinal health specialty solutions · distribution to sites of care, including hospitals,...

Documents