CMAC 2011 Presentation

Preparing For A Specialty
Launch: What You Need To Know
Nathan White, CPC • Executive Director, Access and Reimbursement

CBI „s 2nd Annual Commercialization and Market Access Congress

Philadelphia, PA • December 7, 2011

WE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE.™
1 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™

World’s leading provider of sales,
marketing, and communications The leading management
One of the industry’s consulting group specializing
top global CROs solutions for the healthcare industry
in biopharma

Services include: Services include: Consulting practices include:
 Phase I-II  Outsourced sales teams and  Brand management
(FIH or bioequivalence studies) sales support  Business development
 Phase IIb – Phase IV studies  Advertising, branding and PR
 Clinical development
 Strategic partnerships  Digital and closed loop marketing
 Medical affairs
 Bioanalytical services  Patient outcomes, REMS and
 Pricing and market access
 Clinical data services/technology
Rx access/adherence
 Sales
 Medical education
 Staffing services


The Payer Strikes Back!
“If the pharmaceutical industry‟s principle challenge of the
last 10 years has been reinventing the R&D model to
address declining productivity, the next 10 years could
very likely be termed „the rise of the payer.‟”
- Lujing Wang, Ryan Richardson - Campbell Alliance

TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™

Industry Megatrends

Specialty trend (spend) gaining lots of
attention

• By 2016, 8 of top 10 worldwide drugs will be specialty

Pharma companies will move toward
developing more targeted and tailored
therapies and more personalized medicine
• About 70% of current pipeline drugs have biomarkers associated with them.

Pipeline for specialty is substantial

• 600 new drugs in pipeline (40% oncology and 30% of these infused)

SOURCE: Accredo Keynote Address, Armada Summit, May 2011


Industry Megatrends

Legislative and regulatory activity will shape
our future

• Many of today’s Indigent patients will become insured (underinsured)

The co-pay card tipping point

• The government has already restricted commercial co-pay activity and private payers are next



The beginning of the end…

CVS Caremark Corp.'s pharmacy-benefit business is recommending
customers stop covering more than 30 drugs next year, including diabetes
treatments and an erectile-dysfunction pill, to save money and combat drug-
maker coupons that promote brand-name medicine over cheaper alternatives
WSJ, November 19th, 2011

Drug-company coupons that promote brand-name medicine over cheaper
alternatives could hike drug costs by $32 billion over the next decade,
according to a study from the industry that manages pharmacy benefits
WSJ, November 3rd, 2011


Industry Megatrends

Legislative and regulatory activity will shape
our future

• Many of today’s Indigent patients will become insured (underinsured)

The co-pay card tipping point

• The government has already restricted commercial co-pay activity and private payers may be next

The demonstration of value is becoming
more critical

• Payers are already demonstrating resistance to high cost specialty products w/o a value proposition



What should we care about in a specialty product launch?

VALUE PATIENT ACCESS DATA

1. 2 3.
Clinical & Cost
Effectiveness
To Therapy To support value claims


1. Define Your Goals


Step 1: Define Your Goals!

DEMONSTRATE FOSTER GENERATE

1. 2 3.
Value Patient access to therapy Data to support value demonstration


Company with some US commercialization experience
Mid-size Biotech
launched a lyo-formulated SQ injectable biologic for a
Company
chronic disease into a very crowded market.
Co. had label restricting administration by a HCP in a
market where most competitors were self-
administered
This caused payers to cover the product under the
medical benefit in most cases.
Prescriber adoption was poor due to the hassles with
reimbursement when alternatives were easily
accessible with fewer access hurdles.

Results & Lessons Learned
Better integration with the clinical and regulatory teams could have yielded
better Phase III studies with the commercial environment in mind. They also
could have considered a pro-active risk management program to mitigate
concern with patient education and altered the label pre-approval.


1. Define 2. Build
Your Goals Your Team


2. Build Your Team!


Define the Market Access Function

Market Access Functional Consolidation

Activities Integrated into Previous Functional Area
Market Access Function Overseeing Activity

Payer Marketing / Payer Market Development Brand Management/Marketing

Pricing and Contracting Finance

Account Management/Field Operations Sales

Health Economics and Outcomes Research Medical Affairs

SOURCE: Lujing Wang, Ryan Richardson; Campbell Alliance


Your Internal Team: Current vs. Consolidated

Current Consolidated

• Various budget holders • Single budget holder

• Non-aligned management • Aligned management
and incentives
VS. and incentives

• Turf conflicts • Reduced in-fighting

• Decision by committee • Accountable decision making


Steps to Create the Market Access Function

• Increase internal core competencies:
› Understand payer needs and translate into tactics with clinical team

› Influence marketing strategy and create tactics to achieve goals

› Work with new product planning, business development to ensure payer perspective is taken into
consideration

• Restructure infrastructure and operations
› E.g. HOER contributing at all levels of decision making process

Global VS. Local
Global – large evidence generation, stakeholder management software, prioritization

Local – on-the-ground perspective, knowledge of local politics, institutions, stakeholders

SOURCE: Lujing Wang, Ryan Richardson; Campbell Alliance


Considerations for Strategic Partnerships

Aligned values Long-Term growth
Open communication and innovation
and objectives

› Don’t underestimate the › This includes the › Is the supplier innovating
alignment of values breakdown of typical for 5+ years from now?
client-vendor game
› Objectives and risks playing › Is reimbursement and
should be shared access their core
• E.g. price padding, competency?
• E.g. Stock brokers who exaggeration
get paid by the trade vs. › Do their business groups
your portfolio’s work together to produce
performance results?
• Are they willing to share in
financial risk?


Key Considerations For Specialty Pharmacy Evaluation

• Disease management expertise • Payer and employer relationships • Technology platforms
• Pharma (customized) • Ownership • Linkage to copay assistance
• Legal flexibility in program design • Risk sharing (performance- foundations
• Field resources based) • Price for data
• Training

Programs Contracts Data


Organizational Requirements

The right value evidence needs to be delivered to the right audience at the right time by the right
people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently
and effectively.

Hypothesis Evidence Value
Validation Generation Communication

Strategic Visionary Rigorous Scientist Credible Ambassador


1. Define 2. Build 3. Refine
Your Your Your
Goals Team Strategy


Who cares about value?


What is evidence-based medicine?

―The conscientious, explicit, and judicious use
of current evidence in making decisions about
the care of individual patients. The practice of
evidence based medicine means integrating
individual clinical expertise with the best
available external clinical evidence from
systematic research.‖

SOURCE: Sackett DL, Straus S, Richardson S, Rosenberg W, Haynes RB. Evidence-based Medicine: how to practice and teach
EBM, ed 2. London: Churchill Livingston, 2000


Number of Occurrences of Value Terminology by Year in
Core Clinical Journals

SOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology.
Poster Session, International Society for Medical Publication Professionals.

Percent of Increase of Occurrences of Value
Terminology from 2006 to 2009
in Core Clinical Journals

SOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology.
Poster Session, International Society for Medical Publication Professionals.

How do we define value?

THE PLAYERS

AHRQ NIH

PCORI Payers Patients and
providers


ONC Landmark Study: Pipeline Trends

Increased Pipeline Overlap

The oncology Implications
pipeline has grown…
 Clinical trials will become increasingly difficult to complete
…and become highly because of competition for patients, investigators, and sites.
targeted to…
 Regulatory approval will likely become more challenging as the
…the same molecular standard of care fills with ―me-too‖ oncology products that
pathways in… improve the standard of care on control arms.

…ever narrower  Commercialization efforts will become increasingly vital as
patient populations… companies struggle to differentiate themselves in the oncology
marketplace.
…further fractured by
biomarkers.

The oncology market has matured, and new oncology products will be launched in the face of direct
competition from similar products. Commercialization will become increasingly important in the
decade to come.
SOURCE: Campbell Alliance

ONC Landmark Study: Commercial Trends

New Commercial Realities

Oncology is now a Implications
blockbuster machine…
 Oncology commercialization is at an inflection point.
...saturated with
sales representatives.  In the world of 2000, there were fewer reps, few access issues,
and few concerns about reimbursement. All these have
Oncologists are no changed in 2010, and this implies the need for the following:
longer the sole arbiters  Proactive portfolio management
of therapy…
 Pricing and access preparation early in development
…and payers are  Flawless launch
restricting access.
 Best-in-industry sales representatives
There may be a  Patient co-pay programs and direct-to-consumer outreach
bursting oncology  Medical Affairs investment
asset bubble.

Winning oncology companies will recognize the new reality, and will organize their portfolios,
launch planning, and customer-facing resources to meet this new reality head on.

SOURCE: Campbell Alliance

Innovative Contracting:
The Future of Payer-Pharma Relationships

Innovative Contracting Contract Types

1 2 3
Performance-Based Contracts Risk-Sharing Agreements Traditional With a “Twist”

 An outcome or behavior is  Manufacturer assumes some risk  A standard contract with a rebate
measured and tied to the based on anticipated is tied to another factor besides
structure of the contract. utilization, adverse market share or volume.
events, performance, or some other
 For example, the manufacturer factor.  This can include a price increase
can commit to an outcome or the cap, escalating rebates, rewards
 Variation to the expected level will
plan can commit to programs to for loyalty, portfolio contracts, or
require payment or concessions by
support behaviors such as a one of the parties. anything that is in addition to the
adherence. standard contract.
 For example, the manufacturer can
 The rebate level can be tied to commit to effectiveness within 10
whether the outcome or behavior doses and cover the costs for
is achieved. patients requiring more than 10
doses—the manufacturer takes on
the risk.


Benefit Design Shift Correlates To Goals Of Innovative
Contracts
•Risk (and cost) shift •Both short and long-
to manufacturer. term costs
considered.

Cost
Cost Shifting
Reduction

Budget
Value Focus
Predictability

•Focus shifts to •Some contracts have
outcomes vs. potential benefits.
utilization.

Several trends in benefit management are aligned with the objectives stated for implementing an
innovative contract. As these trends continue, they create an environment where stakeholders are more
open to innovative contracts.

A Glimpse Into the Future:
Prime Therapeutics CareCentered™ Contracting

• PT is a large national pharmacy benefit manager covering 17M
lives for 12 BCBS affiliates
• New PBM-manufacturer outcomes-based contracting initiative
launched Fall 2011
• Under agreement, in the event therapy does not ―work as
expected,‖ manufacturer agrees to either:
› Refund cost of therapy
› Pay for cost of event treatment (such as a bone fracture in
osteoporosis)
• Goes beyond outcomes to include:
› Cost of care
› Adherence
› Patient education


4.
1. Define 3. Refine
2. Build Implement
Your Your
Your Team Your
Goals Strategy
Program


Key Components Of A Patient Access Program

Nursing
Support

Patient Reimburse-
Reported ment and
Outcomes Access

Call
Center &
Web Copay
Specialty Portal Foundation
Pharmacy and Alternate
Coordination Coverage
Assistance

Patient Site of Care
Adherence Coordination


Does Investment Result in Perceived Leadership?

SOURCE: Market Strategies International, ―Good Business and Good Will Go Hand in Hand‖, Oncology Business Review, May 2008


Well respected medical device manufacturer had
Medical Device Firm
challenges with spinal surgeon utilization of artificial
(Co. C)
disc replacement due to negative US coverage policies
(CMS NCD) and technology assessments (BCBS TEC)
Due to high number of initial PA denials, spine
surgeons opted for spinal fusion or other interventions
In spite of negative coverage policies, Co C possessed
many positive case reviews, positive economic
models, 15 years of European peer rev. lit. and a
positive NICE tech. assessment
Co C launched an appeals support program that
collected QoL information from the patient and
submitted a personalized appeal package with
supporting case studies and NICE TA to the payer on
Results & Lessons Learned behalf of the surgeon and patient

Co. C saw increased utilization of product due to lower administrative
burden on the spine surgeon‟s office. Additionally, patients who may have
been denied the procedure obtained approval and were treated.


Focusing On the Patient: Patient Reported Outcomes

• Helps to develop evidence of effectiveness outside an artificial
controlled environment (RCT)
• ―Self-reports‖ by a patient
• Data collected through self-administered questionnaires or
interviews (ex. EQ-5D or SF-36)
› Generic
› Disease specific

• Attempts to assess:
› Impairments to well-being
› Disabilities
› Health perceptions
› Quality of Life (QoL)
› Other healthcare ratings

US Payers Likely To Use Patient Reported Outcomes
(PRO) In Future Decisions
How likely are you to use PRO to make
coverage and reimbursement policy
decisions in the future?

(on a scale of 1 to 7 where # of lives = 4,353,435
1=Not likely, 7= Very likely)
5% # of lives = 19,701,655

26%

n=22
68%
Very Likely
# of lives = 51,127,435
Likely
Mean 4.5
Not Likely

SOURCE: 2011 inVentiv Health Payer Study


US Payers Likely To Follow CMS Lead

If CMS publicly leverages the results
of these studies, how likely are you to
follow CMS‟ lead in utilizing PRO to
guide your coverage decisions?

(on a scale of 1 to 7 where
1=Not likely, 7= Very likely)
1%

14%
n=22

Very Likely
Likely
Not Likely

86%

SOURCE: 2011 inVentiv Health Payer Study


Company with some US commercialization experience
Small Specialty
wanted to create and demonstrate value to payers in
Pharmaceutical
light of loss of patent exclusivity
Company (Co. D)
Post-approval RCT sought to demonstrate superior
effectiveness of buprenorphine medication-assisted
therapy paired with Patient Reported Outcomes (in
opioid-dependent patients)
CAC and trained registered nurses conducted
telephonic surveys designed to encourage
appropriate compliance & persistency
The study concluded that patients were more likely
to take their therapy every day and less likely to
abuse, compared to controls
Results of study presented at AMCP satellite
symposia
Results & Lessons Learned

Better patient support leads to better patient outcomes, reducing overall
payer spend; additional messaging to payers on total value of package
(product + program) was critical


Evidence Development: Pre- and Post-Approval

• Prospective
› Clinical study data
• May include PRO endpoints and cost-benefit analysis
› FDA approved label
• Retrospective
› Pharmacy claims analysis
› Chart review
› Budget impact modeling
› Cost effectiveness analysis (limited use in US)
› Registry
› Phase IV outcomes study with PRO
› Commercial marketing programs

Payer Communication of Value Evidence

Successful communication with payers requires following three principles.

Principles of Payer Communication

I Simplicity II Transparency III Credibility

 A complete story that  Avoidance of ―black  Well-accepted
can be told in a box‖ design and methodology and
definite time window subjective validated design
assumptions
 Concise and crisp  Third-party
takeaways that can  Key foundations for endorsement and
stay in memory audience to interpret KOL partnership
study results

Summary

VALUE
ACCESS
Build endpoints into
studies early DATA
Access programs are
Prepare Phase IV worth the investment
initiatives PRO can be your
Design with data friend
Innovative contracts collection in mind
don’t have to be SP and HUB data
scary Partner with vendors can guide your
who will grow with strategy
you


Thank You!
Nathan White, CPC
nwhite@inventivhealth.com

TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™

CMAC 2011 Presentation

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