PAIN MANAGEMENT MARKETPLACE (CENTERS OF EXCELLENCE MARKETING)

Pain Management Marketplace

A “Global Marketing Excellence” Strategy

Presentation By Andre’ Harrell

This slide presentation is for illustration purposes only and to

show how AH2 & Beyond Consulting can help you build your Global

Marketing Excellence Strategy Plan

All content & data is fictitious and is only for illustration

purposes

Objectives

• Market Analysis

• Competitive Analysis

• Buying Process

• Customer Analysis

– Segmentation

• Value Proposition

• Positioning

• SWOT

• Critical Success Factors

• Strategic Priorities

Below are objectives you can utilize to set up your strategy

Regulatory Key Events (2014) US and EU

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec // 2015

US Target: NDA Approval June 15

FDA RMP mtg NDA Resubmission

Submit RMP Proposal to FDA

=Corporate regulatory submissions (base case)

=Target regulatory approvals/license

=Key regulatory milestones

Understanding the regulatory process/requirements are critical at the beginning build of your marketing

excellence plan

Acute Pain Market

Overview Establishing a Market Overview in your

plan sets up a strategy of “Where To Play”. The next few slides examine a therapeutic class within the healthcare sector as an

example.

A Shifting Perspective on Pain

• The impact of pain is evident on many levels – Social

• Special Congressional mandate declared 2000–2010 as Decade of Pain Control and Research to generate increased understanding and awareness of pain

– Clinical • Pain is now considered the 5th vital sign • Elevated awareness of pain and its clinical sequelae

– Regulatory • JCAHO guidelines recognize that patients have a right to

appropriate assessment and management of pain • Growing RMP requirement • National Patient Safety Goals

– Other • Anesthesiologists no longer reimbursed for post-op pain

management • Growing movement toward outpatient surgery

Surgical Trends Inpatient

• Complexity of inpatient surgeries growing – Neurologic procedures

(craniotomies) – Transplants – Bone

repair/microsurgery

• Inpatient surgical costs scrutinized for most hospitals – Hospitals focusing on

improving clinical efficiencies to maximize cost recovery

• Increase in minimally invasive surgery

Outpatient • Increasing transition

to outpatient surgeries (OP) – Hysterectomy (either

ambulatory or 23-hour) – Shoulder surgery – Cholecystectomy

• The ability to transition surgeries to OP highly dependent upon pain management – 30% of all readmissions

based on pain issues – Inability to tolerate

orals after anesthesia

Inpatient Acute Pain Landscape

Source: Solucient LLC AC Tracker data, HCUP data

54M+ Inpatient Procedures and Diagnoses

5.8M inpatient surgical procedures

[within key specialties]

6.8M inpatient non surgical

procedures and diagnoses

• Orthopedic • OBGYN • General • Urology

“Non-Surgical Acute Pain”

18M Opioid Requiring Patients

1.8M other surgical procedures

[outside key specialties]

• Cardiovascular • Neurological • Vascular(Micro)

38M Unique Inpatients

14M Patients Requiring “Injectable” Opioid

Segments included in revenue forecast

Acute Pain Primary Stakeholders

• Anesthesiology (32,113)

• Anesthesiologists Role – Responsible for the

post anesthesia care unit (PACU)

– Order all epidurals and some IV PCA

– Key influencers in surgeons decision of post op pain plan

– Often lead acute pain teams

• Surgeons – Orthopedic (24,231) – OB/GYN* (42,912) – General (31,822) – Urology* (11,106) – Other (27,292)

• Surgeons Role – Acute pain management

not primary focus – Order most of the IV

PCA, all IM, all orals • Secondary Targets

include: Pharmacists, PACU Nurses, Floor Nurses

Ambulatory Surgery Center Insights

• ASC’s conduct both surgeries and diagnostic procedures

• There are about 3,000 Ambulatory Surgery Centers (ASC)

• Primary specialties involved in ASC’s are GI, Opth, GYN

• There is some IV opioid use in recovery; low levels of PCA mostly for ORS procedures

• Pharmaceutical spend is low, roughly $25/case

• Reimbursement at ASC’s is typically lower than in hospitals

Competitive Landscape

Establishing a Competitive Landscape in your plan can help you set up a strategy of

“Offense”, in addition, gather an understanding of your products strengths

& weaknesses

IV PCA Overview WHY ACCEPTED • Patient in control of

pain management • Lower opioid

consumption • Removes delay in

analgesic delivery / gaps

• Can be customized for each patient – Flexibility (opioids,

dose, duration, basal, etc.)

• Nursing preference – No repeated needle

sticks – Reduce time

requirements for staff & patients

DOWNSIDES

• Invasive (IV access required)

• Potential for programming errors

• Need qualified personnel to administer

• Involves multiple departments in hospital to coordinate and deliver care

Presenter

Presentation Notes

IV PCA Trends

• Addressing IV PCA Safety Issues – Smart pump technology becoming

more prevalent • Bar-coding to minimize errors

• Pre-filled syringes for multiple opioids

• Wireless communication with hospital IM system

Product X

• Company: Product Pharmaceuticals/Skye

• Indication: Intended for single dose administration by the epidural route for the treatment of pain

following major surgery. Administration is prior to surgery.

• Price: $161-191 for 48 hours

• Forecast: $25-30M (net in 2014)

• Sales Force: 150 Hospital Sales Reps

• Clinical Data: 876 patients

(Hip & knee replacement, Lower Ab, C-Section)

• Advantages: Single shot, no need for indwelling catheter, reduce/eliminate PCA

• Disadvantages: Invasive, long lasting, supplemental analgesic requirements

• Initial feedback: Administration issues with Product X

Acute Pain Market - Conclusions

• Broad audience with differing needs • Several factors effect post-op analgesic

selection • Multiple modalities used based upon patient and

surgical processes • IV PCA is cornerstone of post-op pain

management – highly rated based on patient control, flexibility,

and efficacy – drawbacks based upon invasiveness, administration

error, complexities (logistical) • Increasing scrutiny of IV PCA safety issues • Current pump advancements focused on safety

features • Continual monitoring of Product X impact

The “Buying Cycle”

Understanding the “Buying Process” for any product establishes the buying patterns of your

customer in addition to understanding the various buying personalities of your top

customers. Many marketing plans do not have a “Buying Process” which separates our template

from many.

Physician submits P&T request

(Avg 4 weeks)

P&T Committee Agenda & Review

(Avg 5 weeks)

Executive Committee Review

(Avg 4 weeks)

Sub-committee Agenda & Review

(Avg 4 weeks)

Added to formulary (open or restricted)

Rejected for formulary

Trial Period – Formulary/Non-

formulary

Non-formulary available

Hospital Training Process

(Avg 4 weeks)

Forms committee (paper &

electronic)

(Avg 4 weeks)

Variable steps

Product X available

The Buying Process (Example)

Formulary Timing Factors

• Representative access & interactions with physicians

• Formalization of hospital committees

• Lack of summer meetings

Segmentation

Developing a “Segmentation Process” should be a priority of any global

marketing excellence plan. Segmentation provides a microscopic

look at your customers and drives them from a personality and behavior

standpoint.

Initial Segmentation

• Identification of appropriate surgical types

• Patient type segmentation • Institutional segmentation based on IV

opioid use – Led to product positioning – Sales force deployment – Target audience identification – Forecast development

Need further segmentation to allow maximization of sales force direction and marketing spends

Segmentation Deliverables

• Quantify growth opportunities and leverage points

• Identify richest targets – Identify physician characteristics that may

explain likelihood to identify need and advocate for Product X access

– Identify physician characteristics that may explain Product X early adoption

– Identify hospital characteristics that may explain likelihood of Product X access and usage

• Ability to maximize marketing investment by segment – Invest in “richest targets” – Allocations based on launch timing – Institutional targeting plan at a hospital &

physician level

Segmentation “Where to Play”

Which customer segments do we want to target?

Hospital Characteristics

Physician Characteristics 1. Choose the most meaningful and

actionable segmentation variables to put on the axes

2. Put variables 2. Combine variables on each axis in

a way that will further explain differences in behavior(s)

Process for Creating Segmentation Frame

3. Identify, characterize and prioritize the segments within the frame

Presenter

Presentation Notes

Paper

Segmentation Variable Prioritization

Physician Variables

l Specialty

l Physician Age

l Position in Hosp

– P&T Membership

– PMC Membership

– PMT Membership

Hospital Variables

l HSA Population

l HSA Population Density

l Ownership Type (Non-profit, for-profit, govt.)

Variables Used in Segmentation

Frame

Physician Variables

l Specialty

l MSP Behavioral Sgmts

l Target Procedure Decile (from HMS)

l Target Procedure Self-Reported Volume

l Total Target Procedure Volume

l Physician Age

l Position in Hospital

l P&T Membership

l PMC Membership

l PMT Membership

l Tenure

l Fentanyl Use

l Practice Setting

l Basal use with IV PCA

l Negative PCA Experience

Patient Variables

l % Poor Venous Access

l % Elderly Patients

l % Frail Patients

l % Morbidly Obese Pts

Initial Set of Variables

Hospital Variables

l MSA Population

l Population Density

l Hospital Bed Size

l Existence of Rehabilitation Center

l # In-patient Surgical Procedures

l # Surgical IC Beds

l Participation in Healthcare System

l Ownership Type

l COTH Membership

l Geography

l Level of Competition

l Pain Mgmt Program

l Existence of PMC in Hospital

l Pain Team in Hospital

l Inclusion of Pain in Patient Satisfaction Survey

l P&T Committee Size

l Residency Program in Target Specialties

Evaluation Criteria

l Meaningfulness Testing*

– Differences between values generated by cuts in variables

– Statistical significance of differences

– Review of population distribution generated by cuts in variables

l Actionability Examination

– Available in HMS or AHA databases (higher) vs. further investigation or guess work on the part of the sales rep (lower)

l Hypothesizing and assessing correlation between variables

Quantified Action Segmentation®

Note: Target procedures = avg. target procedures per physician in cell. DOT = avg. days of therapy for physicians in cell. Source: Weighted data from IONSYS 2005 Quantitative Segmentation Study, N = 748, AHA data not available for all physicians. Hospital data missing for 3 anesthesiologists, 1 OB/GYN, and 1 general surgeon.

Physician

Hospital

Higher Procedure Volume Surgeons (incl. Gen Surg, Ortho, OB/GYN)

Anesthesiologists

Not Pain Mgmt Team, Committee, P&T or Chief of

Service

Pain Mgmt Team, Committee, P&T or Chief of Service

Not Pain Mgmt Team,

Committee, or P&T Member

Pain Mgmt Team,

Committee, or P&T Member Age <50 Age 50 and

over

HSA Population Less

than 100,000

15% phys (124) 31% launch 54% 6 months 32% ID need 22% advocate




HSA Population 100,000 or

more

Not-for-

profit

Pop Dens <1500 ppl/mi2


Pop Dens 1500+ ppl/mi2


Other (for profit and govt.)


I II III

IVa

V

VI

IVb


IV

Overview: Key Insights

•Specialty (surgeon vs. anesthesiologist), the role of the physician in a hospital and hospital context (surrounding population and ownership type) all have a meaningful impact on physician attitudes and behaviors toward Product X

•Anesthesiologists play a central role for product access

and usage as pain and fentanyl experts sitting on influential pain management and P&T committees and participating in 4-5 times as many procedures as surgeons

•Product X is expected to take significant share across all target procedures from multiple pain alternatives, but particularly IV PCA (50-55% share at 6 months post-launch in target segments)

•~ 80% of P&T members expect Product X formulary approval to be likely, if economically comparable to IV PCA. Only 1% of P&T members expect formulary approval to be very unlikely.

Questions Explored

l What makes physicians more likely to become product advocates for Product X?

– Specifically, what are the drivers for Segment I and III?

l What makes physicians likely to become high users of Product X at launch?

– Specifically, what are the drivers for Segments IV, V and VI?

l What accounts for the differences in product advocacy / usage between older and younger surgeons in Segments IV, V, and VI?

l What other hospital attributes help explain why population density is a meaningful cut of Segment IV?

Understanding the “Why” Behind Product X Segmentation

Physician

Hospital

Higher Procedure Volume Surgeons (incl. Gen Surg, Ortho, OB/GYN)

Anesthesiologists

Not Pain Mgmt Team, Committee, P&T or

Chief of Service

Pain Mgmt Team, Committee, P&T or

Chief of Service

Not Pain Mgmt Team,

Committee, or P&T Member

Pain Mgmt Team,

Committee, or P&T Member Age <50 Age 50

and over

HSA Population Less

than 100,000

HSA Populati

on 100,000 or more

Not-

for-profit

Pop Dens

<1500 ppl/mi2

Pop Dens

1500+ ppl/mi2

Other (for profit and

govt.)

I II

III

IVa

V

VI

IVb

Primary targets for product advocacy

Potential surgeon targets for product

usage

(IVA + IVB)

IV

Conclusions

• Original segmentation assumptions validated by quantitative study – Membership on P&T, Pain Committee, etc. – Role of key stakeholders

• Little difference in Product X share by surgical specialty; practice setting drives usage patterns

• Strong correlation with access targets and high product usage

• Attitudinal insights will help influence messaging

• Pre-launch account planning essential for rapid uptake

“Value Proposition”

Every Global Marketing Excellence plan where a product is featured should have a “Value Proposition”

structure. Detailed in the next few slides provide examples of how the

building of a “Value Proposition” statement/structure is built.

Patient & HCP Safety

Patient & Nurse Satisfaction

Product X

IV PCA Resources Utilization

Product X Value Proposition

Positioning

Who: (target audience) For all healthcare professionals For: (patient types) …..whose patients have acute post op pain and require strong opioids, (competitive framework) patient-controlled Product X is a form of parenteral analgesia which (customer benefit – emotional/end use/functional benefits) is needle-free so it makes my life easier because it is comfortable, safe and easy to use, providing optimal pain relief (reasons to believe –product attributes)

Product X Global Positioning

Emotional benefits

End-use benefits

Functional benefits

Product benefits

Benefit Ladder

Product X Benefit Ladder

Therapeutic equivalence to IV PCA morphine

Similar s/e to IV PCA

Compact, needle free, pre-programmed system

Innovative, single use, off the shelf, disposable system

Comfortable Easy to use, new option Safer Mobility

It makes my life easier

End-use benefits: Anesthesiologist/Surgeon

Quick,safe pain relief

New tool in my armamentarium

Mobility signals recovery

Product X S.W.O.T

Analysis Building a SWOT analysis as part of your

global marketing excellence plan can help you identify where your product can and should receive that best chances to be

successful. Being honest and forthcoming with your SWOT analysis can prepare you

for any market dynamic.

Strengths

• Unique technology • Pre-programmed • Minimizes risk of medication errors • Extensive Health Outcomes platform • Easy to administer • Enhances mobility • Non-invasive technology • Efficacy equivalent to IV PCA morphine • Effective in a broad range of surgical

procedures and patient types • High degree of brand acceptance • Large volume of quality clinical data • Increased nurse and patient satisfaction

Weaknesses

• Perception that one size does not fit all

• Inability to precisely query the system

• Inability to titrate or adjust dosing

• Lack of supplemental dosing recommendations

• No onset of action data

• Challenges to successful implementation of Risk Management Plan (returns & disposal processes)

• Lack of a bolus dosing feature

• Lack of reliability in technical/manufacturing process

• Potential of uncovered accounts in HSA <100k

Opportunities

• Exploit heightened focus on patient safety • Raise noise level on the limitations of

current modalities (IV PCA & IM) • Exploit the growing awareness of safety

concerns with IV PCA • Minimize analgesic gaps through greater

continuity of care • Capitalize on the current nursing shortage • Exploit the fact that our competitors have a

low share of mind among our target audience • Fully prepare the marketplace due to

expected time to launch

Threats

• Lengthy formulary review process • Lack of P&T meetings during summer months

(June launch) • Cost perception may be difficult to overcome • High degree of satisfaction with IV PCA • HCP experience level is low with using

fentanyl in APOPM • Potential for an aggressive competitive

response • Difficulty in accessing customer due to OR

setting • Limited perception of transdermal (patch)

technology

Critical Success Factors

• Establish stronger company presence with key stakeholders pre-launch

• Develop and implement Marketing Mix to strategically target key HCPs

• Gain awareness and acceptance of Product X value proposition

• Accelerate time to formulary approval

• Insure appropriate product procurement and usage

Strategic Priorities

Establishing the Strategic Priorities of your global marketing excellence plan is

probably the most important part of your plan because establishes “goal focus”, “financial focus”, and “Lean Thinking”.

Product X Strategic Priorities

• Disrupt perceived market satisfaction

• Establish leadership presence with target audience

• Exploit uniqueness of the product

• Gain rapid availability and generate positive initial product experience

• Optimize communication of Product X value proposition

Strategic Priorities

• Review brand strategic plan • Gain buy-in on

– Tactical direction – Allocation of funds

• Investment by strategy • Distribution of funds by broad bucket • Pre-launch and Post-launch spends • Spend by key tactic

– Highlight continuing spends from prior year

Product X Strategic Priorities

• Disrupt perceived market satisfaction

• Establish leadership presence with target audience

• Exploit uniqueness of the product • Gain rapid availability and

generate positive initial product experience

• Optimize communication of Product X value proposition

Product X BMEs

Advertising 2,000$ HCP Education 1,160$

Search Program 500$ Speaker Training and Program 4,375$

Marketing Research 1,200$ Promotional Materials 5,250$

Samples 5,300$ Publication Plan 370$

Conventions and Exhibits 2,200$ Internet 600$

Public Relations 870$ Selling Aids 6,335$

Incentive Plan 1,500$ Strategic Customer Marketing 440$

Journal Advertising 2,500$ TOTAL 34,600$

Spend by Strategic Priorities

Establish Leadership Presence With Target

Audience31%

Exploit Uniqueness of Product

19%

Disrupt Perceived Market Satisfaction

14%

Optimize Communication of Value Proposition

2%Gain Rapid Availability and Generate Positive

Initial Product Experience 34%

Forecast

Forecasting your Global Marketing Excellence plan can be a challenging one

because of the unpredictabilities that occur in the marketplace. A solid forecast that’s based on market statistics/dynamics and vision is vital for a product to succeed.

Forecast Architecture

Procedures w.

Injectable Opioid

x Product X

DOT / procedure x

Product X PX

Share

x

Product X Price Per

Day of Therapy

= Product X

Dollars

Step 1 – Product X Days of Therapy

= Product X

Days of Therapy

Product X Total Days of Therapy

Step 2 – Valuation

Assumptions supported by US quant. study and market

analogues From Solucient

Data

Total Surgical

Procedures

Procedures w. Opioid

7.9M

• Total Procedure Growth for Unique Surgical Discharge by Specialty (All Surgical Px Discharges)

• Trending historical Market Unique Discharges and applying findings from market research that overall procedures are moving to outpatient settings (Hysterectomy, Shoulder, Cholecystectomy).

• Penetration of total procedures

• 2012 87.3 %

• 2013 86.3%

• 2014 85.5%

Product X Forecast Assumptions

All Spec Ortho OBGYN General Urology Other2012 -5.6%2013 -4.2%2014 1.5% 2.1% 1.5% -1.5% -4.6% 5.9%YTD 4/12 0.6% 3.9% 1.3% -7.3% 1.1% 3.3%2013 -0.2% 0.7% 0.9% 0.8% -8.8% -1.3%2014 -1.4% 0.2% 0.1% 0.0% -7.3% -3.9%

Shift to outpatient Minimally invasive

• Injectable Opioid Penetration of opioid procedures

• 2012 94.9%

• 2013 95.1%

• 2014 95.9%

• Product X Procedure share of Injectable Opioid

• 2012 Overall Product X Share 1.4% Exit share = 5.4%

• 2013 Overall Product X Share 11.0% Exit share = 14.7%

• Shares calculated from quant study


• Days of Therapy, Units of Product X per Procedure

2013 2014

• All Specialties 2.1 2.1

• Orthopedics 2.1 2.1

• OBGYN 1.6 1.6

• General Surgery 2.8 2.8

• Urology 2.0 2.0

• Other 2.0 2.0

Results of Quant Study, looked at key procedures with in each above specialty to come up with an overall weighted Days of Therapy per Specialty.

• GTN Rates

• 2012 - 91%

• 2013 - 91%


• Stocking and Months of Supply

• Currently built into model is a 5% demand stocking call.

• Current Price

2013 2014

• GOP $116.48 $116.48

• NET $106.00 $106.00

•Pricing research under way to determine latest pricing assumptions and strategies.


Product X Forecast

2013 2014

Injectable Market Px 7.886M 7.830M

Product X Share 1.4% 11.4%

Product X Px 107,796 858,466

Product X Days of Therapy

2.1 2.1

Product X Total Units 228,800 1,822,674

GOP Price per Unit $116.48 $116.48

Pipeline 5% of units 5% of units

GTN Rate 91% 91%

NET Dollars $25.5M $202.9M

Product X P&L Projected Launch 7/2015Product X

$MM'sPreLaunchPost Launch PreLaunch Post Launch

NTS -$ 26.0$

GP -$ 19.9$

Selling 5.0$ -$ -$

Launch Meeting/CD&T 3.8$ 2.5$

Marketing (BME/Mkt Res 10.0$ -$ 16.9$ 11.4$

Clinical 7.7$ -$ 7.3$ -$

Other (dist, net admin, le 2.4$ -$ 4.0$ 7.6$

OI&E -$ -$

Carrying Cost -$ 0.4$

IBT (25.1)$ -$ (32.0)$ (2.0)$

Taxes (8.8)$ -$ (11.2)$ (0.7)$

MNI (16.3)$ -$ (20.8)$ (1.3)$

20152014

This slide presentation is for illustration purposes only and to

show how AH2 & Beyond Consulting can help you build your Global

Marketing Excellence Strategy Plan

All content & data is fictitious and is only for illustration

purposes

Checkout my “Global Sales-Marketing Business Plan” for the Pharma/Med Device Industry featuring Pain Management. http://www.slideshare.net/aharrell2000/example-global-sales-marketing-business-plan You can also checkout my background/work by clicking on the following links: http://www.slideshare.net/aharrell2000 www.linkedin.com/pub/andre-d-harrell/5/13/382/ http://thesalesprofessionalnetwork.blogspot.com/ www.ah2andbeyond.com https://www.facebook.com/pages/Sales-Marketing-Management-Consulting/267898536570725

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Andre’ Harrell

AH2 & Beyond Consulting

www.ah2andbeyond.com

267-221-8529

Contact Us

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PAIN MANAGEMENT MARKETPLACE (CENTERS OF EXCELLENCE MARKETING)

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