The Evolving Biosimilar Tendering Landscape

HOW TECHNOLOGY CAN

HELP YOU UNDERSTAND

YOUR MARKET

© 2019 Model N, Inc. Proprietary and Confidential | 2

Ruven Remo EulSR. PRINCIPAL, GLOBAL PRICING AND TENDER MANAGEMENT

Today’s Agenda

Understanding the impact of the

changing biosimilars’ landscape

and what opportunities exist

leveraging technology.

© 2019 Model N, Inc. Proprietary and Confidential | 3

A New Biosimilars Landscape

Where Technology Fits

In the US & International

Creating a Competitive Advantage

1

2

3

4

© 2019 Model N, Inc. Proprietary and Confidential | 4

>25%of Global Pharmaceutical

Spend is performed via a

form of Tenders

In Europe, Biosimilars are heavily tendered

© 2019 Model N, Inc. Proprietary and Confidential | 5

Insights from our tendering data service THOR powered by HighPoint

Scope of tendersTender re-

opening after Biosimilar entry

Tender Duration

Diff. btw naïvevs. on treatment

Exclusive vs. multiple

awardees

National No9 No Yes

National, Hospital No12 No No

National, Regional No12-20 No No

Hospital No12 No No

Regional No24 No Yes

Regional, Hospital Yes, after 2 months12-48 Yes Yes

National, Regional,

Hospital

Yes, directly after

MA12-24 No Yes

Regional No12 No No

Pricing availability

Estimated bid price

No

Estimated bid price3

Estimated bid price

No

Estimated bid price

Estimated bid price4

Estimated bid price

Complexity level

Entering the US Market soon as well

Across all biologics, Biosimilars are

getting cleared by FDA with an

increasing number of market launches

to be expected in the coming years.

© 2019 Model N, Inc. Proprietary and Confidential | 6

1

2

4

5

7

9

11

12

16

17

2016 Q1 2016 Q2 2016 Q3 2017 Q2 2017 Q3 2017 Q4 2018 Q2 2018 Q3 2018 Q4 2019 Q1

Total Approved Biosimilars by FDA

Based on FDA Website consulted on the 5th of March

American Patients First could have many impacts

Evolving Healthcare Landscape

CONSUMER COST-

SHARE BASED ON

DISCOUNTED PRICE

INSTEAD OF LIST

PRICE

SHIFTING FROM

REBATE

ADJUDICATION TO

PROCESSING POINT-

OF-PURCHASE

CHARGEBACKS

© 2019 Model N, Inc. Proprietary and Confidential | 7

POTENTIAL FOR

CONTRACT

NEGOTIATIONS TO

EVOLVE TO FORMAL

TENDERS

Based on HighPoint’s whitepaper:

THE MANUFACTURER IMPACT OF TRUMP’S BLUEPRINT

Creating new opportunitiesTo leverage globally installed technologies

© 2019 Model N, Inc. Proprietary and Confidential | 8

Price GovernanceMonitor pricing thus implementing only

the proper strategical prices

Contracting ToolsFacilitate all the various steps of the contracting

process from template to implementation

International Price ReferencingCalculate the international impact of pricing decisions

within a country to the other countries.

Gross to NetDeep analytics to understand the impact on the revenues of

the products and channels across all regions and markets

Competitive Pressure

While technology supports Tenders already

© 2019 Model N, Inc. Proprietary and Confidential | 9

Digital Shift

European Public Procurement Directive finally completely

transposed in Europe in October 2018

Making Tenders work

globally – the Pfizer approach

Project Quantum was seen as an

opportunity to optimize tender

management through IT

IMOTEP: Information for the

Management & Optimization of

Tender & Pricing

Companies & Tender Authorities are embracing digital

technologies within the process

Tenders now encompass specialty and branded

products and not only generics

Enforce Digital

Submission

Regulation & Compliance

Ultimately creating a competitive advantage

© 2019 Model N, Inc. Proprietary and Confidential | 10

With a globally integrated platform

.xls templates

• Immediate (limited) implementation

•Enables process education & iteration

•Cumbersome update & no integration

SQL & SharePoint

•2-3m implementation

• improved Tender lifecycle mgmt.

•Existing technology with global reach, integration limited

Globally Integrated Tender and Contracting Software

•2-3y implementation

•End 2 end GTM

•Full x-functional integration

Tran

spar

ency

, In

tegr

atio

n,

Rea

ch

t

A single platform for GPM, IRP

& LSO integrated with

contracting and tendering

Allowing to capture data globally

© 2019 Model N, Inc. Proprietary and Confidential | 11

Ensuring global visibility

Data is the sole

trigger of the

process at any

point in time

Every task

performed locally

benefits from more

data

Data capture should

be enforced to trigger

continuous

improvement

Data tracking

enables proper

planning due to

tender cyclicality

For all the different processes

© 2019 Model N, Inc. Proprietary and Confidential | 12

Facilitating decision making

High Level of Interactivity High Level of Formality

Co

mp

eti

tiv

e P

ressu

re

B2Bcontract

Restricted Tender

Open Tender

RFP

Framework

Agreement

Negotiated Tender

Gov. Programs

Contracting ProcessesInteractive Negotiation

Tendering ProcessesFormal published invitation for bidding

Regulated through National & European Laws

Which may amalgamate in future

© 2019 Model N, Inc. Proprietary and Confidential | 13

Creating the opportunity to globally unify the processes

High Level of Interactivity High Level of Formality

Contracting ProcessesInteractive Negotiation

Tendering ProcessesFormal published invitation for bidding

Co

mp

eti

tiv

e P

ressu

re

B2Bcontract

Restricted Tender

Open Tender

RFP

Negotiated Tender

Regulated through National & European Laws

Gov. Programs

Framework

Agreement

Implementing new strategies

© 2019 Model N, Inc. Proprietary and Confidential | 14

In a biosimilar world of contracting and tendering

Minimum Pricing DeltaSearching to identify what is the

minimum price difference with the 2nd awardee to maximize profit

Stickiness analysisEvaluate the pricing premium offered to an incumbent manufacturer in the

follow up tenders

SustainabilityAnalyze conditions enabling a market to be both profitable for manufacturers and create savings

Tender Authority Impact Validate the premium paid by national authority compare to specialized centers

Renewal ManagementValidate to what extent the tender authorities exercise their rights to renew a tender

Such as tender stickiness

© 2019 Model N, Inc. Proprietary and Confidential | 15

A complex process applicable to all tenders

Stickiness Assumptions

Tender Authority

Bidding Prices

Type of AuthoritiesEvaluation Criteria

Renewal Number of Awardees

Requiring Data

© 2019 Model N, Inc. Proprietary and Confidential | 16

Which can be sourced internally and/or externally

DatesDepicting all the milestones

PricesThe various level from request to

awards

ProductsFrom the customer demand to fulfillment

ResultsThe outcome of the process

01

04

02

03

Leading to your competitive advantage

© 2019 Model N, Inc. Proprietary and Confidential | 17

With a globally integrated platform

.xls templates

• Immediate (limited) implementation• Enables process education & iteration• Cumbersome update & no integration

SQL & SharePoint

• 2-3m implementation• improved Tender lifecycle mgmt.

• Existing technology with global reach, integration limited

Tran

spar

ency

, In

tegr

atio

n,

Rea

ch

t

Globally Integrated Tender and Contracting Software

•2-3y implementation

•End 2 end GTM•Full x-functional integration

A single platform for GPM, IRP

& LSO integrated with

contracting and tendering

THANK YOU

© 2019 Model N, Inc. Proprietary and Confidential | 18

In 2016 – HighPoint Solutions ran the first Life Sciences

Tender benchmarking study with more than 30 companies

delivering 4 specific reports to support companies improve

their current practices. As a thank you, similar to last time,

this year’s participants will automatically receive the

outcomes and intended reports.

Participate in HighPoint’s 2nd Life

Sciences Tender Management

Benchmarking Study

www.surveymonkey.com/r/LSTendermanagement

Referenced by Gartner in: Life Science CIOs Must Deploy Global

Tender Management Solutions to Deliver Optimal Results