Innovative Patient Centred Care Models in Canada; Aligning Specialty Stakeholder Needs

Sandra Anderson VP Consulting & Business Development

Agenda and Objectives

Back Ground on Specialty Market and Role of Patient Support Programs

Health Case Management

Current Gaps and Challenges - Market Access

Private Payer Market Overview

Case Studies

Future Considerations

Specialty Market In Canada; Overview

Specialty share of spending will approach 50% in Canada by 2023

Global orphan drug sales forecast to grow at >11% to 2024

- Will account for almost 22% of global sales

- Molecules for rare cancers forecast to make up 50% of the orphan drug

sales

Oncology will remain strongest specialty segment globally, due to

research in immuno-oncology (I-O), small molecule, and gene and

cell therapy, despite disappointing 2018 research outcomes

Global increase in emerging biopharma (EBP) companies

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Insights from IQVIA and EvaluatePharma syndicated reports

Sources: IQVIA Jan 2019, EvaluatePharma Nov 2018

Specialty Market Forecast Assumptions

Emerging Biopharma Companies are Now Dominant in R&D

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Account for over 70% of the total R&D pipeline; >1/3 of drugs launched in next 5 years will be from EBP companies

EBP companies are increasingly

marketing their own products

Key Trends in Canada

Cost Containment

Alignment

Transparency

Sustainability

Evidence Generation

On-going therapy

management

Work-loads

=

less manageable

Risk-benefit

assessments

Key Considerations for Specialty Medications

Very high drug

costs require

industry

partnerships

The greater the

number of

complex products

Safety concerns &

complexities have

generated a higher

degree of caution

Greater number of

orphan drugs & rare

diseases with smaller

patient populations

Physicians and

manufacturers

increasingly involved

post Rx

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Integrated Capabilities for Customized SolutionsBalancing innovation with operational excellence

Patient Perspective

Where do I pick up my drug or

do I even need to?

How can I afford this?

What forms do I need to fill out to get

reimbursed?

Where do I go for my infusion?

What if I experience side effects?

Can I speak to someone?

Navigating the Patient Experience to Optimize Outcomes

ENROLLMENT CASE

MANAGER

REIMBURSEMENT

DISTRIBUTION PHARMACY

PV BUSINESS

INTEL

CLINIC

INFUSION

NURSE

SCHEDULE

Transition from SAP/Free Goods to Commercial

Integrated Patient Support Program Services

Facilitate HCP enrollment

Enrollment forms

Medical directives

Business Intelligence

Patient level data

Health outcomes metrics

Reimbursement

& Financial

Assistance

Nursing and

Clinics

Specialty

Pharmacy &

Distribution

Patient

Database

Education &

Adherence

AE Reporting &

Medical Info

Current Gaps and Challenges Market Access Landscape in Canada

Drug Regulatory and Reimbursement in Canada

~12-15 Mnths

~12-15 Mnths

~12-15 Mnths

~12-15 Mnths

~12-15 Mnths

Health Canada

Canadian Agency for Drugs and Technologies in Health (CADTH)

Common Drug Review (CDR)

PMPRBMust be notified of drug

price at first sale in Canada

Pan-Canadian Oncology Drug Review pCODR

Quebec Private Insurers

Pan-Canadian Pharmaceutical Alliance

(pCPA)

Provincial Drug Plans

Formulary listing at the discretion of the drug plans

Employers

Patients covered by drug

plan

Cash Paying PatientsApproximately 10% of Rx’s

~12 Mnths

Cost Containment

Government Policy Updates

Bill 160 - consultation

period ended April 7th

– no further updates,

likely delayed due to

new ON Gov.

BC considering a

similar Bill –

consultation period

held over the summer,

no details or draft

regs. yet.

Mark up compression

Transparancy Acts -

Bill 160

(ON & BC)

OHIP + - process

change, ON Gov.

announced public payer

now second after

private payer –

business as usual until

new process initiated

March 2019.

SADIE – Delayed

further due to OHIP+

revisions.

Bill 92 – Draft regs.

published, consultation

period closed,

OHIP+ and SADIE (ON)

Bill 92 (QC)

Expensive Drugs for

Rare Diseases

Evaluation process for

DRDs needs reform

Working group established

to chart a revised pathway

Could be worked into the

HC Alignment processes

More info mid 2019

EDRD

Canadian Drug Agency a

coordinated approach to

assessing effectiveness

and negotiating drug

prices

A national formulary: a

comprehensive, evidence-

based list of prescribed

drugs

A national strategy for

high-cost drugs for rare

diseases (investment of

$1 billion over 2 years

2022-2023, staring with

$500 million

National Pharmacare

PMPRB – The Latest Attempt – “Rethinking the Guidelines”

1. New Economic Factors to reflect value and willingness to pay

- Pharmacoeconomics, market size and GDP

2. Update Comparator Countries

- PMPRB7 to PMPRB12 (OECD average)

3. Update Reporting Requirements – mechanics, generics, OTC

4. Report all Discounts, Rebates, PLAs

5. Target Implementation – was January 1, 2019

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Factors from process started in 2016

Key Takeaways:

• Some payers are encouraging PMPRB to make all prices transparent

• Potential significant impact to industry revenues (IMC - $23 billion)

• PE analyses not appropriate tool for price regulation

• Does not address willingness or ability to pay

Alignment

Health Canada – CADTH Alignment

Pilot program announced in 2018

Goals

- Speed up regulatory approval and public reimbursement

>NOC and CADTH recommendation to be issued around the same time

- Reduce duplication

>Health Canada and CADTH/INESSS will split duties depending on areas of importance

Program now in effect

Look for more life-cycle management approaches going forward

- Pharmacovigilance (PV) and Real World Evidence (RWE)

Part of Regulatory Reform for Drugs and Devices (R2D2)

Transparency

Pan-Canadian Pharmaceutical Alliance (pCPA)

Negotiates Product Listing Agreements

(PLAs) on behalf of public payers

Successful negotiation leads to Letter of

Intent (LOI) following HTA (CDR, pCODR

or INESSS) recommendation

- Forms the basis of terms of Product Listing

Agreement (PLA)

Each province uses its own separate

contract template

- Driven by legislation and regulation of the

province

Relationships between HTA, Pricing & Provincial Listings

1 2 3 4 5

Price Charged

for all Dosage

Forms

Product

Characteristics

(from product

monograph)

Clinical

Efficacy &

Safety Data

Economic

Evaluation

Budget

Impact

Assessment

Critical steps to financial

coverage

Regulatory Pricing HTA Reimbursement

Demand For Evidence Generation

Doctor-level awareness of prescribing patterns

Payer trends and times to reimbursement

KPI tracking

Starts / stops / continue and reasons

Patient reported outcomes that support brand promise

Tracking of real-world outcomes

Retrospective analysis

Identification of risk indexes

(adherence / discontinuation)

Burden of illness

Validation of product value

Resource utilization

Commercial Value of Data Scientific Value of Data

Real-World Data = Client-Added Value

Private Payer Market Updates

Canadian Private Payer Environment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Insurers

% L

ives C

overe

d b

y I

nsure

r

Great West Life

Sun Life

Manulife Financial

Desjardins

SSQ

Other

Implication: More stringent processes are

emerging in the private sector to manage costs,

and restrict coverage

23 million (66%) of Canadians

are eligible for private insurance

Top 5 insurers account for more

than 70% of health plans

Private payers finance more than

half of prescription drug costs

Insurers implementing cost

containment tactics

Increase evidence-based drug plan

& patient management

Medavie Blue Cross

Green Shield

SSQ

RBC

ClaimSecure

Cooperators

Manulife

Designed to delay listing

& reimbursement until

CADTH has reviewed

Manulife will review

based on its own

schedule

Great West Life

SMART Drug Plan

Sun Life

Provincial Integration

Program

Great West Life

Monitoring a patient for

a specific period of time

to ensure the best

health outcome

Now over 80% of plans

have HCM

Manulife

Equitable

Private Sector Policy Initiatives

GWL

Green Shield

Cooperators

Medavie

Sun Life

Manulife

SSQ

RBC

ClaimSecure (+TPA’s)

Desjardins

Industrial Alliance

Equitable Life

Empire Life

Insurers referencing

recommendations

of CADTH/CDR

Health Case

ManagementPPNs

Managing Chronic

Disease

Adherence

5/8/2019 CONFIDENTIAL26

What is Health Case Management – Payer Program

Exceptional patient and

healthcare professional

quality of care equates to

better overall adherence

Phase 3

Monitoring

Monitoring

drugs that

may

impose

significant

financial

cost

Collaborate with the

patient and their

healthcare team during

all phases of the

patient journey from

diagnosis to treatment

and beyond

Phase 1

Coverage Decision

Starting

with the

coverage

decision

Demonstrate both

patient and healthcare

professional excellence

to ensure the seamless

prescription fulfillment

and reduce wastage

Phase 2

Cost & Effectiveness

Coordinating

specialty

drug

access

Collecting meaningful

insights through well-

defined feedback

mechanisms and action

planning

Phase 4

Support

Continuous

focus on

the patient

and their

circle of

care

How can nurse-led HCM benefit?

Improve Health Outcomes

In a study compared to routine care alone, Health Case

Management was shown to improve employee quality of

life and health outcomes.

Workplace benefits related to improved employee quality

of life include:

Decreased work disability

Increased work productivity

Reduced absenteeism

Reduced presenteeism

Health Case Management provides individualized support

for employees throughout their treatment journey while

helping to ensure they find the right drug at the right time.

Experienced

improved quality

of life scores vs.

62% of patients

on routine care

alone

Experienced

lower disease

activity vs. 28%

of patients on

routine care

alone

Experienced

remission vs.

13% of patients

on routine care

alone

84%

54%

46%

PSPs and HCM – How they differ

Manufacturer sponsored to help patients stay

on their prescribed drug

Improve patient adherence to specific therapy

Maximize reimbursement and access to

specialty medications

Provide value to patients and physicians for

specific therapy

More drug specific than disease specific

Patient Support Programs

Both HCM and PSPs offer education and support to the patient.

Both ultimately have the goal of improving patient outcomes.

Payer sponsored

HCM monitor and manage plan member

treatment to optimize therapy

Collect data to achieve more cost-effective

health outcomes

Ensure patients are improving/responding with

their prescribed therapy

Based on clinical guidelines for improvement

Health Case Management

Biosimilar Case Study

Case Study: Fully Integrated Solution for a Client

Launching the first Biosimilar in Canada

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Client was launching a biosimilar with

pharmacokinetics, clinical efficacy and safety

similar to the reference brand. However, they

were lacking any real world health outcomes

and economic impact specific to Canadian

patients.

Client Situation

End-to-end solution from

Market Access to Patient

Support Services

Infusion product in

the inflammatory

disease

marketplace

Patient registry created

and RWE study

conducted based on

data collected

Our SolutionFully Integrated, Customized Service Solution

What We Did

Leveraged Innomar’s unique expertise in

the biosimilar and PSP space in Canada

Cross-functional team: market access,

PSP, pharmacy & distribution, nursing &

clinics, PV allowed for streamlined

launch planning

Innomar helped shape the HTA

processes for biosimilars

What We Found

RWE study conducted through the

PSP benefits from continuous

follow-up as patients are “captive”

within the program

Biosimilar review processes are

now simpler and they have higher

acceptance

The Outcome

Client received positive

recommendations and reimbursement

from payers

Fully integrated PSP service model

including: pharmacovigilance;

reimbursement navigation and

financial assistance support;

pharmacy & distribution; nursing and

clinics

PSP services offered in order to

match support services offered by the

reference brand

5/8/2019 CONFIDENTIAL33

Fully Integrated, Customized Service Solution

Key Insight

Biosimilar use is now

growing in Canada and

Innomar is the leading

provider of PSP services

through its’

HealthForward division

Cell and Gene Therapy

Cell and Gene Therapy

5/8/2019 CONFIDENTIAL35

Integrated Support in the Canadian market

Specialty Distribution

Management & Transport

3PL Coordination & Storage

Importation & QA Services

Clinical Trial & Special Access

Program Support

Specialty Pharmacy Support & Counsel

Nurse Coordination with Patient and Site

of Care

Patient Support Programs

Reimbursement Navigation &

Financial Assistance

Health Outcomes Data Collection and Centralized Data Capture

Regulatory and Market Access

Strategy & Consultation

Future Considerations

Road to Commercialization in CanadaUnderstanding the licensing and regulatory approval process

CONTRACT SALES FORCE

EXIT 4

The Future of PSPs

DataData &

Technology

Integration Consolidation Regulatory

Environment

Different Focus on Evidence Development

Private Payer

Manufacturer

Public Payer

Cost containment

environment- price driven

Pricing will be increasingly

based on evidence

Increased focus on value

and health outcomes in real

world

Prioritize HTA for specific

agency needs

Public Payer

Increased Management of

Drug Programs

Increasingly focused on plan

sustainability

Looking to HTA to show

therapeutic

value/incremental benefit

Interested in indicators that

prove reduced

absenteeism/presenteeism

Private Payer

Value and patient support

Increasing requirement to

prove value through patient

outcomes

Adherence strategies a must

for optimal therapy

Expansion of PSPs from

pure reimbursement to

overall patient wellness

Manufacturer

Biosimilars Approved in Canada 2019

Company Biosimilar NOC CADTH Application/

Recommend’n

pCPA

Negotiation

Status

Provincial Formulary Listing

Status

Amgen Mvasi®

(bevacizumab)

Apr 2018 Oct 2018/

Jan 2019

Not initiated Not initiated

Apobiologix Grastofil®

(filgrastim)

Lapelga®

(pegfilgrastim)

Dec 2015

April 2018

Sept 2015/

Mar 2016

Feb 2018/

Apr 2018

Completed

Under

negotiation

Preferential Listing: ALL (except NS);

Under Review: NS

Under Review: ALL

Eli Lilly Basaglar®

(insulin

glargine)

Sept 2015 Oct 2015/

Apr 2016

Completed Preferential Listing: NL, PEI, NS, NB,

QC, BC; Non-Preferential Listing:

ON, MB, SK, AB

Merck/

Samsung

Bioepis

Renflexis®

(infliximab)

Brenzys®

(etanercept)

Hadlima®

(adalimumab)

Jun 2016

Aug 2016

May 2018

Sept 2017/

Feb 2018

Apr 2016/

Oct 2016

N/A

Completed

Completed

N/A

Preferential Listing: NL, PEI, QC,

ON, MB, AB, BC; Under Review: NS,

NB, SK

Preferential Listing: ALL

N/A

Pfizer Inflectra®

(infliximab)

Jan 2014 June 2014/

Dec 2014

Completed Preferential Listing: ALL (except SK);

Non-Preferential Listing: SK

Sandoz Omnitrope®

(somatropin)

Erelzi®

(etanercept)

Apr 2009

Apr 2017

June 2009/

Dec 2009

Feb 2017/

July 2017

Pre-pCPA

Completed

Preferential Listing: none; Non-

Preferential Listing: all

Preferential Listing: all