Market Access & HealthcarePerspectives on a keystone

Ayman SemaanMarket Access Manager

Algorithm SAL

Health Insight Congress, June 2016

Access to Basics

Globally, 2 billion people still cannot access the medicine they need...

Dynamic EnvironmentRole of Governments & Authorities

Dynamic EnvironmentRole of Governments & Authorities

http://www.who.int/mediacentre/factsheets/fs319/en/

Treatment Innovation

Pressure on Healthcare BudgetDifferent Demographic & Healthcare DriversEpidemiology, Aging, …

Pressure on Healthcare BudgetMENA

US cancer drug spending will grow between 7.5% and 10.5% annually through 2020, moving it from 107 to 150 Billions USD (ref. fiercefarma)

Pressure on Healthcare Budget

However, generics growth in the MENA is among the highest in the world

MENA

Patients Engagement & Public PressureIncreased Patients Expectations

Varied Registration Timelines

LegendFile SubmissionProduct Approval - Best CaseProduct Approval - Base CasePrice Submission/ Price ApprovalINF Submission / INF InclusionIDL Submission / IDL InclusionNPS Possibil ity

Y0

Q1---Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

KSANPS

UAENPS

KuwaitNPS

BahrainNPS

OmanNPS

QatarNPS

LebanonNPS

JordanNPS

EgyptNPS

IraqNPS

IranNPS

Y1 Y2 Y3 Y4

Time, Requirements

Different Access DynamicsSource: Sectors, Hospitals, ProvidersTimelines: Reimbursement, Inclusion

LebanonSources of Funding

- NSSF- Government (MOH, MOD, FSI, COOP, …)- Private Insurances- Cash Payers

Main Selling Channels

- Private Hospital tenders- Public Hospital tenders- MOH/ MOD Tenders- Retail pharmacies

Dynamic EnvironmentSummary

Dynamic Environment

Cost is the biggest health care issue facing most countries. Pressure to contain costs and demonstrate value is coming from all sides — governments, providers, health plans, life sciences companies, and consumers.

Adapting to market forces transformational change is taking place across the global health care sector,requiring providers and health plans to rethink traditional business models: Aging, Epidemiology, HTA, Outcomes, Prioritization, Value, …

Policies reshaping Healthcare industry on the level of pricing, reimbursement, safety, …

Summary

Situational Overview

Authorities role & commitment to build successful healthcare strategy based on maximized patient coverageunderstand industry’s role in innovation and need for sustainabilityDrive a holistic look at source of spending (Pharma, Devices, Hospital, HCP & Human Resource, …)

Industry engagement in understand authorities limitations & needsalign innovation to patients & markets needs while considering balanced outcomes & pricing

Patientsincreased scientific awareness, public engagement

Healthcare Payers, Industry & Patients

Market Access

Understanding the needs of all stakeholders involved in the adoption, positioning and funding of our product

Strategically, market access is about packaging data in the right way, for the right customer at the right time – helping stakeholders make informed decision for an optimized patient access

An Emerging Need

1. Considering the implications your product may have on the wider healthcare market

2. Understanding the impact the changing healthcare market will have on your product

3. Preparing a positive healthcare environment which supports uptake of your product

4. Communicating the ‘value’ of your product to the range of customers who lead access

Market AccessA defined profile

Framework of Market Access

Pricing

Understand the policies (ex. Price Benchmarking)

Set product pricing strategyUnderstand the impact (ex. Payer embracing HTA concepts)

Value driven, Fair approachSustainable to all

Pricing

Price Strategies

Value-based pricingTarget pricing businessContribution margin-basedPremium pricingPrice discriminationPrice leadershipLimit pricingMarginal-cost pricingPenetration pricing

Influencing Parameters

Product Profile, ModelPortfolio ManagementMarket GDP, Healthcare spentPrevalence, IncidenceMarket readiness, awareness, medical investmentsDisease BurdenPoliciesBenchmarks

Pricing

Value Proposition

To provide with lines of argument to engage with payers and to prepare for value assessments

Prove with the information payers want

A compelling evidence, developed with the needs of payers in mind, why a consumer should buy a product or use a service, and how will it add more value or better solve a problem than other similar offerings.

Value Proposition

Value Proposition, at the base of the access steps

Evidence Based for an informed and balanced decision

Health Technology Assessment

A multidisciplinary activity that examines the safety, clinical efficacy, cost, cost-effectiveness, social, and ethical consequences of the application of a health technology (e.g. new drug, medical device, clinical procedure)

This allows healthcare stakeholders (Ministries of Health, reimbursement agencies, hospitals…) to make an informed decision

HTA acts as a ‘bridge’ between evidence and policy-making

Pharmacoeconomic studies are a major part of HTA

Pharmaco Economics

Pharmacoeconomics (PE) measures if the added benefit of a new drug is worth the added cost of that drug

It is the description and analysis of the costs and added value of a drug therapy to healthcare systems and to society

Payers and other decision-makers can use these methods to evaluate and compare the total costs of treatment options and their outcomes

Pharmaco Economics

The quality-adjusted life year or quality-adjusted life-year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value for money of medical interventions. One QALY equates to one year in perfect health.

The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect.

QALYs and ICER

Managed Entry Agreements

A Managed Entry Agreement is an arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to

limit their budget impact.address uncertainty about the performance of technologiesmanage the adoption of technologies maximize effectively their use

MEA

Managed Entry Agreements

Reduces the overall budget impactassociated with a product by non-transparently decreasing price or controlling volume

Ties a product’s price and / or accessdirectly to its clinical performance in an individual patient or patient population

Offers additional services or infrastructurein order to improve a product’s value in the eye’s of payers and / or build goodwill with payers

Financial basedI

Performance based

II

Value-added agreements

III

MEA

Summary of all 12 archetypes (1)Theme Archetype Summary

Discount for a product in exchange for improved market access

Discount for product(s) in manufacturer’s portfolio in exchange for better price/access for another product(s)

A cap set on volume of the product used / purchased, where any additional units of the product purchased over the cap are paid for fully or in part by the manufacturer

Manufacturer makes a commitment to enroll a certain percentage of the payer’s patients in a post-marketing clinical trial, thereby reducing the volume of patients on the drug for the payer

One set treatment cost for all patients regardless of the dose required by a specific patient

Threshold is set for dose per patient or number of treatment cycles per patient. The manufacturer is then responsible for covering the cost of treating the patient beyond the preset threshold

Portfolio discount

Price-volume discount

Clinical trial enrollment

Capitated contract

Utilization cap

Individual drugdiscount

3

4

5

6

1

2

Financial based

I

Managed Entry Agreements

Theme Archetype Summary

Manufacturer pays rebate / refund to the payer if pre-determined clinical goals are not met

Treatment initiation is provided for free or at a discount for all patients; payers pay full price of further therapy for responders

Product reimbursed for set period of time. After that time, additional evidence gathered will determine whether coverage should be expanded, withdrawn, or continued as is. A rebate may also be required if evidence is unfavorable

Manufacturer provided programs for patients that also benefit the payer indirectly

Improve healthcare infrastructure in the payer’s country

Change purchasing agreements to allow for payer to pocket margin or have more cash on hand

Conditional treatment cont.

Coverage with evidence dev.

Patient support

Infrastructure improvement

Improve payer cash flow

Performance guarantee

9

10

11

12

7

8Performance based

II

Value addedIII

Summary of all 12 archetypes (1)Managed Entry Agreements

Pillars of Access-Driven Industry

How do pharmaceutical companies manage access strategies in middle-income countries?

Analysis of how companies target poor populations in middle-income countries (Pricing, Licensing)

How can pharmaceutical companies target pricing strategies toward need?

A measurement of ‘needs-based’ pricing

Local/Regional Manufacturing

Maximizing Value in R&D or Product Development strategies

Partner & Shape optimal Pricing & Price Structure Policies, Price Exposure

Relevance to local industryDifferentiated Business Model

GenericsIn-licensed brandsDistribution of biotech specialty medicine

Strong local and regional expertisePositioned as main partners to multinationals & regional HC providersPatients & policies understanding

Relevance to local industryHigh asset in quality and fair pricing

Competitive Manufacturing FacilitiesDecreased cost for in-licensing manufacturing

Need for policies that support local and regional patient access

Need for increased local partnership & policies shaping to increase share from local healthcare market, and mutual valuable entry agreements

Critical Success Factors

It’s no secret that achieving the triple aim — improved access to higher quality care delivered at a lower cost — requires the collaboration of all health care stakeholders: payers, providers, manufacturers and patients. This, in turn, requires new business models that can upend historically misaligned financial incentives and enable pay-for-success partnerships.

Sanjeev WadhwaEY, US

Partnership & trustful approachPatient orientation

What is a keystone?

Locks all the stones into position, allowing the arch or vault to bear weight, and stand strong and sustainable

THANK YOU!