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!