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Pharmacoeconomics & Outcomes Research
Presented by: Rita Karam, Pharm D. PhD
The International Society for Pharmacoeconomics and Outcomes Research is aninternational organization organized to act as a scientific leader relevant to research inpharmacoeconomics, health outcomes assessment, and related issues of public policy.
ISPOR: Mission & Objectives
The mission of ISPOR: to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care
resources wisely, fairly, and efficiently.
Our Age of Anxiety is, in great part, the result of trying to do today’s job
with yesterday’s tools and yesterday’s concepts.
Marshall Mcluhan
The Challenge
• Lebanese Health System Delivery
• Health and Pharmaceutical Expenditures
• MOPH Services and Coverage
• MOPH Challenges
• Pharmacoeconomics’ Initiatives at MOPH
• MOPH Outlook & Perspectives
Outline
HealthCare Delivery in Lebanon
28%
5%
9%
12%
46%
Social Security Fund
Civil Servants Cooperative
Military Schemes
Private insurance and MutualityFunds
MOPH
HealthCare Expenditurein Lebanon & Life Expectancy
Lebanon Current Pharmaceutical Expenditure: 2011-2019
8
2011 2012 2013 2014 2015 2016f 2017f 2018f 2019f
Pharmaceutical sales, USDbn
1.301 1.301 1.464 1.586 1.711 1.840 1.975 2.117 2.236
Pharmaceutical sales, USDbn, % y-o-y
12.98 -0.05 12.53 8.34 7.90 7.54 7.32 7.17 5.66
Pharmaceutical sales, LBPbn
1,959.757 1,956.508 2,206.254 2,394.382 2,594.092 2,806.342 3,031.514 3,269.973 3,522.053
Pharmaceutical sales, LBPbn, % y-o-y
13.33 -0.17 12.76 8.53 8.34 8.18 8.02 7.87 7.71
Pharmaceutical sales constantexchange rate,USDbn
1.298 1.296 1.461 1.586 1.718 1.859 2.008 2.166 2.333
Pharmaceutical sales, USD per capita
290.6 279.9 303.5 319.3 338.6 362.6 391.8 425.4 455.2
Pharmaceutical sales, % of GDP
3.24 2.94 3.10 3.23 3.31 3.37 3.39 3.39 3.38
Pharmaceutical sales, % of health expenditure 45.5 42.1 48.1 48.8 48.8 48.7 48.7 48.6 48.6
Source: BMI Lebanon Pharmaceutical and Healthcare Repor t -2015
MOPH Services & Coverage
Covers Hospital inpatient expenditures of uninsured
patients
Provides eligible patients with drugs free of charge for severe diseases (Cancer, HIV, MS, Mental illness) through Public Drug Dispensing
System
Supplies Pharmaceuticals by Bids or Agreements
Strengthens Access to Primary Healthcare through a large network of PHC Centers
MOPH ChallengesHow to deal with new expensive drugs, especially cancer and biologics drugs, to
appropriately rationalize their use and lower their price?
How to make a tradeoff between limited resources and access to innovative
drugs?
Severe Diseases Drugs Expenditure at MOPH
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
2008 2010 2011 2012 2013
Drugs budget ($) Oncology drugs($)
Source: Statistics Depar tment at MOPH-2014
Proactive Approach
Better allocation of resources
Rational drug use – Enforcementof evidence based decisions
Better utilization of HTA tools including Pharmacoeconomic analysis
Increasing role of PE
• Reduce the significant cost of wrong health policydecisions
• Optimize the use and the allocation of Limited resourcesof the healthcare system
• Provide a bridge between the world of research and theworld of decision making
Pharmacoeconomics initiatives at MOPH
Discounts/Bonus
Unified Rx and substitution list
Managed Entry Agreements
Pricing structure
Cost-effectiveness
• Adopted during annual Bids
• The generic drugs are priced 30% lower than the corresponding brand drug price
• Newly adopted Approach
• Newly adopted Approach
• Encourage the use of Good Generics/ cost-effective Brands
BIDs Process
MOPH provides drugs for Oncology, Biologics, and rarediseases for the largest number of patients.
Resources allocation and Medicines choice are based on theselection of the lowest price medicines.
Terms of ReferenceActive
Pharmaceutical Ingredients are
listed
Selection of the lowest price of
medicine
MOPH annual budget
allocated for medicines
1st Approach : Cost-Effectiveness (CE) Analysis
Drug Scientific Committee
(DSC)
Tender Committee(TC)
Provides effectiveness by requesting the monograph, NICE or NHS data, clinical studies and other scientific data in which exist
the
The TC calculates the ratio based on
received tender prices and selects the most appropriate
one
2nd Approach : Risk-Sharing Agreement• RSAs between drug manufacturers and payers to provide some form of
collection of additional data after product launch to addressuncertainty about a product’s clinical performance, utilization and/orvalue.
• Also referred to as:
Managed Entry Agreements (MEA)
Outcomes-based Schemes Coverage with evidence development (CED)
Patient Access Schemes (PAS)
Pay-for-Performance Programs (P4P)
and others?
Risk Sharing Agreements are mainly financial non outcome schemes
RSA Models at MOPH
RSA Models
Cost of treatment for the newly recruited patients
Related laboratory tests and supportive programs to follow the
patients’compliance and Adherence to drug, in addition to drug net price and
some bonus.
Cost of the drugs for certain number of treatment cycles
RSA Challenges • Access to reimbursement• Can provide common grounds for negotiation• Savings on pharmaceutical expenditure for non-responding patients• Early access patient to new therapies • Collecting data on real clinical practice• Optimizing the cost-efficacy of new therapies
• Increasing administrative workload for healthcare professionals
• Lack of local Data to design good Programs.• Lack of infrastructure to go beyond financial
schemes
+
-
MOPH Outlook & Perspectives1. Better utilize PE as a scientific tool for pricing/reimbursement
decisions.
2. Generate local CE data and use it in decision making.
3. Implement RSA/MEA to be further emphasized, better designedand utilized
4. Promote Registries for rare diseases (Cancer, RA, MS, etc.) andupdate Local Guidelines in many therapeutic areas
5. Empower and Reinforce the Biostatistics Department at MOPH
MOPH Outlook & Perspectives6. Strengthen role of LSPOR to increase awareness on PE and
Outcome Research
7. Reinforce the Health Technology Assessment (HTA) Unit tofollow Health Economic Outcome Research (HEOR)
Thank you!
Presented by: Rita Karam, Pharm D. PhD