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