To develop a general understanding

of the Pharmaceutical Sector

And of PE / MEA status

in Lebanon

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 2

The Republic of Lebanon : a 10452 sq.km. country on the Mediterranean Sea, located at the

crossroads of three continents: Europe, Asia and Africa.

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 3

• Estimated population of 4 036 000

inhabitants (386 individuals per 1 sq. km)

• Life expectancy is 74 years

• Health spending as a share of GDP has

fallen from 12.7% (1998) to 7.2% (2012) (with

use of preventive and curative services)

• Out of- pocket spending as a share of total

health spending has fallen:

44% (1998) to 37% (2012) (with increase

financial risk protection)

Army & Public Security Services out of pocket MOPH Private Insurances NSSF

Out of

Pocket

30%

5% 49%

3%

13%

Private Insurance MOPH

Military Schemes

NSSF

% of health care coverage of Lebanese population

• The Lebanese public sector has been absent for a long time because of the civil war.

• The health reform that started more than 20 years ago has attained recognized accomplishments

• A series of reforms has been implemented to improve equity and efficiency

• 163 Hospitals: 85% private vs 15% public

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 4

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 5

62.50%

2.27%

20.80%

2.42% 5.19%

6.11%

The government budget allocation to MOPH = 2.67% And has been distributed as follow:

Private sector hospitalizations

Public sector hospitalization

Drugs

NGO contributions

Salaries

The budget allocated to drugs has been increasing on a yearly basis since 2009. Disease Prevalence: CVD (34%), HTN (17%), Hyperlipidemia (16%) and Diabetes (15%).

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 6

MoPH:

Covers Hospital inpatient

expenditures of all

uninsured persons

(50% of the population)

Provides Individual patients with drugs

free of charge for severe diseases

(Cancer, HIV, MS, Mental illness)

through Public Drug Dispensing System

Supplies Drugs by Bids or Agreements through only one Drug

Dispensing Center. It distributes drugs free of charge for all eligible

patients across categories of dreadful diseases

Strengthens Access to primary healthcare through a large network

of

PE and MEA status in Lebanon – 2015 7

Prior to 2014: selection of drugs was based on the tender’s terms of reference (TOR)

Starting 2014: New strategy based on Cost Sharing Agreement –

Three Scenarios where the pharmaceutical company covers:

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

MOPH - MEA Implementation

NSSF Overview & Challenges

NSSF Lebanon is facing main challenges,

like all reimbursement bodies in the countries:

– Limited financial resources

– Increasing costs in healthcare budgets

– High cost therapies

– Defining the cut-off between therapeutic utility and cost

of a new medicine

– Lack of HTA body in helping decisions makers

NSSF Semi-public sector and semi-private sector Own regulations and laws, inspired from the French system

PE and MEA status in Lebanon – 2015 8

PE and MEA status in Lebanon – 2015 9

NSSF– Health Care Funding

Fast Reimbursement for Some Drugs Cancer, MS, HIV, Chronic Hepatitis, Pulmonary Hypertension,

post organ transplantation, hereditary hematological diseases.

NSSF drugs % of reimbursement

Anticancer, Multiple Sclerosis, Pulmonary Hypertension, Cystic Fibrosis:

– 95% for outpatients and inpatients

All the other drugs are reimbursed at

– 80% for outpatients and 90% for inpatients.

NSSF - 2015

9

NSSF MEA Implementation

MEA implementation in NSSF are mostly done on antineoplastic

and immune modulating agents and with a Stronger focus on

budget impact :

1- Free initiation of treatment

– i.e. Fampridine: reimbursing only responders based on T25 walking test evaluation

Saving on pharmaceutical expenditure for non responding patients.

2- limiting access of certain medicines to eligible patients

– i.e. Fingolimod reimbursing only in second line after failure of interferon

3- Free treatment cycles

– i.e. Revlimid (6 boxes reimbursed then 6 FOC), Faslodex (Second box FOC), Lucentis (2

boxes reimbursed then 3rd box FOC)

PE and MEA status in Lebanon – 2015 10

Despite a lot of challenges, the pharmaceutical

market achieved high growth rates over the

past few years:

• 4 times increase in sale over 2 year period.

• Note: private sector accounts for 90%

of local hospitals and pharmacies

Per capita pharmaceutical spending: • is one of the highest in the Middle East

• is a burden and must be tackled

Local pharmaceutical production in Lebanon

remains limited, facing several inefficiencies: • high production cost

• limited production efficiency

• relatively small local market

• uncertain authenticity.

800

820

840

860

880

900

920

940

960

980

1000

2010 2011 2012

Pharmaceutical import in million of U.S.

dollars by year

2010

2011

2012

PE and MEA status in Lebanon – 2015 11

PE & MEA in Lebanon

Aims for optimal healthcare resources allocation

Drivers • Many public and private

institutions with different internal laws and regulations

• Each of these institutions will have different use of PE and MEA

• New requirements by payers

• Changing reimbursement policies from lowest price to cost sharing agreement to risk sharing to MEA

• Further request for local data

• More awareness on PE analysis

• Development of educational activities related to research in health economics

Barriers • Local expertise – education

• Restricted Resources

• Lack of Epidemiologic data or lack of consolidated registry data

• Silos in Healthcare

• Lack of proper definition at country level of Health Priorities & Health Outcomes needs

• Improper communication and collaboration between different stakeholders in healthcare (5Ps): Payers, Physicians, Pharmacists, Pharmaceuticals & Patients

PE and MEA status in Lebanon – 2015 12

Projected Plan

PE & MEA in Lebanon

PE and MEA status in Lebanon – 2015 13

Orienting decisions to cost-effective healthcare based on

local statistical data and PE analysis

MoPH – Short term strategy:

Enhance skills and knowledge Of PE implementation:

i.e. PE expertize in Scientific/Tender Committees:

to measure and value effectiveness of alternatives based on effectiveness rate (local data - drug utilization and statistical database)

to measure and value direct medical costs of each alternative and

to perform a PE analysis

to prepare a recommendation to decision maker based on CEA

PE and MEA status in Lebanon – 2015 14

Long Term Strategies:

Develop criteria for decision making based on PE analysis

Empower and Reinforce the Statistic Department at MOPH/ NSSF

Encourage new University Program –

Master Degree in Pharmacoeconomics

Pharmacoeconomic Awareness organizations –

ISPOR – Lebanon Chapter

Develop New strategy to implement –

Risk Sharing Agreement / Manage Entry Agreement

Projected Plan

PE & MEA in Lebanon

PE and MEA status in Lebanon – 2015 15

To improve PE/MEA in Lebanon

develop criteria for decision making based on PE analysis

Establish PE educational programs, provided by PE experts

Support activities by ISPOR – Lebanon Chapter

Implement MEA, sharing experience in similar countries

ISPOR Global help

Overview of the Lebanese Pharmaceutical Sector – 2015 – Rev:01 16

1. Analysis of Lebanon’s Pharmaceutical Market 2013

2. Business Monitor International, International Federation of Pharmaceutical Manufacturers 2010

3. Good governance in the Public Pharmaceutical Sector 2010

4. Lebanese Customs 2011

5. Ministry of Public Health, Statistical Bulletin 2012

6. National Health Statistics Report in Lebanon 2011

7. World Health report 2010 on Health Care Financing

8. World Health Statistics 2013