Pricing Reimbursement of Drugs and HTA Policies in Morocco

Prof S. Ahid

23th May 2016, Washington, DC

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MOHAMMED V UNIVERSITY - RABATMEDICAL AND PHARMACY SCHOOL PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS RESEARCH TEAM

Presentation outline

• Sociodemographic and economic data

• Resources of the health system

• Medicinal Products in Morocco evaluation

• Financing and reimbursement

• Approval procedures for pricing

• Missions of evaluation commissions

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Sociodemographic and economic data

Total population (2015) 34,378,000

Gross national income per capita (PPP international $, 2013) 7

Life expectancy at birth m/f (years, 2015) 73/75

Probability of dying under five (per 1 000 live births, 0) not available

Probability of dying between 15 and 60 years m/f (per 1 000 population, 2013)

170/121

Total expenditure on health per capita (Intl $, 2013) 438

Total expenditure on health as % of GDP (2013) 6.0

05/07/2016 3Source: WHO

Resources of the health system

Total spending of the national health system could reach 50 billion MAD (5 billion USD)

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Tax revenue (national and

local)25%

International cooperation

1%

Employers (excluding health

insurance)1%

Medical insurance

19%

Direct Payment household

54%

Other0.4%

Overall pharmaceutical market (2015)

Sales turnover = 1.37 Billion USD

Of which 0.9 billion for the private market and 0.1 Billion for export

0.37 billion for the hospital market and clinics

Volume > 425 Million boxes

325 for the private market

100 for the hospital market

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Medicinal Products in Morocco (Ministry of Health)

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Marketing ApprovalDrug and Pharmacy Direction

Pricing

Transparency

CommissionHealth Technology

AssessmentCommission for

Economic and

Financial Evaluation

of Health ProductsImpact budget analysis

1969

2012

2014

Inscription on lists

Moroccan PharmacovigilanceCentre

1991

National Agency of Health Insurance (NAHI)

Medical Assistance Regime(MAR)

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Category

Beneficiaries

Financing

Management

Framing

Compulsory Health Insurance(CHI)

Active and retired populationsof both sectors and theirbeneficiaries

Employer and employeecontributions

CNOPS + CNSS + CMIM + Internal regimes + Privatecompanies

National Agency of Health Insurance (NAHI)

Population not covered by CHI and without sufficient resources

Government: 75% + local communities : 6% + beneficiaries

Ministry of health+ Ministry of Interior

+ NAHI

BASIC MEDICAL COVER

8 million

beneficiaries

25%

0.6 billion USD 0.3 billion USD

8,5 million

Beneficiaries

28%

Financing and Management

GUARANTEED BENEFITS

CONSISTENCE LEVEL OF COVER IN THE PUBLIC

LEVEL OF COVER IN THE PRIVATE

Outpatient care Acts of general medicineand medical and surgicalspecialties, paramedicaltreatment, functionalrehabilitation andphysiotherapy

80% of the nationalreference pricing(NRP)

70% of the nationalreference pricing(NRP)

Hospitalizations Treatments and surgeriesincluding acts ofreconstructive surgeryand labile blood and itsderivatives.

80% of TNT. Thisrate is increased to100% in publichospitals

70% of TNT. Thisrate is increased to90% in publichospitals

Medicines Medicines eligible forreimbursement (CHI)

70% of publicselling price (PSP)

70% of publicselling price (PSP)

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New pricing system

Law No. 17-04 of the drug and pharmacy code (Article 17) : 2006

The decree implementing the law : Decree No. 2-13- 852 (December 18, 2013)

The decree of the Minister of Health No. 3736-13

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Approval procedures for the branded name

For Importedbranded medicine: The MPET is increased by 10%

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MPET : Manufacturer Price (Excluding Tax)

The lowest

MPET of

these

countries

Origin

country

Approval procedures for generic price

If there is an originator in the national market

The Reference Price Maximum (RPM)

In case of absence of the originator in the national market, it sets the theoretical MPET originator of this by applying the rule of the benchmark

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MPET Brandedmedicine

(USD)Dropping

(%)

MPET≤ 1,5 0

15 < MPET< 30 15

30 <MPET < 70 30

70 <MPET < 150 35

150 <MPET < 300 40

MPET> 300 50

MPET : Manufacturer Price (Excluding Tax)

Approval procedures for biosimilar price

• If there is an originator in the national market, the RPM is obtained by a 30% decrease from the initial originator of MPET

• If there is no originator in the national market, the RPM is obtained by decrease from the theoretical originator of MPET

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MPET : Manufacturer Price (Excluding Tax)

RPM : Reference Price Maximum

Transparency Commission: Missions

• An independent scientific committee

• Missions: provide an argued opinion to the Minister of Health on the actual benefit (AB) and / or Improvement of Actual Benefit (IAB) of a marketed medicine to allow its addition to the list of reimbursable products or its removal from the list

• TC started work in September 2012.

• More than 250 medicines have been evaluated by TC since October 2012

Commission for Economic and Financial Evaluation of Health Products: Missions

• Analysis of the economic and financial impact of medicines that had a positive AB by the Transparency Commission, in view of their inclusion on the list of reimbursable drugs

• Analysis of the economic and financial impact, in terms of gains, of medicines to be removed from the list of reimbursed medicines after revaluation of their AB by the Transparency Commission.

Proposal of medical devices (MD) for individual use to be included or removed from the list of eligible MD for reimbursement under the CHI, after studying:

The benefit of the medical device compared to alternatives (other medical devices, medicines, surgical procedure)

The place the medical device in the treatment strategy The ease of use of the medical device The target population

Proposal of the rate for reimbursement of the medical devices added to the list

Commission for Economic and Financial Evaluation of Health Products: Missions

2. Request for reimbursement

3. Draftopinion

1. Drug withMarketing

Authorization

4. Meeting CT / AB/IAB

5. AB Favorable

CT

CEFPS

Decision

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Medicine X evaluated by

TC (AB / IAB)

Medicine X evaluated by

TC (AB / IAB)

Removal from the list of

reimbursable medicines

by CHI (2)

Removal from the list of

reimbursable medicines

by CHI (2)

Introduction to the

list of reimbursable

medicines by CHI (1)

Introduction to the

list of reimbursable

medicines by CHI (1)

Evaluation of the impact

resulting from the

introduction of medicine X

to the list of reimbursable

medicines by CHI

Evaluation of the impact

resulting from the

introduction of medicine X

to the list of reimbursable

medicines by CHI

Has no

equivalent

reimbursable

Has no

equivalent

reimbursable

Has one or +++

reimbursable

equivalents

Has one or +++

reimbursable

equivalents

Reimbursed

expenses CHI

on this drug will

automatically be

considered a

gain for agency

budget

Reimbursed

expenses CHI

on this drug will

automatically be

considered a

gain for agency

budget

the price of the drug X in relation to the

weighted average price per volume of drugs

called equivalent:

1) If X Prize> = weighted average price

equivalent drugs by volume of each,

therefore the financial impact would be

positive (or zero if they are equal) on the

CHI budget.

2) 2) If X Price <weighted average price

equivalent drugs by volume of each,

therefore the financial impact would be

negative on the CHI budget.

the price of the drug X in relation to the

weighted average price per volume of drugs

called equivalent:

1) If X Prize> = weighted average price

equivalent drugs by volume of each,

therefore the financial impact would be

positive (or zero if they are equal) on the

CHI budget.

2) 2) If X Price <weighted average price

equivalent drugs by volume of each,

therefore the financial impact would be

negative on the CHI budget.

Evaluation Approach

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Thank you