introducing new generic medicine on reimbursement list and influence over hif budget

INTRODUCING NEW GENERIC MEDICINE ON

REIMBURSEMENT LIST AND INFLUENCE OVER HIF BUDGET

CASE AMOXICILLIN/CLAVULANIC

ACID

M. Sci. Stevce AcevskiM. Sci. Health management and

pharmacoeconomicsISPOR Republic of Macedonia Regional Chapter

Alkaloid AD Skopje

AGENDA

The structure of the Macedonian Healthcare system

Case study: Amoxicillin/clavulanic acid - Introducing new generic medicine on reimbursement list and influence over HIF

References

THE STRUCTURE OF THE MACEDONIAN HEALTHCARE

SYSTEM

THE STRUCTURE OF THE MACEDONIAN HEALTHCARE SYSTEM

Number of citizens 2 065 769

Population 0-14 y 21,08 %Population 15-64 y 68,30 %Population over 65 y 10,58 %

Skopje (capital) 506 926 (information from 2002 last finished government statistical operation)


Ethnical ReligionMacedonians 64,18 % Orthodox's 67 %Albanians 25,17 % Muslims 30%Turk's 3,85 %, Roma people 2,66 %, Other 3%Serbians 1,78 %, other 2,36 %

(information from 2002 last finished government statistical operation)

THE STRUCTURE OF THE MACEDONIAN HEALTHCARE SYSTEM (2014)

Budget for Health ≈ 370 mil eur

Budget for medicines ≈ 35 mil eur

GDP per capita ≈ 4 585 Eur

Employed 696 046

Rate of unemployment 29 %


Government (Budget)

Ministry of Health

Fund of Health Insurance

Regional funds

Medical Center

Director and Financial director

Hospital Pharmacy

Manager of department

General Hospital

Director and Financial director

Manager of department

Pharmacies

Director

Supplies

Central Vault


Public Health institutions

11 Offices for Health Protection 18 General Hospitals (primary health care) 16 Medical Centers (primary and secondary health care) 15 Special Hospitals 1 Clinical Center (28 separated specialized clinics) 3 Clinical Hospitals Pharmacies (Only in hospitals)


Private Health institutions

447 Private health organizations (265 general and 182 specialist practice) 28 Laboratories 800 Private Pharmacies 90 Wholesales 1 Cardio surgery hospital 4 Gynecology hospital 3 Private general hospital 1 Ophthalmology hospital 20 Dialysis center


Procedure for registrations 15 – 210 days Mutual recognition for medicines from EU Shorter procedure for products origins from USA, Japan,

Canada Re-registration

pharmaceuticals – after 5 y OTC – after 5 y

Bureau for medicines (Ministry of Health) – Agency Working group for pricing every 6 months Working group for reimbursement list every 6 – 12 months

CASE STUDY: AMOXICILLIN/CLAVULANIC ACID - INTRODUCING NEW

GENERIC MEDICINE ON REIMBURSEMENT LIST AND

INFLUENCE OVER HIF BUDGET

AMOXICILLIN/CLAVULANIC ACID Oral antibacterial combination

Penicillin type – amoxicillin Beta lactamase inhibitor – clavulanic acid

Wide range on Gram positive and Gram negative bacteria's

First choice of treatment in almost every infectious treatment

For kid`s and for grown up Suitable in pregnancy (FDA category B) On reimbursement list

CASE STUDY: AMOXICILLIN/CLAVULANIC ACID

Registered (24 different strengths):

Amoklavin BID – Deva Holding A.S. Amoksiklav – Lek Augmentin – Smith Kline Beecham

Pharmaceuticals Panklav – Hemofarm Co - Almacin – Alkaloid (launched September

2013)

BUDGET OF HIF 2012 – 2014

TOTAL Budget HIF

Denars Euro Variation (%)

2012 21.436.410.000

348.559.512 -

2013 21.886.741.000

355.881.967 + 2,1 %

2014 22.600.000.000

367.479.675 + 3,3 %

BUDGET OF HIF SPENT FOR MEDICINES2012 – 2014

TOTAL Budget HIF

Denars Euro Variation (%)

2012 (397 medicines)

1,993,1893567 32,409,586 -

2013 (408 medicines)

2,123,979,165 34,536,246 + 6,6 %

2014(376 medicines)

2,235,842,079 36,355,156 + 5,3 %

10 MOST PRESCRIBED MEDICINES IN 2012

10 MOST PRESCRIBED MEDICINES IN 2013

TOP 10 MEDICINES – BUDGET SPENT 2012

TOP 10 MEDICINES – BUDGET SPENT 2013


Year Pack`s Variation sc (%)

Denars Variation denars (%)

Euro Variation euro (%)

2012 120 821 - 11 147 602 - 181 262 -

2013 130 961 + 8,39% 12 150 899 + 9,0 % 197 576 + 9,0 %

2014 154 260 + 17,79 % 14 053 641 + 15,66 % 228 514 + 15,66 %

o Amoxicillin / clavulanic acid susp. 457 mg/5ml

Year Share of total HIF budget

2012 0,05 %2013 0,06 %2014 0,06 %


Year Pack`s Variation sc (%)

Denars Variation denars (%)

Euro Variation euro (%)

2012 289 693 - 61 792 353 - 1 004 754 -

2013 280 863 - 2,05% 60 802 068 - 1,6 % 988 652 - 1,6 %

2014 340 042 + 21,07 % 69 811 850 + 14,82 % 1 135 152 + 14,82 %

o Amoxicillin / clavulanic acid tbl. 875 mg + 125 mg


2012 0,29 %2013 0,28 %2014 0,31 %


o ATC code J01CR02


2012 0,37 %2013 0,36 %2014 0,40 %


CONCLUSIONIntroducing new generic medicine on the Macedonian market of pharmaceutical product, from group of anti-infective medicines (ATC group J) resulted in increased amount spend for this ATC group and increased spending of HIF budget overall

REFERENCESwww.reglek.com.mk

www.fzo.org.mkwww.moh.gov.mkwww.stat.gov.mk

http://www.reglek.com.mk/

http://www.fzo.org.mk/

http://www.moh.gov.mk/

http://www.stat.gov.mk/

Contact:M. Sc. Stevce Acevski

Health management and pharmacoeconomia

tel. + 389 72 239 [email protected]

THANK YOUFOR YOUR ATTENTION

mailto:[email protected]

introducing new generic medicine on reimbursement list and influence over hif budget

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