FINANCING ARV EXPERIENCE FROM MALAYSIA BY SHA’ARI NGADIMAN, MD, MPH, EIP, AM MINISTRY OF HEALTH MALAYSIA

 Our Structure  National Strategic Plan on HIV and AIDS  Activities  Impacts of the activities  AIDS Expenditure  ARV & Logistic Cycle  Conclusion OUTLINE

OUR STRUCTURE Deputy Minister of Health State Health Office : 15 District Health Office : 141 Government Hospital : 138 Health Center : 985 Involve in process of financing, planning, procurement, distribution, monitoring etc Director Of Disease Control Dep. Director (Comm. Diseases) Sector HIV/STI Sector VBDCP Sector FWB&VPD Sector Zoonotic Sector TB/Leprosy Dep. Director (NCD) Dep. Director (Surveillance) Dep. Director (Env. /Occp H)

OUR STRUCTURE Director of Disease Control Dep. Director (Comm. Disease) Dep. Director (NCD) Dep. Director (Surveillance) Dep. Director (Env & Occp H) Head Sector HIV/STI SPAD Prevention SPAD Treatment and Care SPAD Harm Reduction SPAD Monitoring and Evaluation SPAD Counselor PAD Research Head Sector VBDCP Head Sector Zoonotic Head Sector TB/Leprosy Head Sector FWD&WPD SPAD State HIV/STI Officer

Target of NSP on AIDS  80% MARPs reached prevention programmes  60% of MARPs use condoms consistently.  60% of IDUs use clean injecting equipment.  Able to eliminate vertical HIV transmission  80% ARV coverage for eligible PLHIV,

HIV NOTIFICATION IN MALAYSIA Cumulatifve HIV = 98,279 Cumulative deaths = 15,521 PLHIV (end of 2012) = 82,758 NEW HIV CASE PER 100,000 YEAR TARGET ACHIEVED

CUMMULATIVE ON HAART AS 31 DEC ,028 on ARV in ,000 Adult Eligible for ARV in 2012 (EPP Model)

Expenditure 2008 – 2012 ARV : 2011 – USD mil 2012 – USD mil USD st Line ARV USD nd Line ARV Expenditure (USD) DOMESTIC FUND FOR HIV WORKS 38%

ARV in Malaysia  Eligible criteria  Drugs listed in MOH Drug Formulary  By specialist  Available in hospitals and health centers with specialist  Also at hospitals or health centers without specialist through follow-up by visiting specialist  Can be dispense through Integrated Dispensing Medicine System

ARV in Malaysia  PLHIV above 15 yrs  1 st line – 91.7%  2 nd line – 8.0%  3 rd line – 0.3%  PLHIV below 15 yrs  1 st line – 71.0%  2 nd line – 27.0%  3 rd line – 2.0%

FLOW OF MOH DRUG FORMULARY REVIEW PANEL  Director-General of Health (DG) - Chairman  Deputy DG of Medical Services  Director of Pharmaceutical Services  8 Consultants in Public Services  3 Pharmacists in Public Services

 List of drugs can be used by ALL MOH institutions  Serves as guide for the selection of drug therapy  First published in October 1983  Review 2 – 3 times a year  1530 drugs are listed  Objectives Provides the policy and administrative approach to : Control Promote Encourage rational, safe and cost effective drug prescribing and usage MOH DRUG FORMULARY

PROCUREMENT PRINCIPLES  Public accountability - Procurement should obviously reflect public accountability entrusted with the Government  Transparency - All procurement regulations, conditions, procedures and processes need to be clear and transparent to facilitate better understanding among suppliers and contractors.  Best value for money - Government procurement should yield the best returns for every Malaysian Ringgit spent in terms of quality, quantity, timeliness, price and source.  Open and fair competition - Processes involving Government procurement should offer fair and equitable opportunities to all those participating or competing in any procurement.  Fair dealing - All acceptable bids will be processed fairly based on current rules, policies and procedures.

Policies on Drug Procurement  Local product (priority)  Imported product : have to get approval from Ministry of International Trade and Industry & Ministry of Finance  Value for money  HOW?  Consession Company - Pharmaniaga Logistics Sdn Bhd (Approve Purchased Product List - APPL)  Central Contract (e-Tender/e-Bidding/Direct Negotiation)  Local Purchase by Quotation or Direct Purchase Drug Purchased in 2012

Importing Generic & Local Production  First Asian country issue Compulsory licensing in 2003  Local production of ARVs as part of our effort to confront the challenges of HIV/AIDS.  Currently, domestic pharmaceutical industry has capability to produce almost all dosage form and almost 80% of various categories in National Essential Drug List (NEDL) through the Malaysian Organization of Pharmaceutical Industries (MoPI).

Central Contract Generic Name Category Unit Procurement Data (2012) Line of Treatment QuantityValue (USD) 1Efavirenz 200 mg CapsuleA*pack of 90's2,388196,389.12First Line 2Efavirenz 600 mg TabletA/KKpack of 30's89,8375,559,544.78First Line 3Lamivudine 100 mg TabletA*pack of 28's30,4782,000,819.74First Line 4Lamivudine 150 mg TabletA/KKpack of 60's23,0771,152,003.84First Line 5 Stavudine 30 mg, Lamivudine 150 mg & Nevirapine 200 mg Tablet A/KKpack of 60's12,190660,288.42First Line 6 Tenofovir Disoproxil Fumarate 300 mg & Emricitabine 200 mg Tablet A*pack of 30's20,9361,071,923.20First Line 7 Tenofovir Disoproxil Fumarate 300 mg Tablet A*pack of 30's8,827310,710.40First Line 8 Zidovudine 300 mg & Lamivudine 150 mg Tablet A/KKTab/Cap4,532,4914,400,642.77First Line 9 Indinavir Sulfate 400 mg Capsule A*pack of 180's1,591214, Second Line 10 Lopinavir 200 mg and Ritonavir 50 mg Tablet A*pack of 120's6,1171,831, Second Line 11Ritonavir 100 mg CapsuleA*pack of 168's1,320225, Second Line Total 17,624,437.90

Local Purchase NoGeneric NameCategoryUnit Procurement Data (2012) Line of Treatment QuantityValue (USD) 1Stavudine 40mg (Tab/Cap)A*Tab/Cap First Line 2 Nevirapine 200mg (Tab/Cap)A/KKTab/Cap1,828,241439,737.40First Line 3Lamivudine 10mg/ml Oral Solution (Bottle)A*Bottle4,334321,993.28First Line 4Stavudine 30mg (Tab/Cap)A/KKTab/Cap897,181226,621.91First Line 5Stavudine 1mg/ml Oral Solution (Bot)A*Bottle First Line 6Zidovudine 100mg (Tab/Cap)A/KKTab/Cap206,831195,948.64First Line 7Zidovudine 10mg/ml Syrup (Bot)A*Bottle4,93388,070.40First Line 8Efavirenz 100mg (Tab/Cap)A*Tab/Cap00.00First Line 9Efavirenz 50mg (Tab/Cap)A*Tab/Cap54,33315,209.83First Line 10Zidovudine 1 % Inj. (Vial)AVial94744,480.21First Line 11Zidovudine 300mg (Tab/Cap)A*Tab/Cap328,63534,401.33First Line 12Didanosine 400mg (Tab/Cap)A*Tab/Cap24,21634,832.29Second Line 13Didanosine 100mg (Tab/Cap)A*Tab/Cap69,85133,137.58Second Line 14Didanosine 2g Oral Solution (Bot)A*Bottle39940,755.46Second Line 15Ritonavir 80mg/ml Oral Solution (Bot)A*Bottle225,674.24Second Line 16Didanosine 25mg (Tab/Cap)A*Tab/Cap54,041207,517.44Second Line 17Didanosine 250mg (Tab/Cap)A*Tab/Cap60,13767,790.28Second Line 18Raltegravir 400mg (Tab/Cap)A*Tab/Cap3,96053,539.20Second Line 19 Lopinavir/ Ritonavir Oral solution 533/13.3mg - Kaletra® (Bottle) ABottle2,455712,478.75Second Line Total 2,522,983.16

Drugs of Special Approval NoGeneric NameUnit Procurement Data (2012) Line of Treatment QuantityValue (USD) 1 Tenofovir DF 300 mg +Lamivudine 300mg Tab Tab18,35630,191.95First Line 2 Nevirapine 50mg/5ml Oral suspension (Bot) Bottle72914,683.24First Line 3 Lopinavir/ Ritonavir 100/25mg (Tab/Cap) Tab/Cap77,842143,620.74Second Line 4Abacavir 300mg (Tab/Cap)Tab/Cap54,41044,746.78Second Line 5Darunavir 300mg (Tab/Cap)Tab/Cap3,84016,896.00Second Line 6 Abacavir 600mg + Lamivudine 300mg Tab (listed in MOH Drug Formulary in Nov. 2012) Tab7,05012,994.56Second Line 7Abacavir 20 mg/ml (Bot)Bottle181,301.18Second Line 8Atazanavir 300mg (Tab/Cap)Tab/Cap Second Line Total 265,

Logistic Cycle of ARV’s Supply Serving Clients Selection of ARV Forecasting & Procurement Inventory Management LOGISTIC INFORMATION MOH Drug Formulary Review Physician Ministry of Health (Pharmaceutical, Medical, Public Health) Individual hospital, health center Every level Central Contract Local Purchase Concession Company LIST A* : Consultant/ Specialist for specific indications only LIST A : Consultant/ Specialist LIST A/KK : Consultant/ Specialist/ Family Physician Specialist LIST B : Medical Officer LIST C : Paramedics LIST C+ : Midwifery Paramedics

 System for ARV procurement worked!  Funded by Government (tax payers)  Changing pattern of the epidemic  Reaching 80% coverage for ARV  Continue and enhance current funding & activities  New inovation?  Review NSP CONCLUSION

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