Pricing and Reimbursement Regulations in Turkey Any role ... · Milestones in Pricing and...
Transcript of Pricing and Reimbursement Regulations in Turkey Any role ... · Milestones in Pricing and...
Pricing and Reimbursement Regulations in TurkeyAny role for HTA?
Dr Rabia KahveciGeneral Directorate of Pharmaceuticals and
Pharmacies
Ministry of Health, Turkey
2004-2009
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Pharmaceutical Regulations in Turkey
• Ministry of Health, General Directorate of Pharmaceuticals and Pharmacies– Licencing and Pricing (external reference)– Pharmacovigilance, drug safety, consumer relations,
pharmacies…– Department of Pharmacoeconomics
• Social Security Institution– Reimbursement Decisions
• Reimbursement Commission• Medical and Economical Evaluation committee
– Implementation Guidelines
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Health care expenditures
First 8 months of 2009;
• 23.778.542.000 TL total (10.808.428.000 euros)
• 10.342.669.000 TL pharmaceuticals (4.701.213.000 euros, 43,5% of total)
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• Pharmaceutical expenditures in first 8 months of 2009 compared to first 8 months of 2008– nominal increase as 21,41%
– Real increase as 12,43%
• As volume (3% increase)• first 8 months of 2008: 983.169.883
• first 8 months of 2009: 1.013.309.863
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Nominal Changes in SSI health care expenditures, 2002-2009, (first 8 months), (%)
2003 2004 2005 2006 2007 2008
August 2008-2009
Total 36,56 23,83 4,7 30,54 15,69 20,95 11,67Pharmaceu
ticals 30,74 17,98 7,64 16,01 10,45 16,42 21,41
2003 2004 2005 2006 2007 2008
August 2008-2009
Total 8,99 11,97 -4,94 18,12 6,37 9,51 3,41Pharmace
uticals 4,34 6,67 -2,27 4,98 1,55 5,42 12,43
Real Changes in SSI health care expenditures, 2002-2009, (first 8 months), (%)
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Milestones in Pricing and Reimbursement of pharmaceuticals
• 2004 April..reference pricing• 2004..Reimbursement Commission under Ministry of
Finance• 2005..Regulations on licencing of pharmaceuticals• 2005 ..Positive list for reimbursement• 2006..Pharmaceutical expenditure tracking system
under SSI and MEDULA initiated• 2007..new health budget law adopted• 2008..mandatory pharmacoeconomic analysis in
industry submissions for coverage• 2008..General health insurance• 2009..Drug Track and Trace System• 2009 Sept..Change in Pricing Legislation• 2009 Sept.. Changes in Reimbursement Rules
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In the first three years of the Health Care Transformation Program although health expenditures rose rapidly, increases in both total and public spending on health care seem to have remained affordable because economic growth in Turkey was also rapid….
Increase in access, decrease in pharmaceutical prices, decrease in taxes, increase in GDP…
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1984 Legislation for Pharmaceutical Pricing•System based on costs•Company’s declaration•No discounting
14th February 2004 (revised in 2007) Reference Pricing (5-10 EU member states, lowest exfactory
price is reference, generics get 80% of original)Transparent and Objective CriteriaPrice Evaluation CommissionReimbursement Commission
An annual saving of 900 million USD
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Pharmaceutical Before (2004)Legislation
After (2004) Legislation
%of Decrease
PERMAX 14.570.000 2.900.000 80,10 %ZOCOR 46.098.000 10.920.000 76,31 %PROZAC 5 ML 23.244.000 10.010.000 56,94 %LOSEC 22.408.000 12.910.000 42,39 %DIAMICRON 16.244.000 9.600.000 40,90 %NORVASC 36.168.000 21.860.000 39,56 %TİLCOTİL 10.559.000 6.430.000 39,10 %VİAGRA 63.617.000 55.870.000 12,18 %ASPİRİN 395.000 390.000 1,27 %
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Reference Pricing14th February 2004
MoH
Reimbursement Commission14th February 2004
MoF
Protocol on Public Reimbursement
14th December 20044-11% discount for public
Equivalance Reimbursement Band %30May 2005
Insurances United December 2005 Positive list
January 2006
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Protocol on Public Reimbursement, 2004 Reference countries: Portugal, Spain, France, Italy and Greece
100% of Min Ref
Original Price
80% of Original
Generic Price
11% Public discount
Later than 6 years
11% Public discount
Earlier than 6 years
4% Public discount
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Equivalance Reimbursement Band,2005
• Equivalance defined as: same active substance, same dose, same route..
• A 10 mg 20 tb…30 TL
• B 10 mg 20 tb…35 TL
• C 10 mg 20 tb…37 TL
• D 10 mg 20 tb…41 TL
Band:30 plus 30x30%
39 TL
D is 2 TL above band
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Positive list January 2006
SSI Law PassedMay 2006
Revision of Positive list June 2006
Reimbursement Commission redefined under SSI
June 2007
Equivalance Band narrowed to 22 %
May 2006
Mandatory Pharmacoeconomical Analysis in Submission
May-Oct 2008
Public discount 11 % for allSeptember 2008
Equivalance Band narrowed to 15 %
June 2009 14
Equivalance Reimbursement Band,2006, 2009
• A 10 mg 20 tb…30 TL
• B 10 mg 20 tb…35 TL
• C 10 mg 20 tb…37 TL
• D 10 mg 20 tb…41 TL
Band:30 plus 30x22%
36,6 TL
C and D is above band
Band:30 plus 30x15%
34,5 TL
B, C and D is above band
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September 2009 Regulations!!!
• 18th Sept 2009/revised in 2nd Dec 2009 : New Pricing Legislation ..
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Pricing regulations, 2009
100% of Min Ref
Original Price
80% of Original
Generic Price
11% Public discount
Generics in the market
Org price 66%
11% public discount
11% Public discount
66%
No generic in the market
23%
EXCEPTIONSProducts less than 10 TL
Blood productsEnteral feedingCritical drug list
RadiopharmaceuticalsOTCs
Expected saving 3 billion TL
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Current Problems (1)
• Economical crisis..big issue
• Increasing pharmaceutical expenditures still a problem
• Reference countries do not reflect the lowest prices in Europe
• Reimbursement Prices might still be higher than many wealthier countries
• Need for redefining equivalency and further step for internal reference pricing
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BiphosphonatesAlendronic acid vs Risedronic acidReimbursement Price
15 % band
25,55 TL Andante Tb 70 mg 4 tb
28,43 TL Bonacton Tb 70 mg 4 tb
28,43 TL Bonemax Tb 70 mg 4 tb
28,64 TL Fosamax Tb 70 mg 4 tb
28,43 TL Osalen Tb 70 mg 4 tb
28,43 TL Osteomax Tb 70 mg 4 tb
24,91 TL Vegabon Tb 70 mg 4 tb
Reimbursement Price
15 % band
50,49 TL Actonel 35 mg 4 tb
40,26 TL Arilex 35 mg 4 tb
330,5 TL/year
555,6 TL/year
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Current Problems (2) • Fixed copayment and a long list of no copayment
• No flexibility in reimbursement prices– No risk-sharing
– No internal reference pricing
– Fixed copayments
• Still no value at this stage
• No HTA in pricing
• Need for further improvement in reimbursement criteria based on cost-effectiveness and definite role for HTA here!
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ThanksTHANK YOU