Reimbursement & Pricing in Turkey Association of Research Based Pharmaceutical Companies
Reimbursement & Pricing in Turkey
Association of Research Based Pharmaceutical Companies
Agenda
Trends in Turkish HC System at last Decade
Main Indicators
HC Spend Growth
Drug Consumption Growth
Reimbursement Process in Turkey
Evaluation of Current Assessment Model
Global Budget Implementation
Pricing in Turkey
HTA in Turkey
Trends in Turkish HC System at last Decade
Trends in Turkey HC System at last Decade
Grouping of the Public Hospitals under the MoH (Jan 2004)
Allowing the population to use all health care facilities and pharmacies (Feb 2005)
Prescription drugs extended to Green Card holders as part of their benefit package (May 2005)
Holding the population to equal conditions about access to health care
Generalizing the service procurement from private providers (June 2007)
Establishment of General Health Insurance Scheme
Implementation of Family Physician System
Number of Visits to the Health Care Facilities by Years
9,78,7
7,7
5,5
6,35,84,9
2,7
0
5
10
15
20
2002 2006 2007 2008
Inpatients (per 1.000.000 person) Outpatients (per person)
Source: Ministry of Health
Years
Number of
Visit
Neonatal Mortality Rate by Years (in 1.000 live births)
Source: Ministry of Health
Years
MortalityRate
Under 5 Mortality Rate by Years (in 1.000)
Source: Ministry of Health
Years
MortalityRate
Maternal Mortality Rate by Years (in 100.000 live births)
Source: Ministry of Health
Years
MortalityRate
Visits per Physician by years
16991901
19811886
2004
2178
2742
2936 29523042
0
500
1000
1500
2000
2500
3000
3500
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Source: Ministry of Health
Years
Number ofVisit
Average Length of Stay in Hospitals by Years
Source: Ministry of Health, 2008
Years
days
+ 26%
Bed Turnover Rate by Years
37,9
45,8
51,2
55,5
0 10 20 30 40 50 60
2002
2006
2007
2008
Source: Ministry of Health, 2008
Years
Patient
+ 47%
47 20 33
55 19 26
52 18 30
66 15 18
63 17 20
65 16 19
2004
2005
2006
2007
2008
2009
Satisfied Variable Unsatisfied
Satisfaction about Health Care Services
TÜİK Life Satisfaction Survey 2003-2008
% of Satisfaction
Years
+ 38% - 42%
Total HC spend in Turkey vs. GDP
Source: Turkstat, EIU, OECD, interviews, BCG analysis
+ 32% + 32%
The leading cause is greater and regular access of patients to physicians and hospitals. The frequency of physician calls in turkey rose from 2.7 in 2002 to 6.3 in 2008.
Aging, Improving wealth, Life-styles and Increasing patient awareness
Allowing the reimbursement of outpatient treatments for green card owners
Physiological increased demand due to Family Physician system
The reason for increasing of drug usage in Turkey
Average Drug Utilization per person (Unit)
+ 67%
Source: TUIK & IMS
HC spend evolution in Turkey - Projection
Source: Turkstat, AİFD estimations
+ 20,4%
+ 4,6%
Reimbursement Process in Turkey
Reimbursement Process
Social Security Institution (called SGK) is the key player in the new assessment system with responsibility for determining what treatments and medicines are reimbursed by the new system.
Companies apply to the Social Security Institution in order to determine the reimbursement status of a pharmaceutical.
The other stakeholders involved in the reimbursement evaluation process alongside the Social Security Institution are the Ministry of Finance (MoF), the Ministry of Health (MoH), the State Planning Organization, the Under secretariat of Treasury, KOLs and industry representatives.
The submitted products are primarily evaluated by the Medical & Economic Evaluation Commission and the final decision is taken by Reimbursement Commission.
The final revised list is announced after the official approval of the Head of SGK.
The time from application for reimbursement to a final decision in Turkey is usually up to one year, which is also a cause of delay of market access.
Reimbursement Process
Required Documents for Application
Companies apply to the Social Security Institution in order to determine the
reimbursement status of a pharmaceutical. The written request should be
supported by;
• The FDA marketing authorization and New Drug Application (NDA) number,
• the EMA marketing authorization and co-marketing certificate,
• Regulatory and reimbursement status within OECD countries
• Clinical data
• Safety
• Efficacy
Pharmaco-economic data
– The pharmaco-economic analysis shall be performed and must be annexed with the appropriate sensitivity analysis.
– The comparison should be with the most commonly used alternative
– Cost Minimization, Cost Effectiveness, Cost utility (may be submitted by the applicant) as an annex to the pharmaco-economic analysis.
– Budget impact model from payer perspective
Market Access Steps - Today
Reimbursement Journey - Today
Evaluation of Current Assessment Model
Positive Aspects of Current System Allowing participation of industry representatives to
the assessment process.
Negative Aspects of Current System SGK compares the package prices with alternatives
and omits total treatment cost.
Comparative medical evaluation of products with therapeutic alternatives has not been used in real terms by SGK at current situation
Pharmaco-economic analysis in the reimbursement dossier is not taken into account in discussions
Budget impact discussions dominate the decision
Global Budget Implementation in Turkey
GLOBAL BUDGETGovernment granted a 7% growth for the next 3 years according to 2008 realization
Global Budget Protocol; Pricing
For the new molecules and the innovative treatment products to be introduced into the market, a base public institute discount will be 11% for the application to the List of Drugs to Be Reimbursed.
During the period 2010-2012 when the medium-term fiscal program will be implemented, the therapeutic equivalence will not be applied.
Global Budget Protocol; Acquisitions
At the second step;
The reference rate will be decreased from 66% to 60%incrementally for products with generics.
At the first step;
The discount of original products with no generics willbe increased to 13%
If the Actual expenditures exceeds the budget
AİFD Estimation and Actual for 2010
Source: SSI, IMS (ex factory+ SSI factor) & AIFD*: 10% Safety Margin has been added to first 3 months
***
2010 Drug Expenditure Realization(AİFD Budget – Actual / IMS+SSI Data)
Source: IMS; SSI
January February March April
1.387
1.190
1.304 1.289 1.2921.219 1.214
1.473
1.1411.123
-
200
400
600
800
1.000
1.200
1.400
1.600
Jan Feb March April May
Billio
n T
L
2010 - Budget Estimated by Aİ FD 2010 - ActualsI MS
2010 - ActualsSSI
Pricing in Turkey
Pricing in Turkey / Conditions before 4 December 2009 – (1)
Pricing based on external reference:
The ex-factory price (PTW) is determined by the MoH on the basis of the lowest of the below:
* The price in 5 reference countries (France, Greece, Italy, Portugal and Spain) / August 31
* the price in the country the drug was imported from
* the price in the country where the drug was manufactured (place of batch release)
*if the drug is not sold in the countries above, the lowest STS in the EU.
Pricing based on internal reference:
Reimbursement amount is determined by the Social Security Institution taking into consideration the prices of the equivalent products with the same indication.
• Any change occurring in Turkey exceeding 3% due to fall in the reference price is reported to the MoH and reflected on the prices in at least 3 months.
• For originator products, companies may claim an amount up to maximum 100% of the reference price.
• For generic products, companies may claim an amount up to maximum 80% of the reference price.
• Both generic and originator drug manufacturers may claim prices under the determined price.
• 20-year-old products: The products that were placed upon the world market before 01.08.1987 for the first time
• 20-year-old products are excluded from reference-based pricing and their present prices are maintained.
• Reductions in the prices do not apply to products with PTW under 3 TL.
Pricing in Turkey / Conditions before 4 December 2009 – (2)
Before the decree After the decree
100% of the reference until the generic is placed upon the market
100% of the reference until after the generic is placed upon the market (80% for generics)
100% of the reference until the generic is placed upon the market
66% of the reference after the generic is placed upon the market (the rate is the same for generics)*
Reference price is not applicable to 20-year-old products
20-year-old products** shall be priced over the 100% of the reference price as of 1 January 2010.
* Originator/generic products with PSS over 3.56TL
** 20-year-old products with PSS over 6.79TL
The changes implemented by the new pricing decree – (2)
New concept for Turkey
3 different models were developed (SSI, Hacettepe Uni and
AIFD)
AIFD’s proposal is based on therapeutic improvement, burden of
illness, pharmaco-economic evaluation and budget impact
The collaboration of all stakeholders will be crucial to implement
best model for Turkey
AİFD and SGK will establish a platform to create mutual understanding on the principles and terminology. At the second step we are going to start on creation a sustainable model for Turkey.
HTA in Turkey
Back up Slides
The Medical & Economic Evaluation Commission
The Medical & Economic Evaluation Commission has been composed with 13 members. Social Security Institution has 4 members, the Ministry of Health has 2, the Ministry of Finance, the State Planning Organization and the Treasury has 1, two pharmacologists and 2 industry representatives are regular members of the Medical & Economic Evaluation Commission.
The meeting schedule should be announced at the beginning of each year and The Medical & Economic Evaluation Commission meets 4 times in a year. The decisions are taken by the polling and all participants including industry representatives have one vote.
After Medical & Economic Evaluation Commission meetings, the final decision is taken by Reimbursement Commission according to suggestions of Evaluation Commission. The final revised list is announced after the official approval of the Head of Social Security Institution.