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Pharmaceutical Pricing and
            Reimbursement in Greece




25/5/2011               ΣfΕΕ             1
Greek Pharmaceutical Market Today


                                    Product




                                    Money
                              Everything controlled
                                 by government
                                    (cartel?)




25/5/2011           ΣfΕΕ                              2
Pharmaceutical Pricing Today
                              (retail market, 0% co-pay)

            • Pharma Revenue: Ex-Factory – 4% Rebate
91.08

            • Ex-Factory: Pharma -> Wholesaler
94.88

       • Wholesale: Wholesaler -> Pharmacy
100.00 • 5.4% markup

       • Pharmacy Margin
135.00 • 35% markup

       • Retail: Pharmacy -> Social Security OR Private Payer
143.78 • VAT 6.5%



25/5/2011                                   ΣfΕΕ                3
Pharmaceutical Reimbursement Today
• Negative Reimbursement List
       – All other medicines reimbursed
• 3 levels of co-pay for reimbursed medicines
  based on combination of medicine & disease
       – 0%
       – 10%
       – 25%



25/5/2011                     ΣfΕΕ              4
Contradictions to Free Market
              Principles that Exist Today
• Legislated prices, margins and discounts
  between two private businesses
       – Government created cartels
• Legislated cost burdens between two private
  businesses
       – Who pays for goods shipment
       – Who pays for insurance
       – Who pays for destruction of expired goods
• Government should not legislate any of these

25/5/2011                     ΣfΕΕ                   5
Proposal

            A Win – Win Solution




25/5/2011            ΣfΕΕ          6
Government Benefits
• No medicine shortages
• Total Public Pharmaceutical Expenditure will gradually reach
  approximately 1% of GDP
• Decrease in social security waste
• Increase in VAT
• Increase in Income Tax
• IMF & EU goals for free markets
• Benefits for employment in pharmaceutical & other industries
       – Increased contributions to social security
• Clearer horizon for pharmaceutical investment in research &
  development
• Ability to fund social policy to help patients who need lower co-pay



25/5/2011                               ΣfΕΕ                             7
Prerequisites
• Must Have:
  Full Electronic Medicine Supply Chain Tracking
       – All medicines bought by the government must be recorded
         electronically
       – All medicines sold by pharmacies must be recorded electronically
       – All medicines sold by wholesalers and private clinics must be recorded
         electronically
       – All medicines sold by pharma industry must be recorded electronically
       – Monthly updated data for calculating % of medicines sold that are
         reimbursed
• Useful to Have:
  Full Electronic Patient Health Record
       – Would allow reliable and verifiable indication based reimbursement
       – Would lead to savings in other areas of healthcare



25/5/2011                               ΣfΕΕ                                      8
Pharmaceutical Pricing




25/5/2011             ΣfΕΕ           9
Pricing Goals
• Government should be involved and control prices only
  where government pays
• All prices that government does not pay should be “free”
       – In essence “Free” prices are not free
       – Market forces shape prices more efficiently than any forced
         control:
            •   Competition
            •   Customers
            •   Distribution channels
            •   European Pricing - Parallel Import / Export
            •   Internal Company Policies
       – Free prices will force society (physicians & patients) to become
         more price sensitive



25/5/2011                                   ΣfΕΕ                            10
Pricing
Free Price                                              Reimbursement
for private market buyers                               for government only
•    Pharma Company Sets Wholesale                      •   Social Security will calculate reimbursed wholesale
     Price (Price to pharmacist) and                        price
                                                             –   E.g value based price, international reference price
     Suggested Retail Price                                  –   all prices will be recalculated once a year
       –    Pharma company may offer discounts          •   New products reimbursed when price is available
       –    Wholesalers may offer discounts                 in at least one other European country
       –    Pharmacists may offer discounts                  –   quick access to new medicines for patients
                                                             –   new products repriced every quarter for first 12
       –    Private clinic may offer discounts                   quarters (3 years) to capture new cheaper countries
       –    Public hospitals must transfer              •   Reasonable pharmacy markup/discount
            discounts to social security                •   Social Security will reimburse private clinics at
•    Published online in official SfEE                      wholesale price + 5%
     price bulletin quarterly                           •   Public Hospitals will purchase at hospital price
       – SfEE publishes next quarters prices            •   Social Security will reimburse public hospitals at
         online two weeks before quarter                    their purchase price + x%
         starts                                         •   Reimbursed wholesale price cannot be higher than
       – Companies responsible for                          free wholesale price (RWP <= FWP)
         submitting prices electronically to            •   Prices not published
         SfEE two weeks before publish date


25/5/2011                                        ΣfΕΕ                                                         11
Reimbursed Money Flow
                              Government money




                                Private money
                              (margins and prices
                               not controlled by
                                 government)




25/5/2011             ΣfΕΕ                     12
3 part Pharma Industry Rebate

                • Euro amount for each unit reimbursed
       Fixed    • Difference between free wholesale price and reimbursed
      Amount      wholesale price


                • % of reimbursed wholesale price
                • Based on proportion of total units sold reimbursed
   Variable %   • As % of units reimbursed falls from 100% this variable
                  rebate % increases


     4% Fixed   • 4% of reimbursed wholesale price
      Rebate    • Same as today



25/5/2011                          ΣfΕΕ                                    13
Rebate Paid by Pharma Companies
                                                   (does not include price difference part)

                                16%
                                14%
 Rebate % of reimbursed price




                                12%
                                10%
                                8%
                                6%
                                4%
                                2%
                                0%
                                                                                                    50%
                                             95%
                                                   90%
                                                         85%
                                                               80%
                                                                     75%
                                                                            70%
                                                                                  65%
                                                                                        60%
                                                                                              55%


                                                                                                          45%
                                                                                                                40%
                                                                                                                      35%
                                                                                                                            30%
                                                                                                                                  25%
                                                                                                                                        20%
                                                                                                                                              15%
                                                                                                                                                    10%
                                                                                                                                                          5%
                                                                                                                                                               0%
                                      100%




                                                                           % of total units sold reimbursed
25/5/2011                                                                                ΣfΕΕ                                                                   14
Variable Rebate Mechanism
• At each quarter close government will
  calculate total number of each medicine
  purchased by social security and will compare
  to total sales provided by pharmaceutical
  companies to EOF.
• For every 1% point of non-reimbursed sales
  rebate will increase by 0.1%
       – 0% non-reimbursed sales = 0% + 4% rebate
       – 100% non-reimbursed sales = 10% + 4% rebate


25/5/2011                    ΣfΕΕ                      15
Price System
   (25% free price premium, retail market, 0% co-pay, 65% reimbursed sales)

Today                                                                      Reimbursment Money Flow
Net Rebate 4%                                                              Net Rebate 7.5%
                                                                                 • Pharma Revenue
            •Pharma Revenue: Ex-Factory – 4% Rebate
91.08                                                                            • Ex-Factory – Rebate = 25 + 4% + 3.5% = 32.5


            •Ex-Factory: Pharma -> Wholesaler                                    • Ex-Factory: Pharma -> Wholesaler
94.88

            •Wholesale: Wholesaler -> Pharmacy
                                                                                 • Wholesale: Wholesaler -> Pharmacy
            •5.4% markup
100.00                                                                 125.00

            •Pharmacy Margin                                                     • Retail (before VAT): Pharmacy -> Social Security
            •35% markup                                                          • 25% markup on Reimbursed wholesale price
135.00                                                                 150.00

            •Retail Price: Pharmacy -> Social Security OR Private
             Patient                                                             • VAT (Social Security does not pay VAT)
143.78      •+VAT 6.5%



                        Total Gov Spend = 150.00 – 32.50 rebate = 117.50 (vs 135)
25/5/2011                                                           ΣfΕΕ                                                         16
Price System
  (25% free price premium, 100% contribution, 65% of units sold reimbursed)
Free Market Money Flow                                      Reimbursed Money Flow
                                                            Reimbursed Wholesale Price = 100
                                                            Net Rebate 7.5%
                                                                   • Pharma Revenue
            • Pharma Revenue
                                                                   • =Ex-Factory – Rebate = 25 + 4% + 3.5% = 32.5



            • Ex-Factory: Pharma -> Wholesaler                     • Ex-Factory: Pharma -> Wholesaler



            • Wholesale: Wholesaler -> Pharmacy                    • Wholesale: Wholesaler -> Pharmacy
125.00                                                  125.00

       • Pharmacy Margin                                           • Retail (before VAT): Pharmacy -> Social Security
168.75 • Suggested 35% markup                           150.00     • 25% markup on Reimbursed wholesale price


       • Retail Price: Pharmacy -> Private Patient
                                                                   • VAT (Social Security does not pay VAT)
190.69 • VAT 13%


                Total Gov Spend = 150.00 – 32.50 rebate = 117.50 (vs 130 today)
25/5/2011                                            ΣfΕΕ                                                         17
Co-payment
• Government will legislate social security
  contribution.
       – Patient co-payment will be on free price
            • Will give a small benefit for social security
            • This benefit will finance the necessity for some
              populations to have reduced co-payment




25/5/2011                           ΣfΕΕ                         18
Rebate & Sales Example
                (retail market, fixed units, 25% free price premium, 0% co-pay)
   180,000                                                                                                              0%


   160,000                                                                                                              -2%

   140,000
                                                                                                                        -4%

   120,000
                                                                                                                        -6%
                                                                                Pharma Sales (Before Rebate)
   100,000
                                                                                Pharmacy Sales
euro




                                                                                Total Pharma Rebate
                                                                                                                        -8%
       80,000                                                                   Total Gov Expenditure (After Rebate)
                                                                                Total Pharma Revenue (After Rebate)     -10%
       60,000                                                                   Rebate %

                                                                                                                        -12%
       40,000


       20,000                                                                                                           -14%


           0                                                                                                            -16%
                 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5%                 0%
                                             % of total units sold reimbursed

          25/5/2011                                       ΣfΕΕ                                                         19
Generics
• The use of generics could significantly reduce government pharmaceutical
  expenditure
                                       IF
1. There is ongoing official accreditation to ensure quality of generic
   medicines
2. There is full implementation of generic pricing rules
   (IMF says 60%)
3. Price sensitivity in society increases by the application of this proposal

•       When a molecule has gone off patent and generic competition begins,
        the value of the contribution of social security can decrease.
      –     For example: social security contribution can move to 60% of prototype
            product reimbursed wholesale price for all medicines with that active
            ingredient




25/5/2011                                  ΣfΕΕ                                      20
Issues not yet resolved
• Pharmacy Reimbursed Margin
       – Options could include:
            • Fixed markup
            • Variable discount on total amount purchased
            • Variable discount on how fast payment is made
       – 25% markup used here for examples
         as mentioned in IMF document:
            • reduced profit margin of pharmacies on retail prices directly
              to 15-20 percent or indirectly through rebates
              (25% markup = 20% margin)
• VAT
       – For government VAT is in one pocket out the other
       – For private payers VAT is revenue for government
       – State buyers should not pay VAT


25/5/2011                                 ΣfΕΕ                                21
Reimbursement




25/5/2011         ΣfΕΕ      22
Reimbursement Goals
1. No reimbursement for lifestyle ailments
2. Reimbursement for other illnesses with
   varying levels of patient co-payment
3. Incentive for physicians, pharmacists and
   patients to prefer treatments that represent
   better value for money




25/5/2011              ΣfΕΕ                       23
1. Negative List
• Certain products are not reimbursed
       – Lifestyle
       – Over the counter
       – Inadequate efficacy (do not work)


• Reimbursement for certain diseases with co-pay
       – For some patients these products are not lifestyle
         treatments but chronic illness treatments
       – Some products made lead to significant savings in
         other health care expenses (e.g. smoking cessation)

25/5/2011                       ΣfΕΕ                           24
2. Reimbursement Contribution
     Social security contribution should also have social criteria
     (patient ability to afford, age group, etc)

Contribution categories:
• Full contribution for chronic life threatening diseases /
  therapies
• Large contribution for serious diseases / therapies
• Medium contribution for less serious diseases / therapies
• Low social security contribution
• Very low social security contribution

            (similar to Belgian reimbursement system)

25/5/2011                         ΣfΕΕ                               25
3. Incentive for lower cost
• Create an incentive for cheaper therapies with
  patients as drivers
       – Social security must increase price sensitivity in
         patients who will then influence physicians and
         pharmacists
       – Co-payment is the only way to incent patients to
         select cheaper medicines




25/5/2011                      ΣfΕΕ                           26
Government Benefits
• No medicine shortages
• Total Public Pharmaceutical Expenditure will gradually reach
  approximately 1% of GDP
• Decrease in social security waste
• Increase in VAT
• Increase in Income Tax
• IMF & EU goals for free markets
• Benefits for employment in pharmaceutical & other industries
       – Increased contributions to social security
• Clearer horizon for pharmaceutical investment in research &
  development
• Ability to fund social policy to help patients who need lower co-pay



25/5/2011                               ΣfΕΕ                         27
Contradictions to Free Market
              Principles that Exist Today
• Legislated prices, margins and discounts
  between two private businesses
       – Government created cartels
• Legislated cost burdens between two private
  businesses
       – Who pays for goods shipment
       – Who pays for insurance
       – Who pays for destruction of expired goods
• Government should not legislate any of these

25/5/2011                     ΣfΕΕ                   28

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Pharmaceutical Pricing and Reimbursement in Greece

  • 1. Pharmaceutical Pricing and Reimbursement in Greece 25/5/2011 ΣfΕΕ 1
  • 2. Greek Pharmaceutical Market Today Product Money Everything controlled by government (cartel?) 25/5/2011 ΣfΕΕ 2
  • 3. Pharmaceutical Pricing Today (retail market, 0% co-pay) • Pharma Revenue: Ex-Factory – 4% Rebate 91.08 • Ex-Factory: Pharma -> Wholesaler 94.88 • Wholesale: Wholesaler -> Pharmacy 100.00 • 5.4% markup • Pharmacy Margin 135.00 • 35% markup • Retail: Pharmacy -> Social Security OR Private Payer 143.78 • VAT 6.5% 25/5/2011 ΣfΕΕ 3
  • 4. Pharmaceutical Reimbursement Today • Negative Reimbursement List – All other medicines reimbursed • 3 levels of co-pay for reimbursed medicines based on combination of medicine & disease – 0% – 10% – 25% 25/5/2011 ΣfΕΕ 4
  • 5. Contradictions to Free Market Principles that Exist Today • Legislated prices, margins and discounts between two private businesses – Government created cartels • Legislated cost burdens between two private businesses – Who pays for goods shipment – Who pays for insurance – Who pays for destruction of expired goods • Government should not legislate any of these 25/5/2011 ΣfΕΕ 5
  • 6. Proposal A Win – Win Solution 25/5/2011 ΣfΕΕ 6
  • 7. Government Benefits • No medicine shortages • Total Public Pharmaceutical Expenditure will gradually reach approximately 1% of GDP • Decrease in social security waste • Increase in VAT • Increase in Income Tax • IMF & EU goals for free markets • Benefits for employment in pharmaceutical & other industries – Increased contributions to social security • Clearer horizon for pharmaceutical investment in research & development • Ability to fund social policy to help patients who need lower co-pay 25/5/2011 ΣfΕΕ 7
  • 8. Prerequisites • Must Have: Full Electronic Medicine Supply Chain Tracking – All medicines bought by the government must be recorded electronically – All medicines sold by pharmacies must be recorded electronically – All medicines sold by wholesalers and private clinics must be recorded electronically – All medicines sold by pharma industry must be recorded electronically – Monthly updated data for calculating % of medicines sold that are reimbursed • Useful to Have: Full Electronic Patient Health Record – Would allow reliable and verifiable indication based reimbursement – Would lead to savings in other areas of healthcare 25/5/2011 ΣfΕΕ 8
  • 10. Pricing Goals • Government should be involved and control prices only where government pays • All prices that government does not pay should be “free” – In essence “Free” prices are not free – Market forces shape prices more efficiently than any forced control: • Competition • Customers • Distribution channels • European Pricing - Parallel Import / Export • Internal Company Policies – Free prices will force society (physicians & patients) to become more price sensitive 25/5/2011 ΣfΕΕ 10
  • 11. Pricing Free Price Reimbursement for private market buyers for government only • Pharma Company Sets Wholesale • Social Security will calculate reimbursed wholesale Price (Price to pharmacist) and price – E.g value based price, international reference price Suggested Retail Price – all prices will be recalculated once a year – Pharma company may offer discounts • New products reimbursed when price is available – Wholesalers may offer discounts in at least one other European country – Pharmacists may offer discounts – quick access to new medicines for patients – new products repriced every quarter for first 12 – Private clinic may offer discounts quarters (3 years) to capture new cheaper countries – Public hospitals must transfer • Reasonable pharmacy markup/discount discounts to social security • Social Security will reimburse private clinics at • Published online in official SfEE wholesale price + 5% price bulletin quarterly • Public Hospitals will purchase at hospital price – SfEE publishes next quarters prices • Social Security will reimburse public hospitals at online two weeks before quarter their purchase price + x% starts • Reimbursed wholesale price cannot be higher than – Companies responsible for free wholesale price (RWP <= FWP) submitting prices electronically to • Prices not published SfEE two weeks before publish date 25/5/2011 ΣfΕΕ 11
  • 12. Reimbursed Money Flow Government money Private money (margins and prices not controlled by government) 25/5/2011 ΣfΕΕ 12
  • 13. 3 part Pharma Industry Rebate • Euro amount for each unit reimbursed Fixed • Difference between free wholesale price and reimbursed Amount wholesale price • % of reimbursed wholesale price • Based on proportion of total units sold reimbursed Variable % • As % of units reimbursed falls from 100% this variable rebate % increases 4% Fixed • 4% of reimbursed wholesale price Rebate • Same as today 25/5/2011 ΣfΕΕ 13
  • 14. Rebate Paid by Pharma Companies (does not include price difference part) 16% 14% Rebate % of reimbursed price 12% 10% 8% 6% 4% 2% 0% 50% 95% 90% 85% 80% 75% 70% 65% 60% 55% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 100% % of total units sold reimbursed 25/5/2011 ΣfΕΕ 14
  • 15. Variable Rebate Mechanism • At each quarter close government will calculate total number of each medicine purchased by social security and will compare to total sales provided by pharmaceutical companies to EOF. • For every 1% point of non-reimbursed sales rebate will increase by 0.1% – 0% non-reimbursed sales = 0% + 4% rebate – 100% non-reimbursed sales = 10% + 4% rebate 25/5/2011 ΣfΕΕ 15
  • 16. Price System (25% free price premium, retail market, 0% co-pay, 65% reimbursed sales) Today Reimbursment Money Flow Net Rebate 4% Net Rebate 7.5% • Pharma Revenue •Pharma Revenue: Ex-Factory – 4% Rebate 91.08 • Ex-Factory – Rebate = 25 + 4% + 3.5% = 32.5 •Ex-Factory: Pharma -> Wholesaler • Ex-Factory: Pharma -> Wholesaler 94.88 •Wholesale: Wholesaler -> Pharmacy • Wholesale: Wholesaler -> Pharmacy •5.4% markup 100.00 125.00 •Pharmacy Margin • Retail (before VAT): Pharmacy -> Social Security •35% markup • 25% markup on Reimbursed wholesale price 135.00 150.00 •Retail Price: Pharmacy -> Social Security OR Private Patient • VAT (Social Security does not pay VAT) 143.78 •+VAT 6.5% Total Gov Spend = 150.00 – 32.50 rebate = 117.50 (vs 135) 25/5/2011 ΣfΕΕ 16
  • 17. Price System (25% free price premium, 100% contribution, 65% of units sold reimbursed) Free Market Money Flow Reimbursed Money Flow Reimbursed Wholesale Price = 100 Net Rebate 7.5% • Pharma Revenue • Pharma Revenue • =Ex-Factory – Rebate = 25 + 4% + 3.5% = 32.5 • Ex-Factory: Pharma -> Wholesaler • Ex-Factory: Pharma -> Wholesaler • Wholesale: Wholesaler -> Pharmacy • Wholesale: Wholesaler -> Pharmacy 125.00 125.00 • Pharmacy Margin • Retail (before VAT): Pharmacy -> Social Security 168.75 • Suggested 35% markup 150.00 • 25% markup on Reimbursed wholesale price • Retail Price: Pharmacy -> Private Patient • VAT (Social Security does not pay VAT) 190.69 • VAT 13% Total Gov Spend = 150.00 – 32.50 rebate = 117.50 (vs 130 today) 25/5/2011 ΣfΕΕ 17
  • 18. Co-payment • Government will legislate social security contribution. – Patient co-payment will be on free price • Will give a small benefit for social security • This benefit will finance the necessity for some populations to have reduced co-payment 25/5/2011 ΣfΕΕ 18
  • 19. Rebate & Sales Example (retail market, fixed units, 25% free price premium, 0% co-pay) 180,000 0% 160,000 -2% 140,000 -4% 120,000 -6% Pharma Sales (Before Rebate) 100,000 Pharmacy Sales euro Total Pharma Rebate -8% 80,000 Total Gov Expenditure (After Rebate) Total Pharma Revenue (After Rebate) -10% 60,000 Rebate % -12% 40,000 20,000 -14% 0 -16% 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% % of total units sold reimbursed 25/5/2011 ΣfΕΕ 19
  • 20. Generics • The use of generics could significantly reduce government pharmaceutical expenditure IF 1. There is ongoing official accreditation to ensure quality of generic medicines 2. There is full implementation of generic pricing rules (IMF says 60%) 3. Price sensitivity in society increases by the application of this proposal • When a molecule has gone off patent and generic competition begins, the value of the contribution of social security can decrease. – For example: social security contribution can move to 60% of prototype product reimbursed wholesale price for all medicines with that active ingredient 25/5/2011 ΣfΕΕ 20
  • 21. Issues not yet resolved • Pharmacy Reimbursed Margin – Options could include: • Fixed markup • Variable discount on total amount purchased • Variable discount on how fast payment is made – 25% markup used here for examples as mentioned in IMF document: • reduced profit margin of pharmacies on retail prices directly to 15-20 percent or indirectly through rebates (25% markup = 20% margin) • VAT – For government VAT is in one pocket out the other – For private payers VAT is revenue for government – State buyers should not pay VAT 25/5/2011 ΣfΕΕ 21
  • 23. Reimbursement Goals 1. No reimbursement for lifestyle ailments 2. Reimbursement for other illnesses with varying levels of patient co-payment 3. Incentive for physicians, pharmacists and patients to prefer treatments that represent better value for money 25/5/2011 ΣfΕΕ 23
  • 24. 1. Negative List • Certain products are not reimbursed – Lifestyle – Over the counter – Inadequate efficacy (do not work) • Reimbursement for certain diseases with co-pay – For some patients these products are not lifestyle treatments but chronic illness treatments – Some products made lead to significant savings in other health care expenses (e.g. smoking cessation) 25/5/2011 ΣfΕΕ 24
  • 25. 2. Reimbursement Contribution Social security contribution should also have social criteria (patient ability to afford, age group, etc) Contribution categories: • Full contribution for chronic life threatening diseases / therapies • Large contribution for serious diseases / therapies • Medium contribution for less serious diseases / therapies • Low social security contribution • Very low social security contribution (similar to Belgian reimbursement system) 25/5/2011 ΣfΕΕ 25
  • 26. 3. Incentive for lower cost • Create an incentive for cheaper therapies with patients as drivers – Social security must increase price sensitivity in patients who will then influence physicians and pharmacists – Co-payment is the only way to incent patients to select cheaper medicines 25/5/2011 ΣfΕΕ 26
  • 27. Government Benefits • No medicine shortages • Total Public Pharmaceutical Expenditure will gradually reach approximately 1% of GDP • Decrease in social security waste • Increase in VAT • Increase in Income Tax • IMF & EU goals for free markets • Benefits for employment in pharmaceutical & other industries – Increased contributions to social security • Clearer horizon for pharmaceutical investment in research & development • Ability to fund social policy to help patients who need lower co-pay 25/5/2011 ΣfΕΕ 27
  • 28. Contradictions to Free Market Principles that Exist Today • Legislated prices, margins and discounts between two private businesses – Government created cartels • Legislated cost burdens between two private businesses – Who pays for goods shipment – Who pays for insurance – Who pays for destruction of expired goods • Government should not legislate any of these 25/5/2011 ΣfΕΕ 28