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					Economic Evaluation Applied to Decision Making




                              Portugal

Isaura Vieira
INFARMED, I.P. – National Authority for Medicines and Health Products

I Pan-American Seminar on Economic Regulation of Pharmaceuticals
Brasília, 18th March 2009
         PORTUGAL
     10 Millions inhabitants
  National Health Service that is
universal, comprehensive and free
             of charge
   covers 7 Millions inhabitants
  Other Health Systems (Civil
Servants, and other) responsible
          for 3 millions
All the inhabitants have the right
to health to be delivered through
              NHS
                    Total health expenditure - % gross domestic product



             12

             10

               8

         %     6

               4

               2

               0
                   a   a a al        ia  a ia     a     ia   a  o ia i a     a ia    o  a    ia   a
               an ç anh lg ic tug str arc é c réci Itá l anh nid ngr nd a nd q u urg hec ló n a nd
             Fr lem Bé or Áu na m Su G                                â  l     á                l
                           P                            sp o U Hu in l Ir l ov emb p. C Po Ho
                                                     E in
                A                 Di                       e
                                                                  F
                                                                         Es ux Re
                                                         R                   L
                                           1997                   2006
Source OECD HEALTH DATA 2008, Dez. 08
               Total pharmaceutical expenditure - % of total health
                                      2006

     D ina m a rc a

         Á us t ria

          S ué c ia

       F inlâ ndia

      A le m a nha

          F ra nç a

         B é lgic a

          G ré c ia

            It á lia

       P o rt uga l

       E s pa nha

    R e p. C he c a

         P o ló nia

    E s lo v á quia

         H ungria


                       0   5             10   15       20   25   30   35
                                                   %


Source: OECD HEALTH DATA 2008, Dez. 08
    The Reimbursement System


For being on the market medicines need an authorisation
                     from Infarmed
• Hospitals
  NHS or third payer is responsible for all the
  expenses with in-patient consumed medicines

• Pharmacies
  NHS or third payer is responsible for all or part of
  the expenses with consumed medicines

  on the purchasing act the consumer does not pay or pay
              only a part of medicine’s price
  The Reimbursement System

    Medicines subject to reimbursement
Prescription only medicines


The level of co-payment depends on
medicines therapeutic classification
For example:
Insulins - 100%
Antiepileptics – 95%
Anti-hypertensives and Antibiotics - 69%
Corticosteroids and Analgesics - 37%
             Level of co-payment or
                co-payment rate
% of retail price paid by state/third payer
  General                     Low     Retiring
                                 Pensions

    100 –  only for insulin, imunomodulators, and pituitary
    and hypothalamic hormones and analogues
     95                               +5
     69                              + 15
    37
    15 -   Transitory level - no more than 2 years




               Additional data required after
               reimbursement is granted

Transitoriness of reimbursement status can be used
independently of the level of co-payment
                                                             M edicines Grow t h Rat e
                                                                    1997-2007
       30%


       25%


       20%


       15%
Taxa




       10%


        5%


        0%


       -5%
                                                        P                               R                S                 T                U                V
                       aN             aO           na                 aQ           na               na                na               na               na
                l un           l un           lu               l un           lu               lu                lu               lu               lu               l
             Co             Co             Co               Co             Co               Co                Co               Co               Co               Co


                                                             Li n h a 5             Li n h a 7               Li n h a 1 1
Main Challenges
 • Limited economic growth

 • Increasing costs of R&D

 • Innovation increasing costs

 • Ageing society

 • Society expectations

 • Changes on the disease patterns - more

   chronic diseases
                  Policies Developed
• Price control /price negotiations

• Tendering procedures

• Co-payments

• Reference pricing

• Generics promotion

• Development of information instruments to support doctors decision

• Educational campaigns on rational use of medicines

• Industry payback associated to a level of NHS growth

• Agreements on budgets and prices with companies for drug

  reimbursement

• Relative effectiveness and cost-effectiveness evaluation for

  reimbursement decision – ambulatory and hospital
Generic Medicines Market Share


2001                         2008


0,34%
                                    19,16%
Reference Price System
•   For medicines with generics marketed the retail price still
    exist but the user is responsible for the difference

    between retail price and reference price



• Reimbursement reference price system based on higher

    generic price marketed
         Agreements on budgets and prices with
           companies for drug reimbursement

• Medicines with recognized therapeutic added valued but
    with some doubts or need to make some restrictions, like a
    specific indication or group of patients
Conditions:
•   limited on time (2 years with possibility for renewal)
•   presentation of extra information on relative effectiveness or
    cost- effectiveness
•   reduction on reimbursement or prices of other medicines already
    reimbursed
•   reduction on NHS price for the drug under evaluation
•   definition of a maximum budget for the drug under evaluation,
    once sales exceeded the budget, the MaH should return the extra
    value.
   Relative effectiveness and cost-effectiveness
     evaluation for reimbursement decision –
              ambulatory and hospital

• Instrument to better identify and value the real innovative

  medicines

• Since 1998 for ambulatory care reimbursement decisions

• Since 2007 for hospital medicines funding decisions

   •High level of growth rate

   •Decisions made by each hospital – need for harmonization

   •Iincrease of new medicines approved for hospital use – need for

   increase of rational use
    Relative effectiveness and cost-effectiveness
      evaluation for reimbursement decision –
               ambulatory and hospital

Need to:
    promote the development of new tools to provide
    suport on decision making process - Economic
    Evaluation Studies on Medicines


   creat guidelines to implement good practices on the
    execution and evaluation od Economic Evaluation
    Studies of Medicines - Guidelines




                                                          15
      Relative effectiveness and cost-effectiveness evaluation for
          reimbursement decision – ambulatory and hospital




 Relative effectiveness
                                                Economic Evaluation
/added therapeutic value




                     Evidence based report to
                          suport the decision
The Authorities and the Economic Assessment
              Field of Application


Mandatory for:
Always:
• New Chemical Entities (NCE) for a well defined
therapeutical need.

If required:
• New medicines      with added therapeutic value,
related to other     medicines used for the same
indications
 The Authorities and the Economic Assessment
                 Field of Application

Time for Study submission:
• Before Reimbursement Approval
   • Submission as part of reimbursement dossier
   (very common)
   • When INFARMED ask for it (in this situations
   firms take no less then 6 months to have it done -
   in the meantime the process stops)
• After Reimbursement Approval
   •In some well defined situations MA holder can
   celebrate an agreament with Infarmed in order to
   get fast access to reimbursement market, and has
   12 to 24 months to submit additional information
   (health economic study; new clinical trials ,
   epidemiological data etc)
The Authorities and the Economic Assessment
                Field of Application

Main problems
•Population under study

•Dificult to have good evidence to suport added

therapeutical value

•Cost identification and measuring and valuing costs

•Evaluation of medicines for rare deaseases

•Lack of cost-effectiveness evidence for sub-groups of

population or for restricted indications

•Budget Impact – data on prevalence and incidence and

need to imclude all the alternatives used for the same

indication
 The Authorities and the Economic Assessment
                  Field of Application

 Results
The utilisation of HTA techniques as an integrated
instrument to support the assessment of the reimbursement
processes, led to:
- acceptance of reimbursement conditions for some new
medicines;
- decrease in the price of some new medicines;
- refusal of reimbursement of some medicines.
The submitted Economic Drug Assessment studies allowed
the reimbursement of cost-effective medicines, on the
basis of a better knowledge of the medicines’ properties and
its effect in the population that is supposed to use them.
The Authorities and the Economic Assessment
                 Field of Application

Results

• Time taken to assess the studies led, in some products to
  delays in the market assess;


• At the present MA holders seek to prove on scientific basis
  the add value of new products;


• The costs involved in the production/adaptation of
  economic evaluation studies keep opportunistic products
  out of the premium price market;
Thank you for your attention




 isaura.vieira@infarmed.pt

				
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posted:8/29/2012
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