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ISPOR Croatia Chapter: Croatian Pricing & Reimbursement Overview. ISPOR Belgrade conference, March 2009. Viola Macolić Šarinić. Croatian Pricing & Reimbursement Overview. ISPOR Belgrade conference, March 2009. ISPOR Croatia Chapter. ISPOR Belgrade conference, March 2009. ISPOR Croatia.

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slide1

ISPOR Croatia Chapter:

Croatian Pricing & Reimbursement Overview

ISPOR Belgrade conference, March 2009.

Viola Macolić Šarinić

slide2

Croatian Pricing & Reimbursement Overview

ISPOR Belgrade conference, March 2009.

slide3

ISPOR Croatia Chapter

ISPOR Belgrade conference, March 2009.

ispor croatia
ISPOR Croatia
  • Was established in May 2008 under the name Croatian Society for Pharmacoeconomics and Outcome Research – ISPOR Croatia.
  • 32 members
    • academia, research institutes, and the pharmaceutical industry
    • medical doctors, pharmacists
  • Executive Board:
    • Pero Draganic, MD PhD – president
    • Ljubica Besker-Ivasovic MD PhD –president elect
    • Viola Macolic-Sarinic MD M.Sc - secretary
ispor croatia6
ISPOR Croatia
  • Internal education for the members
  • Lecture topics (2008):
    • Introduction in Pharmacoeconomics
    • Outcome Research
    • Incremental Cost-Effectiveness Ratio
    • Main Principles of Conduction of Pharmacoeconomics Analyses
  • ISPOR Book of Terms – translation into Croatian language
  • Development of Pharmacoeconomic guidelines
  • Workshops
slide8

Croatian Pricing & Reimbursement Overview

ISPOR Belgrade conference, March 2009.

slide9

General Market Overview

  • - More than 80 marketing authorization holders
  • All major pharma companies present
  • 3 domestic generic companies
  • Only one (state-owned) health insurance company, so far
  • A & B reimbursement list: without and with co-payment
  • A special fund for rare-disease and expensive medications
slide10

Major Problems

Pricing

- lack of stimulation for innovation;

- high prices of generics.

Reimbursement

- lack of transparency and EBM use;

- insufficient understanding of Health Technology Assessment;

- no clear guidelines within reimbursement process.

Drug Prescription & Dispensing

- no incentives for generic use – only penalties for budget overruns;

- co-payments

slide12

Current Decision Process

  • National Level
  • Only one (state-owned) health insurance company (HZZO);
  • Both pricing and reimbursement levels depend solely on HZZO;
  • Few legislative acts define reimbursement processes and pricing
  • A new Ordinance from May 2008 (Gazette 60/08) includes
  • pharmacoeconomic analysis
  • Private insurances – just additional health insurance
slide13

Current Decision Process(cont.)

  • Regional Level
  • administrative role
  • decision making process is mostly centralised
slide14

Current Decision Process(cont.)

  • Hospital Level
  • Independent Hospital Formularies
  • own decision making boards (Hospital Drug Committees);
  • Separate negotiations with state health insurance for hospital drug budget
  • Hospital budget is limited and is negotiated on the basis of:
    • previous period expenditures
    • assessment of expected drug expenditures for the negotiating period
slide17

Short Description of Reimbursement Process

  • Main principles defined by law (Acts on pricing, including onto the list
  • A or list B, launching, marketing)
  • MAH applies for the reimbursement
  • Health Insurance Drug Committee (independent experts) - application
  • assessment
  • Health Insurance Board of Directors – final decision
slide18

Short Description of Reimbursement Process (cont.)

  • MAH APPLICATION
    • wholesale price proposal
      • compared with reference countries
      • level of difference (price difference year – to - date)
    • pharmaco-toxicological expert opinion
    • clinical expert opinion
    • pharmacoeconomic analysis;
slide19

Short Description of Reimbursement Process(cont.)

  • MAH APPLICATION
  • applications are reviewed on regular basis by the Health Insurance Drug Committee and either accepted, rejected or sent back for recalculations;
  • DECISION MAKING
  • accepted applications are forwarded to the Health Insurance Board of Directors (various influences involved into the final decision)

Generic drugs – shortened procedure - approvals 6 – 8 times a year

Innovative drugs: “bulk” approvals usually once or twice a year!

slide20

“Disadvantages” of pharmacoeconomic analysis use

- Due to the substantial impact of new drugs on the health budget a price is a principal guide for successful reimbursement !

- Cost minimization analysis generally used, often inadequately !

- Cost effectiveness analysis often misinterpret (generally associated with substantially increased expenses) !

  • Problems with acceptance of innovative drugs
slide21

Funding Mechanisms

  • All levels of the health insurance generally funded from the state budget
  • Co-payment introduced but not fully cleared
  • DRG based reimbursement list is being developed
slide22

Refferent Countries and Resulting Prices

- 11%

- 16%

- 30,67%

- 31%

…innovative drugs to 80-90% level of AVG refferent price!

… generic drugs to 60% level of AVG refferent price!

slide23

Timing

  • Drug Committee - monthly meetings
  • Generic and parallel drugs 3-6 months
  • Generic drugs with lower price – regularly approved;

- Innovative drugs up to one year (depends on the time of submission)!

slide26

Critical review

  • Burden of new drugs extremely high even for the richest countries

Spending for Medicare Part B, which covers drugs administered in a physician's office setting (of which cancer treatments make up a large proportion), rose from $3 billion in 1997 to $11 billion in 2004.

Nelson R. N Engl J Med. 2009

Cancer patients with private health insurance are at risk for huge medical debts, personal bankruptcy, and delaying or forgoing treatment.

Mulcahy N. Medscape Medical News, 2009

slide27

Critical review(cont.)

  • LIMITATIONS
    • In qualitative assessment of applications
      • APPROPRIATE WEIGHT OF OUTCOMES
      • ISOLATED ASSESSMENTS
      • DATA INTERPRETATION
      • DATA TRANSFERABILITY

ACKNOWLEDGEMENT

Of concern to health economists, said Dr. Bach, is that, at least in some cases, the cost of oncology drugs appears to be rising faster than the health benefits associated with them. Several experts have suggested a pattern of "diminishing returns," for example, in the treatment of metastatic colorectal cancer.

Nelson R. N Engl J Med. 2009

slide28

Critical review (cont.)

  • LIMITATIONS
    • In final decision
      • SOCIO-ECONOMIC INFLUENCE
      • POLITICAL INFLUENCE
      • DATA INTERPRETATION
      • OTHER INFLUENCES
slide29

Future Developments

MAGIC SOLUTION – hardly to be expected!

slide30

Future Developments (cont.)

  • financial ability insuficient to follow growth of drug expenditures
  • more (private) insurance companies;
  • higher impact of external fundings (co-payments, funds, additional insurance, etc.)
  • efforts for better expenditure control:
    • more precisely rules definitions
    • strenghtening of the pharmacoeconomy role
    • HTA Agency
    • education on all reimbursment levels
slide31

Potential Future Developments in HTA

  • Following has to be enacted:
  • clear guidelines for analysis conduct;
  • types of analysis stated;
  • clear perspective of analysis;
  • discounting rate;
  • financial tresholds have to be decided upon (CUA & CEA).
slide32

Authors

Marijo Vukušić

Marinko Bilušić

Viola Macolić Šarinić