Global Health Technology Assessment Road Maps

POLAND - REIMBURSEMENT PROCESS

(Updated October 2008)

Description of Health Care System

In Poland an insurance-budgetary model of health care funding is in place, regulated mainly by the law on health benefits financed from public means.  

The services are provided free at the point of service in case of sickness, injury, pregnancy, child-birth and confinement, as well as in prevention of diseases and health promotion. For the purpose of those tasks the National Health Fund (NHF) – a non-profit body provided with legal personality - collects funds from premiums paid by citizens ( with a total annual budget at the level of 15,3 bil.€ in 2008). NHF manages the funds and contracts providers to render health services, both for prophylaxis and therapy. The majority of resources are allocated for inpatient treatment (hospitals), followed by reimbursement of medications (high, ~20%), outpatient general care and specialized outpatient care. Administrative costs of NHF are relatively low.

General practitioners are paid on per capita basis. Referral to specialists is needed with an exclusion of selected specialists e.g. oncologist, gynecologist and in case of certain diseases e.g. tuberculosis, HIV infection. Dentistry coverage from public funds is limited, so patients usually pay out-off-pocket for these services. In hospitals, where referral is also needed (apart from emergency cases), a DRG system has been recently introduced.

The law defines in a uniform way the responsibilities of individual and public bodies cooperating with the state in the area of citizens’ health care.

Poland has also private insurance coverage in the form of healthcare financing and delivery (~200 mln ), which is outside the public system. The role of this segment increases, according to estimates, 20% per year.

Reimbursement and Pricing Approval Process

Reimbursement Process

A registration of medicinal product is granted either by the European Medicines Agency (EMEA) or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Rzeczpospolitej Polskiej)
The reimbursement approval process is performed by the Ministry of Health (Ministerstwo Zdrowia, MoH) and requires pharmaceutical companies to complete a reimbursement submission form. The submission form can be sent to the MoH during the first seven days of each quarter. The reimbursement decision should be granted in no longer than 90 days, if together with price application, in no longer than 180 days. According to the law on health benefits financed from public means reimbursement criteria are the following:

  • necessity to provide health care for the society
  • making medicines accessible
  • safety
  • importance of a drug in a treatment of conditions associated with high epidemiological threat
  • influence of a drug on direct medical costs
  • affordability for the public payer obliged to finance healthcare services

There are 4 levels of reimbursement: 0% (non-reimbursed), 50%, 70% and 100% with price limits within international names groups and therapeutic groups (see below).

Health Technology Assessment Agency (AOTM) was established as an advisory body to the Ministry of Health. Its opinion is said to be crucial for the MoH, but the decisions in practice are not always consistent (reimbursement granted by MoH without or with negative opinion of AOTM, reimbursement not granted by MoH when the opinion was positive).

Health Technology reports, prepared by manufacturers or consulting firms according to guidelines (see below) are submitted to AOTM and then assessed by this organization. Reports are also prepared by independent institutions on request of AOTM.

Pharmacoeconomics studies are part of the reimbursement process for innovative drugs. There are published guidelines, both HTA (official, currently under revision) and Pharmacoeconomics (ISPOR Polish Chapter).

According to the Directive 89/105/EEG, the pricing and reimbursement process should not take longer than 180 days. However, past experiences clearly indicate that it takes longer to make a reimbursement decision.

Pricing Approval Process

The prices for non-reimbursed drugs are determined by the manufacturer (“free pricing”).
If a manufacturer seeks for reimbursement, the price for the product will be set through a negotiation with a special unit (Drug Management Team) of the Ministry of Health. There are representatives of the Ministry of Health, the Ministry of Finance, the Ministry of Economy and the National Health Fund in the Drug Management Team. The negotiated price is the maximal one (introduction of fixed prices and margins are currently under discussions in Poland).
The following criteria are taken into account:

  • Production cost (provided by the manufacturer)
  • Cost of daily treatment
  • Cost of standardized therapy
  • Risk-benefit ratio compared to alternative pharmaceuticals for that indication
  • Therapy costs per day in comparison to products with the same efficacy
  • Evaluation of the economic impact on the national health system
  • Estimated sales of the new pharmaceutical product
  • Prices in countries with similar GDP

In Poland reference pricing system is in place, same limits exist within the group with the same international name (INN) as well as within so called therapeutic groups  based on the same indication, comparable efficacy, the same way of administration and similar adverse effects (but different INNs).

Pricing & reimbursement decisions are made on the national level and published in the official journal (Dziennik Ustaw).

Acronyms

MoH (MZ): Ministry of Health

NHF (NFZ): National Health Fund

AOTM: Health Technology Assessment Agency

GDP: Gross Domestic Product

Reimbursement Organizations/HTA Organizations

Ministerstwo Zdrowia (MZ) - Ministry of Health

Agencja Oceny Technologii Medycznych (AOTM) - Health Technology Assessment Agency

Narodowy Fundusz Zdrowia (NFZ) - National Health Fund

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Rzeczpospolitej Polskiej - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Suggested Reading

  1. Health Technology Assessment Guidelines www.aotm.gov.pl
  2. Orlewska E., Mierzejewski P. Polish Guidelines for Conducting Pharmacoeconomic Evaluation Farmakoekonomika 2000, supl. 1:1-20 and www.farmakoekonomika.pl

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