Health Insurance Fund refutes the accusations of Pealtnägija

The TV programme Pealtnägija addressed the Health Insurance Fund in relation to the suspicions presented by the Estonian Haemophilia Society. Since 2009, the society applied for the listing of a new type of recombinant factor preparation (rFVIII) into the health care services list. So far the Health Insurance Fund has refused to finance the treatment, referring to the high price of the medication and the equality of its effect compared to the treatment that is currently compensated for. Pealtnägia referred to the suspicions of the Haemophilia Society, according to which the refusal to finance the service might be connected to a possible conflict of interests, which might have occurred due to family connections between a Management Board Member of the Health Insurance Fund and the manager of OÜ Covalent.

  The Health Insurance Fund has refuted the accusations of the Haemophilia Society. Valid legal acts of the Republic of Estonia and the internal procedure rules of the Health Insurance Fund completely exclude the possibility of any one person making decisions in any health insurance compensation issues alone. Neither the members of the Health Insurance Management Board or the Chairman has the possibility to unilaterally decide whether to add services to the lists of health care services or finance a certain treatment procedure. The financing of the service has been declined since the better cost efficiency of recombinant factor compared to plasma-derived factor VIII preparations has not been verified. There is no scientific evidence that would allow claiming that the recombinant factor is more effective or safe compared to plasma-derived clotting factors that are produced with contemporary production methods. Although the new medicine has no advantages over the current one, the price for the recombinant factor that should be paid to the holder of the marketing authorisation of the medicine is approximately 2 times higher than that of the current medicine.   Additionally, the Board Member has no business connections with Covalent OÜ and the relevant parties have always been notified about the existence of family ties. Also, during her work in the Health Insurance Fund, the Board Member has always filled in her declarations of economic interests correctly.

In order to clarify the situation, we hereby provide the questions of Pealtnägija and an overview of the responses sent by the Health Insurance Fund: 

Question 1: With the support of the Haemophilia Society, the Estonian Society of Hematology has applied for the implementation of a recombinant factor of a contemporary and non-human blood based medicine by the Estonian Insurance Fund since 2009. So far, the application has been rejected for different reasons. Why has the Health Insurance Fund not supported this medicine so far?

Answer: The application has been rejected because the better cost efficiency of recombinant factor compared to plasma-derived factor VIII preparations that are currently in use has not been verified. The price that the drug companies are asking for the recombinant factor is twice as high, resulting in an increase of 600,000 euros in health insurance costs, which is about to go up even more in the coming years. At the same time, there are no scientific data that would allow claiming that the recombinant factor is more effective or safe compared to plasma-derived clotting factors that are produced using contemporary production methods. Therefore, taking additional risks for health insurance is not justified.   In Estonia, the safety of medicines is assessed by the State Agency of Medicines. The State Agency of Medicines has commented this issue on 16.10.2012: "The State Agency of Medicines will confirm that all medicines of haemophilia that currently have a valid marketing authorisation, both plasma-derived as well as those produced using the recombinant method, are suitable for treatment and safe and Estonian patients have not caught any dangerous infections due to using these medicines (the full opinion of SAM can be found at: http://www.ravimiamet.ee/ravimiameti-kommentaar-vereplasmast-valmistatud...).   Question 2: As far as we know, Estonia is currently the only country in the European Union where patients do not have access to the recombinant factor. Why do other countries prefer the newer type of medicine and Estonia does not?   Answer: In Estonia the analysis is conducted and the decisions are made according to extensive international evidence-based information, also following the valid legal acts and the rules for assessing the efficiency and cost of a medicine. The new treatment guidelines of the World Federation of Hemophilia do not prefer the clotting factor preparations manufactured using the recombinant method and suggest that the decisions in a country should be made based on valid local criteria.   The financing decisions of other countries do not affect the decisions of Estonia. We do not have information whether, under which conditions and to what extent the recombinant clotting factor has been implemented elsewhere.   Question 3: Why does the circle of people who decide whether to add the medicine with the recombinant factor (rFVIII) into the compensation list include a person who has direct family ties with the importer of the currently used haemophilia medicine?   Answer: Valid legal acts of the Republic of Estonia and the internal procedure rules of the Health Insurance Fund completely exclude the possibility of any one person making decisions in any health insurance compensation issues alone. A member of the Health Insurance Management Board or the chairman cannot unilaterally decide whether to add services to the lists of health care services or finance a certain treatment procedure.   The proceedings for amending the list of health care services has been stipulated in the above-mentioned regulation of the Government of the Republic "Amendment criteria for the list of health care services of the Estonian Health Insurance Fund and their assessment procedure" ("Eesti Haigekassa tervishoiuteenuste loetelu muutmise kriteeriumid ja nende hindamise kord").   The health care services list amendment procedure foresees that before adding a service into the list, it has to be assessed by several parties: • the evidence base of the service is assessed by the Faculty of Medicine of the University of Tartu or an expert appointed by the State Agency of Medicines; • the cost efficiency of the service and its effect on health insurance budget is assessed by the Health Insurance Fund (several specialists have been involved in the process, the proceedings related to one service often include approximately ten people); • the effect of the service on society and its compatibility with the state's health care politics is assessed by the Ministry of Social Affairs.   Only after different parties have assessed these criteria is the Management Board of the Health Insurance Fund entitled to make a proposal to the Council to add the service into the list of services. It is important to keep in mind that according to the Health Insurance Fund Act, the decision of the Management Board is deemed as accepted only if at least two Board Members vote for it, i.e., 2/3 of the members of the Health Insurance Fund's Management Board, which has three members altogether. The Council will also assess the proposals and by the proposal of the Minister of Social Affairs, the list of health care services is established with a regulation of the Government of the Republic.   Question 4: How does the Health Insurance Fund respond to the suspicion of the Haemophilia Society that this situation could involve a serious conflict of interests?   Answer: The Health Insurance Fund does not agree with the suspicions of the Haemophilia Society. In addition to the reasons listed above, it is a legal obligation of Board Member of the Health Insurance Fund to inform the Management Board or Council Chairman about a conflict of interests. The Management Board Member has not done so and the Health Insurance Fund has no reason whatsoever to doubt about the legal compliance of its Management Board Member. In addition to the abovementioned, we would like to add that the Management Board Member has no business connections with Covalent OÜ and she has informed relevant parties about her family ties. Also, during her work in the Health Insurance Fund, the Board Member has always filled in her declarations of economic interests correctly.   ***   Additionally, it was stated in Pealtnägija that treatment with the recombinant clotting factor is only applied for two newborn patients. According to the data presented by haematologists, it is only a short-term prognosis and already in a few years, the planned usage of the recombinant would entail additional expenses in a total sum of approximately one million euros. According to the Health Insurance Fund, it is not legally correct to limit treatment according to the patient's age and evidence-based medical criteria should be considered instead. In case of valid proof that plasma-derived clotting factor preparations that are manufactured with contemporary technology and controlled with contemporary methods involve a considerable infection risk, it is not justified to limit the treatment to just two patients, but the treatment for all patients that need it should be financed. Such evidence, however, has not been presented so far. Unjustified additional expenses are never warranted as we must consider the benefit of a maximum number of people when using our resources.

For additional information about the effect and safety of haemophilia medicines, please address the State Agency of Medicines.