Abbott Wins Court Case on Reimbursement Calculation as Several New Innovative Drugs Gain Reimbursement in Czech Republic

U.S. pharmaceutical concern Abbott has won a court case against the Czech state concerning the improper method of calculating reimbursement for its drug Tarka (trandolapril + verapamil), used to treat high blood pressure and for post-heart attack treatment, reports Czech newspaper Mlada Fronta Dnes. According to the source, the court ruled that the coefficient used to calculate the reimbursement of the drug was meaningless.

There are now concerns that numerous other pharmaceutical companies could follow Abbott in making similar claims. The Czech ministry of health is appealing against the court's verdict in favour of Abbott, and its level of concern is demonstrated by the fact it has stated that such a decision threatens the collapse of the entire system of reimbursing drugs under public health insurance in the Czech Republic. Mlada Fronta Dnes reports that five similar cases are already underway, and two more are in preparation.

Use of Coefficients in SUKL's Calculation of Reimbursement Criticised

Experts and pharmaceutical companies' associations have drawn attention to flaws in the system of calculating the reimbursement level using coefficients, which is used by the Czech State Institute for Drug Control (SUKL). According to one independent expert on pharmaceutical issues, Josef Suchopar, quoted by Mlada Fronta Dnes, the use of these coefficients means that patients have to take significantly higher numbers of weaker pills, instead of small numbers of stronger pills, if they do not want to become liable to pay a co-payment, because the weaker pills are completely reimbursed by the state, whereas the stronger pills are not. He gives an example of epilepsy drugs, positing that patients can either take 18 tablets that are completely reimbursed by the state, and cost 81 koruna (US$4.3), or they can take two stronger pills, for which the reimbursement provided by the state is four times less.

Miroslav Patek, a representative of German pharmaceutical producer Berlin Chemie, is quoted by the source as saying that the company has filed a complaint concerning a similar type of situation with one of its drugs.

Czech MoH and SUKL Play Down Criticisms

Deputy Health Minister Marek Snajdr has played down the criticisms, reports the source, stating that it is normal that an organisation—in this case the SUKL—can sometime make wrong decisions, and that it is necessary to remember that the SUKL has also helped to save billions of Czech koruna thanks to its system of reimbursement. He also emphasised that the court's verdict had been appealed by the MoH, and that there was still a chance it would be reversed. For his part, Martin Benes, the head of the SUKL, is reported by the source as saying that the decisions taken by the SUKL in the case of the Abbott drug were entirely in compliance with the law, and that those who question the decisions always have the right to appeal.

Three New Innovative Products Gain Reimbursement in March Update

Meanwhile, the SUKL published its monthly update to the Czech drug reimbursement list at the beginning of March, which includes three new innovative products. French firm Sanofi-Aventis' Type 2 diabetes drug Amaryl (glimepiride) has gained reimbursement status, along with Nasonex (mometasone furoate monohydrate), U.S. pharma major Schering Plough's nasal allergy symptom-relief drug. Also included on the list are six different presentations (all in injectable solution form) of Sanofi-Aventis' anticoagulant Clexane (enoxaparin). The full list of new drugs included on the Czech reimbursement list in March is available—in Czech—here.

As well as new additions to the reimbursement list, the March update features many changes in reimbursement levels, the majority of which are reductions in reimbursement. Significantly, many different presentations of the AstraZeneca (U.K.) high cholesterol and atherosclerosis drug Crestor (rosuvastatin) have had their reimbursement cut quite substantially by the SUKL. The full list of reimbursement changes is available—in Czech—here.

Outlook and Implications

The fact that the SUKL is coming under criticism is nothing unusual, considering the diverse criticism it has received from various groups in recent months; it has only been responsible for setting prices and reimbursement levels since the beginning of 2008, and planned changes in legislation in this area are still pending, so that the SUKL is limited in its ability to actually change the situation (see Czech Republic: 27 January 2010: Complicated Regulations on P&R Keep Drug Costs in Czech Republic High, Say Critics). If the Czech MoH loses its appeal against the verdict in favour of Abbott, and subsequent pharmaceutical companies are also successful in legal appeals against reimbursement decisions in the Czech Republic, it could prove to be very costly for the Czech government. However, the positive side of this situation should be emphasised, namely that there is an effective process of appeal, and that improper decisions by reimbursing authorities can be overturned. Ultimately, it is likely that the implication of the present court cases and appeals will be a change in legislation relating to the calculation of the reimbursement of pharmaceutical products.