IHS Global Insight Perspective | |
Significance | Poland's Ministry of Health (MoH) has released its delayed draft update to the country's reimbursement list—the second update in a year. It contains just two new proprietary drugs, as well as 110 new generics. |
Implications | Several generic versions of blockbuster drugs Singulair (montelukast) and Zyprexa (olanzapine) are included in the list, which the MoH estimates will result in significant annual savings for its drug reimbursement bill. |
Outlook | The anticipated boom in the number of proprietary drugs on Poland's drug reimbursement list has been stalled by the economic downturn, as the new draft update demonstrates. |
Poland's MoH has released a new draft update to its drug reimbursement list that had originally been planned for release in July. The update, which is due to come into effect on 16 October, does not include long-acting insulin analogues, which the MoH had previously stated would be on the new list (see Poland: 8 June 2009: Changes in Poland's July Reimbursement List to Favour Chronic Diseases, Cancer, and Diabetes Sufferers). Only two new proprietary drugs are included on the draft list, while 110 new generics are included.
Two New Proprietary Drugs on New List
Two new proprietary drugs feature on the new draft reimbursement list. German company Boehringer Ingelheim's Pradaxa (dabigatran etexilate), indicated for the primary prevention of venous thromboembolic events in adults who have had elective hip- or knee-replacement surgery, is included on the draft list following a positive recommendation from the Polish Agency for Health Technology Assessment in December of last year. It will cost the Polish National Health Fund (NFZ), the organisation responsible for paying for drug reimbursement in Poland, around 5 million zloty (US$1.76 million) per year to provide reimbursement for this drug.
The other proprietary drug on the list is Swiss pharma Roche's Valcyte (valganciclovir), an antiviral drug used to treat the symptoms of cytomegalovirus retinitis, an eye infection that principally affects AIDS sufferers. The annual cost of the reimbursement of this drug is estimated at 22 million zloty per year.
Several Generic Versions of Singulair Added to Draft Reimbursement List
The Polish MoH has added generic versions of U.S. company Merck & Co's asthma and allergic rhinitis drug Singulair produced by five different companies to the list. Among the generic versions of Singulair on the draft list are Slovenian firm Krka's Monkasta, Polish company Genexo's Montest, and Hardic, produced by Israeli firm Teva's Polish subsidiary Pliva Krakow.
As a result of the addition of these versions of Singulair, the upper limit for the price of drugs containing the active pharmaceutical ingredient (API) montelukast will be brought down to 75.03 zloty per package. The current retail price of Singulair is 126.76 zloty per package; however, all drugs containing this API will become subject to the same upper price limit when the draft list comes into effect in October. The Polish MoH estimates that it will make savings of 30 million zloty per year due to these changes.
The MoH estimates that the inclusion on the draft list of generics including the API montelukast, together with the inclusion of new generic versions of the Eli Lilly (U.S.) schizophrenia drug Zyprexa and versions of the synthetic opiate fentanyl, it will save a total of around 80 million zloty per year. In total, some 110 new generics are included on the draft list.
Draft List Means Small Saving on Drug Reimbursement Budget
The planned drug reimbursement budget of the NFZ in 2009 is 7.43 billion zloty, according to the MoH; the addition of the new drugs on the draft reimbursement list would mean that this figure would be overshot by around 35 million zloty, the MoH estimates. However, the predicted savings of around 80 million zloty on drugs containing the APIs montelukast, olanzapine and fentanyl means that the MoH now estimates that drug reimbursement expenditure for 2009 will reach around 40 million zloty less than the planned budget.
Outlook and Implications
The draft update of the reimbursement list was due to be released in July; as was the case with the update due at the beginning of 2009, which was eventually released in mid-March, the new update is very late. Part of the reason for this is the deliberations within the Polish MoH concerning the inclusion of long-acting insulin analogues, and the high cost of including them (see Poland: 25 August 2009: Poland's Delayed Reimbursement List Update Unlikely to Contain Long-Acting Insulin Analogues ).
The addition of two new proprietary drugs in the draft update indicates that although the Polish MoH is not reverting to its policy of excluding all new proprietary drugs from reimbursement, the anticipated boom in the number of new proprietary drugs on the list is not going to happen, particularly in view of the current economic downturn in Poland (see Poland: 9 July 2009: NFZ Seeks to Make Drug Reimbursement Savings, Signals Change of Direction in Polish Reimbursement Policy). In these circumstances, the Polish MoH is focused on savings, and this is likely to continue for the rest of 2009 and into 2010.
It is significant that the Polish MoH has decided to add several generic versions of the Merck & Co asthma drug Singulair to the list, as well as versions of the Eli Lilly schizophrenia drug Zyprexa, as this is another example of the MoH seeking to benefit from the more lax application of patent laws in Poland, and make savings on these widely used drugs. Singulair is patent-protected in Europe and the United States until 2012 (see Poland: 6 May 2009: Ban on Krka's Monkasta Overturned by Polish Court and United States - Israel: 20 August 2009: U.S. Court Favours Merck & Co in Singulair Patent-Infringement Case). With the reduction of the limit for the maximum price of drugs containing montelukast, Singulair is likely to lose reimbursement status when the draft list comes into effect in October, unless its price is reduced.