New Polish Reimbursement List Update Published, Disappointment for Innovative Pharma

New Reimbursement List Update Due to Come into Effect on 1 March

The Polish Ministry of Health (MoH) has published its new draft reimbursement notice, updating the list of medicines reimbursed by the National Health Fund (NFZ) via pharmacies. The new list contains 216 new medicines, although practically all of these are generics, reinforcing the sense of a reversal in the Polish MoH's pharmaceutical policy after a brief period in which reimbursement list updates were apt to contain at least several new innovative products. The new updated list is due to come into effect on 1 March, and it can be accessed in its entirety, from the MoH's website, here.

No New Innovative Medicines

An analysis by IMS Health of the new draft reimbursement notice, reported by Polish healthcare news provider Rynek Zdrowia, shows that there is not one single new, innovative therapeutic indication on the list, and that the only new molecule on the list is rosuvastatin—the active ingredient in the AstraZeneca (UK) blockbuster cholesterol-reducing medicine Crestor. However, only generic versions of rosuvastatin are included on the list. The full list of new medicines included in the draft notice can be accessed here.

Changes to the level of co-payments required by patients have taken place in the case of 235 of the 313 of the "limit" groups—the Polish version of internal reference pricing. IMS Health is reported as stating that in the case of 600 medicines, the level of co-payments required from patients has gone down, while in the case of 547 medicines, patients will be required to pay more. Additionally, it is reported that the new draft notice contains 186 more medicines than the previous one, which came into force on 1 January and was the first reimbursement list update to be implemented in the form of a "notice"—an innovation which came into effect under the Reimbursement Act, which came into force at the beginning of the year.

Many Prices Set to Fall

The draft reimbursement notice envisages a reduction in the price of many medicines, some of which are set to undergo significant price cuts. Among these are the UCB Pharma (Belgium) innovative epilepsy drug Keppra (levetiracetam), the price of which is set to fall in the case of its many presentations—for example, in the case of the presentation containing 100 tablets of 1,000 mg, the price is set to fall from 745.74 Polish zloty (USD240.81) to PLN559.31. A good number of generics are set for even more drastic cuts—for example, in the case of the Krka (Slovenia)'s generic version of Pfizer (US)'s Alzheimer's disease medicine Aricept (donepezil), in its presentation containing 28 5-mg tablets, the price is being reduced from PLN81.0 to PLN46.4. The full list of medicines which are due to experience a price cut can be accessed here.

The MoH has also published a list of medicines which can be reimbursed for indications outside of their registered indications—i.e., off-label. In total, some 808 medicines are on the list of those for which reimbursement is set to be allowed for indications outside of their strictly registered indications. The full list of these can be accessed here.

Medical Community Reportedly United in Criticism of MoH

In response to the publication of the draft reimbursement notice, there has been strong criticism from the medical community in Poland. Maciej Hamankiewicz, the head of Poland's Supreme Medical Council (NRL), is reported in newspaper Rzeczpospolita as saying that the manner of the implementation of the reimbursement notice is "scandalous", mainly because there were promises from the MoH that there would be a two-week period between the initial publication of the draft notice and its coming into effect, while in fact, the draft notice was revealed to the public less than a week before it is due to come into effect. The source reports Hamankiewicz as saying that the entire medical community is united in its condemnation of how the MoH is handling the updating of the reimbursement list, as well as other aspects of the Reimbursement Act.

Outlook and Implications

The tide of Poland's pharmaceutical policy has definitely shifted from a more pro-innovative stance, which crept in over the past three years, back to the more restrictive, savings-focused, pro-generic model of the recent past. Although the reimbursement list does not include the medicines included in the various therapeutic programmes and special lists of medicines used in hospitals, where the majority of the innovative medicines used in Poland are focused, it has been customary in the recent updates to the list for several new innovative treatments to feature; not this time, however.

The fact that the MoH has revealed the contents of the draft reimbursement notice only days before it comes into effect—after promising not to do this after doing so with the most recent update—is hardly good publicity for the MoH, amid its continuing battles with doctors over new regulations introduced under the Reimbursement Act, from the beginning of 2012 (see Poland: 20 February 2012: Promised Update to Polish Drug Reimbursement List Fails to Appear). The failure of the MoH to observe a proper vacatio legis in the implementation of the reimbursement notice is also negative for the pharmaceutical industry, since there is such little time in which to declare any issues or concerns associated with the notice.

On the other hand, the publication by the MoH of all the documents associated with the reimbursement list on its website, in a clear, highly detailed form, points to an improvement in the transparency of its operations. IHS Global Insight expects the strong cost-containment trend to lower growth in value-based drug sales and health spending going forward.