Global Insight Perspective | |
Significance | The Polish Ministry of Health has yet again added more generic medicines to the national reimbursement list, managing to negotiate price reductions in 85 cases. |
Implications | As part of continuing cost-containment efforts, no new innovative medicines were added to the list. |
Outlook | Present P&R policy is creating difficult operating conditions for pharmaceutical companies, which are proposing changes to reimbursement rules. It remains to be seen whether the new reimbursement criteria announced by the Health Ministry take any of these proposals into account. |
The Health Ministry in Poland has added 23 new generic medicines to the new drug-reimbursement list, reports local Pharma Poland News. Health Minister Ewa Kopacz confirmed that 140 drugs have been removed from the list and that no new innovative medicines were approved. Reductions in drug prices were also achieved for 85 drugs from the list. The Ministry plans to use the savings made of around 8 million zloty (US$3.7 million) for the treatment of chronic diseases: epidermolysis bullosa and ciliary dyskinesia, as well as pancreatic-resection treatment (see Poland: 20 May 2008: Polish Health Minister to Reimburse Drugs for Rare Child Diseases). The list has yet to be published, considering that the Ministry of Health is still awaiting a decision from the Medical Technologies Assessment Agency on several drugs, including cardiovascular drug ivabradine, two unnamed analgesics, psychiatric and gynaecological drugs.
In a separate development, the Ministry of Health has announced the introduction of new prescription forms for physicians from September-October 2008. The new prescription forms will contain an identification number to track the physician who wrote it with a watermark similar to the ones used in banknotes. The new prescription forms are intended to eliminate the forging of prescriptions and false reimbursement claims. Additionally, problems with flawed prescriptions are a frequent occurrence in Poland, causing severe delays in reimbursement payments to pharmacists by the NFZ (see Poland: 22 May 2008: Polish Pharmacies Protest Against "Unlawful" Drug Reimbursement Practices). Pharmacists claim that mistakes are made by prescribing physicians and the new prescription forms could help track back prescriptions more easily.
Infarma Keen to See Change
The association of innovative drug companies operating in Poland, Infarma, wants to see a change in the drug-reimbursement policy in the country. Their major concern is transparency in decision making and compliance with European Union (EU) legislation. Infarma is proposing that reimbursement decisions be made by a new Reimbursement Committee that would include experts from the Medical Technologies Assessment Agency and would be made according to four criteria:
- depending on the level of innovation, each drug should be fall into one of seven categories;
- the committee should assess the drug's medical and pharmacoeconomic data, cost of therapy and planned spending by the country's National Health Insurance Fund (NFZ);
- the drug's clinical effectiveness should be compared to standard therapies and categorised in one of nine drug groups; and
- for each drug, an estimated number of patients should be determined.
A separate category, Infarma suggests, will be the reimbursement of specialist treatments for specific groups of patients that need to meet predetermined criteria in order to qualify for reimbursement of such expensive treatment.
Another change proposed by Infarma is the creation of so-called Negotiations Committee that would set the official prices of medicines, as the average of the lowest prices in five EU member-states, or as the average of official prices in the Czech Republic, Slovakia, Hungary, and the Baltic states. So far, reimbursable drugs have been subject to reference-pricing based on therapeutic groups, where the price of a medicine was calculated on the basis of defined daily doses. Although changes to the way reimbursement decisions are being made have been announced by the Ministry, no concrete steps have been made yet
Outlook and Implications
The new drug-reimbursement list composition is no surprise, and it is a continuation of Poland's stringent drug-reimbursement policy. Only recently the Ministry of Health made its first step towards reducing the price of reimbursed prescription medicines. Contrary to previous practice, whereby the price was set in reference to the price of the cheapest drug in a given therapeutic group, the Polish Ministry of Health is to give a fixed reimbursement sum of how much it is prepared to pay for each therapeutic drug category (see Poland: 7 April 2008: New Polish Reimbursement Regulations to Reduce Rx Drug Prices). In addition, a new model of assessing healthcare procedures eligible for reimbursement is expected to be revealed in June that aims to reduce the number of treatment categories together with the publication of an essential list of treatments. Infarma's new reimbursement policy proposal is aimed at improving the transparency of the whole process, which has been dogged by scandals (see Poland: 6 May 2008: Ex-NFZ President Embroiled in Corruption Allegations Over Drug Reimbursement).
Global Insight expects that some parts of the proposal will be adopted, but the most critical ones, such as decision-making powers as well as democratising and standardising the nature of the process will be difficult and will certainly depend on the political power of Infarma to see them through.