Poland's Ministry of Health has revealed the new draft update to the drug reimbursement list, which is set to come into effect from May and includes three new innovative drugs and indication extensions for another innovative drug already on the list.
IHS Global Insight perspective | |
Significance | The Polish Ministry of Health (MoH) has revealed the draft update to the drug reimbursement list that is set to come into force at the beginning of May; it includes three new innovative drugs never previously reimbursed in the country, as well as indication extensions for an innovative drug already on the list. |
Implications | Considering the very slow pace of innovative drugs being added to the list in 2012, this new draft confirms 2013 as already being a better year for new drugs gaining reimbursement in Poland. |
Outlook | The innovative pharmaceutical industry will be keenly monitoring whether the Polish MoH is fulfilling its promises of providing greater access to innovative, high-cost medicines, and so far 2013 has already proven to be more favourable in this regard than 2012. With a considerable backlog of medicines still to be added to the list, it remains to be seen whether this trend will continue until the end of the year; the actions of the Polish MoH in this regard are hard to predict and do not always follow from macroeconomic trends. |
Three new innovative drugs to be added to list in May
Poland's Ministry of Health (MoH) has published the draft of the update to its reimbursement list, due to take effect from the beginning of May. The draft update includes three new innovative medicines never previously reimbursed in the country, as well as extensions of the indication for one innovative medicine already on the reimbursement list.
Trobalt reimbursed via community pharmacies
UK firm GlaxoSmithKline's Trobalt (retigabine) is to be included in the reimbursement list for the first time, and is set to be available via community pharmacies as an adjunctive therapy in patients over the age of 18 with focal epilepsy with a lack of seizure control or intolerance to treatment after a minimum of two attempts at adjunctive therapy. As the MoH states, this is the first time Polish patients have had access to reimbursement for third-line epilepsy treatment. Patients will only have to pay a lump-sum payment of PLN3.2 (USD1.0) to receive Trobalt.
Incivo and Victrelis added to drug programme
Two new medicines are set to be added to the drug programme for the treatment of chronic hepatitis C. US firm Merck & Co.'s Victrelis (boceprevir) is to be added, as well as compatriot company Johnson & Johnson's Incivo (telaprevir). Treatment with these medicines – according to the terms of the drug programme – will be restricted to patients with compromised liver function, including cirrhosis, in whom fibrosis is confirmed at the level of at least 2 on the Scheuer scale, and who have been previously unsuccessfully treated using the combination therapy of pegylated interferon alpha and ribavirin, or those who have not been previously treated but in whom a specific genotype is confirmed. As the drugs are set for inclusion in a drug programme, patients will not have to pay anything towards their cost.
Enbrel set for indication extensions
US firm Pfizer's Enbrel (etanercept) is set to be reimbursed for several more indications. Currently, Enbrel is reimbursed under the drug programme "treatment of rheumatoid arthritis and treatment of aggressive juvenile idiopathic arthritis". It is due to be reimbursed under two other drug programmes, according to the May update: "treatment of aggressive psoriatic arthritis" and "anti TNF [tumour necrosis factor]-alpha treatment of severe active ankylosing spondylitis".
Lastly, Merck & Co.'s Emend (aprepitant), which is already on the list of drugs available with reimbursement via community pharmacies, is set to be added to the list of drugs available as part of the National Health Fund's standard chemotherapy package, as an adjunctive therapy in adults for the prevention of early or delayed vomiting associated with highly emetogenic cancer chemotherapy using cisplatin.
Outlook and implications
A lot of attention is being focused on whether Poland's MoH is going to fulfil its commitments to increasing access to high-cost innovative medicines as part of the Reimbursement Act introduced into law at the beginning of 2012. In the previous two updates to the list, which came into effect at the beginning of January and the beginning of March, six new innovative drugs and one new drug were added, respectively, although it should be emphasised that quite a number of indication extensions were added for innovative drugs in the March update. Thus, it can be assessed that there is a moderate improvement in terms of new drugs being added to the list in comparison with previous years. However, it should be remembered that even when new drugs are added to the lists, in the case of those drugs used within the auspices of drug programmes and chemotherapy, it takes at least several months in most cases for these to actually start being reimbursed, as contracts have to be agreed with service providers in hospitals before this can start.
The MoH's press release giving general information on the draft update can be accessed, in Polish, here. The full updated reimbursement list can be accessed, in Polish, here.