IHS Global Insight Perspective | |
Significance | Two innovative Type 2 diabetes treatments have been recommended by the Polish health technology assessment agency (AOTM) for 50% reimbursement; meanwhile, hepatocellular carcinoma drug Nexavar has been recommended by the AOTM for reimbursement as part of the therapeutic programmes run by the Polish national health fund. |
Implications | Pressure is mounting on the Polish ministry of health to reimburse innovative treatments for diabetes sufferers in general, while in spite of increased spending on cancer treatments, access to the most modern treatments remains comparatively challenging. |
Outlook | With the next update to the drug reimbursement list already very delayed, it is a matter for debate as to when any of the treatments recommended for inclusion on the list by the AOTM will finally be added. In the case of Nexavar, it is likely that this drug will be available to Polish patients more quickly, thanks to Bayer's price cut. |
The Consultative Council of the Agency for Health Technology Assessment in Poland (AOTM) has issued a number of new recommendations for drugs to be reimbursed under the auspices of the Polish national health fund (NFZ), at its most recent session on 5 July. The council issued position papers on two Type 2 diabetes drugs, both of which are dipeptidyl peptidase-4 (DPP-4) inhibitors, one in fixed combination with metformin. The two drugs are Januvia/Xelevia (sitagliptin; Merck & Co, U.S.), and Eucreas (vildagliptin + metformin; Novartis, Switzerland), and the council has recommended both to be reimbursed 50%, as part of the general drug reimbursement list. It also issued a position paper recommending the reimbursement of German firm Bayer's hepatocellular carcinoma (HCC) drug Nexavar (sorafenib) under the therapeutic programmes managed by the NFZ.
AOTM Changes View of Januvia/Xelevia
The AOTM's recommendation of Merck's DPP-4 inhibitor Januvia (also marketed under the name Xelevia) represents a change from the agency's recommendation not to reimburse the drug when it was assessed last year. Januvia is now recommended for the treatment of Type 2 diabetes in combination with metformin and a sulphonylurea when diet and exercise, together with the use of the aforementioned medicines, do not yield adequate control of blood-sugar levels. The AOTM emphasises that there is no evidence that Januvia has superior efficacy compared with other DPP-4 inhibitors, and this is the reason for it being recommended for the same level of reimbursement as these. Significantly, however, the AOTM's decision to recommend Januvia for reimbursement is based on extended safety analysis, which shows that there was no statistically significant risk of upper respiratory tract infections, inflammation of the nose or throat, or hemorrhagic pancreatitis occurring as a result of using the drug. The full text of the AOTM's position paper (the same for both Januvia and Xelevia), can be found, in Polish, here.
Eucreas Recommended for 50% Reimbursement
The AOTM has also recommended Novartis' fixed-combination Type 2 diabetes treatment Eucreas; it has specified the drug's reimbursement in the case of patients who have failed to obtain sufficient control of blood-sugar levels despite the maximum possible use of metformin in monotherapy, or in the case of patients who have been treated with vildagliptin in the form of the non-combination drug Galvus, together with separate tablets of metformin. The AOTM points out that Eucreas is cheaper than Galvus and metformin in separate forms, and therefore it recommends reimbursement of the drug under the same conditions as Galvus. The full text of the position paper can be found, in Polish, here.
Nexavar Recommended for HCC Treatment for Specific Sub-Groups
Meanwhile, the AOTM has also changed its recommendation in the case of Nexavar, which according to the agency's previous decision, was not recommended for reimbursement, on the basis of the fact that there were "no significant data" of the drug's efficacy, and also on the basis the perceived excessive cost of treatment (see Poland: 15 January 2010: Three Kidney Cancer Treatments Given Negative Recommendations in Poland, NFZ's Drug Budget Cut by US$142.9 mil.). However, on this occasion, the AOTM has recommended the drug for the treatment of HCC as part of the NFZ's therapeutic programmes, judging that for particular sub-groups of patients—defined in the proposed therapeutic programme—treatment of HCC with Nexavar has a satisfactory ratio of risk to clinical effects, and is now the only therapeutic option that has proven effectiveness. Significantly, the AOTM praises the price quotation provided by the drug's manufacturer, Bayer, which significantly reduces the cost of therapy with Nexavar. The full position paper can be found, in Polish, here.
Outlook and Implications
For Merck & Co in particular, the new recommendation from the AOTM is a positive turnaround, having been previously rejected on safety grounds. To receive a recommendation such as this from a health technology assessment agency is certainly a boost to the profile of Januvia in general.
Meanwhile, although the AOTM has recommended Januvia, Eucreas, and a number of other next-generation Type 2 diabetes drugs in recent months, there is still no indication of when they will actually be included on the country's reimbursement list. There has been no update to the Polish drug reimbursement list since December last year, and although it had been announced that there would be an update in the first half of 2010, this has not materialised. There is pressure mounting on the Polish ministry of health to reimburse innovative diabetes drugs, and in particular, long-acting insulin analogues (see Poland: 27 May 2010: Pressure Mounts to Include Long-Acting Insulin Analogues on Polish Drug Reimbursement List).
The recommendation for the reimbursement of Nexavar comes only several months after the drug was rejected, and it can be assumed—on the basis of the AOTM's position paper—that Bayer has offered a substantial cut in the cost of treatment with the drug. In this case, it is likely that the drug will be included fairly quickly as a guaranteed treatment, as part of a therapeutic programme. Nevertheless, the restrictions imposed on its reimbursement will mean that access to it will be quite difficult; there are no explanations available as yet concerning which sub-groups patients must belong to in order to qualify for treatment with Nexavar. Also, there is discontent in Poland in general, and especially over the slow pace of access to the most modern cancer treatments compared with other countries (see Poland: 15 July 2010: Polish Chemotherapy Expenditure Rises to US$345 Mil. in 2009, Patients Complain of Obstacles to Accessing New Cancer Drugs).