Polish MoH's Revlimid Stance Criticised; New Direction on Non-Standard Chemotherapy Announced as Efient Reimbursement Application Rejected

Celgene Questions Methodology of Comparison Between Multiple Myeloma Treatments

Barbara Wojcik-Klikiewicz, director of the department of pharmaceutical economics at the Polish national health fund (NFZ), has stated that the Celgene (U.S.) multiple myeloma treatment Revlimid (lenalidomide) could be made available to patients in Poland within the framework of the existing therapeutic programme for the disease, reports Polish healthcare news provider, Rynek Zdrowia. However, she also stated that the high price of the drug, which is said to be almost twice as much as the other main multiple myeloma treatment Velcade (bortezomib; Millennium, U.S.), remains an obstacle to reimbursement. Celgene put forward a lower price for Revlimid in March 2009, but this was rejected by the Polish Ministry of Health (MoH), the source reports. The drug was in fact recommended by the Agency for Health Technology Assessment (AOTM) in Poland, but with the proviso that its price is reduced to a similar level as that of Velcade.

According to Celgene, the methodology for comparing the prices of the two drugs is flawed, reports Rynek Zdrowia. In the case of Velcade, the drug is administered for a previously defined period of time or number of treatment cycles; however, in the case of Revlimid, administration is carried out with constant monitoring of the response to the treatment, which it is not possible to predict for each individual. As a result, a different methodology for calculating the price should be implemented for these drugs, according to Celgene's director in Poland, Joanna Tomczak-Halaburda, quoted by Rynek Zdrowia. Celgene most recently applied for reimbursement of Revlimid in the autumn of 2009, although according to the company, the MoH has not yet met with the company to discuss its latest application.

Patients are calling for Revlimid's inclusion in the appropriate therapeutic programme, whereas at present it is only available under the auspices of non-standard chemotherapy, and only 50–60 people have access to the drug. It is emphasised by Dr. Artur Jurczyszyn, a haematologist and head of the Krakow-based Multiple Myeloma Treatment Centre Foundation, that in many other countries Revlimid has been a standard treatment for three years for multiple myeloma patients who are resistant to other treatments, or after the recurrence of the disease. The foundation believes that there is insufficient access to treatments for this disease, reports Pharma Poland News, pointing out the fact that in the Czech Republic, despite the country's lower population than Poland, four times more patients are receiving reimbursement for Revlimid.

Deputy Health Minister Clears Confusion over Non-Standard Chemotherapy

Meanwhile, Poland's deputy health minister Marek Twardowski has made a statement clearing up the confusion regarding the MoH's ordinance on non-standard chemotherapy in January. Twardowski emphasised that ongoing non-standard chemotherapies employing medicines that have received negative recommendations from the AOTM since the beginning of the individual course of treatment are to be continued in cases where the patient has had a positive response to the medicine in question. Non-standard chemotherapy is contained in the NFZ's therapeutic programmes, and in the case of each individual patient, a positive recommendation from the AOTM is needed before treatment is granted, and a regional chief doctor must also approve each treatment case.

AOTM Gives Negative Recommendation for Efient

In another recent pricing and reimbursement development in Poland, the AOTM has given a negative recommendation for the proposed reimbursement from state finances of Efient (prasugrel; Eli Lilly, U.S.), used for the prevention of atherothrombotic events in patients with acute coronary syndrome. The AOTM stated that although Efient was an effective medicine, it was inadequately tested, and on the basis of tests, it is associated with an increased risk of serious bleeding and the development of tumours. Additionally, the much higher cost of Efient in comparison with treatments that are currently on the reimbursement list is also a factor in its rejection.

Outlook and Implications

The fact that Revlimid is only available as a non-standard chemotherapy, which has to be given approval on a case-by-case basis by the NFZ, means that gaining access to the drug is a complicated and time-consuming process. The groundswell of opinion in Poland is that patients should have the possibility of access to a variety of multiple myeloma treatments—including Revlimid, Velcade, and Thalidomide—based on each individual patient's needs. The fact that the MoH has not yet met with Celgene to discuss its latest reimbursement application for Revlimid (according to the company) indicates the sometimes challenging nature of the process of obtaining market access in Poland for pharmaceutical companies. The comparison made between Poland and the Czech Republic in terms of numbers of patients who have access to Revlimid is apposite: the Czech government dedicates a substantially higher proportion of its budget to healthcare, and is also more predisposed to reimbursing new, innovative medicines more readily.

The statement regarding non-standard chemotherapy comes after it was announced that the MoH would only allow access to such treatments in very exceptional cases (see Poland: 22 January 20010: Poland's AOTM Gives Negative Assessment of Non-Standard Chemotherapy). However, this at least clears up the confusion that had been caused among the medical profession in Poland, and it means that even negative recommendations for drugs by the AOTM will not mean that courses of non-standard chemotherapy treatment that are shown to be successful will be stopped as a result of the negative recommendation. This does not change the fact that access to these treatments remains difficult.