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The new list of reimbursed drugs, as of July 1, will not include a drug used in the treatment of multiple myeloma. Doctors are calling for him to be put back on the list. “Daratumumab is a breakthrough drug not only because of its mechanism of action, but also because of its high effectiveness,” they write in a letter addressed to the Ministry of Health.
- This is not a good time for cancer patients
- In May, drugs used in disseminated HER2-positive breast cancer disappeared from the list of reimbursed drugs
- The new reimbursement list will not include daratumumab – a drug needed by patients with multiple myeloma, a malignant tumor of the hematopoietic system
- Polish hematologists cannot accept it. In a letter to the Ministry of Health, they appeal to return the drug to the list
- More information can be found on the Onet homepage
Daratumumab has disappeared from the reimbursement list – hematologists protest
On July 1, a new list of reimbursed drugs will come into force. It will miss, among others daratumumab, a medicine used to treat multiple myeloma. Doctors who deal with this type of cancer cannot come to terms with it. Hematologists associated with the Polish Myeloma Group and the Polish Myeloma Consortium sent a letter to Maciej Miłkowski, Undersecretary of State at the Ministry of Health.
“We have noticed with concern that the project does not include the drug daratumumab, which has so far been reimbursed in the D-Vd regimen (daratumumab, bortezomib, dexamethasone) for patients with relapsed / refractory multiple myeloma who meet the relevant criteria for inclusion in the Drug Program B.54” – the doctors write in a letter signed by prof. Krzysztof Jamroziak and Dr. hab. Dominik Dytfeld.
«Daratumumab, approved in 2015 by the European Medicines Agency (EMA), is an anti-CD38 monoclonal antibody with a complex mechanism of action including direct induction of myeloma cell death, complement and effector cell dependent cytotoxicity, and immunomodulatory activity.
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Daratumumab is a breakthrough drug not only due to its mechanism of action (the first monoclonal antibody approved for the treatment of myeloma), but also its high effectiveness (the most active in monotherapy of all currently approved anti-myeloma drugs). Daratumumab, due to its very high effectiveness and good safety profile documented in numerous third phase studies, is recommended by international scientific societies: IMWG (International Myeloma Working Group) and ESMO (European Society of Medical Oncology) and the Polish Myeloma Group for use. at every stage of treatment »- we read in the letter.
Daratumumab – how effective is it?
«In Western Europe and the USA, daratumumab regimens such as D-Rd (daratumumab, lenalidomide, dexamethasone), D-VMP (daratumumab, bortezomib, melphalan, dexamethasone) and D-VTD (daratumumab, bortezomib, thalidomide) are now dex the basis of the first-line treatment, which clearly underlines the high value of the drug »- hematologists write.
- Multiple myeloma – do all patients in Poland have equal chances of access to optimal treatment?
«Among many currently registered in Europe immunochemotherapy regimens with daratumumab in Poland, this drug is reimbursed only in the most economical DVd scheme and additionally in the patient population, which is strongly limited by the criteria of the Drug Program.
The registration of the DVd regimen was based on the results of the CASTOR Phase 3 clinical trial where it was compared with Vd therapy (bortezomib, dexamethasone). A recently reported analysis of the mature results of this study after 52 months of follow-up showed that a reduction in the risk of disease progression or death in patients receiving a DVd regimen was 69% for the ITT population and 79% for the second line of treatment » – experts emphasize.
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Doctors in the letter also stress that “there is no reason to believe that other treatments would be more effective in this population”.
Leave daratumumab on the list of reimbursed drugs
“The proposed decision deprives Polish patients of any access to one of the most effective drugs in the history of multiple myeloma, which was reimbursed only in a very limited form” – the doctors write.
They emphasize in the letter that the use of daratumumab in the D-Vd and DVTD regimens received a positive recommendation from the president of the Agency for Health Technology Assessment and Tariffication.
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«We are aware of the limitations, but we believe that maintaining access to currently reimbursed therapies, and, if possible, further prudent broadening of the spectrum of modern treatment options for selected patients with multiple myeloma, is key to improving the length and quality of life of patients with this extremely aggravating cancer .
Therefore, on behalf of Polish hematologists, we would like to ask you to consider keeping daratumumab on the list of reimbursed drugs »- write the authors of the letter: prof. dr hab. Krzysztof Jamroziak from the Polish Szpiczakowe Group and dr hab. Dominik Dytfeld, president of the Polish Myeloma Consortium.
Also read:
- Tumors that kill fastest
- Defeat myeloma
- What do Polish women die most often? New report
- Mechanisms of tumor formation
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