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Last week, a storm swept through Polish social media over Kadcyla. It is a drug used in the treatment of particularly aggressive breast cancer. On May 1, Kadcyla disappeared from the reimbursement list in not entirely clear circumstances. It turns out, however, that cancer patients also lost access to other key therapies.
- Since 2020, Kadcyla has been on the list of reimbursed drugs in the case of disseminated HER2-positive breast cancer
- On May 1, the drug was not on the list, which, according to the Ministry of Health, is to be corrected on July 1
- – I would like to note that it is not only Kadcyla in patients with brain metastases – says Prof. Piotr Wysocki, head of the Clinical Oncology Department of the University Hospital in Krakow. There are more changes that appear quietly, and doctors are just beginning to learn about them
- More information can be found on the Onet homepage.
What happened to the drug for breast cancer patients? “It seems impossible for them to take these drugs”
The new list of reimbursed drugs entered into force on May 1. It was only after a few weeks that doctors and patients began to realize that it lacked, among others, Kadcyli, a drug used in the treatment of particularly aggressive breast cancer. One that grows rapidly and spreads to distant organs.
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Kadcyla was added to the list on January 1, 2020. Previously, if the oncologist wanted to include this therapy in a specific patient, he had to write an application under Emergency Access to Drug Technologies. It was then considered by the Ministry of Health. When information spread on social media that Kadcyla had disappeared from the reimbursement list, it was an unpleasant surprise not only for patients, but also for oncologists.
– In fact, the last list lacked two lines of treatment for patients with HER2-positive breast cancer – commented for MedTvoiLokony Nikola Jennek, director of external relations of the Polish Society of Oncology. – The doctors with whom I spoke cannot explain why this happened. However, this is probably a mistake of the ministry. It seems impossible for them to take these drugs because that is the standard of treatment. We have no feedback on whether they will be restored or not. We hope that it is a classic mistake – someone did not notice, did not take care of it. There were no discussions on this topic so that these drugs would not be included in the latest list – he adds.
To clarify the situation and get a concrete answer about what happened and whether the patients could continue to receive the drug, we contacted the Ministry of Health.
The Ministry of Health comments: correction as soon as possible
The reply we received from the Ministry of Health did not shed any new light on the matter. We publish it in full:
The Ministry of Health emphasizes that no drug included in the drug program B.9. – Treatment of breast cancer patients (ICD-10 C50) has not ceased to be reimbursed in accordance with the announcement of the Minister of Health on the list of reimbursed drugs, foodstuffs for particular nutritional uses and medical devices in force from May 1, 2021.
The Ministry of Health emphasizes that from May 1, 2021, the program has been modified. More than 100 changes have been made to it to simplify it and increase access for patients.
The Ministry of Health published a draft of the assumed changes in advance in order to verify its correctness by applicants, patients, foundations, service providers, doctors, specialists and other persons or entities interested in the list of reimbursed drugs.
Project of a new version of the drug program B.9. – Treatment of patients with breast cancer (ICD-10 C50), has been assessed by AOTMiT as well was consulted both with specialists in the field of clinical oncology, the National Consultant for clinical oncology and all applicants of the drug program B.9. who are its participants.
None of the responsible entities to which the products of Novartis Poland Sp. z o. o. – Tyverb (lapatinib) and Roche Polska Sp. z o. o. – Kadcyla (trastuzumab emtansine) did not raise any comments to the proposed provision of the drug program directly related to the treatment of patients with HER2-positive breast cancer with CNS metastases and finally accepted its content, which is in force from May 1, 2021.
When creating new provisions of the program, the Ministry of Health collaborated with experts who know the issues from the clinical point of view and since the publication of the project announcement of the Minister of Health, i.e. April 16, 2021 on the list of reimbursed drugs, foodstuffs for particular nutritional uses and medical deviceswhich will enter into force on May 1, 2021. no comments and official letters related to the change of the subject provision of the drug program were received.
Although the new version of the program has been in force for almost a month, only now there have been voices in the media by doctors who indicate that clinical practice means that some new patients will not be able to participate in the program. Of course in Therefore, the Ministry of Health will correct the content of the drug program as soon as possible, i.e. as part of the planned announcement on July 1, 2021. At the same time, it should be emphasized that the basic condition for the changes made is to obtain consent from all entities participating in the B.9 drug program
In addition, the Ministry of Health asks to raise objections in the future in a written version addressed to the Ministry of Health, and not via the media, because this causes unnecessary anxiety among patients.
The Ministry of Health emphasizes that the drug program B.9. is one of the most developing oncology programs in recent years.
We learn from the magazine that some patients will not have access to the therapy, which has been reimbursed so far. However, a correction is planned, which may take place on 1 July. It’s over a month. Will new patients receive the drug during this time? And what about those women who are already in therapy? We asked about it, however in the message we received there was no answer to these questions.
Oncologist: “It’s not just a Kadcyla”
A week later, we contacted prof. Piotr Wysocki, head of the Clinical Department of Oncology at the University Hospital in Krakow. In this way, we found out that the procedure before January 1, 2020 has now been returned to. For the patient to be treated with Kadcyla, an appropriate application is required as part of Emergency Access to Drug Technologies.
– The Ministry of Health declares that it will unscrew these changes so that patients with HER2-positive breast cancer with metastases to the brain can continue to receive this drug – says Prof. Wysocki in an interview with Medonet. – Until July 1, when this is to take place, oncologists must write individual applications to the Ministry to include individual patients in this therapy. I would like to believe it was a technical error. However, if this were a deliberate decision, it would be very unfair and harmful to patients who are in a dramatically poor health situation and in a direct threat to their lives.
The specialist sheds new light on the matter. It turns out that as of May 10, doctors cannot apply for more than 100 other medications. Including medicine for cancer patients.
– I would like to note that this is not only Kadcyla in patients with brain metastases. In the latest decisions of May 10, there were, inter alia, bans on financing as part of emergency access to drug therapies: Kadcyli in adjuvant treatment of patients with HER2-positive breast cancer after ineffective preoperative chemotherapy or immunotherapy for kidney cancer patients in the third line of palliative treatment. These decisions completely block patients’ access to therapies, which are not only recommended in Polish and international recommendations, but also reimbursed in most European Union countries. In Poland, these drugs have not yet been reimbursed, and the only option was a doctor’s application for emergency access to drug therapy. At the moment, to incl. These drugs (the new list of drugs and indications not approved by the Ministry has over a hundred items) access for Polish patients was definitely blocked.
Prof. Wysocki says straightforwardly: access to therapy for many patients is increasingly limited.
– We have the impression that, on the one hand, people are saying loudly how much the “green island of oncology” will be cared for, and on the other hand, for many patients who are absolutely necessary, access to therapy is increasingly limited without publicity. There are many such small changes that appear quietly without consulting the community of oncologists and patient organizations, and they are extremely difficult to reverse. Both doctors and patients are slowly learning about these new decisions. And this only happens when they decide to apply for access to life-saving therapy.
Also read:
- More and more Polish women die of breast cancer. Money from the government is not helping
- It develops quickly, it is easy to mistake it for something else. It’s an insidious tumor
- Paulina Młynarska has undergone a prophylactic mastectomy. Up to 300 people qualify for it. Polish women
- They know they are dying. How do I talk to cancer patients?
- Poland: more and more malignant tumors
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