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A blow to prostate cancer patients: the drug will not enter the basket Israel today


Outrageous decision • The treatment was ranked first and defined as life-saving, but the committee will not be able to complete the process - due to difficulty in registration • Teva: "groundbreaking treatment" • Ministry of Health: "does not meet the criteria"

The drug abiraterone was submitted to the drug basket committee for the treatment of non-metastatic prostate cancer patients for approximately 300 patients per year.

The Israeli Oncology Association chose it as the most essential drug among more than 40 drugs.

"The treatment significantly increases the cure rates in patients at high risk of disease recurrence and mortality," it was written when the recommendations were submitted.

The treatment with abiraterone succeeded in bringing about the survival of 86% of the patients, compared to 77% today.

Last week, the committee determined that the drug moves to the next stage of discussions.

However, until this moment the drug has not been registered for use in Israel for this indication.

Therefore, it cannot be included in the medicine basket.

until the next discussion.

The 2022 health basket committee, photo: Ministry of Health

The drug is taken in a pill, and it lowers testosterone levels for prostate cancer patients.

It has so far been approved for patients in an advanced stage and with this indication it also entered the health basket about five years ago and was registered for use in Israel.

However, new studies have found that when the drug is given in a non-metastatic phase, it may double the chances of recovery.

Therefore, the early treatment is included in the guidelines of the American Association for Cancer Research (NCCN) as well as in Europe.

"bureaucratic matters"

The original drug of Abiraterone is Zytiga from Janssen.

Zytiga's patent has expired.

Companies have no interest in funding dedicated research.

Therefore, it is difficult to register it.

However, even about five years ago, no dedicated research was carried out and yet the treatment with the drug was registered.

"We hope that the Ministry of Health will approve."

Teva, photo: Reuters

"It is impossible for bureaucratic matters to stop life-saving drugs," says Dr. Eli Rosenbaum, a specialist in urological oncology who served as the chairman of the Israeli Department of Uro-Oncology.

"We need to find a solution to this. There are unequivocal data. It is about improving the chances of patients, some of them young, to get well and have the opportunity to change many lives. The treatment is easy and effective, and the side effects are tolerable."

The cost of the medicine is about a quarter of a million shekels per patient for two years privately.

"The price of the medicine is far from the reach of an individual patient. We collect leftovers from 'friends of medicine' so that those who need treatment can receive it," concludes Dr. Rosenbaum.

The Teva company stated: "Teva operates out of a deep commitment to improving the health of patients, and therefore in light of the importance of the life-saving indication, Teva has applied to the Ministry of Health with a request to register the new indication of abiraterone also for the treatment of prostate cancer without metastases and is also working to integrate it into the drug basket so that it is accessible to as many patients as possible. We hope that the Ministry of Health will approve the registration and accessibility of the innovative treatment which, according to all the studies on the subject, is groundbreaking and life-saving.

In order to include a new drug for use in the drug basket, it must be registered in Israel.

Ministry of Health, photo: Oren Ben Hakon

The Ministry of Health stated: "Naturally, for reasons of protecting commercial information, the Ministry of Health does not disclose applications for registration submitted to the Drug Registration Department in the Pharmacy Division or the content of decisions on these applications. Ministry of Health policy states that in order to include a new drug for use in the drug basket, it must be registered in Israel ".

"It will be clarified that applications for the registration of preparations even with changes to the labels are examined in a number of key aspects, including proof of the quality, efficacy and safety of the preparation. These criteria are intended to protect public health and to ensure that the drug treatment given to patients does not cause harm and is effective in treating the requested indication. All new preparations and labels are required establish their compliance with these criteria for the purpose of their registration. It should be emphasized that in this case the preparation was submitted for registration at the Ministry of Health but did not meet the criteria. It is important to note that the preparation is not registered for the requested indication in any recognized country defined by law."

The Jansen company stated in response: "The drug abiraterone acetate has successfully treated thousands of patients with metastatic prostate cancer. The indication discussed in this year's drug basket refers to local metastatic cancer patients. This indication has no registration research in the world and therefore the company is unable to submit this indication for registration in Israel."

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Source: israelhayom

All life articles on 2022-11-30

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