Funding for Daratumumab was recently approved in Israel for the treatment of newly diagnosed multiple myeloma (NDMM) patients in first line treatment, in large part thanks to a strong collaboration between the MPE Israeli member, AMEN, with local haematologists and pharmaceutical companies in Israel.
Each year, the Israel Ministry of Health nominates a Health Committee to discuss and recommend approval and extension for a new “health basket,” which includes all the services, medications, supplies, and medical equipment that one is entitled to receive according to the National Health Insurance Law. This year the initial budget was expanded from 550M NIS (145M Euro) to 650M NIS (176M Euro).
In the “Health Basket” a specific medicine is associated with not only a disease (e.g. Venetoclax is approved for CLL patients, but not for myeloma patients), but approved with specific labeling, including a specific line of treatment, history of treatments taken, certain risk categories, transparent eligible/ineligible, etc.
The road to approve Daratumumab for NDMM
In January 2023, Daratumumab was finally approved for first line treatment for NDMM patients as an outcome of a 2023 basket extension.
The road to approval has taken AMEN and other stakeholders four years of dedicated advocacy.
“This fantastic news is hopefully the last step of a long and difficult saga,” said Zvika Zilberman, AMEN representative and MPE Board Member.
Daratumumab was first approved for myeloma patients in the fourth line of treatment back in 2017. A year later, the Health Committee decided to include Daratumumab for myeloma patients starting from the second line of treatment. In addition, it also extended the fund to include it in combination with another drug, Revlimid. At the time, only funding for a single medicine was approved, so this was important progress for patients.
Over the last four years, AMEN, in a collaboration with myeloma physicians and pharmaceutical companies, submitted a request to include Daratumumab as part of first line treatment. This demand was supported by the results of the 2020 GRIFFIN trial which showed Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns.
“We all knew that it may cost more to include this as first line of treatment; however, it will be worthy for all with longer remission and less healthcare expenses in the future,” said Zilberman.
Despite the drug receiving a high categorization on the health committee’s list, year after year, it was not approved for first line treatment.
“While some other important drugs were approved, we knew that Daratumumab for new patients was the highest priority for us,” said Zilberman
Last year, AMEN campaigned again to advocate for the approval of Daratumumab. On a cold morning during December 2021, some of the volunteers of AMEN arrived early to protest in front of the Health Committee conference and speak with the head of the committee.
Despite these efforts, in January 2022 Daratumumab was not approved again due to incorrect information received by the Health Committee on the cost of Daratumumab.
Shortly after, a meeting was held with AMEN leaders and the head of the Health Committee, where AMEN presented the actual costs and asked the Committee to change the results accordingly. However, it was too late for the final approved list of 2022.
Therefore, AMEN decided to demand it legally by acting directly with the Supreme Court of Israel.
In the first week of July 2022, a few volunteers traveled to the Supreme Court in Jerusalem to take an active presence during the discussion. Unfortunately, the Supreme Court decided not to interfere with the Health Committee’s decision, despite the wrong information about the price of Daratumumab.
Finally, in the Health Basket of 2023, Daratumumab was discussed again and this time it was approved to include first line treatment for NDMM patients.
After four tough years of raising this issue, meeting with decision-makers, and advocating for better treatment options for myeloma patients in Israel, patients now have access to Daratumumab in first line.
“These efforts show what can be done when advocates demand better access and options for patients. By working with the hematology community and industry, and continuing to push the committee, we made a difference in the lives and future of patients,” said Zilberman.