The first oral drug to be listed on the 1st of next month… “Reducing the burden of visiting hospitals and improving the quality of life”
Ninraro (ingredient name ixazomib, Takeda), the first oral proteasome inhibitor-based multiple myeloma treatment, will be listed on the health insurance benefit list from the 1st of next month.
On the 24th, the Ministry of Health and Welfare (Minister Kwon Deok-cheol) announced some revisions of the “Pharmaceutical Benefit List and Benefit Limit Table”, including the establishment of a new salary for 3 doses of Ninraro capsules (Ministry of Health and Welfare Notice No. 2021-54).
According to the notice, the maximum salary was set at 1.45 million won for all three doses of Ninraro (2.3 mg, 3 mg, and 4 mg).
Accordingly, Ninraro can receive benefits for multiple myeloma patients who have failed the previous treatment starting on the 1st of next month (March) if they use it as a combination therapy with lenalidomide and dexamethasone.
The basis of the salary is the’TOURMALINE-MM1′ study. In this study of 722 adult patients with relapsed or refractory multiple myeloma, Ninraro confirmed the efficacy and safety profile.
As a result of the study, Ninraro extended the median progression-free survival time (mPFS) by about 6 months compared to the placebo group when co-administered with’lenalidomide + dexamethasone’ (IRd therapy) (median PFS: 20.6 months vs. 14.7 months in the placebo group, HR=0.74, p=0.01)
In addition, in a retrospective real-world observational study conducted in an actual medical environment in the United States, the time to follow-up treatment (TTNT, time to next) compared to the group treated with carfilzomib 3 drug combination therapy (KRd) and bortezomib 3 drug combination therapy (VRd). therapy, the surrogate scale for PFS in real world analysis) was found to be longer (median TTNT when administered with ninraro, carfilzomib and bortezomib in the 2nd and 3rd treatments, respectively: 16.8 months in the ninraro group vs. Pilzomib administration group 9.5 months, Bortezomib administration group 14.6 months)
In particular, it is evaluated that it is significant in that an oral option has been added to the secondary treatment of multiple myeloma, which had to rely on injections for the past time due to the entry of Ninra to pay.
With the addition of the oral medication option, the burden of visiting the hospital can be reduced for patients who had to visit regularly for medication, especially those with discomfort due to compression fracture of the spine, one of the complications of multiple myeloma.
In fact, recently, in the United States and Europe, cases of converting existing injection-medicated patients to oral drugs have been reported in order to minimize the number of patients due to Corona 19, according to Professor Ki-Hyun Kim of the Department of Hematology and Oncology at Samsung Medical Center.
Ninraro takes 4 weeks (28 days) as a cycle, 1 to 3 weeks, once a week (1 day, 8 days, 15 days), withdrawal from week 4, and only once a month.
In this regard, at a press conference held by Takeda Pharmaceutical Korea (CEO Hee-Seok Moon) online on the 26th in commemoration of Ninra’s salary registration, Professor Kim said, “The drug that shines the most in this situation where ontact is common due to corona. I think it’s a ninja.”
In addition, Professor Yoon Deok-Hyun of the Department of Oncology, Asan Medical Center in Seoul emphasized, “In the case of injections, treatment is possible only after visiting the hospital. In the case of patients with disabilities, this should be considered when selecting a treatment.”
In particular, he said, “It takes a considerable amount of time for not a few patients to visit the hospital from home,” he said. “In that respect, oral medication will be a very good treatment option for patients who are difficult to visit.”
In addition, they explained that it has advantages over conventional injections in terms of side effects. In the TOURMALINE-MM1 study, there was no significant difference in grade 3 or 4 adverse events compared to the placebo group.
In this regard, Professor Kim emphasized, “Compared to the injections (bortezomib formulation) that were previously available through health insurance benefits, there are fewer heart-related complications, so it is a priority option for heart failure or arrhythmia patients.”
In addition, he added, “The results of the phase 3 clinical trial have improved the quality of life of patients. In summary, the effect is good, patients are relatively well tolerated, the medication schedule is relatively simple, and the number of visits to the hospital is small.” .
However, although proteasome inhibitors are not without hemonuclear toxicity due to the nature of proteasome inhibitors, they are not significantly different from other treatments, and they are already widely known to experts in multiple myeloma, so they can be managed sufficiently.
In this regard, Professor Deok-Hyun Yoon said, “The important thing is that multiple myeloma requires combination therapy rather than using one drug. Among these, the emergence of oral drugs is very important in terms of expanding the patient group who can receive combination therapy. There is,” he emphasized.
He said, “We look forward to the day when patients with relapsed or refractory multiple myeloma from the previous treatment will be cured through better treatment.”
Meanwhile, Hee-Seok Moon, CEO of Takeda Pharmaceutical Korea, said, “I am pleased to add a major treatment option that can bring a drastic change in the treatment pattern of patients with relapsed and refractory multiple myeloma in Korea through the application of insurance benefits to Ninra.” “I hope that patients will be able to continue their daily life with steady and active treatment during the treatment period, as it is possible to use a combination of three oral drugs with improved convenience.”
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