[Ip-health] Novartis refuses to register 400 mg tablet of imatinib mesylate (Gleevec®) in Korea

[Shadi Razmdjou]

Novartis refuses to register 400 mg tablet of imatinib mesylate (Gleevec®) in Korea

It has been a long and tedious battle for Korean cancer patients to access imatinib – a life saving treatment for patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumor (GIST).

The drug is expensive (20 US$ for a 100 mg tablet) and the Korean government provides it to patients under the National Health Insurance. However any decisions to reduce the price of the drug by the Ministry of Health, Welfare and Family Affairs has been met with Novartis first threatening to stop supplying the drug or more recently with court cases against the Korean government.

There is another dimension to this battle for access to imatinib. The daily dosage of one patient is at least 400 mg, but Novartis has only registered the 100 mg tablet in Korea. This means that patients in Korea need to take at least 4 pills a day.

This not only means higher costs for the government but also higher risks of side effects.
For the coating of the tablet contains iron (III) oxide and patients taking 4 tablets of 100 mg a day rather than one 400 mg tablet are in a higher risk of developing iron toxicity. This is an avoidable additional side effect to all the other severe side effects which go along with every chemo - therapy. Besides the 400 mg dosage marks only the minimum dosage a day. Patients in advanced stages of the blood cancer and patients who do not show any response to the therapy with lower dosages have to start a treatment with 600-800 mg per day.

The reason why Novartis refuses to register and introduce the 400 mg form of imatinib is profit. If it sells the 100 mg tablet it gets approximately 80 US$ for 400 mg but if it sells it as a single tablet of 400 mg it will get 48$ in Korea. According to local pricing regulations in Korea higher concentrations of the same drug can be only 2.4 times more expensive than the lower concentrated version.

But Novartis wants approximately 76 US$ for the 400 mg tablet from the Korean government so it has chosen to not register the 400 mg as it means a reduction in its profits. Again a giant multinational pharmaceutical company sets profit over the lives of patients.

Novartis has obtained patent for imatinib in Korea and therefore generic versions of the 400 mg tablet cannot be marketed in Korea.


For more information please contact:

Korea Leukemia Patient Group or
Leena Menghaney (leenamenghaney@gmail.com)
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