Japan's NHI drug list gets nine added NCEs, including Lamictal and Fosrenol

Among nine New Chemical Entities/13 products added to Japan's National Health Insurance drug price list effective December 12, were European drug majors GlaxoSmithKline's Lamictal (lamotrigine), for the treatment of epilepsy, and Bayer Healthcare's Fosrenol (lanthanum carbonate) for the control of hyperphosphatemia in chronic renal failure patients on hemodialysis.

The price of Lamictal tablets (pediatric dose: 2mg and 5mg; and for adults 25mg and 100mg) for patients with epilepsy who did not adequately respond to other treatments, and in combination with other anti-epileptics, was set at 16.60 yen ($0.18), 31.80 yen, 99.80 yen and 267.40 yen, respectively. Although Lamictal 100mg had once been set at 269.80 yen, with premiums of 5% for usefulness and 15% for pediatric use, the price was reduced to 267.40 yen due to the foreign price adjustment. The new indication of Lennox-Gastaut Syndrome was evaluated as usefulness. Sales of the drug are expected to reach 1.0 million yen in the first year on the market and 8.43 billion yen at peak in the 10th.

Prices of Fosrenol chewable tablets 250mg and 500mg were set at 195.30 yen and 286.60 yen, respectively. No premiums were added but the foreign price adjustment boosted it to the new level for 500mg tablets. Sales of the drug are forecasted to reach 680 million yen in the first year and 10.53 billion yen at peak in the 10th.