IHS Global Insight Perspective | |
Significance | Some 13 drugs are set to be reimbursed in Japan's NHI system starting from 16 April following the positive recommendations given by Chuikyo. Novo Nordisk's diabetes drug Victoza was not listed due to the disagreement on its prices between the pricing agency and the manufacturer. |
Implications | Exforge and Rezaltas' prices experienced reductions compared with the expected level under the old pricing system as a result of the first-time adoption of the 80% rule. |
Outlook | With the successful listing, Equa is poised to snap up a fair share of sales in Japan's DPP-4 inhibitor market before the roll-out of future rivals including Takeda's alogliptin. Victoza, on the other hand, has to experience a further wait for the NHI listing and subsequent launch. In terms of fixed-dose combinations, the drug makers will face lower price levels from now on while the MHLW is set to obtain savings from the new pricing rule. |
Japan's Central Social Insurance Medical Council (CSIMC, Chuikyo) has granted its positive opinion to the National Health Insurance (NHI) listing of 13 drugs, effective from 16 April, at a meeting held at the end of March, according to a report by Pharma Japan. Swiss drug giant Novartis has its dipeptidyl peptidase-4 (DPP-4) inhibitor Equa approved for NHI listing at ¥104.70 (US$1.1) per 50 mg, which matches the daily treatment cost of the first DPP-4 inhibitor approved in Japan, Januvia (sitagliptin; Merck & Co, U.S). However, another diabetes treatment, Danish firm Novo Nordisk's glucagon-like peptide-1 (GLP-1) analogue Victoza (liraglutide), experienced delay in its listing due to disagreement over its price.
New Pricing Adopted for Fixed-Dose Combination Therapies
Among the 13 products, two fixed-dose combination treatments, namely Rezaltas and Exforge, have been priced under the new rule of combination drug pricing in Japan. According to the new pricing ruling, prices of new fixed-dose combinations will be set at 80% of the sum of the combined active ingredients' prices, instead of the previous calculation, which simply add up the prices of combined active ingredients. The prices of Exforge and Rezaltas are therefore set at ¥60.1 and ¥42.5 lower respectively than the levels under the old pricing system, added the source.
Japan: Selective Products in April 2010 Listing | ||||
Drug Name | Active Ingredient | Manufacturers | Indications | Expected Peak Annual Sales |
Equa | Vildagliptin | Novartis (Switzerland) | Type 2 diabetes | ¥27.49 billion |
Cymbalta | Duloxetine | Lilly/Shionogi (U.S./Japan) | Depression | ¥24.4 billion |
Exforge | Valsartan/amlodipine | Novartis | Hypertension | ¥42.65 billion |
Rezaltas | Olmesartan/azelnidipine | Daiichi Sankyo (Japan) | Hypertension | ¥47.6 billion |
Aloxi | Palonosetron | Taiho (Japan) | Chemotherapy-induced nausea and vomiting | - |
Temodal | Temozolomide | Merck (Schering-Plough; U.S.) | Malignant glioma | - |
Xalacom | Latanoprost/timolol | Pfizer (U.S.) | Glaucoma; Ocular hypertension | ¥14.7 billion |
Source: Pharma Japan | ||||
Outlook and Implications
The April NHI listing has come largely as expected, two-to-three months after the concerned drugs obtained their marketing approval from the Ministry of Health, Labour and Welfare (MHLW). The positive recommendations will see the forthcoming launches of the 13 drugs in the Japanese market. Following Januvia, Equa is to become the second DPP-4 inhibitor rolled out in Japan in a bid to take up a promising market share ahead of further competition from other rivals in this drug class. By contrast, Japanese drug major Takeda's alogliptin has fallen behind although its approval is expected shortly following the positive recommendation of a MHLW panel in early March (see United States - Japan: 5 March 2010: Takeda Secures Recommendation for Alogliptin in Japan, Changes Heartburn Drug Name in U.S. to Avoid Confusion). For Novo Nordisk, however, the postponed listing will hold back the commercialisation of Victoza in the Japanese market by at least two months as the next discussion will be held in June. Novo Nordisk will then face another round of decisions on whether or not to accept the price proposed by Chuikyo for Victoza.
The new round of NHI listing has seen for the first time the new pricing rule for fixed-dose combination drugs adopted. As in the cases of Exforge and Rezaltas, drugs falling into this category will face 20% lower NHI prices than they should have expected in the previous simple-sum system. In addition, if an ingredient in the combination has generic versions available on the market, its price used in the new calculation will have to refer to the lowest-available generics level. Drug manufacturers of fixed-dose combination products will therefore expect lower reimbursement prices in Japan. On the other hand, the Japanese government can achieve considerable savings on their NHI spend on fixed-dosed combination medicines with the help of this new pricing system.