Global Insight Perspective | |
Significance | A number of potential blockbusters have been given National Health Insurance (NHI) price approval in Japan, including oncology Merck KGaA's (Germany) drug Erbitux (cetuximab) and Pfizer's (U.S.) age-related macular degeneration (AMD) drug Macugen. |
Implications | Erbitux's price included a 19.2% premium on average operating profit ratio (AOPR), while Macugen's included a 35% premium for usefulness and a 10% premium for marketability. However, both were excluded from reimbursement in diagnosis procedure combination (DPC) hospitals. |
Outlook | Erbitux is expected to generate peak sales of ¥8.58 billion in year four, while Macugen is expected to generate peak sales of ¥7.36 billion in year 10. However, both are expected to be eclipsed by Astellas's (Japan) irritable bowel syndrome (IBS) drug Irribow (ramosetron), whose peak sales were forecast at ¥11.2 billion in year 10. |
According to Pharma Marketletter, the full list of new Japanese National Health Insurance (NHI) price approvals includes Schering-Plough's (U.S.) allergic rhinitis drug Nasonex (mometasone); Pfizer's HIV-related infection treatment Mycobutin (rifabutin); Galderma's (Switzerland) acne vulgaris treatment Differin Gel (adapalene); Astellas's immunosuppressant Graceptor (tacrolimus) and irritable bowel syndrome (IBS) drug Irribow (ramosetron); Novartis's (Switzerland) immunosuppressant Simulect IV (basiliximab); and Genzyme's (U.S.) immunosuppressant Thymoglobulin (anti-thymocyte globulin; rabbit). Specific details of the price approvals are as follows:
- Erbitux Injection 100 mg was priced at ¥35,894 (US$331.15), which represented a 19.2% premium on average operating profit ratio (AOPR). Sales were expected to reach ¥2.15 billion in the first year and to peak at ¥8.58 billion in year four.
- Irribow 2.5 Eg and 5 Eg tablets were priced at ¥86.30 and ¥141.10 yen respectively, which included a 5% premium for usefulness. Sales were expected to reach ¥2.0 billion in the first year, and to peak at ¥11.2 billion in year 10.
- Macugen IVT Injection Kit 0.3 mg was priced at ¥123,457, which included a 35% premium for usefulness and a 10% premium for marketability. The drug's degree of innovation was judged by a comparison with Novartis's Visudyne (verteporfin). Sales were expected to reach ¥1.78 billion in the first year, and to peak at ¥7.36 billion in year 10.
- Differin Gel 0.1% was priced at ¥117.70, which included a 10% premium for usefulness. Sales were expected to reach ¥500 million in the first year, rising to a peak of ¥2.1 billion in year five.
- Graceptor was priced respectively at ¥514.50, ¥905.20 and ¥3,361.10 for its 0.5-mg, 1-mg and 5-mg presentations. Sales were expected to reach ¥400 million in the first year, peaking at ¥16.1 billion in year 10.
- Nasonex Nasal Solution 50 Eg 56 Spray was priced at ¥1,947.40. Sales were expected to reach ¥340 million in the first year, peaking at ¥7.67 billion in year six.
- Thymoglobulin IV Drip 25 mg was priced at ¥37,460, which represented a 19% premium on AOPR. Pharma Marketletter reported that sales were expected to reach ¥150 million in the first year, peaking at ¥139 million in year 10.
- Mycobutin Capsule 150 mg was priced at ¥753, which included a 21.1% premium for innovation (19% AOPR x 110%). Sales were expected to reach ¥109 million in the first year, and to peak at ¥721 million in year 10.
- Simulect IV 10 mg for paediatric use was priced at ¥193,379, which included a 10% premium for paedriatric use. In this paediatric setting, sales were expected to reach ¥12.4 million in the first year, peaking at ¥25.7 million in year 10.
DPC Reimbursement Withheld from Erbitux, Macugen, Thymoglobulin
Pharma Marketletter reported that Erbitux, Macugen and Thymoglobulin were all excluded from lump-sum reimbursement in diagnosis procedure combination (DPC) hospitals. This was because the price of these drugs was judged to be excessive in relation to the DPC reimbursement price for existing therapies.
Outlook and Implications
Over the past few months, Global Insight has reported on the marketing approvals of most of the drugs that have now been given an NHI listing (see various Related Articles, below). Of the newly listed drugs, Erbitux and Macugen are likely to generate the biggest ripples, despite the fact that DPC reimbursement has been withheld. However, on a pure sales basis, it is Astellas's Irribow that is set to lead the way.
Related Articles
- Japan: 18 July 2008: Nasonex Approved for Treatment of Allergic Rhinitis in Japan
- Japan: 17 July 2008: Astellas Wins Japanese Approval for Once-Daily Tacrolimus
- Japan: 16 July 2008: Erbitux Approved for Treating Colorectal Cancer in Japan
- Japan: 1 July 2008: Japan's CDFS Confirms Drug Approval Recommendations
- Japan: 10 June 2008: Modified-Release Tacrolimus Listed Among New Approval Recommendations in Japan