|
|
 |
|
Viewing report
|
|
|
|
Opportunities and Challenges in the Japanese Market for Cancer Therapies
Decision Resources, Inc., Dec 2005, Pages: 9
For the past 25 years, cancer has been the leading cause of death in Japan, and cancer mortality in that country has grown rapidly. This trend will continue into the future, in part driven by the aging of the Japanese population: the elderly are projected to account for approximately 26% of the total Japanese population by 2015. As a consequence, the Japanese oncology market, which has already experienced tremendous growth, is poised to achieve further dynamic expansion. If pharmaceutical companies are to capitalize on these opportunities, they must first find their way around the unique obstacles posed by the Japanese market.
This report focuses on the dynamics of Japans oncology market. We review the Japanese governments efforts to expedite access to international gold-standard cancer therapies and measures it has taken to broaden the range of approved indications for oncology drugs. We also examine the consequences of the shortage of chemotherapy specialists in Japan and recent steps taken to tackle this deficit. In addition, we present a discussion of changes in the procedures for clinical development and drug approval, and consider economic issues in cancer treatment in Japan.
Business Implications
- Lack of access to international gold-standard cancer therapies haslong been one of the main deficiencies of the Japanese oncology system. To accelerate the launch of important new drugs in Japan, in January 2005, the Ministry of Health, Labor, and Welfare (MHLW) established the Study Council on the Use of Unapproved Drugs. The manufacturers of drugs recommended by the council are asked by the MHLW either to begin clinical trials on these compounds or to conduct supplementary trials that would allow wider access to these agents before they are formally approved. In these circumstances, the public health insurance system covers all treatment costs except the cost of the product itself, which patients have to pay out of pocket. This initiative seeks to reconcile two opposing imperatives: patients’ desire to have access to international gold-standard therapies as soon as possible and the need to maintain the safeguards provided by Japan’s existing clinical trial system.
- Because the public health insurance system reimburses medicines only if they are prescribed for an approved indication, Japanese physicians tend to avoid off-label use of cancer therapies. To promote the approval of oncology drugs for broader indications, the MHLW established the Committee for Combination Therapy With Anticancer Drugs in December 2003. A working group identifies drugs that could be approved for additional indications and gathers
evidence on the efficacy and safety of these drugs from the literature and other sources. The MHLW may ask manufacturers of selected drugs to submit an application for new indications.
- A chronic shortage of chemotherapy specialists has constrained the development of the Japanese market for oncology drugs, but three new certified training programs should help to remedy this situation. The Japanese Society of Medical Oncology (JSMO) hopes to train 3,000-4,000 oncologists over the next decade. A new collaborative certification system is expected to raise standards of overall cancer treatment. And a certified training program for oncology
pharmacists aims to train 1,500 students in its first five years of operation. However, until large numbers of physicians and pharmacists
trained in the new oncology programs are working in institutions across the country, the use of innovative cancer drugs in Japan is likely to remain limited.
- In Japan, approval of oncology drugs has generally been based on evidence of tumor shrinkage from Phase II clinical trials. After April
2006, however, applications for therapies for common cancers (e.g., colorectal cancer, stomach cancer, breast cancer, non-small-cell lung cancer) will generally be required to include data from a Phase III study that uses survival rate and survival period as primary end points. Provided they comply with the terms of the revised guidelines, these Phase III trials may be conducted in Japan or overseas. Oncology drugs that are judged to be clearly innovative on the basis of solid clinical data may be approved prior to completion of a Phase III clinical trial (as is currently the case). A leading oncologist involved in the revision of national guidelines told us that the MHLW evidently wants to discourage the commercialization of “me-too” drugs in Japan.
Customers who bought this item also bought
Triple Analysis: The Drug Target Atlas of Apoptopic Drugs in Oncology and Special Focus on Breast and Prostate Cancer
Triple Analysis: The Drug Target Atlas of Apoptopic Drugs in Oncology and Special Focus on Lung Cancer and Melanoma
Targeted Cancer Therapies: Innovative Drugs And Their Impact On The Future Of Oncology
Cancer Therapies - Global Strategic Business Report
Cancer Therapies - Global Market Opportunities
Cancer Therapies - Global Market Opportunities
Biomarker Technology Platforms for Cancer Diagnoses and Therapies
Stakeholder Insight: Pricing and Reimbursement in Oncology - Do Payers Believe Oncology Drugs Offer Good Value?
Stakeholder Opinions: Bladder Cancer - New Drugs Needed to Challenge Ineffective 20-year Old drugs
Oncology Devices Clinical Trial Analysis
Cancer Therapeutics Markets
Pipeline/Commercial Insight: Supportive Care In Oncology - Significant Growth Opportunities Exist In New Supportive Care Indications
|
|
|
|
