|
市場調查報告書
美國新一代診斷的價格設定及補助
Pricing and Reimbursement of Next Generation Diagnostics in the United States
|
本報告已在2011年12月21日停止出版。
新一代診斷雖可望更加提昇疾病的診斷能力或成為鎖定標的的有力藥物療法，但在美國仍有價格設定及補助結構的重大課題存在。
本報告書內容包括：新一代診斷概要及2001年之後經認可的新一代診斷、目前的價格設定及償付、Medicare的角色、未來預測等。內容綱要摘記如下：
實施概要
介紹
何謂新一代診斷？
2001年之後經認可的新一代診斷試驗
- Roche/Affymetrix的amplichip CYP450
- third Wave Technologies的UGT1A1分子檢查
- 其他經許可的新一代診斷
目前的價格設定及補助環境
補助診斷藥時Medicare的角色
透過民間企業補助
未來預測
Abstract
Introduction
Next-generation diagnostics promise to offer an enhanced ability to diagnose
disease and to provide moretargeted drug therapy to patients. However, for
manufacturers of these new technologies, navigating the current pricing and
reimbursement structure of major payers in the United States is a tremendous
challenge.
In this report, Catherine Shaffer, M.Sc., lends her expertise in biotechnology
to provide a comprehensive overview of current next-generation diagnostics.
Neil Grubert, M.A., director of pricing and reimbursement research at Decision
Resources, Inc., presents a thorough analysis of the current U.S. pricing and
reimbursement environment for diagnostics with a special focus on Medicare
policies. The discussion includes strategies that diagnostics companies may
employ in the quest to bring products to market successfully and to achieve a
favorable reimbursement status.
Get the Answers You Need to Shape Your Strategy
- Next-generation diagnostic tests build upon existing molecular
technologies, resulting in either a greatly enhanced version of older
technology or in a completely new approach. Which novel diagnostics have
received approval, and what improvements do they offer over existing
technologies?
- The greatest diffi culty in entering the market with a novel diagnostic
test is navigating the existing pricing and reimbursement structure of the
major payers. How do Medicare and private payers determine coverage for
diagnostic tests? Which private payer has the most transparent coverage
policies for diagnostics?
- Manufacturers of diagnostic tests must meet rigorous requirements for
patient outcomes data and showcase a test' s clinical value before payers,
particularly Medicare, will approve reimbursement. How has Genomic Health
successfully secured coverage for its product Oncotype DX, a test that
quantifi es the likelihood of recurrence of breast cancer?
- Similar to the controversy surrounding personalized medicine, which calls
into question the notion of market restriction with the use of targeted
therapies, there is limited fi nancial incentive to invest in developing a
diagnostic test. What strategies can companies employ to increase the
uptake of a diagnostic test during commercialization?
Scope
- Birth of next-generation diagnostics: overview and description of
diagnostic tests that improve upon existing immunoassay and nucleic acid
testing (NAT) technologies.
- Next-generation diagnostics approved since 2001: coverage of select
diagnostics for indications such as drug metabolism, chemotherapy side
effects, oncology, cystic fi brosis, and HIV.
- Current pricing and reimbursement environment for diagnostics: path
to market, challenges of collecting health outcomes data, and
commercialization strategies.
- Medicare' s role in the reimbursement of diagnostics: description of
the agency' s policies in determining coding, coverage, and payment levels.
- Private payers' role in the reimbursement of diagnostics: overview
of private payers' policies.
- Outlook: a look at the future pricing and reimbursement environment
for next-generation diagnostics.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- What Are Next-Generation Diagnostics?
- Next-Generation Diagnostic Tests Approved Since 2001
- Roche/Affymetrix' s AmpliChip CYP450
- Third Wave Technologies' UGT1A1 Molecular Assay
- Other Approved Next-Generation Diagnostic Tests in Select Indications
- Oncology
- Cystic Fibrosis
- HIV
- Current Pricing and Reimbursement Environment for Diagnostics
- Challenges of Health Outcomes Data
- Introducing a New IVD Test to the Market
- Strategies for Commercialization
- Medicare' s Role in Reimbursing Diagnostics
- Reimbursing Diagnostics Through Private Payers
- Outlook
Tables
- 1. Select Approved Next-Generation Diagnostic Tests, 2001-2007
- 2. Requirements for the Award of Each Category of CPT Codes
Figures
- 1. Process for Developing Local Medicare Coverage Determinations
- 2. Process for Developing National Medicare Coverage Determinations
- 3. Percentage of HMOs That Restrict Use of Select Targeted Cancer
Therapies to Patients with Relevant Gene Mutations
- 4. HMO Pharmacy Directors' Views on the Importance of Positive Biomarker
Test Results As a Condition for the Use of Select Targeted Cancer Therapies
- 5. HMO Pharmacy Directors' Views on the Importance of Accompanying,
Validated Biomarker Tests As a Condition for Formulary Inclusion of Future
Targeted Therapies for Select Cancers
Sidebars
- Value of Outcomes Data: the Experience of Genomic Health
- Aetna-Spearheading Coverage of Next-Generation Diagnostics
- Format for Formulary Submissions-a Model for the Diagnostics Industry?
|
