Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer
Identification of alterations in ALK gene and development of ALK-directed therapies have increased the need for accurate and efficient detection methodologies. To date, research has focused on the concordance between the two most commonly used technologies, fluorescent in situ hybridization (FISH) a...
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| Format: | Article |
| Language: | English |
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MDPI AG
2016-01-01
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| Series: | Diagnostics |
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| Online Access: | http://www.mdpi.com/2075-4418/6/1/4 |
| _version_ | 1811187354094796800 |
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| author | Shivang Doshi David Ray Karen Stein Jie Zhang Prasad Koduru Franz Fogt Axel Wellman Ricky Wat Charles Mathews |
| author_facet | Shivang Doshi David Ray Karen Stein Jie Zhang Prasad Koduru Franz Fogt Axel Wellman Ricky Wat Charles Mathews |
| author_sort | Shivang Doshi |
| collection | DOAJ |
| description | Identification of alterations in ALK gene and development of ALK-directed therapies have increased the need for accurate and efficient detection methodologies. To date, research has focused on the concordance between the two most commonly used technologies, fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). However, inter-test concordance reflects only one, albeit important, aspect of the diagnostic process; laboratories, hospitals, and payors must understand the cost and workflow of ALK rearrangement detection strategies. Through literature review combined with interviews of pathologists and laboratory directors in the U.S. and Europe, a cost-impact model was developed that compared four alternative testing strategies—IHC only, FISH only, IHC pre-screen followed by FISH confirmation, and parallel testing by both IHC and FISH. Interviews were focused on costs of reagents, consumables, equipment, and personnel. The resulting model showed that testing by IHC alone cost less ($90.07 in the U.S., $68.69 in Europe) than either independent or parallel testing by both FISH and IHC ($441.85 in the U.S. and $279.46 in Europe). The strategies differed in cost of execution, turnaround time, reimbursement, and number of positive results detected, suggesting that laboratories must weigh the costs and the clinical benefit of available ALK testing strategies. |
| first_indexed | 2024-04-11T14:01:47Z |
| format | Article |
| id | doaj.art-bc5717a0087048249e02d76ba460d5c9 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-04-11T14:01:47Z |
| publishDate | 2016-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-bc5717a0087048249e02d76ba460d5c92022-12-22T04:20:07ZengMDPI AGDiagnostics2075-44182016-01-0161410.3390/diagnostics6010004diagnostics6010004Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung CancerShivang Doshi0David Ray1Karen Stein2Jie Zhang3Prasad Koduru4Franz Fogt5Axel Wellman6Ricky Wat7Charles Mathews8Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USAErnest Mario School of Pharmacy, Rutgers University, 160 Frelinghuysen Rd, Piscataway Township, NJ 08854, USANovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USANovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USAUT Southwestern Medical Center, 2330 Inwood Road, Dallas, TX 75235, USAPenn Presbyterian Medical Center, Department of Pathology, Philadelphia, PA 19104, USAThe Pathological Institute Celle, Wittinger Str. 14, 29223 Celle, GermanyBoston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USABoston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USAIdentification of alterations in ALK gene and development of ALK-directed therapies have increased the need for accurate and efficient detection methodologies. To date, research has focused on the concordance between the two most commonly used technologies, fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). However, inter-test concordance reflects only one, albeit important, aspect of the diagnostic process; laboratories, hospitals, and payors must understand the cost and workflow of ALK rearrangement detection strategies. Through literature review combined with interviews of pathologists and laboratory directors in the U.S. and Europe, a cost-impact model was developed that compared four alternative testing strategies—IHC only, FISH only, IHC pre-screen followed by FISH confirmation, and parallel testing by both IHC and FISH. Interviews were focused on costs of reagents, consumables, equipment, and personnel. The resulting model showed that testing by IHC alone cost less ($90.07 in the U.S., $68.69 in Europe) than either independent or parallel testing by both FISH and IHC ($441.85 in the U.S. and $279.46 in Europe). The strategies differed in cost of execution, turnaround time, reimbursement, and number of positive results detected, suggesting that laboratories must weigh the costs and the clinical benefit of available ALK testing strategies.http://www.mdpi.com/2075-4418/6/1/4Anaplastic lymphoma kinase (ALK) gene rearrangementimmunohistochemistry (IHC)fluorescent in situ hybridization (FISH)non-small cell lung cancer (NSCLC)cost-impact model |
| spellingShingle | Shivang Doshi David Ray Karen Stein Jie Zhang Prasad Koduru Franz Fogt Axel Wellman Ricky Wat Charles Mathews Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer Diagnostics Anaplastic lymphoma kinase (ALK) gene rearrangement immunohistochemistry (IHC) fluorescent in situ hybridization (FISH) non-small cell lung cancer (NSCLC) cost-impact model |
| title | Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer |
| title_full | Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer |
| title_fullStr | Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer |
| title_full_unstemmed | Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer |
| title_short | Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer |
| title_sort | economic analysis of alternative strategies for detection of alk rearrangements in non small cell lung cancer |
| topic | Anaplastic lymphoma kinase (ALK) gene rearrangement immunohistochemistry (IHC) fluorescent in situ hybridization (FISH) non-small cell lung cancer (NSCLC) cost-impact model |
| url | http://www.mdpi.com/2075-4418/6/1/4 |
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