Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer

Diagnostics

Shivang Doshi⁵  David Ray⁴  Karen Stein³  Jie Zhang³  Prasad Koduru¹  Franz Fogt⁶  Axel Wellman²  Ricky Wat⁵  Charles Mathews⁵ 

[1] UT Southwestern Medical Center, 2330 Inwood Road, Dallas, TX 75235, USA;The Pathological Institute Celle, Wittinger Str. 14, 29223 Celle, Germany;Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA;Ernest Mario School of Pharmacy, Rutgers University, 160 Frelinghuysen Rd, Piscataway Township, NJ 08854, USA;Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USA;Penn Presbyterian Medical Center, Department of Pathology, Philadelphia, PA 19104, USA;

关键词: Anaplastic lymphoma kinase (ALK) gene rearrangement;    immunohistochemistry (IHC);    fluorescent in situ hybridization (FISH);    non-small cell lung cancer (NSCLC);    cost-impact model;   

DOI  :  10.3390/diagnostics6010004

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY   
© 2016 by the authors; licensee MDPI, Basel, Switzerland.