title: Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer.
abstract: 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.
authors.affiliation: Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USA. sdoshi@bostonhealthcare.com.
authors.forename: Shivang
authors.initials: S
authors.lastname: Doshi
authors.affiliation: Ernest Mario School of Pharmacy, Rutgers University, 160 Frelinghuysen Rd, Piscataway Township, NJ 08854, USA. david.ray@novartis.com.
authors.forename: David
authors.initials: D
authors.lastname: Ray
authors.affiliation: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. karen.stein@novartis.com.
authors.forename: Karen
authors.initials: K
authors.lastname: Stein
authors.affiliation: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. jie.zhang@novartis.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.affiliation: UT Southwestern Medical Center, 2330 Inwood Road, Dallas, TX 75235, USA. Prasad.Koduru@UTSouthwestern.edu.
authors.forename: Prasad
authors.initials: P
authors.lastname: Koduru
authors.affiliation: Penn Presbyterian Medical Center, Department of Pathology, Philadelphia, PA 19104, USA. Franz.Fogt@uphs.upenn.edu.
authors.forename: Franz
authors.initials: F
authors.lastname: Fogt
authors.affiliation: The Pathological Institute Celle, Wittinger Str. 14, 29223 Celle, Germany. axel.wellmann@pathologen.net.
authors.forename: Axel
authors.initials: A
authors.lastname: Wellman
authors.affiliation: Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USA. ricky.wat@jhu.edu.|Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218, USA. ricky.wat@jhu.edu.
authors.forename: Ricky
authors.initials: R
authors.lastname: Wat
authors.affiliation: Boston Healthcare Associates, 75 Federal Street, Boston, MA 02110, USA. cmathews@bostonhealthcare.com.
authors.forename: Charles
authors.initials: C
authors.lastname: Mathews
keywords: Anaplastic lymphoma kinase (ALK) gene rearrangement; cost-impact model; fluorescent in situ hybridization (FISH); immunohistochemistry (IHC); non-small cell lung cancer (NSCLC)
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