PMID- 26313558
OWN - NLM
STAT- MEDLINE
DCOM- 20160418
LR  - 20191210
IS  - 2374-2445 (Electronic)
IS  - 2374-2437 (Linking)
VI  - 1
IP  - 9
DP  - 2015 Dec
TI  - Necitumumab in Metastatic Squamous Cell Lung Cancer: Establishing a Value-Based 
      Cost.
PG  - 1293-300
LID - 10.1001/jamaoncol.2015.3316 [doi]
AB  - IMPORTANCE: The SQUIRE trial demonstrated that adding necitumumab to chemotherapy 
      for patients with metastatic squamous cell lung cancer (mSqCLC) increased median 
      overall survival by 1.6 months (hazard ratio, 0.84). However, the costs and value 
      associated with this intervention remains unclear. Value-based pricing links the 
      price of a drug to the benefit that it provides and is a novel method to 
      establish prices for new treatments. OBJECTIVE: To evaluate the range of drug 
      costs for which adding necitumumab to chemotherapy could be considered 
      cost-effective. DESIGN, SETTING, AND PARTICIPANTS: We developed a Markov model 
      using data from multiple sources, including the SQUIRE trial, which compared 
      standard chemotherapy with and without necitumumab as first-line treatment of 
      mSqCLC, to evaluate the costs and patient life expectancies associated with each 
      regimen. In the analysis, patients were modeled to receive gemcitabine and 
      cisplatin for 6 cycles or gemcitabine, cisplatin, and necitumumab for 6 cycles 
      followed by maintenance necitumumab. Our model's clinical inputs were the 
      survival estimates and frequency of adverse events (AEs) described in the SQUIRE 
      trial. Log-logistic models were fitted to the survival distributions in the 
      SQUIRE trial. The cost inputs included drug costs, based on the Medicare average 
      sale prices, and costs for drug administration and management of AEs, based on 
      Medicare reimbursement rates (all in 2014 US dollars). MAIN OUTCOMES AND 
      MEASURES: We evaluated incremental cost-effectiveness ratios (ICERs) for the use 
      of necitumumab across a range of values for its cost. Model robustness was 
      assessed by probabilistic sensitivity analyses, based on 10 000 Monte Carlo 
      simulations, sampling values from the distributions of all model parameters. 
      RESULTS: In the base case analysis, the addition of necitumumab to the treatment 
      regimen produced an incremental survival benefit of 0.15 life-years and 0.11 
      quality-adjusted life-years (QALYs). The probabilistic sensitivity analyses 
      established that when necitumumab cost less than $563 and less than $1309 per 
      cycle, there was 90% confidence that the ICER for adding necitumumab would be 
      less than $100 000 per QALY and less than $200 000 per QALY, respectively. 
      CONCLUSIONS AND RELEVANCE: These findings provide a value-based range for the 
      cost of necitumumab from $563 to $1309 per cycle. This study provides a framework 
      for establishing value-based pricing for new oncology drugs entering the US 
      marketplace.
FAU - Goldstein, Daniel A
AU  - Goldstein DA
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia.
FAU - Chen, Qiushi
AU  - Chen Q
AD  - H. Milton Stewart School of Industrial & Systems Engineering, Georgia Institute 
      of Technology, Atlanta, Georgia.
FAU - Ayer, Turgay
AU  - Ayer T
AD  - H. Milton Stewart School of Industrial & Systems Engineering, Georgia Institute 
      of Technology, Atlanta, Georgia.
FAU - Howard, David H
AU  - Howard DH
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia3Department of Health Policy and Management, Rollins 
      School of Public Health, Emory University, Atlanta, Georgia.
FAU - Lipscomb, Joseph
AU  - Lipscomb J
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia3Department of Health Policy and Management, Rollins 
      School of Public Health, Emory University, Atlanta, Georgia.
FAU - Ramalingam, Suresh S
AU  - Ramalingam SS
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia.
FAU - Khuri, Fadlo R
AU  - Khuri FR
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia.
FAU - Flowers, Christopher R
AU  - Flowers CR
AD  - Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia.
LA  - eng
GR  - T32CA160040-02/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - JAMA Oncol
JT  - JAMA oncology
JID - 101652861
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2BT4C47RUI (necitumumab)
SB  - IM
CIN - JAMA Oncol. 2015 Dec;1(9):1301-2. PMID: 26313294
CIN - JAMA Oncol. 2016 Mar;2(3):401. PMID: 26967186
CIN - JAMA Oncol. 2016 Mar;2(3):401-2. PMID: 26967187
CIN - JAMA Oncol. 2016 Mar;2(3):402. PMID: 26967188
CIN - JAMA Oncol. 2016 Mar;2(3):402-3. PMID: 26967189
MH  - Antibodies, Monoclonal/*economics/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Carcinoma, Non-Small-Cell Lung/drug therapy/*economics/mortality
MH  - Cost-Benefit Analysis
MH  - Disease-Free Survival
MH  - Drug Costs
MH  - Humans
MH  - Lung Neoplasms/drug therapy/*economics/mortality
MH  - Markov Chains
MH  - Medicare
MH  - Quality-Adjusted Life Years
MH  - United States
EDAT- 2015/08/28 06:00
MHDA- 2016/04/19 06:00
CRDT- 2015/08/28 06:00
PHST- 2015/08/28 06:00 [entrez]
PHST- 2015/08/28 06:00 [pubmed]
PHST- 2016/04/19 06:00 [medline]
AID - 2430476 [pii]
AID - 10.1001/jamaoncol.2015.3316 [doi]
PST - ppublish
SO  - JAMA Oncol. 2015 Dec;1(9):1293-300. doi: 10.1001/jamaoncol.2015.3316.