Analytical Framework for Examining the Value of Antibacterial Products. 3.2.3 Clinical Phase and NDA/BLA Submission Costs

04/15/2014

There is very limited data on phase costs by therapeutic class in the public domain.  The most widely cited estimates are from DiMasi et al (2004) and are based on confidential data collected from 10 pharmaceutical companies.  For anti-infectives, DiMasi et al (2004) report mean clinical trial phase costs of $23 million, $20 million, and $137 million in 2000 dollars for Phase 1, Phase 2, and Phase 3, respectively.  As acknowledged by the authors, these phase costs are largely driven by the relatively high development costs for antiretroviral drugs for treatment of persons with HIV/AIDS included in the anti-infectives category.

Our discussions with experts and drug sponsors that specialize in antibacterial drug development yielded estimates that are widely different than those of DiMasi et al (2004).  According to experts and company representatives interviewed, current Phase 1 costs for antibacterial drugs range from $7.3 to $12.0 million which includes data management and statistical analysis costs.  Further, our interviewees noted that Phase 2 and Phase 3 costs are likely to vary by the type of indication the new drug is designed to treat.  Among the six indications considered in this study, Phase 2 and 3 costs are likely to be highest for HABP/VABP around $15.0 million and $100.0 million, respectively.  This is primarily because 1) VABP is difficult to clearly define and diagnose and 2) in order to enroll sufficient number of VABP patients in a trial, a large number of trial sites are required, thereby increasing trial costs significantly.  Table 6 shows the clinical phase costs and their likely ranges used in this study.  The DiMasi et al (2004) estimates are presented in the same table for comparison purposes only.


Table 6: Clinical Phase Cost Estimates (in 2012 $ million), by Indication

Estimate ABOM [c] ABSSSI CABP CIAI CUTI HABP/VABP
Phase 1 DiMasi et al (2004) [a] $36.6
ERG Min $7.3
Mean $9.7
Max $12.0
Phase 2 DiMasi et al (2004) [a] $31.8
ERG [d] Min [e] $7.4 $7.12 $7.28 $7.68 $7.28 $12.48
Mean $9.2 $8.9 $9.1 $9.6 $9.1 $15.6
Max [e] $11.0 $10.68 $10.92 $11.52 $10.92 $18.72
Phase 3 DiMasi et al (2004) [a] $218.0
ERG [d] Min [e] $33.36 $26.88 $31.04 $40.48 $35.04 $81.12
Mean $41.7 $33.6 $38.8 $50.6 $43.8 $101.4
Max [e] $50.04 $40.32 $46.56 $60.72 $52.56 $121.68

[a] The figures are inflated to 2012 dollars using the CPI inflator.

[b] Italics indicate that the estimate is extrapolated based on the provided range or point estimate.

[c] Phase 2 and Phase 3 trial costs for ABOM is extrapolated by averaging the costs for ABSSSI, CABP, CIAI, and CUTI for the respective phases.

[d] Costs are based on outsourcing expenditures plus an average of 4.5 FTEs for the duration of the clinical trial phase to the drug sponsor to manage project outsourcing with CRO.  The cost per FTE is estimated at $94,000 per annum based on earnings data provided by the Bureau of Labor Statistics.

[e] The interval around the point estimate is assumed to be ±20%.


The reported new drug application fee for those drug or biologic product applications requiring clinical data is $1,958,800 for fiscal year 2013.  Thus, we use this figure as the NDA/BLA submission cost in the model.

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