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No. 1, 2006

Clinial and Health Systems Research Branch Update

Potential TB Treatment Cost Savings Using Moxifloxacin-Based Regimens

Moxifloxacin has been proposed as a first-line anti-TB medication that may permit shortening of therapy for TB disease from 6 months to 4. In TB Trials Consortium Study 28, a phase-2 trial, moxifloxacin (M) will be substituted for isoniazid (H) in the initial 2-month intensive phase of TB treatment. The study will assess whether this new regimen will shorten the time to sputum culture conversion; studies in mice have suggested that it will. An anticipated 4-month regimen would consist of 2 months of moxifloxacin, rifampin, pyrazinamide, and ethambutol (2MRZE) followed by 2 months of moxifloxacin and rifampin (2MR) administered 5 days per week. Other regimens containing moxifloxacin that might be considered for study in the future include twice-weekly dosing in both initial and continuation phases (2MRZE2/2MR2), twice-weekly dosing in both initial and continuation phases substituting rifapentine for rifampin (2MPZE2/2MP2), and a Denver-like regimen of 2 weeks’ daily dosing of MRZE followed by 6 weeks of MRZE taken twice weekly followed by 2 months of MR twice weekly (.5MRZE/1.5MRZE2/2MR2).

As a follow-up to an article published in TB Notes No. 4, 2003, describing the potential cost savings of all recommended TB treatment regimens compared with the daily standard, we now add the TBTC Study 28 initial phase moxifloxacin study regimen with a 2MR continuation phase regimen. The table presents estimated costs per patient to TB programs and to society for implementing the various regimens. Direct costs are those incurred by TB programs for medications and personnel to conduct directly observed therapy (DOT). Total costs add patient productivity losses to the direct costs, to estimate the costs to society. All doses are assumed to be administered by DOT. The costs of DOT were estimated by applying the 2001 Medicare allowable charge for a home DOT visit ($49),1 updating it to 2004 dollars ($56), and converting it to a cost by multiplying it by 0.502, which is the average cost-to-charge ratio for pulmonary diseases.2 Patient productivity losses are estimated based on computations of a daily wage from the Bureau of Labor Statistics Average Weekly Earnings,3 adjusted upwards by 22% to include benefits.4 Since most TB programs purchase their medications through the Public Health Service (PHS), estimates of PHS prices are used. All costs have been updated and are reported in 2004 dollars.

The standard regimen of 2 months of daily HRZE followed by 4 months of daily HR is estimated to cost $3,970 in direct costs and $8,162 total. The least costly approved regimen (at $1,469 in direct costs and $2,758 total) is 2 weeks of HRZE followed by 6 weeks of twice weekly HRZE followed by 4 months of isoniazid and rifapentine taken once weekly (0.5HRZE / 1.5HRZE2 / 4HRPT1), which is currently restricted to use in HIV-uninfected patients who do not have cavitary disease and are not culture-positive at 2 months. The 2MRZE/2MR regimen, the initial phase of which is to be investigated in Study 28, is estimated to cost $2,843 in direct costs and $5,423 total, a potential savings of 34% over the standard daily regimen. While it is not the least costly regimen, the proposed Study 28–derived 4-month regimen, if of equal efficacy compared to approved regimens, would add to our list of potential treatment choices that might be quite cost-effective (and very likely to be cost-saving) over the standard daily 6-month regimen. This would be especially true if a new 4-month regimen resulted in significantly greater adherence to treatment and completion, caused similar or fewer adverse events, and was not associated with initial or acquired drug resistance in the populations in which it will be used. The other potential moxifloxacin regimens are projected to be among the least expensive regimens ever, with 2MRZE2/2MR2 potentially saving 73% over the standard daily regimen, 2MPZE2/2MP2 saving 69%, and .5MRZE/1.5MRZE2/2MR2 saving 67%.

It should be emphasized that these moxifloxacin-based regimens are under active study presently. No published trials yet support the safety and efficacy of these proposed regimens, but their promise is substantial. CDC is working in partnership with Bayer pharmaceuticals, the Global Alliance for TB Drug Development, the National Institutes of Health, and other collaborators to evaluate these potential improvements in treatment of TB.

Table. TB Treatment Regimen Implementation Costs
    Total PHS   Estimated DOT Estimated Estimated Estimated Percent Percent
  Regimen Doses Tot Med Cost Cost/Dose Personnel Cost Pt. Prod Loss Direct Costs Total Cost Cost Reduction Direct Cost Reduction
                  From Daily From Daily
Recommended Regimen Initial phase for active TB               Standard Standard
1 2HRZE (300, 600, 1500, 1200) 40 $235 $6 $1,118 $1,290 $1,354 $2,644    
2 .5HRZE/1.5HRZE2 (300,600,1500,1200/900,600,3000,2800) 22 $198 $9 $615 $709 $813 $1,522    
3 2HRZE3 (900, 600, 2500, 2000) 24 $221 $9 $671 $774 $892 $1,666    
4 2HRE (300, 600, 1200) 40 $137 $3 $1,118 $1,290 $1,255 $2,545    
Study 28 2MRZE (400, 600, 1500, 1200) 40 $399 $10 $1,118 $1,290 $1,517 $2,807    
2MRZE2 (400, 600, 1500, 1200) 16 $159 $10 $447 $516 $607 $1,123    
2MRZE3 (400, 600, 1500, 1200) 24 $239 $10 $671 $774 $910 $1,684    
2MPZE2 (400, 900, 1500, 1200) 16 $341 $21 $447 $516 $788 $1,304    
2MPZE2 (400, 1200, 1500, 1200) 16 $407 $25 $447 $516 $854 $1,370    
.5MRZE/1.5MRZE2 (400,600,1500,1200/400,600,3000,2800) 22 $286 $13 $615 $709 $901 $1,610    
.5MPZE/1.5MPZE2 (400,900,1500,1200/400,900,3000,2800) 22 $535 $24 $615 $709 $1,150 $1,860    
  .5MPZE/1.5MPZE2 (400,1200,1500,1200/400,1200,3000,2800) 22 $626 $28 $615 $709 $1,241 $1,950    
  2HPZE2 (600, 900, 1500, 1200) 16 $277 $17 $447 $516 $724 1,240    
  2HRZE2 (900, 900, 1500, 1200) 16 $105 $7 447 $516 $552 1,068    
                     
  Continuation phase for active TB                  
1a 4HR (300, 600) 90 $100 $1 $2,517 $2,902 $2,617 $5,518    
1b,2a 4HR2 (900, 600) 36 $45 $1 1,007 $1,161 $1,052 $2,213    
3a 4HR3 (900, 600) 54 $68 $1 $1,510 $1,741 $1,578 $3,319    
1c,2b 4HP1 (900, 600) 18 $153 $8 $503 $580 $656 $1,236    
  4HP1 (900, 900) 18 $227 $13 $503 580 $730 $1,310    
  4HP2 (900, 600) 36 $305 $8 $1,007 $1,161 $1,312 $2,473    
  4HP2 (900, 900) 36 $454 $13 $1,007 $1,161 $1,460 $2,621    
4a 7HR (300, 600) 155 $173 $1 $4,334 $4,998 $4,507 $9,504    
4b 7HR2 (900, 600) 62 $78 $1 $1,734 $1,999 $1,812 $3,811    
  2MR (400, 600) 40 $208 $5 $1,118 $1,290 $1,326 $2,616    
  2MR2 (400, 600) 16 $83 $5 $447 $516 $531 $1,046    
  2MR3 (400, 600) 24 $125 $5 $671 $774 $796 $1,570    
  2MP2 (400, 900) 16 $265 $17 $447 $516 $712 $1,228    
  2MP2 (400, 1200) 16 $331 $21 $447 $516 $778 $1,294    
                     
  Initial and continuation phases for active TB                  
1/1a 2HRZE/4HR 130 $336 $3 $3,635 $4,191 $3,970 $8,162    
1/1b 2HRZE/4HR2 76 $281 $4 $2,125 $2,450 $2,406 $4,856 41% 39%
1/1c 2HRZE/4HP1 58 $388 $7 $1,622 $1,870 $2,010 $3,880 52% 49%
2/2a .5HRZE/1.5HRZE2/4HR2 58 $243 $4 $1,622 $1,870 $1,865 $3,735 54% 53%
2/2b .5HRZE/1.5HRZE2/4HP1 (600 mg of P) 40 $350 $9 $1,118 $1,290 $1,469 $2,758 66% 63%
3/3a 2HRZE3/4HR3 78 $289 $4 $2,181 $2,515 $2,470 $4,985 39% 38%
4/4a 2HRE/7HR 195 $309 $2 $5,452 $6,287 $5,762 $12,049 -48% -45%
4/4b 2HRE/7HR2 102 $215 $2 $2,852 $3,289 $3,067 $6,356 22% 23%
  2MRZE/2MR 80 $607 $8 $2,237 $2,579 $2,843 $5,423 34% 28%
  2MRZE2/2MR2 32 $243 $8 $895 $1,032 $1,137 $2,169 73% 71%
  2MRZE3/2MR3 48 $364 $8 $1,342 $1,548 $1,706 $3,254 60% 57%
  .5MRZE/1.5MRZE2/2MR2 38 $369 $10 $1,063 $1,225 $1,431 $2,657 67% 64%
  .5MPZE/1.5MPZE2/2MP2 (900 mg of P) 38 $800 $21 $1,063 $1,225 $1,862 $3,088 62% 53%
  .5MPZE/1.5MPZE2/2MP2 (1200 mg of P) 38 $957 $25 $1,063 $1,225 $2,019 $3,244 60% 49%
  2MPZE2/2MP2 (900 mg of P) 32 $606 $19 $895 $1,032 $1,500 $2,532 69% 62%
  2MPZE2/2MP2 (1200 mg of P) 32 $737 $23 $895 $1,032 $1,632 $2,664 67% 59%

—Reported by Suzanne Marks, MPH, MA
Div of TB Elimination

References
  1. Health Care Consultants of America, Inc. 2001 Physicians Fee and Coding Guide. Augusta, GA. 2002.
  2. The DRG Handbook: Comparative Clinical and Financial Standards. Ernst & Young LLP. 1998:21.
  3. US Department of Labor. Bureau of Labor Statistics. Average Weekly Earnings of Production Workers. Average for 2001. (www.bls.gov)
  4. Grosse SD. Appendix I: Productivity Loss Tables. In Haddix AC. Teutsch SM, Corso PS. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Second Edition. Oxford University Press, 2003.

 

 
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