Exhibit 4. Results of four logistic regression models analyzing patient characteristics associated with non-adherence to SERM or AI therapy among elderly hormone receptor-positive female breast cancer patients enrolled in a Medicare Part D prescription drug plan, May 2006 - December 2007.
| Dependent variable: 1=non-adherent; 0=adherent | SERM | AI | ||||||
|---|---|---|---|---|---|---|---|---|
|
|
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| Non-low income subsidy | Low income subsidy | Non-low income subsidy | Low income subsidy | |||||
|
|
||||||||
| N | 2,072 | 560 | 5,094 | 1,651 | ||||
| Independent variable | Odds ratio | 95% CI | Odds ratio | 95% CI | Odds ratio | 95% CI | Odds ratio | 95% CI |
|
|
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| Part D benefit-related | ||||||||
| Average out-of-pocket cost for | ||||||||
| 30 day supply1 | ||||||||
| No Part D low income subsidy | ||||||||
| $0 - $4.99 | 1.00 | — | 1.00 | — | ||||
| $5.00 - $14.99 | 1.41 | (1.09, 1.82) | 1.24 | (0.78, 1.96) | ||||
| $15.00 - $29.99 | 3.312 | (2.14, 5.12) | 4.52 | (3.05, 6.69) | ||||
| $30.00 + | — | 4.47 | (3.02, 6.61) | |||||
| Part D low income subsidy | ||||||||
| $0 - $1.99 | 1.00 | — | 1.00 | — | ||||
| $2.00 - $4.99 | 2.153 | (1.25, 3.71) | 1.37 | (1.03, 1.84) | ||||
| $5.00+ | — | 2.00 | (1.37, 2.93) | |||||
| Coverage gap benefits | 1.16 | (0.87, 1.55) | 0.60 | (0.37, 0.97) | ||||
| Plan type | ||||||||
| MAPD | 1.12 | (0.85, 1.47) | 1.46 | (0.87, 2.43) | 0.93 | (0.80, 1.08) | 0.97 | (0.68, 1.39) |
| PDP | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| Demographic/health status | ||||||||
| Age at Part D enrollment | ||||||||
| 65 – 69 | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| 70 – 79 | 0.88 | (0.65, 1.20) | 0.94 | (0.55, 1.60) | 1.05 | (0.90, 1.22) | 0.97 | (0.72, 1.31) |
| 80 + | 1.15 | (0.82, 1.61) | 0.87 | (0.48, 1.58) | 0.99 | (0.82, 1.20) | 1.09 | (0.76, 1.55) |
| Race/ethnicity | ||||||||
| White non-Hispanic | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| White Hispanic | 1.38 | (0.83, 2.28) | 0.81 | (0.42, 1.58) | 1.31 | (0.98, 1.74) | 1.17 | (0.79, 1.72) |
| Black (non-Hisp. & Hisp.) | 2.60 | (1.39, 4.87) | 1.23 | (0.62, 2.43) | 1.86 | (1.35, 2.55) | 1.41 | (0.96, 2.06) |
| Other/unknown | 0.62 | (0.33, 1.20) | 0.79 | (0.36, 1.75) | 1.00 | (0.72, 1.40) | 1.25 | (0.77, 2.04) |
| Married | 1.02 | (0.82, 1.28) | 1.07 | (0.64, 1.78) | 0.77 | (0.68, 0.88) | 1.09 | (0.81, 1.48) |
| Urban/rural | ||||||||
| Large metro area | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| Metro/urban | 0.98 | (0.72, 1.35) | 0.93 | (0.50, 1.75) | 1.11 | (0.93, 1.34) | 1.20 | (0.83, 1.73) |
| Less urban/rural | 0.86 | (0.51, 1.47) | 0.64 | (0.25, 1.60) | 1.15 | (0.80, 1.64) | 0.69 | (0.37, 1.31) |
| Median income at census tract/ZIP Code level | ||||||||
| < $30K | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| $30K - $49K | 1.11 | (0.74, 1.65) | 0.44 | (0.25, 0.75) | 1.01 | (0.79, 1.30) | 1.01 | (0.74, 1.39) |
| $50K + / unknown | 1.08 | (0.71, 1.65) | 0.66 | (0.34, 1.27) | 0.90 | (0.70, 1.16) | 0.68 | (0.46, 1.01) |
| HCC risk score | ||||||||
| < = 1.00 | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| 1.01 - 2.00 | 1.19 | (0.93, 1.53) | 0.64 | (0.39, 1.04) | 1.04 | (0.90, 1.21) | 1.16 | (0.84, 1.60) |
| 2.01 + | 1.73 | (1.24, 2.40) | 0.79 | (0.45, 1.37) | 1.15 | (0.96, 1.38) | 1.47 | (1.05, 2.07) |
| Cancer-related | ||||||||
| Year of diagnosis | ||||||||
| 2003 | 0.86 | (0.65, 1.13) | 1.09 | (0.64, 1.86) | 1.13 | (0.97, 1.32) | 1.21 | (0.88, 1.68) |
| 2004 | 0.97 | (0.74, 1.27) | 1.26 | (0.72, 2.21) | 1.02 | (0.88, 1.18) | 1.36 | (1.01, 1.82) |
| 2005 | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| Stage at diagnosis | ||||||||
| I | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| II | 0.91 | (0.71, 1.18) | 1.27 | (0.81, 1.99) | 0.94 | (0.82, 1.08) | 1.35 | (1.02, 1.78) |
| III/IV | 1.54 | (0.89, 2.68) | 1.71 | (0.76, 3.87) | 1.00 | (0.79, 1.26) | 1.29 | (0.87, 1.92) |
| Initial course of therapy | ||||||||
| Mastectomy | 1.00 | — | 1.00 | — | 1.00 | — | 1.00 | — |
| BCS + radiation | 1.10 | (0.84, 1.44) | 1.11 | (0.67, 1.82) | 0.98 | (0.84, 1.14) | 1.15 | (0.85, 1.54) |
| BCS, no radiation4 | 0.91 | (0.65, 1.29) | 0.93 | (0.50, 1.73) | 1.22 | (1.00, 1.49) | 1.10 | (0.76, 1.59) |
1
Prior to the coverage gap.
2
Includes 22 cases with out-of-pocket costs of $30+.
3
Includes 11 cases with out-of-pocket costs of $5+.
4
Includes unknown radiation therapy status.
Notes:
- SERM = selective estrogen receptor modulator; AI = aromatase inhibitor; BCS=breast conserving surgery; MAPD=Medicare Advantage prescription drug plan; PDP=stand-alone prescription drug plan; CI=confidence interval; HCC=Hierarchical Condition Category.
- Table includes beneficiaries diagnosed between 2003 and 2005 with at least 12 months of Part D enrollment between May 2006 and December 2007.• Cases with both AI and SERM were excluded from this analysis.
- The models exclude 12 SERM and 57 AI non-low income subsidy cases with no pre-coverage gap claims.
- Non-adherence is defined as a medication possession ratio of less than 80 percent.
- The model also includes variables for each SEER registry (data not shown in table). Source: SEER-Medicare.