Session Information
Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Safety of Biologics and Small Molecules in Rheumatoid Arthritis
Session Type: Abstract Submissions (ACR)
Background/Purpose: An algorithm based on administrative claims data (in lieu of clinical measures) was validated using data from the Veteran’s Affairs (VA) Rheumatoid Arthritis (RA) Registry (VARA). It can be used to evaluate effectiveness of biologic disease modifying anti-rheumatic drugs (DMARDs) and cost per effectively treated patient.
Methods: National VA pharmacy and administrative claims for US veterans initiating biologics (abatacept (ABA) (intravenously [IV]), adalimumab (ADA), etanercept (ETN), infliximab (INF), or rituximab (RIT)) from Jan 1, 2008 to Jan 1, 2011 were evaluated. Patients were included if they newly initiated biologic treatment ≥365days after VA enrollment and were followed for 1-year. Only biologics with ≥100 patients were evaluated.
Clinical effectiveness was estimated using an algorithm based on claims data. Patients who did not fail any of the six algorithm criteria; biologic dose escalation, switching biologics, adding a new non-biologic DMARD, receiving >1 intra-articular glucocorticoid injection, increasing glucocorticoid dose, or low treatment compliance (<80%) were categorized as effectively treated. Cost per effectively treated patient was calculated using annual medication and administration cost divided by the percentage of patients categorized as effectively treated.
Subgroup analyses stratified by age, smoking status, serologic status, and body mass index (BMI) were conducted.
Results: A total of 4,696 patients (mean age 61 years, 87% male) met all inclusion and exclusion criteria. Demographic characteristics were similar across groups. The percentage of patients categorized as effectively treated ranged from 25% to 33% and was higher for self-injected than IV biologics. Annual cost was higher for INF and RIT compared to ABA, ADA, and ETN.
Outcomes were similar across all subgroups other than gender. Men had higher drug cost, but a higher percentage were categorized as effectively treated and the cost per effectively treated patient was lower, ($40.7k vs. $57.5k). Cost per effectively treat patient was lower for current non-smokers, patients with positive rheumatoid factor, positive anti-cyclic citrullinated peptide antibodies (aCCP), and BMI ≥30, but the differences were not statistically significant.
Conclusion: In US veterans, the percentage of patients categorized as effectively treated using the algorithm was highest for ADA (33%) and ETN (32%) and the cost per effectively treated patient was lowest for ETN ($39.4k) and ADA ($41.5k). Male gender was associated with higher annual drug cost but lower cost per effectively treated patient.
|
All (n=4,696) |
ABA (n=117) |
ADA (n=1,989) |
ETN (n=2,069) |
INF (n=254) |
RIT (n=267) |
|
|
n (%) (95% confidence interval) |
||||||
|
Demographics |
|
|
|
|
|
|
|
Age (mean) at index (years) |
61 (61-61) |
62 (60-64) |
61 (60-61) |
61 (60-61) |
62 (60-63) |
63 (61-64) |
|
Gender |
|
|
|
|
|
|
|
Male |
87% (86 – 88%) |
80% (73-88%) |
87% (85-88%) |
87% (86-89%) |
85% (80-89%) |
85% (80-89%) |
|
Smoking Status |
|
|
|
|
|
|
|
Current |
34% (32-35%) |
28% (20-36%) |
33% (31-35%) |
35% (33-37%) |
31% (25-37%) |
31% (25-36%) |
|
Former |
37% (36-39%) |
40% (31-49%) |
37% (35-40%) |
37% (35-39%) |
35% (29-41%) |
39% (33-45%) |
|
Never |
16% (15-17%) |
20% (12-27%) |
17% (15-18%) |
16% (14-17%) |
17% (12-21%) |
16% (12-21%) |
|
Unknown |
13% (12-14%) |
12% (6-18%) |
12% (11-14%) |
13% (12-14%) |
17% (13-22%) |
14% (10-18%) |
|
CCP |
|
|
|
|
|
|
|
Positive |
47% (45-48%) |
46% (37-55%) |
47% (45-49%) |
47% (45-50%) |
43% (36-49%) |
46% (40-52%) |
|
Negative |
20% (19-21%) |
19% (12-26%) |
21% (19-22%) |
21% (19-23%) |
17% (12-22%) |
16% (12-21%) |
|
Unknown |
33% (32-34%) |
35% (26-44%) |
33% (30-35%) |
32% 30-34%) |
41% (35-47%) |
37% (32-43%) |
|
Rheumatoid Factor |
|
|
|
|
|
|
|
Positive |
61% (59-62%) |
57% (48-66%) |
61% (58-63%) |
61% (59-63%) |
51% (45-57%) |
66% (60-71%) |
|
Negative |
28% (27-30%) |
26% (18-34%) |
572 (29%) (27-31%) |
28% (26-30%) |
32% (27-38%) |
25% (20-30%) |
|
Unknown |
11% (10-12%) |
16% (10-23%) |
212 (11%) (9-12%) |
11% (10-12%) |
17% (12-22%) |
9% (6-13%) |
|
BMI (kg/m2) |
30 (30-30) |
30 (29-31) |
30 (29-30) |
30 (29-30) |
30 (29-31) |
29 (28-30) |
|
Outcomes |
|
|
|
|
|
|
|
Effectively treated |
32% (31%-33%) |
25% (17%-33%) |
33% (31%-35%) |
32% (30%-34%) |
26% (21%-32%) |
27% (22%-32%) |
|
Annual Drug Cost ($1,000/patient) |
13.5 (13.3-13.7) |
13.8 (12/5-15.2) |
13.9 (13.5-14.2) |
12.8 (12.4-13.1) |
14.4 (13.4-15.4) |
15.7 (14.8-16.7) |
|
Cost per effectively treated patient ($1,000/patient) |
42,2 (41.1-43.4) |
55.8 (44.8-66.7) |
41.5 (39.8-43.2) |
39.4 (37.8-41.1) |
54.5 (47.0-62.1) |
58.32 (51.5-65.0) |
|
Gender |
||
|
Data presented with 95% CI |
Male (n=4,068) |
Female (n=628) |
|
Annual Drug Cost ($1,000/patient ) |
13.7 (13.4-13.9) |
12.3 (11.0-12.0) |
|
Patients Effectively Treated |
34% (32%-35%) |
21% (18%-25%) |
|
Cost per Effectively Treated Patient ($1,000/patient) |
40.7 (39.6-41.9) |
57.5 (51.9-63.0) |
|
Smoking Status |
||
|
Smoker (n=1,575) |
Nonsmoker (n=2,510) |
|
|
Annual Drug Cost ($1,000/patient ) |
13.2 (12.8-13.5) |
13.7 (13.5-14.0) |
|
Patients Effectively Treated |
29% (27%-32%) |
33% (31%-35%) |
|
Cost per Effectively Treated Patient ($1,000/patient) |
45.00 (42.8-47.3) |
41.5 (40.0-43.0) |
|
aCCP Status |
||
|
Positive (n=2,199) |
Negative (n=949) |
|
|
Annual Drug Cost ($1,000/patient ) |
13.8 (13.4-14.1) |
13.4 (12.9-13.8) |
|
Patients Effectively Treated |
33% (31%-35%) |
29% (26%-32%) |
|
Cost per Effectively Treated Patient ($1,000/patient) |
41.1 (39.5-42.7) |
45.8 (42.7-48.8) |
|
|
Rheumatoid Factor Status |
|
|
Positive (n=2,843) |
Negative (n=1,326) |
|
|
Annual Drug Cost ($1,000/patient ) |
13.5 (13.2-13.8) |
13.4 (13.0-13.8) |
|
Patients Effectively Treated |
33% (31%-35%) |
30% (28%-32%) |
|
Cost per Effectively Treated Patient ($1,000/patient) |
41.0 (39.6-42.5) |
44.5 (42.1-46.9) |
|
|
BMI (kg/m2) |
|
|
≥ 30 (n=1,857) |
<30 (n=2,468) |
|
|
Annual Drug Cost ($1,000/patient ) |
13.8 (13.4-14.1) |
13.6 (13.1-13.6) |
|
Patients Effectively Treated |
33% (31%-35%) |
31% (30%-33%) |
|
Cost per Effectively Treated Patient ($1,000/patient) |
41.9 (40.2-43.7) |
42.5 (40.8-44.1) |
Disclosure:
G. W. Cannon,
Amgen Inc.,
2;
C. C. Teng,
Amgen Inc.,
2;
T. He,
Amgen Inc.,
2;
J. Leng,
Amgen Inc.,
2;
C. C. Lu,
Amgen Inc.,
2;
D. Tang,
Amgen,
3,
Amgen,
1;
N. Shah,
Amgen,
3,
Amgen,
1;
D. J. Harrison,
Amgen,
3,
Amgen,
1;
B. Sauer,
Amgen Inc.,
2.
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