Medical Data Analytics Osteoporosis Treatment after Vertebral and Hip Fractures: Analysis of a Managed Care Population in the US Ankita Modi *1, Amber

Medical Data AnalyticsMedical Data AnalyticsMedical Data Analytics

Osteoporosis Treatment after Vertebral and Hip Fractures: Analysis of a Managed Care Population in the US

Ankita Modi*1, Amber Wilk2, Chun-Po Steve Fan3, Shiva Sajjan1 and Panagiotis Mavros1

1Merck & Co. Inc., 2Virginia Commonwealth University, 3AsclepiusJT LLC

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Medical Data Analytics

Abstract

Purpose: It is recommended that fractures patients be treated with pharmacological treatment for osteoporosis to mitigate subsequent fracture risk. This study examined osteoporosis treatment use after vertebral or hip fractures in a US managed care population.Methods: A retrospective analysis using i3 Invision Datamart, a large claims database, from January 2003 to June 2012 (study period) was conducted. Women ≥ 50 years of age with vertebral and/or hip fracture during the study period with continuous enrollment 24 months before (pre-index) and 12 months after (post-index) the first fracture (index date) were included. Women with Paget's disease or malignant neoplasms were excluded. Fractures were identified using ICD-9 diagnosis codes. Osteoporosis treatment included bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid) and non-bisphosphonates (calcitonin, raloxifene, teriparatide, denosumab), which were identified by NDC and HCPCS codes. Charlson comorbidity index (CCI) was used to quantify a patient’s overall comorbid conditions. Pre- and post-index osteoporosis treatment use was assessed by fracture site. Results: 11,433 women ≥ 50 years of age (7,834 vertebral; 3,599 hip fracture) were included in the study. Hip fracture patients were on average older than the ones with vertebral fracture patients (71.3 vs. 66.8 years, p<.001). Hip fracture patients had a significantly higher average CCI than vertebral fracture patients (1.5 vs. 1.3, p<.001). Despite occurrence of fracture, 82.1% of patients did not receive treatment within the 3-month post-index period, and 77% remained untreated at 1-year post-index. The number of hip fracture patients not receiving treatment within 3-month and 1-year post-index periods was significantly higher than that of the vertebral fracture patients (3-month untreated rate: 81.6% vs. 69.4%, p< .001; 1-year untreated rate: 75.0% vs. 62.5%, p<.001). Among those treated within 3-month (1-year) post-index, the average time between fracture and treatment were 13.8 (46.5) and 20.7 (65.4) days for vertebral and hip fracture patients, respectively. Conclusions: This study shows a high rate of undertreatment of osteoporosis with medications after patients experienced vertebral and hip fractures despite treatment recommendations for these high-risk patients. This warrants a need for further education regarding osteoporosis management for patients with prior fractures.

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Background & Rationale

Osteoporosis-related fractures are a significant burden to both healthcare systems and patients. They are associated with increased morbidity, disability, mental health issues, and mortality.

It is recommend that patients with osteoporotic fractures be treated with pharmacological treatment for osteoporosis to mitigate subsequent fracture, especially among patients with vertebral or hip fractures

Despite available treatment options, persistent treatment gaps leave fracture patients at increased risk for repeat fractures

• Understanding the characteristics of patients with osteoporotic fracture and their osteoporosis medication use patterns after fracture is critical for the successful management of healthcare costs and osteoporosis

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Study Objective

• To examine osteoporosis treatment use after vertebral or hip fractures in a US managed care population.

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Methods

• Data Source:

– i3 Invision Datamart database (now known as the Clinformatics™ Data Mart), a large US administrative claims dataset containing medical and pharmacy claims in the study period (Q1 2003-Q2 2012)

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Methods (continued)

Study Population•Inclusion Criteria:

– Women 50 years or older who had an vertebral and hip fractures during the index period from January 1, 2005 to June 30, 2011

– Continuous enrollment for at least two years before (baseline) and one year after (follow-up) the first osteoporosis fracture (index date)

– No prior osteoporosis fracture during the two or more years prior to the index date

•Exclusion Criteria:– Paget's disease (ICD-9 code 731.0) ever in the claims

history– Malignant neoplasms in the two years before and one

year after index date

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Methods (continued)

Study Design

24 Months Baseline Period

12 Months

Follow-up

Jan 1, ‘05 Jun 30, ‘11

Index Date

Index Period

Jan 1, ‘03 Jun 30, ‘12

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Methods (Continued)

• Osteoporosis fractures were assessed based on the following ICD-9 CM diagnosis codes

Fracture Type

ICD-9 CM Code

Vertebral Dorsal & Lumbar: 733.13, 805.2, 805.4Other: 805.0, 805.1, 805.3, 805.6, 805.8, 805.9, 806.xx

Hip Neck of femur: 733.14, 820.xx

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Methods (Continued)

•Osteoporosis medications were identified from pharmacy (NDC) and medical claims (J-codes) and included bisphosphonates (alendronate, risedronate, ibandronate, and zoledronic acid), and non-bisphosphonates (calcitonin, raloxifene, teriparatide, and denosumab)

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Methods (continued)

• Patient groups based on treatment prior to fracture– Treated at baseline: patients who were prescribed any

osteoporosis medication at any time during the baseline period– Currently treated: patients who were treated at baseline and

whose days of supply overlap the index date• Medication adherence

– A patient was said to be adherent to therapy if the medication possession ratio (MPR) was at least 80%.

– The MPR was calculated as the ratio of the medication days supply over the 24-month baseline and 12-month follow-up period.

• Patient characteristics included – Age at fracture; Charlson comorbidity index; medication

adherence; fall history; use of corticosteroids; estrogen, and NSAIDs; and osteoporosis-related comorbidities

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Table 1: Patient Accrual

N= 249, 072

Women ≥1 diagnosis of OP-related fractures in the study period

N = 213,226

Age ≥ 50 as of Index Date (first fracture date)

N = 212,816

Patients without Paget’s disease of the bone

N = 70,084

Patients with 24 months of baseline and 12 months of follow-up continuous eligibility

Patients without malignant neoplasms in the baseline and study period

N = 47,171

Patients with non-vertebral (N=34,396) or with multiple fractures at index ( N=1,342)

Excluded from current analysis

Patients with either vertebral or hip fractures (N=11,433)

Hip (N=3,599)Vertebral (N=7,834)

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Results

• 7, 834 women with vertebral and 3,599 women with hip fractures were eligible for inclusion in this study– Women with hip fractures were older than those with

vertebral (71.3 vs. 66.8 years)– More than half of women with vertebral fractures were

between 50 – 69 years– 27.7 % of women with vertebral fractures were treated at

baseline compared to 20.2% of the women with hip fractures

• 15.1% of vertebral and 9.4% of hip fractured women were treated at the time of the fracture (currently treated)

– History of falls of any type was slightly higher among patients with hip than vertebral fractures (8.7% vs. 7.5%)

– Hip fracture women had a significantly higher average CCI than vertebral fracture women (1.5 vs. 1.3)

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Table 2: Baseline Characteristics by Fracture Type

Characteristic Vertebral (N=7,834)

Hip (N=3,599)

P-value

Age at Index

Mean Age in Years (SD)66.8 (10.2) 71.3 (9.6) <.0001

Age Group 50-592469 (31.5) 610 (16.9) <.0001

Age Group 60-691901 (24.3) 657 (18.3)

Age Group 70-792563 (32.7) 1651 (45.9)

Age Group 80+901 (11.5) 681 (18.9)

Patients w/ Prior Osteoporosis Diagnosis

2,230 (28.5) 745 (20.7) <.0001

History of Falls of Any Type587 (7.5) 313 (8.7) 0.0264

Baseline Osteoporosis Medication 2,171 (27.7) 727 (20.2) <.0001

Currently Treateda 1,181 (15.1) 338 (9.4) <.0001

Charlson Comorbidity Index – Mean (SD)

1.3 (1.7) 1.5 (1.8) <.0001

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Table 3: Concomitant Medications and Comorbid Conditions by Fracture Type

Characteristic Vertebral (N=7,834)

Hip (N=3,599) P-value

Concomitant Medication UseGastroprotective agent

2291 (29.2) 988 (27.5) 0.0491NSAID

3240 (41.4) 1270 (35.3) <.0001Glucocorticoids

2581 (32.9) 839 (23.3) <.0001Estrogens

1467 (18.7) 422 (11.7) <.0001

Comorbid Conditions

Osteopenia1600 (20.4) 506 (14.1) <.0001

Arthritis4808 (61.4) 2151 (59.8) 0.1020

Myocardial Infarction319 (4.1) 168 (4.7) 0.1428

Cerebrovascular Disease1162 (14.8) 731 (20.3) <.0001

Chronic pulmonary Disease2124 (27.1) 857 (23.8) 0.0002

Hypothyroidism1874 (23.9) 747 (20.8) 0.0002

Diabetes1466 (18.7) 757 (21.0) 0.0036

Obesity554 (7.1) 177 (4.9) <.0001

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Results (continued)

• The rate of under treatment did not change drastically before and after the fractures, especially when considering the treatment recommendations for patients with vertebral and hip fractures during the study period– Between baseline and follow-up, about 10%

decrease in under treatment rate was observed among vertebral fractured women compared to approximately 5% in women with hip fractures

– The fact that most of the decrease in under treatment is attributed to treatment receipt during the last 9 months of the follow-up is suggestive of a delay in treatment initiation following a vertebral or hip fracture

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Figure 1: Under-treatment Rate by Fracture Type

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Results (continued)

• Among women treated during the 12 months after fracture:– Majority of women with hip fracture and those with

vertebral fractures (77.1% and 67.4 respectively) received bisphosphonates only therapy

• Women with hip fractures were less adherent to bisphosphonates only therapy as compared to those with vertebral fractures (18.9% vs. 29.2%)

– 7.2 % of women with hip fracture and 12.4% those with vertebral fracture used both bisphosphonate and non- bisphosphonate therapies as a result of switching from one class to another

• 20.6% of women in the hip fracture group being adherent to treatment as compared to 44.4% of those in the vertebral fracture group

– The overall analysis of all women who received treatment after fracture showed that women with hip fractures had lower adherence to therapy compared to those with vertebral fractures (21.2% vs. 29.4%)

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Figure 2: Baseline and After Fracture Adherence rate by Fracture Type

aAdherence defined as MPR ≥0.80; bPatients were switched between bisphosphonate and non-bisphosphonate (not concomitant use)

Notes:[1] Baseline adherence rate were calculated among 2,898 patients who were treated at baseline and experienced vertebral or hip fractures [2] Post-fracture adherence rate among 3,834 patients who were treated following vertebral or hip fractures

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Table 5: Medication Possession Ratio (MPR) and Adherence to Osteoporosis Medications at Baseline

Women with medication use at Baseline

Characteristic Vertebral (N=2,171) Hip (N=727)

Bisphosphonate use only

Users, n (%) 1607 (74.0) 532 (73.2)

Pre-index MPR, mean (SD) 0.48 (0.32) 0.44 (0.31)

Adherent patients,a n (%) 377 (23.5) 91 (17.1)

Non-Bisphosphonate use only

Users, percentage (n) 361 (16.6) 136 (18.7)



Bisphosphonate and Non-Bisphosphonate

use only

Users, n (%) 203 (9.4 ) 59 (8.1)



Baseline osteoporosis treatment overall


Adherent patients, n (%) 532 (24.5) 145 (19.9)


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Table 6: Medication Possession Ratio (MPR) and Adherence to Osteoporosis Medications 12 months

After FractureWomen with medication use at post-index

Characteristic Vertebral (N=2,936) Hip (N=898)

Bisphosphonate use only

Users, n (%)1679 (67.4) 692 (77.1)

Post-index MPR, mean (SD) 0.55 (0.31) 0.49 (0.29)


Non-Bisphosphonate use only

Users, n (%)594 (20.2) 141 (15.7)



Bisphosphonate and Non-Bisphosphonate

use only

Users, n (%)

363 (12.4) 65 (7.2)


Adherent patients,a n (%) 161 (44.4 ) 30 (20.6)

Post index osteoporosis treatment overall


Adherent patientsn (%) 864 (29.4) 190 (21.2)


bAdherence percent is based on the number of users in each drug class categories

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Limitations

• Due to the nature of administrative claims data, inaccuracies associated with coding errors might lead to misclassification of patients

• The analysis relied on prescription claims as a proxy for medication use

• The results are not adjusted for confounders and may be subject to biases

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Conclusions • This study demonstrates that, despite treatment

recommendations, a high percent of women remain untreated or are not adherent to therapy after experiencing vertebral and hip fractures.

• Despite being at high risk for repeat fractures, only a 37.5% of vertebral fracture and 25% of hip fractured women received osteoporosis treatment 12 months after fracture– A significant unmet medical need exists among

women experiencing fractures– Novel osteoporotic treatments may provide

additional tools for disease management• Further education regarding osteoporosis

management to both patients and physicians as well as adherence programs may contribute to improved outcomes and lower health care costs.

Documents

Medical Data Analytics Osteoporosis Treatment after Vertebral and Hip Fractures: Analysis of a Managed Care Population in the US Ankita Modi *1, Amber