advertisement

Cost-effective Treatment and Fracture Risk

60 %
40 %
advertisement
Information about Cost-effective Treatment and Fracture Risk
Health & Medicine

Published on January 28, 2009

Author: demiss

Source: slideshare.net

advertisement

Cost Effective Treatment of Osteoporosis Utilizing the US Adapted WHO Fracture Risk Algorithm Sanford Baim MD, FACR, CCD Colorado Center for Bone Research Lakewood, Colorado

Discussion Points Why consider “ absolute fracture risk ” when considering patients future osteoporotic fracture risk? What is the World Health Organization Fracture Risk Assessment Tool (FRAX™)? Why consider new guidelines for osteoporosis treatment when the T-score based cut-points work fine? What are the National Osteoporosis Foundation cost-effective treatment guidelines?

Why consider “ absolute fracture risk ” when considering patients future osteoporotic fracture risk?

What is the World Health Organization Fracture Risk Assessment Tool (FRAX™)?

Why consider new guidelines for osteoporosis treatment when the T-score based cut-points work fine?

What are the National Osteoporosis Foundation cost-effective treatment guidelines?

WHO Bone Density Criteria: A Diagnostic Threshold Diagnostic criteria* Classification T is above or equal to -1 Normal T is between -1 and -2.5 Osteopenia (low bone mass) T -2.5 or lower Osteoporosis T -2.5 or lower + fragility fracture Severe established osteoporosis * T-score is the number of standard deviations above or below the average peak bone density in young adults

Treatment Guidelines Prior to 2008 Based on BMD and CRFs T-score thresholds Treat Do not Treat BMD + CRFs NOF NOF Risk Factors AACE Risk Factors NAMS Risk Factors ACOG Risk Factors ALL Fragility Fracture (with or without low BMD) -2.5 -2.0 -1.5

Clinical Utility of the WHO T-score Diagnostic Classification Definition of osteoporosis based on DXA only Easy to understand and used worldwide Increased diagnosis and treatment Identifies high risk patients prior to a fracture Correlation with fracture risk Comparability

Definition of osteoporosis based on DXA only

Easy to understand and used worldwide

Increased diagnosis and treatment

Identifies high risk patients prior to a fracture

Correlation with fracture risk

Comparability

Caveats of the WHO T-score Diagnostic Classification Application to other races/ethnicities WHO selection of femoral neck only for diagnosis Influenced by reference databases used Refers only to DXA spine and hip (1/3 radius) BMD alone results in low sensitivity Inappropriate/inadequate treatment of patients based on WHO T-scores and professional society intervention thresholds

Application to other races/ethnicities

WHO selection of femoral neck only for diagnosis

Influenced by reference databases used

Refers only to DXA spine and hip (1/3 radius)

BMD alone results in low sensitivity

Inappropriate/inadequate treatment of patients based on WHO T-scores and professional society intervention thresholds

BMD and Relative Risk Bone Density (T-score) Relative Risk for Fracture Marshall, BMJ, 1996

Gradients of Risk in Women for a 1 SD Decrease in BMD Below Age-adjusted mean Site of Measurement Distal radius Hip Lumbar spine Forearm Fracture 1.7 1.4 1.5 Hip Fracture 1.8 2.6 1.6 Vertebral Fracture 1.7 1.8 2.3 All Fractures 1.4 1.6 1.5 Marshall, BMJ, 1996

Example of Relative Risk Using T-scores in Fracture Prediction Compare 50 and 70 y/o Caucasian woman Both have a femoral neck T −2.0 and Z −1.0 Relative risk of hip fracture at FN is 2.6 Increased fracture risk is 2.6  for every 1 SD decrease in BMD (gradient of risk) RR = GR (T or Z score) = 2.6 (2) = 6.8 What is RR compared to a patient of the same age with a T or Z score of 0.0 ? C Marshall D, BMJ. 1996:312:1254 .

Compare 50 and 70 y/o Caucasian woman

Both have a femoral neck T −2.0 and Z −1.0

Relative risk of hip fracture at FN is 2.6

Increased fracture risk is 2.6  for every 1 SD decrease in BMD (gradient of risk)

RR = GR (T or Z score) = 2.6 (2) = 6.8

What is RR compared to a patient of the same age with a T or Z score of 0.0 ?

Marshall D, BMJ. 1996:312:1254 .

Relative Risk Using T-scores and GR 50 y/o T – 2.0 hip fracture risk 6.8 times greater than 50 y/o with a T = 0.0 2.6 times greater than 50 y/o with a Z = 0.0 70 y/o T – 2.0 hip fracture risk 6.8 times greater than a 70 y/o with a T = 0.0 2.6 times greater than a 70 y/o with a Z = 0.0 Absolute Risk Using FRAX ™ 50 y/o 10-year hip fracture risk = 1.3% (7.5% MF) 70 y/o 10-year hip fracture risk = 2.5% (19% MF)

50 y/o T – 2.0 hip fracture risk

6.8 times greater than 50 y/o with a T = 0.0

2.6 times greater than 50 y/o with a Z = 0.0

70 y/o T – 2.0 hip fracture risk

6.8 times greater than a 70 y/o with a T = 0.0

2.6 times greater than a 70 y/o with a Z = 0.0

50 y/o 10-year hip fracture risk = 1.3% (7.5% MF)

70 y/o 10-year hip fracture risk = 2.5% (19% MF)

Problem with Relative Risk and Fracture Prediction Fracture risk expressed as relative risk does not provide a true assessment of the likelihood (probability) of fracture Using DXA for determination of fracture risk only provides one component of bone strength Does not measure qualitative strength Clinic based technologies do not provide a complete appreciation of bone strength

Fracture risk expressed as relative risk does not provide a true assessment of the likelihood (probability) of fracture

Using DXA for determination of fracture risk only provides one component of bone strength

Does not measure qualitative strength

Clinic based technologies do not provide a complete appreciation of bone strength

Problem with Fracture Prediction Using T-scores and WHO Diagnostic Criteria

C Number of subjects BMD in Patients With and Without Fractures EPOS Study Group, JBMR , 2002

Relationship Between Fracture Risk & BMD Osteoporosis is a multi-factorial disease BMD only captures a minority of fracture risk From 50 – 90 y/o annual incidence of hip fracture increases 30 fold Using BMD, loss with age would result in an increases hip fracture risk 4 fold Increase risk of hip fracture with age is 7 fold greater than explained by BMD alone Intervention thresholds based on BMD Low sensitivity and low positive predictive value Kanis, OI , 2008

Osteoporosis is a multi-factorial disease

BMD only captures a minority of fracture risk

From 50 – 90 y/o annual incidence of hip fracture increases 30 fold

Using BMD, loss with age would result in an increases hip fracture risk 4 fold

Increase risk of hip fracture with age is 7 fold greater than explained by BMD alone

Intervention thresholds based on BMD

Low sensitivity and low positive predictive value

Effect of Gradient of Risk on Prediction of Future Fracture Risk

Age as an Independent Risk Factor for Fracture Adapted from Kanis , OI , 2001 Probability of clinical osteoporotic fractures in Swedish women Gradient of risk Ten Year Fracture Probability (%) Age 80 70 60 50

Prior Fracture as an Independent Risk Factor for Fracture Klotzbuecher , JBMR , 2000 RR Incident Fracture Prevalent Fracture Wrist Vertebra Hip Wrist 3.3 1.7 1.9 Vertebra 1.4 4.4 2.3 Hip NA 2.5 2.3

Combined Effect of BMD and Clinical Risk Factors on Fracture Risk Rate of hip fracture (per 1000 woman-yr) Calcaneal bone density No. of risk factors Cummings, N EJM, 1995 27.3 14.7 9.4 0 5 10 15 20 25 30 Lowest third Middle third Highest third 0-2 3-4 >4

Fracture Probability

WHO Scientific Group on Assessment of Osteoporosis at the Primary Health Care Level John A Kanis (Chairman) Philippe Bonjour Juliet Compston Bess Dawson-Huges Helena Johansson Edith Lau Robert Lindsay Joseph Melton III Michael McClung Anders Oden Bruce Pfleger Ger Teilen Patricia Clark WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008 Cyrus Cooper Chris De Laet Claus Gluer Olof Johnell Nikolai Khaltaev E. Michael Lewiecki Paul T Lips Eugene V McCloskey Paul Miller Socrates E Papapoulos Stuart Silverman Natalia Toroptsova

John A Kanis (Chairman)

Philippe Bonjour

Juliet Compston

Bess Dawson-Huges

Helena Johansson

Edith Lau

Robert Lindsay

Joseph Melton III

Michael McClung

Anders Oden

Bruce Pfleger

Ger Teilen

Patricia Clark

Cyrus Cooper

Chris De Laet

Claus Gluer

Olof Johnell

Nikolai Khaltaev

E. Michael Lewiecki

Paul T Lips

Eugene V McCloskey

Paul Miller

Socrates E Papapoulos

Stuart Silverman

Natalia Toroptsova

Develop a standardized methodology CRFs combined with BMD to improve sensitivity for any specificity Increased gradient of risk Greater positive predictive value Quantitative fracture risk assessment Can be used for intervention thresholds Application to men and women, all ethnicities and worldwide WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008

Develop a standardized methodology

CRFs combined with BMD to improve sensitivity for any specificity

Increased gradient of risk

Greater positive predictive value

Quantitative fracture risk assessment

Can be used for intervention thresholds

Application to men and women, all ethnicities and worldwide

Large prospective population-based epidemiologic studies correlate CRFs +/- BMD for Fx outcomes Initial analysis 12 prospectively studied cohorts Over 60,000 subjects (250,000 person-years) Rotterdam, EVOS, CMOS, Rochester, Sheffield, DOES, EPIDOS, OFELY, Kupio, Hiroshima, Gothenburg (2) Validated in additional 11 study cohorts Over 230,000 subjects (1.2 million person-years) EPIDOS, SOF, Geelong (2), OPUS, PERF, YORK, THIN, SEMOF, WHI, Miyama WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008

Large prospective population-based epidemiologic studies correlate CRFs +/- BMD for Fx outcomes

Initial analysis 12 prospectively studied cohorts

Over 60,000 subjects (250,000 person-years)

Rotterdam, EVOS, CMOS, Rochester, Sheffield, DOES, EPIDOS, OFELY, Kupio, Hiroshima, Gothenburg (2)

Validated in additional 11 study cohorts

Over 230,000 subjects (1.2 million person-years)

EPIDOS, SOF, Geelong (2), OPUS, PERF, YORK, THIN, SEMOF, WHI, Miyama

WHO Fracture Risk Model -FRAX™- Identify 10-year hip/major osteoporosis fracture intervention threshold Country specific cost and health consequences of fracture CRFs selected Likelihood risk identified amenable to treatment Easy use of risk factor in clinical practice as a baseline or outcome variable WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008

Identify 10-year hip/major osteoporosis fracture intervention threshold

Country specific cost and health consequences of fracture

CRFs selected

Likelihood risk identified amenable to treatment

Easy use of risk factor in clinical practice as a baseline or outcome variable

FRAX ™ Model Analysis of CRFs Meta-analysis for each CRF and for M/F Covariates examined (age, sex, BMD, time since assessment and covariate itself) Merging of each risk factor to account for interdependence of the risk factors chosen Risk provided by any combination of CRFs With or without BMD

Meta-analysis for each CRF and for M/F

Covariates examined (age, sex, BMD, time since assessment and covariate itself)

Merging of each risk factor to account for interdependence of the risk factors chosen

Risk provided by any combination of CRFs

With or without BMD

FRAX™ Clinical Risk Factors Age (40-90 years) Gender BMI (height and weight) Prior fragility fracture (y/n) Current smoking (y/n) Other secondary etiologies (y/n) Family history of hip fracture (y/n) Glucocorticoids ever used (y/n) Rheumatoid arthritis (y/n) Alcohol ≥3 units/d (y/n) WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008

Age (40-90 years)

Gender

BMI (height and weight)

Prior fragility fracture (y/n)

Current smoking (y/n)

Other secondary etiologies (y/n)

Family history of hip fracture (y/n)

Glucocorticoids ever used (y/n)

Rheumatoid arthritis (y/n)

Alcohol ≥3 units/d (y/n)

Secondary Etiologies Associated With Increased Fracture Risk Rheumatoid arthritis Other diseases and medical conditions Untreated hypogonadism Oophorectomy, orchidectomy Anorexia, chemotherapy, hypopituitarism Inflammatory bowel disease Prolonged immobility Type 1 Diabetes Thryroid (untreated and over-treatment) Organ transplantation WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008

Rheumatoid arthritis

Other diseases and medical conditions

Untreated hypogonadism

Oophorectomy, orchidectomy

Anorexia, chemotherapy, hypopituitarism

Inflammatory bowel disease

Prolonged immobility

Type 1 Diabetes

Thryroid (untreated and over-treatment)

Organ transplantation

FRAX 10-year Fracture Risk Using the Same Demographics Except for Race/Ethnicity 74 year old female 65 kg 165 cm Previous fracture FN T – 1.5

74 year old female

65 kg

165 cm

Previous fracture

FN T – 1.5

FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool

FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool

FRAX – USA (Caucasian Female) http://www.shef.ac.uk/FRAX/tool

FRAX USA – (Hispanic female) http://www.shef.ac.uk/FRAX/tool

FRAX USA – (Asian female) http://www.shef.ac.uk/FRAX/tool

FRAX – USA (Black female) http://www.shef.ac.uk/FRAX/tool

Secondary osteoporosis / No BMD Secondary osteoporosis + BMD Secondary osteoporosis/No BMD+RA BMD without secondary CRFs ☻ ☻ ☻ ☻

Low BMI / No BMD Normal BMI / No BMD Normal BMI + BMD Low BMI + BMD

FRAX™ Caveats Does not include all CRFs (risk of falling) Does not model known dose-dependence of several CRFs and those that exceed assumptions Multiple fractures Severity of fractures Multiple risk factors (RA + hypogonadism) Dose of glucocorticoids Other meds FRAX™ does not apply to patients on treatment, premenopausal women and younger men

Does not include all CRFs (risk of falling)

Does not model known dose-dependence of several CRFs and those that exceed assumptions

Multiple fractures

Severity of fractures

Multiple risk factors (RA + hypogonadism)

Dose of glucocorticoids

Other meds

FRAX™ does not apply to patients on treatment, premenopausal women and younger men

Treatment below AR/Rx threshold Younger female (32 y/o) with surgical menopause (considered very low risk) Woman 35 y/o vs. 55 y/o (male 35 y/o ) on glucocorticoids (considered very low risk) DXA machine (GE) uses weight adjustment Lumbar spine T/Z scores not allowed AVN of hips OA of hips Bilateral THA FRAX™ Caveats

Treatment below AR/Rx threshold

Younger female (32 y/o) with surgical menopause (considered very low risk)

Woman 35 y/o vs. 55 y/o (male 35 y/o ) on glucocorticoids (considered very low risk)

DXA machine (GE) uses weight adjustment

Lumbar spine T/Z scores not allowed

AVN of hips

OA of hips

Bilateral THA

For T-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD Female Caucasian dbase for all For Z-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD Caucasian female db for all females Caucasian male dbase for all males All central DXA machines use 1995 NHANES III database for mean BMD and SD calculation FRAX™ website and DXA machine patch needed FRAX™ Caveats

For T-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD

Female Caucasian dbase for all

For Z-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD

Caucasian female db for all females

Caucasian male dbase for all males

All central DXA machines use 1995 NHANES III database for mean BMD and SD calculation

FRAX™ website and DXA machine patch needed

FRAX Patch http://www.orost.com/fraxpatch

FRAX TM T-scores FN BMD was the primary data source from observational databases T-scores for all subjects calculated using NHANES III Caucasian female database (1998) Adjustment for gender and ethnic differences between BMD and fracture risk accomplished with country-specific gender and ethnic databases in FRAX TM FRAX ™ Patch: Background Courtesy of Mike McClung

FRAX TM T-scores

FN BMD was the primary data source from observational databases

T-scores for all subjects calculated using NHANES III Caucasian female database (1998)

Adjustment for gender and ethnic differences between BMD and fracture risk accomplished with country-specific gender and ethnic databases in FRAX TM

FRAX TM T-scores Hologic NHANES database uses 1995 data Non-Hologic BMD values were transformed into “Hologic-equivalents” by the formulae of Lu et al. ( Osteoporos Int 2001;12:438-444) None of the T-scores generated by DXA machines is correct for use in FRAX TM FRAX ™ Patch: Background Courtesy of Mike McClung

FRAX TM T-scores

Hologic NHANES database uses 1995 data

Non-Hologic BMD values were transformed into “Hologic-equivalents” by the formulae of Lu et al. ( Osteoporos Int 2001;12:438-444)

None of the T-scores generated by DXA machines is correct for use in FRAX TM

FRAX ™ Patch Calculator to provide the appropriate T-score to use in FRAX TM model – Enter brand of DXA machine – Enter FN BMD (gm/cm 2 ) – FRAX T-score provided NOF website Incorporated into FRAX website calculator to replace T & Z-scores? Courtesy of Mike McClung

Calculator to provide the appropriate T-score to use in FRAX TM model

– Enter brand of DXA machine

– Enter FN BMD (gm/cm 2 )

– FRAX T-score provided

NOF website

Incorporated into FRAX website calculator to replace T & Z-scores?

Summary Courtesy of Mike McClung www.orost.com/fraxpatch

Courtesy of Mike McClung www.orost.com/fraxpatch

Use of FRAX™ on DXA Machines Manufacturers absolute fracture risk (FRAX ™) software approved by FDA Manufacturers software converts femoral neck BMD into appropriate T-scores for insertion in WHO FRAX ™ software added to manufacturers DXA computer Enter clinical risk factors into algorithm 10-year major and hip fracture risk calculated

Manufacturers absolute fracture risk (FRAX ™) software approved by FDA

Manufacturers software converts femoral neck BMD into appropriate T-scores for insertion in WHO FRAX ™ software added to manufacturers DXA computer

Enter clinical risk factors into algorithm

10-year major and hip fracture risk calculated

Integrated FRAX Report Risk Factors 61 yr Caucasian female T-score = -1.7 Previous Fracture Smoking Major Osteoporotic Fracture 21% Hip Fracture 3.6%

Risk Factors

61 yr Caucasian female

T-score = -1.7

Previous Fracture

Smoking

Major Osteoporotic Fracture 21%

Hip Fracture 3.6%

 

 

NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis Development Committee Bess Dawson-Hughes (Chair), NOF Robert Lindsay (Co-chair), NOF Sundeep Khosla, NOF L. Joseph Melton III, NOF Anna N.A. Tosteson, NOF Murray Favus, ASBMR Sanford Baim, ISCD Interspecialty Medical Council Reviewers Laura Tosi, AAOS Kenneth W. Lysles, AGS Martin Grabois, AAP Helena W. Rodbard, AMA Richard W. Kruse, AAP Marc F. Swiontkowski, AOA Partricia Graham, AAPMR Kendrin Van Steenwyk, AOA Donald Berman, AACE Shonni Silverberg, ASBMR William C. Andrews, ACOG E. Michael Lewiecki, ISCD Michael Gloth III, ACP John L. Melvin, ISPRM Ronald Bernard Staron, ACR Wendi El-Amin, NMA Lenore Buckley, ACRheum Carolyn Becker, TES

NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis –Contents– Osteoporosis Impact and Overview Basic pathophysiology Approach to the Dx and Rx of osteoporosis NOF adapted FRAX™ with US inputs Cost-effective thresholds for Rx Universal recommendations Pharmacologic therapy Physical medicine and rehabilitation www.nof.org/professionals/Clinicians_Guide.htm

Osteoporosis Impact and Overview

Basic pathophysiology

Approach to the Dx and Rx of osteoporosis

NOF adapted FRAX™ with US inputs

Cost-effective thresholds for Rx

Universal recommendations

Pharmacologic therapy

Physical medicine and rehabilitation

NOF Technical Reports Cost-effective Osteoporosis Treatment Thresholds: The US Perspective Calibration of the WHO fracture algorithm to USA for 10-year hip fracture (major osteoporotic fracture) probability National age-, sex and race-specific death rates Age-and sex-specific hip fracture incidence rates 10-year hip fracture probability (major osteoporotic fracture) at which treatment becomes cost-effective Tosteson, OI , 2008

Cost-effective Osteoporosis Treatment Thresholds: The US Perspective

Calibration of the WHO fracture algorithm to USA for 10-year hip fracture (major osteoporotic fracture) probability

National age-, sex and race-specific death rates

Age-and sex-specific hip fracture incidence rates

10-year hip fracture probability (major osteoporotic fracture) at which treatment becomes cost-effective

NOF Technical Reports Implications of Absolute Fracture Risk Assessment for Osteoporosis Practice Guidelines in the USA Cost-effective to treat patients Fragility fractures Osteoporosis by WHO DXA diagnostic criteria Osteopenia with CRFs Dawson-Hughes, OI , 2008

Implications of Absolute Fracture Risk Assessment for Osteoporosis Practice Guidelines in the USA

Cost-effective to treat patients

Fragility fractures

Osteoporosis by WHO DXA diagnostic criteria

Osteopenia with CRFs

Determination of US Cost-Effective Treatment Threshold Clinical Measurement (BMD) Clinical risk factors Pharmacologic treatment (efficacy/cost) Epidemiologic US fracture major/hip fracture incidence Mortality and morbidity from fractures Life expectancy Economic Factors (wealth of nation-GDP/capita) Disease-related costs Cost of intervention and longer life Willingness to pay (health care expenses/priorities) Borgstrom , OI, 2 006

Clinical

Measurement (BMD)

Clinical risk factors

Pharmacologic treatment (efficacy/cost)

Epidemiologic

US fracture major/hip fracture incidence

Mortality and morbidity from fractures

Life expectancy

Economic Factors (wealth of nation-GDP/capita)

Disease-related costs

Cost of intervention and longer life

Willingness to pay (health care expenses/priorities)

NOF Methodology and Assumptions Incidence of clinical fractures* Other female races/ethnicities Black women 57% less likely to fracture Asian women 50% less Hispanic women 47% less Other male races/ethnicities Black men 47% less likely to fracture Asian men 36% less Hispanic men 42% less *Clinical Fractures: hip, wrist, spine and “other” including proximal humerus, rib, pelvis, & tibia/fibula ( ♀ only) Tosteson, OI , 2008

Incidence of clinical fractures*

Other female races/ethnicities

Black women 57% less likely to fracture

Asian women 50% less

Hispanic women 47% less

Other male races/ethnicities

Black men 47% less likely to fracture

Asian men 36% less

Hispanic men 42% less

NOF Methodology and Assumptions Treatment course of 5-years Persistence of 100% Treatment off set at 5-years Fracture reduction 35% Cost for interventions & treating fractures same for all ages, races/ethnicities, gender Tosteson, OI , 2008

Treatment course of 5-years

Persistence of 100%

Treatment off set at 5-years

Fracture reduction 35%

Cost for interventions & treating fractures same for all ages, races/ethnicities, gender

NOF Methodology and Assumptions Annual bisphosphonate drug cost of $600 Physician visit $49 per year DXA study $82 in second year of treatment Duration of fracture-related loss in QOL (5 years) Annual age, sex- and race specific mortality rates from 2001 USA life-tables Tosteson, OI , 2008

Annual bisphosphonate drug cost of $600

Physician visit $49 per year

DXA study $82 in second year of treatment

Duration of fracture-related loss in QOL (5 years)

Annual age, sex- and race specific mortality

rates from 2001 USA life-tables

Mean health state values derived from EuroQol NOF Methodology and Assumptions Tosteson, OI, 2008

Mean health state values derived from EuroQol

NOF Methodology and Assumptions Loss of health-related QOL for each fracture (disutility) limited to a 5-year horizon Tosteson, OI , 2008 Parameter Hip Fracture Disutility in 1 st year 0.208 Disutility in 2 nd year 0.187 Cost in 1 st year $29,449 Cost-subsequent years $7,156

Loss of health-related QOL for each fracture (disutility) limited to a 5-year horizon

Impact of Duration in Fracture-Loss in Quality of Life on 10-year Hip Fracture Which Treatment Becomes Cost-effective Tosteson, OI , 2008

NOF Methodology and Assumptions Cost analysis Cost per QALY gained (cost-effectiveness Rx vs. no treatment) Incremental cost-effectiveness ratios (ICERs) Calculated by dividing the difference in mean total discounted costs between treated and untreated divided by the respective difference in QAL expectancy Willingness-to-pay threshold as cost effective = $60,000 per QOL gained Tosteson, OI , 2008

Cost analysis

Cost per QALY gained (cost-effectiveness Rx vs. no treatment)

Incremental cost-effectiveness ratios (ICERs)

Calculated by dividing the difference in mean total discounted costs between treated and untreated divided by the respective difference in QAL expectancy

Willingness-to-pay threshold as cost effective = $60,000 per QOL gained

NOF 2008 Treatment Recommendations Postmenopausal women and men age 50 and older presenting with the following: A hip or vertebral (clinical or morphometric) fracture T-score ≤ -2.5 at the femoral neck, total hip or spine after appropriate evaluation to exclude secondary causes Low bone mass at the femoral neck, total hip, or spine and a 10-year probability of hip fracture ≥3% or a 10-year probability of major osteoporosis-related fracture ≥20% based on the U.S.-adapted WHO algorithm www.nof.org/professionals/Clinicians_Guide.htm

Postmenopausal women and men age 50 and older

presenting with the following:

A hip or vertebral (clinical or morphometric) fracture

T-score ≤ -2.5 at the femoral neck, total hip or spine after appropriate evaluation to exclude secondary causes

Low bone mass at the femoral neck, total hip, or spine and a 10-year probability of hip fracture ≥3% or a 10-year probability of major osteoporosis-related fracture ≥20% based on the U.S.-adapted WHO algorithm

10-year Fracture Risk 50 Year Old White Female with BMI 24 5.2% 0.4% 9.4% 2.5% 2.5% 9.2% 16% 2.6% 10% 4.3% 17% 4.5% 28% 8.3%

2003 NOF Physician Guide Treatment Recommendations Core data from Kanis, OI , 2001 McClung, Bone , 2005

2008 NOF Clinician Guide Treatment Recommendations Core data from Kanis , OI, 2001 McClung, Bone, 2005 NOF Clinician Guide, 2008, www.NOF.org

Summary and Implications of NOF Cost-effective Intervention Threshold Statistical modeling that incorporates many societal, economic and medical assumptions Cost-effective to treat at a specific 10-year hip/major osteoporosis fracture probability Diagnostic classification of osteoporosis will not change Patients with clinical and DXA diagnosis of osteoporosis are treated (no change) www.nof.org/professionals/Clinicians_Guide.htm

Statistical modeling that incorporates many societal, economic and medical assumptions

Cost-effective to treat at a specific 10-year hip/major osteoporosis fracture probability

Diagnostic classification of osteoporosis will not change

Patients with clinical and DXA diagnosis of osteoporosis are treated (no change)

Summary and Implications of NOF Cost-effective Intervention Threshold Distinguishes between diagnostic threshold and intervention threshold Fewer younger patients at low risk treated; more higher risk older patients treated Clinical Guidance only, not rules Do not preclude consideration of alternative intervention strategies Does not mandate treatment Treatment on a case-by-case basis www.nof.org/professionals/Clinicians_Guide.htm

Distinguishes between diagnostic threshold and intervention threshold

Fewer younger patients at low risk treated; more higher risk older patients treated

Clinical Guidance only, not rules

Do not preclude consideration of alternative intervention strategies

Does not mandate treatment

Treatment on a case-by-case basis

2008 NOF Guide “ Because these are recommendations and not rigid standards, they should not be interpreted as quality standards. Nor should they be used to limit coverage for treatment.” “… intended to serve as a reference point for clinical decision making… www.nof.org/professionals/Clinicians_Guide.htm

“ Because these are recommendations and not rigid standards, they should not be interpreted as quality standards. Nor should they be used to limit coverage for treatment.”

“… intended to serve as a reference point for clinical decision making…

Caveats of the NOF Therapeutic Guidelines Inconsistent recommendations 50 y/o female with T-2.5 and low risk is treated Recommendations for treatment without evidence of benefit (normal T-score & osteopenia w/o fx) Uncertainty of risk factors (dose/additive) Previous fractures Secondary etiologies Unexpected variability in fracture probability Fracture probability depends in part on life expectancy Assumption variability

Inconsistent recommendations

50 y/o female with T-2.5 and low risk is treated

Recommendations for treatment without evidence of benefit (normal T-score & osteopenia w/o fx)

Uncertainty of risk factors (dose/additive)

Previous fractures

Secondary etiologies

Unexpected variability in fracture probability

Fracture probability depends in part on life expectancy

Assumption variability

Gestalt Psychology of Clinical Decisions Clinician Fracture probability Exclude secondary etiologies Extra-skeletal factors influence drug of choice (B/R ratio) Co-morbidities that may affect decision Route of administration Efficacy of therapy based on patient-based research Safety of therapy Drug adherence long term Patient Patient expectations and preferences Insurance coverage / affordability Societal Cost-effectiveness of treatment Competition for resources/WTP

Clinician

Fracture probability

Exclude secondary etiologies

Extra-skeletal factors influence drug of choice (B/R ratio)

Co-morbidities that may affect decision

Route of administration

Efficacy of therapy based on patient-based research

Safety of therapy

Drug adherence long term

Patient

Patient expectations and preferences

Insurance coverage / affordability

Societal

Cost-effectiveness of treatment

Competition for resources/WTP

Add a comment

Related presentations

Related pages

The Assessment of Fracture Risk - National Center for ...

Bone mineral density is considered to be the standard measure for the diagnosis of osteoporosis and the assessment of fracture risk. The majority of ...
Read more

At what hip fracture risk is it cost-effective to treat?

At what hip fracture risk is it cost ... 10-year hip fracture risk at which treatment ... at which treatment became cost-effective varied between ...
Read more

Primary care use of FRAX: absolute fracture risk ...

... absolute fracture risk assessment in postmenopausal ... and cost-effective treatment is ... fracture risk assessment ...
Read more

At what hip fracture risk is it cost-effective to treat ...

Introduction. Intervention thresholds (ITs), the 10-year hip fracture risk at which treatment can be considered to be cost-effective, have previously been ...
Read more

To Treat or Not to Treat: Reducing Fracture Risk in ...

fracture risk level at which it is cost-effective to treat can be derived. ... Reducing Fracture Risk in ... Cost-effective osteoporosis treatment ...
Read more

Identifying cost-effective treatment with raloxifene in ...

Identifying cost-effective treatment with raloxifene in postmenopausal women using risk algorithms for fractures and invasive breast cancer M. Ivergårda ...
Read more

Prevention of Osteoporosis and Fractures - American Family ...

Prevention of Osteoporosis and Fractures ... years of treatment, with the risk of fracture reduced from ... efficacious and cost-effective, ...
Read more

OsteoEd - Osteoporosis Education - UW Departments Web Server

... FRAX is a fracture risk assessment tool that allows for calculation of future risk of fracture ... Cost-effective osteoporosis treatment ...
Read more