Cost-effective Treatment and Fracture Risk

2,322 views

Published on

Published in: Health & Medicine
0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,322
On SlideShare
0
From Embeds
0
Number of Embeds
33
Actions
Shares
0
Downloads
0
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide
  • Cost-effective Treatment and Fracture Risk

    1. 1. 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
    2. 2. Discussion Points <ul><li>Why consider “ absolute fracture risk ” when considering patients future osteoporotic fracture risk? </li></ul><ul><ul><li>What is the World Health Organization Fracture Risk Assessment Tool (FRAX™)? </li></ul></ul><ul><li>Why consider new guidelines for osteoporosis treatment when the T-score based cut-points work fine? </li></ul><ul><ul><li>What are the National Osteoporosis Foundation cost-effective treatment guidelines? </li></ul></ul>
    3. 3. 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
    4. 4. 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
    5. 5. Clinical Utility of the WHO T-score Diagnostic Classification <ul><li>Definition of osteoporosis based on DXA only </li></ul><ul><li>Easy to understand and used worldwide </li></ul><ul><li>Increased diagnosis and treatment </li></ul><ul><li>Identifies high risk patients prior to a fracture </li></ul><ul><li>Correlation with fracture risk </li></ul><ul><li>Comparability </li></ul>
    6. 6. Caveats of the WHO T-score Diagnostic Classification <ul><li>Application to other races/ethnicities </li></ul><ul><li>WHO selection of femoral neck only for diagnosis </li></ul><ul><li>Influenced by reference databases used </li></ul><ul><li>Refers only to DXA spine and hip (1/3 radius) </li></ul><ul><li>BMD alone results in low sensitivity </li></ul><ul><li>Inappropriate/inadequate treatment of patients based on WHO T-scores and professional society intervention thresholds </li></ul>
    7. 7. BMD and Relative Risk Bone Density (T-score) Relative Risk for Fracture Marshall, BMJ, 1996
    8. 8. 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
    9. 9. Example of Relative Risk Using T-scores in Fracture Prediction <ul><li>Compare 50 and 70 y/o Caucasian woman </li></ul><ul><li>Both have a femoral neck T −2.0 and Z −1.0 </li></ul><ul><li>Relative risk of hip fracture at FN is 2.6 </li></ul><ul><ul><li>Increased fracture risk is 2.6  for every 1 SD decrease in BMD (gradient of risk) </li></ul></ul><ul><ul><li>RR = GR (T or Z score) = 2.6 (2) = 6.8 </li></ul></ul><ul><li>What is RR compared to a patient of the same age with a T or Z score of 0.0 ? </li></ul>C <ul><ul><ul><li>Marshall D, BMJ. 1996:312:1254 . </li></ul></ul></ul>
    10. 10. Relative Risk Using T-scores and GR <ul><li>50 y/o T – 2.0 hip fracture risk </li></ul><ul><ul><li>6.8 times greater than 50 y/o with a T = 0.0 </li></ul></ul><ul><ul><li>2.6 times greater than 50 y/o with a Z = 0.0 </li></ul></ul><ul><li>70 y/o T – 2.0 hip fracture risk </li></ul><ul><ul><li>6.8 times greater than a 70 y/o with a T = 0.0 </li></ul></ul><ul><ul><li>2.6 times greater than a 70 y/o with a Z = 0.0 </li></ul></ul>Absolute Risk Using FRAX ™ <ul><li>50 y/o 10-year hip fracture risk = 1.3% (7.5% MF) </li></ul><ul><li>70 y/o 10-year hip fracture risk = 2.5% (19% MF) </li></ul>
    11. 11. Problem with Relative Risk and Fracture Prediction <ul><li>Fracture risk expressed as relative risk does not provide a true assessment of the likelihood (probability) of fracture </li></ul><ul><li>Using DXA for determination of fracture risk only provides one component of bone strength </li></ul><ul><ul><li>Does not measure qualitative strength </li></ul></ul><ul><ul><li>Clinic based technologies do not provide a complete appreciation of bone strength </li></ul></ul>
    12. 12. Problem with Fracture Prediction Using T-scores and WHO Diagnostic Criteria
    13. 13. C Number of subjects BMD in Patients With and Without Fractures EPOS Study Group, JBMR , 2002
    14. 14. Relationship Between Fracture Risk & BMD <ul><li>Osteoporosis is a multi-factorial disease </li></ul><ul><li>BMD only captures a minority of fracture risk </li></ul><ul><ul><li>From 50 – 90 y/o annual incidence of hip fracture increases 30 fold </li></ul></ul><ul><ul><li>Using BMD, loss with age would result in an increases hip fracture risk 4 fold </li></ul></ul><ul><ul><li>Increase risk of hip fracture with age is 7 fold greater than explained by BMD alone </li></ul></ul><ul><li>Intervention thresholds based on BMD </li></ul><ul><ul><li>Low sensitivity and low positive predictive value </li></ul></ul>Kanis, OI , 2008
    15. 15. Effect of Gradient of Risk on Prediction of Future Fracture Risk
    16. 16. 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
    17. 17. 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
    18. 18. 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
    19. 19. Fracture Probability
    20. 20. WHO Scientific Group on Assessment of Osteoporosis at the Primary Health Care Level <ul><li>John A Kanis (Chairman) </li></ul><ul><li>Philippe Bonjour </li></ul><ul><li>Juliet Compston </li></ul><ul><li>Bess Dawson-Huges </li></ul><ul><li>Helena Johansson </li></ul><ul><li>Edith Lau </li></ul><ul><li>Robert Lindsay </li></ul><ul><li>Joseph Melton III </li></ul><ul><li>Michael McClung </li></ul><ul><li>Anders Oden </li></ul><ul><li>Bruce Pfleger </li></ul><ul><li>Ger Teilen </li></ul><ul><li>Patricia Clark </li></ul>WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008 <ul><li>Cyrus Cooper </li></ul><ul><li>Chris De Laet </li></ul><ul><li>Claus Gluer </li></ul><ul><li>Olof Johnell </li></ul><ul><li>Nikolai Khaltaev </li></ul><ul><li>E. Michael Lewiecki </li></ul><ul><li>Paul T Lips </li></ul><ul><li>Eugene V McCloskey </li></ul><ul><li>Paul Miller </li></ul><ul><li>Socrates E Papapoulos </li></ul><ul><li>Stuart Silverman </li></ul><ul><li>Natalia Toroptsova </li></ul>
    21. 21. <ul><li>Develop a standardized methodology </li></ul><ul><ul><li>CRFs combined with BMD to improve sensitivity for any specificity </li></ul></ul><ul><ul><ul><li>Increased gradient of risk </li></ul></ul></ul><ul><ul><ul><li>Greater positive predictive value </li></ul></ul></ul><ul><ul><li>Quantitative fracture risk assessment </li></ul></ul><ul><ul><li>Can be used for intervention thresholds </li></ul></ul><ul><li>Application to men and women, all ethnicities and worldwide </li></ul>WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
    22. 22. <ul><li>Large prospective population-based epidemiologic studies correlate CRFs +/- BMD for Fx outcomes </li></ul><ul><ul><li>Initial analysis 12 prospectively studied cohorts </li></ul></ul><ul><ul><ul><li>Over 60,000 subjects (250,000 person-years) </li></ul></ul></ul><ul><ul><ul><li>Rotterdam, EVOS, CMOS, Rochester, Sheffield, DOES, EPIDOS, OFELY, Kupio, Hiroshima, Gothenburg (2) </li></ul></ul></ul><ul><ul><li>Validated in additional 11 study cohorts </li></ul></ul><ul><ul><ul><li>Over 230,000 subjects (1.2 million person-years) </li></ul></ul></ul><ul><ul><ul><li>EPIDOS, SOF, Geelong (2), OPUS, PERF, YORK, THIN, SEMOF, WHI, Miyama </li></ul></ul></ul>WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
    23. 23. WHO Fracture Risk Model -FRAX™- <ul><li>Identify 10-year hip/major osteoporosis fracture intervention threshold </li></ul><ul><li>Country specific cost and health consequences of fracture </li></ul><ul><li>CRFs selected </li></ul><ul><ul><li>Likelihood risk identified amenable to treatment </li></ul></ul><ul><ul><li>Easy use of risk factor in clinical practice as a baseline or outcome variable </li></ul></ul>WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
    24. 24. FRAX ™ Model Analysis of CRFs <ul><li>Meta-analysis for each CRF and for M/F </li></ul><ul><li>Covariates examined (age, sex, BMD, time since assessment and covariate itself) </li></ul><ul><li>Merging of each risk factor to account for interdependence of the risk factors chosen </li></ul><ul><ul><li>Risk provided by any combination of CRFs </li></ul></ul><ul><ul><li>With or without BMD </li></ul></ul>
    25. 25. FRAX™ Clinical Risk Factors <ul><li>Age (40-90 years) </li></ul><ul><li>Gender </li></ul><ul><li>BMI (height and weight) </li></ul><ul><li>Prior fragility fracture (y/n) </li></ul><ul><li>Current smoking (y/n) </li></ul><ul><li>Other secondary etiologies (y/n) </li></ul><ul><li>Family history of hip fracture (y/n) </li></ul><ul><li>Glucocorticoids ever used (y/n) </li></ul><ul><li>Rheumatoid arthritis (y/n) </li></ul><ul><li>Alcohol ≥3 units/d (y/n) </li></ul>WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
    26. 26. Secondary Etiologies Associated With Increased Fracture Risk <ul><li>Rheumatoid arthritis </li></ul><ul><li>Other diseases and medical conditions </li></ul><ul><ul><li>Untreated hypogonadism </li></ul></ul><ul><ul><ul><li>Oophorectomy, orchidectomy </li></ul></ul></ul><ul><ul><ul><li>Anorexia, chemotherapy, hypopituitarism </li></ul></ul></ul><ul><ul><li>Inflammatory bowel disease </li></ul></ul><ul><ul><li>Prolonged immobility </li></ul></ul><ul><ul><li>Type 1 Diabetes </li></ul></ul><ul><ul><li>Thryroid (untreated and over-treatment) </li></ul></ul><ul><ul><li>Organ transplantation </li></ul></ul>WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
    27. 27. FRAX 10-year Fracture Risk Using the Same Demographics Except for Race/Ethnicity <ul><li>74 year old female </li></ul><ul><li>65 kg </li></ul><ul><li>165 cm </li></ul><ul><li>Previous fracture </li></ul><ul><li>FN T – 1.5 </li></ul>
    28. 28. FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool
    29. 29. FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool
    30. 30. FRAX – USA (Caucasian Female) http://www.shef.ac.uk/FRAX/tool
    31. 31. FRAX USA – (Hispanic female) http://www.shef.ac.uk/FRAX/tool
    32. 32. FRAX USA – (Asian female) http://www.shef.ac.uk/FRAX/tool
    33. 33. FRAX – USA (Black female) http://www.shef.ac.uk/FRAX/tool
    34. 34. Secondary osteoporosis / No BMD Secondary osteoporosis + BMD Secondary osteoporosis/No BMD+RA BMD without secondary CRFs ☻ ☻ ☻ ☻
    35. 35. Low BMI / No BMD Normal BMI / No BMD Normal BMI + BMD Low BMI + BMD
    36. 36. FRAX™ Caveats <ul><li>Does not include all CRFs (risk of falling) </li></ul><ul><li>Does not model known dose-dependence of several CRFs and those that exceed assumptions </li></ul><ul><ul><li>Multiple fractures </li></ul></ul><ul><ul><li>Severity of fractures </li></ul></ul><ul><ul><li>Multiple risk factors (RA + hypogonadism) </li></ul></ul><ul><ul><li>Dose of glucocorticoids </li></ul></ul><ul><ul><li>Other meds </li></ul></ul><ul><li>FRAX™ does not apply to patients on treatment, premenopausal women and younger men </li></ul>
    37. 37. <ul><li>Treatment below AR/Rx threshold </li></ul><ul><ul><li>Younger female (32 y/o) with surgical menopause (considered very low risk) </li></ul></ul><ul><ul><li>Woman 35 y/o vs. 55 y/o (male 35 y/o ) on glucocorticoids (considered very low risk) </li></ul></ul><ul><li>DXA machine (GE) uses weight adjustment </li></ul><ul><li>Lumbar spine T/Z scores not allowed </li></ul><ul><ul><li>AVN of hips </li></ul></ul><ul><ul><li>OA of hips </li></ul></ul><ul><ul><li>Bilateral THA </li></ul></ul>FRAX™ Caveats
    38. 38. <ul><li>For T-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD </li></ul><ul><ul><li>Female Caucasian dbase for all </li></ul></ul><ul><li>For Z-scores FRAX™ uses 1998 NHANES III database to calculate mean BMD and SD </li></ul><ul><ul><li>Caucasian female db for all females </li></ul></ul><ul><ul><li>Caucasian male dbase for all males </li></ul></ul><ul><li>All central DXA machines use 1995 NHANES III database for mean BMD and SD calculation </li></ul><ul><ul><li>FRAX™ website and DXA machine patch needed </li></ul></ul>FRAX™ Caveats
    39. 39. FRAX Patch http://www.orost.com/fraxpatch
    40. 40. <ul><li>FRAX TM T-scores </li></ul><ul><ul><li>FN BMD was the primary data source from observational databases </li></ul></ul><ul><ul><li>T-scores for all subjects calculated using NHANES III Caucasian female database (1998) </li></ul></ul><ul><ul><li>Adjustment for gender and ethnic differences between BMD and fracture risk accomplished with country-specific gender and ethnic databases in FRAX TM </li></ul></ul>FRAX ™ Patch: Background Courtesy of Mike McClung
    41. 41. <ul><li>FRAX TM T-scores </li></ul><ul><ul><li>Hologic NHANES database uses 1995 data </li></ul></ul><ul><ul><li>Non-Hologic BMD values were transformed into “Hologic-equivalents” by the formulae of Lu et al. ( Osteoporos Int 2001;12:438-444) </li></ul></ul><ul><ul><li>None of the T-scores generated by DXA machines is correct for use in FRAX TM </li></ul></ul>FRAX ™ Patch: Background Courtesy of Mike McClung
    42. 42. FRAX ™ Patch <ul><li>Calculator to provide the appropriate T-score to use in FRAX TM model </li></ul><ul><ul><ul><li>– Enter brand of DXA machine </li></ul></ul></ul><ul><ul><li>– Enter FN BMD (gm/cm 2 ) </li></ul></ul><ul><ul><li>– FRAX T-score provided </li></ul></ul><ul><li>NOF website </li></ul><ul><li>Incorporated into FRAX website calculator to replace T & Z-scores? </li></ul>Courtesy of Mike McClung
    43. 43. Summary Courtesy of Mike McClung www.orost.com/fraxpatch
    44. 44. Courtesy of Mike McClung www.orost.com/fraxpatch
    45. 45. Use of FRAX™ on DXA Machines <ul><li>Manufacturers absolute fracture risk (FRAX ™) software approved by FDA </li></ul><ul><li>Manufacturers software converts femoral neck BMD into appropriate T-scores for insertion in WHO FRAX ™ software added to manufacturers DXA computer </li></ul><ul><li>Enter clinical risk factors into algorithm </li></ul><ul><li>10-year major and hip fracture risk calculated </li></ul>
    46. 46. Integrated FRAX Report <ul><li>Risk Factors </li></ul><ul><ul><li>61 yr Caucasian female </li></ul></ul><ul><ul><li>T-score = -1.7 </li></ul></ul><ul><ul><li>Previous Fracture </li></ul></ul><ul><ul><li>Smoking </li></ul></ul><ul><li>Major Osteoporotic Fracture 21% </li></ul><ul><li>Hip Fracture 3.6% </li></ul>
    47. 49. 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
    48. 50. NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis –Contents– <ul><li>Osteoporosis Impact and Overview </li></ul><ul><li>Basic pathophysiology </li></ul><ul><li>Approach to the Dx and Rx of osteoporosis </li></ul><ul><ul><li>NOF adapted FRAX™ with US inputs </li></ul></ul><ul><ul><li>Cost-effective thresholds for Rx </li></ul></ul><ul><li>Universal recommendations </li></ul><ul><li>Pharmacologic therapy </li></ul><ul><li>Physical medicine and rehabilitation </li></ul>www.nof.org/professionals/Clinicians_Guide.htm
    49. 51. NOF Technical Reports <ul><li>Cost-effective Osteoporosis Treatment Thresholds: The US Perspective </li></ul><ul><ul><li>Calibration of the WHO fracture algorithm to USA for 10-year hip fracture (major osteoporotic fracture) probability </li></ul></ul><ul><ul><ul><li>National age-, sex and race-specific death rates </li></ul></ul></ul><ul><ul><ul><li>Age-and sex-specific hip fracture incidence rates </li></ul></ul></ul><ul><ul><li>10-year hip fracture probability (major osteoporotic fracture) at which treatment becomes cost-effective </li></ul></ul>Tosteson, OI , 2008
    50. 52. NOF Technical Reports <ul><li>Implications of Absolute Fracture Risk Assessment for Osteoporosis Practice Guidelines in the USA </li></ul><ul><ul><li>Cost-effective to treat patients </li></ul></ul><ul><ul><ul><li>Fragility fractures </li></ul></ul></ul><ul><ul><ul><li>Osteoporosis by WHO DXA diagnostic criteria </li></ul></ul></ul><ul><ul><ul><li>Osteopenia with CRFs </li></ul></ul></ul>Dawson-Hughes, OI , 2008
    51. 53. Determination of US Cost-Effective Treatment Threshold <ul><li>Clinical </li></ul><ul><ul><li>Measurement (BMD) </li></ul></ul><ul><ul><li>Clinical risk factors </li></ul></ul><ul><ul><li>Pharmacologic treatment (efficacy/cost) </li></ul></ul><ul><li>Epidemiologic </li></ul><ul><ul><li>US fracture major/hip fracture incidence </li></ul></ul><ul><ul><li>Mortality and morbidity from fractures </li></ul></ul><ul><ul><li>Life expectancy </li></ul></ul><ul><li>Economic Factors (wealth of nation-GDP/capita) </li></ul><ul><ul><li>Disease-related costs </li></ul></ul><ul><ul><li>Cost of intervention and longer life </li></ul></ul><ul><ul><li>Willingness to pay (health care expenses/priorities) </li></ul></ul>Borgstrom , OI, 2 006
    52. 54. NOF Methodology and Assumptions <ul><li>Incidence of clinical fractures* </li></ul><ul><ul><li>Other female races/ethnicities </li></ul></ul><ul><ul><ul><li>Black women 57% less likely to fracture </li></ul></ul></ul><ul><ul><ul><li>Asian women 50% less </li></ul></ul></ul><ul><ul><ul><li>Hispanic women 47% less </li></ul></ul></ul><ul><ul><li>Other male races/ethnicities </li></ul></ul><ul><ul><ul><li>Black men 47% less likely to fracture </li></ul></ul></ul><ul><ul><ul><li>Asian men 36% less </li></ul></ul></ul><ul><ul><ul><li>Hispanic men 42% less </li></ul></ul></ul>*Clinical Fractures: hip, wrist, spine and “other” including proximal humerus, rib, pelvis, & tibia/fibula ( ♀ only) Tosteson, OI , 2008
    53. 55. NOF Methodology and Assumptions <ul><li>Treatment course of 5-years </li></ul><ul><li>Persistence of 100% </li></ul><ul><li>Treatment off set at 5-years </li></ul><ul><li>Fracture reduction 35% </li></ul><ul><li>Cost for interventions & treating fractures same for all ages, races/ethnicities, gender </li></ul>Tosteson, OI , 2008
    54. 56. NOF Methodology and Assumptions <ul><li>Annual bisphosphonate drug cost of $600 </li></ul><ul><li>Physician visit $49 per year </li></ul><ul><li>DXA study $82 in second year of treatment </li></ul><ul><li>Duration of fracture-related loss in QOL (5 years) </li></ul><ul><li>Annual age, sex- and race specific mortality </li></ul><ul><li>rates from 2001 USA life-tables </li></ul>Tosteson, OI , 2008
    55. 57. <ul><li>Mean health state values derived from EuroQol </li></ul>NOF Methodology and Assumptions Tosteson, OI, 2008
    56. 58. NOF Methodology and Assumptions <ul><li>Loss of health-related QOL for each fracture (disutility) limited to a 5-year horizon </li></ul>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
    57. 59. Impact of Duration in Fracture-Loss in Quality of Life on 10-year Hip Fracture Which Treatment Becomes Cost-effective Tosteson, OI , 2008
    58. 60. NOF Methodology and Assumptions <ul><li>Cost analysis </li></ul><ul><ul><li>Cost per QALY gained (cost-effectiveness Rx vs. no treatment) </li></ul></ul><ul><ul><ul><li>Incremental cost-effectiveness ratios (ICERs) </li></ul></ul></ul><ul><ul><ul><li>Calculated by dividing the difference in mean total discounted costs between treated and untreated divided by the respective difference in QAL expectancy </li></ul></ul></ul><ul><ul><li>Willingness-to-pay threshold as cost effective = $60,000 per QOL gained </li></ul></ul>Tosteson, OI , 2008
    59. 61. NOF 2008 Treatment Recommendations <ul><li>Postmenopausal women and men age 50 and older </li></ul><ul><li>presenting with the following: </li></ul><ul><ul><li>A hip or vertebral (clinical or morphometric) fracture </li></ul></ul><ul><ul><li>T-score ≤ -2.5 at the femoral neck, total hip or spine after appropriate evaluation to exclude secondary causes </li></ul></ul><ul><ul><li>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 </li></ul></ul>www.nof.org/professionals/Clinicians_Guide.htm
    60. 62. 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%
    61. 63. 2003 NOF Physician Guide Treatment Recommendations Core data from Kanis, OI , 2001 McClung, Bone , 2005
    62. 64. 2008 NOF Clinician Guide Treatment Recommendations Core data from Kanis , OI, 2001 McClung, Bone, 2005 NOF Clinician Guide, 2008, www.NOF.org
    63. 65. Summary and Implications of NOF Cost-effective Intervention Threshold <ul><li>Statistical modeling that incorporates many societal, economic and medical assumptions </li></ul><ul><li>Cost-effective to treat at a specific 10-year hip/major osteoporosis fracture probability </li></ul><ul><li>Diagnostic classification of osteoporosis will not change </li></ul><ul><li>Patients with clinical and DXA diagnosis of osteoporosis are treated (no change) </li></ul>www.nof.org/professionals/Clinicians_Guide.htm
    64. 66. Summary and Implications of NOF Cost-effective Intervention Threshold <ul><li>Distinguishes between diagnostic threshold and intervention threshold </li></ul><ul><li>Fewer younger patients at low risk treated; more higher risk older patients treated </li></ul><ul><li>Clinical Guidance only, not rules </li></ul><ul><li>Do not preclude consideration of alternative intervention strategies </li></ul><ul><li>Does not mandate treatment </li></ul><ul><li>Treatment on a case-by-case basis </li></ul>www.nof.org/professionals/Clinicians_Guide.htm
    65. 67. 2008 NOF Guide <ul><li>“ 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.” </li></ul><ul><li>“… intended to serve as a reference point for clinical decision making… </li></ul>www.nof.org/professionals/Clinicians_Guide.htm
    66. 68. Caveats of the NOF Therapeutic Guidelines <ul><li>Inconsistent recommendations </li></ul><ul><ul><li>50 y/o female with T-2.5 and low risk is treated </li></ul></ul><ul><li>Recommendations for treatment without evidence of benefit (normal T-score & osteopenia w/o fx) </li></ul><ul><li>Uncertainty of risk factors (dose/additive) </li></ul><ul><ul><li>Previous fractures </li></ul></ul><ul><ul><li>Secondary etiologies </li></ul></ul><ul><li>Unexpected variability in fracture probability </li></ul><ul><ul><li>Fracture probability depends in part on life expectancy </li></ul></ul><ul><li>Assumption variability </li></ul>
    67. 69. Gestalt Psychology of Clinical Decisions <ul><li>Clinician </li></ul><ul><ul><li>Fracture probability </li></ul></ul><ul><ul><li>Exclude secondary etiologies </li></ul></ul><ul><ul><li>Extra-skeletal factors influence drug of choice (B/R ratio) </li></ul></ul><ul><ul><li>Co-morbidities that may affect decision </li></ul></ul><ul><ul><li>Route of administration </li></ul></ul><ul><ul><li>Efficacy of therapy based on patient-based research </li></ul></ul><ul><ul><li>Safety of therapy </li></ul></ul><ul><ul><li>Drug adherence long term </li></ul></ul><ul><li>Patient </li></ul><ul><ul><li>Patient expectations and preferences </li></ul></ul><ul><ul><li>Insurance coverage / affordability </li></ul></ul><ul><li>Societal </li></ul><ul><ul><li>Cost-effectiveness of treatment </li></ul></ul><ul><ul><li>Competition for resources/WTP </li></ul></ul>

    ×