Challenges in the Treatment of Osteoporosis Disclosure Institutional Grant / Research Support Amgen Consulting Amgen, Radius, Shire, Alexion Speaking Shire, Alexion E. Michael Lewiecki, MD New Mexico Clinical Research & Osteoporosis Center University of New Mexico School of Medicine Albuquerque, NM Trustee / Director NOF, ISCD, OFNM, ECHO A Few of the Many Challenges Osteoporosis treatment gap Access to care Fear of drugs Uncertainties and controversies Understanding and communicating benefits and risks without treatment and with treatment Effective use of available therapeutic agents Educating healthcare providers with many competing healthcare priorities A Brief History of Osteoporosis How did we get where we are today? E. Michael Lewiecki, MD Personal Opinion Osteoporosis Care Better Worse WHO Diagnosis Criteria USA DXA Reimbursement Cuts (2007) ONJ AFF Media Reports Bureaucracy FRAX Limited Time Guidelines Competing More Marketing Priorities Competing Approval of More Drugs Guidelines US Surgeon General s Report Increasing Availability of DXA Risk Communication Bone Mass Measurement Act Mass Marketing Approval of Alendronate CRISIS Fear of Side Effects Drug Holidays 1994 Now Calcium Vitamin D 1. Treatment Gap 2. Crisis 3. Call to Action
The Surgeon General s Call for National Action Encourages individuals and communities to join together to promote bone health by: Increasing awareness Promoting lifestyle changes Defining and implementing prevention and treatment options for people of all ages 2008 Lewiecki EM et al. Osteoporos Int. 2008;19:1505-1509. 2009 2004 Lewiecki EM. The Female P atient 2009; 34(1);17-18. 2014 2016 Khosla S, Shane E. J Bone Miner Res. 2016;31:1485-1487. https://www.asbmr. or g/c all-to-acti on.as px Not enough DXAs. Mostly in urban areas. Varthakavi PK et al. Indian J Endocrinol Metab. 2014;18:441-44 2. Signed by 39 professional societies and organizations in many countries. It is an international crisis. Treatment After Hip Fracture Review of US insurance claims data (commercial + Medicare) in 96,887 patients hospitalized with hip fracture, 2002-2011 HEDIS Report Card HEDIS Measure 2002 2011 The percentage of women age 67 years with a fracture who had either a BMD test or prescription for a drug to treat or prevent osteoporosis in the 6 months after the fracture. Solomon DH et al. J Bone Miner Res. 2014;29:1929 1937. http://www.ncqa.o rg/ Re po rtca rd s/h ealt hpla ns/st at eof He alth Car eq uali ty/ 20 16T abl eof Co nte nts/
Low Treatment Rates After Fractures in Canada Treatment Gap in EU Countries 95% 57% 25% Leslie WD et al. Osteoporos Int. 2012;23:1623 1629. Kanis JA et al. Arch Osteoporos. 2013; 8:144. Reduced Bisphosphonate Prescription Rates Starting in 2008 Access to Care DXA Reimbursement Jha S et al. J Bone Miner Res. 2015;30:2179-2187. 2007 Medicare reduced office-based DXA reimbursement from $139 to $82 Rates continued to fall in subsequent years, now about $42 ISCD, AACE, TES, ACR (Rheum) commissioned a study by The Lewin Group to assess costs of providing office based DXA services The Lewin Group Final Report October 31, 2007 Survey of 163 DXA providers Median cost per DXA = $134 Reimbursement of $82 is 61% of median cost Projected consequences, 2008-2012 Closure of many DXA facilities Fewer patients diagnosed, fewer treated, more fractures Medicare saves $643 million due to 4.3 million fewer DXAs Medicare spends extra $2.1 billion for fracture-related expenses Considering costs of treatment, net cost to Medicare by reducing DXA reimbursement is $1.1 billion The Lewin Group; Dobson/DaVanzo, LLC. Assessing the Costs of Performing DXA Services in the Office-based Setting: Final Report. 2007.
Loss of about 1000 DXA Office Providers per Year since 2008 Decline in DXA Reimbursement $139 DXA Medicare Payments $82 $42 Direct Research LLC, Medicare PSPS Master Files and Medicare 5 Percent Sample LDS SAF, analysis by Peter M. Steven, PhD. 2016. Lewiecki EM et al. ASBMR Oral Presentation #1077. 2016. 26% 24% Decline in DXA Testing 26% 24% Decline in Osteoporosis Diagnosis Percent of Women Age 65+ 22% 20% 18% 16% 14% 12% $139 DXA Medicare Payments DXA Testing $82 13.2% $42 Percent of Women Age 65+ 22% 20% 18% 16% 14% 12% DXA Medicare Payments $139 Osteoporosi s Diagnosis DXA Testing $82 13.2% 17.9% $42 14.8% 10% 11.3% 10% 11.3% Lewiecki EM et al. ASBMR Oral Presentation #1077. 2016. Lewiecki EM et al. ASBMR Oral Presentation #1077. 2016. Percent of Women Age 65+ 26% 24% 22% 20% 18% 16% 14% 12% US Hip Fracture Trends 2002-2015 884 $139 Hip Fracture DXA Medicare Payments Osteopor osi s DXA Testing Rates Diagnosis $82 14,391 additional hip fractures $576 million additional expenses 2,878 additional deaths 13.2% 17.9% $42 738 693 14.8% 900 850 800 750 700 650 600 550 Fr actur es per 100,000 Wom en Age 65+ Age-adjust ed to the 2014 Age Distr ibution Fear of Drugs 10% 11.3% 500 Lewiecki EM et al. ASBMR Oral Presentation #1077. 2016.
Fear of Drugs 2003 ONJ Robert E. Marx, DDS 2005 AFF Australian Broadcasting Company. ONJ with bisphosphonates. Dec 11, 2007. Osteoporosis Wheel of Fear Atrial Fib Jaw Rot Joint Pain Brittle Bones Muscles Ache Femur Snaps Back Pain Fatal Stroke March 8, 2010 Heartburn Blood Clots
Controversies / Uncertainties Uncertainties and Controversies Evaluation DXA Indications Testing intervals Quality Reimbursement Fracture risk assessment Wise use of FRAX Other algorithms Secondary causes Best w/u for a patient Treatment Non-pharmacological Best exercise Calcium and CV disease Target vitamin D level Pharmacological Initial drug selection How long to treat Changing therapy Combining therapy Benefit vs. risk Overcoming the Challenges Short term Better messaging to physicians and patients Monitor for AFFs (DXA long femur view, etc) Intermediate term Identify patients at high risk for AFF Long-term Pharmacogenomics, drug development, guideline coordination, patient engagement Khosla S et al. J Bone Miner Res. 2016 Dec 29. doi: 10.1002/jbmr. 30 74. [Epub ahead of print] Alignment of Incentives New ways to guide patient decisions Better physician and patient education Better adherence to therapy New drug development Include complementary and alternative options Herbal medications New osteoporosis research Better funding Healthcare systems (Kaiser, Geisinger, other countries) have shown improvement outcomes and cost savings by identifying and treating high risk patients to prevent fractures Most healthcare in the US is delivered in profit centers A change in healthcare delivery with alignment of incentives of all stakeholders is needed Stoecker WV et al. J Bone Miner Res. 2017 March 31. doi: 10.1002/jbmr.3 14 5. [Epub ahead of print]
Restore DXA Reimbursement to Sustainable Levels Reimbursement below the cost of providing the procedure is causing DXA facilities to close and limiting access to needed services Adequate reimbursement will provide access to care for more patients, allowing identification and treatment of those at high risk Low DXA Reimbursement Leads to Poor DXA Quality Losing money with DXA No investment in education and training Suboptimal DXA studies Inappropriate clinical decisions Potential harm to patients and higher medical expenses: unnecessary lab tests, wrong treatment, fractures that might have been prevented DXA Quality Open access: download FREE at www.iscd.org How to use DXA Best Practices if you are a bone densitometrist Download DXA Best Practices Be familiar with it Follow the recommendations Be trained and stay updated Get certified (if not already) Facility accreditation is the best way to demonstrate that high quality DXA is being performed DXA Best Practices. Lewiecki EM et al. J Clin Densitom. 2016;19(2):1 27-1 40. How to use DXA Best Practices if you are NOT a bone densitometrist Ask the DXA facility about the following Certification for DXA tech and interpreter Facility accreditation Precision assessment has been done and least significant change is known Look at the report Make and model of DXA instrument are identified One diagnosis per patient, not different diagnosis for each skeletal site One fracture risk assessment per patient, not different one for each skeletal site Better Risk Communication and Patient Education Risk of fractures when untreated compared to treated Consequences of fractures (especially loss of independence) Balance of benefits and risks with treatment Individualized risk probability Shared decision making
10-Year Probabilities 80 year-old woman with FN T-score = -3.3 Includes 0.01% Atypical Femur Fracture Risk Includes 0.5% Atypical Femur Fracture Risk More Effective Use of Available Treatments Use best drug for the right patient Know when to start, stop, change, and combine treatments Fall prevention Follow-up after starting treatment Untreated probability of major osteoporotic fracture calculated by FRAX. ONJ estimate is ~1/100,000 patienttreatment-years from ASBMR Task Force by Khosla S et al. J Bone Miner Res 2007;22:1479 149. AFF estimate untreated is ~0.01/10,000 and treated is ~5/10,000 patient-years from Schilcher J et al. N Engl J Med. 2011;364:1728-1737. Risk estimates assume long-term bisphosphonate therapy resulting in 50% reduction in fracture risk. MVA and murder data from the CDC at http://www.cdc.gov/nchs/data/nvsr/nvsr56/nvsr56_10.pdf. Image copyright 2017 Lewiecki EM. Slide version. Treat-to-Target Fracture Liaison Service (FLS) National Bone Health Alliance (NBHA) Fracture Prevention Central www.nbha.org/fpc American Orthopaedic Association (AOA) Own the Bone www.ownthebone.org Cummings SR et al. J Bone Miner Res. 2017;32:3-10. International Osteoporosi s Foundation (IOF) Capture the Fracture www.iofbonehealth.org/capture-fracture Novel Strategies to Educate Healthcare Professionals Current paradigm of educating PCPs is not fully effective Not enough specialists Alternative strategy Move knowledge not patients Raise the level of knowledge of a few motivated PCPs in underserved communities Offers advanced level of care for all patients in the community Bone Health
UNM ECHO Institute at University of New Mexico, Albuquerque, NM, USA Bone Health TeleECHO Launch, October 6, 2015 Bone Health USA Participants: 15 Months Bone Health TeleECHO Launch, October 6, 2015 Bone Health Self-Efficacy Outcomes Measures After ECHO* Before ECHO *P = 0.005 Bone Health ECHO learners with direct patient care responsibilities who attended more than 10 clinics (n=10)
Summary Many challenges in osteoporosis care Consequences of poor care are great International problem Many causes We can do better