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From: The Rheumatologist, July 2012

California Rheumatologists Explore Managed Care, Treatment Options

by Larry Beresford

Questions about healthcare reform, including how to improve recognition and reimbursement for the medical contributions of cognitive specialists such as rheumatologists, were firmly in the background of the 8th Annual Medical and Scientific Meeting of the California Rheumatology Alliance (CRA), held May 19–20, 2012, in San Francisco. The 750-member CRA, founded in 2004, with most of its membership drawn from the Northern California, Southern California, and San Diego Rheumatology Societies, devoted two of eight sessions to reform and payment issues at state and national levels.

One of the outstanding questions involves the Supreme Court’s anticipated ruling on legal challenges to the Affordable Care Act (ACA), with a decision expected in June. “Since we don’t know what will happen, we will proceed in accordance with what we are trying to accomplish in health care reform,” observed Brent Barnhart, director of the California Department of Managed Care.

“California has embraced reform and all of the components of ACA,” added Jane Ogle, deputy director of the state Department of Health Care Services. Even if the national law were overturned, the state likely would continue down the path of reform in such areas as encouraging the emergence of accountable care organizations and medical homes; improving integration and coordination of health services (such as through a new demonstration project to combine Medicare, Medicaid, long-term care, and other in-home supportive services1); finding more robust ways to measure quality of care; and pursuing pay-for-performance and value-based purchasing.

Value-based payment modifiers for Medicare will apply to all physicians between 2015 and 2017, said Betsy Thompson, MD, DrPH, chief medical officer for Region IX of the Centers for Medicare and Medicaid Services. Implementation of electronic health records is a necessary but not sufficient condition for value-based payment for physicians, “some of which will be very good for people in your specialty, although any big change is likely to be painful,” she said.

Pathways to Care Delivery

Opening speaker David G. Borenstein, MD, immediate past president of the ACR, described a rheumatoid arthritis (RA) clinical pathways program to streamline care delivered by rheumatologists in Maryland, Virginia, and the District of Columbia, including his own rheumatology practice at George Washington University Medical Center in Washington, D.C.

The pathway was negotiated with CareFirst BlueCross BlueShield, working with Cardinal Health Specialty Solutions, a Dublin, Ohio-based healthcare services company. Based on evidence-based best practice, outcomes measurement, and a “treat-to-target” approach, it allows for RA treatment with methotrexate for 12 weeks, followed by an additional disease-modifying antirheumatic drug if that is not working, and a second-line agent after a further 12 weeks. “For the provider, we have access to biologics, and there are fewer preauthorizations or denials,” Dr. Borenstein said. “So it’s more predictable.”

Payment for medical evaluation and management (E&M) services has improved under the pathway, he added. The payer supplies an iPad computer and proprietary software for patients and physicians to enter essential authorizing information and to report outcomes—including pain and severity scales assessed by the physician. However, under the pathway, providing RA treatment infusions in an acute hospital, rather than an outpatient setting, is viewed by the payer as noncompliance.

Dr. Borenstein’s group has not participated in the program for very long, so “at this point, I have more questions about it than answers,” he said. However, if the process allows for give and take, for the ultimate benefit of the provider, patient, and payer, then it will be a significant step forward in healthcare delivery, he noted.

Radiographic Evidence Isn’t Always What it Seems

Edward Keystone, MD, professor of medicine at the University of Toronto, Canada, reviewed current trends and recent research in the treatment of RA, focusing on radiographic outcomes—a key measure of irreversible joint damage—and their role in defining treatment. “Things are not always what they seem,” when it comes to evaluating and treating RA, he said. Trying to reconcile discrepancies between radiographic versus clinical evidence in guiding treatment decisions presents challenges for the clinician.2 “But if one is aware of the pitfalls of these definitions, one will be better at interpreting the results of the studies.”

Remission in RA is a complex topic, but “is it really remission that we’re shooting for?” Dr. Keystone posed. “How is remission defined in RA? How do you interpret nonresponse?” Radiographic remission is characterized by the absence of significant synovitis upon sensitive imaging, whereas true RA remission is defined as a state of low disease activity with no progression of structural damage to the joints.

What causes clinical inflammation is not what causes joint damage, Dr. Keystone said. Clinical remission in response to treatment is not as easy to achieve as radiologic remission. Some patients don’t have a good response to treatment, yet, according to the radiologic evidence, their disease is not progressing, while others would fit definitions of remission. Still, the radiologic evidence shows that the disease is progressing. Nonresponders to methotrexate or biologics, as measured by radiographic evidence, sometimes improve significantly in terms of symptoms and functioning.

Timing of response to treatment can be just as important as the target reached when it comes to predicting long-term outcome, Dr. Keystone said, since rapid control of symptoms—within 12 weeks—is correlated with positive outcomes in the long run. Elaborating on the other trade-offs that rheumatologists must consider, he said that diagnosing from the imaging alone, without clinical evidence such as evaluation of joint swelling, will give a different and perhaps incomplete picture of what is really going on. Swollen joints are more important than tender joints in defining progression of disease, and joint space narrowing is more important than joint erosion. Composite indices such as ACR-20 still allow for a degree of clinical symptoms or evidence of synovitis when achieving remission.

Dr. Keystone also discussed other composite indices for assessing RA, including the RAPID3 (routine assessment of patient index data), which he believes is a predictor of radiologic progression.3 “TSS [Total Sharp Score] means less than the probability of radiologic progression and may lead you astray,” he said, because a substantial change in TSS is needed to register any noticeable change in physical functioning.

He reviewed several landmark studies showing benefits of combined therapies, infliximab, adalimumab, or etanercept with methotrexate, for patients at various stages of disease progression. He pointed out that RA patients today tend to be seen earlier in their disease progression, with more moderate symptoms, and receive higher doses of methotrexate than in the past.

Hot Topics in Osteoporosis Treatment Reviewed

Paul Miller, MD, CCD, medical director of the Colorado Center for Bone Research, reviewed a number of current topics in osteoporosis treatment, including the issue of drug “holidays” from bisphosphonate treatments. He outlined these drugs’ unusual properties; for example, that they are not metabolized by the body. Half of the treatment binds to the bone while half is secreted by the kidney. Uptake, retention, and detachment of the drug from bone surfaces continue during treatment and beyond, at different rates of detachment for different bisphosphonates, and when recycled into the bloodstream, the drugs are still biologically active. These properties “allow us to consider a break from treatment,” he said.

Drug holidays from bisphosphonates are not the current standard of care in the United States, despite concerns about potential long-term side effects, Dr. Miller said. On September 11, 2011, the Food and Drug Administration (FDA) convened an advisory panel to consider whether it should change its prescribing label for bisphosphonates. The committee opted not to make a change at this time, acknowledging that there is no consensus to support regulatory restriction on duration of drug use, although it recommended that the labeling be updated. The FDA continues to express concerns about long-term safety and efficacy, with limited data to demonstrate the effectiveness of these treatments beyond five years.

Recently in the New England Journal of Medicine, the FDA reviewed its concerns about duration of bisphosphonate use for achieving and maintaining protection against fracture while minimizing rare but serious adverse events associated with these drugs, such as atypical fractures, osteonecrosis of the jaw, esophageal cancer, and atrial fibrillation.4,5 The evidence is clear that bisphosphonate treatment for three or four years is effective in reducing vertebral and nonvertebral fractures in osteoporotic women, although the optimal duration of treatment remains controversial. In both NEJM articles and other recent reviews on bisphosphonate benefit–risk ratios, there seems to be a consensus emerging that drug holidays in high-risk patients may be associated with a greater risk of subsequent fractures, Dr. Miller said.6,7 “High risk” is defined as the preexistence of a low trauma fracture or a femoral neck T-score of -2.5 or lower.

No drug can abolish fracture risk, he said. Fractures in patients on long-term therapy may still occur. A certain type of fracture, the atypical subtrochanteric femur fracture, has been associated with long-term (five years or longer) use of bisphosphonates, although no causality has yet been established. “When these fractures happen, they’re dramatic...with an oblique pattern on the slant of the femoral shaft.”

Such fractures have also been the target of widespread media coverage, such as a 2010 ABC-TV News segment by Diane Sawyer, he said, noting that Richard Dell, MD, an orthopedic surgeon with Kaiser Permanente, has calculated that for every atypical fracture related to ongoing treatment, about 100 to 115 hip fractures are prevented.8 Considerations for the clinician include: why to stop treatment; when—and if—to restart it; whether a different osteoporotic therapy should be started in high-risk patients who discontinue bisphosphonates; and what happens for patients who go off treatment and subsequently experience fractures.

“The atypical subtrochanteric fracture risk seems to drop off abruptly when the treatments are discontinued, although no one knows why,” Dr. Miller said, adding that there is a prodrome of anterior pain in the thigh that precedes the atypical fracture by some months and might aid in its prevention. “I tell my patients if they have this [symptom] to call me,” he says. When there is concern about atypical fractures, he discontinues the bisphosphonate treatment, confirms symptoms radiologically, and encourages the patient to use some kind of extremity support such as a cane or crutch.

Other current topics discussed by Dr. Miller include the optimal interval for repeating bone-density tests, which were once targeted for a specific population of postmenopausal women, but now are used more widely. “Clinical judgment is still a good thing, and we have medications to improve bone-mass loss,” he says, “while inadequately managed osteoporosis is associated with poor outcomes.”9

He also reviewed new drugs for treating osteoporosis, including denosumab, which has been shown to decrease fracture risks at all skeletal sites.10 “Concerns about infections associated with denosumab use in the postmenopausal or cancer population are becoming less, but we still must be vigilant about this side effect as more people get treated.” Other research targets include the new drug odanacatib, a cathepsin-K inhibitor now in phase V trials; the antisclerostin antibody; and monoclonal antibodies to neutralize Dickkoff-1 inhibitory function on osteoblasts. The latter two will represent novel agents to increase new bone formation, he said.

Current Lupus Treatments are Not Enough

David Wofsy, MD, professor of medicine and microbiology/immunology at the University of California, San Francisco, reported on recent advances in the treatment of systemic lupus erythematosus (SLE). The challenge of developing new biologic therapies for SLE is underscored by the inadequacy of conventional therapies, he said. For example, hydroxychloroquine, an antimalarial drug, has demonstrated effectiveness in treating active disease, reducing frequency of flares, preventing thrombosis, and reducing mortality in people with SLE. “Unless there are contraindications to its use, it is now considered the standard of care for everyone with a diagnosis of lupus to be on this drug,” he says. “However, it is equally clear that this approach is insufficient for the majority of lupus patients.”

There has also been progress in understanding how to administer pulse cyclophosphamide (CTX), another conventional therapy for SLE, Dr. Wofsy said. The recent Euro-Lupus Nephritis Trial (ELNT), conducted in Europe, concluded that low-dose treatment with pulse CTX was just as effective as high-dose treatment, and with fewer infections.11 To date, there has been reluctance in the U.S. to generalize from its results, he noted, largely due to concerns that low-dose CTX might not be as effective in racial and ethnic minorities in the U.S. To address this concern, UCSF has been studying the effects of the ELNT regimen in diverse populations.

The recent approval of belimumab, a monoclonal antibody that inhibits B-cell function, has generated great excitement in the lupus community, Dr. Wofsy said. Two trials have demonstrated its benefits in lupus patients with diverse manifestations of the disease, but further studies are currently in progress to determine which manifestations of lupus, and which patient subpopulations, might benefit most from this therapy. Numerous other biologic therapies are currently under investigation, he said.

 


Larry Beresford is a freelance journalist based in California.

References

  1. For information, see: www.calduals.org. Accessed June 12, 2012.
  2. Aletaha D, Martinez-Avila J, Kvien TK, Smolen JS. Definition of treatment response in rheumatoid arthritis based on the simplified and the clinical disease activity index. Ann Rheum Dis. 2012 Mar 27. [Epub ahead of print].
  3. Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: Proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008;35:2136-2147.
  4. Black DM, Bauer DC, Schwartz AV, Cummings SR, Rosen CJ. Continuing bisphosphonate treatment for osteoporosis—for whom and for how long? NEJM. 2012;366:2051-2053.
  5. Whitaker M, Guo J, Kehoe T, Benson G. Bisphosphonates for osteoporosis—where do we go from here? NEJM. 2012;366:2046-2051.
  6. Boonen S, Ferrari S, Miller PD, et al. Postmenopausal osteoporosis treatment with antiresorptives: Effects of discontinuation or long-term continuation on bone turnover and fracture risk—a perspective. J Bone Miner Res. 2012;27:1-12.
  7. Khosla S, Bilezikian JP, Dempster DW, et al. Benefits and risks of bisphosphonate therapy for osteoporosis. J Clin Endocrin Metab. 2012 Apr 20. [Epub ahead of print].
  8. Romo C, Salahi L. Osteoporosis drugs, like Fosamax may increase risk of broken bones in some women. Published March 8, 2010. Available at http://abcnews.go.com/WN/WorldNews/osteoporosis-drugs-fosamax-increase-risk-broken-bones-women/story?id=10044066. Accessed June 12, 2012.
  9. Lewiecki E, Laster A, Miller P, Bilezikian J. More bone density testing is needed, not less. J Bone Miner Res. (in press).
  10. Miller PD. A review of the efficacy and safety of denosumab in postmenopausal women with osteoporosis. Ther Adv Musculoskelet Dis. 2011;20:1-12.
  11. Houssiau FA, Vasconcelos C, D’Cruz D, et al. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide. Ann Rheum Dis. 2010;69:61-64.

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