Value Propositions

VBCR - February 2014, Volume 3, No 1 - Value Propositions

PET Useful for Prevention, Early Detection, and Monitoring of Inflammatory Arthritic Disease
Positron emission tomography (PET) is a useful tool to monitor rheumatic disease activity, including rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and reactive arthritis, according to a systematic review of the current literature. The analysis included 18 studies encompassing 276 patients with an inflammatory disease; 79% of the patients were diagnosed with rheumatoid arthritis. The results showed that PET visualized inflammatory arthritis with a high sensitivity corresponding with clinical assessments.

In addition, PET was found to be similar to ultrasound and magnetic resonance imaging in monitoring disease activity in patients with clinically active disease. PET can also detect subclinical disease activity. The authors acknowledged that PET will not be useful in clinical practice for the imaging of active disease in patients with inflammatory arthritis that can be easily determined by clinical assessment, because of the high costs and radiation burden associated with this modality. However, PET may be used to detect the preclinical phase of the disease, to monitor disease activity, and/or to predict therapeutic efficacy. Bruijnen ST, et al. Arthritis Care Res (Hoboken). 2014;66(1):120-130


First Biosimilar Monoclonal Antibody Approved in Europe
The European Commission has approved the first biosimilar monoclonal antibody in Europe, Remsima (by Celltrion) and Inflectra (by Hospira), a biosimilar version of Remicade (infliximab). Although biosimilars are available in other drug classes, especially drugs for the treatment of cancer, this is the first drug class for the treatment of rheumatic diseases to be approved as a biosimilar. The approval of a biosimilar for rheumatic diseases is a positive step toward providing lower-cost therapies for patients with these conditions. This will also have implications for drug development in Europe and in the United States. Although the US Food and Drug Administration (FDA) has yet to approve any biosimilar drugs, the FDA does have a path for biosimilars, but it has not reached a consensus on the proper regulations and guidances needed for these new drugs.

The cost of biosimilars is expected to be lower than biologics, but it is widely expected that the cost difference in the United States between the original biologic and its biosimilars will be much less than the cost difference between small-molecule brand name and their generic alternatives. Nevertheless, the availability of biosimilars as alternatives to the original biologic agents is expected to save patients, insurers, and the federal government billions of dollars annually in treatment costs. However, the US patent for Remicade does not expire until September 2018; therefore, a biosimilar for the treatment of rheumatic diseases may not become available for quite a while longer. Decision Resources; December 5, 2013


Medical Test Results Now Accessible to Patients Directly from the Laboratory
Patients, or individuals designated by patients, may have direct access to their laboratory test results, according to the US Department of Health and Human Services (HHS). “The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act Privacy Rule,” said HHS Secretary Kathleen Sebelius. “Information like lab results can empower patients to track their health progress, make decisions with healthcare professionals, and adhere to important treatment plans.” This rule amends the Clinical Laboratory Improvement Amendments of 1988 to allow laboratories to give a patient, or a person designated by a patient, access to the patient’s completed test reports on the patient or his/her representative’s request. Although patients can continue to receive their laboratory test results directly from their physicians, they now have the ability to access the information directly from the laboratory and maintain strong protections for their privacy. This rule is being issued by the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights. Health & Human Services Press Release; February 3, 2014


Protein Linked to Bone Growth in Mice
WNT7B—a protein associated with cell proliferation, fate decision, polarity, and migration—may also promote bone formation, according to a recent study from Washington University School of Medicine, St Louis. The mechanism of action is partly mediated through the mammalian target rapamycin complex 1 (mTORC1). “We have been looking for new ways to stimulate bone formation,” said principal investigator Fanxin Long, PhD. “The tools we already have are very good at slowing the breakdown of the bone, but we need better ways to stimulate new bone growth.” In addition to enhancing increasing osteoblast number and activity, they found that WNT7B stimulates bone acquisition in the embryo, enhances bone accrual in postnatal cells, and stimulates bone formation in part through mTORC1; WNT7B and WNT3A activated mTORC1 signaling. Specifically, the WNT proteins activated mTORC1 through phosphoinositide 3-kinase (PI3K)-AKT signaling, the authors explained. Furthermore, mTORC1 appeared to increase osteoblast activity in response to the WNT7B protein. These results may lead to new therapies for patients with osteoporosis. Chen J, et al. PLoS Genet. 2014;10:e1004145


Bipartisan Proposal to Repeal Medicare’s SRG and Implement Value-Based Physician Payment
A bipartisan group of House and Senate lawmakers proposed the SRG Repeal and Medicare Payment Modernization Act, which intends to permanently repeal Medicare’s sustainable growth rate (SRG) formula for physician payments and replace it with annual increases of 0.5% between 2014 and 2018. These increases would be maintained through 2023 so that physicians have time to receive additional payments through a merit-based incentive payment system. The proposed act would apply to clinical nurse specialists, nurse practitioners, and physicians of medicine or osteopathy. The summary of the legislation suggests that the new payment system would encourage care coordination initiatives for patients with chronic illnesses.

In addition, the legislation would require the US Department of Health and Human Services to make public a list of clinical decision support tools, which would be used in a program that would require clinicians ordering scans for their patients to consult with one of the listed qualified systems and ensure the scans follow “appropriate use criteria” before Medicare coverage. Clinicians found to be noncompliant with these criteria would require prior authorization before using applicable imaging services. It would also require electronic health records to be interoperable by 2017. “Congress has been debating the shortcoming of the SRG policy for more than a decade,” American Medical Association President Ardis Dee Hoven, MD, said in a statement. “Continuing the cycle of short-term patches by merely addressing the 2014 cut that is imminent on April 1 without solving the underlying problem would be fiscally irresponsible and further undermine the Medicare program.” California Healthline; February 7, 2014

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Last modified: May 21, 2015
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