Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System.

Biologics are indicated for the treatment of a wide range of conditions and have transformed care in several therapeutic areas; however, they are expensive for both health care systems and patients. The use of biosimilars, which are approved by the US Food and Drug Administration as being "highly similar" to the originator biologic, has the potential to change the health care landscape in the biologic space through considerable cost savings for both payors and patients. With the introduction of biosimilars, organizations are increasingly evaluating how to switch patients from originator biologics to biosimilars. While published studies have evaluated the outcomes of patients switched from originator biologics to biosimilars, there are few publications describing the process health care systems have used to adopt and switch patients to biosimilars. Since 2016, Kaiser Permanente Colorado (KPCO) has undertaken several biosimilar switches starting with the first biosimilar introduced to the market, filgrastim, and has been able to successfully switch 91.8% of patients receiving infliximab, 99.8% receiving rituximab, and 100% receiving filgrastim, trastuzumab, and bevacizumab originator biologics to their respective biosimilars. In an effort to support other health care systems and provide a framework for implementing biosimilar switches, the purpose of this paper is to describe the biosimilar switch model and share learnings from the KPCO experience.

Improving quality, affordability, and equity of multiple sclerosis care.

OBJECTIVE: The prevailing approaches to selecting multiple sclerosis (MS) disease modifying therapies (DMTs) have contributed to exponential increases in societal expenditures and out-of-pocket expenses, without compelling evidence of improved outcomes. Guidance is lacking regarding when and in whom the benefits of preventing MS-related disability likely outweighs the risks of highly effective DMTs (HET) and when it is appropriate to consider DMT costs. Our objective was to develop a standardized approach to improve the quality, affordability and equity of MS care. METHODS: MS experts partnered with health plan pharmacists to develop an ethical, risk-stratified, cost-sensitive treatment algorithm. We developed a risk-stratification schema to classify patients with relapsing forms of MS as high, intermediate or low risk of disability based on the best available evidence and, when the evidence was poor or lacking, by consensus. DMTs are grouped as highly, modestly or low/uncertain effectiveness and preferentially ranked within groups by safety based on pre-specified criteria. We reviewed FDA documents and the published literature. When efficacy and safety are equivalent, the lower cost DMT is preferred. RESULTS: Assignment to the high-risk group prompts treatment with preferred HETs early in the disease course. For persons in the intermediate- or low-risk groups with cost or health care access barriers, we incorporated induction therapy with an affordable B-cell depleting agent. Based on more favorable safety profiles, our preferred approach prioritizes use of rituximab and natalizumab among HETs and interferon-betas or glatiramer acetate among modestly effective agents. INTERPRETATION: The risk-stratified treatment approach we recommend provides clear, measurable guidance in whom and when to prescribe HETs, when to prioritize lower cost DMTs and how to accommodate persons with MS with cost or other barriers to DMT use. It can be adapted to other cost structures and updated quickly as new information emerges. We recommend that physician groups partner with health insurance plans to adapt our approach to their settings, particularly in the United States. Future studies are needed to resolve the considerable uncertainty about how much variability in prognosis specific risk factors explain.

Multiple sclerosis.

Multiple sclerosis is a chronic, unpredictable, and disabling disease. Significant advances have been made in recent years supporting an earlier, more accurate, diagnosis and have led to more than 15 disease-modifying therapies approved by the Food and Drug Administration for relapsing forms of multiple sclerosis. Disease-modifying therapies are now being classified into categories based on level of efficacy. Strategies to use disease-modifying therapies earlier and in a more customizable manner are also emerging. A clinical case study will be used throughout this pearl to review the disease-modifying therapies and use patient-specific factors to develop and provide recommendations on therapeutic strategies for individuals with relapsing forms of multiple sclerosis.

Therapeutic Interferon Interchange in Relapsing Multiple Sclerosis Lowers Health Care and Pharmacy Expenditures with Comparable Safety.

INTRODUCTION: For patients with a less-active (fewer relapses or complete recovery from relapses, less radiologic burden of disease, or no or limited disease-related disability) relapsing form of multiple sclerosis (MS), interferon (IFN) beta-1b subcutaneous is similar in efficacy to IFN beta-1a intramuscular and subcutaneous. The purpose of this study was to assess the impact of patient interchange from an IFN beta-1a to IFN beta-1b. METHODS: This was a retrospective, pre-post study of adult patients with relapsing MS who underwent interchange from an IFN beta-1a to IFN beta-1b between April 15, 2014, and April 30, 2015. Health care financial and utilization outcomes between the 6 months before and after interchange were compared, and safety outcomes after interchange were assessed. RESULTS: A total of 36 primarily white, middle-age, and female patients underwent interchange. Monthly total health care and pharmacy expenditures decreased by approximately 40% and 44%, respectively, from pre-to-post interchange (p < 0.001). Health care utilization was unchanged (p < 0.05). Seven (43.8%) patients underwent interchange back to IFN beta-1a intramuscular. No patients underwent interchange back to IFN beta-1a subcutaneous. The most common adverse effect reported after interchange was injection-site reaction. CONCLUSION: Health care expenditures decreased and adverse effects were limited among patients with MS who underwent an interchange from an IFN beta-1a to IFN beta-1b. These findings suggest that a therapeutic interchange between IFNs for patients with less-active MS disease is well tolerated. Further research is needed to determine the impact of such an interchange on disease progression.