J Clin Pathways. 2016;2(1):14
The National Association of Specialty Pharmacy is a trade association dedicated to education, national policy advocacy, and engagement of all stakeholders in the specialty pharmacy industry. Its 71 corporate members and 1,200 individual members include the nation’s leading specialty pharmacies, pharmaceutical and biotechnology manufacturers, GPOs, and distributors.
The 2015 NASP Annual Meeting & Expo, held September 30–October 1, 2015, in National Harbor, MD, presented a program that included 21 educational sessions on an array of topics including: the payer-manufacturer interface; accreditation and criteria for quality management; legislative and regulatory issues confronting specialty pharmacy; the institutional practice of specialty pharmacy; the integration of medical and pharmacy benefit management; and clinical topics such as hepatitis C, oral oncolytics, oncology guidelines, and HIV.
Presentations at this year’s meeting reflected the increasing focus on determining the value of specialty pharmaceuticals. Although these drugs tend to be costly, they also tend to be used for the treatment of complex, chronic, and debilitating diseases for which there is a high unmet need. The NASP meeting provided an opportunity for manufacturers, payers, and providers to discuss the best way to balance these factors to ensure that patients receive the best treatments with the highest value.
The Use of Guidelines to Address Challenges in Oncology Management
Oncology management continues to be a major challenge for many payers. In a session titled “Challenges in Oncology Management: Are Guidelines Working?,” Debbie Stern, RPh, senior vice president of medical Oncology & Specialty Drug Management at eviCore Healthcare, and Michael Kolodziej, MD, FACP, national medical director of Oncology Solutions at Aetna, presented some of the current practices in oncology management.
Before offering insight on the use of guidelines in oncology, Ms. Stern opened her presentation by reviewing the current state of cancer in the United States. An estimated 1.7 million cancer cases will be diagnosed in 2015, with 1620 individuals expected to die each day. At the same time, there has been a 39% increase in 5-year survival rates across all cancer types since 1975. Between the increased prevalence of cancer, the increased survival associated with the disease, and the rapid rise of drug costs, it is not surprising that oncology has become the therapeutic class with the highest spend, representing more than $23 billion in costs.
Ms. Stern also addressed the troubling state of medical practice, illustrating the realities of shortages of medical doctors, soaring costs, and payers’ focus on cost rather than quality, outcomes, and value. Furthermore, 1 in 3 patients treated with chemotherapy does not receive a treatment plan consistent with current medical evidence.
Clinical pathways, when built on a foundation of quality evidence, can be an excellent tool for both oncologists and payers to keep clinical benefit high and costs low, said Ms. Stern. Pathways programs should be developed from a clinical perspective, easy to utilize, and accepted by practitioners. Multiple treatment modalities such as lab and genetic testing, radiation therapy, advanced imaging, and end-of-life care, should be included in addition to drugs.
Ms. Stern listed some examples of approaches supported by pathways: a focus on palliative care versus chemotherapy in patients with solid tumor cancers who would be unlikely to benefit from therapy; limiting combination therapy for metastatic breast cancer unless the patient needs a rapid response; and using targeted therapy only when biomarkers are present.
Dr. Kolodziej reiterated many of the same points in his presentation, calling attention to the troubling state of cancer care and imploring that it is time to focus on value as the solution. Value, for Dr. Kolodziej, means the implementation of guideline-based therapies in order to improve survival, improve quality of life, and reduce negative outcomes such as toxicity and time spent in hospitals.
Dr. Kolodziej drew support from a study on non-small-cell lung cancer published in 2010, which showed a dramatic reduction in costs for patients treated on a pathway and nearly identical overall survival rates. Independent studies by Dr. Kolodziej and Aetna have yielded similar results, showing a reduction in overall costs and a relative improvement of 43% in patients who were treated with evidence-based pathways versus those who were not.
Dr. Kolodziej outlined the steps that he considers to be the basis of pathway development: define, measure, explore, develop, implement. Pathways need to be built upon evidence, but they also must be allowed to evolve constantly in order to determine how well they are working and to take into consideration new information. Today, there are a number of different pathways vendors capable of providing clinical support to hospitals and physicians. Physicians now have access to instantaneous data that wasn’t previously available, including efficacy data. Clinical data amassed from electronic medical records and claims data taken from payers can inform decision-making, resulting in treatment decisions that are based on the best possible evidence leading to the best possible care, even for unique situations.
Optimizing Treatment Selection for Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an inflammatory autoimmune disease affecting about 1.3 million Americans, causing joint damage and an increased risk of cardiovascular disease. The average per patient medical cost of managing RA is about $13,012, and the total annual population cost is about $22.3 billion.
Current practice in RA management suggests starting drug therapy slowly. However, in a session titled “The Evolving Landscape of RA for Specialty Pharmacists,” panelists discussed the benefits of early intervention in RA. New data suggests that early intervention with the drug tocilizumab induces and maintains remission better than delayed treatment, which can lead to uncontrolled inflammation and irreversible tissue damage.
The panelists also discussed the development of new treatments that target disease escalation, as well as different combination therapies. In many instances, monotherapy or disease-modifying antirheumatic drugs (DMARDs) can be effective, if initiated early. DMARDs in particular are associated with good toxicity profiles and strong adherence. However, the addition of other drugs at low doses can help to manage disease activity or flares. When head-to-head comparisons of different drugs are not available, comparative-effectiveness research can help to inform decision-making. The panelists cautioned that effective RA therapy should not be discontinued, and medication should be given at the optimal dose for 3 months before escalating or switching therapies.
Presenters also spoke about methods for reducing the costs associated with RA care, particularly with regard to how drugs are administered. Patients can choose between oral, subcutaneous, and infusion therapy. Although oral therapies tend to be the most costly, they often are preferred by patients who fear injections. Similarly, the site of care can also influence cost. Doctor’s office or home infusions cost significantly less than infusions in hospital settings. Presenters emphasized that costs can be reduced 5–10% by enhancing the coordination of care. This could entail implementing specialty management programs to design better workflows and training staff on the proper dosing, management, and adherence of medications.
