Trends in Specialty Pharmacy and Personalized Medicine

San Antonio—Specialty pharmacy is transforming from a drug distribution model to an integrated system that coordinates many aspects of patient care, enabling health plans to manage populations across all benefits and distribution channels. In parallel, the emergence of personalized medicine is revolutionizing the treatment paradigm for a growing number of disease states. As a result, there is a need for a sophisticated understanding of treatment plans and pathways—a need that can be filled by specialty pharmacy programs.

This topic was discussed by a panel of experts in personalized medicine, payer coverage, and specialty pharmacy during a session at the AMCP meeting titled When Specialty Pharmacy Meets Personalized Medicine. The session began with a look at the sales and growth of specialty pharmacy. Diana Brixner, RPh, PhD, professor and chair in the department of pharmacotherapy at the University of Utah College of Pharmacy, said that spending on specialty drugs are projected to surpass sales of traditional agents by 2018. See Figure 1. Personalized medicine will be a growing component of specialty medicine. Furthermore, the growth on pharmacy spending on specialty drugs in commercial plans is expected to continue as coverage is shifted out of the medical benefit. See Figure 2. Personalized medicine decisions will be increasingly driven by a pharmacy and therapeutic committee due to the increase in healthcare spending. Oncology represents 14.3% of specialty drug costs and is a primary area for personalized medicine, noted Dr. Brixner.

Dr. Brixner, who serves as the director of outcomes for the Program in Personalized Health Care at the university, explained the difference between evidence-based medicine and personalized medicine. Evidence-based medicine focuses on statistical notions and epidemiological data, gathered through systematic meta-reviews of randomized controlled trials. Personalized medicine is based on the mechanistic explanation of molecular interactions, metabolic pathways, and biomarkers. “Both paradigms should represent 2 compatible, but alternative ways of informing the clinical practice,” she said.

Personalized Medicine and Patient Perceptions

Patient knowledge, attitudes, and behaviors hold a key for personalized medicine, according to Diana Dobrovolny. She highlighted a 2013 study by Gfk Bridgehead that looked at consumer perception of personalized medicine. The online survey included 602 respondents. The study found that only 27% of participants are familiar with the term “personalized medicine,” just 8% considered themselves “very knowledgeable about the concept.” A majority of the respondents have a vague or false perception of what personalized is: 53% thought personalized medicine refers to medical care geared toward “individual needs,” while 9% thought the phrase had something to do with doctor/patient collaboration. Only 4% associated personalized medicine with genetics, which generally is a key element.

After receiving more knowledge about personalized medicine, 64% of respondents thought it would have a “very positive” impact. The study also found that men and women react somewhat differently to the value characteristics of personalized medicine. When considering specific elements of personalized medicine, more women (53%) are interested in tailoring treatments once diagnosed, while 57% of men are more interested in predicting disease. Furthermore, the study also showed that 87% of respondents expected personalized medicine would increase healthcare costs either “significantly” or “moderately” over the next 5 years. Only a very small group of respondents said they were generally interested in predicting what diseases they might get in the future; but, when asked about specific life-threatening illnesses—such as Alzheimer’s disease and diabetes—70% to 80% said they would want to know if they were at risk.

Personalized Drug Criteria

Eric Cannon, PharmD, chief of pharmacy for SelectHealth, continued the presentation with a discussion of the criteria payers use to classify personalized drugs in the medical benefit versus the pharmacy benefit. Drugs classified in the pharmacy benefit include oral medicines that are self-administered. Whereas, drugs classified in the medical benefit include injectable and infusion medicines administered in an office.

He highlighted the advantages and disadvantages for both benefits. The advantages of personalized drugs classified in the medical benefit include reduced managed care organization/employer financial responsibility, increased price awareness, good fit with traditional therapies, and out-of-pocket protection. The disadvantages include that the cost is out of member reach, negative affect on compliance, lack of data, and perverse incentives.

Personalized drugs under the pharmacy benefit allow for increased flexibility with member cost share, improved data, average wholesale pricing, real-time adjudication, and improved safety with electronic prescribing, explained Dr. Cannon. He cited 3 disadvantages, including possible lack of out-of-pocket maximum, lack of billing capabilities in most medical clinics, and potential to increase split billing. 

Future of Personalized Medicine

Steven Avey, RPh, vice president of specialty pharmacy programs at MedImpact HealthCare Systems, Inc, a provider of pharmacy benefit management (PBM) systems, rounded out the session by identifying specific ways in which specialty pharmacy can support the promise and benefits of personalized medicine. Although MedImpact does not own a specialty pharmacy, the PBM performs the assessments on all new agents and include genetic testing in the utilization criteria for its clients.

Oncology and hepatitis C are 2 therapeutic areas in which personalized medicine is interfacing with MedImpact’s population-based formulary, according to Dr. Avey, who presented an outcome analysis MedImpact conducted of drugs for these 2 disease states. The analysis for oncology medicine for various types of cancer found that MedImpact “did not have good success in tracking dollar savings to their utilization management program and believe preventing a patient from taking an oncology medication that is not likely to work is more of a patient care model,” said Dr. Avey.

He said that MedImpact saw some good potential savings when teleprevir and boceprevir first entered the market for treatment of hepatitis C, but physicians have been diligent about now doing the genotyping. Dr. Avey noted that all new agents coming out in the next 18 months will require genotyping. Currently, the greatest savings in hepatitis C is the duration of therapy.

The impact of personalized medicine is a considerably higher focus on genetic testing in the past 3 years. Costs are also driving greater management from new and evolving areas. Furthermore, pharmaceutical companies have substantially raised prices on new entities knowing that genetic testing will decrease the potential patient population.

The future of personalized medicine includes the development of more diagnostic tests, development of greater utilization management criteria, treating fewer patients with targeted medications, and protecting patients and reducing adverse events and side effects, concluded Dr. Avey.