Steven G. Avey, RPh, MS, FAMCP

As payers aim to control costs, they seek better data and reporting on specialty drug use and clinical outcomes.

Over the past decade, the sharp increase in spending for specialty medications has led payers to scrutinize new, high-cost therapies and question their clinical benefits and return on investment.

Estimates suggest specialty spending will rise from $290 per member per year (PMPY) in 2012 to $845 PMPY by 2018.

 Numerous organizations have suggested that specialty prescriptions, which typically represent approximately 1% of pharmacy claims, will represent 50% of the total drug spend within the next few years.

There has been a substantial increase in utilization and trend for specialty drugs over the past few years (Table 1), according to MedImpact Healthcare Systems, Inc, the nation’s largest privately held pharmacy benefit management (PBM) company. Specialty trend for 2015 is expected to increase to 25.8%, with the average prescription costing more than $3300.

Given the rapidly increasing specialty trend, payers want better data and reporting on specialty drug utilization and clinical outcomes. The EMD Serono Specialty Digest, 11th Edition, surveyed health plans and other categories of payers trying to determine their interest in data and analytics on specialty drugs.

Health plans responded they are more likely to receive reporting on specialty drug use from the pharmacy benefit versus from the medical benefit (83% vs 59%, respectively). In response to pharmacy benefit specialty reporting, 83% currently receive reporting and 43% receive integrated pharmacy and medical benefit specialty reporting.

It is reasonable for employers to request evidence that paying more than $5000 per month for a multiple sclerosis (MS) drug provides health benefits to their employees and dependents. Although that kind of research and analysis is expensive and difficult, it is possible to move toward that goal with interim steps.

The first step is to quantify how many patients are taking their medications correctly, develop ways to improve adherence, and determine the health status of patients over time as a result of taking these specialty drugs. MedImpact has worked with select specialty pharmacies to deliver reporting that provides real-world experience with drug therapies.

Several of these pharmacies have developed analytics on select disease states to assist with the patient experience and to report on outcomes of therapy. Following are examples of specialty pharmacies providing analytics that assist the payer in understanding what happens in the real world as opposed to what occurred in a clinical trial setting.

Savings Through Hepatitis C Intervention 

In one of the many phase 3 trials performed on the new hepatitis C agents, the rate of sustained virologic response was 94% with 8 weeks of ledipasvir/sofosbuvir, 93% with 8 weeks of ledipasvir/sofosbuvir plus ribavirin, and 95% with 12 weeks of ledipasvir/sofosbuvir.

Health plans and pharmacy benefit managers made individual decisions on which patients needed to be treated for hepatitis C. These same organizations have been attempting to determine the outcomes from their treated populations, where drug treatment costs are approximately $90,000 per patient (based on the average wholesale price [AWP] of Harvoni).

In order to report outcomes on hepatitis C, viral load data would need to be obtained, which has proven to be difficult. BioPlus, a specialty pharmacy under contract with MedImpact, developed a reporting dashboard for their clients that includes viral load data and other important information as shown in Table 2 and Figure 1.

Not only are they able to show a breakdown of important hepatitis C information, they also report on prescriber-targeted interventions when therapy appears inappropriate. In an analysis of their book of business, BioPlus reported that with the use of Harvoni, 23% of patients were initiated on an 8-week regimen, 57% on a 12-week regimen, and 20% on a 24-week regimen.

This is important information due to the relative difference in cost among these differing durations of therapy. BioPlus clinicians were able to reach out to physicians and reduce the duration of therapy from 12 weeks to 8 weeks where appropriate.

That intervention created a savings of approximately $30,000 per patient (based on the AWP of Harvoni).

According to a report in Healthline, MS affects approximately 400,000 people in the United States and is the most widespread disabling neurological condition of young adults around the world.

Although a person can develop MS at any age, it is most commonly diagnosed between the ages of 20 and 40 years.

The impact of this debilitating illness, in terms of pain, suffering, absenteeism, lost productivity, and health care costs, is staggering. For MedImpact clients, the cost of MS typically ranks in the top 4 disease states driving specialty drug costs.

According to an analysis by MedImpact analysts on total book of business data, the average cost for MS specialty medications has increased 34% in the past 2 years. Many payers question how well their members with MS are being managed and what can be done to ensure these high-cost therapies are effective.

One of MedImpact’s contracted specialty pharmacies, US Bioservices, has taken an important step to improve payers’ understanding of the outcomes of MS specialty drug therapy. They administer a modified expanded disability score survey (EDSS) to all patients with MS when they are on-boarded, and they administer follow-up surveys every 6 months. The EDSS survey scores range from 0 to 10 in 0.5-unit increments.

A score of 10 represents the highest level of disability. Scoring is based on either an examination by a neurologist or a survey by a clinician. US Bioservices is able to report on the EDSS scores of patients with MS they are managing longitudinally.

They also show the distribution of patients with different scores and the projected cost of total medical care for patients in each category. Analytics can provide insight to payers on the ability of specialty medications to keep patients at the lower end of the disability scale.

This not only improves patients’ mobility and quality of life, it also reduces hospital and physician office visit costs. In addition to this analysis of outcomes, US Bioservices also performs a behavioral classification assessment of each patient to determine what types of adherence assistance would be most effective.

Figure 2 shows the traits possessed by different patient personality types. The customized patient adherence programs assist all patients in staying on therapy as prescribed by their specialists.

The use and cost of specialty medications continues to climb substantially. Analytics reporting on the ablility of pharmacies to keep patients on therapy will likely become more common as payers push for more actionable data and information to demonstrate the value these expensive specialty medications provide. 

		The growing cost of specialty pharmacy—is it sustainable? 

 Express Scripts. Published March 2015. http://lab.express-scripts.com/drug-trend-report/.

		EMD Specialty Digest 11th ed. EMD Serono: Rockland, MA; 2015.

		Kowdley KV, Gordon SC, Rajender Reddy K, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-1888. doi: 10.1056/NEJMoa1402355.

		Pietrangelo A, Higuera V. Multiple sclerosis by the numbers: facts, statistics, and you. Healthline website. Published on March 24, 2015. www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#sthash.Ug7eotvB.dpuf.

		Expanded disability status scale. Multiple Sclerosis Trust website. www.mstrust.org.uk/atoz/edss.jsp. Updated October 29, 2013.

 is a distinguished expert in managed care and namesake of the Academy of Managed Care Pharmacy (AMCP) Foundation’s prestigious lifetime achievement award, the Steven G. Avey Award. AMCP renamed their award in recognition of his achievements in quality measurement programs and improving drug assessment processes in the United States. As vice pesident of specialty programs at MedImpact, Steve is responsible for setting the overall business strategy in the specialty arena. Steve began his career in retail practice, but following graduate school, managed-care pharmacy became his focus. He initially started with Prospective Health (now Relay Health), where he helped establish and run its data services division. In 2000, after serving as treasurer and president of AMCP, he was hired as the executive director of its foundation. In 2005, he left AMCP to become vice president of managed care at Partners Rx Management. He then joined RegenceRx, where we worked to assess the company’s services, network rates, and rebates to determine how RegenceRx could better service its health plan. Steven holds a Master of Science degree in pharmacy administration from the University of Utah.

Steven G. Avey, RPh, MS, FAMCP

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