To say there’s a growing demand for specialty pharmacy is an understatement of vast proportions.

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Today, some 57 million working-age Americans with chronic illnesses are able to stay on the job due to advances in biotechnology and the development of specialty pharmaceuticals. The effectiveness of these drugs, combined with demand from patients, has pushed drug companies to develop additional new drugs for chronic, debilitating illnesses.

For example, in 2008, 25 percent of all drugs approved by the U.S. Food and Drug Administration were considered specialty drugs—what the FDA calls new molecular entities—and that number only has gone up since. Now, more than 50 percent of all drugs approved by the FDA are specialty drugs.

Right now there are some 900 new drugs in the specialty pipeline, and about 40 percent of those are oncology drugs. The impact of this biotech explosion is evident in the results of a community tracking study done by the Center for Studying Health System Change. By 2014, according to the study, seven of the nation’s top 10 drugs will be biotech, compared to five in 2008, and just one in 2000.

For many years, specialty drugs were referred to as high-cost injectables. These specialty treatments were covered under the patient’s medical benefits because they were injectable products and, historically, medical professionals provided the vast majority of all injectable treatments by administering them in their offices. But as the industry evolved, new oral specialty drugs have been developed. Today, specialty pharmacy may be delivered under several types of distribution channels, with about half covered under pharmacy benefits and half covered under medical benefits.

Because specialty drugs are generally high cost and difficult to manage, many pharmacy benefit managers have developed specialty programs designed to improve access and delivery, aid in therapy management, increase adherence, and provide educational support to patients receiving their drugs through the PBM. While this works well for those getting medication under their pharmacy benefits, it may not do enough to support many of the patients still receiving specialty pharmacy through their medical coverage. And, it doesn’t do anything to help payers manage these high-cost therapies under the medical benefit.

And therein lies, perhaps, the greatest challenge ahead. With some specialty drugs covered under medical plans and others covered under pharmacy plans, how do we—PBMs, health insurers and medical professionals—ensure patients get the support they need to stay compliant with their prescribed therapy and, therefore, receive maximum benefit from treatment?

Getting support

When considering specialty pharmacy management, there are a couple of givens that must be considered:

First, because the delivery systems for specialty drugs are often unique to each drug, these pharmaceuticals cannot simply be moved from the medical benefit to the pharmacy benefit. We expect there always will be some specialty drugs covered by medical plans and some covered by pharmacy.

And regardless of the method by which specialty drugs are delivered, as a “rule of thumb,” patients must be at least 90 percent compliant in order for specialty pharmaceuticals to be effective. Non-compliant patients generally have more relapses, more office visits and more hospitalizations, resulting in cost increases on the medical side. Therefore, it is in everyone’s best interests to ensure patients remain compliant.

So, how do we ensure patients get the support they need to manage their condition and remain compliant with their prescribed therapy? We believe the answer involves providing individualized care through the integration of services—synchronizing the services from both the medical and the pharmacy side for the benefit of the patient. In the future, specialty pharmacy will no longer be simply about drug distribution; it will be about helping a health plan manage this population across all benefits and via a complex array of distribution channels and sites of service.

In a nutshell, the patient should receive ongoing education and support services related to his/her condition and prescribed treatment, regardless of whether the specialty drug is delivered through the doctor’s office, home infusion, hospital, specialty pharmacy, or out-patient hospital pharmacy. The goal is to empower patients by increasing their knowledge about their disease. By helping them manage their conditions and lifestyle, their quality of life also is enhanced.

At OptumRx, we strongly believe in this approach that we began putting this type of synchronized platform into place four years ago. We now work with patients’ doctors, caregivers, alternate sites of care and payers to provide the same member-centric support and appropriate management of drug utilization and distribution for patients who get their drugs through their medical benefit as we do for patients who get their drugs through us, their PBM.

Our specialty pharmacy engages each patient through the appropriate clinical management program: autoimmune disorders, hemophilia, hepatitis C, HIV/AIDS, multiple sclerosis, oncology and transplant. Our clinicians work with each patient individually, providing education about the patient’s disease, the importance of adherence, and other types of general support. The client is screened for depression or anxiety—and if the assessment indicates the potential for a problem, we refer the patient into the OptumHealth Behavioral Health programs, or into any other program that is part of their benefits. We are careful to coordinate care between the clinicians on both the medical and pharmacy sides, ensuring patients get the support and service they need.

Personalized medicine growth

Look for personalized drugs to make more of an impact in the near future. These drugs are individually tailored and dosed to each patient’s genetic make-up, the goal of which is to enlist the help of a person’s own immune system to help combat diseases such as cancer. A recent introduction in this field is Provenge, a treatment for metastatic prostate cancer that utilizes the patient’s own cells in the manufacturing process. Provenge is designed to stimulate the natural ability of the body’s immune cells to target and attack advanced prostate cancer.

Biosimilar drugs enter the marketplace

There are currently more than 40 biosimilar drugs in development. These biologic drugs are very similar, although not identical, to previously approved, complex biotech drugs. Even though the molecular structure of proteins means that biosimilars may never be exactly the same as the original drugs, most people agree that there are many illnesses for which biosimilar drugs could be very effective.

The European Union approved the use of biosimilars in 2005; its European Medicines Agency has approved 14 biosimilar drugs thus far.

In the U.S., the FDA is working to establish procedures for the approval of biosimilar drugs. As part of the Patient Protection and Affordable Care Act signed into law on March 23, 2010, the FDA is required to set appropriate user fees, and performance and safety goals for biosimilars to be implemented by Oct. 1, 2012.

The opening up of the U.S. biosimilar pathway is further evidenced by a joint announcement in late 2011 from Amgen, Inc., the world’s largest biotech firm, and Watson Pharmaceuticals, Inc., a leading generic drug manufacturer. The two companies announced an agreement to collaborate in the production of biosimilar versions of several biologic cancer medications.

Employers need help

Specialty pharmacy is moving faster than many employers’ ability to understand it.

Survey data released last fall by one of the nation’s largest business coalitions, the nonprofit Midwest Business Group on Health in Chicago, reveals an almost urgent need for employer education about specialty pharmacy trends and costs.

The survey showed that 25 percent of employers have little or no understanding of specialty pharmacy. In addition, of 120 employers who said their specialty pharmacy was managed by their health plan, 70 percent did not know how much their company was spending on specialty drugs. And 30 percent didn’t know how much their total specialty pharmacy claim costs had increased over the previous three- to five- year period.

Keeping a finger on the specialty pulse

Specialty pharmacy is evolving from simply a drug distribution model to a means of helping health plans manage their specialty population across all benefits and distribution channels. This change offers opportunities to more effectively manage and balance treatment cost and patient care by synchronizing patient support. Since about half of the specialty drug spend is on the medical side of the equation and, realistically, should stay there, it is important to focus on providing comprehensive specialty management for clients, regardless of the drug delivery method utilized.

The progression of specialty pharmacy into new and exciting areas like personalized medicine and biosimilar drugs means that management programs that synchronize care across both the pharmacy and medical benefits will become even more critical. Just as important, however, is the need to provide ongoing education for employers so they understand the impact of specialty pharmacy on outcomes and costs, and have the knowledge they need to better manage their own health care plans.