Leveraging specialist counsel adds insight into specialty drugs

Specialty pharmacy as a managed benefit has arrived at the same place pharmacy benefit management was several years ago (offering open formularies, flat co-pays, etc.). Yet, currently, little is being done to address specialty pharmacy as a managed benefit. Some payers have specialty co-pay tiers in place, and some have limited networks (patients must have their specialty medications filled at a certain pharmacy), but since traditional pharmacy has evolved to tiered co-pays and formularies, the question is why not specialty?

Some categories within specialty are not candidates for this approach, but, because some categories would be applicable, Pharmacy and Therapeutics (P&T) committees are evaluating specialty drugs, including biologics, from an expanded perspective. They are reviewing evidence-based literature and also seeking counsel of specialists about specific disease states such as rheumatoid arthritis, hepatitis C, and multiple sclerosis.

As specialty drugs become more complex and sophisticated, it is increasingly important that those chosen for the formulary are the most effective and appropriate, as they are life-saving/life-changing medications vital to management of rare and debilitating diseases. It is critical that patients have access to these medications, and that a management strategy (clinical and financial) be implemented.

By including a practicing specialist in their meeting, the P&T committee can gain insight into the real-world management of the identified disease state, since head-to-head comparison studies are rare. This is valuable because:

The committee recognizes that specialty and biological medications play a significant role in therapy, as well as have considerable drug spend implications. Specialty medications are prominent within the new drug pipeline. According to the FDA, in 2007, nine of 18 new molecular entities and biologics were specialty drugs, and more than half the medications in Phase III clinical trials were specialties.

Efficacy vs. cost

One challenge facing P&T committees is the growing trend for specialty medications to be used more often and earlier in the treatment regimen/protocol. Two studies included in the package insert for rheumatoid arthritis treatment, Enbrel, are examples of data suggesting earlier use of specialty medications for certain disease states. One clinical study compares use of Enbrel vs. methotrexate in patients early in the RA disease process and who had never been treated with methotrexate (MTX). Results suggest Enbrel works slightly better. A second similar study compares MTX vs. Enbrel vs. Enbrel+MTX. The results suggest Enbrel+MTX provides the most effective outcome.

With "biosimilar" medication approval process still some time away, there will be no significantly lower-cost generic equivalents in the near future. Based on clinical information and specialist recommendations, the products within the growth hormone category, for example, are very similar. One approach is to consider contracting with certain manufacturers to reduce the net drug spend through rebates. For a specialty benefit design with 10% co-insurance (maximum of $75) for "preferred" growth hormone and 20% co-insurance (maximum $150) for non-preferred, the rebates for the preferred product may prevent additional cost shifting to the member and still manage the overall drug spend from the client's perspective.

Future of specialists

Specialist participation in P&T committee meetings is not likely to occur permanently because these physicians are so specialized, and as specialty drugs are evaluated, the committee will need advice from various specialists who treat specific diseases. It is realistic, therefore, for P&T committees to create a position for a "rotating specialist," who would vary based on the therapeutic category being discussed. Specialist involvement in P&T committees will continue to increase as the industry evolves and utilizes various management tools and strategies to address specialty pharmacy.

Ryan Haynes, R.Ph., is director of clinical services of HealthTrans.