Specialty drugs and the role of managed care pharmacy

Specialty pharmaceuticals will have a profound impact on the practice of pharmacy over the next 10 years. They will affect all pharmacy practice settings and accelerate the importance of medication management to ensure the appropriate use of these important therapeutic agents.

For treatment of chronic diseases (e.g., asthma, diabetes, hypertension, etc.) in large patient populations, the current practice of dispensing and distributing traditional drugs through retail and mail pharmacies will continue.

Specialty pharmaceuticals, which tend to be directed toward smaller patient populations, have a different model for distribution. They require special storage and handling, close patient monitoring, and complex clinical management.

Retail, mail, and specialty pharmacies account for the distribution of about 45% of specialty drugs. The other 55% is distributed primarily from the physician’s office, with outpatient hospital and home infusion making up the rest.

Coming Soon

The current use of limited sites of service for infused and injectable drugs will change over the next 10 years, as managed care pharmacy practice will move specialty drug volume to the providers who can make a positive impact on health outcomes in the most cost-effective way.

The next 10 years will also see the emergence of a specialty pharmacist, based in the physician’s office, who will manage the patients taking certain specialty medications.

As the costs of specialty pharmaceuticals escalate, some in excess of $50,000 annually (e.g., Solvaldi, Olysio), it makes sense for managed care to place pharmacists closer to the patient. Use of these medications will benefit from pharmacist availability to physicians or even, through housecalls, to patients in their homes.

Areas of focus

Ultimately, a managed care pharmacy practice will focus on the following areas:

• Claims administration: The managed care pharmacist can determine whether a specialty drug falls under the medical or pharmacy benefit.

• Cost management: The managed care pharmacist can determine whether a specialty medication should be administered in the physician’s office or a pharmacy, and can also manage those pesky medication lists.

• Utilization management: The managed care pharmacist can be responsible for prior authorizations and tracking, handle compliance matters and follow-up, and measure health outcomes.

Tools and systems

At present, patients taking specialty pharmaceuticals represent only 1% of the patient population, yet they represent an amazing 30% of total drug spend. One responsibility of managed care pharmacy practice will be development of the systems needed to track patients across the healthcare system and monitor use. Currently, only the healthcare plans (e.g., Blue Cross Blue Shield, commercial health insurers, and regional health plans), with their claims databases, cover all the sites of service.

When pharmaceuticals were considerably less expensive, if patients tried a drug and it didn’t work even 35% of the time, the cost-risk was acceptable to most stakeholders. Conversely, when the therapeutic window is narrow and adverse events are possible, we will need more tools to predict effectiveness vs. risk. This applies to all medications, including specialty products.

While still in its infancy, the science of genomics is one tool that provides evidence needed to make such decisions on the optimal use of certain drugs. The growing “personalized medicine” movement tailors the use of drugs and specifies doses to the individual patient’s cellular and genetic makeup. Genetic testing, for example, can provide information abouta patient’s liver enzymes and predict the rate he/she metabolizes specific drugs.

A new approach

Clearly, healthcare will need to take a different approach to specialty pharmaceuticals. We have known this for years. When accompanied by a collection of screening tools and monitoring processes called for by specialty products, they just may become more available.

While some of these processes are mandated by FDA, most are not. We will need creativity and focus to show just how far specialty pharmaceuticals can take us.

As specialty products consume more of the healthcare dollar, the role of managed care pharmacy will be critical.

Perry Cohen is chief executive officer of The Pharmacy Group.