Specialty Pharmacy Practice in the Community Setting: Challenges and Opportunities

Pharmacies in the community setting have led the way in patient compliance, but have been largely ignored by MCOs and the pharmaceutical industry.

Over the past decade, the community pharmacy setting has enjoyed considerable success in the marketplace as well as accolades from the health care community. The pharmacies in this setting have led the industry in maintaining a high level of patient compliance by counseling their patients to assist them in managing their particular disease(s). However, this branch of pharmacy has been largely ignored by the managed care organizations (MCOs) and the pharmaceutical industry with regard to the management of the patient for specialty pharmaceutical products.

The industry has shifted away from the community pharmacy and toward large central-fill entities. Among the reasons for this is a better pricing structure for the MCO, a belief that the data derived from these entities is more accurate and timely, and the belief that a patient is more tightly controlled in the central-fill environment. While it is acknowledged that the central-fill model is appropriate and very effective in some disease states, it must also be recognized that the community pharmacist can play a major role in managing patients who require specialty pharmaceutical products.

Specialty pharmacy is centered on products used to treat specific disease states. The focus on appropriate drug utilization in conjunction with the ongoing monitoring of patient care provides the opportunity for the pharmacy to show its value to the payer community.

Examples of the types of diseases addressed by specialty pharmacy include:

• Crohn’s disease
• Gaucher’s disease
• Growth hormone deficiency
• Hemophilia
• Hepatitis C
• HIV/AIDS
• Immune disorders
• Infertility
• Multiple sclerosis
• Oncology
• Pulmonary hypertension
• Rheumatoid arthritis

Community-based pharmacies are beginning to represent a trend in the delivery of these products. These pharmacies consistently add significant value to the benefits manager— and the patient—by concentrating on the holistic delivery of both specialty pharmaceuticals and traditional pharmaceuticals. For instance, the types of disease states using specialty pharmaceuticals that have been successfully addressed by community pharmacy include cystic fibrosis, hemophilia, growth hormone deficiency, and infertility. Community pharmacy also has an expanding and important role in the management of more macro-based disease states such as oncology, multiple sclerosis, and rheumatoid arthritis. These diseases and their patients are complex and require a multi-model approach to therapy to have an effective response to the drug regimen.

In order to have a successful model and be effective, the community pharmacy must be willing to add the infrastructure in terms of software systems and human resources. The complex nature of the routes of administration in combination with the expertise, human resource commitment, and space requirements will determine each individual pharmacy’s ability to participate in the space of specialty pharmacy. There is good news, though, in the pipeline of medications coming to market—many of the products in near-term development use oral or injectable routes of administration. These routes of administration ease the coordination and handling of the product. Also, most of these products will fall under a pharmacy benefit, which is less complicated and more efficient for delivery of payment in a timely manner.

The most significant difference between specialty pharmacy and community pharmacy has been the specialty pharmacy’s ability to provide expert and focused therapy management and related services. Patient management has been a true value for specialty pharmacy, highlighting the fact that the community pharmacy must have the commitment of its owners to build out the staff and systems needed to support these complex therapies.

Challenges to Overcome

There are many specialty disease states that can be managed within a community pharmacy setting. Following are some important challenges that community pharmacy has to overcome to be successful in the competitive specialty pharmacy environment.

Reimbursement is key to any pharmacy dispensing products costing an average of $1500 per month. In recent years, the trend has been for the MCO community to move self-injectable drugs to the pharmacy benefit (versus the medical benefit), where they are adjudicated like traditional oral products. This trend has provided benefits to the payer, including the tracking of compliance and persistency, and the ability to monitor price trends in these expensive disease states. Community pharmacy can take advantage of this trend by offering competitive services on products billed through the pharmacy billing systems.

Examples of specialty pharmaceuticals that can be adjudicated using standard pharmacy systems include those for rheumatoid arthritis, multiple sclerosis, growth hormone deficiency, infertility, and oncology. The success of the specialty pharmacy model in controlling the cost and utilization of these products is what led the managed care industry to make expanded use of this model. The result is that this access provides an increasing opportunity for community pharmacy to participate in specialty pharmacy services and distribution.

Another key driver of growth within specialty pharmacy has been the ability of specialty pharmacy to offer the MCO competitive and discounted pricing across a number of these disease states, where specialty pharmacy has already built the tools needed to manage the complex patient and has marketed that ability to the managed care community.

Community pharmacy needs to establish its value and niche in specialty pharmacy to contract with plan sponsors and be included as a specialty pharmacy provider. It is recommended that the community pharmacy in the specialty space first prove its value at a local level and with the local MCOs. Once the value and niche for that pharmacy is established, it is time to create a more national strategy by partnering with like-minded pharmacies across the country. This method will then establish a national network of community- based specialty channels that can offer an appealing alternative to the payer interested in giving its membership choice in the venue of care.

To successfully compete with existing specialty pharmacies (ie, centralfill pharmacies), community pharmacies will need to develop much closer associations with manufacturers of specialty products. These relationships will lead to better discounts and fee-for-service opportunities with the manufacturer. These services include:

• Reimbursement support
• Therapy management
• Patient counseling
• 24/7 clinical support
• Patient registration
• Clinical tracking
• Reporting

Community pharmacies should consider the following criteria to have a strong relationship with the manufacturer— identification of the key disease states in which they would like to engage agreements and also the identification of the specific manufacturer with whom they would like to engage these types of agreements. The community pharmacy can share the benefit of its experience with the targeted patient population and can also help the manufacturer with prelaunch planning and ongoing decision making. The potential for providing real-time, baseline data about the patient population, use of current therapies, and information on prescribers offers keen insight that may not otherwise be available in a timely fashion.

Also, by having access to the patient’s entire drug history, the community pharmacy may provide the manufacturer partner with utilization and outcomes data to help trend the progress and issues of present and future medications. The ability to capture and share this data presents a unique opportunity for community pharmacy.

Providing Services

The introduction of services such as reimbursement support, clinical tracking, and reporting may represent a barrier to entry when initially entering the field of specialty pharmacy services. One solution is to provide these services for many individual community pharmacies through a hub concept. The hub would enable multiple community pharmacies to provide services comparable to existing central-fill specialty pharmacies. Also, this entity can be used for a central-fill specialty pharmacy to supply those medications that a community pharmacy may not want to stock or are unable to access at this point in time. A common or interfaced platform leads to an efficient structure in providing specialty pharmacy services from both a distribution and clinical perspective.

Key Advantages of Community Pharmacy

A key advantage for community pharmacy is to be able to address issues for patients with multiple conditions, since patients treated with specialty products generally have multiple disease conditions. A disease management approach that addresses all the needs of a given patient would both enhance care and provide very effective management services for both the manufacturer and the plan sponsor. Here are some scenarios where this strategy would work:

• A combination of community pharmacy dispensing and central distribution of pharmacy order fulfillment for specialty medications within targeted disease states
• Clinical programs that will positively impact appropriateness and utilization and ensure proper compliance with and persistency to prescribed therapies
• Disease management programs
• Reimbursement support transparent to the community operation
• Ability to accept assignment of benefits for physicians and the payer
• Benefit design and formulary consulting
• Ability to provide immediate drug access to the patient

It is important for the community pharmacy to consider all of the above factors in forming its specialty strategy. Commitment to infrastructure, development of MCO relationships, and development of relationships with the manufacturer, as well as the hub services offered by the manufacturers, will ensure a place in therapy management for the community pharmacy. SPT

Nick Calla, RPh, JD, is the vice president of industry relations for the Community Specialty Pharmacy Network (CSPN). He has responsibility for the development of the relationships with the manufacturer community as well as the managed care community. Prior to CSPN, Nick was vice president of trade relations for Walgreens Specialty Pharmacy. Prior to coming to Walgreens, Mr. Calla worked as director of clinical programs and network administration for Eckerd Health Services. He was also president and general manager of Oncology Pathways, a group purchase organization founded by the UPMC Cancer Center and Medmark Specialty Pharmacy. Mr. Calla has expertise in the area of compliance, disease management, intervention programs, and negotiations with providers for a network. He received his bachelor of pharmacy degree from the University of Pittsburgh and a Juris Doctorate from Duquesne University.