Nicodemo 'Nick' Calla, RPh

A personal look at personalized medicine, its many ramifications, and a new era of pharmaceutical care. 

	Personalized medicine—the tailored treatments that a few patients now receive based on their own DNA&mdash;is finally headed for the greater public. Here are a few examples of how personalized medicine is making an impact on health care today.

	We have witnessed the introduction of Provenge from Dendreon in the past 6 months. This product is indicated for metastatic prostate cancer. The product is made by using the cells of the afflicted patient in the manufacturing process.

	At least 2 million Americans with an abnormal, clot-triggering heart rhythm take the drug warfarin, sold as Coumadin (Bristol-Myers Squibb) among others. Getting too little of this medication can lead to a stroke, and getting too much can cause life-threatening bleeding. To find the right dose for each patient, doctors use trial and error—and the errors lead to tens of thousands of hospitalizations and deaths every year.

	About 1000 patients who have a condition known as atrial fibrillation will take part in a project that will match their warfarin dose to their specific genetic needs. This genetic fingerprinting should single out the many people whose bodies break down warfarin faster or slower than normal—and their doctors can immediately adjust their dosage to prevent dangerous complications.

	Personalized health care is a rapidly evolving science that is guiding the development of so-called “designer drugs” that will be individually tailored, administered, and dosed based on a patient’s specific genetic composition. The goal is to have fewer side effects and holds the promise of treating diseases years before the symptoms would become apparent.

	The evolving future of personalized medicine as it affects the pharmacy community is a positive one. The entire health care delivery system must respond with changes in medical education and medical practice. Thirdparty payers, health care facilities, and regulatory agencies must all embrace the promise and benefits of personalized medicine and adapt their processes accordingly. Pharmacy will play an important role in a number of situations, including monitoring patients and their response to therapy. We will discuss later how pharmacy can play a role in the management of the Risk Evaluation and Mitigation Strategy (REMS) required by the FDA to allow a product to come to market.

	In oncology, for example, a therapeutic arena in which medications may cost a single patient hundreds of thousands of dollars a year, understanding the complex genetic pathways that will identify whether a patient will respond to a particular therapy is becoming an essential component of care. This aspect of medical practice is truly personalized to the individual.

	The FDA provides a table of Valid Genomic Biomarkers (www.fda.gov) that can assist physicians in therapeutic decision making as well as provide pharmacists with risk identification. In light of the accelerating science, it is recommended that pharmacists be aware of the developments in genomic science and technologies of prescription medicine. This will put pharmacy in a good position to assist the medical community in ensuring that the patient has gone through proper testing before being placed on a particular therapy.

	Policymakers and federal agencies are 2 other groups whose efforts must be engaged in the goals of personalized medicine. The recently signed HR 3590 Health Reform bill includes a section that will establish a Patient-Centered Outcomes Research Institute responsible for “developing and improving the science and methods of comparative clinical effectiveness,” also known as comparative effectiveness research.

	The inclusion of this policy was greeted as another important step toward bringing personalized medicine officially into mainstream health care delivery. The process by which industry develops new drugs through a personalized genomic approach versus the traditional “one size fits all” approach to blockbuster drug research is also facing an overhaul. In order to facilitate this, however, changes must include a meaningful amendment of the FDA regulatory process affecting the way new drugs are developed and how quickly they can be brought to market.

	The pharmacy community encourages the FDA to build on Prescription Drug User Fee Act provisions related to personalized medicine by continuing to direct resources for staff and outreach activities. This is a fast-growing field that will continue to impact the drug approval and labeling process. Much education and outreach is needed on this evolving practice and on pharmacogenomics. We encourage the FDA to work with partner organizations— such as various pharmacy organizations and advocacy groups&mdash;to help increase awareness and educate practitioners on how pharmacogenomics and personalized medicine can improve patient safety and outcomes.

	The pharmacy community has been actively involved in many REMS discussions with the FDA and other stakeholders throughout the past few years. As mentioned, the pharmacy community supports the FDA’s efforts to assure patient safety and the appropriate and safe use of medications. We recognize that the FDA has dedicated a great deal of staff to work on REMS issues. We also appreciate that the FDA has acknowledged the important role of pharmacists and pharmacies in implementing REMS programs, and the administrative and workflow challenges that must be addressed for both prescribers and pharmacists.

	Unfortunately, REMS programs at this point have been inconsistent in their methodology and implementation. Pharmacy must play a role in helping the FDA to ensure that:

		Manufacturers and the FDA receive input from front-line pharmacists, physicians, and other prescribers early in the development of any REMS.

		Manufacturers are made aware early in the drug approval process if a REMS is going to be required.

		Standardized processes and components are used to address administrative, logistical, and workflow implementation challenges.

		Components are proved to be effective in mitigating the defined risks, and are workable for all stakeholders (patients, prescribers, pharmacists, manufacturers, wholesalers, and system vendors).

		Outcome metrics capture the reason for patient failure and/or success, rather than just documenting the occurrence.

		The potential impact of pharmacistprovided clinical care, such as in improving patient safety as an element of a REMS, is recognized in addition to the need for a business model for implementing such requirements.

	We are entering a new era of pharmaceutical care. The pharmacist is now considered an integral part of the health care team. We must embrace this role and focus our efforts on proper counseling for the patient. We need to partner with the manufacturer community to deliver effective methods of managing a REMS process.

	We need to align our profession to serve a role in the identification of the correct patient population as it relates to personalized medicines that are now entering our space and to monitor the successes and failures of the patient.

	Pharmacy must have the ability to report these outcomes back to the provider so adjustments can be made quickly for the patient’s safety and benefit. Only then will our profession truly be viewed as an important component of the overall health care community. SPT

Nick Calla, RPh, is vice president, trade relations, Walgreens Specialty Pharmacy. He is an editorial board member of Specialty Pharmacy Times.

Articles

Personalized Medicine: Where Is Specialty Pharmacy Heading? 

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:

	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&mdash;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.

	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:

	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.

	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.

	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

		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. 

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.