Randell J. Correia, PharmD

As the pipeline for new cancer therapies continue to grow, clinical managment programs throughspecialty pharmacy can lead to better outcomes and better management of the new oral  oncology therapies. 

	Specialty drugs are “hot.” They are positioned to become the dominant players in the branded pharmaceutical marketplace as older nonbiologic medications become available as generics.

	Specialty now accounts for more than 25% of the total pharmacy benefit drug spend, and estimates suggest that this will climb to more than 40% by 2030. The medical benefit specialty drug spend adds an additional 22% to the total drug spend beyond the pharmacy benefit for most payers. Specialty drugs for cancer are even hotter—industry forecasters predict that biotech products targeting cancer will be among the top 10 selling pharmaceuticals in 2016.

	The benefits of specialty drugs are well known. For some patients, these drugs have been nothing short of miraculous in treating or managing cancer. And the pipeline for these new cancer therapies is bulging. A record 887 medicines for various cancers are in clinical trials or awaiting FDA review—well over double the number in the pipeline just 6 years ago, according to a recent report (April 2011) by the Pharmaceutical Research and Manufacturers of America. Not all of these will be specialty drugs, but many will have major implications for how to manage costs and outcomes.

Oral Drugs Can Still Be Considered Specialty 

	Until recently, specialty drugs for cancer were almost exclusively infused or injectable chemotherapy drugs, which required administration by a health care professional in the office or clinic setting. However, advances in drug design and technology have led to the development of more oral oncology medications, which patients typically take each day at home. These oral oncology drugs still fit the definition of “specialty” because they have the following traits:

—Costs vary depending on the type of cancer being treated and the regimen of cancer drugs prescribed&mdash;the average monthly prescription cost for an oral oncology medication is $4400.

—Like intravenous chemotherapy agents, oral oncology medications are cytotoxic, and patients or caregivers need to know how to administer them and the proper procedures for handling these medications. They also have the potential to cause severe side effects and require regular follow-up and monitoring of the patient.

—Oral medications do not typically need special preparation, handling, or refrigeration, as is common with injectable therapies. However, patients still need high levels of education on their oral oncology medication and ongoing follow-up care to control side effects and ensure adherence with the prescribed therapy to get the best outcomes.

	While one could assume that an oral medication would be less expensive and more accepted than an injection or infusion, this has not always turned out to be the case. Some drugs, such as Gleevec (Novartis Oncology) for leukemia, have great value and they cure people. Others, like Sutent (Pfizer Oncology) for advanced renal cell carcinoma or gastrointestinal stromal tumors, and Tarceva (Genentech/ (OSI) Oncology) for lung or pancreatic cancers, are extremely expensive and, in some cases, may only offer limited survival benefits.

	Payers across the spectrum, from large employers to the public sector, are struggling to figure out how they are going to pay for these expensive oral oncology therapies, and how they can best balance cost versus outcome. As the head of specialty pharmacy for one of the country’s largest PBMs, I can attest to my own sleepless nights. However, the cautiously optimistic view is that the path forward is beginning to emerge more clearly. It is rooted in 3 words: Value, Management, and Support. 

	There is growing acceptance that the conversation needs to move away from the cost of therapy and toward the outcomes that result from it. We refer to this as “value.” There have been many instances where a payer may be willing to spend more up front for a therapy that provides better outcomes at an overall lower total health care cost. Disease registries are an effective tool for identifying the value of specific therapies. This has been shown to be extremely effective in the field of pediatric oncology, for example, where certain treatment regimens have been shown to produce superior outcomes and have become the gold standard of therapy.

	Specialty pharmacy registries won’t be created overnight and require a willingness on the part of providers to share their data, which is not always an easy task. However, the information that could be gained from them would be powerful in not only defining a drug’s economic value but, more importantly, its ability to extend life.

	Management is a 10-letter word—not a 4-letter one. Yet many providers and patients view a managed approach to specialty pharmacy negatively or at least with some skepticism. But the numbers don’t lie&mdash;managing access to and utilization of specialty drugs helps control costs for payers and for patients alike.

	UnitedHealthcare implemented a designated specialty pharmacy program for oral oncology medications in August 2007 that has produced positive clinical, satisfaction, and economic results for its stakeholders. The improved outcomes are due to the increased clinical oversight and support provided by the specialty pharmacies’ oncology-trained nurses and pharmacists who help to manage these patients, providing a mean of 2.5 contacts per member per month with a median of 10 minutes per contact.

	Prescription Solutions became a specialty pharmacy for oral oncology medications in this program in December 2008 and has been providing the oncology medications and the clinical management and adherence programs. IVP/Walgreens is the other specialty pharmacy in this program.

	The results have been striking and will be presented at the upcoming American Society of Clinical Oncology annual meeting in June. Offevidence drug use presents a special problem for oncology, which is the latest disease area to move toward recognized treatment algorithms. A move toward more standardization of clinical care is a necessary step in managing costs and improving health outcomes.

	Clinical management programs add power to specialty pharmacies by enhancing medication adherence and improving outcomes. In fact, it is expected that in the near future specialty pharmacies will have to offer more outcomes-specific results to their clients, not just evidence of cost reductions and typical methods of utilization management.

	The clinical programs offered by PBMs and specialty pharmacies vary widely, but the most common elements include patient outreach and education, including disease and drug information; 24/7 access to specialist clinicians; advice about managing side effects and symptoms; guidance about interactions with foods and other drugs; and adherence programs, such as refill reminder calls and adherence assessment and interventions, as needed.

	The trend in specialty pharmacy is toward offering more, rather than fewer, clinical management programs, to yield even better outcomes and savings. Additional services provided during the clinical management calls might include:

	• Facilitating patient access to financial assistance programs.

	• Consultation with a specialty pharmacist or nurse to discuss the patient’s needs, answer questions, and provide relevant information. This clinician will get to know the patient’s history and remain the patient’s main point of contact within the specialty pharmacy throughout treatment with the specialty medication.

	• A personalized care plan developed specifically for the patient based on the information gathered during the initial consultation with the specialty pharmacist or nurse.

	• Collection and monitoring of relevant laboratory and therapeutic response parameters.

	• UnitedHealthcare offers innovative specialty pharmacy integration between Prescription Solutions and OptumHealth Behavioral Solutions (OHBS) that focuses on the link between medical and mental health. During clinical management calls, the specialty pharmacy clinician screens the patient for depression, which can be a common comorbid condition for those with cancer. If the patient screens positive for depression, he or she is offered a referral to OHBS for follow-up and appropriate mental health services. In all cases, clinical management programs and the specialty pharmacy services are positioned as an extension of the services provided by the oncologist and office nursing staff, not a replacement. These programs provide clinical oversight between doctor visits to help patients identify and manage side effects that could affect adherence and the drug’s ultimate value.

Total Care Management Leads to Better Health 

	How can payers afford to provide these extensive care management programs and still produce savings for clients? It is far less expensive to provide a patient with educational materials and call them to discuss their issues than it is to have them hospitalized with side effects or complications due to poor adherence. Patients become more engaged in their treatment and health because they have a support system available to them between physician visits. By focusing on the whole person, patients are better able to follow their treatment plan—leading to better health and lower total health care costs.

	Payers will only be able to ensure patient access to new therapies that are proven to work by creating customized solutions that focus on Value, Management, and Support. As an industry and as part of the broader health care system, specialty pharmacies must continue to take a responsible, evidence-driven, and patient-centered approach to evaluating and managing new oral oncology therapies.

Randell J. Correia is a senior vice president of Prescription Solutions, an innovative pharmacy benefit management company managing the prescription drug benefit of commercial, Medicare, and other governmental health plans, as well as those of employers and unions. A UnitedHealth Group company, Prescription Solutions serves members through a national network of 64,000 community pharmacies and state-of-the-art mail service pharmacies in Carlsbad, California, and Overland Park, Kansas. Dr. Correia is responsible for the mail service and specialty pharmacy business lines, which serve more than 200 clients and 11 million mail service—covered lives and more than 180 clients and 21 million specialty pharmacy–covered lives, respectively, representing more than $3.8 billion in annual revenue with a service area spanning the entire United States and territories. 

Articles

Oral Oncology Therapies: Specialty Pharmacy's Newest Challenge 

The velocity of growth in the specialty pharmacy field presents challenges to both academia and industry leaders as we examine our readiness.

	Specialty pharmacy is on an evolutionary fast track and will grow to consume greater than 60% of the total US payer drug spend by 2013—the pharmacy and medical benefit combined. Disease states will continue to expand as new life-saving products come into the market, and more patients will require highly-trained medical professionals. As a result, the demand for uniquely qualified specialty pharmacists will intensify.

	The velocity of such growth presents special challenges to employers such as managed care providers, industry, and highly-focused pharmacy operations that may be seeking pharmacists who not only understand the drug and disease aspects of specialty pharmacy practice, but also how this market sector differs from other pharmacy practice settings.

	Today, there is limited coursework and practice settings (rotations) specifically on specialty pharmacy being offered in schools of pharmacy or through other accredited bodies. Interviews with some of the country’s top pharmacy school educators indicate that, while they have an eye on this emerging practice setting, their core curriculum continues to be focused on a “generalist” training that broadly prepares their students for serving the largest segments of the population. Pharmacy schools do an exceptional job of academically preparing pharmacists but are challenged by the rapidly growing volume of drug and medical information that must be communicated in preparing students for the real world of specialty practice. Some schools have expanded their curricula to meet the information demand using enhanced technologies such as online databases, networked PDAs/iPads tied to specialized software. Even with additional courses and content, schools have not been able yet to make specialty pharmacy a fully integrated part of their educational programs, short of expanding the curriculum beyond the present 6-year programs leading to a PharmD.

	In a nonscientific survey of specialty pharmacists from several different pharmacy schools, all reported that none of their academic or experiential training prepared them for the actual practice of specialty pharmacy as it exists today. Even those conditions and drugs that are frequently encountered by a specialty pharmacist (such as multiple sclerosis, rheumatoid arthritis, hepatitis C, and so on) were only briefly taught in pharmacy school. Further, all of the pharmacists reported that the concept of specialty pharmacy as a practice setting was not mentioned during coursework. Internships and experiential training with specialty pharmacies were of great value in learning about this practice setting, but these opportunities have not been widely available to pharmacy students. Perhaps leaders in specialty pharmacy should consider offering rotations to nearby pharmacy schools. Students can be an excellent resource to specialty operations, including taking on tasks for the operation, adding to their efficiency.

	Understandably, pharmacy schools are responsible for providing society with professionals who can care for the most prevalent conditions, offering the greatest good to the broadest population. However, these schools recognize it is their role to continue to improve what they teach, and how they teach it, as the field pharmacy evolves along with the larger health care system.

	As mentioned before, the greatest area of growth is specialty products—and to educate the next generation of pharmacists. Academia and specialty pharmacy practice must take on greater responsibility, or else our pharmacists will be obsolete prior to entering practice.

	As the United States struggles with the overall cost of health care, pharmacists are on the front lines of balancing the demand for costly specialty pharmaceuticals by small patient populations with the larger societal call for more affordable medications. Specialty pharmacy, therefore, is a logical part of the educational preparation that new pharmacists should receive. As evidenced by government and private payer concerns about the diseases and treatments that fall under the specialty pharmacy “umbrella,” a very clear shift of focus has occurred and will only continue to increase. Specialty pharmacy has the ability to optimize patient care with these high cost products and provide optimal outcomes. In the absence of quality pharmaceutical care, costs run the risk of going up.

Systems vs. Disease Approach—A Better Educational Model?

	While many schools of pharmacy gain insights from business sector advisory groups, it is unlikely that a unique specialty pharmacy curriculum can or will be developed and implemented as a short-term priority. However, instituting a systems approach (eg, managed care, hospital, home care, long-term care, radiopharmaceutical, and specialty) versus a drug and disease approach might help bridge the educational gap. Other creative concepts mentioned by pharmacy schools include optional specialty pharmacy educational tracks, residencies, post-graduation specialized training, survey courses, and “tool kits” that can all prepare pharmacists for specialty pharmacy practice.

	A collaborative educational process can be developed if academia and specialty pharmacy align around a set of electives whereby students can opt-in to courses and practical experiences around specialty practice. An informal survey of specialty pharmacy peers validates that specialty pharmacy is ready to provide the resources—if academia can wrap around the real world setting of specialty practice.

	Currently, most specialty pharmacy training happens on the job, although some experiential programs exist as feeder programs for PBMs and other companies. A more strategic approach would follow traditional pharmacy training, leading to a more prepared and expert specialty pharmacy workforce.

	Specialty pharmacy, and its growing importance to society and health economics, offers an exciting career opportunity for pharmacists. To ensure the best possible educational and practice outcomes, our profession must examine its readiness as the specialty stampede heads its way. 

Randell J. Correia, PharmD, is a senior vice president of Prescription Solutions by OptumRx, an innovative pharmacy benefit management organization managing the prescription drug benefit of commercial, Medicare, and other governmental health plans, as well as those of employers and unions. One of the Optum companies of UnitedHealth Group, Prescription Solutions serves members through a national network of 64,000 community pharmacies and state-of-the-art mail service pharmacies in Carlsbad, California, and Overland Park, Kansas. Dr. Correia is responsible for the mail service and specialty pharmacy business lines, which serve more than 200 clients and 13 million mail service covered lives and more than 180 clients and 22 million specialty pharmacy covered lives, respectively, with a service area spanning the entire United States and territories. 

The velocity of growth in the specialty pharmacy field presents challenges to both academia and industry leaders as we examine our readiness.


Workforce Trends: How Will the Market Supply the Growing Demand for Specialty Pharmacists?

Current trends in the marketplace dictate new approaches and analyses. 

	There’s a tsunami of specialty pharmaceuticals headed our way. It is estimated that approximately 57 million working age Americans live with diabetes, asthma, rheumatoid arthritis, cancer, HIV, and other serious diseases.

 Many of these people are able to continue working and be productive members of their communities due, in large part, to the introduction of these highly effective specialty pharmaceuticals.

	For the first time since the pharmacy industry began tracking such things, the consensus forecast is that by 2014 the top-selling drugs by revenue in the United States will move from so-called “small molecule oral solids” to larger molecule injectable specialty medications, including several new oncology products.

	For example, the consensus forecast for 2010 sales is:

	1. Lipitor (cholesterol)* $11.7 billion Pfizer

	2. Plavix (anti-clot)* $9.6 billion Sanofi/Bristol

	3. Advair (asthma/COPD) $9 billion GlaxoSmithKline

	In comparison, the top 3 pharmaceuticals in 2014 will be specialty or oncology drugs—forecasted to represent $25.4 billion in sales:

	2. Humira (arthritis) $8.5 billion Abbott

	3. Enbrel (arthritis) $8 billion Pfizer/Amgen

	While the definition of specialty continues to evolve, most classifications include nearly 400 different drugs across 25 therapeutic categories. Specialty pharmaceuticals now represent more than 25% of the total drug spend, with estimates that this will climb to more than 40% by 2030. In such an environment, where the pipeline is filling up with specialty drugs, it will be even more challenging to ensure that payers, employers, and their members receive affordable, clinically sound treatment options.

	Adding the 12-year exclusivity for biologics in the new Patient Protection and Affordable Care Act only heightens the importance of thoughtfully addressing the delivery and clinical management components for these often highly effective, yet most expensive prescription medications.

	The cost of a biologic agent for just one patient averages between $1000 and $1500 per month,

 with certain treatments vastly exceeding these averages. Despite the cost challenges, the substantial demand by patients and the push for new discoveries by drug companies will drive increasing utilization of these treatments. Thus, employers’ health plans and government stakeholders must explore new methods to control the cost/benefit equation of these drugs and therapeutic regimens. While costly, their value must not be underestimated. Specialty drugs can improve clinical outcomes, productivity, and quality of life for millions of patients with chronic illnesses.

Meaningful Total Health Outcome Analytics 

	While cost-effective treatments and regimens have always been the stated goal of any payer or health care provider, these new drugs bring increasing attention to the overriding desire to control health care costs while providing optimal outcomes, particularly in the post—health reform era. It is currently the payers and most recently the FDA— through Risk Evaluation and Mitigation Strategies (REMS) controls over pharmaceutical manufacturers&mdash;that are driving the requirements of products and services included in the specialty pharmacy sector.

	These distinct stakeholders are the catalysts for new and enhanced specialty pharmacy services. Such services are employed to maximize the value of medications to patients who need them, with an eye toward meaningful total health outcome analytics not widely or sufficiently available today.

	While exceptions do exist across the pharmacy industry, payers are increasingly viewing most traditional pharmaceutical delivery systems as being challenged by the rapidly shifting dynamics associated with specialty pharmaceuticals. Payers will continue to establish requirements and influence business models that can achieve the total health outcomes and costs controls that must be achieved. To date, selected models have included open and limited networks, partnerships, management agreements, payer in-sourcing, and variations of these.

	One size may not fit all, and the best-fit model will depend on a complex set of factors, including a fair amount of trial and error over time. However, the current trend is for payers to move away from the traditional community pharmacy networks in search of systems that can better achieve the overarching goals. Likewise, pharmaceutical manufacturers driven by REMS requirements and the need to have better controls over their products and related services are narrowing their contacting networks.

	With these forces coming to bear, what are some of the differentiated aspects of a sophisticated specialty pharmacy that will drive the business models of tomorrow?

	As a baseline, traditional, efficient delivery systems with high-quality service to consumers and payers at competitive prices are and will be mere “table stakes” when competing in the specialty sector.

	• “High touch” proactive care management systems; sophisticated data collection, reporting and analytics; and effective and evidence-based adherence and persistency programs along with protocol driven clinical management programs, to name but a few.

	• The ability to address and solve for the differences in pharmacy versus medical drug benefits relative to provider networks, reimbursement, and regulatory requirements.

	• Participation in REMS programs and associated pharmaceutical company service agreements.

	These and other aspects of specialty pharmaceuticals have resulted in new business and pharmaceutical care models that exist today, with further evolution and change expected going forward. The ultimate goal is an integrated system of evidence-based total health outcomes where rational and timely product and service decisions can be made. Only systems that can contribute to this goal will be able to participate in the future.

	While this exciting and rapidly evolving segment of pharmaceutical care offers great opportunity for the pharmacy services industry, all participants will be significantly challenged by the dynamics driving the specialty business models of tomorrow.

	1. Center for Studying Health System Change. 2003 community tracking study household survey.

	2. Reuters. Factbox—world’s top-selling drugs in 2014 vs 2010. Available at: www.reuters.com/article/idUSLDE63C0BC20100413.

	3. Pharmaceutical Care Management Association. How pharmacy benefit managers help employers provide safer, more affordable prescription drug benefits. Available at: www.pcmanet.org/assets/2008-03-25_Research_How%20PBMs%20Help%20Employers.pdf.

Dr. Correia is Senior Vice President of Mail Service and Specialty Pharmacy of Prescription Solutions, one of the nation’s largest pharmacy benefit management companies and a unit of UnitedHealth Group. “RJ” has 29 years’ experience in pharmacy enterprises and serves as a governing board member of the University of the Pacific School of Pharmacy Entrepreneurial and Innovation program and for the Pharmaceutical Care Management Association (PCMA) specialty pharmacy council. He joins 

as an Editorial Board member with this inaugural issue. 

What Will Drive the Specialty Pharmacy Models of Tomorrow?

There’s a tsunami of specialty pharmaceuticals headed our way. It is estimated that approximately 57 million working age Americans live with diabetes, asthma, rheumatoid arthritis, cancer, HIV, and other serious diseases.

For the first time since the pharmacy industry began tracking such things, the consensus forecast is that by 2014 the top-selling drugs by revenue in the United States will move from so-called “small molecule oral solids” to larger molecule injectable specialty medications, including several new oncology products.

For example, the consensus forecast for 2010 sales is:

1. Lipitor (cholesterol)* $11.7 billion Pfizer

2. Plavix (anti-clot)* $9.6 billion Sanofi/Bristol

3. Advair (asthma/COPD) $9 billion GlaxoSmithKline

In comparison, the top 3 pharmaceuticals in 2014 will be specialty or oncology drugs—forecasted to represent $25.4 billion in sales:

2. Humira (arthritis) $8.5 billion Abbott

3. Enbrel (arthritis) $8 billion Pfizer/Amgen

While the definition of specialty continues to evolve, most classifications include nearly 400 different drugs across 25 therapeutic categories. Specialty pharmaceuticals now represent more than 25% of the total drug spend, with estimates that this will climb to more than 40% by 2030. In such an environment, where the pipeline is filling up with specialty drugs, it will be even more challenging to ensure that payers, employers, and their members receive affordable, clinically sound treatment options.

Adding the 12-year exclusivity for biologics in the new Patient Protection and Affordable Care Act only heightens the importance of thoughtfully addressing the delivery and clinical management components for these often highly effective, yet most expensive prescription medications.

The cost of a biologic agent for just one patient averages between $1000 and $1500 per month,

While cost-effective treatments and regimens have always been the stated goal of any payer or health care provider, these new drugs bring increasing attention to the overriding desire to control health care costs while providing optimal outcomes, particularly in the post—health reform era. It is currently the payers and most recently the FDA— through Risk Evaluation and Mitigation Strategies (REMS) controls over pharmaceutical manufacturers&mdash;that are driving the requirements of products and services included in the specialty pharmacy sector.

These distinct stakeholders are the catalysts for new and enhanced specialty pharmacy services. Such services are employed to maximize the value of medications to patients who need them, with an eye toward meaningful total health outcome analytics not widely or sufficiently available today.

While exceptions do exist across the pharmacy industry, payers are increasingly viewing most traditional pharmaceutical delivery systems as being challenged by the rapidly shifting dynamics associated with specialty pharmaceuticals. Payers will continue to establish requirements and influence business models that can achieve the total health outcomes and costs controls that must be achieved. To date, selected models have included open and limited networks, partnerships, management agreements, payer in-sourcing, and variations of these.

One size may not fit all, and the best-fit model will depend on a complex set of factors, including a fair amount of trial and error over time. However, the current trend is for payers to move away from the traditional community pharmacy networks in search of systems that can better achieve the overarching goals. Likewise, pharmaceutical manufacturers driven by REMS requirements and the need to have better controls over their products and related services are narrowing their contacting networks.

With these forces coming to bear, what are some of the differentiated aspects of a sophisticated specialty pharmacy that will drive the business models of tomorrow?

As a baseline, traditional, efficient delivery systems with high-quality service to consumers and payers at competitive prices are and will be mere “table stakes” when competing in the specialty sector.

These and other aspects of specialty pharmaceuticals have resulted in new business and pharmaceutical care models that exist today, with further evolution and change expected going forward. The ultimate goal is an integrated system of evidence-based total health outcomes where rational and timely product and service decisions can be made. Only systems that can contribute to this goal will be able to participate in the future.

While this exciting and rapidly evolving segment of pharmaceutical care offers great opportunity for the pharmacy services industry, all participants will be significantly challenged by the dynamics driving the specialty business models of tomorrow.

1. Center for Studying Health System Change. 2003 community tracking study household survey.

2. Reuters. Factbox—world’s top-selling drugs in 2014 vs 2010. Available at: www.reuters.com/article/idUSLDE63C0BC20100413.

3. Pharmaceutical Care Management Association. How pharmacy benefit managers help employers provide safer, more affordable prescription drug benefits. Available at: www.pcmanet.org/assets/2008-03-25_Research_How%20PBMs%20Help%20Employers.pdf.