Oral Oncology Therapies: Specialty Pharmacy's Newest Challenge

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:

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

• High Complexity—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.

• High Touch—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.

The Path Forward

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.

Value

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

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—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.

About the Author

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.