The Lynx Group

The Impact of Therapy Type on Clinical Fragmentation in Oncology Care

July 2011, Vol 2, No 4

Philadelphia, PA—Fragmentation in oncology care significantly influences physicians’, payers’, and patients’ understanding of how cancer therapies lead to improved quality of care. The main reason for fragmentation is the challenge in linking pharmacy and medical data in a way that generates usable information, according to Atheer A. Kaddis, PharmD, Vice President, Managed Markets, Diplomat Specialty Pharmacy.

The Oncology Drug Marketplace

“Improving the capture of data on the medical and pharmacy benefits sides and integrating data to apply this information to decision-making will help us meet the challenge,” Dr Kaddis said.

The oncology drug market is undergoing a major shift from injectable to oral oncolytics, which to a large extent revolves around Medicare. Plans offering Medicare Part D prescription drugs must include in their formulary all approved drugs in a specific category or class.

A significant evolution has occurred in the number and types of medications. Before 1985, specialty disease states had limited or zero drug treatment choices. Today, several specialty disease states—including multiple myeloma, breast cancer, and transplant— are treated mostly with oral therapies. And several specialty disease states are expected to have an oral drug option within 2 years, including acute myelogenous leukemia and melanoma.

As a result of the increased number of specialty therapies, Dr Kaddis said, “My bold prediction is that there’s going to be a bigger role for specialty pharmacies going forward when it comes to oncology. Part of that is being driven by oral oncolytics, and also it is because of what’s going on in clinical pathways, accountable care organizations, and even 340B programs and the trend toward contracted pharmacies.”

The clinical and economic implications of oncology drugs are:

  • Reimbursement remains the primary method for controlling chemotherapy costs and utilization from a managed care perspective.
  • Oral oncolytics are changing the direction of channel management
  • Integration of pharmacy and medical data presents a significant challenge.

Management Challenges
The oncology drug management challenges are directly related to health insurance or payer benefit design, according to Kirby J. Eng, RPh, Director, Medical Pharmacy Manage - ment, CVS Caremark. The clinical challenges include the site of service and coordination of care, therapy information, and adherence to therapy.

The drug formulation has several implications to health plans (Figure). If a drug is a tablet or a capsule, the site of service typically would be a pharmacy channel. Benefit coverage, given the site of service and drug formulation, overwhelmingly, would fall under pharmacy benefit. For selfadministered injectable drugs, the site of service would be the physician’s office or, increasingly, the pharmacy— retail or specialty. Health plans were split on benefit coverage for selfadministered injectables; increasingly it is placed under the pharmacy rather than the medical benefit.

If a drug is intravenous or injectable, it is likely going to be administered in a physician’s office or a specialty pharmacy, and coverage would fall under medical benefit. Mr Eng said that the stakeholder implications of oncology drug therapy management depends on the party involved, in the following way:


  • Patients:
    –Out-of-pocket costs
    –Therapy information (eg, from the Web, physician, nurse, pharmacy)
    –Therapy adherence and coordination of care
  • Payers:
    –Providing access to quality and costeffective care
    –Benefit coverage determination
  • Pharmacy:
    –Medication therapy management, including education and patient adherence
    –Coordination of care
  • Physicians:
    –Education and coordination of care
  • Manufacturers:
    –Market management of hospitals, patients, payers, pharmacy, and prescribers.

Another health plan, Excellus Health Plan, Blue Cross Blue Shield, initiated a review of all the drugs going through their medical benefit, as well as the high cost of these therapies a few years ago, said Kristen M. Reimers, RPh, Clinical Pharmacy Operations Manager, Excellus, and Director of Specialty Pharmacy Pro grams at FLRx Pharmacy Management.

Excellus actively targeted some of the clinical fragmentation of the oncology drug market. On the pharmacy side, the plan evaluated the therapies and determined there needed to be a group that would manage high-cost therapies, said Ms Reimers.

Excellus formed a team of specially trained, highly specialized nurses and pharmacists and medical directors to initially manage 3 therapies. Now the health plan manages >60 therapies which are primarily focused in oncology.

Management tools for the pharmacy benefit include specialty pharmacy contracts, formulary management and physician reimbursement, and operational improvements. Critical to specialty pharmacies is the patient-centered approach, such as patient adherence.

The hot issue in specialty drug management, according to Ms Reimers, is related to oral oncolytics management. The challenges identified by Excellus are:

  • Lack of respect for some drugs when first introduced
  • Lack of control: physicians were used to ordering therapies in the offices, and patients would then receive them in the office
  • Therapeutic and clinical risk if patients were not taking drugs (nonadherence) or were not taking them as prescribed; risk of drug interactions and severe adverse effects; no feedback loop to physician offices, so physicians are left in the dark as to whether patients were getting the therapies
  • Cost issues, including high-cost therapies and risk of waste.

Among physicians, patients, and payers, there were similar concerns with regard to oral oncology management. For one, oncologist offices had lack of control, because they didn’t know if patients were taking the medications and if they took them as prescribed. In addition, getting drugs covered for the patient can be difficult when therapies are available only in limited distribution channels.

On the payer’s side, there was high cost and risk of high waste. “Payers don’t want to pay for drugs that patients aren’t taking,” Ms Reimers said.

From a member’s perspective, the concern is simple—expense. “Patients don’t know if they can afford therapies or if it’s even worth it for them to take these therapies,” she said.

Specialty Drug Program
Excellus worked with specialty pharmacies to develop a high-touch specialty drug program for oral oncology agents to ensure appropriate utilization of the medications. Education was deemed necessary to the program to address adverse events and how to manage such events.

“The program was designed to be high-touch so patients felt they were part of their own care,” Ms Reimers said.

As part of the program, oral oncology agents were incorporated into the mandatory specialty network. All patients using these therapies were required to receive them from one of Excellus’ specialty pharmacies; they could then participate in programs that were clinician based at the pharmacies. Nurses and pharmacists who were trained in oncology would make assessments. When therapy was first initiated, assessments occurred every 7 to 10 days. Patients were instructed in how to manage issues such as adverse effects.

“Excellus also wanted to address concerns of the physician and close the loop on what they saw as fragmentation in not knowing whether the patient was actually getting their therapy,” Ms Reimers said.

The program included a concise 1- page document in the form of a progress note that included information about when patients started and stopped therapy and whether there were adverse events. Everything was documented.

In the first 18 months of running the high-touch specialty pharmacy program, 400 patients were using oral oncology therapies, and 256 of those opted into the program. (They were considered in the program unless they chose not to participate.)

Patients had access to clinicians and pharmacists 24 hours a day, 7 days a week. There were follow-up reminders, assessments on patients, and reports back to physicians and the health plan.

The adherence rate of patientmissed doses was only 8.2%. The discontinuation rate on advice of physicians was 10% (27 of 256 patients). This is in contrast to the national discontinuation rate of oral oncology medications, which is about 30%.

To prevent future fragmentation, the health plan has instituted new ongoing strategies to manage drug therapies:

  • Monitoring the drug pipeline for drugs being developed
  • Off-label use program
  • Development of unique medical drug treatment to manage intravenous therapies
  • Continue to manage provider fee schedule
  • Seek ways to manage waste and vials
  • Development of adherence programs, especially on the medical side
  • Provider discussions with community oncologists seeking input on our programs.
  • Tracking health plan data and trends to determine where to eliminate fragmentation.

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