Specialty Pharmacy

Drug Appropriateness, Oral Drugs Pose Major Oncology Concerns

Reprinted from the December 2006 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

The pipeline of oral oncolytics promises to have an enormous impact on the specialty pharmacy industry, as does the appropriateness of physicians' prescribing habits for oncology therapies, contended speakers at a recent conference. These topics were but a couple of the issues that several hundred payers and manufacturer representatives heard speakers discuss at the ICORE 3rd Annual Oncology Summit in Las Vegas on Oct. 13.

Kjel Johnson, Pharm.D., senior vice president of ICORE, maintained that the last three years have clearly proven the effectiveness of his company's business model. Product preferencing (with or without rebates) and solid pharmacoeconomic data that identify lowest cost/therapeutically equivalent alternatives will save payers significant dollars, he contended.

Winston Wong, Pharm.D., associate vice president of pharmacy management for CareFirst Blue Cross Blue Shield, presented results from the first year of his company's work with ICORE. CareFirst now manages provider-administered injectables in three basic steps - product preferencing, which includes some rebates; rational reimbursement for physicians; and operational improvements, including a manual review of all "dump codes" prior to payment.

After one year, the plan reduced year-to-year total cost of provider-administered injectables by 7.6% (net after figuring in 4.4% drug inflation) and achieved nearly 100% of its first year's goal of $18 million in savings. According to Wong, analytical reports can now be generated that provide the basis for expanding the program, identifying outlier providers, and selling the program's efficacy.

Steven Sembler, vice president of Roche Laboratories, updated the group on oral oncology trends. There were just six "oral-only" forms of therapy in the category in 1995, he pointed out. That number, however, jumped to 16 as of 2006 — a number that pales by comparison with more than 50 oral oncolytics that have no injectable counterpart and are in late-stage trials, he said.

With potentially dozens more oral oncology therapies, Sembler said Roche believes specialty pharmacies will be needed to fill a critical-care management role for oncology patients. As patients see their physicians less often, the need to monitor compliance closely becomes a real concern, he said, one that specialty pharmacies are already tackling in other therapeutic categories.

Lee Newcomer, M.D., medical director for oncology services at UnitedHealthcare, spoke about how challenging it is for health plans to manage oncology. Oncology clinical pathways are only now evolving, he said, and even when fully developed, pathways need to be adopted by the practicing physicians.

In the meantime, he said, managing drug appropriateness is a thorny issue. A drug may be readily reimbursable on a plan's formulary, but there is little to prevent a physician from prescribing that high-cost oncology therapy in conjunction with another costly product also on the formulary, under the presumption that if one is good, two must be better. In fact, he said, there is evidence that continuing use of a therapy that has failed in conjunction with a new-line therapy generally offers no added value and just costs lots of money. Just as disturbing, he added, is evidence that 45% of oncology patients receive less therapy than the standards of care indicate.

Finally, he said, physicians often prescribe therapy when it is just assumed that it is needed. As an example, Newcomer explained, a review of thousands of UnitedHealthcare claims showed that erythropoietin was prescribed with no confirming test for hematocrit levels in 12% of patients. By comparison, when red blood counts were validated, claims showed that utilization actually went down by more than 30%, indicating that the dosing was patient appropriate, not prescriber-pattern based, according to Newcomer.

Costs High in Unexpected Demographic Group

Grant Lawless, M.D., Amgen's director of medical affairs, closed the conference with some findings that will be reported in a soon-to-be-released study. Contrary to general belief, he said, the most costly segment of the chronically ill population is not patients in the most severe categories — those with drug spend of more than $10,000 annually. In fact, according to Lawless, the study clearly detailed that patients with annual drug spend in the $2,000 to $10,000 range are fueling the majority of spend, with most of that on non-biotech products.

The report, said Lawless, will also debunk another health care myth: that all types of patients turn over their health plan membership approximately every 24 months. While that may be true for non-chronically ill patients, he said, health plans should plan on supporting the clinical needs of chronic and severely chronic patients for upwards of four to eight years, according to Lawless. Furthermore, the belief that most patients are dependents of the primary policy holder also appears to be false — more than 70% of the high-cost patients are still "on the job," he said.

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