Trends in utilization of alternative analgesics after rofecoxib withdrawal

The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.

METHODOLOGY Administrative pharmacy and medical claims from a Midwestern health plan were identified. A data set was created of members continuously enrolled between September 2004 and February 2005 who had a rofecoxib prescription with a day's supply extending to at least the rofecoxib withdrawal date of September 30, 2004 (the rofecoxib pre-withdrawal group).

Pharmacy claims from between June 2004 and mid-February 2005 were compiled within the rofecoxib pre-withdrawal group for proton pump inhibitors (PPIs) (eg, omeprazole, pantoprazole), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen, and COX-2 inhibitors), warfarin, and oral steroids.

Patients at elevated risk for gastrointestinal adverse events were those aged 65 years and older; those who were taking an anticoagulant, corticosteroid, or a PPI plus an NSAID; or those who had one of the ICD-9CM codes mentioned previously in their medical records.

The costs are plan paid and total paid (plan paid and member paid), excluding other insurance/Medicare.

BACKGROUND/TIMELINE The following timeline related to COX-2 inhibitors was compiled as background for this study:

September 30, 2004: Rofecoxib withdrawn from the market.

November 2004: Prescribing information for valdecoxib was updated; black box warning added for serious skin reactions and contraindication for use immediately following coronary artery bypass graft (CABG) surgery.

December 17, 2004: Pfizer announces that the Adenoma Prevention with Celecoxib (APC) trial demonstrated increased cardiovascular risk with celecoxib.

December 21, 2004: Naproxen study for the prevention of Alzheimer's disease was stopped; trial demonstrated an increased risk for cardiovascular problems such as heart attacks and strokes.

December 23, 2004: FDA Public Health Advisory issued concerning the use of COX-2 inhibitors as well as naproxen.

February 1, 2005: Pfizer reported that a 1999 Alzheimer's disease prevention study demonstrated increased cardiovascular risk with celecoxib.

February 16–18, 2005: FDA holds a joint meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss COX-2 inhibitors and other NSAIDs.

STUDY LIMITATIONS Limitations of the study included:

RESULTS Enrollment was approximately 1.7 million members (as of September 2004); about 1.3 million were continuously enrolled between September 2004 and February 2005.

Of the 7,834:

Of the 3,477 with GI risk factors:

CONCLUSIONS Conclusions of the study included:

Editors' Note:
This study was originally presented as a poster at the Academy of Managed Care Pharmacy (AMCP) 17th Annual Meeting & Showcase, April 20–23, 2005, in Denver, Colo.

Dr Gunderson is a senior clinical pharmacist, Clinical Consultative Services, Prime Therapeutics LLC, Eagan, Minn. He can be reached at bgunderson@primetherapeutics.com
. Prime Therapeutics LLC is a leader in the pharmacy benefit management industry, focusing on a customer-aligned and flexible business model. Prime Therapeutics is collectively owned by various Blue Cross and Blue Shield plans, subsidiaries, or affiliates of those plans. Dr Gleason is the director of Medical & Pharmacy Integration Services, Prime Therapeutics, and clinical assistant professor, University of Minnesota College of Pharmacy, Minneapolis, Minn. Dr Johnson is the senior director, Clinical Consultative Services, Prime Therapeutics, and clinical instructor, University of Minnesota College of Pharmacy. Dr Heaton is the director of pharmacy, Blue Cross and Blue Shield of Minnesota, Eagan, Minn; clinical assistant professor, University of Minnesota College of Pharmacy; and adjunct faculty, University of Minnesota School of Public Health. A not-for-profit, taxable organization, Blue Cross is the largest health plan based in Minnesota, covering 2.6 million members in Minnesota and nationally through its health plans or plans administered by its affiliated companies. Blue Cross and Blue Shield of Minnesota is an independent licensee of the Blue Cross and Blue Shield Association, headquartered in Chicago, Ill.