A recent edition of PCHIfocus spotlighted the ongoing campaign on the part on AstraZeneca allegedly claiming superiority of Nexium (esomeprazole) over other available proton pump inhibitors (PPIs). Excessive claims on the part of the pharmaceutical industry should come as no surprise. The FDA routinely issues warnings to the industry for inappropriate advertising claims. These warning letters, issued by the Division of Drug Marketing Advertising and Communication, can be found on the FDA website at: http://www.fda.gov/cder/warn/index.htm. What is surprising is that many clinicians in the PCHI network and here at the MGH are surprised and offended by what appears to be an unsupported advertising claim. The reality is that company representatives are paid to sell product, not educate physicians or to provide a balanced view of a class of drugs.

The PCHIfocus has also raised questions within the MGH community on the choice of Nexium as the primary PPI for use for inpatients. The decision to sign a contract with AstraZeneca was announced to the MGH community in May 2001 in an edition of Drug Therapy. The decision was made at a network level with input from clinicians at PHS hospitals. Some clinicians have questioned the legitimacy of this decision and suggested that the decision will negatively affect patients leaving the Hospital. It seems reasonable to provide a bit more detail on the decision-making process.

The increasing use of the PPI Prilosec (omeprazole) has been recognized previously as a substantial economic burden for the Hospital. This economic burden was borne on an inpatient basis as well as for patients receiving their prescription drugs under "free care." Based on surveys conducted at the MGH, approximately 50% of the inpatients placed on Prilosec had a defined and clinically recognized indication for this drug. Despite repeated attempts to improve this prescribing, Prilosec use continued almost unabated. After discussions with key clinicians, a decision was made by the MGH and by the Partners hospitals to seek a competitive bid for a single PPI. Contract negotiations were held for many months and with all of the makers of PPIs. After many discussions, a decision was made to contract with AstraZeneca. This decision was brought to the Drug Therapy Committee for approval.

The Drug Therapy Committee examined the clinical data available at the time and concluded that all of the PPIs were equivalent. Economics was the sole decision point. The impending availability of a generic form of Prilosec was, in fact, considered. The reality is that the availability of a generic form of omeprazole is many months away, with the courts likely deciding the availability date. The decision to replace Prilosec with Nexium will save the MGH well in excess of $300,000 annually. Waiting for the courts to settle the myriad of legal issues around the Prilosec patent did not seem like a viable option.

In the May 2001 edition of Drug Therapy, the authors noted, "Outpatient prescribing of PPIs should be based on clinical and economic data as well." Some clinicians have argued that the Provider Order Entry system discharge module makes it too easy to continue medications used during an inpatient stay on discharge. It should be noted that there are no restrictions against the prescribing of any other PPI on discharge. PCHI rightfully recommends the use of Protonix (pantoprazole) as the PPI of choice. The Drug Therapy Committee approved this choice. The latest information we have available suggests that Prilosec still is the market leader, followed by Prevacid (lansoprazole), Nexium, Protonix and Aciphex (rabeprazole). (http://www.spancoalition.org/NewNews/10.29.01.htm)

But the choice of which PPI to prescribe is somewhat less important than the decision to prescribe one at all. PPIs constitute a major healthcare expense. When used for appropriate clinical indications, this money is spent wisely. When used on a chronic basis for incompletely diagnosed gastrointestinal symptoms, the use of PPIs is questionable both clinically and financially.

Here are the approximate costs for the PPIs from the PCOI website Drug Formulary Lookup:

Key to Insurance coverage:

B= Blue Cross Blue Shield
H=Harvard Pilgrim
P=Partners Healthcare System
T=TAHP
U=United Healthcare
3= third tier and most expensive patient co-pay