A patient calls you stating he's received conflicting information about the availability of oral proton pump inhibitors (PPIs). He's calling to clarify which drugs are and are not available through the NMOP. He's had prescriptions for Prevacid® 'approved' at a local pharmacy through the new DoD/TRICARE pharmacy program and had it 'disapproved' through the National Mail Order Pharmacy (NMOP - Merck-Medco). He was advised by a representative from Merck-Medco that Prilosec® was available through the NMOP but according to the PEC website, the drug was removed from the basic core formulary (BCF), effective 1 Oct 01. He is totally confused at this point. Is Prevacid® available or not? What about other PPIs?

A lot has changed recently regarding the PPI class, esp after the August 2001 DoD P&T committee meeting. Let's try to clarify all of this.

As you all know, prior to 1 October 2001, the drug manufacturer, Astra Zeneca, makers of omeprazole [Prilosec ®], had a closed class national contract with DoD for this drug, which included the stipulation that it was the only PPI on the Basic Core Formulary (BCF), and the only PPI on formulary at the National Mail Order Pharmacy (NMOP). This meant all DoD MTFs were required to carry omeprazole on their local formulary, and they could not add any other PPI to their MTF formulary. As with all national contracts, patients could fill prescriptions for non-formulary drugs if the prescriber provided evidence the patient has a "medical necessity" for the non-formulary drug. This usually means the patient is allergic to the drug, has unacceptable side effects when taking the drug, or the drug does not sufficiently treat the patient's condition. Closed class contracts bring greater uniformity to the system (i.e. everyone has to carry the drug) and bring the DoD system the greatest cost savings (approximately $22M in FY 01 in this class alone!).

The last option year of the closed class PPI contract was due to start 1 October 2001, unless DoD decided NOT to exercise that option. The market place had changed significantly in the last year. The market place went from only 2 PPIs (Prilosec® and Prevacid®) to 5 PPIs with the market addition of rabeprazole [Aciphex®], pantoprazole [Protonix®], and esomeprazole [Nexium®].

In the past, with each option year, the manufacturer voluntarily lowered the price of Prilosec®. For whatever reason in this option year, they did not. The DoD P&T committee debated what to do with this class. They reviewed the class again, polled providers and experts in the field, and determined that ANY of the PPIs would be equally safe and effective. (See August 2001 DoD P&T committee minutes for details). Once the committee settled the therapeutic equivalence issue, the committee looked at prices. The makers of Aciphex® gave the government a FSS price of $0.22/tablet, significantly less than the contract price for Prilosec of $1.10/capsule, good through December 2002. Generic omeprazole is still tied up in litigation (currently, at least FOUR generic manufacturers). Based on all this info, the committee decided to 1) not exercise the final option year on the Prilosec® contract, 2) open the PPI class on the BCF, 3) add rabeprazole to the BCF, 4) remove omeprazole from the BCF, and 5) add rabeprazole and pantoprazole to the NMOP formulary.

What the heck does all this mean? 

1) Since rabeprazole is now the BCF agent, by definition, all MTFs must have this agent on their formularies. Since the PPI class is now open, MTFs are free to add other PPIs to their formularies and are free to leave omeprazole on their local formularies (if they choose) despite the increase in its price to $2.09/capsule. The PEC is strongly encouraging providers to consider switching patients to rabeprazole. Given the fact there is strong evidence that rabeprazole is as effective as omeprazole and the rabeprazole price is only 10% of the current price of Prilosec® ($0.22/tablet vs. $2.09/capsule). 

2) Aciphex®, Protonix®, and Prilosec® are available through the NMOP. Aciphex® and Protonix® were added to the NMOP formulary because of good effectiveness and a very favorable price. Prilosec® was kept on the NMOP formulary because of the thousands of patients currently filling prescriptions for Prilosec® there. Unlike the MTFs, if the committee had removed Prilosec® from the NMOP formulary, patients would have immediately been unable to fill prescriptions for this drug there, except with documented medical necessity. This would have created too much inconvenience for this group of patients. 

3) Prevacid® and Nexium® are not available through the NMOP. The P&T Committee decided that these drugs did not offer sufficient additional benefit to patients to justify their significantly greater cost relative to other PPIs. Since patients had previously been unable to fill prescriptions for these products in the NMOP, the committee felt this would cause minimal inconvenience to patients since the only patients receiving Prevacid® and Nexium® from the NMOP were those who already had documented medical necessity for one of these drugs. 

4) All PPIs are available through the retail network.

Generic/Brand Dose Current Price After 1 Oct 2001

Generic name    Brand Name/Strength     Cost BEFORE 1 Oct 2001  Cost after 1 Oct 2001  
Rabeprazole     Aciphex 20 mg                           $0.22 (FSS)                  $0.22 (FSS)    
Lansoprazole    Prevacid 30 mg                          $2.06 (FSS)                  $2.06 (FSS)    
Pantoprazole    Protonix 40 mg                           $1.27 (FSS)                  $1.27 (FSS)    
Omeprazole      Prilosec 20 mg                           $1.09 (contract)            $2.02 (FSS)    
Esomeprazole    Nexium 20 mg                           $2.35 (FSS)                  $2.35 (FSS)    
FSS = Federal Supply Schedule; BPA = Blanket Purchase Agreement

For additional information, please see the DoD P&T committee minutes at http://www.pec.ha.osd.mil/PT_C/Aug_01_P&T/Aug01_PT_Exec_Minutes.pdf. See page 7 of the minutes for the PPI discussion and update.