Do you support this addition or not? Why or why not?

** THANKS to CAPT Kevin Lier for the idea for this Pearl. **

NO - do not support the formulary addition. Explanation to follow.

First of all, my apologies to those non-DoD recipients of the Pearls. This one will probably leave you confused not being in the DoD system.

Anyway, the reason for this formulary denial is because there is a closed class contract for the statin (HMG-CoA reductase inhibitor) class on the DoD Basic Core Formulary (BCF). A closed class on the BCF requires that MTFs have the selected BCF agent's) on their formulary and that they cannot add another other drugs from that class to their formulary. There are currently 3 closed class contracts on the BCF. The classes and the formulary agents in those closed classes are:

Statins - cerivastatin, simvastatin

Proton Pump Inhibitors (PPIs) - omeprazole

Non-sedating antihistamines - fexofenadine

The reasons for closed class (and all) contracts are:

     1) Provide a "uniform pharmacy benefit" throughout the military system. This has been a repeated theme throughout most recent Health Affairs and TRICARE policy guidance as well as the National Defense Authorization Acts of 2000 and 2001.

     2) Maintain or improve the outcomes of drug therapy by making selected agents uniformly available at ALL DoD (and VA, if joint contract) MTFs to ensure a consistent standard of care across the system. For example, patients started on lisinopril will be able to get the same brand of lisinopril at any DoD MTF in the world since it's 1) on the BCF and, 2) it's a contract for a specific brand of a multisource drug.

     3) Leverage the market share and volume of all of DoD (and often the VA) to obtain a better price for all of DoD (and VA), saving the taxpayers' dollars. Closed class contracts generally yield greater cost savings than open class contracts but require more work on the part of MTF providers and pharmacy staffs. The cost avoidance achieved for all the national pharmaceutical contracts in FY2000 for DoD was $65 MILLION.

Contracts are NOT meant to limit care. If a patient has a clinical need (i.e. medical necessity) for a non-formulary drug, there is nothing in any DoD contract that precludes a MTF from obtaining a non-formulary drug(s) to meet the patients' clinical needs. MTF providers and pharmacists need to work together to discern requests based on preference and/or habit vs. those based on true medical necessity and good clinical evidence.

Although non-formulary agent's) in closed classes cannot be added to the formulary, these medications are available through a special purchase process if medical necessity is shown. For example, if a patient cannot reach his/her NCEP LDL goals with the maximum dose of a formulary statin (cerivastatin, simvastatin) a non-formulary drug may be obtained. If a patient cannot tolerate the formulary drugs or is on interacting drugs, medical necessity requires that a non-formulary agent be obtained. If a specific operational requirement demands a non-formulary medication(s) (ex. An AF pilot requires a statin, neither cerivastatin nor simvastatin are currently "waiverable" in AF aircrew members), then medical necessity requires a non-formulary drug be obtained.

The BCF is another mechanism to ensure a "uniform pharmacy benefit". It's scope is targeted to the primary care arena and not subspecialties. A recent informal survey showed approximately 73% of all prescriptions filled in MTFs were filled with BCF drugs. The Health Affairs (HA) policy letter covering the BCF can be found at http://www.tricare.osd.mil/policy/fy98/bfc98034.html. Barring any contraindications, BCF drugs are considered the first line/preferred agents in the treatment of the patient. A complete listed of the BCF can be found at http://www.pec.ha.osd.mil/BCF/BCF_genr.htm. The BCF is a "required minimum" list of drugs that ALL MTF's must carry and/or make available. MTFs may choose to add to their local formularies over and above what's required by the BCF based on provider and patients needs, budgetary considerations, etc.

A couple of other points:

     1) Besides closed class contracts, there are open class contracts or contracts for a single brand of a multisource drug. For example, since ranitidine [Zantac®] went off patent there a bunch of manufacturers that produce generic ranitidine. DoD/VA have contracted with a single manufacturer of generic ranitidine (Geneva generics) at a price of $ 0.03/tablet. Besides ensuring that all DoD MTFs have this drug on their formularies (ranitidine is a BCF agent) MTFs must buy this specific brand. Besides uniformity, this prevents patients from getting a blue pill this month, then an orange pill next month, and a pink pill the month after that.

     2) The DoD P&T committee has the responsibility and authority for maintenance (adding, deleting, etc) of the BCF. This committee meets quarterly. The minutes can be viewed at http://www.pec.ha.osd.mil/PT_Committee.htm. Any MTF provider can submit a request to change the BCF using the online request form located on the web at http://www.pec.ha.osd.mil/Forms/BCF_Request_Form.dot.

     3) The P&T committee uses the best available evidence to decide what to add/delete from the BCF. Also, cost effectiveness is a mechanism to decide which agent's) to add. Since this approach uses cost and effectiveness, a higher unit price for a drug may be balanced by it's clinical effectiveness when compared to other active moieties or placebo.

     4) Contracts are officially executed by the Defense Supply Center Philadelphia (DSCP). Neither the P&T committee nor the PEC have contracting authority. The PEC does the clinical research and reviews for the P&T committee. The P&T committee makes a decision based on the clinical reviews and other factors. This is forwarded to DSCP to officially start and execute the contracting process.

There are cost effectiveness studies and cost minimization studies. The cost effectiveness study takes cost as well as clinical efficacy (LDL lowering, BP control, curing of an infections, disease prevented, etc). An example of this in DoD is the statin contract. The primary deciding factor in the statin contract was cost efficacy (cost divided by an efficacy measure). Cost efficacy for this initiative was defined as 1) Cost: Annual drug cost per patient for a given statin, 2) Efficacy: Percentage of patients who are predicted to reach their LDL-C goals when treated with a given dose of a given statin, and 3) Cost-efficacy ratio: Annual drug cost per patient treated to the LDL-C goal.

A cost minimization study is where some person/group (in our case the DoD P&T committee) decides that two or more agents are therapeutically equivalent and the outcomes from using any of the considered agents are equal. Once this decision is made, the product are competed on price alone. For example, once daily diltiazem products (Cardiazem CD®, Tiazac®, Dilacor XR®, and others) we determined therapeutically equal. Once the P&T committee made this decision, the products were competed on price.

This is just a very brief explanation of how some and why DoD formulary decisions are made. The P&T committee doesn't just choose "the low bidder". If you have comments regarding the process or a particular decisions, feel free to share your thoughts and comments with us via the email addresses on our website at www.pec.ha.osd.mil.