You receive a request for a non-formulary statin. The patient has elevated LDL with only one other risk factor. The patient has no allergies and is on no other medications. The patient has no other significant medical history. The provider has not tried the formulary statin nor any other formulary hyperlipidemic agent and wants to go directly to this non-formulary agent. He argues it's clinically appropriate and you should get it for his patient.

In the current fiscal year, your budget is running very tight and you've come under significant heat to control your costs. Do you approve the non-formulary request or not?

SELECT  here for discussion

No.

This one requires some discussion and explanation, so bear with me.

In the world of pharmacy benefit management, whether it be military or civilian, the pharmacy benefit manager (PBM) is given a set amount of money to administer a set pharmacy benefit over the year. One of the ways to manage cost is to control the formulary. Formulary agents should be the first line agents. They often come with a significant price decrease through a contract with the PBM for adding it to the formulary. This is often the case within the DoD and the VA. The high potency statin class is an example.

Leveraging the large volume of statins purchased in the system, the DoD was able to negotiate a sizeable price concession from the manufacturer. The cost per statin dose dropped ~ 40% after implementation of the contract and the addition of the contract statin to the basic core formulary (BCF). In other words, we were able to treat ~ 40% MORE patients with hyperlipidemic therapy than we did before the contract and all at THE SAME COST as DoD spent on statins BEFORE the contract. To give you an idea of the money we're discussing here - DoD MTFs spent almost $80 MILLION on statins in FY01. Every time we prescribe the non-contract/non-formulary statin vice the contract statin we chip away at this savings.

Other methods of managing cost include controlling access and co-pays. In DoD, we cannot control access and cannot charge co-pays within the MTF. Co-pays are in place in the mail order and retail network pharmacies. The other tool (a blunt one at that) is deleting things from the formulary.

Most, if not all, plans have some mechanism where providers may request non-formulary agents IF they are "medically necessary". At WHMC, we want to get our patients the drugs they NEED and NOT give them the drugs they DON'T NEED. See the attached 2 x 2 table to illustrate. There IS a difference between "medically necessary" and "clinically appropriate". The best way to describe this difference is with a clinical example.

Example - our patient above - has hyperlipidemia and needs a statin.

For this example, we'll say the formulary statin is pravastatin. Although it may be "clinically appropriate" to use another statin to treat hyperlipidemia, it's not "medically necessary" in this case. Since there's no pressing reason not to use this, pravastatin should be prescribed.

2nd example - similar patient but has already tried and failed your formulary statin(s) or had an adverse drug reaction to the formulary statin or had a significant drug-drug interaction or didn't reach their LDL goal with the max dose of the formulary statin, one could reasonably state it's "medically necessary" to prescribe a non-formulary statin.

These examples used statins but similar scenarios could be used with a multitude of other high cost/high use drugs classes such as second generation antihistamines, COX2s vs NSAIDs, PPIs, antidepressants, etc. These classes are consistently in the top 10 drugs, by cost, in DoD.

Generic definitions of "medical necessity" definitions (from the Uniform Formulary Final Rule, published in the Federal Register, 1 April 2004) are listed below and applicable to most/all situations when medical necessity is an issue. They include:

1) The use of formulary pharmaceutical agents is contraindicated

2) The patient experiences significant adverse effects from formulary pharmaceutical agents, or the provider shows that the patient is likely to experience significant adverse effects from formulary pharmaceutical agents;

3) Formulary pharmaceutical agents result in therapeutic failure, or the provider shows that the formulary pharmaceutical agent is likely to result in therapeutic failure;

4) The patient previously responded to a non-formulary pharmaceutical agent and changing to a formulary pharmaceutical agent would incur unacceptable clinical risk;

5) There is no alternative pharmaceutical agent on the formulary.

Your individual hospital, clinic, HMO, or insurance plan may have their own criteria (general or specific to an individual drug or drug class). Formularies vary from place to place as do medical necessity criteria. The above are examples from the DoD Uniform Formulary rules and are reasonable examples of what a PBM would look for.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The US Air Force, the 59th Medical Wing (MDW), and 59th MDW Pharmacy assume no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.