John Fox, MD, MHA, associate chief medical officer at Priority Health
Integrating new drugs into our formularies can be a simple or complex process. For drugs for which no other alternatives exist, it’s a fairly straightforward decision. The rules and regulations vary by state, but in our state (Michigan), we’re required to cover FDA-approved drugs (even for non—FDA-approved indications). And certainly, in orphan indications or in lines of therapy where no alternatives exist, the question is not whether or not we cover the drug. The question is, what kind of management strategies or parameters are we going to put around the drug?
In circumstances where we have another therapeutic option in a specific cancer and a specific line of therapy, the most critical thing for us to ask is, what are the survival advantages to that patient? Unfortunately, most of the time when new drugs come to the market, we don’t have survival data. We have progression-free survival data or overall response data, and in that circumstance, we’ll add that drug to the formulary. But perhaps it is a disadvantage to physicians. In other words, patients can get the drug and providers can prescribe it, but there may be additional cost sharing or additional requirements in order to be able to get that drug.
Most P&T (pharmacy and therapeutics) Committees meet on a regular basis every month, every 2 months, or every 3 months. The decision on how quickly to add a drug to the formulary is often dependent on whether or not there is an unmet need that is filled by that drug. So, a drug that is a new indication for a new line of therapy or a new type of cancer, for which there is no alternative, often gets fast-tracked in the P&T process. Medicare requires that we review all drugs within 3 months, and because, in our system, we review Medicare, Medicaid, and commercial at the same time, all drugs will be reviewed within that 3-month time period. But again, if there are unmet needs, it will be available almost immediately.
When formulary changes are made, they’re almost immediately updated on our website where the prior authorization forms and information are available to providers. But to be clear, most providers don’t want to infuse a drug or prescribe a drug unless they know it’s going to be covered. So, there is a pretty quick communication to the plan if providers want to use that drug because most of them will want to ensure the drug has been approved before they administer it.
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