Why are new-to-market blocks deployed?

More and more controllers are now instituting new-to-market blocks, which block access to new drugs for up to 180 days, on at least a subset of newly launched drugs in therapeutic areas with other available treatment options.

These blocks function largely as a risk mitigation strategy. If the payer allows a drug to be covered for a patient immediately after launch but later the P&T committee decides not to cover the drug, the payer is then obligated to allow any patients on the drug to continue treatment or accept the risk of switching medications. This creates a burden for the payer, especially for high-cost specialty medications.

Many controllers also use new-to-market blocks to allow for the collection of additional real-world evidence of efficacy and success. They might also track which payers are covering the drug and determine how patients are using it before making a coverage decision. This wait-and-see period is quite common for drugs that have been fasttracked by the FDA, which do not yet have long-term efficacy data. (See Payer Coverage of Fast-Tracked Therapies: A Cautionary Tale for more details.)

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