2012 drug approvals won’t be easy on pharmacy budgets

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For years, we’ve heard about the coming tidal wave of specialty drugs. In 2012, 25 of them crashed ashore as big pharma and small biotechs continued the pursuit of personalized medicine.

Biologics and other specialty therapeutics made up almost two thirds of new molecular entities approved last year, and their record number furthered the upward trend in approvals since the fast-track process was made law in 2007.

Notably, 12 of the 25 were orphan drugs, and at least seven carry six-figure prices for a year’s worth of treatment — increasingly common for drugs that address rare conditions, sometimes in populations of fewer than 1,000.

FDA drug approvals, 2007–2012

Sources: FDA, Express Scripts

Oncology agents: Not your average formulary decisions

Eleven drugs approved in 2012 were for oncology. Most are targeted agents sure to strain pharmacy budgets, but because of coverage mandates or the paucity of treatments available for their indications, they are unlikely to meet stiff payer resistance. For instance, Erivedge ($7,500 a month) is the first drug approved to treat advanced basal-cell carcinoma, giving it all but a free pass to the formulary.

The cost of addressing unmet needs

— Michael D. Dalzell