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
|Indication||mCRPCa||Medullary thyroid cancer||mCRCb|
|Cost per monthc||$7,450||$9,990||$9,350|
|Competing productsd||Zytiga ($5,495/mo)
Jevtana ($6,400 per 3-week cycle)
Provenge ($93,000/single course)
|Caprelsa ($10,000–$12,000/mo)||Zaltrap ($11,063/mo)
Erbitux ($4,032 loading dose, $2,880 weekly dose)
amCRC=metastatic colorectal cancer
bmCRPC=metastatic, castrate-resistant prostate cancer
cPublished average wholesale price, before rebates
dCompeting does not imply substitutable.
Pricing sources: American Society of Clinical Oncology, Cancer Letter, DailyRx, Fallon Community Health Plan, New York Times, The Pharma Letter, Reuters, Seeking Alpha
— Michael D. Dalzell