Tecfidera’s impressive launch hit by supply and reiumbursement problems

June 20 2013 | By Márcio Barrahm duno

Tecfidera, Biogen’s idec of first-line oral treatment for people with relapsing forms of Multiple Sclerosis  approved back in March in the US and EU, is having a very impressive start, selling so well that it’s expected to break the blockbuster barrier by next year according to the The Wall Street Journal. But the demand is such among patients, doctors and pharmacies that supply hasn’t been able to fully satisfy the demand.  Supply chain and manufacturing snags also interfered with distribution, said Biogen’s CEO George Scangos.

Reimbursement has also been an issue, with insurers in the US taking several weeks to approve Tecfidera’s reimbursement, and some even requesting proof that patients have failed on other MS drugs before they reimburse Tecfidera. The drug’s price could also be an issue here – $54,900 a year, cheaper than Novart’s Gilenya ($60,000 per patient per year), but more expensive than Sanofi’s Aubagio ($48,000 per year) and some non – oral treatments like Biogen’s own Avonex (interferon beta-1a).  To counter, Biogen has offered Tecfidera for free to patients who have to wait more than two weeks for reimbursement.

There was also a launch delay in Europe, owing to the still ongoing economic crisis and harsher restrictions on drug costs.

Tecfidera, due its improved safety profile versus Gilenya and Aubagio, is widely expected to become the No. 1 oral treatment for Multiple Sclerosis, with annual sales topping $3 billion. Aubagio carries the risk of liver injury, birth defects and comes along with a boxed warning. As to Gilenya, although first to market, it has been held back by heart safety concerns. Tecfidera causes a decrease in a person’s white blood cell count, alongside nausea, vomiting, and diarrhea, but these tended to get better over time without stopping the drug.

This drug acts primarily by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, which helps protect nerve cells from damage and inflammation, thus easing multiple sclerosis symptoms like muscle weakness and difficulty with coordination and balance.


The Wall Street Journal

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