Ofev Approved for the Treatment of Idiopathic Pulmonary Fibrosis

October 15, 2014 – Boehringer Ingelheim received approval from the US Food and Drug Administration (FDA) for Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).  Ofev is a kinase inhibitor which works by blocking multiple pathways that may involve scarring of lung tissue in patients with IPF.

Patients should have liver function tests conducted prior to beginning treatment and during treatment with Ofev.   Launch is anticipated to be by the end of October and treatment is estimated to cost about $9,600 per month.  Ofev will be distributed through a limited network of specialty pharmacies.  It is anticipated that a patient would be on this medication for an extended period of time, or until they experience negative side effects which may require temporary dose reduction, treatment interruption or possible discontinuation of therapy.

If you have any questions you can contact our Client Services Call Center at 1-877-723-6005.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.