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DESCRIPTIONKalydeco is classified as a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. Kalydeco is the first available treatment for cystic fibrosis (CF) that targets the defective CFTR protein, which is the underlying cause of CF.
FDA APPROVED INDICATIONS
POLICYPrior authorization is required.
Kalydeco® is considered medically necessary for the treatment of cystic fibrosis in patients age 2 years and older who have one of the following mutations in the CFTR gene detected by an FDA-cleared CF mutation test: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H. A maximum of 60 tablets per month will be approved.
After six months of therapy, documentation of improvement in FEV1, symptoms, and stabilization of disease is required for continued treatment.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/26/2012: New policy added.
03/14/2014: FDA Approved Indications and Policy sections revised to include the following specific gene mutations for treatment: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
05/28/2015: FDA Approved Indications and policy statement updated to change the age for treatment from "6 years and older" to "2 years and older" and to add the following mutation: R117H.
08/28/2015: Medical policy revised to add ICD-10 codes.
SOURCE(S)Kalydeco® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.