Highlights of Recommendation - PDF document

Highlights of Recommendation: Letrozole (Femara) is a drug used to treat breast cancer in women who have already experienced menopause. The drug is an alternative to tamoxifentherapy for patients with hormone-receptor positive breast cancer, meaningthat estrogen or progesterone hormonemay cause their tumours to grow. The Committee reviewed the results of a study that reported patients takingletrozole (Femara) experienced a longercancer-free period than patients takingtamoxifen. The cost of letrozole (Femara) is similar to other medications in the same class. Overall, the Committee noted thatletrozole (Femara) delivered a longerdisease-free period for patients thantamoxifen, and that the productdemonstrated value for money.  The CED recommended that OntarioPublic Drug Programs reimburse letrozole(Femara) for the treatment of early-stagebreast cancer as a Limited Use benefit,with specified criteria. (Please refer to the“Detailed Discussion” section for details of the criteria.)  The CED worked jointly with asubcommittee involving cancer expertsto review this cancer drug, as is done for all other cancer drug treatments. Background: Breast cancer is one of the most common Committee to Evaluate Drugs (CED) Product:LETROZOLE (Femara®) 2.5 mg tabletAromatase inhibitor; anti-estrogen agentIndication: Adjuvant treatment of breast cancerManufacturer:Novartis PharmaceuticalsLetrozole Health and Long-Term Care Executive Officer DecisionBased on the CED’s recommendation,the Executive Officer has decided tolist letrozole (Femara) on the ODBFormulary under Limited Use benefit. StatusFunding available through theOntario Public Drug Programs. CED Recommendation The CED recommended that letrozole(Femara) 2.5 mg tablet be listed on theOntario Drug Benefit (ODB) Formularyas a Limited Use benefit, with criteria,on the basis that it delivers longerdisease-free survival time thantamoxifen, an alternative therapycommonly used for the adjuvanttreatment of breast cancer. January 2008 This document posted continued… Detailed Discussion: The manufacturer, NovartisPharmaceuticals, asked the OntarioMinistry of Health and Long-Term Care to change the status under which itreimburses letrozole (Femara) on the ODBFormulary, to extend its reimbursementto the treatment of hormone-receptorpositive early-stage breast cancer in post-menopausal women.  The Committee reviewed the BIG-1-98trial as the key study that supports t

heuse of letrozole in the adjuvant treatmentof early-stage breast cancer, in hormone-receptor positive patients.  According to the study, the disease-freesurvival period was longer for patientstaking letrozole (Femara) (84% at fiveyears) than for those taking tamoxifen(81.4% after five years).  The Committee noted there was nosignificant benefit in overall survival in the letrozole (Femara) arm of the study,but there is supportive evidence thatdistant disease-free survival can be usedas a surrogate marker for overall survival.  Patients taking letrozole (Femara) mayexperience greater risk of cardiovasculartoxicity than patients taking tamoxifen,while patients on tamoxifen experiencedmore throboembolic events, hot flashes,night sweats, and vaginal bleeding.  Overall, the Committee noted there was a clinically significant improvementin disease-free survival for letrozole(Femara) vs. tamoxifen. The Committeealso accepted that disease-free survival is a valid surrogate marker for overallsurvival in breast cancer. The incremental cost-effectiveness ratio(ICER) varies depending on the nodalstatus of the patient. The ICER forletrozole (Femara) falls within the rangewhere a therapy is typically consideredcost-effective. As such, letrozole (Femara)for the adjuvant treatment of breastcancer appeared to demonstrate valuefor money.  The CED recommended that letrozole(Femara) continue be funded as a LimitedUse benefit, with the following additionalcriterion:–As an alternative to tamoxifen for the adjuvant treatment of post-menopausal women withhormone-receptor positive early breastcancer for a maximum of five years. Cancer Care Ontario (CCO) Information: Information on Cancer Care Ontario’schemotherapy regimens for breast cancer is available at:http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htmThe Cancer Care Ontario’s Breast CancerDisease Site Group (DSG) Program inEvidence-Based Care (PEBC) guideline for the use of chemotherapy in breastcancer is available at:http://www.cancercare.on.ca/index_breastCancerGuidelines.htm CEDAC Recommendation: (http://www.cadth.ca/index.php/en/cdr/recommendations)The Canadian Expert Drug AdvisoryCommittee did not review letrozole(Femara). Health and Long-Term Care Ministry of Health and Long-Term Care Ontario Public Drug Programs415 Yonge Street, Suite 1601Toronto, Ontario M5B 2E7 or click: www.moh.on.gov.ca/dss/cedFor more information, please contact