Download Pharmacy Policy Bulletin

Pharmacy Policy Bulletin
Title:
Vismodegib (Erivedge)
Policy #:
Rx.01.118
Application of pharmacy policy is determined by benefits and contracts. Benefits may vary
based on product line, group, or contract. Some medications may be subject to
precertification, age, gender or quantity restrictions. Individual member benefits must be
verified.
This pharmacy policy document describes the status of pharmaceutical information and/or
technology at the time the document was developed. Since that time, new information
relating to drug efficacy, interactions, contraindications, dosage, administration routes,
safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as
scientific and medical literature becomes available. This information may include new FDAapproved indications, withdrawals, or other FDA alerts. This type of information is relevant
not only when considering whether this policy should be updated, but also when applying it to
current requests for coverage.
Members are advised to use participating pharmacies in order to receive the highest level of
benefits.
Intent:
Vismodegib (Erivedge) is indicated for the treatment of adults with metastatic basal cell carcinoma, or with
locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery,
and who are not candidates for radiation.
The use of Vismodegib (Erivedge) requires prior authorization (i.e. clinical pharmacy and/or Medical Director
review).
Description:
Vismodegib (Erivedge) is an inhibitor of the Hedgehog pathway.
Policy:
Vismodegib (Erivedge) is approved when the following inclusion criteria is met:
•
Documentation of use for the treatment of adults with metastatic basal cell carcinoma, or with locally
advanced basal cell carcinoma that has recurred following surgery or who are not candidates for
surgery, and who are not candidates for radiation.
Guidelines:
Refer to the specific manufacturer's prescribing information for administration and dosage details and
any applicable Black Box warnings.
BENEFIT APPLICATION
Subject to the terms and conditions of the applicable benefit contract, the applicable drug(s) identified in
this policy is (are) covered under the pharmacy benefits of the Company’s products when the medical
necessity criteria listed in this pharmacy policy are met. Any services that are
experimental/investigational or cosmetic are benefit contract exclusions for all products of the Company.
References:
Erivedge [package insert]. South San Francisco CA. Genentech USA Inc. 2012
Padzur R. NDA approval letter: vismodegib (NDA 203388). Food and Drug Administration Web site.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203388s000ltr.pdf. Published January 30,
2012. Accessed January 30, 2012.
Vismodegib. ClinicalTrials.gov Web site. http://www.clinicaltrials.gov. Published October 19, 2011. Accessed
October 19, 2011.
Cohen DJ, Liebes L, Xu R, et al. A randomized, double-blind placebo-controlled phase II study of FOLFOX with
or without GDC-0449 (vismodegib) in patients with advanced gastric and gastroesophageal junction carcinoma
(NCI 8376) [abstract]. J Clin Oncol. 2011;29(suppl):TPS173.
Palmer SR, Erlichman C, Zernandez-Zapico Y, et al. Phase I trial erlotinib, gemcitabine, and the hedgehog
inhibitor, GDC-0449 [abstract]. J Clin Oncol. 2011;29(suppl):3092.
Curis announces submission of new drug application by collaborator Genentech for vismodegib in advanced
basal cell carcinoma. Business Wire Web site. http://www.businesswire.com. Published September 12, 2011.
Accessed September 29, 2011.
Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell
carcinoma. N Engl J Med. 2009;361(12):1164-1172.
Roche announces positive pivotal phase II results for hedgehog pathway inhibitor in advanced basal cell
carcinoma [news release]. Roche; March 21, 2011. http://www.roche.com/media/media_releases/med-cor2011-03-21.htm. Accessed September 29, 2011.
Basal cell carcinoma (skin cancers). National Cancer Institute Web site.
http://www.cancer.gov/cancertopics/types/skin. Published 2011. Accessed October 19, 2011.
Wong CS, Strange RC, Lear JT. Basal cell carcinoma clinical review. BMJ. 2003;327(7418):794-798.
Graham RA, Lum BL, Morrison G, et al. A single dose mass balance study of the hedgehog pathway inhibitor
vismodegib (GDC-0449) in humans using accelerator mass spectrometry. Drug Metab Dispos.
2011;39(8):1460-1467.
LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in
patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011;17(8):2502-2511.
Giannetti AM, Wong H, Dijkgraaf GJ, et al. Identification, characterization, and implications of speciesdependent plasma protein binding for the oral hedgehog pathway inhibitor vismodegib (GDC-0449). J Med
Chem. 2011;54(8):2592-2601.
Wong H, Alicke B, West KA, et al. Pharmacokinetic-pharmacodynamic analysis of vismodegib in preclinical
models of mutational and ligand-dependent hedgehog pathway activation. Clin Cancer Res. 2011;17(14):46824692.
LoRusso PM, Jimeno A, Dy G, et al. Pharmacokinetic dose-scheduling study of hedgehog pathway inhibitor
vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors. Clin Cancer Res.
2011;17(17):5774-5782.
Singh BN, Fu J, Srivastava RK, Shankar S. Hedgehog signaling antagonist GDC-0449 (vismodegib) inhibits
pancreatic cancer stem cell characteristics: molecular mechanisms. PLoS ONE. 2011;6(11)e27306.
Ding X, Chou B, Graham RA, et al. Determination of GDC-0449, a small-molecule inhibitor of the hedgehog
signaling pathway, in human plasma by solid phase extraction-liquid chromatographic-tandem mass
spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2010;878(9-10):785-790.
Lum BL, Morrison GE, Jorga CK, et al. A phase I, open-label mass balance study of the hedgehog pathway
inhibitor (HPI) GDC-0449 in healthy female subjects of non-childbearing potential [abstract]. J Clin Oncol.
2010;28(suppl 15s):2558.
Graham RA, Morrison GE, Jorga CK, et al. Bioavailability of the hedgehog pathway inhibitor GDC-0449 in a
phase I pharmacokinetic study in healthy female subjects [abstract]. J Clin Oncol. 2010;28(suppl):e13009.
Wong H, Chen JZ, Chou B, et al. Preclinical assessment of the absorption, distribution, metabolism and
excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an orally
bioavailable systemic Hedgehog signaling pathway inhibitor. Xenobiotica. 2009;39(11):850-861.
Curis announces presentation of positive vismodegib pivotal clinical data in advanced basal cell carcinoma.
Business Wire Web site. http://www.businesswire.com. Published June 20, 2011. Accessed September 29,
2011.
Sekulic A, Migden MR, Oro AE, et al. A pivotal study evaluating efficacy and safety of the hedgehog pathway
inhibitor (HPI) vismodegib (GDC-0449) in patients with locally advanced (la) or metastatic (m) basal cell
carcinoma (BCC) [abstract]. Melanoma Res. 2011;21:e9
Genentech submits new drug application to FDA for vismodegib for rare form of advanced skin cancer. Business
Wire Web site. http://www.businesswire.com. Published September 12, 2011. Accessed September 12, 2011.
FDA approves new treatment for most common type of skin cancer [news release]. Silver Springs, MD: Food
and Drug Administration; January 30, 2012.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289545.htm. Accessed February 2,
2012.
Applicable Drugs:
Inclusion of a drug in this table does not imply coverage. Eligibility, benefits, limitations, exclusions,
precertification/referral requirements, provider contracts, and Company policies apply.
Drug
Name
Erivedge
Generic Name
Vismodegib
Cross References:
Policy Version Number:
1.00
P&T Approval Date:
May 10, 2012
Policy Effective Date:
August 01, 2012
Next Required Review Date:
May 10, 2013
The Policy Bulletins on this website were developed to assist AmeriHealth in administering the provisions
of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member,
please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your
coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee
the outcome or results of any medical services/treatments. The facility and professional providers are
responsible for providing medical advice and treatment. Facility and professional providers are
independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical
condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or
update its Policy Bulletins. ©2012 AmeriHealth, Inc. All Rights Reserved.