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Date Printed: August 18, 2017: 07:55 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-66

Original Effective Date: 05/15/12

Reviewed: 10/12/16

Revised: 11/15/16

Subject: Vismodegib (Erivedge®) Capsules

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Vismodegib (Erivedge®) was approved by the US Food and Drug Administration in January 2012 for the treatment of adults with metastatic basal cell carcinoma or in adults with locally advanced basal cell carcinoma that has recurred following surgery. Vismodegib exerts its anti-cancer effects by inhibiting the hedgehog (Hh) signaling pathway. The Hh signaling pathway regulates normal cell development, replication, and differentiation and hair growth. Dysregulation of the pathway has been associated with basal cell carcinoma development.

A single, international, single-arm, multi-center, open-label, 2-cohort trial was conducted in 104 patients with either metastatic basal cell carcinoma (mBCC) (n = 33) or locally advanced BCC (laBCC) (n = 71). Patients with laBCC were required to have lesions that had recurred after radiotherapy, unless radiotherapy was contraindicated or inappropriate and where the lesions were either unresectable or surgical resection would result in substantial deformity. Patients were to receive 150 mg vismodegib daily until disease progression or unacceptable toxicity. The primary outcome was objective response rate (ORR). The median duration of treatment was 10.2 months (range 0.7 to 18.7 months). The ORR in the mBCC and laBCC were 30.3% and 42.9%, respectively, with median response duration of 7.6 months in both groups.

The National Comprehensive Cancer Network (NCCN) guidelines for the treatment of basal cell skin cancer (version 2.2016) recommend a hedgehog pathway inhibitor for: (1) high-risk disease if residual disease is present and further surgery and radiation are contraindicated or if negative margins are unachievable by MOHS surgery or more extensive surgical procedures, or (2) when there is nodal or distant metastases (both category 2A recommendations). The NCCN notes that BCCs may develop resistance to hedgehog pathway inhibition. Initial studies have shown no clinical benefit of switching to a different hedgehog pathway inhibitor after disease progression.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

The initiation of vismodegib (Erivedge®) meets the definition of medical necessity when ALL of the following are met:

1. The member has EITHER of the following indications AND all associated criteria are met:

a. Metastatic basal cell carcinoma (mBCC) [including basosquamous cell variants]

b. Locally advanced basal cell carcinoma (laBCC) [including basosquamous cell variants] and EITHER of the following:

i. Member’s basal cell carcinoma has recurred following previous surgical resection

ii. Member is not a candidate for both surgical resection AND radiation (reasons for non-candidacy must be provided)

2. The member is not taking another hedgehog pathway inhibitor [e.g., sonidegib (Odomzo®)] concurrently with vismodegib

3. The member has not previously experienced disease progression during treatment with another hedgehog pathway inhibitor (e.g., sonidegib)

4. The member’s dosage of vismodegib does not exceed 150 mg once daily

Approval duration: 1 year

3. The member is not taking another hedgehog pathway inhibitor (e.g., sonidegib) concurrently with vismodegib

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: vismodegib 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 in persons who are not candidates for surgery or radiation. The recommended dose is 150 mg once daily, with or without food, until disease progression or unacceptable toxicity. Capsules should be swallowed whole and should not be opened or crushed. If a dose is missed, dosing should be resumed with the next scheduled dose. No dose adjustment is required in patients with hepatic or renal impairment.

Drug Availability: vismodegib is supplied as a 150 mg capsule.

PRECAUTIONS:

Boxed Warning:

• Vismodegib can result in embryo-fetal death or severe birth defects. Pregnancy status should be verified prior to initiation with vismodegib. Female and male members should be advised of these risks and the need for contraception, including potential risk for female partners via exposure through semen.

Contraindication:

• None

Warnings and Precautions:

• Blood donation: Advise members not to donate blood or blood products while receiving vismodegib and for at least 7 months after the last dose of vismodegib.

• Semen donation: Advise males not to donate semen during and for 3 months after therapy.

• Lactation: Advise a nursing woman that breastfeeding is not recommended during therapy and for 7 months after the final dose.

BILLING/CODING INFORMATION:

HCPCS Coding:

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C44.01

Basal cell carcinoma of skin of lip

C44.111 – C44.119

Basal cell carcinoma of skin of eyelid, including canthus

C44.211 – C44.219

Basal cell carcinoma of skin of ear and external auricular canal

C44.310

Basal cell carcinoma of skin of unspecified parts of face

C44.311

Basal cell carcinoma of skin of nose

C44.319

Basal cell carcinoma of skin of other parts of face

C44.41

Basal cell carcinoma of skin of scalp and neck

C44.510

Basal cell carcinoma of anal skin

C44.511

Basal cell carcinoma of skin of breast

C44.519

Basal cell carcinoma of skin of other part of trunk

C44.611 – C44.619

Basal cell carcinoma of skin of upper limb, including shoulder

C44.711 – C44.719

Basal cell carcinoma of skin of lower limb, including hip

C44.81

Basal cell carcinoma of overlapping sites of skin

C44.91

Basal cell carcinoma of skin, unspecified

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Basal cell carcinoma (BCC) - abnormal, uncontrolled growths or lesions that arise in the skin’s basal cells, which line the deepest layer (i.e., basal cell layer) of the epidermis. BCCs often look like open sores, red patches, pink growths, shiny bumps, or scars, and rarely metastasize beyond the original tumor site. BCC is the most frequently occurring form of all cancers, and the most common skin cancer (8 of 10 skin cancers).

Basosquamous cell (BSC) - is considered an aggressive variant of basal cell carcinoma (BCC) with an increased risk of recurrence and metastases. It shares histologic features of both basal cell and squamous cell carcinoma and is often linked by a transition area. It is also known as metatypical basal cell carcinoma.

Squamous cell carcinoma (SCC) - uncontrolled growth of abnormal cells arising in the squamous cells, which compose most of the skin’s upper layers (the epidermis). SCCs often look like scaly red patches, open sores, elevated growths with a central depression, or warts; they may crust or bleed. About 2 of 10 skin cancers are SCC. SCCs are more likely to grow into deeper layers of skin and spread to other parts of the body than BCC, but this is still uncommon.

RELATED GUIDELINES:

Mohs’ Micrographic Surgery - 02-10000-03

Sonidegib (Odomzo) - 09-J2000-45

OTHER:

None

REFERENCES:

  1. Basset-Seguin N, Hauschild A, Grob JJ, et al. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. Epub 2015 May 13.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com. Accessed 9/16/16.
  3. Danial C, Sarin KY, Oro AE, et al. An Investigator-Initiated Open-Label Trial of Sonidegib in Advanced Basal Cell Carcinoma Patients Resistant to Vismodegib. Clin Cancer Res. 2016 Mar 15;22(6):1325-9.
  4. Erivedge (vismodegib) [package insert]. Genetech, Inc. South San Francisco (CA): May 2015.
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 9/16/16.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 9/16/16.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.106. Basal Cell Skin Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/nmsc.pdf. Accessed 9/16/16.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016 Sept 16]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  9. Sekulic A, Migden MR, Lewis K, et al. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015 Jun;72(6):1021-6.e8.
  10. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9.
  11. Silapunt S, Chen L, Migden MR. Hedgehog pathway inhibition in advanced basal cell carcinoma: latest evidence and clinical usefulness. Ther Adv Med Oncol. 2016 Sep;8(5):375-82.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

05/15/12

New Medical Coverage Guideline.

11/15/13

Review and revision to guideline; consisting of reformatting position statement, updating dosage/administration section, precautions section, program exceptions and references.

11/15/14

Review and revision to guideline; consisting of reformatting position statement and updating references.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Review and revision to guideline consisting of updating description, position statement, dosage/administration, precautions, billing/coding, related guidelines, and references.

11/15/16

Review and revision to guideline consisting of updating the description, position statement, dosage/administration, precautions, billing/coding, definitions, related guidelines, and references

Date Printed: August 18, 2017: 07:55 PM