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Medical Policy                                                                     

Policy Num:      05.001.021
Policy Name:    CAPRELSA (Vandetanib) - Oral Chemotheray
Policy ID:          [05.001.021]  [Ac / L / M+ / P+]  [0.00.00]

Last Review:     October 24, 2024
Next Review:      ARCHIVED

Related Policies:

02.004.045  PRUEBAS GENETICAS PARA MUTACIONES PALB2

11.003.009 Molecular Analysis for Targeted Therapy of Non-Small-Cell Lung Cancer

 CAPRELSA (VANDETANIB)  – ORAL CHEMOTHERAPY

SUMMARY

The medication vandetanib is an inhibitor of the "tyrosine kinase" which is selectively targeted to RET proto oncogene, blocking VEGFR (Vascular Endothelial Growth Factor Receptor) and EGFR (Epidermal Growth Factor Receptor), preventing the progression and angiogenesis.

Caprelsa is a kinase inhibitor indicated for symptomatic or progressive medullary thyroid cancer in patients 18 years of age or older, with unresectable locally advanced or metastatic disease. Caprelsa should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or congenital long QT syndrome. Hypocalcemia, hypokalemia, and/or hypomagnesemia must be corrected prior to Caprelsa administration and should be periodically monitored. The Risk Evaluation and Mitigation Strategy (REMS) program for Caprelsa is required by the FDA

Off label indication;  Non-Small Cell Lung Cancer ; Patient’s tumor is confirmed to have RET gene rearrangements

OBJECTIVE

The objective of this review is to evaluate the indications, contraindications and adverse effects of the medication.

POLICY STATEMENTS

A.  Vandetanib is considered medically indicated in the treatment of metastatic or unresectable locally advanced medullary thyroid cancer (symptomatic or progressive)..

B.    The decision to treat a patient with vandetanib must be based on the following criteria: 

a.    Base Electrocardiogram

b.    Base electrolyte as: K, Ca and Mg

c.     Base TSH

C.    By Triple-S, it is considered for payment for the treatment with vendetanib in the following conditions, identified by their corresponding ICD-10 codes. 

D.    Triple-S does not consider for payment the use of vandetanib under the following circumstances: 

a.    When there is documentation of: 

                                          i.    Congenital syndrome with prolongation of the QT segment

                                         ii.    <18 years of age

 Off label indication;  Non-Small Cell Lung Cancer ; Patient’s tumor is confirmed to have RET gene rearrangements

POLICY GUIDELINES

Caprelsa may be considered medically necessary for patients 18 years of age or older for treatment of symptomatic or progressive medullary thyroid cancer if the conditions indicated below are met.

Caprelsa is considered investigational in patients less than 18 years of age and for all other indications.

Prior-Approval Requirements

Age 18 years of age or older

Diagnosis

Patient must have the following:

            Symptomatic or progressive medullary thyroid cancer

AND ALL of the following:

                            1. Unresectable locally advanced disease or metastatic disease

                             2. NO hypocalcemia, hypokalemia, or hypomagnesemia before the initiation of Caprelsa

3. NO congenital long QT syndrome

4. Physician must complete Risk Evaluation and Mitigation Strategy (REMS) program 

PriorApproval Renewal Requirements

Age 18 years of age or older

Diagnosis

Patient must have the following:

Symptomatic or progressive medullary thyroid cancer

AND the following:

1. Physician must complete Risk Evaluation and Mitigation Strategy (REMS) program

Off label indication;  Non-Small Cell Lung Cancer ; Patient’s tumor is confirmed to have RET gene rearrangements

BENEFIT APPLICATION

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

 Vandetanib is a kinase inhibitor approved for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Vandetanib inhibits endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis

REGULATORY STATUS

FDA-approved indication: Caprelsa is a kinase inhibitor indicated for symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Caprelsa carries a boxed warning of QT prolongation and torsades de pointes. Vandetanib can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving vandetanib. Vandetanib should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or congenital long QT syndrome. Hypocalcemia, hypokalemia, and/or hypomagnesemia must be corrected prior to vandetanib administration and should be periodically monitored. Drugs known to prolong the QT interval should be avoided. Given the half-life of 19 days, ECGs should be obtained to monitor the QT interval at baseline, at 2 to 4 weeks and 8 to 12 weeks after starting treatment with vandetanib, and every 3 months thereafter. Following any dose reduction for QT prolongation or any dose interruptions of more than 2 weeks, QT assessment should be conducted as previously described. Because of the 19-day half-life, adverse reactions, including a prolonged QT interval, may not resolve quickly

Caprelsa is available only through a restricted distribution program called Caprelsa REMS. Only prescribers and pharmacies certified by the program may prescribe and dispense Caprelsa. The Risk Evaluation and Mitigation Strategy (REMS) program for Vandetanib is required by the FDA and is intended to help manage known and potential serious risks associated with Vandetanib as well to ensure the benefits outweigh the risks for each patient

Safety and effectiveness in pediatric patients have not been established.

RATIONALE

Vandetanib inhibits EGFR-dependent cell survival in vitro. In addition, vandetanib inhibits epidermal growth factor (EGF)–stimulated receptor tyrosine kinase phosphorylation in tumor cells and endothelial cells and VEGF-stimulated tyrosine kinase phosphorylation in endothelial cells. Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 

Índividuals with Thyroid cancer. 

CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Population Reference No.  2 

Índividuals with  Non-Small Cell Lung Cancer  (Off label indication)

SUPPLEMENTAL INFORMATION

N/A

PRACTICE GUIDELINES AND POSITION STATEMENTS

N/A

MEDICARE NATIONAL COVERAGE

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable.  https://www.cms.gov/medicare-coverage-database/search.aspx.

REFERENCES

1.   1.  Dipiro, Joseph T. (2008) Pharmacotherapy: A Pathophysiologic Approach. Thyroid Disorder. Chapter 78. 8^th Edition, McGraw Hill. Pp. 1243

 2 National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology-2011 Update. [online] Available in: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [Retrieved October 2011]

3.    3.Food And Drug Administration, 2011. Prescribing Information of Caprelsa®. [online] Available in: http://www.fda.gov [Retrieved October 2011]

4.    4. Medline plus [online] Available in: http://www.medlineplus.gov [Retrieved October 2011]

5.     5. Instituto Nacional de Cancer [online] Available in: http://imaging.cancer.gov/clinicaltrials/imaging [Retrieved October 2011]

6.    6. BCBS. (2011). Vandetanib (caprelssa). Specialty pharmacy combined capacity repor,

7.   7. ICD-9 CM Codes [online] Available in: http://www.icd9data.com/2009/volume1 [Retrieved October 2011]

8.   8. American Thyroid Association [Online] Available in: http://www.thyroid.org/professionals/advocacy/icd9.html [Retrieved October 2011]

9.   9. Base de datos: MICROMEDEX® 2.0 [online] Available in: http://www.thomsonhc.com/home/dispatch [Retrieved October 2011]

10. 10.Medical Coverage Guideline Florida Blue (Dec 15,2018) 09-J1000-38

11. Vandetanib [package insert] Wilmington, DE: AstraZeneca Pharmaceuticals; July 2016

12.  Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 8.2017. National Comprehensive Cancer Network, 2017. (Off label indication)

13.  Caprelsa [package insert]. Cambridge, MA; Genzyme Corporation; June 2020. Accessed September 2021.

14.  Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for vandetanib. National Comprehensive Cancer Network, 2021

15. Caprelsa PI HIGHLIGHTS OF PRESCRIBING INFORMATION  Rev Dec 2022

16.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for vandetanib. National Comprehensive Cancer Network, 2023

CODES

APPLICABLE MODIFIERS

N/A

POLICY HISTORY