ph-0513
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Adakveo® (crizanlizumab-tmca)

Policy Number: PH-0513

 

Intravenous

 

Last Review Date: 01/05/2021

Date of Origin: 12/16/2019

Dates Reviewed: 12/2019, 01/2021

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 6 months initially and may be renewed annually thereafter.

  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

  • Adakveo 100 mg/10 mL single-dose vials: 6 vials at weeks 0 and 2 and every 4 weeks thereafter

B.  Max Units (per dose and over time) [HCPS Unit]:

  • 120 billable units at weeks 0 and 2 and every 4 weeks thereafter
  1. Initial Approval Criteria1,2

Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information.

Coverage is provided in the following conditions:

Universal Criteria

  • Therapy will not be used in conjunction with voxelotor (Oxbryta) or L-glutamine (Endari); AND

Sickle Cell Disease1-3 Ф

  • Patient is at least 16 years of age; AND
  • Patient has a confirmed diagnosis of sickle-cell disease, of any genotype (e.g., HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+-thalassemia, and others) as determined by one of the following:
    • Identification of significant quantities of HbS with or without an additional abnormal β-globin chain variant by hemoglobin assay; OR
    • Identification of biallelic HBB pathogenic variants where at least one allele is the p.Glu6Val pathogenic variant on molecular genetic testing; AND
  • Patient had an insufficient response to a minimum 3-month trial of hydroxyurea (unless contraindicated or intolerant); AND
  • Patient experienced one or more vaso-occlusive crises (VOC)* in the previous year despite adherence to hydroxyurea therapy

*VOC is defined as an event prompting either a visit or outreach to the provider which results in a diagnosis of VOC being made necessitating subsequent interventions such as narcotic pain management, non-steroidal anti-inflammatory therapy, hydration, etc.

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria1,3

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion related reactions (e.g., ever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, shortness of breath or wheezing), etc.; AND
  • Disease response compared to pretreatment baseline as evidenced by a decrease in the frequency of vaso-occlusive crises (VOC) necessitating treatment, reduction in number or duration of hospitalizations, and/or reduction in severity of VOC
  1. Dosage/Administration

Indication

Dose

Sickle-cell Disease

Administer Adakveo 5 mg/kg by intravenous infusion over a period of 30 minutes at Week 0, Week 2, and every 4 weeks thereafter.

  1. Billing Code/Availability Information

HCPCS:

  • J0791  Injection, crizanlizumab-tmca, 5 mg; 1 billable unit=5 mg

NDC:

  • Adakveo 100 mg/10 mL (10 mg/mL) single-dose vial: 00078-0883-xx
  1. References
  1. Adakveo [package insert]. East Hanover, NJ; Novartis Pharmaceuticals, Inc., November 2019. Accessed November 2020.
  2. Bender MA. Sickle Cell Disease. 2003 Sep 15 [Updated 2017 Aug 17]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2019. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1377/.
  3. Ataga KI, Kutlar A, Kanter J, et al. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. N Engl J Med. 2017 Feb 2;376(5):429-439. doi: 10.1056/NEJMoa1611770. Epub 2016 Dec 3.
  4. Yawn BP, Buchanan GR, Afenyi-Annan AN, et al. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

D57.00

Hb-SS disease with crisis unspecified

D57.01

Hb-SS disease with acute chest syndrome

D57.02

Hb-SS disease with splenic sequestration

D57.03

Hb-SS disease with cerebral vascular involvement

D57.09

Hb-SS disease with crisis with other specified complication

D57.1

Sickle-cell disease without crisis

D57.20

Sickle-cell/Hb-C disease without crisis

D57.211

Sickle-cell/Hb-C disease with acute chest syndrome

D57.212

Sickle-cell/Hb-C disease with splenic sequestration

D57.213

Sickle-cell/Hb-C disease with cerebral vascular involvement

D57.218

Sickle-cell/Hb-C disease with crisis with other specified complication

D57.219

Sickle-cell/Hb-C disease with crisis unspecified

D57.3

Sickle-cell trait

D57.40

Sickle-cell thalassemia without crisis

D57.411

Sickle-cell thalassemia with acute chest syndrome

D57.412

Sickle-cell thalassemia with splenic sequestration

D57.413

Sickle-cell thalassemia, unspecified, with cerebral vascular involvement

D57.418

Sickle-cell thalassemia, unspecified, with crisis with other specified complication

D57.419

Sickle-cell thalassemia with crisis unspecified

D47.42

Sickle-cell thalassemia beta zero without crisis

D57.431

Sickle-cell thalassemia beta zero with acute chest syndrome

D57.432

Sickle-cell thalassemia beta zero with splenic sequestration

D57.433

Sickle-cell thalassemia beta zero with cerebral vascular involvement

D57.438

Sickle-cell thalassemia beta zero with crisis with other specified complication

D57.439

Sickle-cell thalassemia beta zero with crisis unspecified

D57.44

Sickle-cell thalassemia beta plus without crisis

D57.451

Sickle-cell thalassemia beta plus with acute chest syndrome

D57.452

Sickle-cell thalassemia beta plus with splenic sequestration

D57.453

Sickle-cell thalassemia beta plus with cerebral vascular involvement

D57.458

Sickle-cell thalassemia beta plus with crisis with other specified complication

D57.459

Sickle-cell thalassemia beta plus with crisis unspecified

D57.80

Other sickle-cell disorders without crisis

D57.811

Other sickle-cell disorders with acute chest syndrome

D57.812

Other sickle-cell disorders with splenic sequestration

D57.813

Other sickle-cell disorders with cerebral vascular involvement

D57.818

Other sickle-cell disorders with crisis with other specified complication

D57.819

Other sickle-cell disorders with crisis, unspecified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

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 Article (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

ADAKVEO® (crizanlizumab-tmca) Prior Auth Criteria
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