Trastuzumab-pkrb for Injection, for Intravenous Use (Herzuma®) HCPCS Code Q5113: Billing Guidelines

Tuesday, May 19, 2020

Effective with date of service March 16, 2020, the Medicaid and NC Health Choice programs cover trastuzumab-pkrb for injection, for intravenous use (Herzuma®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q5113 - Injection, trastuzumab-pkrb, biosimilar, (Herzuma®), 10 mg.

Strength/Package Size(s): 

  • For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution
  • For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution

Indicated for the treatment of: 

  • HER2-overexpressing breast cancer
  • HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Recommended Dose:  
Adjuvant Treatment of HER2-Overexpressing Breast Cancer (administer either):

  • Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of Herzuma®, administer 6 mg/kg as an IV infusion over 30−90 minutes every three weeks to complete a total of 52 weeks of therapy
  • Initial dose of 8 mg/kg over 90 minute IV infusion, then 6 mg/kg over 30 to 90 minute IV infusion every three weeks for 52 weeks

Metastatic HER2-Overexpressing Breast Cancer
Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions

Metastatic HER2-Overexpressing Gastric Cancer
Initial dose of 8 mg/kg over 90 minute IV infusion, followed by 6 mg/kg over 30 to 90 minute IV infusion every 3 weeks

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are:  C16.0 - Malignant neoplasm of cardia; C16.1 - Malignant neoplasm of fundus of stomach; C16.2 - Malignant neoplasm of body of stomach; C16.3 - Malignant neoplasm of pyloric antrum; C16.4 - Malignant neoplasm of pylorus; C16.5 - Malignant neoplasm of lesser curvature of stomach, unspecified; C16.6 - Malignant neoplasm of greater curvature of stomach, unspecified; C16.8 - Malignant neoplasm of overlapping sites of stomach; C16.9 - Malignant neoplasm of stomach, unspecified; C50.011 - Malignant neoplasm of nipple and areola, right female breast; C50.012 - Malignant neoplasm of nipple and areola, left female breast; C50.019 - Malignant neoplasm of nipple and areola, unspecified female breast; C50.021 - Malignant neoplasm of nipple and areola, right male breast; C50.022 - Malignant neoplasm of nipple and areola, left male breast; C50.029 - Malignant neoplasm of nipple and areola, unspecified male breast; C50.111 - Malignant neoplasm of central portion of right female breast; C50.112 - Malignant neoplasm of central portion of left female breast; C50.119 - Malignant neoplasm of central portion of unspecified female breast; C50.121 - Malignant neoplasm of central portion of right male breast; C50.122 - Malignant neoplasm of central portion of left male breast; C50.129 - Malignant neoplasm of central portion of unspecified male breast; C50.211 - Malignant neoplasm of upper-inner quadrant of right female breast; C50.212 - Malignant neoplasm of upper-inner quadrant of left female breast; C50.219 - Malignant neoplasm of upper-inner quadrant of unspecified female breast; C50.221 - Malignant neoplasm of upper-inner quadrant of right male breast; C50.222 - Malignant neoplasm of upper-inner quadrant of left male breast; C50.229 - Malignant neoplasm of upper-inner quadrant of unspecified male breast; C50.311 - Malignant neoplasm of lower-inner quadrant of right female breast; C50.312 - Malignant neoplasm of lower-inner quadrant of left female breast; C50.319 - Malignant neoplasm of lower-inner quadrant of unspecified female breast; C50.321 - Malignant neoplasm of lower-inner quadrant of right male breast; C50.322 - Malignant neoplasm of lower-inner quadrant of left male breast; C50.329 - Malignant neoplasm of lower-inner quadrant of unspecified male breast; C50.411 - Malignant neoplasm of upper-outer quadrant of right female breast; C50.412 - Malignant neoplasm of upper-outer quadrant of left female breast; C50.419 - Malignant neoplasm of upper-outer quadrant of unspecified female breast; C50.421 - Malignant neoplasm of upper-outer quadrant of right male breast; C50.422 - Malignant neoplasm of upper-outer quadrant of left male breast; C50.429 - Malignant neoplasm of upper-outer quadrant of unspecified male breast; C50.511 - Malignant neoplasm of lower-outer quadrant of right female breast; C50.512 - Malignant neoplasm of lower-outer quadrant of left female breast; C50.519 - Malignant neoplasm of lower-outer quadrant of unspecified female breast; C50.521 - Malignant neoplasm of lower-outer quadrant of right male breast; C50.522 - Malignant neoplasm of lower-outer quadrant of left male breast; C50.529 - Malignant neoplasm of lower-outer quadrant of unspecified male breast; C50.611 - Malignant neoplasm of axillary tail of right female breast; C50.612 - Malignant neoplasm of axillary tail of left female breast; C50.619 - Malignant neoplasm of axillary tail of unspecified female breast; C50.621 - Malignant neoplasm of axillary tail of right male breast; C50.622 - Malignant neoplasm of axillary tail of left male breast; C50.629 - Malignant neoplasm of axillary tail of unspecified male breast; C50.811 - Malignant neoplasm of overlapping sites of right female breast; C50.812 - Malignant neoplasm of overlapping sites of left female breast; C50.819 - Malignant neoplasm of overlapping sites of unspecified female breast; C50.821 - Malignant neoplasm of overlapping sites of right male breast; C50.822 - Malignant neoplasm of overlapping sites of left male breast; C50.829 - Malignant neoplasm of overlapping sites of unspecified male breast; C50.911 - Malignant neoplasm of unspecified site of right female breast; C50.912 - Malignant neoplasm of unspecified site of left female breast; C50.919 - Malignant neoplasm of unspecified site of unspecified female breast; C50.921 - Malignant neoplasm of unspecified site of right male breast; C50.922 - Malignant neoplasm of unspecified site of left male breast; C50.929 - Malignant neoplasm of unspecified site of unspecified male breast
  • Providers must bill with HCPCS code: Q5113 - Injection, trastuzumab-pkrb, biosimilar, (Herzuma®), 10 mg
  • One Medicaid and Health Choice unit of coverage is: 10 mg 
  • The maximum reimbursement rate per unit is: $100.98
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 63459-0303-43 and 63459-0305-47
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012 Special Bulletin National Drug Code Implementation Update
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail
  • The fee schedule for the PADP is available on Medicaid's PADP web page

Contact

NCTracks Contact Center: 800-688-6696