To receive this drug treatment, the patient must contact their treating physician at the relevant medical facility.

About the Program

This support program is implemented within the framework of medical assistance and service provision to the population through state order.

Requirements

Patients can receive treatment with Trastuzumab 600 mg if they meet the following criteria:

• They are in the pre-operative (neoadjuvant) or post-operative (adjuvant) treatment phase.
• Their HER2/neu receptor status is confirmed by immunohistochemical (IHC) analysis (a result of 3+).
• In case of a HER2/neu 2+ result, it must be confirmed by any method of in situ hybridization (ISH, such as FISH/CISH) testing.

Required Documents

To receive this drug treatment, the following documents are necessary:

• The patient's epicrisis (the data included is determined by the disease stage).
• A copy of the patient's identity document and, if available, a copy of the individual medical record (medical card).
• Contact information.

Scope of Support

In the first year, the patient is allocated a maximum of 13 vials of the drug. In subsequent years, a maximum quantity of 17 vials is allocated.

By the physician's decision, this medication may be administered through 9 injections over a six-month period instead of 17 injections (in the case of elderly patients).

Delivery period and Procedure

First, the patient's treating physician and the head of the respective department confirm the diagnosis.

Following the confirmation, the chemotherapy regimen and the Trastuzumab drug are prescribed.

The treated patient's repeat epicrisis must be submitted to the consultant on oncology at the Ministry of Health every 6 months.

Supplementary investigations in the clinical phase are indicated if there are suspicions of a metastatic process:

• Complete Blood Count (CBC).
• Comprehensive Metabolic Panel, including liver function tests and determination of alkaline phosphatase.
• Radionuclide Bone Scintigraphy (or PET/CT*), if there are elevated alkaline phosphatase levels or complaints of bone pain.
• In cases of abnormalities in alkaline phosphatase or liver function tests, presence of abdominal symptoms, or abnormalities found during physical examination of the abdomen and pelvis, Contrast-Enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) with contrast of the abdominal and pelvic organs is indicated.
• Contrast-Enhanced Chest CT scan, if pulmonary symptoms are present.
• PET/CT (Poly-organ Contrast-Enhanced CT scan may be used instead of this investigation).

If the clinical stage corresponds to  ≥ T2, M0 or  ≥ N1, M0, the following data must be present in the epicrisis:

• Medical history and physical examination.
• Bilateral mammography data.
• Sonographic examination data, if necessary.
• Axillary investigation data: ultrasound examination; consider core biopsy of suspicious lymph nodes.
• Pathological examination data of the tumor.
• Immunohistochemical examination of the tumor and receptor status determination.
• Mandatory use of a pregnancy test in all women with childbearing potential (not mandatory in all circumstances, but must be considered).

Reference to Legislation

Order N 1094-L of the Minister of Health of the Republic of Armenia, dated March 25, 2020.

The Order can be found on the Ministry of Health of the Republic of Armenia website: moh.am.