Optune Pax® Now FDA-Approved for LAPC

Now FDA-approved

Optune Pax^® is intended for the treatment of adult patients with locally advanced pancreatic cancer (LAPC), concomitant with gemcitabine-nab paclitaxel.

Optune Pax is a wearable therapeutic device that may kill cancer cells selectively by targeting their electrical properties

Optune Pax with gem/nab-pac vs gem/nab-pac significantly extended overall survival

mOS in the ITT population†:

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16.2 months (95% CI: 15.0–18.0) vs 14.2 months (95% CI: 12.8–15.4)

mOS in the mPP population‡:

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18.3 months (95% CI: 16.1–20.0) vs 15.1 months (95% CI: 13.4–17.0)

Device-related adverse events (AEs) occurred in 81% of patients and the majority were skin AEs, which were observed in 76.3% of patients. The majority of skin AEs were mild to moderate.

Optune Pax was studied in PANOVA-3, a phase 3, open-label, randomized study evaluating the safety and effectiveness of Optune Pax concomitant with gem/nab-pac in patients with LAPC (N=571).

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Patients were randomized 1:1 to receive either Optune Pax + gem/nab-pac vs gem/nab-pac alone

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Primary endpoint: OS with Optune Pax + gem/nab-pac vs gem/nab-pac alone

^† PANOVA-3 was a global, randomized, open-label, phase 3 trial (N=571) of patients with locally advanced pancreatic cancer. The trial included patients with unresectable LAPC who had histological or cytological diagnosis, ECOG PS 0–2, and no other concurrent anticancer treatment. Patients were randomized 1:1 to receive treatment with either Optune Pax with gem/nab-pac or gem/nab-pac alone. The primary endpoint was overall survival in the Intent-to-Treat population. Follow-up was performed every 4 weeks. Optune Pax treatment continued until local disease progression, death, or unacceptable device-related adverse events. Chemotherapy continued until disease progression, death, or unacceptable toxicity.

^‡ The mPP population includes only those patients who received at least 1 cycle of gem/nab-pac (both arms) and, for the Optune Pax with gem/nab-pac arm, also received at least 4 weeks (28 days) of TTFields therapy.

^†† A statistically significant difference in the OS distribution between study arms was observed. ITT population: HR: 0.82; 95% CI: 0.68–0.99; P=0.039; mPP population: HR: 0.77; 95% CI: 0.62–0.97; P=0.023.

See the data ↗

Coding Information (including HCPCS and ICD-10-CM codes) for Optune Pax

The coding information provided is for informational purposes only, is subject to change, and should not be construed as legal advice. The codes listed herein may not apply to all patients or to all health plans. Conversely, additional codes not listed may apply to some patients. Providers should follow payer-specific coding requirements and exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect the services and products furnished to a specific patient.

Relevant HCPCS Code

HCPCS Code

E0766

Code Descriptor

Electrical stimulation device used for cancer treatment, includes all accessories, any type.

Relevant ICD-10-CM Diagnosis Codes

Cancer Type

Code Type

ICD-10-CM Code

Code Description

Pancreatic

ICD-10-CM

C25.0

Malignant Neoplasm of Head of Pancreas

Pancreatic

ICD-10-CM

C25.1

Malignant Neoplasm of Body of Pancreas

Pancreatic

ICD-10-CM

C25.2

Malignant Neoplasm of Tail of Pancreas

Pancreatic

ICD-10-CM

C25.3

Malignant Neoplasm of Pancreatic Duct

Pancreatic

ICD-10-CM

C25.7

Malignant Neoplasm of Other Parts of Pancreas

Pancreatic

ICD-10-CM

C25.8

Malignant Neoplasm of Overlapping Sites of Pancreas

Pancreatic

ICD-10-CM

C25.9

Malignant Neoplasm of Pancreas, Unspecified

ICD-10-CM = International Classification of Diseases, 10th Revision, Clinical Modification.

Indication and Important Safety Information

Indication for Use

Optune Pax^® is intended for the treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.

Important Safety Information

Contraindications

Do not use Optune Pax in patients with an electrical implant. Use of Optune Pax together with electrical implants has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune Pax in patients with a known sensitivity to conductive hydrogels. In patients with this sensitivity, skin contact with the gel used with Optune Pax may commonly cause increased redness and itching. In rare cases, it may lead to severe allergic reactions that can cause a drop in blood pressure and difficulty breathing.

Warnings and Precautions

Optune Pax can only be prescribed by a healthcare provider who has completed the required certification training provided by Novocure^® (the device manufacturer).

Do not prescribe Optune Pax for patients who are pregnant, who you think might be pregnant, or who are trying to get pregnant. Women who are able to get pregnant must use birth control when using the device. Safety and effectiveness of Optune Pax in these populations have not been established.

The most common (≥10%) adverse events involving Optune Pax concomitant with gemcitabine and nab-paclitaxel were neutropenia, anemia, thrombocytopenia, leukopenia, diarrhea, nausea, vomiting, abdominal pain, constipation, fatigue, peripheral edema, pyrexia, pain, COVID-19, infection, respiratory tract infection, urinary tract infection, pneumonia, hepatic enzyme increased, anorexia, hypokalemia, hypoalbuminemia, hyperglycemia, musculoskeletal pain, peripheral neuropathy, taste disorder, dizziness, sleep disorder, dyspnea, alopecia, skin-related disorders, and hypotension.

Optune Pax device-related skin adverse events (≥5%) include dermatitis, rash, pruritus, maculo-papular rash, erythema, skin irritation, skin reaction, and skin ulcer. Other device-related adverse effects associated with the use of Optune Pax include overheating of the array, leading to pain and/or local skin burns, allergic reaction to the adhesive or gel from the transducer arrays, and local warmth and tingling sensation beneath the arrays.

If the patient has an underlying skin condition on the abdomen, evaluate whether this may prevent or temporarily interfere with Optune Pax treatment.

Please see the Optune Pax Instructions for Use (IFU) for complete information regarding the device’s indication, contraindications, warnings, and precautions at OptunePaxHCP.com.