Roche's biobetter Phesgo to be covered by health insurance starting this month
Roche's Phesgo(trastuzumab/pertuzumab), a biobetter for Roche's Herceptin+Perjeta fixed-dose combination subcutaneous injection that significantly improves dosing convenience for patients, will be covered by health insurance starting this month.
On Wednesday, the Health Insurance Review and Assessment Service (HIRA) announced the “Details on the Application Criteria and Methods of Medical Treatment Benefits” for drugs prescribed to cancer patients.
Phesgo won approval from the Ministry of Food and Drug Safety (MFDS) for combination therapy with chemotherapy as preoperative adjuvant therapy for patients with locally advanced, inflammatory, or early-stage (>2 cm in diameter) HER2-positive breast cancer, combination therapy with chemotherapy as postoperative adjuvant therapy for patients with HER2-positive early-stage breast cancer at high risk of recurrence, and combination therapy with docetaxel in patients with metastatic or unresectable locally recurrent breast cancer in HER2-positive patients who have not received anti-HER2 therapy or chemotherapy for metastatic disease.
Under the benefit announcement, Phesgo will get coverage for “upfront chemotherapy” and “postoperative adjuvant therapy” in early breast cancer and first-line treatment of metastatic breast cancer, with the exception that the patient copayment rate for the trastuzumab plus pertuzumab combination will be the same as for pertuzumab intravenous (IV) (Perjeta).
In other words, patients with early-stage breast cancer will pay 30 percent of the cost of Phesgo for upfront chemotherapy and 100 percent of the cost of Phesgo for postoperative adjuvant therapy. In addition, patients with metastatic breast cancer will have to pay only 5 percent of the cost of Phesgo as a first-line treatment due to a special cancer calculation.
Phesgo maximizes patient convenience by significantly reducing the treatment time for Herceptin+Perjeta from nearly an hour and a half of intravenous infusion to five to 10 minutes.
It was recognized as an improved biological product (biobetter) and the reimbursement price was calculated at 110 percent of the upper limit of the target product. Phesgo’s registered price is 3.49 million won ($2,554) for pertuzumab/trastuzumab 600/600 mg vial and 5.91 million won for 1,200/600 mg vial.
HIRA considered Phesgo's financial impact and awarded the same total risk-sharing reimbursement as Perjeta. Thus, Phesgo could enter the reimbursement list no earlier than a year after it passed the Cancer Disease Review Committee in late August last year.
“Based on a comprehensive review of the MFDS approval, textbooks and guidelines, approved clinical papers, and scientific opinions, Phesgo demonstrated non-inferiority to single-agent combination therapy, improved administration compared to previously covered therapies, and no additional financial impact. Phesgo has set the proposed reimbursement in the same range as the single-agent combination therapy based on clinical evidence,” HIRA said.
However, regarding the co-payment rate for the applicant drug, HIRA decided to set the co-payment rate for the applicant drug to be the same as that of pertuzumab, considering that the current reimbursement standard does not demonstrate cost-effectiveness for upfront chemotherapy and postoperative adjuvant therapy for early breast cancer, which is covered by a screening benefit (30/100) and full co-payment (100/100), it added.
According to the HIRA announcement, the agency also clarified the coverage criteria for Cyramza (ramucirumab) in combination with paclitaxel for the second-line treatment of patients with advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Previously, the eligibility criteria were patients who had failed [fluoropyrimidine + platinum (cisplatin, oxaliplatin) ± anthracycline (doxorubicin, epirubicin)] as a first-line therapy. However, it has been changed to “disease progression during or within four months of prior therapy (including neoadjuvant therapy for surgical candidates) with the combination [fluoropyrimidine + platinum (cisplatin, oxaliplatin) ± anthracycline (doxorubicin, epirubicin)].
In addition, the reference to Lynparza (olaparib) capsules for maintenance therapy for ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) was removed.
“As the production, import, and supply of olaparib capsules are scheduled to be discontinued, tablets with the same ingredients are allowed to be switched (March 1, 2022), and the drug has been removed from the Drug Benefit List and Benefit Ceiling Amount Table (subject to nursing benefits until July 31), the related benefit standard is deleted,” HIRA said, explaining the background for its move.