A woman has requested that the government grant reimbursement for using Kadcyla of Roche in treating people with early breast cancer at high risk of recurrence, on Cheong Wa Dae's petition website.
On July 31, the petitioner posted the demand titled, "The government should not discriminate patients who have cancer that is difficult to treat in accessing new effective drugs."
The woman, who introduced herself as a daughter of a patient suffering from HER2 positive breast cancer patient, said that she had to give up treatment for her mother due to the expensive treatment cost of Kadcyla. The petition has won more than 770 signatures as of Tuesday.
"Because my mother's cancer was large, she received chemotherapy as an adjuvant therapy before surgery," the petitioner said. "However, a postoperative examination showed that cancer remained, and I was grief-stricken after hearing that recurrence risk is high and the treatment is more difficult in such cases."
The petitioner said that the hospital told her that Kadcyla could reduce the probability of recurrence by half compared to treatments covered by existing insurance.
"However, as the treatment was not subject to the government's reimbursement plan, we would have to pay around 100 million won ($84,300) to receive the treatment," she said. "As we could not afford such an expensive treatment, my mother is using an existing treatment covered by insurance instead of the new drug."
The petitioner said that while some HER2 positive breast cancer patients receive reimbursement to use targeted therapy, other HER2 patients, like her mother, could not use the treatment due to the government's lack of financial support.
"I ask the government to support treatment without discrimination so that there are no cases of poor treatment due to lack of money," she said.
Kadcyla is a targeted therapy that received regulatory approval in Korea to treat HER2-positive metastatic breast cancer in 2014. The treatment also obtained reimbursement through the government's risk-sharing agreement (RSA) program as a second-line treatment for metastatic breast cancer.
A research team has recently published a study showing that Kadcyla, as a postoperative adjuvant therapy for early breast cancer patients, can lower the risk of recurrence by 50 percent compared to Herceptin, the existing standard treatment. The study has resulted in the treatment receiving extended indications for early breast cancer treatment in August of last year.
However, health insurance benefits are still given only to metastatic breast cancer patients, so early HER2-positive breast cancer must receive treatment at their own expense.
Roche has submitted a reimbursement application for Kadcyla to the Health Insurance Review and Assessment Service and is awaiting review from the Cancer Disease Review Committee.
Despite such efforts, additional reimbursement for Kadcyla is uncertain. A report published by the Ministry of Health and Welfare showed that breast cancer treatments already account for a significant amount of funds among the treatments covered by reimbursement this year.
The annual funds required for drugs, which were newly registered or whose reimbursement standards have been expanded until July 1 through the Health Insurance Policy Deliberation Committee’s resolution, total 132.5 billion won.
Funds allocated to Ibrance and Verzenio, both hormone-receptor-positive advanced breast cancer treatments, amounted to 40.5 billion won, accounting for 30 percent of the total.
These explain why industry experts believe that it will be difficult for the government to invest additional funds in breast cancer treatment within this year, even considering the size of the patient population.
However, the problem is that early breast cancer patients who need Kadcyla are high-risk patients with a high risk of recurrence. Another study has shown that 34 percent of HER2-positive early breast cancer patients did not achieve complete remission despite adjuvant therapy before surgery and showed invasive residual lesions.
The research further indicated that patients with residual cancer have a higher risk of recurrence and metastasis than those who do not.
Although Korea has excellent records in early breast cancer treatment, the prognosis is still fatal for relapsed patients. While the five-year survival rate for early breast cancer exceeds 90 percent, the average survival time for relapsed patients is only about 19 months.
It is for these reasons that Kadcyla has become standard therapy for early breast cancer patients with a high risk of recurrence in other foreign countries. The latest National Comprehensive Cancer Network guideline also recommends Kadcyla as a Category 1 for postoperative adjuvant therapy for HER2-positive early breast cancer patients.
For the same reason, Australia's Pharmaceutical Benefit Scheme and the U.K. National Institute for Health and Clinical Excellence recognized the need for reimbursement for Kadcyla in treating early breast cancer patients in April and June of this year, respectively.
"Through Kadcyla treatment, it became possible to significantly reduce the risk of recurrence in high-risk patients who did not show complete pathologic remission after adjuvant therapy before surgery or after surgery," Professor Jung Joon at Gangnam Severance Hospital said. "Kadcyla has excellent clinical outcomes in improving survival rates, and is a drug well worth the government's investment of resources when considering the prevalence of early breast cancer patients."