Unpredictable Cancer Committee make all kinds of decisions

Opdivo green-lit 3 years after, Keytruda deferred again

Committee skeptical about PARP inhibitor on BRCA-negative indication

No to Revlimid maintenance therapy, OKs Pomalyst second-line therapy

The expression on all the pharmaceutical companies accepting the final outcome varied as the meeting concluded.

 

But for sure, no one had a perfect game.

 

On June 3, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee was convened to discuss two immunotherapies, two poly ADP-ribose polymerase (PARP) inhibiting targeted therapies and two multiple myeloma treatments.

 

◆ Keytruda and Opdivo The decision on MDS’s Keytruda (pembrolizumab) has been deferred yet again.

 

The Committee reviewed granting reimbursement on Keytruda’s five indications, including first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma.

 

In the April meeting finally convened after being postponed twice due to COVID-19, the Cancer Committee deferred the decision on the immunotherapy.

 

Although not required, the multinational company submitted an economic evaluation data and financial impact solution plan on using the immunotherapy as a first-line treatment (mono and combination therapy) in patients with non-small cell lung cancer (NSCLC) to better express its commitment to receive the extended reimbursement.

 

Regardless, the committee did not give a satisfying answer, explaining that they did not have sufficient time to review properly.

 

Bristol Myers Squibb (BMS) and Ono’s Opdivo (nivolumab), on the contrary, gave up on the lung cancer indication and won the benefit in Yervoy (ipilimumab) combination therapy.

 

Apparently, BMS and Ono have also submitted an economic evaluation data to secure the coverage on Opdivo plus Yervoy combination therapy.

 

In April, the Cancer Committee cleared the reimbursement on Opdivo for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but denied the indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy.

 

And at the latest meeting, the committee gave a nod to Opdivo’s indication to treat renal cell carcinoma as a first-line therapy.

 

After receiving the first reimbursement as a second-line therapy in patients with NSCLC in September 2017, Opdivo has taken three years to pass the Cancer Committee.

 

◆Lynparza and Zejula Without a surprise, the Cancer Committee’s answer to PARP inhibitor’s indication on BRCA-negative patients was ‘no.’ AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) were half-successful in the end.

 

The Cancer Committee reviewed Lynparza’s tablet indicated to as a maintenance therapy following a first-line therapy in patients with BRCA-mutated advanced ovarian cancer, second or later-line treatment in platinum-sensitive patients with relapsed high grade serous epithelial ovarian, treatment in patients with HER2-negative metastatic breast cancer.

 

The committee recognized the need for first and second-line maintenance therapy in BRCA-mutated ovarian cancer, but ruled out mBRCA-negative patients included in the second-line therapy indication.

 

Also, the committee seemed skeptical of the breast cancer indication.

 

Zejula also had a similar outcome.

 

The review was on using the drug as maintenance therapy of patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy.

 

Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed.

 

The government is still conservative about an anticancer treatment indicated to treat ‘all comers.’

◆ Revlimid and Pomalyst Multiple myeloma treatments seem to be struggling with maintenance therapy.

 

Deferred by the Cancer Committee last September, Revlimid (lenalidomide) once again requested a review on extended coverage on a maintenance therapy to prevent relapse in patients who had stem cell transplantation, which was not granted.

 

The combined company of Bristol Myers Squibb (BMS) and Celgene offered a financial impact solution plan for the coverage on the maintenance therapy indication, but the committee did not change its mind.

 

However, the committee green-lit the reimbursement on Pomalyst (pomalidomide) as a second-line therapy, extended from the current coverage on third-line therapy.

 

Specifically, the approval was granted on the Pomalyst, Velcade (bortezomib) and dexamethasone combination therapy in patients with multiple myeloma, who have previously received one or more treatment including Revlimid.

 

With the latest approvals, BMS and Celgene combined have received approval on two out of three items in the first Cancer Committee meeting held since their merge.