ICER Draft Report Assesses Value of 3 PARP Inhibitors for Ovarian Cancer

A new draft report from the Institute for Clinical and Economic Review (ICER) evaluates the evidence on the effectiveness and value of 3 drugs used to treat ovarian cancer.

A new draft report from the Institute for Clinical and Economic Review (ICER) evaluates the evidence on the effectiveness and value of 3 drugs used to treat ovarian cancer.

The 3 drugs in question—rucaparib, niraparib, and olaparib­—are poly ADP-ribose polymerase (PARP) inhibitors. They have mainly been used in women whose cancer has recurred after multiple chemotherapy regimens, or as maintenance therapy for women with at least 2 prior lines of platinum-based chemotherapy who were in complete or partial response to the most recent regimen.

ICER’s report analyzed the results of several relevant clinical trials in these populations. The primary outcomes of these trials included overall survival (OS) and progression-free survival (PFS), partial and complete response rates, overall objective response, and health-related quality of life (QOL).

Based on the trials, the draft report stated that median OS was 16.6 months with olaparib for recurrent, BRCA-mutated cancer, compared with typical OS of 6 to 9 months with standard therapy. PFS was significantly longer in those taking olaparib for maintenance therapy compared with a placebo. There were no available data on niraparib for recurrent disease, but as maintenance therapy it produced significantly longer PFS compared with placebo. Finally, PFS for recurrent disease was around 10 months with rucaparib, while typical PFS with standard therapy is 6 months in similar patients.

QOL data with the 3 PARP inhibitors were either not found in the literature or indicated no difference from placebo. Safety data indicated that some common side effects of the drugs are nausea, vomiting, anemia, thrombocytopenia, and neutropenia.

Beyond the data on survival, which was often inconclusive, the ICER draft report aimed to summarize the other benefits of PARP inhibitors. For instance, they resulted in milder adverse events compared with chemotherapy and could be taken orally, which is more convenient as it eliminates the need to travel to infusion centers. However, PARP inhibitors are significantly more costly than other therapies, and could be taken for a longer duration than chemotherapy, further increasing healthcare costs.

The report calculated the cost-effectiveness of each drug and found that olaparib for recurrent, BRCA-mutated cancer would be the most cost-efficient use of a PARP inhibitor. Discounts would be required to meet value thresholds for maintenance therapy with olaparib, use of rucaparib for BRCA-mutated disease, and niraparib as maintenance therapy for BRCA-mutated disease. ICER’s revised Evidence Report, to be released in late August, will include value-based benchmark prices for the drugs.

Despite these cost calculations and the lack of long-term effectiveness data, the report highlighted the fact that ovarian cancer currently has high mortality rates and sparse treatment options. These factors make additional research into PARP inhibitors even more important, as “these agents offer a novel mechanism of action and add an additional tool for the treatment armamentarium.”

“The potential of PARP inhibitors to improve upon existing therapeutic paradigms, and the fact that they provide additional options to patients and their providers cannot be overlooked,” the report stated.