The Institute for Clinical and Economic Review (ICER), an independent body that assesses the value of drugs newly approved by the U.S. Food and Drug Administration, confirmed that evidence is lacking for comparisons of outcomes using poly-ADP ribose polymerase (PARP) inhibitors to treat women with ovarian cancer.
At the same time, ICER recommended lowering prices to increase affordability and patient access.
Part of ICER’s Final Evidence Report summarized a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). The independent council voted on the evidence presented in ICER’s report.
Particular attention was paid to the effectiveness and value of PARP inhibitors in treating women receiving maintenance therapy for recurrent disease that had responded to a platinum-based chemotherapy, and women with a breast cancer (BRCA) gene mutation treated for recurrent disease.
The council voted that Tesaro’s Zejula (niraparib) has shown evidence of greater net health benefit in both populations of patients, and AstraZeneca’s Lynparza (olaparib) in women taking it as a maintenance therapy. But no consensus existed on the net benefit of Lynparza or Clovis Oncology‘s Rubraca (rucaparib) in patients with recurrent disease.
The council voted on important added benefits of PARP inhibitors. With input from patient representatives present at the meeting, the benefits cited were mainly less-complicated treatment regimens, less caregiver burden, and the new mechanism of action of the drugs.
ICER made policy recommendations, including the need to address gaps in evidence about effectiveness in order to give clinicians and patients a better basis for their treatment decisions. The need to lower the price and broader eligibility for patient assistance programs also were recommended by ICER.
“Our report and meeting highlighted the need for further research on the long-term efficacy and safety of PARP inhibitors. In particular, information on improvement in overall survival is not yet available, and the trials of each agent differ in study population, design, and measurement of key outcomes. Some key studies involved no comparison to alternative treatments. Further, the high costs of the drugs do not align with their benefit to patients,” Dan Ollendorf, PhD, ICER’s chief scientific officer, said in a press release.
Ollendorf continued: “Despite these shortcomings, PARP inhibitors are the first novel treatments available for ovarian cancer in many years, and do have the potential to improve upon existing treatment options for many patients. Stakeholders must collaborate to conduct additional research that provides more clarity on the appropriate clinical use of these drugs, and to ensure that the high costs do not lead to restricted access for patients with already limited options. Our hope is that the objective analyses provided in our report can serve as a starting point for critical conversations around future research, pricing, and access.”