Comparative Value of PARP Inhibitors is Lacking, According to ICER Report
The Institute for Clinical and Economic Review, also known as ICER, is a non-profit organization that analyzes the value of new medical tests, treatments, and drugs approved by the U.S. Food and Drug Administration (FDA). The goal of ICER is to use the value of these innovations and develop reports for the purpose of driving improvements within the healthcare system. Throughout its work, ICER has played a crucial role in creating progress in both clinical practice and policy.
Most recently, ICER confirmed that comparative value of poly-ADP ribose polymerase (PARP) inhibitors to treat women with ovarian cancer is lacking. A part of ICER’s Final Evidence Report included a public meeting with the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). The Midwest CEPAC is a nationally-recognized community forum and core program of the ICER. The council reviewed ICER’s evidence report and looked over the value of PARP inhibitors in attacking cancer cells without causing damage to surrounding cells. They paid particular attention to the effectiveness of PARP inhibitors in women with BRCA1 or BRCA2 gene mutations treated for recurrent cancer, and also women receiving maintenance therapy for recurrent cancer after responding to platinum chemotherapy.
Comparing niraparib, olaparib, and rucaparib
To date, three PARP inhibitors have received approval from the FDA – niraparib (known as Zejula), olaparib (known as Lynparza), and rucaparib (known as Rubraca).
The council voted that niraparib had presented sufficient data of health benefits to patient populations. The drug’s approval is designed for maintenance therapy of women with non-BRCA mutated cancers of the ovaries, fallopian tubes, or primary peritoneal cancer, who showed partial or complete response to platinum chemotherapy. Olaparib had also presented sufficient data of health benefits to women taking it as a maintenance therapy. The drug’s approval is prescribed for women with BRCA-mutated advanced ovarian cancer, who have undergone 3 or more chemotherapy rounds.
Still, olapraib and rucaparib have yet to show health benefits in patients with recurrent disease. Rucaparib is indicated for women with BRCA-positive advanced ovarian cancer, who have undergone at least 2 chemotherapy rounds. The council took into consideration the additional benefits of PARP inhibitors, with feedback gathered from patient representatives who were present at the meeting. The benefits indicated were less caregiver burden, fewer treatment regime complications, and new drug action mechanisms.
ICER’s recommendations across the board
At this point, ICER created key policy recommendations, including the following:
- Prices must be reduced in order to increase affordability and broaden patient access
- Payers and manufacturers need to work as a team in order to create innovative payment methods for the purpose of increasing affordability for patients
- Additional research needs to be conducted in order to identify patients who would most likely benefit from maintenance therapy as well as surveillance
- Gaps must be bridged by researchers, patient groups, and manufacturers in the effectiveness of the presented evidence in order to offer both physicians and patients a better foundation for their clinical decisions and treatment plans;
- Manufacturers must expand their eligibility criterion for patient assistance programs and fixate on prices for PARP inhibitors based on dosage strength in order to counter the financial burdens of cancer patients
“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,” said Dan Ollendorf, ICER’s chief scientific officer. He went on to note that “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.”
Criticism against ICER
Still, a representative from Tesaro spoke out about ICER and their significant concerns – “We appreciate the efforts that ICER has made to seek and incorporate input from stakeholders,” she said. Moreover, she noted that PARP inhibitors are currently a new class of medications with limited treatment options. “The ICER preliminary report, based on assumptions that are not supported by sound evidence, should not be used to restrict access to this valuable new therapy for women living with ovarian cancer,” she concluded. A representative from AstraZeneca also chimed in to say that the organization continues to “have concerns with how ICER evaluates products from both a clinical and economic perspective.” She added that AZ “supports patient-centric value assessments that comprehensively measure available data, costs, and budget impact, taking into consideration personalized approaches to care delivery. However, we believe these tools need to be carefully constructed to ensure they do not restrict patient access to appropriate therapies and support continued innovation to address unmet medical needs.”
While ICER needed additional information in order to completely finalize their report, they decided to publish their initial findings due to the fact that PARP inhibitors are currently on the market and stakeholders require information in order to make appropriate drug-related decisions. Olldendorf said that as more evidence becomes available, ICER plans to update its report. After receiving a grant for $5 million dollars from the Laura and John Arnold Foundation to review U.S. drug pricing, ICER sparked frustration among players in the pharmaceutical industry due to their cost-effectiveness reports.
Most recently, ICER expressed that multiple MS drugs on the market are high-priced. They also noted that a few immuno-oncology and cholesterol drugs by Pharma, as well as osteoporosis drugs by Radius and Eli Lilly are too expensive. Yet, following the criticism that they received, ICER set up a meeting with a group of players from the pharmaceutical industry in order to receive feedback and change their assessment techniques if necessary. Following the meeting, ICER expanded its quality-adjusted life-year (QALY) measure to $50,000-$150,000 and commended to review and analyze drugs at their price, not taking into account refunds, amongst other necessary modifications.
Advancements in ovarian cancer care
In a 2017 interview with CURE regarding PARP inhibitors, Kathleen N. Moore, associate director of Gynecologic Oncology at the Stephenson Oklahoma Cancer Center, stated that they are bringing out significant advancements in the treatment of ovarian cancer. “There's just quite a wave of very exciting new agents coming behind these very effective PARP inhibitors, so clinical trials and clinical trial participation will continue to be really critical. Even though we've had some successes here, we just still have so many questions to answer. We're not curing people yet, we want to cure people, and so there's still a lot of questions to ask. Clinical trials are going to be important in answering these questions, and there's a lot of really exciting agents -- immune agents, DNA agents, targeted chemotherapy, other pathway targeted drugs -- which may have relevance in ovarian cancer. It's a hopeful time for patients to finally have some new, potentially better options with things on the way” she said.
References
https://icer-review.org/about/
https://icer-review.org/programs/midwest-cepac/
https://icer-review.org/announcements/ovarian-cancer-parp-final/
