With three PARP inhibitors battling it out in ovarian cancer, competition is heating up between AstraZeneca, which reached the market first, and smaller players Tesaro and Clovis Oncology as new approvals and new indications upend the field. But U.S. cost watchdog ICER has drawn some conclusions about the class—mostly that they're too expensive.
In a new draft evidence report (PDF), the Institute for Clinical and Economic Review found that AstraZeneca’s Lynparza meets common cost-effectiveness thresholds to treat recurrent BRCA-mutated ovarian cancer, but that the medication would need discounts of 50% to 80% to be cost-effective as a maintenance therapy.
The FDA granted a priority review in March for that indication, which would expand Lynparza's market considerably, with an action date set for the third quarter. Patients on maintenance therapy—used after a patient responds to initial treatment—stay on their treatments for longer periods of time.
Boston-based ICER says Tesaro's Zejula, already approved as a maintenance therapy, would have to be discounted 60% to 90% to achieve common cost-effectiveness thresholds in ovarian cancer patients with a germline BRCA mutation, "while there is no price that would achieve the thresholds in women without the mutation." Zejula won FDA approval for all patients regardless of mutation.
And for Clovis’ Rubraca in BRCA-mutated ovarian cancer? ICER says that med would have to be discounted 50% to 75% to achieve common cost-effectiveness thresholds. The group noted that Rubraca “provides substantial clinical benefit” at a high cost. All of the findings are open to public comment until Aug. 9.
ICER’s model incorporates total payer costs, progression-free survival time, life years, quality-adjusted life years, incremental cost-effectiveness ratios and other factors, according to the report. Since the group started reviewing cost-effectiveness back in 2015, it’s frequently earned the ire of the drug industry, which has claimed the calculations are biased.
Lynparza's wholesale acquisition cost is $13,679 per month, according to ICER, while Zejula costs $14,965 per month before discounts. The cost watchdog says Rubraca is priced at $13,940 per month before discounts. The FDA granted Lynparza approval back in 2014, while Rubraca won U.S. approval in December and Zejula won approval in March.
A spokesperson for Tesaro said “we appreciate the efforts that ICER has made to seek and incorporate input from stakeholders,” but added the company has “significant concerns” with the draft report.
“PARP inhibitors are a new, paradigm-shifting class of medicines for a disease with limited treatment options,” she said in a statement. “ … 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.”
AstraZeneca's spokesperson said the company continues to "have concerns with how ICER evaluates products from both a clinical and economic perspective."
She said 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."
Rubraca is "priced appropriately," according to a Clovis representative. She added that the ICER report "does not fully account for the investment made in Rubraca or other, approved PARP inhibitors, nor the true cost benefits of these precision-medicine therapies and their potential, long-term value to women with ovarian cancer, their families and physicians."
Speaking with FiercePharma, ICER chief scientific officer Dan Ollendorf said his group has always been “open and transparent about the assumptions that we are making.
“We invite comment and concerns about those assumptions,” he said. “Those are out there for anyone to make comment on and to understand.”
While ICER received the request to delay the report so it could include more data, the group decided to go ahead and publish its draft findings because the PARP drugs are on the market and stakeholders need to make decisions on the meds, Ollendorf said. As more data become available, ICER plans to “update the report accordingly."
Since winning a $5 million grant from the Laura and John Arnold Foundation to look into U.S. drug pricing, ICER has sparked anger from drug industry players on a number of occasions for its cost-effectiveness reviews. The group recently said osteoporosis meds from Radius and Eli Lilly are far too expensive. Before that, it concluded most multiple sclerosis drugs on the market are overpriced. It’s also hit at pharma’s pricing for PCSK9 cholesterol meds, immuno-oncology therapies and other drug classes. Pharma has hit back by blasting the nonprofit's review methods.
In response to the criticism, ICER last year convened a discussion with a broad group of players to change its assessment methods. Afterward, the group broadened its quality-adjusted life year threshold to $50,000 to $150,000 and committed to reviewing drugs at their price minus rebates, among other changes.
Editor's note: This story has been updated with comments from ICER chief scientific officer Dan Ollendorf.