England’s cost-effectiveness watchdogs are a tough audience, and they've often angered cancer drugmakers when meds were turned away. Recently, however, a steady stream of oncology meds have made it through the gates at England's National Institute for Health and Care Excellence. What's changed?
Pricing, for one.
Merck & Co.’s blockbuster-to-be Keytruda passed NICE’s examination recently after the company presented a “fairly priced” proposal, according to NICE Center for Health Technology Evaluation Director Carole Longson. That followed a recommendation for Roche’s Perjeta in early-stage breast cancer. Both drugs had been previously rejected and won partly on new pricing.
All told, as part of an overhaul of the troubled Cancer Drugs Fund, a second go-round at NICE has so far yielded routine coverage recommendations for more than 75% of drugs formerly covered only on the CDF. And a majority of those meds won a recommendation after their makers offered a revised or improved "access scheme," the term NICE uses for a pricing offer, an agency spokesperson said.
“Where there was a revised patient access scheme, the committee could recommend them as cost effective whereas previously, they could not,” a NICE representative said in an email. “In those cases, ... the company offered a better discount to bring the (incremental cost-effectiveness ratios) within the cost-effectiveness range.”
As those drugs come off CDF coverage and into the routine NHS program, “funding in the CDF can be freed up and used for newer, innovative cancer treatments,” executive director Andrew Dillon said in a statement. “This is good news all round for patients.” In part, "sensible pricing" has helped drugmakers secure the recommendations, Dillon said, along with better data in some instances.
Roche, which has called for reform at NICE, says it’s “encouraged by the positive progress” at the agency, especially in breast cancer. “We hope this momentum continues so that patients can access and benefit from innovative treatments now and in the future,” the company said via email.
Karl Claxton, senior research fellow at the Centre for Health Economics at University of York, said in an interview that drugmakers have a “very strong incentive” to offer discounts for CDF drugs that are going back to NICE for reappraisal.
That’s because companies can either win coverage on a lower price or be turned away altogether. “Manufacturers are willing to offer discounts and negotiate on price if there’s an effective prospect of them being rejected and not getting market access,” he said.
That’s different from an initial review with NICE. At that point, drug companies “have got a choice,” Claxton said. “They can try and offer discounts to get immediate, routine NHS funding, or they can maintain high prices and the level of uncertainty and hope for funding through the CDF.”
New therapies can be placed on the CDF while their manufacturers set out to collect real-world data to justify long-term cost-effectiveness. But if a drug gets CDF funding, Claxton said authorities might not have the “political will” to stop coverage after two years, regardless of real-world findings.
That’s one potential issue with the new CDF that gives manufacturers a “route into continued sales for medicines with prices that are too high,” Claxton said.
Nowadays, many companies know what they have to do to win coverage in the U.K. and realize they have to “go through it,” King’s College London Institute of Cancer Policy director Richard Sullivan recently told The BMJ. That includes pricing meds “where they know [they] will meet NICE’s threshold.”
Despite the series of recent recommendations for drugs following a reappraisal, though, many haven't had similar luck at the initial assessment stage. For one, Bristol’s Opdivo was turned away in lung cancer back in October. NICE did recommend that the company seek coverage through CDF for its immuno-oncology star. That med earlier this year won coverage as part of a combo in melanoma.
Following that route, AstraZeneca’s Tagrisso in early October became the first therapy to be placed in the revamped CDF, making it available for 300 non-small cell lung cancer patients in England and Wales. Tagrisso was rejected in May on long-term efficacy concerns and AstraZeneca has said it’ll continue to seek wider coverage.