Payers want ever more evidence to support drug pricing and to help determine access levels for members. Biopharmas want to be in front of the curve when developing the value proposition for their products. Slowly, the two are moving toward the middle.
Last year, Novartis and regulatory officials in the United Kingdom hatched an unusual collaboration.
Preparing to launch a late-stage clinical trial for an experimental psoriasis medication, the company approached the National Institute for Health and Clinical Excellence (NICE) with an interesting idea: How could it design the study to gather the data NICE needed to evaluate the cost-effectiveness of the drug?
“We had proof-of-concept data,” says Joseph Jimenez, chief of pharmaceuticals at the Swiss pharma giant, “but we had not yet designed the phase 3 trial. So we asked, ‘What evidence would you need to see when we come with the full clinical package of results to be able to recommend that this be reimbursed on the U.K. market at a particular price, based on the risk/benefit profile?’
“They looked at the benefit of the drug, what it could do for patients, and costs that could be avoided downstream, and NICE was able to come back to us with very valuable and clear information on what they would need to see. And that enabled us to design the phase 3 [trial] in a way that could answer some of those questions.”
Jimenez isn’t about to let all the details out of the bag for the competition to see, but he’s clear that in a world in which third-party payers are taking a hard look at the therapies they’re paying for, the earlier you start making your case for cost-effectiveness, the better chance you’ll have of getting approval for reimbursement.
That view does not stop at the borders of the United Kingdom.
Australia and other countries have signaled their interest in the test pilot study. It also could play a role in the United States, says Jimenez, where there are a variety of public and private payers to court.
And this is one trend, adds Jimenez, that can only swell in significance with time.
“I do believe that this will spread and will benefit pharmaceutical companies, payers, and reimbursement agencies, providing more of a complete package of cost/benefit analyses,” he says.
“The reality is that we do ration healthcare,” says senior analyst Murray Aiken, of IMS Health. “We just don't do it in a very transparent way.”