Policy Changes, Price Negotiations Challenge Oncology Innovation: Ryan Haumschild, PharmD, MS, MBA, CPEL

New policies are challenging oncology innovation and shifting clinical trial focus toward rare diseases that are exempt from these laws, according to Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of ambulatory pharmacy at Emory University and Winship Cancer Institute.

He moderated a panel discussion on the evolving oncology innovation landscape today at the Patient-Centered Oncology Care® (PCOC) conference in Nashville, Tennessee, titled "Innovations in Industry: Looking at the Next Decade."

This transcript has been lightly edited; captions were auto-generated.

Transcript

Which new policies pose the biggest challenges for innovation, and how are stakeholders navigating them?

There's a lot of new policies coming, from the Inflation Reduction Act to manufacturer-negotiated pricing to the Most Favored Nation, even to changes in the Enhancing Oncology Model network. I think it's really important right now to stay tuned in.

They're impacting us in terms of the way we think about value, the way we think about pricing, and, lastly, the way we think about access. Now, if you're seeing prices that are being negotiated or changes in out-of-pocket expenses, you've got to make sure, number 1, that you're able to stay competitive but still bring on innovative products and not let any negotiation or the Inflation Reduction Act hinder that innovation.

At the same time, how do you leverage some of the Inflation Reduction Act, where it's reducing or capping patient out-of-pocket expenses, to make sure that they're staying on their therapies and getting access?

How are policy and funding changes affecting access to clinical trials? What impact might this have on the quality and size of the oncology pipeline in the coming years?

Clinical trials are so essential to everything we do. I always recommend, if there's not a good standard-of-care therapy, how do we get that patient in a clinical trial, number 1, to provide more research for the future, but also provide them a great outcome? As we look at these changes in clinical trials, we think about price-negotiated medications, and, obviously, it's the bottom line of somebody, whether it be a pharmaceutical company, etc.

We're seeing more of a pivot towards more of the rare diseases that are exempt from some of these recent policy changes. I think, in a way, you will see a little bit of a shift in funding. Hopefully clinical trials continue, but I think we're going to see more clinical trial study around more of those rare orphan diseases, which is great for patients who have high unmet need, but it also gives pharma a good chance to invest in areas that might be a little more protected from some of the price negotiations.

With much of today's oncology innovation focused on precision medicine, do you think the policy infrastructure is keeping pace with where the science is heading? What new payer solutions may be needed?

The science is moving quick, which is a good thing. It's good for our patients, it's good for precision medicine, and, nowadays, we have blood-based biomarkers coming out for everything. But oncology has been one of the really key therapeutic areas that's led the way. I think payers are expanding but probably need to expand faster.

We need to cover more of the broad panels, not just for clinical trial purposes now, but for standard of care. How do we make sure that we're having appropriate policy coverage on not just initial, first-line therapy, but subsequent, as well? As we know, some of these biomarkers, genetic mutations, or genetic drivers are changing via exposure to treatment, or even subsequent lines of progression.

I think that we've got work to do. I think payers are kind of getting more in tune with this, because they want to provide the best coverage possible. I think if we do that, and we give patients the best therapies, we can prolong their efficacy and reduce the total cost of care.