A step towards improving patient access to transformative therapies

Yesterday, BIO provided feedback on a number of recent regulatory proposals by the Centers for Medicare and Medicaid Services (CMS), some of which would help improve patient access to new transformative therapies. 

As background, Medicaid Best Price (MBP) provisions and Average Manufacturer Price (AMP) reporting requirements have long had the unintended consequence of inhibiting the adoption of value-based purchasing agreements (VBPs), such as pay-over-time or pay-for-performance.

But last month, CMS released a proposed rule meant to help facilitate negotiation for payment of new and innovative therapies based on patient outcomes by commercial health plans and states—an important first step towards improving patient access. 

The proposed rules would modify current rules that require manufacturers to report a single price by allowing them to report multiple “best prices” for a therapy under the Medicaid Drug Rebate Program, if the prices are tied to a VBP arrangement, among other things. 

BIO supports the provisions that would advance VBPs, which we said in our comments are an important first step towards the adoption of voluntary VBPs.

But we’re strongly opposed to the rule's proposals for line extensions and copay accumulators, which would negatively affect patient access to biotech’s cures, as we explain in detail. 

Dan’s Deep Dive: BIO welcomes these regulatory proposals for value-based purchasing arrangements as an important first step towards policies to pay for value rather than volume when it comes to medicines. However, additional clarity and work is needed to advance policies that bring value to patients. We look forward to working with CMS, the states, and our members to improve patient access to innovative medicines. – Dan Durham, BIO’s EVP for Health Policy  

Read our comments.

Want to know more? Read BIO’s principles on the value of pharmaceuticals, the first-ever industry-endorsed set of commitments to support comprehensive and sustainable solutions related to access to and affordability of innovative therapies.

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Studies show that race is the most important factor in determining whether or not someone lives in a more polluted environment, writes BIO’s Cornelia Poku in a new blog post. The good news is biotech offers many solutions to help end some of these inequities.

Race is the most important factor in determining the likelihood of someone living in a more polluted environment—even more than socioeconomic status, according to a 2018 Environmental Protection Agency (EPA) study. 

This manifests in many ways—from more plastic ending up in the streets and the water supplies of Black and Brown communities, to the disproportionately detrimental impact of air pollution and heat waves on pregnant Black women compared to pregnant white women.

But very little has been done about it. “Lack of access to clean water, good air quality, and even fresh foods, are all forms of environmental racism—the outgrowth of Jim Crow laws, segregation, and redlining confining generations of Black and Brown people to certain communities and then acting slowly or outright refusing to serve those communities,” Cornelia writes. 

Biotech solutions can help—from creating biobased plastics that dissolve completely after disposal, to replacing polluting fossil fuels with clean, renewable fuels made from reusable waste products like cooking oil, animal fat, municipal solid waste, or corn waste, as just two examples.

The bottom line: “Biotechnology can’t solve everything, but its benefits to air quality, water quality, soil health, and food availability are vast and proven. Innovation can be a great equalizer in our efforts to counter social injustice,” she concludes.

Read the whole thing.