A step towards improving patient access to transformative therapies

July 21, 2020
Before tuning into today’s must-watch hearing on COVID-19 vaccine development, we revisit the recent regulatory proposals by CMS that would help improve patient access to innovative medicines, and discuss how biotech innovations can help end environmental racism. Read…

Before tuning into today’s must-watch hearing on COVID-19 vaccine development, we revisit the recent regulatory proposals by CMS that would help improve patient access to innovative medicines, and discuss how biotech innovations can help end environmental racism. Read to the end for a look ahead at what’s happening on the Hill. Here are 830 words, about 4 minutes. 

P.S. The U.S. Chamber of Commerce is launching a webinar series about how companies are enlisting the latest scientific advancements and innovations to fight COVID-19. BIO President and CEO Dr. Michelle McMurry-Heath will join the launch today at 3:30 PM ET to discuss the unprecedented innovation happening across the industry. Click here to register.

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.


More Health Care News: 

Biopharma Dive: Pfizer and BioNTech coronavirus vaccine gets boost from German data
“Pfizer and BioNTech released data Monday from an early German-based study of its coronavirus vaccine BNT162b1 showing for the first time that it stimulated a virus-specific response from immune cells as well as antibodies.” 

STAT News: Studies provide glimpse at efficacy of COVID-19 vaccines from Oxford-AstraZeneca and CanSino
“A COVID-19 vaccine being developed by Oxford University and the drug giant AstraZeneca generated an immune response in a study of roughly 1,000 patients, according to interim results published Monday.”


Environmental racism is real. Biotech can help.

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.

BIO Beltway Report

President Trump’s Tuesday: According to the official schedule, he's signing a “memorandum”—but unclear what it’s about. He’s also bringing back the coronavirus briefings. Meanwhile, VP Pence is visiting hard-hit South Carolina to discuss COVID-19.

What’s Happening on Capitol Hill: The House and Senate are working on the National Defense Authorization Act for 2021, per POLITICO. Today’s the day of the House Energy and Commerce panel featuring five drug manufacturers discussing the outlook for a COVID-19 vaccine. We’ll have a recap tomorrow; in the meantime, check out this infographic on the vaccine development timeline. More hearings we’re watching this week below. 

On Deck This Week:

Tuesday, July 21, 2020 at 9:30 AM ET | Senate Committee on the Aging: The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities

Thursday, July 23, 2020 at 10:15 AM ET | House Education & Labor Early Childhood, Elementary, and Secondary Education Subcommittee: Underfunded & Unprepared: Examining How to Overcome Obstacles to Safely Reopen Public Schools

Thursday, July 23, 2020 at 10:30 AM ET | House Financial Services: The Heroes Act: Providing for a Strong Economic Recovery from COVID-19 

Thursday, July 23, 2020 at 2:00 PM ET | House Ways & Means Trade Subcommittee: Trade, Manufacturing, and Critical Supply Chains: Lessons from COVID-19

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