Advancing biofuels and patient access to transformative therapies

June 18, 2020
Today, we have news from Washington on legislation that would support biofuels as well as a proposed rule that would help patients access transformative new therapies. All the details, in around 900 words, 4 and a half minutes. BTW, on June 22, the Duke-Margolis…

Today, we have news from Washington on legislation that would support biofuels as well as a proposed rule that would help patients access transformative new therapies. All the details, in around 900 words, 4 and a half minutes.

BTW, on June 22, the Duke-Margolis Center for Health Policy will hold a webinar on manufacturing capacity for COVID-19 therapeutics, featuring results from BIO’s recent survey with Boston Consulting Group on current manufacturing needs and capacity. Click here to register.

A step towards advancing biofuel innovation

Yesterday, Sen. John Thune (R-SD) introduced legislation that would advance biofuel innovation at a time when America’s air quality and rural communities need it the most. Here’s our take. 

The legislation (S.3986) would approve certain advanced biofuel registrations, which have “languished before the Environmental Protection Agency (EPA) despite the fuels being successfully used in at least one state,” says Sen. Thune’s press release.

If passed, the EPA would need to 1. make a decision within 90 days on any registration application pending for at least 180 days AND 2. take action on completed pathway petitions pending for at least 180 days. 

FYI, pathways are “feedstock methods” for producing certain renewable fuels—like corn kernel fiber, grain sorghum, or renewable biogas, as a few examples. 

So, what would be the impact? Here's an example. Corn kernel fiber was approved as a pathway in 2014—but since then, EPA has not taken action on numerous registration applications, “despite applicants meeting stringent peer review requirements and being approved for sale in at least one state,” as Sen. Thune explains. Basically, the legislation would require EPA to get moving.

What they’re saying: “The [Renewable Fuel Standard] intends for fuel technology to progress, not for prolonged EPA inaction to stifle it. At a time when the farm economy continues to face headwinds and uncertainty, my bill would improve the bottom line of numerous biofuel operators without direct federal assistance, adding value to the corn crop and increasing margins until fuel demand is restored,” said Sen. Thune

Why it matters: We have to do something about air pollution, climate change, and the economy. Biofuels can help solve all three problems at once. It’s that simple. 

Stephanie’s Sage Words: EPA’s continued delays in approving biofuel pathways and facility registrations have led to an erosion of the RFS as Congress intended. Developing and producing these fuels and attracting investment to sustainable fuel projects has been curtailed as a result of EPA’s actions. This hampers the growth of rural America and stymies the development of the bioeconomy. BIO applauds Senators Thune and Shaheen for introducing legislation to provide sustainable fuel producers certainty. Bringing these innovative technologies online will be critical to creating a resilient, healthier energy sector in a post-COVID economic recovery. – Stephanie Batchelor, VP of BIO’s Industrial and Environmental Section


More Agriculture and Environment News:

The New York Times: Emissions are surging back as countries and states reopen
“After a drastic decline this spring, global greenhouse gas emissions are now rebounding sharply, scientists reported, as countries relax their coronavirus lockdowns and traffic surges back onto roads.”


A step towards patient access to transformative therapies

BIO’s Health Policy team gave us the scoop on a new proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would empower commercial health plans and states to negotiate payment for innovative new therapies based on patient outcomes. The takeaway? This is an important step towards improving patient access to biotech’s cures. Details below.

For many years, Medicaid Best Price (MBP) provisions and Average Manufacturer Price (AMP) reporting requirements have had the unintended consequence of inhibiting the adoption of value-based payments (VBPs), such as pay-over-time or pay-for-performance arrangements.

Now, CMS has proposed rules that would allow manufacturers to report multiple “best prices” for a therapy under the Medicaid Drug Rebate Program, if the prices are tied to a VBP arrangement.

Also, the proposal would clarify that VBP arrangements can be defined as “performance requirements” under the definition of “bundled sale.” This will facilitate VBP arrangements, especially for small population drugs. 

Furthermore, CMS would permit revisions to AMP and MBP reporting beyond the current 36-month limit to allow revisions to pricing metrics as a result of settling VBP arrangements. The proposed rule also contains provisions aimed at curbing fraud and abuse related to opioids and Medicaid third-party liability, among other issues. 

Dan’s Deep Dive: Value-based arrangements, where payments are tied to the value the therapy provides to patients and the health care system, help improve access for patients who rely on innovative treatments and transformative therapies. BIO supports this effort and looks forward to working with CMS and other stakeholders to modernize our health care system and support innovative payment models that reward the value a medicine provides rather than the volume that’s prescribed. This is one important step, but more action is needed to truly realize the promise of value-based pricing for prescription medicines. Policymakers should remove all current legal and regulatory hurdles to value-based agreements to better ensure patients have access to the life-saving treatments and cures they need. – Dan Durham, BIO’s EVP for Health Policy 

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: 'Warp Speed' plan for coronavirus vaccines comes into focus
“Drugmakers selected for ‘Operation Warp Speed,’ the White House's ambitious plan to develop a coronavirus vaccine in record time, will enjoy priority access to manufacturing capacity secured by the U.S. government, as well as to needed supplies like glass vials.”

STAT News: A majority of Americans fear pharma will use COVID-19 as an excuse to raise prices
The Gallup/West Health poll finds 55% are “very concerned” about price hikes, while 33% are “somewhat concerned.”

BIO Beltway Report

President Trump’s Thursday: Holding a roundtable with governors on reopening small businesses.

What’s Happening on Capitol Hill: Today, we’re watching the House Ways and Means Select Revenue Measures Subcommittee hearing on tax relief for workers and families during the COVID-19 pandemic.

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