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On the President’s Drug Cost Plan, Three Important Concerns

Part 1. Restricting access under Medicare Part D 

The Trump administration is out with its plan to lower the cost of prescription drug for America’s patients. The plan rightly rejects the flawed schemes we hear regularly from pundits and the media – importation and direct government price negotiation in Medicare – that together would weaken the safety of our nation’s pharmaceutical supply chain, reduce patient access and do little to lower costs.

The plan contains some positive ideas, such as encouraging value-based pricing agreements, fixing the flaws in the 340B drug discount program, limiting pharmacy gag clauses, and passing rebates through to patients in Medicare Part D and capping their out-of-pocket costs. However, buried in the details are proposals that could harm the ability of patients to get the medicines they need both now and in the future.

Today, BIO is starting a blog series that will highlight three proposals in particular that could pose significant challenges to patients. As the first in a three-part series, this blog will look at proposals in the president’s drug pricing plan that would affect a popular prescription drug program for America’s seniors.

Restricting access under Medicare Part D. 

The Medicare Part D prescription drug program has been a remarkable success for both seniors and taxpayers.

  • The program cost $349 billion less over 10 years than initially expected;
  • Average premiums dropped 3% in 2018 to less than $34 per month; and
  • Hospital admissions for seniors have also dropped by 8%.

It’s no wonder then that nearly 90% of seniors are satisfied with the program.

Medicare Part D generally covers medicines that patients buy at a retail pharmacy and take themselves. The private health plans administering the Part D program are required to provide at least two drugs for each class of drugs that exists. Then there are six “protected classes” of drugs for patients facing particularly devastating diseases like cancer, HIV and mental illnesses. Health plans are required to cover “all or substantially all” medicines that fall within these protected classes.

Current policies help provide seniors and people with disabilities with choices, and more choices means more competition that can lead to lower costs. However, under the Trump administration’s proposal, health plans would only be required to provide one drug per class, down from the current requirement of at least two. The administration may also eliminate some of the protected classes altogether. These changes would leave doctors and patients with fewer options, forcing beneficiaries to pay more if the medicines their doctors prescribe aren’t covered.

Health plans would also be allowed to increase the use of so-called utilization tools – such as “step therapy” or “prior authorization.” These bureaucratic hurdles are already far too common, and while these “tools” may help insurers protect their bottom line, they also bury doctors in paper work and make it harder for patients to get the right medicines at the right time. 

The nation’s biopharmaceutical innovators support taking steps to strengthen the Medicare Part D program. That effort should focus on lowering seniors’ out-of-pocket costs and ensuring they have broad access to the medicines they need.

Stay tuned for the second part of this three-part blog series, which will look at proposed changes to the Medicare Part B program.

BIO 2018 Wednesday Keynote: I’ll have what she’s having

The famous line-”I’ll have what she’s having”-from the movie classic When Harry Met Sally is on every list of best movie quotes and is displayed above the table where the scene was shot in Katz’s Delicatessen in NYC. The famed director of this and countless other hit movies is the keynote speaker for Wednesday morning, June 6 during the BIO International Convention. Rob Reiner made history with his role as Michael Stivic, or Meathead as his character’s father-in-law called him, in “All in the Family”-a sitcom that broke ground tackling issues like race, rape and homosexuality.  His career grew to include directing, producing and even political activism.

In 2015 Reiner directed his most personal film, Being Charlie, which was written by his son Nick who suffers from drug addiction. The fictional piece follows the struggles of a troubled teenager who runs away from a rehab facility and must face the consequences.

BIO’s President and CEO, Jim Greenwood, who will interview Reiner at the Wednesday, June 6 keynote from 9 – 10:30 AM ET, had this to say about the acclaimed director: “Rob is a passionate advocate for those living with substance abuse disorders and addiction. His poignant story of helping his son overcome his battle with drug addiction will inspire attendees and our industry in its quest to discover next generation, non-addictive pain therapies. I look forward to our discussion.”

Registration is open for this year’s event, which promises to be the most comprehensive biotech convention in the world. In addition to the 19 educational tracks covering all sectors of biotechnology, including genome editing, opioids, digital health and more, BIO 2018 will feature the most influential global leaders in this year’s lineup of Super Sessions. Recent speakers announced include:

  • Johnson & Johnson Innovation – Marianne De Backer
  • Genentech – Dr. Thomas Zioncheck
  • Takeda – Rejeev Venkayya
  • Biogen – John Pieracci
  • Pfizer – Bob Smith
  • FUJIFILM Diosynth Biotechnologies – Steve Bagshaw
  • Bristol-Myers Squibb – Dr. Thomas J. Lynch, Jr.
  • Sanofi Genzyme – Bill Sibold
  • Harvard Medical School – Scott D. Solomon
  • Flatiron Health – Marta Bralic
  • Verily – Dr. Luba Greenwood
  • Tufts University School of Medicine – Kenneth Kaitlin
  • NOVOVAX – Stanley Erck
  • Seqirus – Gordon Naylor

Other notable programing includes:

  • BIO One-on-One Partnering™ – Expected to top last year’s more than 41,000 individual meetings held over the course of four days.
  • Engaging exhibits such as the Patient Advocacy Pavilion, Emerging Innovators Zone, Digital Health Zone, and Start-Up Stadium – a “Shark Tank”-like program where startups present to leading subject-matter experts in the industry.

This year the Convention will be making an official Guinness World Records® attempt for the “Largest Business Partnering Event.” The industry-leading BIO One-on-one Partnering™ will facilitate nearly 1,300 partnering meetings per hour during the event with the grand total expected to approach over 44,000 business-to-business meetings over the course of four days.

Looking forward to more updates on the Convention? Keep following the posts here on the blog and sign up for news updates.

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2017 Rosalind Franklin Award Recipient: CRISPR has the potential to address important challenges

As we’ve covered here before, gene editing holds tremendous promise in advancing modern agriculture. And it’s not hard to see why. With gene editing tools like CRISPR, researchers have the capability to engineer plants to be, amongst other things, better for the environment, more nutritious and disease-resistant.

BIO’s 2017 Rosalind Franklin Award for Leadership in Biotechnology recipient Vonnie Estes is an agtech innovation consultant who is tuned into the current conversations happening at farms and agricultural businesses across America. And a lot of those conversations revolve around the new gene editing technology.

In a blog for Ag Funder News, Estes entertains the question: Should You Be Using CRISPR for Your Ag Business? In addressing this question, Estes starts by outlining the “number of challenges” that must be addressed before CRISPR becomes widely adopted, including the regulatory landscape:

One of the biggest restrictions to the global commercial use of gene editing is uncertainty around regulation. The USDA just ruled it would not regulate plants that could otherwise have been developed through traditional breeding techniques, as long as they are not developed using plant pests. This is a good start, however, there are a limited number of improvements that can be made within these criteria. If Agrobacterium is used as a delivery method or a greater number of genes are edited – which will be needed for complex traits – it will be considered GMO and more highly regulated. Most crop genetics and food production companies operate globally: shipping seeds, plant materials, or final foods worldwide. The EU has not yet ruled if gene edited crops fall under the genetically modified organism rule, although there is some indication that may change. Until this is clear, many crop genetics companies will not risk the potential trade barriers of using gene editing technology.

Vonnie Estes, Agtech Innovation Consultant

Estes then goes on to note that because of the contentious debate around GMOs and the public’s confusion around the difference in the science behind the two technologies, gene editing will be susceptible to similar pushback. However, Estes believes the younger generation of consumers will be receptive, especially if the benefits are clearly defined and explained:

Consumers are more likely to accept the technology if they get a direct benefit, such as better taste or higher nutritional value. Food producers are right to be cautious, but I’m hoping the younger, tech-savvy, more demanding food consumers will be accepting of gene editing technology.

Nevertheless, the potential for the technology to solve some of the world’s food challenges is encouraging and the science community is enthusiastic:

As the world’s population rapidly approaches eight billion, modern food production methods will need a radical transformation. Gene editing can certainly help meet that challenge of production, along with making food more flavorful and nutritious. The path to widespread usage is currently complicated – from the science to consumer acceptance. But with the tremendous enthusiasm of the research community, gene editing technologies will improve rapidly along with the all of the techniques and technologies needed to support crop use.

Read Vonnie Estes full piece at AgFunderNews.com.

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2018 World Congress: Start Planning with BIO’s Partnering Webinar

It’s hard to believe but the 2018 World Congress on Industrial Biotechnology in Philadelphia is only two months away! With the tri-state region of Delaware, New Jersey and Pennsylvania ranking as one of the top markets for biotechnology and home to many startups, this year’s World Congress is perfect for those looking to establish lasting partnerships in the industrial biotechnology industry.

The BIO One-on-One Partnering™ system takes the stress out of coordinating and scheduling meetings at the World Congress, so you can focus on your partnering strategy. Through BIO’s One-on-One Partnering, attendees can request meetings, message potential partners pre- and post-World Congress and create company profiles to showcase your company’s mission or latest breakthrough.

In case you missed it, BIO has put together a One-on-One Partnering Webinar to get you up to speed on how the system works. In the webinar, BIO’s Director of Partnering Products & Services Willie Reaves, along with BIO’s Director of Industrial and Environmental Policy Stephanie Batchelor, present a comprehensive overview of everything that can be accomplished in the platform.

From accessing attendee lists to reviewing programming and plenary details to strategies for getting the most out of your meetings, the Partnering Webinar covers everything you need to know to master BIO’s One-on-One Partnering system. Here’s a sneak preview of what is covered in the webinar:

  • What’s new at the 2018 BIO World Congress on Industrial Biotechnology
  • Comprehensive overview of World Congress programming, including plenaries, education tracks and more
  • Tips and Tricks for getting the most out of your partnering meetings
  • Tutorial of the BIO One-on-One Partnering system
  • Q&A with Webinar Presenters

In 2017, the BIO World Congress hosted 2,130 partnering meetings in just 3 days – a 9% increase from the number of meetings held in 2016. And with a 123% increase in partnering meetings since the 2014 World Congress, we expect 2018 to be even bigger. Don’t miss out on making lasting partnerships at the 2018 World Congress and be sure to view the Partnering Webinar.

If you haven’t done so yet, register to attend the 2018 World Congress.

And for those that have already registered to attend the World Congress in July and received their login information, BIO’s One-on-One Partnering is now open. Start building out your company’s profile and use BIO’s tips and tricks to get a head start, so you can begin partnering day one in Philadelphia!