The Senate votes down the “Skinny Repeal” of the ACA. Learn more.

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July 28, 2017

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FEATURED STORY
 

Thumbs Down: Three Strikes and ACA Repeal Is Out

 
 

Late last night, with the third repeal vote in 3 days, Affordable Care Act (ACA) repeal/replace efforts likely ended in the Senate with a thumbs down (literally) “no” vote from Senator John McCain (R-AR).

Strike One: On Tuesday, the Senate voted to open debate on the Better Care Reconciliation Act (BCRA), by a 51-50 margin, with Vice President Mike Pence breaking the tie. This vote turned out to be a hollow victory, as the bill ultimately failed to pass with a vote of 43-57. The BCRA was a repeal-and-replace bill; it included rolling back Medicaid expansion, cuts to Medicaid, getting rid of the individual mandate and state waivers for health insurance marketplaces, and cutting individual subsidies.  

Strike Two: On Wednesday, Senators voted 45-55 against the Obamacare Repeal Reconciliation Act (ORRA), a “clean repeal” bill that would have repealed much of the ACA without offering a replacement. Seven Republicans voted against the measure. In 2015, however, all Republicans currently in office besides Senator Susan Collins (R-ME) supported the earlier version.

Strike Three: With a last gasp, the Senate released the Health Care Freedom Act (HCFA) late Thursday night. The HCFA would have eliminated the individual and employer mandates, repealed the medical device tax for 3 years, and defunded Planned Parenthood for 1 year.

The Congressional Budget Office (CBO) estimated that 15 million people would lose coverage in the next year. This was a bill that no one really liked, but Senate leaders were trying to secure votes by positioning it as a placeholder to conference with the House, where the “real” ACA repeal/replace would take shape. With moments of drama, the Thursday evening/Friday morning debate was primetime viewing for political dorks. But ultimately, reassurances from House Speaker Paul Ryan (R-WI) that there would be debate and transparency fell short for McCain, and the HCFA failed to pass with a vote of 51-49.

While everyone is still sleeping off the effects of last night, it looks like ACA repeal debate is out and the GOP will move on to other looming issues such as the budget and tax reform.

 
LEGISLATIVE UPDATES
 

Dems Hope Americans Are Ready for “A Better Deal”

 
 

While President Trump and the GOP are trying to “Make America Great Again,” the Democratic Party is struggling to gain traction, losing all of their run-off Congressional elections since November 8th.  

On Monday, Democratic leaders rolled out “A Better Deal,” a re-branding of their image in an effort to appeal to American voters who they believe may not understand what their party truly embodies. This move comes in anticipation for an upcoming 2018 Congressional cycle that is expected to be tumultuous and heated.

The core tenets of the Better Deal are lowering prescription drug prices, increasing the minimum wage to $15 per hour, better consumer protection, and additional job training. Most, if not all, of these policies have been part of the Democrat playbook for decades, including the failed campaign of Hillary Clinton in 2016.

With respect to “unconscionable” price increases of prescription drugs, the Democrats would create a new agency dedicated to “stopping this outrageous behavior in its tracks”; the agency would be headed by a “price gouging enforcer.” The Price Gouging Czar [Editor’s note: best job title ever] would also have the authority to fine pharmaceutical companies for gouging, with the funds collected to be directed to drug research.

Additionally, manufacturers would be required to report to the Department of Health and Human Services (HHS) justifications for drugs having “significant” price increases. This information would be made public.

Another part of the ‘Better Deal’ is a proposal to give the federal government authority to negotiate with manufacturers over the cost of prescription drugs covered under Medicare Part D. This policy has long been advocated by Democrats but has been cautioned against by the CBO and Centers for Medicare & Medicaid Services (CMS) actuaries as being unable to match the savings potential of Part D plans.

Shortly after the announcement of “A Better Deal,” the Biotechnology Innovation Organization (BIO) denounced the proposal, saying it ignored other large components of healthcare costs such as inpatient care and provider services. The organization stated that the proposals ignore the power of the free market to use innovation to reduce cost and would have a “chilling effect” on investment in new therapies.

It is hard to gauge what impact “A Better Deal” will have at the moment; however, it will be important to watch how the message resonates over the coming months and into 2018.

 

C’mon Try It, It’s Terrible: Senators Push for Temporary Importation

 
 

In a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb, Senators Amy Klobuchar (D-MN) and Mike Lee (R-UT), urged the FDA to consider temporary importation to lower prices on prescription drugs that face little or no competition.

Under the Short on Competition Act, the FDA could allow a company to sell a drug that faces little or no competition in the United States (US) if (1) the company already had approval to sell it in another country with similar safety requirements and (2) the product had been on the market in that country for at least 10 years. As a result, a company could market its product in the US while seeking FDA approval, which may alter how manufacturers implement price increases for these drugs.

In the letter, the Senators ask the FDA to communicate with them about its perceived authority, or lack thereof:

“We continue to press for our legislation to clarify the FDA’s authority to use temporary importation in noncompetitive markets. But, we urge the FDA to use its existing temporary importation authority to combat regulatory abuses that increase drug prices. If you determine that the FDA’s authority is insufficient or unclear, we ask you to inform us of what additional authority is needed.”

The importation of drugs has met stiff resistance from those steeped in understanding the consequences of such actions, despite the allure of potentially obtaining high-priced drugs less expensively from abroad. Earlier this year, the 4 most recent FDA commissioners (2 from the Bush Administration and 2 from the Obama Administration) warned Congress that American patients will suffer if they import drugs from other countries, citing fake, substandard, and contaminated drugs as potential consequences.

The same arguments against importation hold true for this bill, as “temporary” importation does not diminish or remove the risks and concerns held by experts—nor does it make it any safer than “permanent” importation.

 

Get the Latest From HTA Quarterly

 
 

Revisiting the Familiar: Time to Re-evaluate the GVD?

While nearly all international market access stakeholders are familiar with the global value dossier (GVD), with ever-increasing demands by health technology assessment (HTA) agencies, it is becoming more difficult to create an impactful, descriptive, and useful document that supports local product submissions. We review the current state of the GVD, the challenges associated with developing an effective GVD, and key actions that can be undertaken to optimize the utility of the GVD.

 

  

 
REGULATORY UPDATES
 

PCMA to Price: Look Away, We’re Awesome

 
 

Recently, the Pharmaceutical Care Management Association (PCMA) sent a letter to HHS Secretary Tom Price containing market-based solutions to improve quality and to reduce prescription drug costs. The letter was in follow-up to their May 16 meeting, as the association wanted to clarify the role its constituent pharmacy benefit managers (PBMs) serve in the healthcare system.

“In order to understand which policy solutions will reduce prescription drug costs, policymakers must first understand how drug pricing works and how PBMs help reduce costs for payers and patients,” PCMA President and CEO Mark Merritt said.

PCMA had the following recommendations to “strengthen private sector tools, encourage competition, and, in doing so, reduce drug costs for patients, employers and taxpayers”:

The letter also extols the benefits of PBMs to help reduce drug costs for payers and cost-share for patients, highlighting that PBMs reduce costs by 30%.
    
PBMs have come under criticism recently for not being particularly transparent about how they apportion rebates from pharma between payers and themselves and also for how they charge patients a full copayment when the prescription cost is less. With the Trump Administration making waves with its stated intent to reduce drugs costs, each stakeholder is trying to demonstrate the benefits it provides to the system.

 
 

A Rolling Stone Gathers No Moss: ICER Plots out 2018 Plans

 
 

On July 26, the Institute for Clinical and Economic Review (ICER) announced their preliminary list of potential topics being considered for review in 2018 “as part of [their] continued effort to provide evidence-based calculations on the prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes.”

Highlights from this announcement include treatments for migraines, hemophilia, and cystic fibrosis, and are included in ICER’s list of potential topics that the organization also anticipates the FDA to be reviewing for marketing approval within the next calendar year.

ICER noted (not coincidentally) that it plans to time the release of its analyses with the expected time of the FDA’s review.

Final determination of therapies for review will be made after ICER assigns topics to one of ICER’s 3 public programs: California Technology Assessment Forum (CTAF), New England Comparative Effectiveness Public Advisory Council (New England CEPAC), or the Midwest CEPAC.

 

Information Buffet (AKA, Other Stuff That Caught Our Attention)

 
 

We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:

  • Massachusetts Health Connector releases Section 1332 State Innovation Waiver proposal
  • The Medicare Payment Advisory Commission (MedPAC) releases its annual Data Book on Healthcare Spending and the Medicare Program
  • As part of its MACRA Tracker Tool, the American Hospital Association releases the proposed components for the calendar year 2018 Physician Quality Payment Program
 
HEARD ON THE STREET
 

“Let’s be clear about what happened in the Senate in the last 24 hours. It was an abject failure of the United States Senate.... I hope that the Senate will not quit. I hope and urge the Senate to stay in Washington, DC until the job gets done."

 

“And, if they are going to quit, then by golly maybe they should start at the top with Mitch McConnell leaving his position and letting somebody new, somebody bold, somebody conservative take the reins so they could come up with a plan they can get through the Senate to serve the needs of the American people."

 

“[McConnell] has a job to do. And, if he can't it, then as The Apprentice would say, ‘You're fired.’”

 

– Rep. Mo Brooks (R-AL), commenting on the Senate’s failure to pass a bill repealing and replacing the ACA

Source: “GOP congressman suggests Mitch McConnell should resign after healthcare failure,” CNN’s New Day, July 28

 
POLICY BY NUMBERS
 

35% vs 15%

 

Merck launched RENFLEXIS™ (infliximab-abda), its biosimilar version of Johnson & Johnson's REMICADE® (infliximab), which was developed by Samsung Bioepis, at a 35% discount to REMICADE’s wholesale acquisition cost.

Pfizer launched its biosimilar of REMICADE, INFLECTRA® (infliximab-dyyb), last fall at a 15% discount to the branded drug.

 
UPCOMING MEETINGS & CONFERENCES
 

The Bioprocessing Summit

August 21–25 l Boston, MA
World Courier, part of AmerisourceBergen, is proud to be a sponsor of The Bioprocessing Summit 2017. In its ninth year, the conference focuses on upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. Visit World Courier at booth #308. Learn more

 

Cell and Gene Meeting on the Mesa

October 46 l LaJolla, CA
The Cell & Gene Meeting on the Mesa is a 3-day conference bringing together senior executives and top decision makers in the industry with the scientific community to advance cutting-edge research into cures. World Courier, part of AmerisourceBergen, is proud to be a Gold Sponsor of this unique event. The meeting features a nationally recognized Scientific Symposium, attended by leading researchers and clinical experts from around the globe, in conjunction with the industry's premier annual Partnering Forum, the first event of its kind dedicated solely to facilitating connections in this sector. Learn more

 

AMCP Nexus 2017

October 1619 l Dallas, TX
Join Xcenda at this year's AMCP Nexus 2017 conference in Dallas, Texas. AMCP Nexus 2017 will explore perhaps the most transformative change taking place in healthcare: how we pay for healthcare and the emergence of value as the defining factor and goal. Xcenda's team of experts can help you navigate the value landscape and maximize access for your product. Visit Xcenda's booth in The Exchange at #503 or contact us to schedule a meeting at the conference. Learn more

 
 
 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
 
FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Director,
Health Policy
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Peyton Howell, MHA
President | Global Sourcing & Manufacturer Relations | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | AmerisourceBergen Specialty Group

Tommy Bramley, PhD, RPh
President | Xcenda

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Reimbursement & Policy Insights | Xcenda

CONTRIBUTING AUTHORS:

Aaron Dancy | Maureen Holmes | Darren Jensen | Scott Shields | Diane Wilson 

PRODUCTION:

Kylie Matthews | Ellen Olson | Tia O'Brien

 

July 28, 2017

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