Manufacturers start voluntary DTC inclusion of list prices.

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Feb. 15, 2019

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FEATURED STORY
 

Never Put Off Till Tomorrow What You Can Do Today: DTC Drug Prices

 
 

Last week, Johnson & Johnson (J&J) announced it will be the first manufacturer to begin listing prices of drugs in direct-to-consumer (DTC) advertising. J&J indicated it will start with its most widely prescribed medicine, the oral anti-coagulant XARELTO (rivaroxaban), and stated this listing will provide “patients clearer, and more valuable, information about the cost of the medicines.” Potential patient out-of-pocket costs will be available through an online resource for patients where they can enter insurance information to obtain more information.
 
Following the Trump Administration’s blueprint last May that included price transparency for brand name drugs in advertising, a flurry of activity has followed. Last October, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to include the wholesale acquisition cost (WAC), or “list price,” in all television advertising for any prescription drug or biological product with a list price greater than $35 for a 30-day supply or typical course of treatment. In response, PhRMA issued DTC advertising principles that recommended manufacturers provide information on potential drug cost and financial assistance through a website. The House Committee on Energy and Commerce is also considering a bill sponsored by Rep. Janice Schakowsky (D-IL) that would impose civil penalties for non-disclosure of WAC in DTC advertising.
 
Some industry experts note prices alone in DTC advertising may be misleading for consumers, as very few actually pay the list price. Dave Ricks, Eli Lilly’s Chairman and CEO, recently said, “Americans are upset and confused about their out-of-pocket costs for prescription drugs. So people need new tools to help them.” Last month, Eli Lilly became the first company to provide such tools in ads for its top-selling diabetes drug TRULICITY (dulaglutide) by directing viewers to a website containing pricing information, estimated out-of-pocket costs, and patient assistance program information. Lilly noted it intends to do the same for all drugs it promotes on TV by the end of February.
 
However, despite these steps by the industry, we expect to see more formal requirements put in place. While referencing PhRMA’s DTC advertising principles, Health and Human Services (HHS) Secretary Alex Azar criticized this approach: “The initiative is a helpful complement to, not a substitute for, what we’ve proposed today. We will not rely on voluntary action to accomplish our goals—including delivering transparency in other areas.” Title courtesy of President Thomas Jefferson.

 
 

CBI Patient Assistance & Access Programs Conference 2019

 
 

Xcenda is a proud Platinum Sponsor of the 20th Annual Patient Assistance & Access Programs Conference coming March 4–6 to Baltimore, MD.

Xcenda’s Vice President of Reimbursement and Policy Insights and Editor-in-Chief of Health Policy Weekly, Jennifer Snow, MPH, will deliver the state of the industry address titled, “The Evolving Healthcare Landscape and the Impacts on Patient Access and Affordability.” Learn more >

Join us in Baltimore and save $300! Use promo code PBC877. Register here.

 

 

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THE VALUE CORNER
 

It’s Easier to Do a Job Right Than Explain Why You Didn’t

 
 

Release of the Institute for Clinical and Economic Review’s (ICER) Unsupported Price Increase (UPI) draft protocol in mid-January has garnered attention from manufacturers and payers. The UPI report is one of ICER’s newest initiatives, designed to examine significant prescription drug price increases and determine if the increases are justified.

Manufacturers have apprehensions regarding how to approach pricing strategies going forward, and they are also concerned about the implications of their drugs appearing on ICER’s “list of shame.” Manufacturers have observed that the report fails to take into account differences between list price and net price, which can vary greatly based on payer negotiations. Payer criticisms around the report include an unclear understanding of what actions to take following the publication of the final UPI report, particularly for high-priced drugs with no alternative treatment options.

Earlier this week, ICER closed its public comment period on the UPI draft protocol. Keep an eye out for a revised draft UPI report protocol (to be published on March 8) to see if, and how, ICER incorporates feedback received from stakeholders.

The close of the public input period for the UPI assessment doesn’t mean ICER is letting stakeholders put down their pens quite yet. The open input period for ICER’s international collaborative effort on “Valuing A Cure” is in progress, which, as reported here in the Corner, is ICER’s initiative to develop and test alternative methods for the evaluation of curative treatments. ICER is currently accepting public comments regarding its key methodological questions. All comments can be submitted by email to publiccomments@icer-review.org by 5:00 PM ET on February 20, 2019. The draft white paper will be posted for additional public comment sometime this summer.

As always, if you need assistance with all things ICER or value-related, please contact Kristen.Migliaccio@xcenda.com. Title courtesy of President Martin Van Buren.

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REGULATORY UPDATES
 

Status Quo Is Latin for “The Mess We’re In”: ACA Suit Update

 
 

Yesterday, a Louisiana-based federal court of appeals judge agreed to let House of Representative Democrats join the defense of the Affordable Care Act (ACA). Thirty-eight state attorneys general and the Department of Justice are battling over whether any or all of the ACA remains constitutional.

In December 2018, a federal district court judge in Texas ruled the ACA’s individual mandate was unconstitutional and inseverable from the rest of the statute, thus imperiling the entire law.

Last month, House Democrats asked the Fifth Circuit Court of Appeals if the House could intervene as a defendant alongside 16 Democratic states and the District of Columbia in the lawsuit Republican states brought challenging the law. Judge Leslie Southwick allowed the House’s participation but denied a request to fast track the appeal.

The Democratic states, no doubt, are appreciative of the additional heft their defendant list just acquired. Title courtesy of President Ronald Reagan.

 

Speak Softly and Carry a Big Stick: NY Medicaid Targets REMICADE

 
 

On Wednesday, the New York State Medicaid Drug Utilization Review (DUR) Board requested the state seek further discounts on Janssen’s REMICADE (infliximab). A 2017 law permits New York Medicaid to cap drug costs by requesting supplemental rebates for high-cost medications identified as being priced too high even with the federally mandated rebate. Federal law requires states to cover drugs discounted at least 23% by manufacturers, but New York Medicaid can limit their use.

Under the New York law, Medicaid can require manufacturers that fail to comply with discount requests to disclose details regarding how price is set, including production costs, research and development, profit margins, and average discounts and rebates. The law empowers the DUR board to require doctors to seek prior authorization from managed care companies before prescribing REMICADE if Janssen refuses to negotiate.

REMICADE is the second drug targeted by the state for a supplemental rebate. As discussed by Health Policy Weekly, the state demanded in April 2018 that Vertex Pharmaceuticals provide a steep discount on ORKAMBI (lumacaftor/ivacaftor)‎, its cystic fibrosis drug listed at $272,000 per year. Vertex refused the request and, because the drug has no alternatives, there was little New York could do.

However, the state may have more success this time because there are 2 biosimilars to REMICADE on the market, INFLECTRA (infliximab-dyyb) and RENFLEXIS (infliximab-abda). Title courtesy of President Theodore Roosevelt.

 

An Honorable Defeat Better Than a Dishonorable Defeat.
UT Tries Partial Medicaid Expansion

 
 

On Monday, Utah Gov. Gary Herbert (R) signed legislation, Medicaid Expansion Adjustments (S.B. 96), that replaced a voter-approved Medicaid expansion with a more restrictive program. In November, Utah citizens voted for the full expansion of Medicaid through a ballot initiative. However, the signed legislation only expands Medicaid partially, with full expansion contingent on federal action. State officials hope the partial expansion would enroll 90,000 people starting April 1.

The Utah Decides Healthcare Act of 2018 initiative approved in November allowed citizens earning up to 138% of the federal poverty level to enroll in Medicaid. The state’s cost of the Medicaid expansion (10%) was to be covered by an increase in sales tax, with the federal government responsible for 90% of the expansion costs.

Instead of the originally proposed 138% cap, S.B. 96 extends Medicaid eligibility up to 100% of the poverty level.

Utah must receive federal approval for a partial Medicaid expansion. The federal government has yet to approve a partial expansion, having denied applications by Arkansas and Massachusetts. If the federal government does not approve, Utah’s legislation allows for the full expansion of Medicaid with additional requirements for enrollees, such as having to work or remaining on workplace insurance.

Should CMS approve Utah’s partial expansion, other states could likely follow suit. Since Medicaid comprises the largest or second-largest line item in almost every state’s budget, the temptation to back off from a full expansion to a partial expansion will be great. Title courtesy of President Millard Fillmore.

 

Whatever Happens, There Will Be No Turning Back: Market Outlook

 
 

In its report, The Global Use of Medicine in 2019 and Outlook to 2023, IQVIA forecasts robust growth in global pharmaceuticals, driven mainly by increased uptake in the US and “pharmerging” markets—specifically in the areas of specialty and orphan drugs. (The pharmerging markets consist of 21 developing countries where use of pharmaceuticals is growing rapidly.) Total spending on medicines is expected to top $1.5 trillion by 2023, up 50% from 2014.

In the US, the loss of exclusivity for many branded drugs and the related increase in biosimilars will result in lower prices for these categories, and patients and manufacturers of both generics and biosimilars may reap the benefits. Patients with less common conditions may also benefit, as manufacturers turn their attention to treatments targeting these smaller populations, albeit at expectedly high costs. On the other hand, while prices of traditional drugs in the US are expected to continue to increase, the rate of increase is currently below the overall rate of inflation and expected to remain there.

Other areas to watch include:

  • Expanding use of next-generation biotherapeutics (eg, cell-based therapies, gene therapies, and regenerative medicines)
  • Advances in artificial intelligence and machine learning
  • Expanding use of real-world evidence in trial design
  • Enactment of US pricing policy reforms
  • Trajectory of the opioid epidemic in the US

In the US, expect many of these trends to be influenced by the run-up to the 2020 presidential election where healthcare is likely to be a key talking point. Title courtesy of President James Buchanan.

 

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:

  • We are in week 3 without a new ICER scoping document, evidence report, or policy recommendation. Sure, it gave us time to write comment letters, but it feels weird.
  • A recent survey conducted by Duke University and the National Pharmaceutical Council suggests that interest in value-based contracts may have been greater than previously thought.
  • Tufts Medical Center announced it will develop a new program this year, the Center for Enhanced Value Assessment, that will be aimed at better understanding cost-effectiveness and value in the delivery of healthcare.


 
HEARD ON THE STREET
 

Readers, you don’t see us—do we exist? We do. And we wash our hands. And we believe in germs.

“I don’t really wash my hands ever. I inoculate myself. Germs are not a real thing. I can’t see them, therefore they’re not real.”

– Fox & Friends host Pete Hegseth. Hegseth, who served with the National Guard in Iraq, was once reported to be Trump’s favored pick to lead the Department of Veterans Affairs. That role would have made him responsible for the health and well-being of 20 million Americans.

Source: “‘Germs are not a real thing’: Fox News host says he hasn’t washed hands in 10 years,” The Guardian, February 11

 

 
POLICY BY NUMBERS
 

42%

 

25 of the 59 new molecular entities that the Food and Drug Administration (FDA) approved in 2018 were personalized medicines, according to the Personalized Medicine Coalition (PMC). PMC defines “personalized medicine” as “an evolving field in which physicians use diagnostic tests to determine which medical treatments will work best for each patient. By combining the data from those tests with an individual’s medical history, circumstances, and values, healthcare providers can develop targeted treatment and prevention plans.”

Source: “Personalized Medicine at FDA: A Progress & Outlook Report,” Personalized Medicine Coalition, February 13

 
UPCOMING MEETINGS & CONFERENCES
 

CBI PAP 2019: 20th Annual Patient Assistance & Access Programs

March 4–6 | Baltimore, MD
Join Xcenda and Lash Group at the upcoming CBI PAP 2019 Conference in Baltimore, MD March 4–6. Xcenda’s Vice President of Reimbursement and Policy Insights and Editor-in-Chief of Health Policy Weekly, Jennifer Snow, MPH, will deliver the state of the industry address titled, “The Evolving Healthcare Landscape and the Impacts on Patient Access and Affordability.” Lash Group President Tommy Bramley, PhD, will deliver the conference’s keynote on “Empathy and Expertise—Evolving Patient Support Programs in the Digital Age.” 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
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Amy Grogg, PharmD
Senior Vice President | Commercialization Solutions | AmerisourceBergen Corporation

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

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

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Anuja Kanaskar | Scott Shields | Stephen Wilson

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Feb. 15, 2019

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