We examine the healthcare-related changes in the White House's FY2020 budget proposal.

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Mar. 15, 2019

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FEATURED STORY
 

Wish Upon a Star: President Trots Out Budget Request

 
 

On Monday, the White House released its fiscal year (FY) 2020 budget proposal, “A Budget for a Better America.” The budget request calls for cutting Medicare and Medicaid costs by $845 billion and $241 billion, respectively, over the next 10 years, and committing $291 million toward ending the spread of HIV in the US within a decade.

Here are some of the health-related changes included in the annual wish list:



White House staff made the rounds on Capitol Hill this week to discuss the budget proposal. On Tuesday, the House Energy & Commerce Committee’s Health Subcommittee held a hearing. On
Wednesday, the Senate Budget Committee held a hearing on the budget proposal, as did the House Appropriation Committee’s Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

While Congress will probably not grant many of the budget requests, it is an important signal of the administration’s priorities and could result in (yet another) funding dispute in October, when the new fiscal year starts.

 

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LEGISLATIVE UPDATE
 

Legislative Bytes

 
 
  • Five pharmacy benefit managers (PBMs) have been called to testify at an April 3 Senate Finance hearing on drug pricing in letters from Chairman Chuck Grassley (R-IA) and ranking member Ron Wyden (D-OR): Cigna (which recently purchased Express Scripts), CVS Caremark and CVS Health Corporation, Humana, OptumRx, and Prime Therapeutics LLC.

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XCENDA ORIGINAL RESEARCH
 

Like a Fox in the Hen House: Accumulators and Patient Access

 
 

Last week, we attended CBI’s 20th Annual Patient Assistance and Access Programs conference in Baltimore, Maryland. Manufacturers, foundations, and patient advocates grapple every day with the ever-growing complexities around patient access and affordability, and hearing their stories and experiences is an important reminder for why we do the work we do.

Corey Ford was fortunate to be able to moderate a panel on the impact of copay accumulator adjustment programs on patients and patient-support programs. Copay accumulator programs exclude the use of manufacturer-sponsored copay assistance from a patient’s accrual of OOP expenses throughout a plan benefit year.

Xcenda has been focused on this space over the past 2 years, and we recently conducted a survey of over 40 national and regional commercial payers to dig deeper on this troubling trend for patients. Nearly 60% of the payer respondents are targeting commercial copay assistance, up from roughly 40% from the same survey in 2018, and nearly all of these payers are employing some form of a copay accumulator program for products in select therapeutic areas. In this issue brief, Rolling Back the Tide: Deploying a Consultative Approach to Tackle the Growing Expansion of Copay Accumulators, we examine the prevalence of these models in the commercial sector, employer decisions driving the uptake of these models, and possible solutions to address accumulators.

We are passionate about discussing patient access, so if you need more information on this or assistance with your patient-support strategy, please reach out to corey.ford@xcenda.com.

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THE VALUE CORNER
 

Trying to Get a Piece of the Pi: ICER Jumps Into the POS Conversation

 
 

On Tuesday, the Institute for Clinical and Economic Review (ICER) announced the publication of a white paper, “Value, Access, and Incentives for Innovation: Policy Perspectives on Alternative Models for Pharmaceutical Rebates.” This effort follows other recent supply chain discussions and summarizes some of the pros and cons of 3 alternative approaches to the rebate model that currently drives pharmaceutical price negotiation in the US; it is a well-timed endeavor that discusses issues relevant to the proposed rule the Trump administration released in January.

The ICER white paper describes the following 3 alternative options for rebate models:

  1. Require that PBMs pass through 100% of rebates and associated manufacturer fees based on list price to plan sponsors
  2. Offer all or a proportion of point of sale (POS) rebate savings directly to patients
  3. Eliminate rebates and move to upfront discounts

The white paper is a product of the ICER Policy Summit, following a December 2018 meeting of ICER's membership program during which various stakeholders convened to share their perspectives on how rebates grew increasingly important for their businesses, the unintended consequences they have had on drug affordability for certain patients, and possible paths forward.

Option #1 is becoming increasingly derided by policy makers, and most manufacturers publicly support its elimination. UnitedHealthcare (UHC) just announced this week it will be offering POS rebates (option #2) for all employer-sponsored plans. (See story in Regulatory Update.) Only when the vast majority of customers are receiving rebate savings at the POS will option #3 gain any traction.

In addition to the rebate white paper, ICER released a Draft Evidence Report on Pi Day that assessed the clinical effectiveness and value of MAYZENT (siponimod) for the treatment of secondary progressive multiple sclerosis.

As always, if you need assistance with all things ICER or value-related, please contact kristen.migliaccio@xcenda.com.

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REGULATORY UPDATES
 

Getting More Than Gum at Check-Out; UHC Working on POS Rebates

 
 

In a press release issued Tuesday, UHC announced it is expanding its consumer POS discount program. Last year, UHC and sister PBM OptumRx launched the first POS discount program to make medications more affordable and improve health outcomes. The expansion will apply to all new employer-sponsored plans beginning January 2020, with some caveats to plans made for existing clients prior to that date and for those currently in the sales cycle for January 1, 2020 effective dates.

UHC’s data analytics demonstrated that medication adherence improved up to 16% when consumers do not have a deductible or large OOP cost, depending on plan design. The company believes this better adherence contributes to better health and reduces healthcare costs for both clients and the system. Serving more than 9 million consumers this year, the existing program has already lowered prescription drug costs for consumers by an average of $130 per eligible prescription.

Before implementing the expansion of this program, OptumRx and UHC delivered negotiated drug manufacturer rebates and discounts directly to employer clients and said they utilized them to either reduce premiums for all members or pass them on at the POS. Existing UHC clients will have the option to adopt these new plan designs during contract renewal.

UHC is riding the crest of momentum to apply prescription-drug rebates at the POS. On January 31, the Department of Health and Human Services (HHS) and the Office of the Inspector General issued a proposed rule to modify the long-standing safe harbor for manufacturer rebates to encourage manufacturers to pass discounts directly to patients enrolled in a Medicare Advantage or Medicaid managed care plan. And last week, Senator Mike Braun (R-IN) introduced the Drug Price Transparency Act (S. 657), which would extend the idea of the HHS OIG rebate rule to the commercial insurance market and prohibit PBMs from receiving any rebates or reductions in price from drug manufacturers.

 

Coyness Is Nice but Payers Say “Ask me. Ask me. Ask me.”

 
 

Earlier this week, the American Medical Association (AMA) issued an update on prior authorization (PA) reform since working with physician and payer stakeholders on a consensus statement last year. According to surveyed physicians, progress on PA reform has been slow and continues to interfere with patient continuity of care.

Based on the survey, over 80% of physicians report an increase in the number of drugs requiring PA and identify PA requirements as interfering with continuity of care. The majority of physicians surveyed also continue to report a lack of transparency with PA criteria and coverage changes. Only a very small number of physicians report contracting with payers for programs exempting them from PAs, and the majority of PAs are still routing via phone and fax.

While overall PA reform may be progressing slowly, initiatives in several states are underway to completely remove PAs for patients requiring treatment for opioid-use disorder. However, the AMA’s efforts at PA reform run counter to where the Administration is moving. Last November, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule soliciting public comments “on potential policies that would remove administrative hurdles to offer lower-cost options to seniors and provide support for private sector partners by providing them the tools to lower the cost of prescription drugs.”

One of the potential policies would be to allow Part D sponsors to implement broader use of PA and step therapy, including to determine use for protected drug class indications.

In the meantime, the AMA’s consensus statement does not include measurable goals for achieving reform and has no firm timelines, which may require the AMA and physician groups to continue working with payer stakeholders to push forward on needed reform for the sake of improving patient access to care.

 

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:

  • HHS Secretary Alex Azar III has appointed Norman Sharpless to be the acting FDA Commissioner. He will replace the current FDA Commissioner, Scott Gottlieb, who announced his resignation on March 5. We doubt his socks will be as cool.
  • CMS updated its drug spending dashboards with data for 2017. The dashboards focus on average spending per dosage unit for prescription drugs within CMS programs, and track the change in average spending per dosage unit over time.
  • CMS released new state tools and guidance that provide standard monitoring metrics and recommended research methods geared specifically for section 1115 demonstrations that test innovative approaches to Medicaid eligibility and coverage policies. See accompanying press release and blog post.
  • Cambia Health Solutions and Blue Cross and Blue Shield of North Carolina announced a strategic affiliation between the 2 not-for-profit companies.
  • The Pew Charitable Trusts released a report on retail pharmaceutical spending from 2012 to 2016 that quantifies the share of overall spending on retail prescription drugs retained by health plans and others in the supply and payment chain.


 
HEARD ON THE STREET
 

“We’ll be working on preparing a notice of proposed rulemaking to implement [the Part B International Price Index (IPI) model] with appropriate modifications as need be, but we’re very committed to Part B.”

– HHS Secretary Alex Azar

At a hearing on the Administration’s FY 2020 budget request for HHS, Azar was asked by House Labor, HHS, Education & Related Agencies Appropriations Subcommittee Chairwoman Rose DeLauro (D-CT) for a status update on the Administration’s potential IPI model that would base Part B drug costs on prices paid overseas.

Source: “Department of Health and Human Services Budget Request for FY 2020,” March 13

 

 
POLICY BY NUMBERS
 

18 | 7 | 4

 

The FDA approved Pfizer’s TRAZIMERA (trastuzumab-qyyp), a biosimilar of Genentech’s HERCEPTIN, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. These indications are the same as those for which the reference product is approved.

TRAZIMERA is the fourth trastuzumab biosimilar, and the 18th biosimilar overall, to receive FDA approval. Of the 18 approved biosimilars, 7 are available on the market.

Source: “Biologic License Application (BLA): 761081,” FDA

 

The Evolving Healthcare Landscape and the Impact on Patient Access and Affordability

 
 

Xcenda experts joined over 450 leaders from the patient assistance and product access field at CBI's 2019 Patient Assistance and Access Programs conference in Baltimore to prepare for what’s ahead in the industry.  

Xcenda’s Jennifer Snow, MPH, Vice President of Reimbursement and Policy Insights, presented the “State of the Industry” session titled, “The Evolving Healthcare Landscape and the Impact on Patient Access and Affordability.” Ms. Snow provided insights on the access and affordability challenges facing patients today and how patient support programs are being impacting by trends in the marketplace.

Download the presentation >

 

 

 

 
UPCOMING MEETINGS & CONFERENCES
 

AMCP Managed Care & Specialty Pharmacy Annual Meeting

March 25–28 | San Diego, CA
Join AmerisourceBergen companies, US Bioservices and Xcenda, at AMCP’s Annual Meeting at the San Diego Convention Center, March 25–28. Meet with our specialty pharmacy, commercialization, and market access experts at the largest gathering of managed care professionals who work, lead, and innovate in the ever-changing world of pharmaceutical management. Visit AmerisourceBergen at booth 818. 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:

Dan Cadle | Corey Ford | Katherine Bridges Maness | Scott Shields | Linnea Tennant

PRODUCTION:

Kylie Matthews | Ellen Olson | Tia O’Brien

 

Mar. 15, 2019

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