The nomination of Dr. Stephen Hahn to lead the FDA heads to the Senate floor.

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Dec. 6, 2019

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FEATURED STORY
 

Quadfecta: Running Through Commissioners

 
 

On Tuesday, the Senate Committee on Health, Education, Labor and Pensions approved (18-5), with bipartisan support, the nomination of Stephen Hahn, MD, to lead the Food and Drug Administration (FDA). If approved, Dr. Hahn, a radiation oncologist and top official at MD Anderson Cancer Center in Houston, will be the fourth FDA Commissioner this year.

Chairman Lamar Alexander (R-TN) recommended the committee support Dr. Hahn’s nomination based upon his experience as an oncologist, leadership at MD Anderson, and work at the National Institutes of Health. He noted, “Now it’s time for him to be confirmed because there is a lot the FDA needs to do—approve new life-saving drugs and devices, regulate tobacco and e-cigarettes, address the opioid crisis and ensure pain patients can receive the medications they need, and protect our nation’s food supply.”

It was not all unicorns and rainbows. Senator Patty Murray (D-WA) expressed skepticism about Dr. Hahn’s lack of government experience, public record on FDA policy issues, and experience in leading a complex organization. Senator Murray, who voted against the nomination, stated she ultimately was dissuaded by Dr. Hahn’s refusal to commit to implementing a strong policy to remove non-tobacco-flavored e-cigarettes that have not undergone FDA review from the market.

The next step is a full Senate vote on Dr. Hahn’s nomination as the next FDA commissioner.

 

HPW Rebuild

 
XCENDA ORIGINAL RESEARCH
 

If at First You Don’t Succeed… You May Eventually Get Your Drug

 
 

Concerns about the rise in step therapy drove Xcenda and Dr. Madelaine A. Feldman to explore the impact of the restrictive utilization-management tool, step therapy, on patients. Step therapy requires patients to first fail on another treatment before covering the treatment originally prescribed by the physician and has been on the rise in recent years. This begs the question: What is driving these requirements, and at what cost to patients?

To better understand the realities of step therapy in practice, Xcenda interviewed payers, specialty physicians, pharmacists, and patients; conducted formulary and data analysis; and performed robust secondary research.

Not surprisingly, we found that, while payers think step therapy has little to no downside in treatment, patients and physicians feel differently. The cost of step therapy requirements on patients is high. For patients with chronic conditions, especially those with heterogeneous diseases, the impact of step therapy generates the disruption of the provider-patient relationship, increased out-of-pocket costs, decreased adherence, and potentially devastating health outcomes.

Additionally, a major concern expressed by medical professionals and patient advocacy groups is that payers use step therapy to increase their profits through rebates and fees passed through to them. This directly affects the cost to the patient (and eventually, the downstream cost to the healthcare system at large), who is forced to fail first on payer-preferred drugs (with coinsurance based on list price, not the rebated price) before receiving coverage for the originally prescribed drug.

The paper recommends that step therapy should be used sparingly and only in situations when it is driven by clinical decision making, as the practice explicitly goes against shared decision making between a healthcare provider and their patient. All stakeholders are urged to take action to change the system and reduce restrictive step-therapy policies.

 

Heading to Las Vegas for ASHP Midyear? Meet Xcenda's FormularyDecisions team for a demo.

 
 

Xcenda's FormularyDecisions is headed to the 54th ASHP Midyear Clinical Meeting and Exhibition in Las Vegas December 8-12!

Stop by AmerisourceBergen booth #1437 for a demo of FormularyDecisions, the largest online community of US formulary decision makers and home of AMCP eDossiers.

Learn more >

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LEGISLATIVE UPDATE
 

Legislative Bytes

 
 
  • On December 10, the House Committee on Energy and Commerce, Subcommittee on Health will hold the long-awaited hearing on universal healthcare, or “Medicare for All.” On the same day, the committee will also hold a hearing on the oversight of the FDA’s foreign inspection program.
  • Rep. Earl Carter (R-GA) introduced a bill to improve transparency and prevent the use of abusive spread pricing and related practices in the Medicaid program (H.R. 5281).
  • Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released a request for information on 21st Century Cures 2.0, seeking feedback by December 16 from the public on how to build upon the current legislation in areas including digital health and exploring how reform of Medicare coding, coverage, and payment could better support patients’ access to innovative therapies.

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THE VALUE CORNER
 

Some Cracks in ICE(R)?

 
 

Yesterday, the Institute for Clinical and Economic Review (ICER) announced that it will be evaluating bluebird bio’s LentiGlobin for the treatment of beta thalassemia. LentiGlobin is already available in Europe under the brand name ZYNTEGLO with approval from the FDA anticipated by the end of next year. ICER is accepting stakeholder comments during the Open Input Period for this topic through December 20. The final assessment will be discussed during a public meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC) in July 2020.

On Monday, November 25, ICER announced that it began accepting nominations for new members to all 3 of its independent evidence appraisal committees: the California Technology Assessment Forum (CTAF), the Midwest CEPAC, and the New England CEPAC. Nominees are not required to have clinical training in the topics areas that will be considered for future reports, but they should have experience interpreting and applying clinical evidence across healthcare delivery systems. All applications, which should include a CV and letter of interest, need to be submitted to ICER by January 20.

The following day, ICER announced the publication of its final Evidence Report evaluating Janus kinase (JAK) inhibitors for the treatment of rheumatoid arthritis (RA). Although members of CTAF voted that there was high certainty of a substantial net health benefit for RINVOQ (upadacitinib) and XELJANZ (tofacitinib) compared to conventional disease-modifying antirheumatic drugs, the evidence was insufficient to make this comparison for OLUMIANT (baricitinib). However, the cost-effectiveness findings demonstrated that RINVOQ exceeded ICER’s cost-effectiveness threshold range of $100,000 to $150,000 per quality-adjusted life-year (QALY) using HUMIRA (adalimumab) as the comparator, which would require a 25% to 26% discount on the list price; ICER did not calculate a value-based price benchmark for XELJANZ or OLUMIANT due to a lack of available head-to-head evidence.

Last Wednesday, the National Pharmaceutical Council (NPC) posted a blog commenting on ICER’s white paper that described its final methods adaptations for assessments of potential curative and other treatments defined as single and short-term therapies (SSTs). Although NPC acknowledges that ICER made several changes to its draft methodology in response to its recommendations, the organization is concerned that ICER is assigning a price to transformative therapies and contended that no single value assessment framework (VAF) alone will be able to the capture the full benefits of these treatments. NPC also expressed eagerness to review the final changes to ICER’s 2020 VAF, which has been delayed to January 31, 2020.

On Tuesday, the Innovation and Value Initiative (IVI) published an opinion article in Morning Consult describing the need to look at the value of a wide range of healthcare interventions. Jennifer Bright, the author and IVI’s Executive Director, argues that VAFs must be able to support comparative assessment beyond pharmaceuticals to be truly relevant to healthcare decision makers. The commentary also describes the importance of incorporating real-world evidence in decision-relevant contexts, including some of the current initiatives to catalyze this effort, as well as the significance of including patient-defined measures of value in economic models. Finally, Ms. Bright emphasizes the use of an open-source model development platform to encourage transparency and propagate model improvements by allowing multiple stakeholders to be involved in value assessment.

In the December issue of Value in Health, a publication authored by the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center reports the results of an investigation into the influence that industry comments have on ICER’s cost-effectiveness analyses (CEAs). The authors reviewed 15 CEAs from 2017 through 2019 to determine whether ICER made any changes to its incremental cost-effectiveness ratios between the draft and final reports and quantified the responses based on 4 criteria: no change, text revised, assumption(s) revised, or conclusion revised. Of the 53 ratios identified, 84.9% were revised, but the majority of these changes were considered small (defined as <10%). Of the 256 industry-submitted comments, the overwhelming majority (95%) did not describe the impact of the draft-estimated ratio, and only 2% of submitted comments resulted in ICER changing its conclusions.

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
 

Maryland, Not Just Crabs and Football: All-Payer Results Are in

 
 

Last week, the Centers for Medicare & Medicaid Services (CMS) released the final evaluation report that highlighted progress from the agreement with Maryland to test whether a statewide all-payer system with capitated hospital payments was an effective model for reducing costs and improving access and quality.

Under the All-Payer Model, Maryland hospitals are exempted from Medicare’s inpatient and outpatient payment systems and expected to limit per capita total hospital cost growth for all payers, including Medicare.

Key findings of the report include:

  • Reduction in total expenditures for Medicare beneficiaries and total hospital expenditures for both Medicare beneficiaries and commercial plan members (reductions in hospital outpatient expenditures drove the Medicare savings)
  • Reductions in hospital admissions and potentially avoidable hospitalizations, but no impact on emergency department visits or unplanned readmissions for Medicare beneficiaries

In addition to financial and utilization outcomes, Maryland’s All-Payer Model operation showed that hospitals, clinicians, and other stakeholders are willing to accept the uncertainty of a major change to payment methodology to transform delivery of services. With the House hearing next week on universal healthcare, the Medicare program may make the case for broadening an all-payer model as a way to decrease healthcare expenditures.

 

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:

  • The CMS Office of the Actuary released the 2018 National Health Expenditures, reporting that US healthcare spending grew 4.6%, reaching $3.6 trillion or $11,172 per person. Health spending accounted for 17.7% of the nation’s gross domestic product. (We’ll dive in deeper on the data next week.)
  • Mylan and Biocon announced the launch of their trastuzumab biosimilar, OGIVRI (trastuzumab-dkst). OGIVRI is the second HERCEPTIN (trastuzumab) biosimilar to be launched, with 12 biosimilars now available in the US.
  • Last week, the FDA released a draft guidance intended to help guide efficient product development by clarifying what data and information may—or may not—be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product. See the accompanying FDA statement.
  • Virginia Medicaid Director Karen Kimsey asked CMS to delay finalizing the state's pending Medicaid waiver, which includes a work requirement and premiums for some enrollees. Kimsey cited the Democratic takeover of the state legislature in this fall's election leading to the request.
  • Vermont submitted a Concept Paper to the Department of Health and Human Services (HHS) on importing drugs from Canada, noting estimated savings of $1 million to $5 million by accruing savings through commercial plans, rather than through public programs, as Florida proposes.
  • On Tuesday, the White House Council on Economic Advisors released a report on H.R. 3, estimating that the package would cost the economy $1 trillion annually over 10 years and could result in a reduction of as many of 100 new drugs entering the market. 
  • Also on Tuesday, a Centers for Disease Control and Prevention (CDC) report found about 154,000 (14%) people are unaware they have HIV and only 1 in 5 (18%) of the 1.2 million people who could benefit from preexposure prophylaxis, or PrEP, are receiving the drug. On the same day, HHS announced their initiative, Ready, Set, PrEP, a national program to provide PrEP drugs at no cost to people without prescription drug insurance coverage.
  • This week, hospital and industry groups filed suit against HHS on the transparency Final Rule that requires hospitals to post payer-negotiated rates for 300 shoppable services on the internet beginning in 2021. The American Hospital Association, the Association of American Medical Colleges, the Children's Hospital Association, and the Federation of American Hospitals argue that being required to publish negotiated rates with insurers infringes on their First Amendment rights and is outside the scope of the Affordable Care Act to provide consumers with “standard charges.”


 
OPEN ENROLLMENT BY THE NUMBERS

It’s that time again...open enrollment for the insurance exchanges. As we have done each year, we will compare weekly enrollment in the current and previous years for the 38 states that use the HealthCare.gov platform for the 2020 benefit year, including the federally facilitated exchanges, state partnership exchanges, and some state-based exchanges.

 

 

 

 
HEARD ON THE STREET
 

“Based on guidance from the Congressional Budget Office, we anticipate that H.R. 3 will save approximately $500 billion over the next 10 years that we plan to reinvest in the American people.”

 – Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ), Ways and Means Committee Chairman Richard E. Neal (D-MA), and Education and Labor Committee Chairman Bobby Scott (D-VA) press release on H.R. 3 hearing next week.

Source: “Pallone, Neal and Scott Announce Lower Drug Costs Now Act’s Historic Investment in Medicare and Search for New Cures,” House Committee on Energy and Commerce, December 5, 2019

 
POLICY BY NUMBERS
 

$28.9 billion vs $35.9 billion

 

CMS announced that the Medicare fee-for-service improper payment rate has fallen $7 billion from FY 2017–2019 to a total of $28.9 billion, its lowest level since FY 2010.

Source: “Fiscal year (FY) 2019 Medicare fee-for-service improper payment rate is lowest since 2010, while data points to concerns with Medicaid eligibility,” CMS Press Release, November 19

 
UPCOMING MEETINGS & CONFERENCES
 

ASHP Midyear Clinical Meeting and Exhibition 2019

December 8—12 | Las Vegas, NV
Xcenda's FormularyDecisions is headed to #ASHP19 in Las Vegas December 8-12! Stop by AmerisourceBergen booth 1437 for a demo of FormularyDecisions, the largest online community of US formulary decision makers and home of AMCP eDossiers. Learn more

 
 

Effectively Communicating Pipeline Information to Drive Payers’ Attention

 
 

As payers are conducting product reviews for budgetary planning and formulary decision making, they are increasingly looking for information—data and evidence—earlier in their process, before regulatory approval.

What pre-approval information are payers looking for, and when do they need it?

What resources are available to both payers and manufacturers to help facilitate this information exchange?

Xcenda explored these questions at a recent presentation at AMCP Nexus 2019 where we provided clarity on:

  • The payer perspective and their current pre-approval needs
  • What payers are using as an active resource for pre-approval product reviews
  • The manufacturers’ role in pre-approval information exchange

Download the presentation to learn more about the information delivered at the conference.

 

 
 

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:

Doug Cook
President | Commercialization Services & Animal Health

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:

Jenna Kappel | Anne Loos | Reeya Patel | Scott Shields | Diane Smith

PRODUCTION:

Kylie Matthews | Ellen Olson | Tia O'Brien

 

Dec. 6, 2019

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