Maryland kicks off Prescription Drug Affordability Board to address drug pricing.

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Jan. 10, 2020

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FEATURED STORY
 

Start Me Up: Maryland’s New Prescription Drug Affordability Board Takes Shape

 
 

In 2019, the Maryland General Assembly passed a bill to create a Prescription Drug Affordability Board (HB 768). To better understand public concerns, a series of listening forums will be held over the next few weeks. The first forum took place on Monday, and the first official board meeting is set for next week in Annapolis.

The 5 board members have recently been appointed:

  • Chairman Van Mitchell, a former state health secretary, selected jointly by Senate President Thomas Mike Miller and House of Delegates Speaker Adrienne Jones
  • Dr. Eberechukwu Onukwugha, an associate professor at the University of Maryland School of Pharmacy, appointed by Jones
  • Dr. George S. Malouf Jr., an ophthalmologist, appointed by Miller
  • Gerard F. Anderson, director of the Johns Hopkins Center for Hospital Finance and Management, appointed by Maryland Attorney General Brian Frosh
  • Dr. Joseph Levy, an assistant scientist at the Johns Hopkins Bloomberg School of Public Health, appointed by Gov. Larry Hogan

The first of its kind, this independent 5-person board plans to review any prescription drugs meeting the following 3 criteria:

  • New branded prescription drugs launched with a wholesale acquisition cost (WAC) ≥$30,000 for either a year or 1 course of treatment
  • Existing branded prescription drugs with a WAC increase of ≥$3,000 for either a year or 1 course of treatment
  • Existing generic prescription drugs with a WAC increase of ≥200% for either a year or 1 course of treatment

The board will also review drugs that present a “substantial affordability challenge” to the Maryland healthcare system.

If the Board determines a reviewed medication presents an affordability challenge for Maryland residents, it has the authority to set an upper payment limit that state or local government healthcare plans would pay for that drug. However, before setting such a limit, the Board must analyze and report the associated supply chain, give manufacturers the opportunity to justify their prices, and present other options to address cost concerns.

Overall, this development is reflective of the ongoing national dialogue around the rising costs of prescription drugs and is likely the first of a series of upcoming changes; other states, including Illinois, Maine, Nevada, and New Jersey, attempted to pass legislation in 2019 forming similar boards to lower prescription drug costs. As well, preliminary motions to move forward on an equivalent bill in the Washington State Senate (SB 6088) were also filed at the end of December 2019, and a similar bill was prefiled in Virginia yesterday that would establish a Prescription Drug Affordability Board.

What this activity signals is that, despite the Sturm und Drang about prescription drug costs at the federal level, the real movement with potential for action is happening in the states. It may be flying below the radar of many observers, but the states have dedicated, aligned policymakers, which makes their actions much more likely to cause real change.

 
 

Have Questions on the Impact of AMCP Format v4.1?
Xcenda Has Answers.

 
 

The Academy of Managed Care Pharmacy (AMCP) released its new Format for Formulary Submissions (Version 4.1). The Format provides updated guidance on the evidence and information exchange between industry and payers for unapproved products and for new indications under US Food and Drug Administration (FDA) review for approved products. It is anticipated these changes will impact the content manufacturers can share and the method by which they will provide this kind of pre-approval information.

Xcenda and the FormularyDecisions team closely tracked the development of the new Format and are available to address questions and provide additional guidance surrounding these updates.

Turn to us to help align your organization’s information dissemination process with payers according to the new Format.

Contact us today >

HPW Rebuild

 
THE VALUE CORNER
 

Jumpin’ JAK Flash

 
 

Yesterday, the Institute for Clinical and Economic Review (ICER) announced the publication of its Final Evidence Report and Report-at-a-Glance assessing Janus kinase (JAK) inhibitors for the treatment of rheumatoid arthritis (RA). Members of the California Technology Assessment Forum (CTAF) unanimously voted that adding upadacitinib (RINVOQ), tofacitinib (XELJANZ), or baricitinib (OLUMIANT) to conventional disease-modifying anti-rheumatic drugs (cDMARDs) provided a superior net heath benefit relative to cDMARDs alone.

Although a majority of the panel also concluded the evidence was adequate to demonstrate that RINVOQ was superior to adalimumab (HUMIRA), CTAF members voted that the evidence was inadequate to distinguish any differences between RINVOQ and XELJANZ or whether XELJANZ is superior to HUMIRA. Despite achieving commonly accepted thresholds of cost-effectiveness, the council votes were split between “low” and “intermediate” long-term value for money for RINVOQ compared to HUMIRA due to concerns over real-world applicability. The recommended value-based price benchmark range of $44,000 to $45,000 for RINVOQ, consistent with the assumed discount price manufacturers are offering, represents a 25% reduction from the list price.  

On Tuesday, the Innovation and Value Initiative (IVI) announced the release of the latest iteration of its RA Value Assessment Model, intended to help stakeholders understand which therapies for moderate-to-severe RA represent a high value. The IVI-RA model now includes additional options for treatment (eg, triple therapy) as well as updated estimates of treatment effects and costs. IVI’s Executive Director Jennifer Bright highlighted the importance of open-source economic models for value assessment, like IVI-RA, that involve a range of healthcare decision makers in the development process and, thus, better represent how real-world patients experience the disease. IVI will continue to make revisions to the model throughout 2020, including updates that will allow users to determine the effect of prior therapies and length of maintenance treatment.

On Monday, ICER announced the release of its Draft Scoping Document evaluating luspatercept-aamt (REBLOZYL) and LentiGlobin for the treatment of beta thalassemia. REBLOZYL was approved in November 2019 by the FDA, and LentiGlobin is expected to be approved by the end of next year. Notably, the analysis will not compare the 2 therapies to each other. ICER is accepting stakeholder comments on the Draft Scoping Document through January 27, and the final report will be discussed during a public meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC) in July.

Last Friday, ICER announced it will be assessing valoctocogene roxaparvovec for the treatment of hemophilia A. The analysis will likely compare valoctocogene roxaparvovec, which is expecting an FDA decision by mid-2020, to factor VIII replacement therapy and emicizumab (HEMLIBRA). The Open Input Period for this topic began on January 3 and will close on January 22. The final evaluation will be reviewed by the New England CEPAC in August.

If you need assistance with all things ICER or value-related, please reach out to Michelle.Friedman@xcenda.com.

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REGULATORY UPDATES
 

Signed, Sealed, Delivered:
FDA Approved 48 Novel Therapies and Record Number of Biosimilars in 2019

 
 

This week, the FDA released its annual report, Advancing Health Through Innovation: New Drug Therapy Approvals, outlining new drugs approved in the US. In 2019, the agency approved 48 novel drugs, including 21 to treat rare diseases.

Nearly half of the drugs (20) approved in 2019 are considered first in their therapeutic classes and include treatments for bladder cancer and post-partum depression. Other approvals expanded uses of already approved drugs.

The new drugs for rare diseases include agents used in the treatment of cystic fibrosis and sickle cell disease.

The agency also approved a record 10 biosimilars, bringing the total number of approved biosimilars to 26. The biosimilars are used in place of 9 branded products, including several used to treat RA. Not all of the biosimilars are available for sale in the US, as several are tied up in court proceedings or on hold until their brand originator loses patent protection.

The FDA approved 59 novel therapies in 2018 and 46 in 2017, signaling an upward trend since 2016, when the agency approved just 22 drugs.

 

MIPS: 1 Isn’t the Loneliest Number

 
 

This week, the Centers for Medicare & Medicaid Services (CMS) announced the 2018 Quality Payment Program (QPP) performance results for the Merit-based Incentive Payment System (MIPS) program. MIPS is the quality-based program for providers who are reimbursed largely through fee-for-service, as opposed to an Advanced Alternative Payment Model (APM) track which includes risk-based accountable care organization (ACO) models.

Only 2% of participating providers will receive a negative payment adjustment and 98% will receive positive payment adjustment in 2020. While this is good news, the quality performance threshold for positive adjustment was set relatively low (15 points) for this year, and payments are likewise low, with 13% of participating providers receiving 0% to 0.2% payment adjustment and 84% receiving 0.21% to 1.68% payment adjustment. Negative payment adjustments range from −0.01% to −5% for 2% of participating providers.

CMS also reported an increase in the number of participants in MIPS and double the number of providers in APM in 2018.

For the 2020 reporting year, penalties will increase to −9% and the quality performance threshold will be raised to 45 points to avoid these negative penalties, making MIPS more difficult. In addition, changes to which measures providers will need to report through the MIPS Value Pathways (MVPs) are set to begin in 2021. MVPs will bundle measures across categories based on specialties or medical conditions and reduce the overall number of measures upon which providers will need to report. Manufacturers should examine their prescriber groups’ applicable reporting measures to determine how best to support reporting of measures or provide feedback to CMS on measures.

 

Satisfaction? AMCP Releases Format for Formulary Submissions, Version 4.1

 
 

On December 23, the Academy of Managed Care Pharmacy (AMCP) released an update to the Format for Formulary Submissions (AMCP Format Version 4.1). Major changes include new guidance addressing how manufacturers can provide evidence, and information exchange between manufacturers and healthcare decision makers (HCDMs), for unapproved products and unapproved uses of already approved products.

These revisions were made in response to the June 2018 FDA Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities and the 21st Century Cures Act to clarify what, when, and how manufacturers can provide such information. Given the increasing trend for HCDM requests for product information earlier and anticipated wave of high cost therapies coming to market, this timely update is likely to support HCDM evidentiary needs and assist in formulary decision-making processes, ultimately helping patients to obtain their medications affordably.

Join Xcenda’s Evelyn Sarnes and FormularyDecision’s Elizabeth Sampsel on the upcoming Xcenda and AMCP webinar, “Embracing Format v4.1 for Early, Effective Exchange of Information With Payers” to discuss implications of the new Format for HCDMs and manufacturers. Click here to register now, as space is limited.

 

Getting Closer to Value: No Longer Dancing in the Dark

 
 

In December, the American Journal of Managed Care (AJMC) published findings from a 2010–2014 retrospective study comparing healthcare utilization and total spend data among Medicare Advantage (MA), ACO, and Traditional Medicare (TM) groups. The study focal group included Banner Health-covered Medicare and commercial members in Maricopa County, AZ.

  • The research utilized claims and encounter data provided by Banner Health to measure patients’ hospital utilization and spending. Findings showed the following: Parts A and B costs, hospitalization rates, and number of days in a skilled nursing facility (SNF) were significantly lower among Banner MA compared to the TM/ACO groups.
  • However, consistent and progressive narrowing was observed between MA and TM/ACO groups.
  • Only in the case of weight-adjusted evaluation and management (E&M) office visit rates did the margin of difference grow between Banner TM/ACO and Banner MA groups.
  • Inverse to the previously mentioned metrics, emergency department (ED) visit rates for Banner MA groups outpaced TM/ACO groups over time.   

Analysis of the commercial side includes similar comparisons between the commercial ACO and non-Banner TM groups, showing low levels of variation between groups. The authors suggest that the low level of variation may be attributed to “the greater degree of churn among commercial ACO patients than the Medicare patients.”

These findings indicate that value-based payment systems improve health and reduce costs. In particular, MA plans reduced Part A and B costs, hospitalization rates, SNF days, E&M services, and weight-adjusted ED visits. All reductions indicate better patient outcomes and, subsequently, a lower cost burden on the healthcare system—aligning with CMS’ push away from fee-for-service reimbursement.

 

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 Department of Health and Human Services and CMS announced that Brad Smith will serve as Director of the Center for Medicare and Medicaid Innovation and Senior Advisor to Secretary Alex Azar for Value-Based Transformation.
  • CMS released the 2021 Medicare Advantage Advance Notice Part I containing information on risk adjustment. See the fact sheet.
  • CMS issued best practices for avoiding 340B duplicate discounts in Medicaid.
  • As reported by The Center for Biosimilars, Pfizer has announced that its AVASTIN (bevacizumab) biosimilar, ZIRABEV (bevacizumab-bvzr), has launched and will be available next week. ZIRABEV is the 13th biosimilar available on the market and the second AVASTIN biosimilar.
  • Jonathan Gruber surveyed the work performed by the National Bureau of Economic Research (NBER) Health Care Program over the last 7 years, highlighting a few key areas of study by researchers on the Affordable Care Act, physician behavior, hospitals, pharmaceutical economics, health insurance markets, and international comparisons.


 

Embracing Format v4.1 for Early, Effective Exchange of Information With Payers

 
 

AMCP Webinar | Tuesday, January 28, 2020 | 2:00 PM ET

With the recent release of AMCP Format v4.1, what does it mean for the preapproval information exchange between payers and manufacturers?

Join Xcenda’s Evelyn Sarnes, PharmD, MPH, Vice President of Medical Communications, and other key stakeholders for a live webinar on January 28. Moderated by Elizabeth Sampsel, PharmD, MBA, BCPS, Senior Director of Payer, Provider, and Partner Alliances at Xcenda, the expert panel will give perspective and guidance on the early, effective exchange of information in light of these latest changes as well as highlight tools that can help in this endeavor.

Register today >

 
HEARD ON THE STREET
 

“For many people with MS [multiple sclerosis]—a chronic, debilitating, unpredictable and currently incurable disease—daily life can be a challenge. AHSCT [autologous hematopoietic stem cell transplantation] has the potential to halt the progress of relapsing MS, eliminate the need for a person to take lifelong medication, and allow the body to partially regain function. However, we need to be certain that the benefits of this form of treatment outweigh its serious risks.”

 – National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, discussing a new clinical trial that has begun testing an experimental stem cell treatment against the best available biologic therapies for severe forms of relapsing MS

Source: “New Multiple Sclerosis Treatment Trial Compares Stem Cell Transplantation to Best Available Drugs,” National Institutes of Health, January 7

 
POLICY BY NUMBERS
 

2.2%

 

Researchers on Wednesday reported the largest-ever 1-year decline in the US cancer death rate, a drop they credited to advances in lung tumor treatments. The overall cancer death rate has been falling about 1.5% a year since 1991. It fell 2.2% from 2016 to 2017. That’s the largest drop ever seen in national cancer statistics going back to 1930.

Source: “Facts & Figures 2020 Reports Largest One-Year Drop in Cancer Mortality,” American Cancer Society, January 8

 
 

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:

Isabell Kang | Anne Loos | Reeya Patel | Scott Shields | Diane Smith | Aileen Soper | Ryan Sullivan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Jan. 10, 2020

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