The Senate Aging Committee and the House Ways and Means Health Subcommittee hear more testimony on drug pricing.

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Mar. 8, 2019

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FEATURED STORY
 

Sequels Rarely Good, Much Less Threequels—Drug Pricing Hearings Update

 
 

This week, the Senate Aging Committee and the House Ways and Means Health Subcommittee heard testimony in separate hearings from patients and policy experts on the trials and tribulations of dealing with rising drug prices as well as actions that could be taken to make an impact. As a follow-up to last week’s hearing that included testimonies from 7 pharmaceutical manufacturer executives, on Wednesday in her opening statement of the Aging Committee’s hearing on rising drug costs, part I of II, Sen. Susan Collins (R-ME) stated:

“The entire drug supply chain is appallingly opaque…. The complexity in the current system seems designed to benefit everyone except the patient.”

A common conclusion from all 3 hearings was there is not one policy that, if pursued, would lead to reduced drug costs for consumers.

During the Senate hearing on Thursday, it was noted that 3 bills were being introduced including:

Ideas presented included past proposed legislation or proposed regulations, with several suggestions from Senate and House committee members and witnesses to:

At the Senate hearing, Sen. Collins also noted that the committee plans to hear from Administration officials later this spring on their proposed solutions. As has been made clear, both chambers will be relentless about exploring drug pricing. Leading up to the 2020 elections, neither party appears to want to cede ground on this topic.

 

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LEGISLATIVE UPDATES
 

Legislative Bytes

 
 
  • Sen. Mike Braun (R-IN) introduced the following bills to address drug prices:
    • S.660, which would address the abuse of the Food and Drug Administration’s (FDA’s) citizen petition process by brand drug manufacturers
    • S.658, which would provide for accelerated approval pathway for certain drugs authorized to be lawfully marketed in other countries
    • S.657, which would establish requirements with respect to prescription drug benefits
  • Sen. John Kennedy (R-LA) introduced S.640, which would require pharmacy-negotiated price concessions to be included in negotiated prices at the point-of-sale under Medicare Part D.
  • Rep. Nanette Barragan (D-CA) introduced H.R.1506, which would amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.
  • Rep. Bobby Rush (D-IL) introduced H.R.1499, which would prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay entry of generic drugs into the market.

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BEEN THERE DONE THAT
 

Building Toward a Better Future for Patients: CBI PAP 2019

 
 

At CBI’s Patient Assistance and Access Programs 2019 conference in Baltimore, 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.” Here is a brief reflection on the experience.

A hotel under construction might be the perfect metaphor for patient support programs (eg, patient assistance programs [PAPs], commercial copay programs). Patient support programs can’t be static—they must constantly evolve and meet the patients where they are. Sometimes it means literally changing the site of care or changing how programs operate in order to work through new marketplace dynamics such as copay accumulators.

With the din of jack-hammering providing this metaphoric backdrop, the conference was a lively venue to learn more from people who work in this space (pharmaceutical PAPs, independent foundations, patient groups, etc) as well as from patients themselves. We laughed, learned, and, yes, cried. Hearing from the patients themselves on what they go through was inspirational for everyone in the audience. I was honored to be able to present the keynote on the policy and market landscape and considerations for these programs moving forward. The slides are available here. Balancing access and affordability will not get easier, but having the discussions about how the spaces are changing is critical.

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REGULATORY UPDATES
 

Biosimilars Can’t Catch a Break: FDA Updates Naming Draft Guidance

 
 

The FDA updated its draft guidance for naming biological products and announced:

  1. It has decided not to add a 4-digit suffix to biologics that have already been approved under the Public Health Service (PHS) Act.
  2. Transitioning products, such as growth hormone or insulins, will not be given a 4-digit suffix.
  3. The FDA will continue to assign a suffix to biosimilar agents.
  4. Any biosimilars that are designated interchangeable will have the usual 4-digit suffix, which will be “devoid of meaning.” (In other words, the suffix will not distinguish a biosimilar as interchangeable from one that is not.)

The guidance states, “FDA has determined that the core objectives of the naming convention—pharmacovigilance and safe use—can be accomplished by applying the naming convention to biological products 170 at the time they are licensed under section 351 of the PHS Act, and without applying it to licensed biological products that do not contain a suffix in their proper names. This approach is intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients, given that the nonproprietary names of drugs seldom change postapproval.”

This latest development will likely lead to confusion stemming some biologics’ and biosimilars’ names containing suffixes, while other biologics’ names will not contain suffixes.

 

We Research Commerce Laws So You Don’t Have to: RFI on Interstate Insurance Sale

 
 

On Wednesday, CMS announced a request for information (RFI) seeking public input on how to facilitate the purchase of health insurance coverage across state lines. “We are looking for information and ideas from the public on how to create a more dynamic health insurance market with more insurers participating and competing to meet the needs of the American people just like we see in markets for so many other products and services that enhance our daily lives,” stated CMS Administrator Seema Verma.

Until enactment of the Affordable Care Act (ACA), federal law did not expressly allow for, or prohibit, interstate purchasing of health insurance. Under Section 1333 of the ACA, however, states are permitted to form healthcare choice interstate compacts to allow insurers to sell policies in any state participating in the compact. According to the Commonwealth Fund, measures allowing insurers to enter into interstate compacts have been enacted in at least 6 states—Georgia, Kentucky, Maine, Rhode Island, Washington, and Wyoming—although no insurers have, to date, expressed interest in participating.

The National Association of Insurance Commissioners (NAIC) has issued a brief opposing the interstate sale of health insurance, stating “interstate sales will start a race to the bottom by allowing companies to choose their regulator, and reduce the options available to consumers.” Furthermore, “it would also make insurance less available, make insurers less accountable, and prevent regulators from assisting consumers in their states."

Purchasing health insurance across state lines has long been on the Republican wish list to bring down costs, but—as shown by the Commonwealth Fund—it has not gained much traction yet.

The RFI will be open for public comment for 60 days.

 

Xcenda Original Research:
We Can Hear the Movie Trailer—In a World Where ICER Rules Medicaid Formularies…

 
 

The utilization of cost-effectiveness as the single barometer for the definition of value has severe implications for beneficiary access to medications. Following up on our work last year looking at how Medicare would change if it adopted Institute for Clinical and Economic Review (ICER)-based thresholds, Xcenda conducted an analysis examining the impact if Medicaid began using ICER-based formularies.

Our findings suggest a significant number of patients with multiple sclerosis (MS), rheumatoid arthritis (RA), non-small cell lung cancer (NSCLC), multiple myeloma (MM), and psoriasis would lose access to the treatments their doctors determined was best for them if Medicaid relied on ICER-based formularies. For example, Xcenda research suggests that over 99% of prescriptions to treat MS would be switched and that 3/4 or more of prescriptions to treat RA, NSCLC, and psoriasis would have to be shifted to an ICER-recommended drug. In the balance of affordability and access, restricting physicians to a limited number of treatment options eliminates flexibility that is sometimes needed to treat patients on an individual basis; an ICER-based formulary ignores these clinical considerations.

 

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:

  • Rules season is starting:
    • CMS sends proposed rule on FY2020 hospice wage index, payment rate update, and quality-reporting requirements to the Office of Management and Budget (OMB)
    • CMS sends proposed rule on policy and technical changes to Medicare Advantage (MA) and the Medicare prescription drug benefit programs for CY2020 to OMB
    • CMS sends proposed rule on FY2020 Inpatient Rehabilitation Facility (IRF) Prospective Payment System rate update and quality-reporting requirements to OMB
  • The Center for Medicare and Medicaid Innovation posted the slides from the following webinars:
  • Eli Lilly announced it will sell HUMALOG (insulin lispro) as an authorized generic, sold at a 50% discount to the brand’s wholesale acquisition cost.
  • HIV is reported cured in a second patient, a “milestone in the global AIDS epidemic.”
  • An American Academy of Actuaries report evaluated proposals to expand insurance coverage through public plans.


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BIOSIMILAR PRICING TRACKER
 

Historical and Second Quarter 2019 ASP Amounts

 
 

This week, we’re posting our tracking of average sales price (ASP) for reference products and their biosimilars, as we are as interested as you in understanding how the introduction of biosimilars will impact the prices of their reference products. We will update these graphs on a quarterly basis, as CMS posts the new ASP files.

Below, we have included graphs tracking the ASP payment amounts for the reference products and the available biosimilars. Contact us if you have questions or would like more information.




 
HEARD ON THE STREET
 

– President Donald Trump, commenting on FDA Commissioner Scott Gottlieb’s decision on Tuesday to resign

 

 
POLICY BY NUMBERS
 

$2,378,727:
$1,440,217 to $3,697,916

 

A recent estimate showed physicians generate an average of $2.38 million per year in net revenue on behalf of their affiliated hospitals. Cardiovascular surgeons are the biggest revenue generators, earning their hospitals an average of nearly $3.7 million a year, while ophthalmologists earned an average of $1.4 million per year.

Source: “2019 Physician Inpatient/Outpatient Revenue Survey,” Merritt Hawkins, February 25

 

Executive Q&A With Jennifer Snow on Moving Medicare Coverage

 
 

Shifting coverage for some drugs from Medicare Part B to Medicare Part D is perhaps one of the most talked-about proposals within the Trump Administration’s blueprint for lowering drug costs.

In an executive Q&A, Xcendas Jennifer Snow, Vice President of Reimbursement and Policy Insights and Editor-in-Chief of Health Policy Weekly, provides insights on the impact of shifting coverage from Part B to Part D. She also shares what healthcare stakeholders need to know about the potential impact of this change. Learn more >

 

 

 

 
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:

Jenna Kappel | Reeya Patel | Scott Shields | Jennifer Snow | Stephen Wilson

PRODUCTION:

Laurie Kozbelt | Ellen Olson | Tia O’Brien

 

Mar. 8, 2019

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