Recent JAMA Viewpoint article recommends replacing cancer compendia. Learn more.

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August 26, 2016


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Editor’s note: We will not be publishing Health Policy Weekly next week. Our next issue will be September 9. We hope everyone enjoys the Labor Day weekend.

Replace Cancer Compendia?

A JAMA Viewpoint published online yesterday recommended replacing the cancer compendia for determining off-label coverage of oncology drugs. Two researchers at the University of North Carolina’s Lineberger Comprehensive Cancer Center and a JAMA associate editor suggested the compendia’s function could “most appropriately” be performed either under the direct oversight of the Food and Drug Administration (FDA) or by a consortium of public and private payers “with enforced policies to limit relationships with industry.”

The authors believe the current system has 4 flaws:
  1. The quality of evidence cited in compendia appears to be less rigorous when compared to the FDA’s standards
  2. The multiple (currently 5) designated compendia can create confusion since they use different criteria
  3. The compendia may be influenced by the pharmaceutical industry
  4. The compendia are not free of charge
Given the importance of compendia on coverage of cancer drugs, stay tuned for additional analyses as this story develops further.

Live Sept. 29 Webinar: Real-World Evidence: What Does It Mean for Your Commercialization Plans?


To ensure successful commercialization, manufacturers need to understand the crucial role real-world evidence (RWE) is now playing in product planning and determine best practices for evidence dissemination.

Join Xcenda’s Michael Eaddy, PharmD, PhD, Vice President, Real-World Evidence Generation, and Patricia Wolfangel, Vice President, Market Access Consulting & Communications, for a live webinar on September 29. This complimentary webinar will explore the critical role and impact of RWE on product life-cycle management from concept through post-launch. Insights will be provided on use of RWE to demonstrate product value, as well as best practices to ensure decision makers receive data in a timely and actionable format. Learn more.



Congress Is Out of Session


With Congress currently out of session, we will continue our legislative updates when the session resumes September 6.


Tommy Bramley, President of Xcenda, Featured in FiercePharma


Manufacturers today are going “beyond the pill” and incorporating digital health technologies into treatments. Xcenda President Tommy Bramley, PhD, RPh, shares insights with FiercePharma about the benefits of better demonstrating the clinical and economic value of digital health technologies to payers. Read more.



HHS Indicates Increased Tax Credits Will Offset Exchange Premium Hikes


A new analysis published by the Department of Health and Human Services (HHS) suggests patients enrolled in health insurance marketplace plans will not be on the hook for the rate hikes many payers are implementing in 2017. The analysis, released on Tuesday, indicates that premium increases will not deepen the financial burden on all enrollees. Rather, more corresponding financial subsidies will be available for eligible enrollees, and additional enrollees will be eligible to receive financial subsidies. In 2016, 85% of enrollees are receiving financial subsidies.

The analysis assumes a hypothetical scenario in which all qualified health plans in the marketplace increased premiums by 25% in 2017. The results show that, even with significant increases in premiums, 78% of consumers would still find coverage for $100 or less per month. According to HHS, this demonstrates how the structure of the program will continue to keep plans affordable for consumers.

While the scenarios are hypothetical and vary by geography and plan type, many plans have already increased premiums next year, from as low as 3% in Los Angeles to as high as 62% in Tennessee, although HHS review and approval are still pending.

Some states have pushed back on payers’ attempts to increase rates above a certain threshold, and, as a result, some of the largest insurers (including Blue Cross, Humana, UnitedHealthcare, and Aetna) have recently exited a number of markets, leaving consumers in some markets with considerably fewer health insurance options.

Despite the rate hikes and few plan options in select markets, HHS’ analysis indicates most patients will receive increased tax credits to offset rate increases.


Experts Urge CMS to Tweak Part B Drug Pricing Model


Amidst swirling rumors of the Medicare Part B Drug Payment model final rule release next month, 2 prominent Medicare policy thought leaders suggested modifications to the proposed demonstration in an editorial on Tuesday. Mark McClellan, former administrator of the Centers for Medicare & Medicaid Services (CMS), and Peter Bach, former senior adviser to the CMS administrator, put forth recommendations to spare providers from payment cuts and to maintain beneficiary access to important pharmaceuticals. While they support the core concept of Part B drug payment reform as a complement to other reforms the agency and private payers are instituting, they believe CMS needs to tweak the proposed mechanisms to be in alignment.

To keep specialty practices from going underwater on drug purchases, Drs. Bach and McClellan suggest CMS raise the flat fee associated with Phase I of the demonstration. Additionally, they believe CMS could opt to tie drug add-on fees to payments for proper patient care management and coordination and, in doing so, align with many of the other physician reforms currently in play. CMS could take this further by rolling add-on payments to the patient level and even building in a gain-sharing component.

Drs. Bach and McClellan emphasize the need to get modifications underway quickly to test their efficacy during the demonstration. Despite the challenges, the 2 policy experts see the potential for a successful demonstration.

Earlier this year, Dr. Bach, Director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Center, published a paper exploring the impact of the proposed Medicare Part B Drug Payment model on oncology care. Dr. McClellan, Director of the Robert J. Margolis Center for Health Policy at Duke University, has also commented publicly on the proposal.


Effectiveness and Value of Advanced NSCLC Treatments Reviewed


On Friday, the Midwest Comparative Effectiveness Public Advisory Council (CEPAC), a core program of the Institute for Clinical and Economic Review (ICER), released the Non-Small Cell Lung Cancer (NSCLC) Draft Evidence Report evaluating health outcomes and economic impact of tyrosine kinase inhibitors (TKIs) and programmed death 1 (PD-1) immunotherapy agents in advanced NSCLC.

ICER found the cost-effectiveness of the 3 TKIs was within “commonly-cited thresholds” but the 3 PD-1 immunotherapy agents were outside the range of cost-effectiveness. However, ICER stressed that variability in those drugs’ overall survival and progression-free survival benefits led to uncertainty about the cost-effectiveness estimates used in its analysis.

Value-based price benchmarks will be provided as part of its full evidence report, due in late September. ICER’s past pricing benchmarks have come under heavy criticism by the pharmaceutical industry for being focused on payer needs instead of patient needs.

Comments on the Draft Evidence Report will be accepted for 4 weeks, until September 16. On October 20, the Midwest CEPAC will host a public meeting where the Draft Evidence Report, submitted comments, and draft voting questions will be deliberated and discussed.

The comment period and public meeting present excellent opportunities for those interested in the TKIs and PD-1 agents to have their viewpoints heard and included in the public record.


Factors Driving Drug Prices in the US


Prescription drug expenditures have outpaced the cost of overall health expenditures in recent years, but what is driving these costs? Recently published in JAMA, “The High Cost of Prescription Drugs in the United States” provides an evaluation of peer-reviewed literature from medical and health policy journals from the past decade to identify several key factors leading to high drug prices and costs. The article also outlines potential policy solutions.

The high pricing of certain branded products is one major component of the expense of prescription drugs. Branded drugs account for 72% of overall drug spending in the US, even though only 10% of dispensed prescription drugs are for branded products.

Drug prices have also remained high due to patent and intellectual-property legislation, as well as the pharmaceutical industry’s assertion that its prices are representative of the research and development costs to develop drugs. However, the authors observe not all new drugs are developed by pharmaceutical companies. Research leading to drug approvals is often developed in academic institutions funded by public sources or in small biotech companies funded by venture capitalists.

In addition, Medicare cannot negotiate drug prices by law, yet the federal program is required to provide broad drug coverage. Furthermore, most state Medicaid programs must cover all drugs approved by the FDA, even if other products are safer, more effective, and/or provide cost savings.

To address these issues, the authors’ suggestions include tightening the requirements for secondary patents, creating more competition through improving the timeliness of the FDA approval process for manufacturing generic drugs, allowing governmental payers to negotiate drug prices, conducting more studies around comparative cost-effectiveness of drugs, and educating patients and physicians about the availability and effectiveness of drug products so they can make value-based decisions.

Implementation of these policies will be difficult and are not guaranteed to succeed in driving drug prices down, but, as the authors concluded, “There is little evidence that such policies would hamper innovation, and they could even drive the development of more valuable new therapies rather than rewarding the persistence of older ones.”


“I would characterize the exchange market in Tennessee as very near collapse...and that all of our efforts are really focused on making sure we have as many writers in the areas as possible, knowing that might be one. I’m doing everything I can to prevent a situation where that turns to zero.”

– Tennessee Insurance Commissioner Julie Mix McPeak, commenting on the need to accept insurers’ high premium rate requests to ensure residents would have health insurance options in 2017:

  • Cigna asked for and received an average 46.3% increase
  • Humana asked for and received an average 44.3% increase
  • BlueCross BlueShield of Tennessee asked for and received a 62% increase
Source: “Tennessee insurance commissioner: Obamacare exchange ‘very near collapse,’The Tennessean, August 23

2 | 22


In 2000, there were only 2 states where cancer was the leading cause of death; in 2014, there were 22.

Source: Heron M, Anderson RN. Changes in the leading cause of death: recent patterns in heart disease and cancer mortality. NCHS data brief, no 254. Hyattsville, MD: National Center for Health Statistics. 2016.


AMCP Nexus 2016

October 3–6 | National Harbor, MD
Join Xcenda in National Harbor for AMCP Nexus 2016. This premier, in-depth, educational event provides managed care pharmacy professionals with insights and tools to improve outcomes and reduce healthcare spending. Visit booth #612 to meet experts from Xcenda to help you navigate today’s healthcare environment. Learn more.


ISPOR 19th Annual European Congress

October 29November 2 | Vienna, Austria
Join Xcenda’s global team of HEOR experts at ISPOR’s Annual European Congress in Vienna, Austria. Xcenda will be hosting a morning symposium on Tuesday, November 1, titled, “Should the European Market Be Used as a Model for the United States? Insights From Payers and Considerations for Manufacturers.” Learn more.


HPW Rebuild


Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.


HPW Rebuild


Jennifer Snow
Health Policy

Scott Shields
Associate Director,
Health Policy



Peyton Howell, MHA
President | Global Sourcing & Manufacturer Relations | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | AmerisourceBergen Specialty Group

Loreen Brown, LMSW
Senior Vice President | Product, Strategy & Commercialization Excellence | Lash Group

Tommy Bramley, PhD, RPh
President | Xcenda

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

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

Ana Stojanovska
Vice President | Reimbursement & Policy Insights | Xcenda


Zachary Bridges | Amanda Forys | Vikram Harish | Marla KugelJennifer Le | Scott Shields | Diane Wilson


Laurie Kozbelt | Ellen Olson


August 26, 2016


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