We examine ICER's highly anticipated list of potential options for assessment in 2019.

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Aug. 10, 2018


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HPW Readers: We’re here for you. We know it is mid-August but we’re here to bring you some relief. We didn’t set out to be superheroes. But sometimes life doesn’t go the way you planned.


Mirror, Mirror on the Wall, Who Will Be the Fairest of Them All?
ICER Releases 2019 Topics


Late last week, the Institute for Clinical and Economic Review (ICER) released its highly anticipated list of Potential Options for Assessment in 2019. While this list is not a guarantee that every topic will be evaluated, historically, the vast majority of potential topics have become actual topics of ICER evaluations. Only 2 of 9 potential topics for 2018 have not been evaluated. In 2019, it appears that ICER will increase the number of evaluations (including updates of prior reports).

The topics themselves are interesting, as there are apparent extensions of (or updates to) prior ICER topics such as multiple sclerosis, CAR-T therapy, rheumatoid arthritis, and lower back pain—along with new areas such as peanut allergy, schizophrenia, wet age-related macular degeneration, and paroxysmal nocturnal hemoglobinuria, among others. Non-pharmacologic topics may address medical devices and behavioral health intervention. It appears that ICER could update its methodology to include adaptations specific to medical device evaluation.

The potential topics for 2019 are particularly noteworthy in light of the following other benefits or disadvantages and contextual considerations:

  • ICER methods
    • ICER’s 2017-2019 methodology is due to be opened up for public comments, reviewed, and updated in 2019
    • The implementation of ICER’s guidance on real-world evidence to inform drug coverage and formulary decisions may be more fully realized in 2019, with stakeholders having sufficient time to generate the evidence since the document was released in April 2018
    • 2019 will mark the first full year of ICER’s pilot program for releasing economic models for review by stakeholders as part of their evaluation process
  • Extended funding in 2017 will also continue to foster ICER’s growth and expansion in several important ways:
    • The inaugural annual report examining whether price increases on prescription drugs are unsupported by new clinical evidence is anticipated by Q1 2019
    • ICER anticipates performing more frequent evidence updates to existing reviews
    • There will be increased collaboration with employers and payers on innovative benefit design and reimbursement programs
    • Expect further development of ICER’s methods around stakeholder engagement

Next steps to take if you’re in the potential spotlight of ICER:

  • Plan ahead
  • Create a roadmap to assist in planning and identifying evidence needs
  • Understand the value landscape for your asset(s)
  • Know what to expect from an ICER evaluation
  • Proactively address evidence needs
  • Develop a strategic and tactical plan
  • Ready your team with knowledge

Don’t go it alone: For all of the above, Xcenda provides strategy and support with an integrated, unparalleled breadth and depth of subject matter expertise to custom-fit your ICER value-assessment needs.


Just Keep Swimming: Administration (Re)Introduces Step Therapy in Part B


On Tuesday, the Centers for Medicare & Medicaid Services (CMS) issued a memo to Medicare Advantage (MA) plans on utilization management of the Part B benefit, reversing its guidance from 2012 to now allow step therapy for Part B drugs and services beginning January 1, 2019. CMS also released an accompanying fact sheet on the guidance.

Under the new guidance, CMS will permit the following types of step therapy in Part B:

  • Require 1 Part B drug to be used before a different Part B drug
  • MA plans that also offer prescription drug coverage (MA-PD plans) may require a Part D drug before a Part B drug
  • MA-PD plans may require a Part B drug before allowing a Part D drug

The administration believes enacting step therapy may decrease average sales prices (ASPs) for Part B drugs due to increased market competition and rebates. The shared savings from Part B price reductions will be passed on, in part, to beneficiaries through rewards as a part of a drug-management, care-coordination program. These rewards must equal more than half of the amount saved on average per patient. Due to anti-kickback legislation, “rewards” cannot be monetary but may be offered as gift cards or other items of value.  

The intention of this guidance is to fulfill the administration’s promise on lowering drug costs to patients, and the impact is projected to be mostly with higher-cost Part B drugs.

With about a third of all Medicare patients enrolled in an MA plan, CMS is showing its willingness to experiment with more market competition to lower drug costs while trying to safeguard patients, with the following caveats included in the memo:

  • Plans must provide adequate disclosures regarding Part B step edits during open enrollment from Oct. 15 through Dec. 7, 2018
  • If a patient is not satisfied with their MA plan, they have a 1-time option to select a new MA plan or Original Medicare from Jan. 1 through Mar. 31
  • Step therapy may only be applied to new prescriptions or administrations of Part B drugs for enrollees who are not actively receiving the affected medications
  • Standard exception requests are required for step edits, and they can be expedited upon request

CMS is also advising MA plans to leverage pharmacy and therapeutics committees and processes in the development of Part B step edits, and it is beginning to look more and more like Part B and D drugs will have a more level playing field in terms of utilization management by MA-PD plans in the not-too-distant future. This also feels like a phase in the potential shift of Part B drugs to Part D formularies, yet there are many unanswered questions regarding what would happen to the remaining two-thirds of Medicare beneficiaries with original fee-for-service Part B benefits where Part D is optional.

Continue to be on the lookout for other changes raised in the Trump Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (Blueprint), as it appears incremental changes, such as this one, may be precluding larger policy-based changes that require public review and comment.

XCENDA—Behind the Policy

CAP: The Past Can Hurt, But You Can Run From It or Learn From It


Last month, buried in the Medicare 2019 Outpatient Prospective Payment System (OPPS) proposed rule, was a Request for Information (RFI) looking for public comments on alternatives to the buy-and-bill Part B drug reimbursement methodology that uses the ASP methodology. Potential options include (1) a reboot of the shuttered Competitive Acquisition Program (CAP), (2) a group purchasing organization (GPO)-like model, called the Drug Value Program (DVP) that was dreamed up by the Medicare Payment Advisory Commission (MedPAC), or (3) a hybrid model.

There are many reasons CAP failed a decade ago. Based on work with our sister company, IntrinsiQ, we do not see evidence that the add-on incentivizes physicians to prescribe higher-priced drugs to increase their profits, but, with the administration determined to make changes, being solution-oriented is in vogue.

In Xcenda’s analysis of the posted comments to the Blueprint, we found that stakeholders are concerned that neither the CAP-like model nor the DVP, with its private vendors using formularies and utilization-management criteria, would lead to lower prices for Medicare Part B drugs. However, we found a few dozen comments on the CAP program and considerations for revamping the program. Almost universally, stakeholders believe that CAP should be a voluntary program and start with a few select therapies.

Comments also zeroed in on how the program could be changed to allow more just-in-time dispensing and provide administrative fee payments to participating providers. Many commenters also focused on not allowing CAPs to develop formularies, because they felt such utilization management could differentiate care among patients and hinder patient access.

Is CAP the answer? It depends on what problem you’re trying to solve. It seems unlikely to lower drug prices because Medicare Part B buy-and-bill is already lower than private payers and as transparent as it gets. But, if you’re hoping to keep providers from participating in Medicare, perhaps providing an alternative to the financial risk of buy-and-bill might work for some specialties.  Discussing ways to learn from the past and considering ways the environment has changed may be the best path forward.


Emerging Trends in PBM Restrictions on Commercial Copay Assistance


CBI 6th Annual Reimbursement & Access 2018

Join experts Corey Ford, MHA, Director, Reimbursement Strategy & Tactics, Xcenda, and Jim Dickey, Director, Product Experience, Lash Group, at the 6th Annual Reimbursement and Access conference August 15–16 in Philadelphia to learn more about copay accumulator programs and their impact on manufacturers and patients.

Learn more >



HPW Rebuild


I’m Watching You, Maine, Always Watching You:
Maine Gives Generic Manufacturers Access to Brand Samples


Last month, Maine became the first state to enact a law intended to prevent companies from withholding samples from generic manufacturers through closed distribution systems implemented as part of a Risk Evaluation and Mitigation Strategy (REMS).

Suggesting that companies are exploiting REMS, Food and Drug Administration (FDA) Commissioner Gottlieb recently released a list of companies potentially blocking access to samples needed for generic drug development and further issued guidance addressing the process for sharing the REMS by brand and generic manufacturers. “The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market," said Commissioner Gottlieb.  

The new Maine law will require a manufacturer or wholesaler licensed in Maine to make a branded drug available for generic manufacturers without invoking the REMS provision as a means to block such request and at a price no greater than the wholesale acquisition cost (WAC). The law also includes liability protection for the branded manufacturer and stipulates that generic manufacturers may not charge consumers in Maine more than the WAC.

Since REMS is a federal restriction managed by the FDA, state laws are expected to be contested in court. Meanwhile, this issue continues to gain support at the federal level. In June, the Senate Judiciary Committee voted to bring the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Under CREATES, generic manufacturers could pursue civil action against companies suspected of delaying access to testing samples or seek their own REMS program from the FDA.

HPW Rebuild


Even Miracles Take a Little Time: FDA Looking at COAs


Last week, the FDA issued an announcement soliciting public comment ahead of its planned work to promote development of clinical outcomes assessments (COAs) and endpoints to be used in clinical trials and to support drug approval decision making. The FDA is interested in identifying the diseases and treatment impacts that matter most to those living with the disease or condition and has published 17 different questions around specific components of COA development, with the goal of developing publicly available core set(s) of COA measures and endpoints.

Since 2012, the FDA has conducted patient-focused meetings in different disease areas to hear directly from patients about the impact of disease on their daily life and the burden of current treatments. But separate, independent efforts by different patient advocacy groups and drug sponsors within and across disease areas are resulting in a diversity of measures and proprietary COA tools. The FDA is seeking to provide guidance to streamline their development and provide consistency in future COAs.

By producing these guidelines, there may be opportunity for additional direction for industry sponsors on how to support integrating the patient experience into their drug-development programs. Also, this may help guide the next steps for other external stakeholders around developing tools for use in various disease states.

The comment period ends on October 15. The FDA is holding a workshop on October 15 and 16 about methods to identify what is important to patients and select, develop, or modify fit-for-purpose COAs. Discussion documents are expected to be published by the FDA, outlining topic areas for a draft guidance, approximately 1 month before the workshop.


Just Because It’s Done, Doesn’t Mean It Should Be: Questionable Drug Revenue Findings


A recent analysis published on the Health Affairs blog attempts to quantify the amount of prescription-drug spending each supply-chain participant “captures.” The authors estimated the retained revenues and/or gross profits associated with prescription drugs’ path from the manufacturer to the patient and allocates the total amount of drug spending among manufacturers, purchasers, and payers. Given the recent attention to supply-chain dynamics, this research is coming at an interesting time.

According to the analysis, the US spent an estimated $480 billion on prescription drugs in 2016, including the gross profits of all intermediaries. $323 billion of this spending was manufacturers’ net revenue excluding rebates, discounts, and other price concessions but did not account for manufacturing expenses. In comparison, the study measured the gross profits of other supply-chain stakeholders, such as pharmacies ($73 billion), providers ($35 billion), wholesalers ($18 billion), and pharmacy benefit managers (PBMs ) ($23 billion) for the remaining $157 billion.

The blog post implies that manufacturers “capture” 67% of total drug spending, dwarfing the amount captured by all other participants, including PBMs, wholesalers, pharmacies, providers, and health insurers. However, the authors counted retained revenue by manufacturers, but gross profits by the other elements in the supply chain, and failed to explain the difference in metrics used. Retained revenue would include research and development costs, a not-insignificant cost.

Recent actions, such as President Donald Trump’s May 11 speech on lowering prescription drug prices, and many statements from the pharmaceutical industry, have put increased pressure on PBMs, in particular, and the role they play in drug prices. The article implies manufacturers play a far bigger role, but that conclusion is marred by the inconsistent metrics used to determine spending.


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:


How Policy Impacts Patient Support


Seismic shifts in the healthcare policy landscape can play a considerable role in altering the need and demand for patient support services offered by manufacturer programs.

Since the inauguration of President Donald Trump, congressional Republicans have launched significant undertakings to reform the laws that govern America’s complex healthcare system. Despite the push, efforts to repeal and replace the Affordable Care Act (ACA) have fallen short. 

Xcenda's Ana Stojanovska and Corey Ford, both with the Reimbursement & Policy Insights team, examine the impact of policy changes to patient support in a new Insights article.  Read now >




Public Health Announcement: "You're braver than you believe, and stronger than you seem, and smarter than you think." (Unless you’ve been drinking, and that’s the problem)

“I’ve seen drunk people wandering into the street around 2 or 3 in the morning like zombies. When you get drunk, you think you can rule the world. You may not be paying attention to anything else.”

 - Austin Loan, a bouncer checking IDs at Hawthorne, a restaurant with 5 bar areas and DJs on the weekends

Source: “Thousands of inebriated pedestrians die each year in traffic accidents,” The Washington Post, August 6





Insurers offering exchange plans in the 38 states that use HealthCare.gov are seeking average 2019 rate hikes for individual plans of 5.4%, a CMS official said at a National Association of Insurance Commissioners meeting.

Source: “CMS: Modest 5.4 percent rate hikes for HealthCare.gov states,” Politico, August 6


CBI Reimbursement and Access 2018

August 15–16  | Philadelphia, PA
Xcenda’s Corey Ford, MPH, Director of Reimbursement Strategy and Tactics, will team up with Lash Group’s Jim Dickey, Director of Product Experience, to present a session titled, “Emerging Trends in PBM Restrictions on Commercial Copay Assistance.” They will examine and discuss the emerging copay accumulator trends. Learn more


AMCP 2018 Nexus

October 22–25  | Orlando, FL
Xcenda is proud to support AMCP at this year's AMCP Nexus conference in Orlando, Florida. Meet with Xcenda's team of experts and consultants at booth #407. Students are also welcome to join our team at the Residency and Fellowship Showcase on Wednesday, October 24 from 5:00–8:00 PM ET. 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.


Jennifer Snow
Senior Director,
Health Policy

Scott Shields
Associate Director,
Health Policy



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 | Reimbursement & Policy Insights | Xcenda


Maureen Holmes | Isabell Kang | Jenna Kappel | Kristen Migliaccio-Walle | Scott Shields | Diane Smith | Jennifer Snow | Stephen Wilson


Kylie Matthews | Ellen Olson | Tia O’Brien


Aug. 10, 2018


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