Members of the moderate House “Tuesday Group” caucus work on reviving the AHCA. Learn more.

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Apr. 28, 2017


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Hey, Batter-Batter-Swing-Batter: GOP Tries Again to Move ACA Repeal-Replace


Rep. Tom MacArthur (R-NJ), Co-chair of the more moderate House “Tuesday Group” caucus, has been working with the House Freedom Caucus to seemingly bring the American Health Care Act (AHCA) back from the dead, in spite of the bill’s ignominious retirement several weeks ago. The amendment is an effort to bridge the gap between the 2 groups.

The amendment would maintain most of the Affordable Care Act’s (ACA) market reforms, including:

  • Prohibition on pre-existing condition exclusions
  • Prohibition on discrimination based on gender
  • Guaranteed issue and renewability requirements
  • Coverage of adult children up to age 26 on their parents’ plans
  • Community rating, except as permitted by waiver

However, MacArthur’s amendment would allow states to seek waivers to weaken several key ACA insurance reforms that protect those with pre-existing conditions, essential health benefits, and the ban on allowing carriers to charge more based on a person’s health background. Any state choosing to opt out of the ACA regulations must establish a high-risk pool to help cover sick patients whose premiums might surge.

This amendment addresses some of the complaints of Congressional Republicans, who said the original AHCA was just “Obamacare lite” and who wanted the states to have more power.

On Wednesday, the Freedom Caucus announced it would support the AHCA as long as it has the MacArthur amendment. However, on Thursday night, House Republican leadership indicated the bill wouldn’t be voted on until next week or such time (if there is one) that the bill musters the votes for passage.


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Panning Fool’s Gold? A Step Closer to Single-Payer in California


A costly proposal to create a government-run, single-payer healthcare system in California passed its first major hurdle Wednesday, as the state’s Senate Health Committee passed the Healthy California Act (S.B. 562) in a 5-2 vote.

Under the bill, all state residents would be covered, including Medicare beneficiaries, Medicaid enrollees, undocumented residents, and even Californians who already have health insurance through their employers.

The Healthy California Act is similar to a single-payer system that Vermont tried, only to see it fall apart in 2014 after the governor decided it would cost too much. California residents will pay higher taxes instead of paying premiums; the tax revenue will fund the insurance plan.

The committee’s analysis estimates the plan would cover 17.5 million residents with employer-based coverage, 11 million Medi-Cal enrollees, 4 million Medicare beneficiaries, 2.6 million individually insured residents, and 3 million uninsured.

Financing the plan is a forbidding prospect. The federal government is expected to contribute $261 billion originally allocated for Medicare, Medicaid, and the state exchange. However, according to an August 2016 UCLA Center for Health Policy Research study mentioned in the bill analysis, the cost for those with employer-provided insurance would be $106.5 billion.

The Healthy California Act now goes to the Senate Appropriations Committee, where members have the unenviable task of determining how to fund the plan. While it seems unlikely that the bill will be enacted, this is another example of states driving innovation in healthcare coverage and access.


Laying Down the Law: Supreme Court Finally Hears Biosimilar Case


This week, the Supreme Court of the United States heard oral arguments from Sandoz and Amgen in the ongoing battle over the Sandoz biosimilar of Amgen’s NEUPOGEN® (filgrastim), marking the first time the Court has dealt with the Biologics Price Competition and Innovation Act (BPCIA) since it went into effect in 2010.

As we have been chronicling in Health Policy Weekly, in June 2016, the Supreme Court asked the Solicitor General to weigh in on Sandoz v. Amgen before it decided whether to hear the case.

The case centers on 2 issues involving information exchange and the 6-month waiting period before a biosimilar can be launched.

Information Exchange

The Supreme Court will decide whether one of the BPCIA’s key information exchange provisions governing disclosure of the biosimilar application and manufacturing information to the reference product sponsor is mandatory or optional, and what the consequences of opting out of this exchange provision should be. Sandoz believes it is optional, while Amgen believes it is mandatory.

6-Month Waiting Period

The Supreme Court will also decide if or when a biosimilar company should provide notice to the reference-product manufacturer of its intent to market a biosimilar, thus triggering a 6-month waiting period. Amgen is arguing that the notice to market a biosimilar cannot begin until Food and Drug Administration (FDA) approval. Sandoz believes such an interpretation would mean an additional 6-month “exclusivity windfall” that Congress did not intend with the BPCIA.

A decision is expected in late June or early July. The consequences are enormous; as this is a nascent marketplace, these decisions will affect basic guidelines of marketing and launching biosimilars.


Didn’t We Tell You? Value-Based Payment Is the Future of Healthcare


The World Economic Forum (WEF) said Wednesday that shifting the global focus of healthcare to outcomes would enable health systems to address the rising costs. The WEF presented its recommendations in its report, Value in Healthcare: Laying the Foundation for Health-System Transformation, to be implemented in 4 pilot locations starting in Atlanta this year.

The report stems from concern over the sustainability of healthcare across the globe. The report notes that costs are growing at roughly double the rate of growth in gross domestic product, “putting severe pressure on healthcare budgets and constraining further development.” The WEF identified 3 principles on which it believes the value-based approach to care rests:

  1. Measuring systematically the health outcomes that matter to patients and the costs required to deliver those outcomes across the full cycle of care
  2. Tracking those outcomes and costs for defined population segments on an ongoing basis
  3. Developing customized interventions to improve value for each population segment

Though many entities have recommended various avenues to reduce escalating healthcare costs, WEF’s approach is unique because of its implementation in Atlanta this year, with the blessing and participation of staff at the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC).

The 3-year Atlanta pilot will study how to improve patient outcomes and reduce costs for heart failure. A group of 20 payer, provider, supplier, and government associations in Georgia will convene 4 times over the next 6 months to flesh out the framework of the pilot.

Obviously, the value-based payment model has high visibility, with many payers, providers, and life sciences companies professing interest. However, data on long-term impacts have been scarce; WEF’s pilot in Atlanta might provide another data point, as paying for value gains momentum.


Like Taking Your Car to the Dealer for Service: Site of Care Matters for Cancer Costs


A recent systematic literature review, based on claims data, reports cancer treatment costs are significantly lower in the community clinic/physician office setting when compared to the hospital outpatient setting. Costs were found to be on average 38% greater in the outpatient setting, regardless of the datasets and years examined, types of cancers, or treatments used.

Cancer severity, the need for inpatient care, and coding are possible reasons for these cost differences, as detailed in the review:

  • Hospital systems often differ in the specific codes submitted for chemotherapy when compared to clinics/physician offices
  • Outpatient payment per unit is often twice the amount of the clinic/physician office rate
  • Outpatients had a higher rate of hospitalization than clinic/physician office patients

The review also suggested outpatients may simply have more chronic conditions, requiring more care and cost. Some support for this idea was found in a study commissioned by the American Hospital Association. This study also found hospital cancer outpatients differ in other and potentially contributing aspects from office cancer patients, such as income and education level, and they are more likely to have Medicaid.

When evaluating treatment locations, it is paramount to note that reviews based on claims data are unable to address patient and provider rationales for treatment locations, choice of treatment plans, and patient outcomes.


Clinical-Trial Eligibility Not Based on Eeny Meeny Miny Moe, Right?


According to a recent opinion article in the New England Journal of Medicine, eligibility criteria for clinical trials need to move beyond standard protocols that protect patients from undue harm, define the study population, and permit collection of safety and efficacy data specific to the intended population. The authors’ believe, in many cases, that: investigators lack a sound clinical rationale for excluding certain patients; and that restrictive inclusion and exclusion criteria often exclude patients who will most likely be prescribed the drug once it’s approved.

FDA regulations do not establish specific eligibility criteria, but manufacturers know regulatory approval is based on data derived from enrolled patients who are expected to represent the appropriate US population and medical prescribing behavior.

The authors make clear that, although the primary objective of eligibility criteria is to protect patients, re-evaluating standard criteria may offer a more accurate safety and efficacy profile for patients taking the medications in the real world.

As payers and other framers of value—particularly in the oncology space—redefine the full extent of what controlled trials can and should accomplish, drug makers and their clinical teams may want to identify and adapt their enrollment criteria to reflect the real population cohorts prescribers need to treat.


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:

  • Reuters reported that UniQure is canceling the Western world’s first gene therapy and the most expensive prescription medicine in history due to lack of demand.
  • Because a week wouldn’t be complete without an Institute for Clinical and Economic Review (ICER) update…ICER announced an upcoming report to review drugs for tardive dyskinesia.
  • And that makes 5—the FDA approved the fifth biosimilar, Samsung Bioepsis’ RENFLEXIS® (infliximab-abda), which is biosimilar to Janssen’s REMICADE® (infliximab).
  • The House Energy and Commerce Health Subcommittee announced a hearing to examine improvements to the regulation of medical technologies on May 2.

The Future of FDAMA 114—How Will It Impact Access to Specialty Therapies?


Asembia Specialty Pharmacy Summit | April 30–May 3 | Las Vegas

With increased scrutiny surrounding specialty drug pricing, has the demand for health economic (HE) information and real-world evidence stretched beyond the limitations of FDAMA 114?

Matt Sarnes, PharmD, Senior Vice President of Commercial Consulting, and Jay Jackson, PharmD, MPH, Senior Vice President of Scientific Consulting, will present, “The Future of FDAMA 114—How Will It Impact Access to Specialty Therapies?” at the upcoming Asembia conference. They will shed light on recent recommendations shared with the FDA, new research regarding payers’ requests for data, common practices and challenges in producing and sharing this information, and the emerging role of providers as they take on more economic risk for their patients.

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“[Johnson and Johnson has] an innovative portfolio in pharma and the innovation comes with greater patient outcome and therefore evidence that supports the pricing for the products. That’s the vast majority of the portfolio in oncology, immunology, neuroscience. In certain parts of the portfolio cardiovascular and metabolic in particular, that’s a little bit more crowded; it’s not a specialty focused, more primary care focused. And that’s where the payer community has more influence over rebates and the like. I don’t think that we’re going to see a dramatic change in our pricing methodologies, it’s all evidence based….And so we’ve had modest price increases on a net price basis and we think that’ll be the case going forward.”

– Dominic Caruso, EVP and CFO, Johnson and Johnson, responding to a Wall Street analyst’s question about the company’s approach to pricing its pharmaceutical products

Source: “Johnson & Johnson (JNJ) Q1 2017 Results—Earnings Call Transcript,” Seeking Alpha, April 16


From 30% to 60%


The share of oncology practices owned by hospitals and health systems has doubled since the expansion of 340B-eligible facilities, from less than 30% in 2010 to nearly 60% in 2015, despite the authors finding “little evidence” the ACA’s 340B expansion contributed to the consolidation.

Source: “Evaluating the Role of Payment Policy in Driving Vertical Integration in the Oncology Market,” Health Affairs, April 2017


Asembia Specialty Pharmacy Summit 2017

April 30–May 3 l Las Vegas, NV
Join Xcenda at the largest US conference for specialty pharmacy. Matt Sarnes, PharmD, Sr. Vice President of Commercial Consulting, and Jay Jackson, PharmD, MPH, Sr. Vice President of Scientific Consulting, will present, “The Future of FDAMA 114—How Will It Impact Access to Specialty Therapies?” at the upcoming Asembia conference. Meet leaders and experts from AmerisourceBergen at booth #316. Learn more


ISPOR 22nd Annual International Meeting

May 20–24 l Boston, MA
Join Xcenda’s Jay Jackson, PharmD, MPH, Senior Vice President of Scientific Consulting, as he moderates a Tuesday lunchtime symposium titled, “FDAMA 114 and the 21st Century Cures Act: Insights From Payers and Manufacturers, and Implications for the Exchange of Health Care Economic Information,” at the ISPOR 22nd Annual International Meeting in Boston May 20–24. Visit us at booth #817 to meet with our global HEOR team and learn more about our award-winning research. Learn more


2017 ASCO Annual Meeting

June 2–6 l Chicago, IL
Join leaders and experts from AmerisourceBergen at ASCO’s Annual Meeting in Chicago. This meeting brings together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. Visit AmerisourceBergen’s booth at #6135. Learn more


HDA 2017 Business and Leadership Conference

June 11–14 l Phoenix, AZ
HDA’s Business and Leadership Conference (BLC) is the healthcare distribution industry’s signature annual conference. The conference brings together high-level executives and influencers across the healthcare supply chain to hold strategic business discussions on the industry’s most pressing issues. AmerisourceBergen’s John Wernicki, Senior Director of Strategic Accounts, will join a panel titled, “Ask the Distributors: How Personalization Works,” on June 12 from 11:45 AM–3:30 PM to provide tips on how to help the independent pharmacy channel grow its front end and drive a more profitable business mix. Learn more


2017 BIO International Convention

June 19–22 l San Diego, CA
Join experts from World Courier and Xcenda at the 2017 BIO International Convention in San Diego. This annual conference, hosted by the Biotechnology Innovation Organization (BIO), is the largest global event for the biotechnology industry and attracts the biggest names in biotech. Visit the World Courier booth at #5408. In addition, Jennifer Snow, MPH, Director of Health Policy at Xcenda, will participate on a panel titled, “The Whole Picture: Consideration of Personalized Medicine in Value Assessment Frameworks” on June 22 at 10:15 AM PT. Learn more


2017 Pharmaceutical End-to-End Supply Chain Management Summit

July 24–25 l Philadelphia, PA
Matt Sample, Senior Director, Secure Supply Chain at AmerisourceBergen, will present, “Utilize Serialization and Traceability Data to Ensure End-to-End Supply Chain Visibility.” He will discuss standardized product packaging and serialization, show how to integrate data standards within the commercial supply chain for enhanced visibility, and review the methods to secure the data and ensure interoperability throughout the end-to-end supply chain. 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
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

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


Bernard Falkoff | Scott ShieldsDiane Wilson | Stephen Wilson


Laurie Kozbelt | Ellen Olson


Apr. 28, 2017


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