Sanofi announces its “pillars of drug pricing principles.” Learn more.

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May 12, 2017

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FEATURED STORY
 

Priming the Pump: Sanofi’s Pricing Principles

 
 

Sanofi planted a stake in the ground regarding prescription drug pricing and how it affects the inflation of US healthcare costs. Earlier this week, the company issued a press release outlining its future approach to drug-pricing and price-transparency initiatives, based on what Sanofi calls its “pillars of drug pricing principles.”

To fulfill its commitment, Sanofi has established the following 3 pillars:

  • Clear rationale for pricing globally at the launch of a new medicine
  • Limited price increases in the US on medicines over time
  • Greater transparency in the US around pricing decisions

Sanofi maintains that innovation and scientific advancement will continue, while it also promotes patient access and drug affordability. To achieve this commitment, Sanofi’s drug price increases will remain below the national health expenditures (NHE) growth projection (estimated to be 5.4% in 2017). Additionally, Sanofi will be transparent with price increases and pricing decisions, saying it will disclose aggregate gross and net price increases in the US.

Sanofi’s stance on drug pricing and healthcare costs in the US may set the bar for the pharmaceutical industry; it is an interesting next step from Allergan CEO Brent Saunders’ principles articulated last September about the healthcare industry’s “unwritten social contract” between biopharma and society.

 

AmerisourceBergen’s Dave Picard, Vice President of Biosimilars and Injectables, Speaks on the Challenges of the US Biosimilars Market in Pharmaceutical Processing

 
 

Biosimilars May Be Similar, but Their Barriers to Entry Are Unique

In a Pharmaceutical Processing feature, Dave Picard, Vice President of Biosimilars and Injectables, speaks to the hurdles that stand in the way of bringing biosimilars to the US market as he addresses challenges related to the regulatory environment and biosimilar interchangeability. Read more

“The innovators are aggressively defending their biologic assets (IP and patents). There are a couple of biosimilars that have received FDA approval, but are not going to see the market for some time because of that legal hurdle.”  – Dave Picard

 
 

 
LEGISLATIVE UPDATES
 

Ask and Ye Shall Receive: Senate Hearing on Drug Spending

 
 

Looks like the Republican-controlled Senate will hold a hearing on drug costs. On Monday, Senators Bill Cassidy (R-LA) and Al Franken (D-MN) sent a bipartisan letter to Senators Lamar Alexander (R-TN) and Patty Murry (D-WA), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), requesting a committee hearing to address the “rising drug spending and the impact on overall health spending.”

Cassidy and Franken asserted the need for a comprehensive approach to “identify trends related to growing drug spending, bring down overall health care costs, improve and reward quality, and promote innovation.”

The following day, Alexander agreed to schedule a hearing, in the near future, “on drug spending in the US, including what we currently spend in the US, on what types of drugs, and what projections are for drug spending in the future.”

Increased attention to drug pricing on the Hill, the rumor of the Department of Health and Human Services (HHS) releasing a drug-pricing white paper in the next few weeks, and the White House’s ongoing listening sessions with healthcare stakeholders, signal we might start to see some government action on drug prices or spending after months of hints.

 

Drug Importation Fails to Hitch a Ride on Senate’s Skinny UFA Legislation

 
 

Yesterday, the Senate HELP Committee passed S.934, the Food and Drug Reauthorization Act, by a vote of 21-2, with Senators Rand Paul (R-KY) and Bernie Sanders (I-VT) voting no. The Sanders Amendments, which would have allowed the importation of prescription drugs from Canada and member countries of the Organization for Economic Co-operation and Development (OECD), were tabled by a slim vote of 13-10, but only after a lengthy discussion on the pluses and minuses of importation as a mechanism to help moderate drug pricing and assurances that importation is not completely off the table.

A few amendments were able to get on board the Food and Drug Administration (FDA) User Fee Authorization legislation. Sen. Orrin Hatch’s (R-UT) amendment, which would require the FDA to expand patient access to experimental treatments in clinical trials, passed by voice vote. Sen. Susan Collins’ (R-ME) amendment, which is a modified version of her bill, Increasing Competition in Pharmaceuticals Act (S.297) that would establish an expedited time frame for review of certain generic drug applications among other provisions, also passed by voice vote. Sen. Mike Bennet’s (D-CO) amendment, which incorporated his RACE Act bill (which would have expanded the FDA’s pediatric testing requirements), was introduced and withdrawn after Chairman Alexander agreed to continue working with him on the measure.

 
REGULATORY UPDATES
 

Expanded Access No Guarantee of Health Behaviors

 
 

A research paper published through the National Bureau of Economic Research found that while the Affordable Care Act (ACA) achieved success in its goal of expanding access to Americans, expanded access did not immediately translate into better health behaviors among newly covered individuals.

Researchers analyzed data from 2011 to 2015 from the Behavior Risk Factor Surveillance System, which conducts annual nationwide telephone surveys and aggregates data based on self-reported replies from more than 300,000 individuals. While the ACA reduced the number of uninsured individuals nationally by 44%, researchers found that these improvements in access to healthcare did not statistically significantly affect risky behaviors and health status; decreases in smoking, substance abuse, and obesity were not greater, nor was self-reported health status more improved, than in the earlier years of the survey.

While minor variations were found—for example, older, non-elderly adults in Medicaid expansion states reported slightly better self-assessed health—researchers noted that simple access to healthcare did not immediately change health behaviors, stating that “improved access to medical care may be of only limited value with regard to health behaviors since they are generally not as easy to treat as acute conditions.” They also noted that the survey results do not capture the effect of expanded access on clinical outcomes, such as the treatment of diabetes or asthma within the context of these self-reported results.

This study tracks the results from the “Oregon Medicaid Experiment,” which found that insurance (via Medicaid) led to increased access to and utilization of health care, substantial improvements in mental health, and reductions in financial strain, compared to not having insurance. However, analyses showed that Medicaid had no statistically significant impact on physical health measures. Or, as health journalist Megan McArdle has said, “Insurance can give you access to a doctor, but it cannot make you take your medicine.”

 

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:

  • Senate confirms nomination of Scott Gottlieb for Commissioner of the FDA
  • The Congressional Budget Office announces it will release a cost estimate for the House-passed version of the Affordable Health Care Act (AHCA) early in the week of May 22
  • The Institute for Clinical and Economic Review releases a host of materials:
  • A study in The BMJ (formerly the British Medical Journal) found the quantity and quality of post-approval clinical evidence varied substantially for novel drugs approved by the FDA on the basis of a single pivotal trial, pivotal trials that used surrogate markers of disease, or both
  • The Centers for Medicare & Medicaid Services updated its Electronic Clinical Quality Measures for calendar year 2018 reporting
 

FDAMA 114 and the 21st Century Cures Act: Insights From Payers and Manufacturers, and Implications for the Exchange of Health Care Economic Information

 
 

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.

Read more

 
 

 
HEARD ON THE STREET
 

“Among the many confounding aspects of recent health policy debates was how much attention focused on the wrong issues. The conversation devolved into a proxy war over the Affordable Care Act instead of dealing with the deep-rooted flaws in our health system.”

– Dave A. Chokshi, MD, MSc, Chief Population Health Officer of OneCity Health and Senior Assistant Vice President at New York City Health + Hospitals

Source: “Reframing the Health Policy Discourse,” JAMA Forum, May 8

 
POLICY BY NUMBERS
 

18.4%

 

National health spending as a percentage of gross domestic product (GDP) reached an all-time high at just below 18.4% in March.

Source: “Slowdown Continues in Health Care Job Growth, but Health Spending Share of GDP Reaches All-Time High,” Altarum Institute, May 11  

 
UPCOMING MEETINGS & CONFERENCES
 

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

 
 
IN THE NEWS
 

Biosimilars May Be Similar, but Their Barriers to Entry Are Unique

Pharmaceutical Processing, May 10, 2017
When will biosimilars grow up? In a Pharmaceutical Processing feature, Dave Picard, Vice President of Biosimilars and Injectables, speaks to the hurdles that stand in the way of bringing biosimilars to the US market as he addresses challenges related to the regulatory environment and biosimilar interchangeability. Read more

 

Factors for Manufacturers to Consider as They Enter the Biosimilars Space

The Pharma Letter, May 10, 2017
In a piece penned by AmerisourceBergen’s Rich Tremonte, Senior Vice President of Global Generic Pharmaceuticals, Mr. Tremonte discusses how biosimilars are a hybrid category that occupies a space between innovator brands and generic products. Biosimilars are a new class of medications that requires unique planning and support throughout the development and commercialization process. Read more in The Pharma Letter (subscriber access is required).

 
 

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
Director,
Health Policy
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

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

CONTRIBUTING AUTHORS:

Katherine Bridges Maness | Kylie Matthews | Scott Shields

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

May 12, 2017

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