E.V.I.dently March 2020

Message from NPC

NPC and COVID-19 Operating Status Update

COVID-19 is clearly the topic of the moment, and we hope that you and your loved ones remain safe and healthy during this challenging time. The National Pharmaceutical Council (NPC) is operating under a remote work policy. We remain committed to our members, partners, colleagues and the continuity of our business operations. NPC staff are available via email and phone, and we encourage you to reach out if you have any questions or concerns.

In Social Distancing, Finding Closeness in Community

In an article on LinkedIn, NPC President and CEO Dan Leonard reflects on how communities - even virtual ones - are especially important support mechanisms during this COVID-19 challenge. Mr. Leonard expresses his confidence that the biopharmaceutical industry and its partners in medicine and academia will succeed in discovering the ultimate therapies and powerful vaccines that will win this battle.

NPC Now: A Look at Our Latest Work

Coronavirus and High-Deductible Health Plans: A Double Whammy for U.S. Patients

Almost half of Americans are covered under high-deductible health plans (HDHP). What potential impact can these plans have on consumers, especially in-light of the response to the COVID-19 outbreak? Unlike patients with a chronic condition who may have already hit their deductible for the year, an infectious outbreak affects people who are otherwise healthy and have not yet reached their deductible. This could cause financial stress across the country. In a post on LinkedIn, NPC Vice President for Health Research Michael Ciarametaro proposes five specific actions that healthcare decision-makers should consider in order to avoid the ripple effects of COVID-related services and HDHPs. 

A Behind the Scenes Look at Coverage Decisions 

In his latest column for Specialty Pharmacy Times, Mr. Leonard looks at what’s really behind the discrepancies in coverage decisions from one insurer to the next. Mr. Leonard discusses research that uncovers the reasons for these health coverage policy decisions. “Some variation in the evidence that plans report reviewing is expected, but the extent of variation in the volume, composition and consistency of the cited evidence is notable and may be a key factor behind the inconsistent coverage that patients encounter,” Mr. Leonard writes. “These coverage decisions should be based on a complete review of the comprehensive set of evidence using accepted methods to assess the quality and certainty of evidence.” Read about his recommendations on the Specialty Pharmacy Times website, and check out the on-demand webinar on this research. 

New Research on Value-based Arrangements

NPC researchers published an article, “Are Value-Based Arrangements the Answer We’ve Been Waiting for?,” in Value in Health. This analysis explores the use of value-based arrangements (VBAs) as a mechanism for cost containment in the United States. VBAs link payment for a biopharmaceutical product to its real-world performance. The authors suggest that as VBAs gain traction with U.S. payers, it is increasingly important to recognize the strengths and limitations associated with these arrangements and to set appropriate expectations for what VBAs can realistically achieve.  

Including Indirect Benefits in Measuring Value 

How can health care decision-makers assess the true societal value of prescription medicines and medical services? In a blog published in Health Affairs, NPC researchers say the key is to use a comprehensive approach to measuring value by incorporating less tangible, patient-centered outcomes often referred to as “indirect benefits,” such as improvements in quality of life, productivity and caregiver burden. The researchers describe why it’s critical to consider indirect benefits when determining a treatment’s value and identify opportunities for capturing and improving integration of indirect benefits in health care decision-making.

Other Research and Info

NPC Submits Comments to CMS on 2021 Medicare Advantage Changes

NPC submitted comments to the Centers for Medicare and Medicaid Services (CMS) on Mar. 6, in response to its 2021 Advance Notice and Call Letter for Calendar Year (CY) 2021–Part II. CMS requested information regarding the development of a quality measure related to prior authorizations for inclusion in the Medicare Star Rating program. NPC’s comments focused on stakeholder agreed-upon criteria related to the development, implementation, measurement, and evaluation of step therapy and prior authorization protocols, which permit flexibility for unique patient characteristics and ensure appropriate patient protections. These agreed-upon criteria can inform the development of a quality measure and alert potential plan enrollees of not only the monthly premiums, but also the quality of the health plan options.

NPC Submits Comments to HHS on Notice of Benefits

NPC submitted comments to HHS on the proposed rule, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans,” focused on the need to provide pre-deductible coverage of high-value services, ensure value-based insurance designs include high-value specialty medications, and re-evaluate proposals that would increase patient out-of-pocket costs.

NPC Submits Comments on the Modernization of ClinicalTrials.gov

On Mar. 14, NPC and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) submitted comments to the National Library of Medicine in response to its request for input on infrastructure enhancements aimed at users and submitters of ClinicalTrials.gov as part of a multi-year modernization initiative. NPC and ISPOR’s comments noted that real-world data and the use of real-world evidence (RWE) to guide decision-making are likely to grow in the next two decades. Broader flexibility to include evolving data sources and study designs such as RWE were recommended as ways to streamline the ClinicalTrials.gov site for investigators and improve the value of the information found on the site for users. 

ICYMI: Articles of Note

•  Keehan SP, et al. National Health Expenditure Projections, 2019–28: Expected Rebound in Prices Drives Rising Spending Growth March 24, 2020, Health Affairs

•  Cipriani A, et al. Generating Comparative Evidence on New Drugs and Devices after Approval. March 21, 2020, Lancet 

•  Forbes SP, Dahabreh IJ. Benchmarking Observational Analyses Against Randomized Trials: A Review of Studies Assessing Propensity Score Methods. March 19, 2020, Journal of General Internal Medicine 

•  Dieleman JL, et al. US Health Care Spending by Payer and Health Condition, 1996-2016. March 3, 2020, JAMA

•  Ayanian JZ. The Complex Mosaic of Health Care Spending in the United States. March 3, 2020, JAMA Health Forum

Events and Education

eyeforpharma Philadelphia 2020 Virtual Conference:

NPC Chief Science Officer Robert Dubois, MD, PhD, will join a panel focused on how to “Build a Sustainable Value Model” at the Apr. 15 – 16 virtual conference. He and fellow panelists from the Institute for Clinical and Economic Review (ICER), Biogen and HealthVerity will discuss ICER’s 2020 Value Assessment Framework, valuing high-cost, but transformational therapies, and developing approaches that address affordability and patient access.

Webinar: Getting to the Heart of Health Care Spending

NPC’s Mar. 12 webinar, “Getting to the Heart of Health Care Spending: What’s Been the Bang for the Buck,” addressed how much is spent on health care in the U.S. and the factors that are driving increases in spending. NPC’s Dr. Dubois and experts from RTI Solutions, Harvard University, and Brigham and Women’s Hospital examined the cost of treating specific conditions over time and discussed whether increased costs were commensurate with improvements in patient health.