Insights & Analysis

There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.

Who Will Approve a COVID Vaccine in the US?

As life sciences companies sprint toward COVID-19 vaccines and therapies, the discussion below considers who has the authority to make the call on their availability at the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS).

New ESRD Analytics Featured in Kidney 360

On August 25, “Calcimimetic Use in Dialysis-Dependent Medicare Fee-for-Service Beneficiaries and Implications for Bundled Payment” was published in Kidney 360. The article featured research and analytics conducted by Avalere experts.

5 Activities to Make the Most of the HEDIS® Off-Season

While the HEDIS® collection season lasts for a limited time, the focus on initiatives that impact HEDIS results is a year-round priority. The period between submission and HEDIS season ramp-up, known as the “off-season,” offers an opportunity for health plans to elevate the member experience, amplify quality improvement activities, and improve HEDIS submission effectiveness.

Kelly Brantley

Charitable Assistance Covers a Small Share of Part D Non-LIS OOP Costs

As policymakers discuss ways to curb program expenditures and improve patient affordability in Medicare Part D, the role of charitable assistance in helping beneficiaries with out-of-pocket (OOP) costs has garnered interest. To understand the relationship between charitable assistance and various Part D metrics, Avalere examined Part D prescription drug claims for beneficiaries without the Low Income Subsidy (LIS) for 2014 and 2018.

Bringing COVID-19 Vaccines and Therapeutics to Market

On July 22, Avalere experts discussed the marketplace for COVID-19 vaccines and therapeutics in the “Cutting Through the Noise: Market Evolution and Pathways to Access for COVID-19 Vaccines and Therapeutics” webinar. They examined FDA regulatory considerations, coverage and access challenges, and key pricing and distribution scenarios for optimal US market access.

EOs Direct Drug Pricing Action, Raise Additional Questions

The administration’s 4 drug pricing EOs direct agency action across a host of policy areas, including Part D rebates, Part B reimbursement and pricing, 340B drug discounts, and drug importation. Next steps and a timeline for agency action will vary by EO dependent on the specific policies to be advanced or finalized. In the interim, stakeholders should explore outstanding questions and contemplate near- and longer-term policy scenarios.

Christine Liow

Avalere Vaccines: 2020 Mid-Year Outlook

Vaccine development is at the forefront of global efforts to address the COVID-19 pandemic, with a rapidly growing pipeline of candidates that will expand the existing vaccine landscape.

Avalere Statement on Prescription Drug Pricing Executive Orders

On July 24, the administration released 3 executive orders (EO) and announced the planned publication of a fourth EO, all focused on prescription drug pricing. The EOs reflect a combination of familiar policy goals (e.g., rebate reform, importation, international pricing) and a new 340B initiative, and in combination could have substantial implications for healthcare stakeholders and pharmaceutical markets if implemented.

Emily Belowich

8 Return-to-Work Considerations for Employers Amid COVID-19

As businesses across the country begin to reopen, navigating the COVID-19 pandemic will continually require employers to be resilient, flexible, innovative, and forward looking when it comes to returning employees safely to work sites. Among the myriad of concerns and considerations, organizational leadership will need tools that assist decision making and ensure compliance with Centers for Disease Control and Prevention (CDC) guidance.

Proposed Medicaid Line Extension Definition Alters Rebate Calculation

The CMS proposes to define line extension under the MDRP to broadly include any product that has at least one ingredient in common with the original drug, even if it is a different dosage form. If finalized, this change would have significant implications on classification and rebate liability for a wide set of current and future products.

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