Dana Macher leads the Commercialization & Regulatory Practice.

She advises clients on integrated market access strategies, product commercialization plans, and public and private payer engagement strategies. With more than 20 years in the life sciences industry, she successfully launched several oncology products. Dana has extensive knowledge of hospital inpatient and outpatient settings as well as physician office reimbursement systems by effectively positioning novel drugs with payers. She is deeply involved with Avalere’s policy team assessing the impact of payment reform, especially in oncology.

Prior to joining Avalere, Dana was a senior consultant at DK Pierce & Associates, supporting clients in all aspects of coverage, coding, and payment strategies. She led all marketing research efforts, including advisory boards, qualitative interviews, and quick turnaround surveys with payers, KOLs, and practice administrators. Prior, Dana worked for Chiron Therapeutics, a Bay-area biotechnology company where she launched a novel chemotherapeutic agent and provided strategic direction to oncology business units, highlighted by the orchestration of a significant inpatient DRG payment increase with the Centers for Medicare and Medicaid Services.

Dana earned a BS in chemical engineering from Mississippi State University and an MBA from Dartmouth’s Amos Tuck School of Business.

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Register now to join Avalere experts on January 10, 2019 from 1 – 2 PM EDT as they examine the top healthcare priorities to watch.

Under an indication-based formulary design approach, Part D plans will be able to tailor the drugs that are on their formulary by indication.

Beginning in January 2019, Medicare Advantage (MA) plans will have the flexibility to use step-therapy techniques for Part B drugs, according to a CMS memo released on August 7.

Outcomes-based contracts most common in cardiovascular disease, infectious disease, and oncology.

More than 25% of patients with breast and lung cancers have been treated by a participating Oncology Care Model doctor. Participation trends could accelerate the transformation of treatment for some cancers, according to Avalere experts.

In just two years, on March 23, 2020, biologics currently regulated as drugs will transition to being regulated as biologics. Many aspects of how FDA will implement this transition have yet to be established.

In the US, an interchangeability designation by the Food & Drug Administration (FDA) is perceived as the holy grail in biosimilars development by some and yet regarded as irrelevant by others.

The shift from volume to value has played a significant role in shaping current payer behavior in the oncology space.

Market access teams should consider 3 growing trends in their 2018 strategic planning.

Rule Would Decrease Medicare Reimbursement for Drugs That Cost More than $480 per Day; Seven of the 10 Most Affected Drugs Treat Cancer

User fees are increasingly central to the funding of the drug and device review programs, and in some cases these fees account for a larger proportion of the Food and Drug Administration's (FDA) budget than congressionally-appropriated monies. For example, user fees account for 68 percent of the FDA's review budget for prescription drugs, while 58 percent of the review budget for generic drugs comes from user fees.