Megan West advises clients on policy and market-based strategies related to drug pricing, cell and gene therapy (CGT) development, value-based contracting, and innovative approaches to patient access.
In recent projects, Megan has helped life sciences manufacturers assess how drug pricing reforms in the Inflation Reduction Act will impact their businesses, convening stakeholders across functional units and therapeutic areas (e.g., neurology, immunology, rare disease) to develop and execute strategies spanning from drug discovery and early development through to commercialization. She has also helped CGT manufacturers identify and understand target patient populations, design and validate value- and outcomes-based contracting arrangements, anticipate reimbursement scenarios across channels and care settings, and develop stakeholder engagement strategies.
Before joining Avalere, Megan served as a public policy fellow at Novo Nordisk, where she assessed the impact of public policy developments to support the company’s advocacy priorities. She holds a bachelor’s degree in economics and psychology from Saint Michael’s College and a Master of Public Health in health policy from the George Washington University Milken Institute School of Public Health.
Authored Content
Analysis highlights potential access barriers to a broad set of CAR-T therapies
State Medicaid programs take a range of approaches to gene therapy coverage, management, and reimbursement.
With key health policy differences between presidential candidates, the 2024 elections are an inflection point for the future of US healthcare.
A white paper explores the RNA-based therapy pipeline and how FDA classifications can influence product development, commercialization, and patient access.
Medicare CAR-T payment remains stable; CMS proposed structural changes for New Technology Add-on Payments (NTAP).
Manufacturers anticipating potential selection or therapeutic impact for 2027 Medicare negotiations should begin preparations and align internal decision-making, applying learnings from Year 1.
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts explore policies shaping rare disease drug development and access.
The CGT Access Model will allow CMS to negotiate outcomes-based agreements on behalf of state Medicaid programs for CGTs, beginning with sickle cell disease.
The MDRP proposed rule's Best Price "stacking' provision has direct and indirect impacts on Medicaid rebate liability across drug classes.
Medicare negotiation has ripple effects across therapeutic markets, requiring manufacturers to reassess strategies to stay ahead of the changing drug landscape.
The development and launch of rare disease therapies require tailored strategies that account for unique patient journeys and the broader evolving landscape.
Manufacturers should reevaluate CMS engagement strategies as soon as possible to maximize the opportunity to influence the IPAY 2026 Medicare negotiations.
Medicare CAR-T payment remains stable, but changes to outlier payments and NTAP eligibility may create challenges.
Comments on initial negotiation guidance significantly shaped the revised guidance, underscoring the importance of stakeholder engagement in IRA implementation.
Avalere's policy experts discuss the key provisions and potential impacts of the recent CMS proposed rule related to the Medicaid drug rebate program (MDRP.)
Requiring manufacturers to stack all discounts provided through the supply chain could increase Medicaid rebate liability and complicate rebate dynamics.
The revised guidance contains significant changes to the initial guidance released in March, but important outstanding questions remain.
Stakeholders should consider the interaction of inflation-based rebates, AMP cap removal, and Medicare price negotiation in pricing and contracting strategies.
Policy proposals for Medicare’s CAR-T inpatient reimbursement reflect additional cases and increase clinical trial payment.
Avalere’s assessment highlights a diverse set of over 200 products in development that could challenge payment models across care settings and payers.
In 2022, over half of payers had at least one outcomes-based contract (OBC) and used claims-based outcomes, despite acknowledging the limitations of using claims to measure clinical benefit.
The Inflation Reduction Act (IRA) brings some of the biggest changes affecting the pharmaceutical industry in the last decade. Avalere expert Megan West discusses how these shifts will impact pharmaceutical organizations and how Avalere can support in developing strategies to mitigate risk and identify opportunities across the product lifecycle.
CMMI releases long-awaited response to President Biden’s executive order on drug pricing with a directive for the Centers for Medicare & Medicaid Services (CMS) to develop three models.
Since passage of the Affordable Care Act (ACA), 39 states and DC have expanded Medicaid. Some of the remaining states may reconsider expansion given new federal funding incentives.
President Biden’s executive order directs HHS to identify CMMI model options that could lower drug costs and promote access for Medicare and Medicaid enrollees.
Cell and gene therapy (CGT) technology continues to outpace regulatory and reimbursement mechanisms, requiring sponsors to think proactively about development.
Analysis of updated Senate drug pricing legislation shows Medicare negotiation could reduce manufacturer revenues by $165 billion in Part D and $290 billion in Part B from 2026 to 2032.
An updated Avalere analysis finds that under the changes to the negotiation policy included in the revised version of the Senate reconciliation package, the 100 Medicare Part B and D drugs that are likely to be selected for government negotiation from 2026–2031 represent almost half (45%) of all Part B and D drug spending in 2020.
Avalere research finds that state Medicaid programs have taken a variety of approaches to coverage policy development for innovative therapies, highlighting opportunities for increased consistency and transparency.
Starting July 1, manufacturers can report multiple best prices for some value-based arrangements, which may encourage broader use of innovative contracting.
Avalere analysis estimates more than 120 drugs may be eligible for negotiation under the BBBA by 2030. This count reflects the cumulative nature of the policy.
Join Avalere’s panel of market access and policy experts for a discussion on the growing cell and gene therapy (CGT) pipeline, an in-depth look at the unique opportunities and challenges these novel therapies present, and an overview of the many hurdles stakeholders need to navigate for success.
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on market developments as bundled payment incorporates additional treatments.
The final CMS NCD for amyloid beta-targeting monoclonal antibodies for Alzheimer’s Disease establishes a dual pathway to Medicare coverage based on FDA approval and likely creates access and operational challenges for stakeholders.
Analysis finds that patients face barriers to cell therapy treatments regardless of proximity to cell therapy treatment sites.
Avalere analysis seeks to understand potential access to clinical trial sites by race, given the draft requirement to ensure diverse participation.
Amid recent policy focus on the accelerated approval pathway and questions regarding the pathway’s evidentiary standards and decision framework, Avalere reviewed the history, process, and use of this pathway to date and the potential future use of accelerated approval for pipeline products.
From policy and regulatory changes to COVID-19 and driving customer engagement, the healthcare environment continues to require healthcare stakeholders to adapt their strategies. How will you stay ahead of the trends impacting your business?
Finalized policy for Medicare’s CAR-T inpatient reimbursement builds on policies solidified in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
The intersection of upcoming changes to drug pricing metrics will require new methods of calculating and reporting government pricing with implications for net pricing and contracting strategies.
Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the second in a series focused on cell and gene therapies, experts from our Policy and Market Access practices discuss value-based payment arrangements in cell and gene therapies, and the role they play in facilitating access to these therapies.
Tune into another episode of the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the second in a series focused on cell and gene therapies, experts from our Policy and Market Access practices discuss value-based payment arrangements in cell and gene therapies, and the role they play in facilitating access to these therapies.
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on policies finalized in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
Tune into another episode in the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the first of several discussing cell and gene therapies, experts from our Policy and Market Access practices highlight many of the challenges surrounding these therapies from both the patient and payer perspective.
Manufacturers seeking Food & Drug Administration (FDA) approval for cell therapies will need to assess the financial and logistical burden on patients and develop novel solutions to help alleviate these challenges.
The majority of state legislatures are currently in session, and many states are taking steps to address prescription drug spending and prices through a range of legislative proposals. While states have historically focused on price transparency, state policymakers are now moving beyond those measures to more directly control prescription drug prices through reference pricing, affordability review boards setting upper payment limits, and other price control mechanisms.
The outcome of Georgia’s runoff election—resulting in a Democratic majority in the Senate—combined with the existing Democratic majority in the House and incoming Biden administration, significantly changes the policy outlook for 2021.
State Medicaid programs are likely to face significant budget impacts from emerging cell and gene therapies and may seek to implement a variety of strategies to manage utilization and address provider reimbursement and financing challenges.
Medicaid will continue to experience considerable changes at the state and federal levels, both in terms of beneficiary demographics and the payer landscape. Stakeholders should consider how upcoming elections, policy proposals, and COVID-19 will impact benefits and payer dynamics.
Policy changes to Medicare’s CAR-T inpatient reimbursement set a precedent for high-cost durable treatments. Looking ahead, questions and concerns remain for pipeline cell and gene therapies that have high up-front costs.
Webinar: Market Access Enablement Strategies, Part 2: Navigating Policy and Marketplace Developments
Join Avalere experts for Part 2 of our Market Access Enablement Strategies webinar series to learn about the policy changes and market factors that could impact the future relationships between manufacturers, health plans, and pharmacy benefit managers.
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.
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.
CMS proposes to alleviate drug price reporting barriers that have hindered the adoption of innovative contracting models for prescription drugs. Stakeholders should contemplate the details and implications of CMS’ proposals—including how the changes would impact current contracting—as well as remaining areas of ambiguity.
In the second episode, Sam Ferguson and Michael Kearney, consultants in Avalere’s Market Access practice, along with Megan Olsen, an associate principal in Avalere’s Policy practice, will discuss how to appropriately define the value of durable therapies in oncology and how to pay for those therapies within our current healthcare system.
Prescription drugs are dispensed to patients through a complex supply chain that involves a broad array of entities, contract arrangements, and payments. The following diagram outlines how a typical prescription drug may flow through the drug supply chain.
State Medicaid programs face a series of near- and long-term challenges amid the COVID-19 pandemic due to enrollment growth and financial pressures. Stakeholders should evaluate key drivers shaping the state-by-state Medicaid outlook.
As the economic and social impact of COVID-19 change how patients access and receive care, manufacturers and third-party suppliers must consider how to evolve their patient support programs to meet the shifting access and affordability needs of patients.
With new cell and gene therapies poised to revolutionize treatment for a growing number of disease states, stakeholders are working to reimagine existing value and reimbursement models to meet the special challenges these breakthrough services present.
The Centers for Medicare & Medicaid Services (CMS) announced the Healthy Adult Opportunity, a new Section 1115 demonstration initiative allowing states to shift toward capped Medicaid financing models with an opportunity for shared savings. If the option is chosen by states, it could be the largest change to Medicaid since the ACA.
CMS’s Healthy Adult Opportunity program, a new Section 1115 demonstration initiative, will allow state Medicaid programs to move toward capped financing models for some non-disabled adult beneficiaries with an opportunity for shared savings and additional flexibilities.
New Avalere analysis finds that shifting Part B-covered rheumatoid arthritis (RA) drugs to Part D benefit would increase the share of prescriptions occurring in the catastrophic phase for impacted beneficiaries by more than 5 times.
The interaction of recently announced drug pricing reforms will have differential implications for stakeholders.
The swift proposed implementation timeline will require stakeholders to evaluate quickly operational requirements, behavioral responses, cross-program implications, and impact on contractual arrangements.
Reforms to “eliminate rebates” could have varying impacts based on features of their design.
The Department of Health and Human Services is seeking public input on a variety of proposals related to drug costs, providing stakeholders with an unprecedented opportunity to shape the administration's drug pricing policies.
On March 6, Avalere experts came together to discuss the latest Medicaid developments.
Avalere experts discuss an evolving Medicaid program supported by a new administration and novel state approaches.
Capping Medicaid funding could also shift costs to Medicare
New analysis from Avalere finds that 1.2 million individuals from non-expansion states could gain Medicaid coverage in 2017 should a newly elected governor decide to expand the program.