Keep Health Economics Groups Out of Information Silos

Jacob Presson, health economics groups researcher
By Jacob Presson,
Senior Research Analyst

One of the major organizational challenges presented by health economics groups is the fact that they need data from the clinical and scientific side of the organization in order to make an effective case for payers that may be used to speaking with the commercial side of the company.  This issue is part of why many health economics groups report into medical affairs so that they can preserve their scientific expertise and credibility while bridging the gap to payers as needed. Continue reading

Proactive Communication Key to Managing Challenging Regulatory Agencies

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies.  Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance.  In other instances, one investigator can simply prove more difficult than others.

To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives.  Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading

Build Cross-Functional Support for Medicaid Pricing Activities

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

According to a Cutting Edge Information study, attaining favorable Medicaid pricing remains a key factor in life science companies’ market access preparations.  Broadly, government payer acceptance often sets the precedent for whether private payers will reimburse company products or not. Unsurprisingly, private payers are less likely to support products that fail to meet government approval. As one market access advisor explained, “Failure to receive Medicaid coverage is like a kiss of death for company products.”  Subsequently, market access teams work diligently to ensure that drugs attain Medicare and Medicaid reimbursement. Continue reading

Drug Safety Data and HEOR Driving Clinical Trial Costs and Time

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Analyst

The healthcare marketplace has seen seismic shifts over the past five years.  Austerity measures have strained the reimbursement climate in many EU countries and driven government payers to scrutinize every new drug as never before.  Healthcare reform in the United States has the potential to add coverage for 30 million uninsured Americans.  As a result, pharmaceutical companies are working even harder to gain favorable formulary placement with private payers. Continue reading

A Method to the Madness: Maximizing Managed Markets Account Managers Interactions with Payers

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

As payers demand ever-increasing evidence of product efficacy and cost effectiveness from the pharmaceutical industry, managing relationships with them is growing in strategic importance.  As a result, account managers dedicated to delivering the right kind of data to payers are becoming more vital.  What do pharma companies need to do to maximize this interaction? Continue reading