HEOR Data Needs to be Tailored to Match Market Needs

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

When health economics groups are working on developing HEOR data, they need to keep in mind the different gaps that the research may be needed to fill.  Depending on the market, whether right at launch or years afterwards, payers may see product’s position significantly strengthened by the appropriate HEOR data.  Developing the right information can require customization based on geography or based on the competitive landscape. Continue reading

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