Balancing HEOR Team Priorities Between Short Term Approval Goals and Long Term Market Access Strategy

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

For many pharmaceutical companies, HEOR is a non-stop endeavor. Working to support existing products — while also developing value dossiers for products that are about to launch — can put a strain on available resources.  To a certain extent, the specifics of an HEOR team’s workload is dictated by market needs and external pressures.  But there are steps that can be taken internally to ensure that quality HEOR work is delivered on a consistent basis. Continue reading



Start Early Enough in Development to Get a PRO Instrument Designed Right

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

As companies work to integrate patient reported outcomes into both pre- and post-launch activities, the importance of a well-designed PRO instrument is increasing. There are a number of internal and external stakeholders for patient reported outcomes data — and this number is expected to grow in the next few years.  HEOR teams, clinical groups, and some commercial teams internally are now more interested in making sure that they have the right PRO endpoints to show to payers, regulators, and physicians. The PRO instrument to collect this information is a key part of this process. Continue reading




The Building Blocks of a Successful Launch Sequence: A Strategic Regulatory Affairs Perspective

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

Developing, refining and coordinating a complex pharmaceutical launch sequence can be a significant challenge for even large global groups.  There are a myriad of market considerations on top of commercial priorities that come into play when setting the launch sequence. Bringing a strategic regulatory affairs function into these discussions is also key in order to keep the license cascade in line with the proposed launch sequence. Continue reading


Supplementing Patient-Reported Outcomes: How Accurate Are Patient-Reported Data Online?

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

The pharmaceutical industry’s interest in patient-reported outcomes (PROs) has steady grown since the FDA and EMA released their respective guidances on the subject.  Now, pharma and device companies seek out the best ways to infuse their product support with the patient voice.  For many companies, this can mean looking not only to clinical trials which use PRO measures, but also to available pharmaceutical Big Data. As the patient population becomes more tech savvy, more and more patient data is available online. Continue reading


Medical Device HEOR Groups Use PROs to Support Reimbursement Conversations

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Health economics groups are facing more competitive reimbursement processes worldwide.  To navigate these increasingly difficult negotiations, many medical device HEOR groups are looking to patient-reported outcomes (PROs) to improve their value propositions. One interviewed HEOR consultant explained, “Before PROs, you had a lot of clinician-completed measures and clinician rating scales. Now the FDA and stakeholders want to see how treatments are actually impacting patients, and PROs give the patients a voice in the trial.” Continue reading


Health Outcomes, Patient-Reported Outcomes and Real-World Data Most Preferred Forms of Big Data

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

Because of the varied nature of pharmaceutical Big Data, companies have access to information capable of supporting a number of goals throughout products’ lifecycles.  Teams companywide are able to implement prospective studies to support clinical trials, impact reimbursement conversations with payers and demonstrate product effectiveness.  Data usage for these prospective studies varies depending on the teams’ goals and available information. Continue reading