Achieving Launch Access and Value: Common Pitfalls of IEPs (Part 1)
Authored by Michael Ryan, PharmD and Rita Numerof, Ph.D.
In the past, product approval meant demonstrating safety and efficacy to regulatory bodies in discrete countries—with a placebo comparator. Today companies must anticipate a changing reimbursement, adoption, and policy environment. The need to make population-based decision-makers aware of the value the new product brings while tailoring evidence to the specific requirements of an increasingly diverse and more sophisticated set of audiences has never been more important. New product development requires keen attention to planning and coordination across many internal functions to ensure efficiency and success. The creation of a formal IEP is essential to meet these goals. Changes over time in the methods through which products are approved and launched also require new approaches to Integrated Evidence Planning. Embracing those key IEP considerations will position companies and their products for success in this evolving landscape.
Integrated evidence planning has been used by the pharmaceutical industry for decades. Yet companies often fail to deliver the evidentiary requirements needed to optimize launch sequencing, market access and pricing. This oversight leads to lost revenues and undermines product value. An IEP serves as a formal strategic plan to help a pharmaceutical manufacturer generate the required evidence to meet stakeholder needs. Its purpose is to identify and prioritize evidence gaps aligned with commercial goals in order to obtain regulatory approval in markets of interest, optimize access, and achieve a price that reflects the holistic value of a given asset. The IEP should represent strategic thinking across a company including, but not necessarily limited to, Development, Medical Affairs, Regulatory, Market Access, HEOR, Patient Advocacy, and Commercial experts. The enormous challenges facing the industry require a comprehensive and fully integrated evidence development plan.
Timing of Evidence: As the saying goes, “European drug pricing is a lot like skiing. You start somewhere on the mountain, and it’s all downhill from there.” The fact is that it is difficult, if not impossible, to recoup newly established product value post-launch in the EU. However, the U.S. has always been the largest profit center for biopharma companies. Historically it has been possible in the U.S. to raise prices significantly post launch if additional evidence becomes available to demonstrate a higher value for a drug product. As such, the need to get new products approved and to the market quickly has superseded the need to establish value. Most companies’ IEPs focus solely on gathering the necessary phase 3 dataset required for Regulatory approval and then, post launch, focus on the evidence generation to justify the value and pricing for the product.
However, the U.S. drug pricing environment has changed dramatically in recent decades. It started in 1990 with the approval of the Medicaid Drug Rebate Program (MDRP) which included “inflation rebate requirements” for price increases greater than inflation. It was further accelerated by a phenomenal growth in the 340B market where the 340B ceiling price is heavily influenced by the product’s Medicaid Best Practice. In 2022, the passage of the Inflation Reduction Act (IRA) introduced Medicare penalties for price increases greater than CPI-U. It is very challenging, if not impossible, for biopharma companies to recoup newly established value and price post launch in the U.S. today. Instead, they can now only hope to slow the reduction in the product’s drug pricing over time.
This is an important lesson that many companies have still not learned, and we still see many IEPs that do not ensure that the evidence required to ensure the optimal value of the product is collected and reports out prior to the product’s launch. As the pharmaceutical margins and ROI windows for the industry continue to shrink, this is a dynamic that the industry must recognize and change if it is to continue to succeed.
Inclusion of Appropriate Stakeholders: A common pitfall often seen with IEPs is the failure to include all necessary stakeholders. Since individual departments tend to focus on the evidence needs of their key stakeholders, this can result in serious IEP issues. The most common mistake is that the IEP is developed by a combination of the Medical, Development and Brand teams. Unfortunately, most brand team staff are not sufficiently trained in access and pricing evidentiary standards and study methodologies. As a result, when HEOR, and Value & Access are finally engaged (often 3-9 months prior to launch) it is too late to develop and run the studies required to meet evidentiary standards and significant potential product value is lost at launch that cannot be recovered.
RWD, PRO and QoL: The evidence methodologies utilized to demonstrate the holistic value of a newly launched drug product are essential to ensuring optimal launch access and pricing. An issue seen with IEPs is that these methodologies are often insufficiently prioritized by Development and Medical in favor of their traditional approaches to evidence generation. In addition, a common misconception is that QoL/PRO data was not included in an IEP because “QoL data is not important to U.S. payers.” This is not the case. And the most common problem with the utility of QoL/PRO data in the U.S. is the failure of biopharma to understand how best to derive and use this type of evidence. While it is true that many retail and Part D drug providers are paid on a PMPM basis and therefore are primarily concerned with direct drug cost savings, most still have a true concern for their patients’ welfare, quality of life, and the costs associated with poor QoL.
Assuming the data are collected and analyzed properly, there are ways to increase the PBMs and Prescription Drug Plans (PDPs) focus on RWD, QoL and PRO data. It is best to ensure that such data is not only shared with the PBMs and PDPs, but is also shared with relevant patient advocacy organizations, evidence based clinical practice guideline entities such as the National Comprehensive Cancer Network (NCCN), and health plans that employ PBMs and PDPs. Those organizations are more likely to place a higher priority on the total cost of care and patients’ quality of life.
Budget and Evidence Prioritization: As we discussed earlier, pharmaceutical companies have entered a period of cost optimization, but even in good times there have never been enough budget dollars to complete all the work outlined within an IEP. Project prioritization is essential to ensure the most impactful work is pursued. Prioritization discussions must include all contributing departments: Development, Medical, Brand, HEOR, and Market Access. It is worth noting that most HEOR and Market Access studies, when compared to phase 2 and 3 clinical trials, are far less expensive. Hence, when prioritizing studies within an IEP, it is important to prioritize the project based on the potential ROI and which evidence delivers the greatest commercial value versus simply the number of studies being performed. If tradeoffs are necessary, teams can consider delaying launches into certain markets as a means for spreading HEOR and Market Access studies over a longer period.
The biopharma industry is facing significant challenges that place extreme pressure on having a comprehensive and fully integrated evidence development plan. In addition to evidence on product safety and efficacy, the demand for timely evidence on value and access has been even more essential to achieving launch success. A key to meeting this evidentiary demand is an IEP that addresses the array of needs to position a product launch for success. Among those needs are inclusive, timely evidence that supports the asset’s value and maintains budget controls. Failure to do so puts organizations at a disadvantage for realizing the full economic and clinical benefit a new product can deliver.
Please find the original article here.