In an era where life sciences companies face unprecedented costs to bring novel therapies to market and declining expected returns upon launch, conventional commercialization strategies are insufficient to deliver brand success. The traditional approach of driving demand to the top of the funnel through clinical differentiation, expensive media campaigns, and large field sales forces no longer guarantees adequate product adoption and long-term financial viability under the constraints of intricate utilization management requirements. Thus, a paradigm shift is in order – one that centers around an integrated commercial strategy that is laser-focused on patient access and underpinned by gross-to-net optimization.
Increasingly, insurers are implementing restrictions for costly treatments to contain pharmacy spend, creating challenges for pharmaceutical manufacturers attempting to ensure patients can access their specialty and specialty-lite brands. Drug utilization management requirements such as formulary exclusions, prior authorizations (PAs), and step edits have risen dramatically and are poised for continued growth.
Rigorous payer requirements and increasing out-of-pocket obligations are problematic for both patients and healthcare providers. Up to one-third of patients report they experience difficulties getting their prescription drugs due to delays, denials, and costs. According to a 2022 national survey of physicians, about 20% of prescriptions are impacted by PAs and formulary restrictions, which create an administrative burden. As a result, 80% of providers report that they refrain from prescribing certain medications over half the time due to utilization management requirements.
Low levels of prescribing and adherence make it difficult – if not impossible – to demonstrate value to payers to ensure strong reimbursement. A media campaign may drive demand but does little to ensure access and positive health outcomes with manufacturers often forced to over subsidize access to their therapies. And a traditional sales approach solely focused on selling the science is not positioned to help prescribers navigate the complexity of patient access meaningfully. For life science companies, an integrated commercial approach that also ensures patients have timely and affordable access to their branded therapies should be a top priority.
Gross-to-Net (GTN) refers to the difference between the total revenue generated by a drug (gross sales) and the actual revenue received by the manufacturer after accounting for various discounts, rebates, financial subsidies, and other adjustments (net sales). In other words, it represents the shift from the initial list price to the actual realized revenue. A proactively managed GTN margin is essential for ensuring that innovative treatments remain accessible to patients who need them, and ultimately, for sustainable brand growth.
In today’s pharmaceutical marketplace, the average cost of developing a new drug now exceeds $2 billion, the return on investment is at its lowest in over a decade at 1.2%, and the average peak sales forecast for a pipeline drug fell 22% between 2021 and 2022. Amid these financial outlooks, optimizing Gross-to-Net should be a top commercial priority.
An integrated commercial model that goes beyond outdated, top of funnel strategies and focuses on optimizing patient access and GTN involves three important components:
A modernized patient services program For many pharmaceutical specialty-lite and specialty brands, the patient services program represents a primary touchpoint with patients and healthcare providers (HCPs). Hence, the hub and other offerings must keep pace with consumer and prescriber expectations and demands by ensuring that the hub prescribing process integrates into provider workflows, delivers a digital-first patient experience that is seamless and personalized, and provides transparency across the patient access journey.
A responsive prior authorization strategy The prior authorization process can adversely impact all stakeholders involved in the prescription access journey. Thus, manufacturers should prioritize partnerships that support the process to facilitate high submission rates and provide real-time visibility into prior authorizations. Access to real-time data can provide field teams with the insight they need to close gaps with HCPs and inform dispense workflows at the payer level, ultimately leading to higher adoption rates.
A robust pharmacy network Pharmacy networks play a pivotal role in the distribution, fulfillment, and reimbursement of medications, which means the brand's short- and long-term commercial success ultimately hinges on pharmacy performance. Pharmaceutical manufacturers must cultivate a pharmacy network that will secure a high level of prescription coverage while minimizing uncovered copay utilization. This can be accomplished by ensuring the dispensing network has contracts with the right health plans, aligns incentives with manufacturers, and can effectively support adoption.
By partnering with Phil, life science brands gain access to a nationwide pharmacy network with 98% plan coverage that allows patients to receive prescribed therapy quickly, conveniently, and affordably. The PhilRx Patient Access Platform is designed to ensure manufacturers can drive the adoption of their branded treatments via a digital-first user experience while managing brand growth with unique gross-to-net maximizing capabilities. Read this case study to learn how we unlocked adoption and sustainable growth for a biotech company launching their flagship ophthalmology product.