Value Considerations Should Begin Very Early in the New Drug Development Life Cycle

Value needs to be considered early in the development life cycle of a therapy and should be continued throughout, even into the postlaunch space using real-world studies, according to a presentation on value-based services and their life cycles at the AMCP Nexus 2019 meeting.

Value needs to be considered early in the development life cycle of a therapy and should be continued throughout, even into the postlaunch space using real-world studies, according to a presentation on value-based services and their life cycles at the AMCP Nexus 2019 meeting.

"Right now, we need to start addressing the shift from volume to value. Rather than concentrating on the number of treatments we're putting out, [we should focus on] what's the quality we're putting out and how valuable is that," Sarah Rivera, PharmD, vice president, Clinical Value Based Strategy, Optum Life Sciences, said during the presentation at the AMCP meeting. "Payers are increasingly expecting life sciences firms to quantify the product’s value in terms that are well-defined and measurable with clinical outcomes."

Value-based strategies include looking at how the product fits in the disease state, and includes real-world evidence comparing products and demonstrating key differentiators for each group that improve the value equation. Value does not necessarily look at only the cost of the medications but the overall cost of care, Rivera said. Treatments with the highest value ultimately lead to better outcomes than other available therapies.

"A product's value really should be an integral part of product development and pipeline management throughout the product life cycle," Rivera said. "Phase 3 might be too late sometimes to demonstrate value."

The first step to a value-based drug development strategy is an assessment of the current landscape and pipeline to find an area of need. Once a gap in care has been found, studies should be designed that target these gaps and show value early in the clinical development. Moreover, Rivera noted, the trials should be built in a fashion that correlates to post launch real-world studies. These data can also be analyzed to find additional gaps in care for expanded indications.

Once the clinical develop is finished, the next phase in the process is launch. In this portion of the life cycle, payers' needs should be considered, including potential restrictions. Additionally, budget impact and cost effectiveness thresholds should be considered along with the expected market uptake. Payers will look at the clinical improvement, risk or shared risk, competitive landscape, and the significance of improvements to population’s needs. Value-based agreements and risk shares should also be considered.

"Value-based contracts have been growing in popularity, but there are some issues that come along with them," Deb Curry, PharmD, senior vice president of Clinical Operations at SS&C Health, said during the talk. "One of the questions is: How do you build a contract that's mutually beneficial to both the life sciences company, the payer, and even further from that, to the patient. We want to make sure it is a valuable product to the patients and our clients who are paying the payer. We want to make sure we're looking at the right outcomes and that we're monitoring it appropriately to find where there are failures and successes."

The payer’s approach to value includes a variety of steps, including pharmacy and therapeutics (P&T) review postlaunch and prelaunch, if a high-touch drug or a new disease state. Additionally, restriction criteria are developed by the payers often before launch, although some items cannot be finalized until the label is approved. Once P&T has made a clinical decision, then the financials play into the value for each product, warranting a second review.

Often payers develop their own models for pricing. This is being accomplished more commonly using real-world data, Curry noted. However, it is nearly impossible to have real-world data prior to launch. For this, she recommended conducting a follow up at a year postapproval to assess how the disease state has been impacted by the product.

"Most payers are going to take information they receive and then rework the wheel with their own data to see if they see the same thing provided to them by the life sciences company," said Curry.

The patient impact often gets overlooked but is an important aspect, she added. Depending on the product, there are several factors that might impact compliance and adherence, including costs. Physicians also comprise an important stakeholder in the value discussion. Their acceptance and use of a new medication should be factored into the value decision.

"One key factor is not just access from a payer perspective but also physician behavior. There's prescriber inertia and, at some point, providers just say they're happy where they are at," Curry said. "Some providers may say they have a lot of options and that a new product may not add a lot of value. You need the providers to want to write a prescription for your product as well."

Postlaunch and Future Plans

Even if value was not assessed early in the development process, it can still be analyzed following launch. This evaluation includes postmarketing, phase 4 studies, or analyses of real-world or registry data. If prelaunch work was completed, other factors may still impact the value story after launch, such as changing policies or a late-emerging adverse event that may require additional evidence. Price reforms can additionally impact the disease area as a whole, particularly if another product becomes cheaper.

Once a product launches there are several other steps that can take place, including potential label extensions. As more data become available from the market, the value story can continually be updated to increase market penetration. Stakeholder engagements post-launch can help identify new gaps that were not apparent in the prelaunch phase. There is also the potential to renegotiate, based on real-world experiences.

"It's not over once the drug is on the marketplace. It's not the end all be all. You can gain more access, if you do postlaunch discovery," Rivera said. "Once it is in the marketplace, it is available to everyone and you can really see how it is working."