For years, the pharmaceutical industry has measured R&D productivity at the wrong moment in time: FDA approval. However, approval is only one checkpoint. The harder questions come afterwards: Will payers cover this drug? Will patients start treatment? Will the investment ultimately pay off?
A new index from Norstella is reframing how the industry answers those questions. The Pipeline-to-Patient Productivity Index (P3i) is the first benchmarking tool that follows a molecule across its entire journey: from early disclosure through clinical development, into market access, and on to commercial return.
Built on data from Norstella’s Citeline, Evaluate, and MMIT platforms, the index tracks eight metrics across four stages for the top 25 global biopharma companies by revenue. The result is a more complete picture of productivity than spend-per-approval figures can offer. To explore this new resource, we sat down with the P3i’s author, Daniel Chancellor, vice president of Norstella thought leadership, and Dinesh Kabaleeswaran, general manager of Market Access.
What’s the most surprising thing the data showed you about market access this year?
Daniel Chancellor: For me it’s how consistently new launches achieve about 70% coverage after a year, even though the type of drug changes dramatically over the analysis period. Today’s launches include some highly targeted drugs launching in competitive categories, and more and more orphan drugs. Even with that added complexity, companies have adapted their access strategies to remain at a benchmark of roughly 70%. Of course, one of our main conclusions is that access may be beginning to fade slightly, but I think that should be seen against the broader context of consistency across the last decade.
Dinesh Kabaleeswaran: Drilling down to the therapeutic area reveals a lot of variation in coverage. Across the 2021-25 cohort, the overall benchmark holds at around 68% of covered lives, but there’s a big span depending on the disease area. Oncology drugs reach 78% at one year post-launch, while metabolic agents drag at 52%. As companies prepare for launch, sensitivity to the coverage and restriction dynamics of their specific therapeutic area has strengthened forecasting models and given organizations a clearer view into defining successful access for the first 12 to 18 months post-launch. A brand team can secure broad coverage and still meet some friction from step edits and quantity limits.
That variation by therapeutic area is interesting. What’s behind the lower coverage for metabolic launches?
Daniel Chancellor: Oncology has consistently shown excellent access, not only with high coverage, but the quality of that coverage is also at a peak, 98%. For a metabolic launch, though, it’s a different access playbook. Take GLP-1s, for example. It’s rare for a drug to launch with such a huge addressable market, which can have a tremendous impact on payer budgets. So it is only natural for payer management to be fundamentally different.
GLP-1s definitely have interesting launch characteristics. Their coverage is low, but Lilly and Novo have also pioneered direct-to-patient models, so they are in many ways in a category of their own. Those manufacturers have now paved the way for such therapies to be more broadly reimbursed, and new entrants will benefit from that work as the category expands.
Tell me more about the report’s conclusion that access may be entering a decline.
Daniel Chancellor: For our sample of 121 launches between 2021 and 2025, data from MMIT’s Strategic Launch Report indicated that 68% of patients are covered by their insurer within that first-year timeframe. And the quality of that coverage is pretty high: 91% carry either no prior authorization (PA), or PAs that match the product label.
However, within this time period, there is a degree of variability. Coverage for 2024 launches was down at 64%, and for a partial sample of 2025 launches, it was even lower at 61%. Of course, coverage can be highly influenced by drug type and therapy area, so we would expect some annual fluctuations, but this could be more than just noise. There are a lot of new legislative changes that payers are adapting to.
What’s driving the 2024-2025 dip — is it the drugs themselves, or something structural?
Daniel Chancellor: Both. There’s undeniably a portfolio effect, as we saw a relative drop in oncology launches, from a high of 14 launched in 2023 to only four launched among the P3i companies in 2024. These commonly are among the best covered drugs. But underneath this, we know payers are leaning more heavily on utilization management and adjusting to the Inflation Reduction Act. These two effects are acting in tandem.
How is the IRA specifically changing payer behavior around new launches — and is the impact landing differently across therapy areas?
Dinesh Kabaleeswaran: It is still early, and I would be cautious about attributing the 2024 and 2025 drop-off to policy alone. The IRA’s impacts will become more evident the longer the program has been in effect.
But what we are hearing from manufacturers is that the policy will shape development decisions, possibly leading to launches with broader labels targeting broader groups of patients. This is to offset perceived losses from Medicare drug price negotiations and the so-called pill penalty, which is the shorter clock small molecules get before their negotiated prices take effect, nine years instead of the 13 for biologics. It will be interesting to see if therapeutic areas with a higher percentage of Medicare patients—such as Alzheimer’s, COPD and ESRD—are deprioritized in favor of diseases with more patients covered by commercial plans.
The IRA may have a further effect on small molecule development, which the index already puts at a lower probability of technical and regulatory success than biologics: 6.7% against 10.0%. That gap predates the IRA and the report attributes it to biology rather than policy, so my concern is narrower: if the pill penalty tilts portfolio decisions even further toward biologics, it compounds a disadvantage that’s already there.
Some companies hit 80% launch coverage with no restrictions. What are they doing differently?
Daniel Chancellor: There’s no single lever, but the broad pattern is that access planning must begin upstream in trial design and label strategy, not just in payer negotiations after approval. The best performers use inclusion and exclusion criteria deliberately, so the approved label lines up with what payers are willing to cover. Access is a clinical design decision as much as a commercial one.
Dinesh Kabaleeswaran: It helps to see how small that group is. The majority of companies cluster between 60% and 70% coverage at one year, so the companies reaching 80% with no restrictions are the exception rather than the benchmark. What tends to separate them, in my experience, is that they treat payer-preferred endpoints as a trial design input rather than a commercial afterthought. Payers tend to cover a new drug to label unless there is a meaningful differential in trial results within the category, and the tipping point is usually the achievement of specific endpoints. Knowing which ones drive preferential coverage, and building inclusion and exclusion criteria around them, is what turns upstream design into coverage.
Is there a tradeoff between launch coverage and the quality of coverage, or can companies win on both?
Daniel Chancellor: These can act independently, and we see several companies that are beating benchmarks both on coverage and quality. To speak very broadly, lower coverage suggests less certainty on cost benefit, while lower quality of coverage indicates a competitive treatment algorithm. Companies have greater influence in optimizing launch coverage, but if there are many alternative treatment options, then utilization management levers are always going to be there.
Dinesh Kabaleeswaran: They can win on both, and the index finds little correlation between the two. Coverage has the wider spread, because formulary position is the main lever payers actually pull. I would caution you not to read either number on its own, though.
There is a real difference between how payers say they will manage a drug and what actually happens at the pharmacy counter. Every day, thousands of claims are processed for drugs that are technically not on a published formulary. A drug with a low rate of coverage may still have favorable policies that promote pull-through for a targeted patient population, while a drug with a high rate of covered lives may have to work against utilization management restrictions that go beyond the label.
From an industry standpoint, both numbers are best read together: covered lives tells you the breadth, and quality of coverage tells you how much of your label actually comes with it.
What should a company launching in the next 12-18 months be doing right now?
Daniel Chancellor: Start the access conversation before the label is locked in—well before! Market access is increasingly part of the decision whether to progress drugs through the pipeline after Phase I. But with 12 to 18 months on the countdown, companies should have a pretty clear idea about how their drug will shape up competitively. This gives a good foundation for modelling what coverage will look like, which informs pricing, contracting strategy, and sales force planning.
Dinesh Kabaleeswaran: Segment the payer and provider landscape before you build the engagement plan, not after. A regional health plan with a track record of slow, cost-conscious decision-making needs a different approach than a large national carrier with a known new-to-market block and a mixed record on restriction. Those are not the same conversation, and they should not sit on the same timeline.
Pharma portfolios are aging, with many products approaching LoE. The report predicts that launch portfolios will account for far less revenue share in the next few years, falling from about 29% in 2020 to 18.0% by 2030. What does that mean for how manufacturers should be thinking about their deals with payers today?
Dinesh Kabaleeswaran: The nature of the launch and the size of the company will influence the financial impact at the organizational level, though there are translatable strategies for staying competitive in payer negotiations.
Companies can define where their launch fits within their existing portfolio and therapy area, and the timing of market entry can shift the focus of payer conversations. First-to-market agents can drive access by clearly articulating how their therapy transforms the options available to patients, and companies launching into crowded spaces can address current gaps in care.
The report adds one caution worth keeping in view: success can breed its own problem, since a portfolio concentrated in one large asset looks strong right up until that asset reaches its patent cliff. Our conclusion is that scale alone will not be sufficient. The quality of a launch, market access included, becomes a determining factor in whether a portfolio can rejuvenate.
