You Only Launch Once: Five Ways to Reduce Market Access Risk
For many manufacturers, the period between FDA submission and the PDUFA date feels deceptively quiet. Clinical work is largely complete, pricing assumptions have already been modeled, and commercial teams are waiting for the green light. But in reality, this pre-launch window is one of the most consequential phases of a brand’s lifecycle—and one of the […]
From Compliance to Strategy: How Payers Are Refining Their IRA Playbooks
When the Inflation Reduction Act (IRA) first passed in late 2022, payers rushed to respond. On paper, the bill’s intentions were clear: this legislation sought to lower drug costs, reduce patients’ out‑of‑pocket burden, and empower Medicare to negotiate prices for the first time. In practice, however, the ripple effects have been far more complex for […]
Copay Accumulators and Maximizers, Part 2: Implications for Pharma
Copay accumulator and maximizer programs are now firmly embedded in the commercial market, and their influence on patient access and manufacturer strategy is becoming impossible to overlook. In the first installment of our two-part series on copay accumulators and maximizers, we shared recent Indices research on how payers are deploying and measuring these programs. In […]
Inside the Payer Playbook: Copay Accumulators and Maximizers, Part 1
As payers continue to refine their cost-containment strategies, copay accumulator and copay maximizer programs have quietly become standard tools in their playbook. As of March 2025, 21 states have enacted laws banning payer/PBM use of copay accumulator programs for state-regulated health plans, including the individual, fully insured large-group, and small-group markets. Yet despite this legislation, […]
Emerging Treatments Offer New Hope for Alcohol Use Disorder
The mental health treatment landscape is evolving rapidly, driven by new and innovative therapies. Recent approvals like KarXT (from Karuna Therapeutics, now part of Bristol Myers Squibb) for schizophrenia, as well as many promising pipeline drugs, such as MindMed’s MM-120 for generalized anxiety disorder, highlight this momentum. Amid this progress, alcohol use disorder (AUD) remains […]
Competitive ATTR Dynamics: Key Takeaways for Rare-Disease Commercialization
Transthyretin amyloidosis (ATTR) has rapidly shifted from a rarely recognized, fatal condition into one of the most closely watched rare-disease markets in biopharma. With multiple therapeutic entrants, distinct scientific platforms, and increasingly sophisticated payer strategies, ATTR now serves as a template for how innovation, diagnosis expansion, pricing, and access come together to shape a complex […]
The Cost of Reform: What Payers Expect from the One Big Beautiful Bill Act
In July 2025, the 2025 Federal Budget Reconciliation bill, known colloquially as the One Big Beautiful Bill Act (OBBBA) and officially as H.R.1, was signed into law. This act introduced major, immediate reforms to Medicaid, adding new administrative requirements and eligibility conditions (including work requirements) for patients seeking to enroll in or maintain Medicaid coverage. […]
Antibiotic Resistance and New UTI Treatments: What Payers Need to See
Urinary tract infections (UTIs) rank as the most common bacterial infection for women worldwide. Between 50-60% of adult women experience at least one UTI in their lifetime, and approximately 25% of them suffer recurring infections, defined as two or more episodes within six months. As the prevalence of recurring infection increases with age, older women […]
New Treatments, Diagnostic Tests and Access Barriers in NSCLC
The oncology market is growing rapidly, driven by advancements in diagnostic technology, new biomarker testing, and a wealth of targeted therapies. The non-small cell lung cancer (NSCLC) space is especially crowded, which should be good news for the 226,000 patients diagnosed with this disease each year. Despite the new developments in NSCLC treatment, however, many […]
A New Era in HAE: How Market Entrants Are Reshaping Rare Disease Treatment
As medicine evolves, even smaller therapeutic areas are impacted by scientific breakthroughs and novel technologies, leading to an eruption of new therapies. Hereditary angioedema (HAE), a rare genetic disorder affecting 1 in 50,000 people worldwide, is the latest indication to reap the benefits of several new market entrants. Due to a deficiency of the C1 […]