For nearly two decades, rare diseases have lived in a pricing exception zone. Small patient populations, high unmet need, limited competition, and outcomes that could genuinely change a patient’s life, together, created a widely accepted logic: high prices were simply the cost of innovation. That... Continue reading
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Why the most successful commercial launches are built long before reimbursement discussions begin For years, market access has been treated as a milestone. From developing the therapy, to completing the clinical trials and securing regulatory approval. Then prepare for pricing, reimbursement, and payer negotiations. While... Continue reading
Real-world evidence is no longer optional in market access discussions. Payers expect it. HTA bodies ask for it. Internal teams invest heavily in generating it. And yet, a quiet reality persists: most RWE never meaningfully influences payer decisions. It isn’t rejected outright. It’s acknowledged, parked,... Continue reading
For many biopharma teams, Phase III is treated as the final mountain to climb. Once efficacy and safety are proven, commercial readiness is assumed to follow naturally. In reality, that assumption is one of the most costly missteps in drug development. More assets than ever... Continue reading
Background: A mid-stage biopharma company was advancing a novel CNS therapy into late Phase II, with early clinical signals suggesting meaningful benefit for patients with progressive neurological decline. While the science was promising, leadership faced a familiar CNS challenge: patients needed treatment sooner than regulatory... Continue reading
The Inflation Reduction Act (IRA) continues to reshape the U.S. pharmaceutical market. After the first list of 10 Medicare Part D drugs entered negotiations in 2023, the clock is now ticking toward Phase 2, when the next set of drugs will be named for 2026... Continue reading
For a few years, digital therapeutics were treated as inevitable. Prescription apps would scale like software, improve outcomes like medicines, and disrupt chronic care economics along the way. Venture capital flowed, regulatory clearances multiplied, and early reimbursement wins were celebrated as proof that the model... Continue reading
Cell and gene therapies are no longer a niche category. With more approvals coming through, payers pushing back harder, and health systems struggling to keep up operationally, CGT commercialisation has entered a very different phase. For investors, manufacturers, and global launch teams, the question is... Continue reading
Context: A global biotech developing an ex-vivo gene therapy for a rare neuromuscular disorder engaged Thelansis to build a cross-market patient funnel and uptake forecast. The therapy was approaching regulatory submissions in the US, EU5, and select APAC markets. While early clinical data showed durable... Continue reading
The quiet truth about rare disease medicines is that a brilliant molecule or a one-time gene therapy is only the opening act. Getting the drug from a lab bench miracle into durable, equitable patient benefit now depends on an orchestra of services, diagnostics, payers, and... Continue reading
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