The availability of lower-cost generic medicines has reshaped the cost-effectiveness of fampridine, opening NHS access for eligible patients with multiple sclerosis in England.

People living with multiple sclerosis (MS) in England will soon be able to access fampridine through the NHS after the National Institute for Health and Care Excellence (NICE) recommended the treatment for eligible patients. The decision follows the expiry of patents protecting the original branded medicine, Fampyra, allowing lower-cost generic versions to enter the market and significantly improve the medicine's cost-effectiveness. Fampridine is licensed to improve walking ability in adults with multiple sclerosis who meet specific clinical criteria and has previously been available through the NHS in Wales, Scotland and Northern Ireland. The reimbursement decision marks a significant shift in access for patients in England after several years of previous NICE rejections.

The development illustrates the growing influence of patent expiry on pharmaceutical market access. As branded medicines lose exclusivity, generic competition frequently reduces acquisition costs, enabling health technology assessment (HTA) bodies to reassess therapies that were previously considered too expensive for routine reimbursement. NICE evaluates medicines using clinical effectiveness alongside economic evidence to determine whether treatments represent value for money within the NHS, with pricing playing a central role in those assessments. The arrival of generic fampridine has altered that balance, demonstrating how lifecycle changes can reshape reimbursement decisions without changes to a medicine's underlying clinical evidence.

For pharmaceutical manufacturers, the decision reinforces the importance of lifecycle management beyond patent protection. While the loss of exclusivity often reduces revenues for originator companies, generic competition can significantly expand patient access by lowering treatment costs and improving affordability for publicly funded healthcare systems. According to NHS England, increasing access to clinically effective medicines remains a key objective of delivering high-quality, value-based healthcare, while health technology assessments continue to balance innovation with the sustainable use of NHS resources.

The reimbursement of fampridine also reflects wider trends across European healthcare systems, where rising demand for innovative medicines is increasing pressure on healthcare budgets. Generic medicines play an important role in supporting long-term sustainability by creating headroom for investment in newer therapies while maintaining access to established treatments. Industry organisations such as Medicines for Europe continue to highlight the contribution of generic medicines to improving affordability, strengthening supply resilience and supporting equitable access across healthcare systems.

For the sector, the lesson is clear: patent expiry is no longer simply the end of a product's exclusivity period. It increasingly represents the beginning of a new phase in market access, where generic competition, pricing and health technology assessment combine to determine how established medicines continue delivering value to patients and healthcare systems.

Source: Pharma Phorum / National Institute for Health and Care Excellence (NICE) / NHS England / Medicines for Europe