Earlier this year the UK Department of Health and Social Care (DHSC) concluded a consultation on its revised proposals to update the 5-year Statutory Scheme for cost-containment of NHS spending on branded medicines, with additional updates phased in throughout the year, here we take a look at the most recent changes

The Italian Medicines Agency (AIFA) has restructured its evaluation process by merging the Technical-Scientific Advisory Commission (CTS) and the Pricing and Reimbursement Committee (CPR) into a single entity, known as the Commissione Scientifica ed Economica del farmaco (CSE).

This new guideline provides recommendations for setting criteria and procedures that govern drug pricing decisions and market entry or withdrawal of new pharmaceuticals, offering a framework for their subsequent re-evaluation.

At Decisive Consulting, we are exploring the complex considerations surrounding access to innovative gene therapies for sickle cell disease, a rare disease with high unmet need.

In celebration of International Women’s Day 2024, Decisive Consulting are proud to explore and provide insight for our community on the importance of advocating for inclusion in healthcare and academia.

Since the Innovative Medicines Fund (IMF) launched in June 2022, NICE has yet to make a recommendation for managed access under this agreement. However, four drugs have received interim funding through the IMF. To learn a bit more about this managed access agreement, Decisive Consulting conducted a review of publicly available sources. Megan Watts sought to understand the decision-making criteria for the IMF and gather learnings from the four analogues with interim funding. For companies with medicines that may be candidates for IMF, keeping informed with the latest IMF updates and proactively engaging with NICE and NHS England will be key.

As we look to commemorate World Rare Disease Day on 29th February, we are reminded of the profound challenges faced by individuals and families affected by ultra-rare diseases. At Decisive Consulting, we recognise the critical importance of equitable access to innovative treatments in these uniquely challenging healthcare landscapes.

In our latest Decisive Dialogue, we explore the role of structured expert elicitation in highly specialised technology evaluations to fill data gaps and enhance evidence packages for the assessment of ultra-rare medicines.

Market access for gene therapies in rare diseases demands a comprehensive understanding of the intricate challenges and opportunities within healthcare ecosystems globally.

The Chinese healthcare industry has witnessed significant transformations, particularly in market access and negotiations for the National Reimbursement Drug List (NRDL). These changes, observed from both consulting and industry practice perspectives, reflect a strategic shift in China's approach and attitude towards healthcare and access to innovative medicines.

The United Kingdom's Medical Technology (MedTech) landscape continues to evolve at an unprecedented pace, driven by technological advancements and a growing emphasis on healthcare solutions that leverage the power of data and artificial intelligence. In the dynamic world of MedTech, gaining market access is a pivotal step in bringing innovative solutions to patients and healthcare providers.

As 2023 draws to a close, Decisive Consulting reviews the events of the past year and highlights what the pharmaceutical industry can expect from 2024 as we see anticipated changes in healthcare policy across some of the largest European markets come into effect.

In a critical move towards healthcare reform, China's National Healthcare Security Commission (NHSA) has unveiled the 2023 update of its National Reimbursement Drug List (NRDL). The successful negotiations (84.6%) have led to an average price reduction of 61.7% for the newly listed drugs, reflecting the Chinese government's commitment to enhancing the accessibility and affordability of innovative treatments for all its citizens.

The full documentation of the new Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) scheme has been published. Decisive Consulting Ltd takes a closer look at the final details within the UK's new VPAG scheme with its new affordability mechanism for 'newer' and 'older' medicines. The full publication includes commitments to enhance the commercial flexibilities offered by NHS England and NICE, with further consultations due to take place in early 2024.

In the first of a series of articles dedicated to current, exciting developments in artificial intelligence (AI) and their impact on Market Access. In this article, we focus on the emergence of synthetic data, an approach to generating data that has the potential to revolutionise evidence generation practices, especially for orphan drugs.

Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of health technologies, aiming to respond to decision-makers’ needs for information relating to the introduction, coverage, use or disinvestment of health technologies. The majority of countries have some level of HTA procedure in place for the assessment of pharmaceuticals and often use horizon scanning procedures to support topic selection, however this may differ significantly from country to country in terms of key decision drivers, robustness of the procedures or level of evidence to be submitted.

The UK government has published its response to the consultation reviewing the new Statutory Scheme. Craig Smith and Rob McCaskill at Decisive Consulting Ltd take a closer look at the key decisions proposed for the UK's new Statutory Scheme.

Late last week, German Health Minister Karl Lauterbach unveiled major reforms across the pharmaceutical landscape that include changes in the statutory rebates and implementing confidential discounts.

A new 5-year medicine pricing framework has been agreed upon in the UK: Take a closer look at the UK's new VPAG agreed by the government, NHS England, and the Association of the British Pharmaceutical Industry (ABPI).

Despite the fact that CEAs are currently focused on listed products, if cost-effectiveness takes more of a prominent role in the HTA process at launch this could result in potential new challenges for pricing and market access in Japan.