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Neil Grubert
Independent Global Market Access Consultant
Neil Grubert is an Independent Global Market Access Consultant with over 30 years of experience in the pharmaceutical industry. He specializes in international market access, focusing on strategic planning, market classification, healthcare system analysis, and pricing strategies. Grubert has worked with leading biopharmaceutical companies, providing insights into global access trends and delivering training programs on market access issues.
His career includes significant roles such as Director of Global Market Access and Healthcare Solutions at GSK and Vice President of Global Market Access Insights at Decision Resources. He has authored more than 150 reports on market access and has been involved in high-level analysis of global trends and strategic consulting for various clients in the pharmaceutical sector.1234
Grubert holds a Master of Arts from Queen Mary University of London and is proficient in several languages, including English, German, and French. He has been actively involved in discussions about health technology assessments and market access strategies in Europe, particularly in the context of regulatory changes and their implications for the pharmaceutical industry.23
Highlights
Saudi Arabia has become the first country to successfully use Vertex Pharmaceuticals’ CRISPR-based gene-editing therapy Casgevy (exagamglogene autotemcel [exa-cel]) outside of clinical trials or research, according to the Saudi Press Agency. The treatment was the first drug ever to receive Breakthrough Designation from the Saudi Food and Drug Authority and, in January 2024, the first to be approved through this pathway. The country has among the highest prevalence rates of sickle cell disease and beta thalassaemia in the world. A 13-year-old girl with beta thalassaemia was treated at the King Abdulaziz Medical City in Riyadh. Several more Saudi patients with beta thalassaemia or sickle cell disease are expected to receive treatment with Casgevy in the near future. Vertex is working to qualify additional hospitals as authorised treatment centres and to secure inclusion in their formularies. Saudi Arabia wants to be an early-launch market for innovative medicines, including cell and gene therapies. In June, I co-presented a webinar with Lavni Varyani on the subject “Have Emerging Markets Finally Emerged? China and Saudi Arabia as Trailblazers for Biopharma Growth” (tinyurl.com/2tfeuwan). Our core message was that these two countries in particular should not be overlooked as target markets for the introduction of promising new drugs. Get in touch with me if you would like a copy of our slides or a recording of the webinar.
#Saudi #Casgevy #genetherapy
Australia’s long-awaited HTA review will be “generationally important” and should be published soon, according to Mark Butler, the Minister for Health and Aged Care. Speaking at a press conference to mark expanded PBS coverage of AstraZeneca/Daichi Sankyo’s Enhertu (trastuzumab deruxtecan) in HER2-low breast cancer, Butler responded to a question on equitable access to medicine (tinyurl.com/48sxexp3). The Minister noted that “cell and gene medicines or therapies are coming at us really as something of a tsunami. I mean, there are about seven on the register of therapeutic goods here in Australia right now, only seven. But there are almost 4,000 in development around the world. We know that our system of assessment, approval and then reimbursement on the PBS so that we can get them available to Australian patients at PBS prices is going to need to deal with a much larger group of more expensive but more effective treatments into the future.” He said that “the time taken between the medicine coming to #Australia, being approved by the TGA and the time of listing is too long. That really at the heart of the HTA review.” He believes “we can do better, and we can get them onto the PBS more quickly.” On publication of the recommendations for the reform of the HTA system, Butler said: “We've only just received the review. It's a very significant document. I want to see it out into the community as quickly as possible. I've said, in the next very, very little while, I'd like that review to be out there, and for us as a result, to have a pretty full-throated debate as a country about how to manage these challenges. At the end of the day, taxpayers do have to get value for money for this. There needs to be an independent process that, as I said, assesses the clinical effectiveness and the cost-effectiveness of these medicines and achieves a price that is right for taxpayers as well as for company sponsors. That rolls off the tongue very easily, but is often quite a difficult process, particularly given the scale of new treatments and the price of those new treatments that are coming onto the market right now. I don't pretend this is going to be an overnight thing, really, this generational review to build a system of assessment, approval, and reimbursement of these very different types of therapies that are coming onto the market. We set this review up with very real intention behind it, and I want to get the review out to the public very, very shortly so we can start this process.” He could not, however, give a timeframe for publication of the report. Medicines Australia, the association that represents the pharmaceutical industry, notes on its website that the review recommendations are meant to be implemented by December 2024. It calls for patients to be at the centre of the HTA process, for new evaluation and funding pathways to be established and for time to access to be closer to international standards (tinyurl.com/2dv5m3yu).
#HTA #PBS
