Cogentia Healthcare Consulting

🎄 Wishing you a very Merry Christmas! 🎄 As we wrap up another successful year, we’d like to express our gratitude to all our clients, partners, and colleagues who have supported us throughout 2024. We hope this holiday season brings you time to relax and celebrate. Our team will be doing just that as we take a break over the holiday period from Tuesday 24 December until Monday 6th January. Here’s to a happy, healthy, and prosperous 2025 – we look forward to working with you in the year ahead!

📢 Attention pharma and biotech pricing & market access professionals! We’re seeking your valuable insights! Take these two short (~1 minute) surveys on: 1️⃣ Value-based agreements 2️⃣ International reference pricing in the US Your anonymous responses will help us understand the future evolution of value-based agreements and the potential impact of international reference pricing in the US. Please take five minutes and click the links in the post below from our colleague, Evie C. below to share your opinion. Thank you! #Pharma #Biotech #Pricing #MarketAccess #ValueBasedAgreements #Healthcare

NICE’s public consultation on proposed changes to the Highly Specialised Technologies (HST) routing opened today . NICE’s CMO Jonathan Benger had been clear earlier in the year that the intention of these changes is to provide additional clarity, and remove ambiguity around eligibility for HST. We summarise the proposed criteria below, with detail on how these differ from the existing criteria captured in our accompanying table. 1️⃣ The disease is ultra-rare and debilitating - Defined as having a point prevalence of 1:50,000 or less in England - Is lifelong after diagnosis with current treatment - Has an exceptional negative impact and burden on people with the disease. 2️⃣ The technology is an innovation for the ultra-rare disease To ensure the technology is an innovation for the ultra-rare disease, the technology should:  - Not be a repurposed technology - The indication should not be a significant extension of an indication from another population or disease  - The technology should not currently be being explored in clinical trials for other indications 3️⃣ No more than 300 people in England are eligible for the technology for its licensed indication, and the technology is not an individualised medicine. - ‘Eligible’ refers to everyone who could have the technology under its marketing authorisation in England. 4️⃣ The technology is likely to offer substantial benefit for people over existing established clinical management, and the existing established clinical management is considered inadequate. Though NICE have framed this as neither explicitly aiming to increase, or decrease the number HST routings, based on an initial review, there are a couple of areas likely to be of concern to manufacturers, namely: ➡️ The requirement that a technology should only be indicated for one indication, with no clinical trials in other indications is likely to be of considerable challenge. Given the economics of ultra-rare diseases, manufacturers will often look to expand into new indications to justify clinical development. ➡️ The definition of ‘eligible’ patients being aligned to the full marketing authorisation. For the previous criterion, rationale for the decision was often framed around an epidemiological cascade, that moved from full population through to eligible population (i.e. those likely to receive the treatment). This tightening up of the definition of eligibility is likely to reduce some of the discretion previously available. In summary, although NICE’s proposed changes to HST routing criteria are intended to provide additional clarity, by tightening up various definitions, there is a considerable risk that these criteria greatly reduce available discretion, and consequently result in a lower number of technologies qualifying for HST. Cogentia will be conducting further analysis to see how current HSTs would have fared against these new criteria. Mark Orchard #NICE #HST #pharma

📣 We'd appreciate your help! Please do share your insights in this short survey posted by our colleague, Matias Ricci #pharma #biotech #marketaccess

Meaningful patient involvement in health technology assessment (HTA) ensures that patient perspectives are considered in coverage and reimbursement decisions.   This study analysed publicly available sources to examine methods of involving patients in HTA decision-making across four European countries. Each country's patient involvement initiatives were given a quality rating across five chosen domains. Key strengths were identified to inform suggestions for enhancing patient involvement initiatives across Europe.   Innovation in this area is vital to keep patient voices central to HTAs in Europe and improve their integration into future decision-making processes. #HTAS #Healthcare #patientvoice oscar wright Catherine Akesson

At ISPOR EU this year, we ran an online survey exploring the question: “Will R-based cost-effectiveness models eventually replace Excel as the standard?” Those completing the survey at the conference were eligible to take part in our prize draw for £100 global gift card. We’re delighted to announce a winner has now been selected and contacted, but there is still time for you to have your say as the survey remains open! We will be compiling the results in the New Year to share some insights. Share your thoughts >> https://lnkd.in/evpz_U_V

🥳 What a day! Yesterday, we came together to celebrate an amazing year and kick off the festive season in style! Huge thanks to Stephanie and Nina for organising such a memorable day. We started the afternoon packing and delivery hampers for the incredible Romsey Mill, a local charity supporting families and young people across Cambridge. After a whirlwind of shopping, we had much fun assembling and packing hampers filled with goodies, ready to be delivered to families across Cambridgeshire. It was a heartwarming and laughter-filled way to make a just a small difference. The festive spirit continued with our annual darts game—this year’s winners were James Morris (again!), and Joanna Todd. A special shout out goes to oscar wright for his unique style! 🎯 🏆 To top it all off, we enjoyed a delicious meal at the Giggling Squid, sharing stories and raising a glass to the year ahead. 🍽️🥂 Neil Thompson, David Alderson, Vanessa Buchanan, Abbey Child, Adam Costello,Anne Collins, Bishal Mohindru, MSc, PhD, Catherine Akesson, Claire Elbrow, Evie C., George Hale, Hope Sheppard, Joshua Soboil, Julie Barker-Yip, Karl Herman, Mark Orchard, Matias Ricci, Neil Davies, Warda Tahir, Yifei Wang

In November, NICE published 13 sets of guidance, of which Haematology and Oncology had the largest numbers of published guidance. Eight of the published guidance correspond to Single Technology Assessment, and all 8 were reimbursed by NICE. Seven of the 8 were reimbursed with patient access schemes, in the form of a confidential level of discount from the published list price. Pembrolizumab, a drug with multiple oncological indications, was the only reimbursed pharmaceutical product that was reimbursed with a more complex commercial agreement with NICE. The details of this agreement are not publicly available. The highlights of the NICE published guidance are:  📆 In November 2024, NICE published 13 sets of guidance: eight single technology assessments, four NICE guidance and one Interventional Procedure guidance (IPG) 📈 NICE published across 6 different therapy areas: Haematology, CNS/neurology, Oncology, Immunology, Respirology and Women’s Health. 🌐 All 8 interventions that were assessed were recommended: 7 with patient access schemes (Simple discounts) and one, Pembrolizumab with a commercial arrangement. #NICE #pharma #HTA #haematology #oncology #neurology #Immunology #Womenshealth #Respirology 

The reimbursement landscape for digital health products (DHPs) varies significantly across the US, UK, and EU4 markets, with a mix of centralised and decentralised evaluation processes. Our analysis suggests that whilst there is no standardised pathway, European markets are progressively adopting Germany’s centralised DiGA framework. Given the success of Germany’s DiGA model, there have already been discussions surrounding the future harmonisation of digital HTA assessments, and integration of DHPs within national health systems is expected to provide further alignment across current reimbursement pathways.  Our analysis >> https://lnkd.in/eGG2sMUk #DigitalHealth #Healthcare #MarketAccess #DigitalHTA  

France’s Early Access Programme (AAP) provides a valuable opportunity for manufacturers to launch high-cost innovative medicines with free pricing upon scheme entry. However, price reductions frequently occur following AAP exit, driven by reference pricing often focused on Germany. Our analysis supports the importance of evaluating pricing implications during early access programmes, particularly for manufacturers launching in France who may be stung with retrospective rebates if prices during AAP differ significantly from launch. Our Analysis >> https://lnkd.in/e5W_5YsA #MarketAccess #EarlyAccess #Healthcare #Pharma #Pricing