Cogentia Healthcare Consulting

Correctly communicating the opportunity of a technology platform to potential investors is the corner stone for successful fundraising activities. Cogentia, a market access and health economic specialist consultancy, is uniquely positioned to support pharma/biotech and medical devices to effectively present your platform technology opportunity.   Here we present some services we offer to support your company, and in the future posts we will describe examples on how we have supported platform technology companies in the past.   #marketaccess #heor #platformtechnology #biotech #pharma #medicaldevice

💡 Developers of platform technologies can benefit heavily from early market access and HEOR strategy development.      Our belief in the pivotal role of early strategic thinking in successful platform technology development will be the cornerstone of our next series of LinkedIn posts.    Platform technologies are often developed for use in multiple applications/indications. Examples include:  ➡️ In the pharma space, a gene therapy platform that can be used in different indications or antibodies used for multiple immunology/oncology indications;  ➡️ In the medical device space, liquid biopsies are used for the diagnosis of several conditions, or genetic testing procedures are developed for several different markers.     The potential of a platform technology can be seemingly limitless, which is why it is important for companies, patients, and health systems. The technologies must be focused in areas with the highest unmet needs and optimal returns for the company.     This will become increasingly relevant in the US market following the implementation of the Inflation Reduction Act (IRA), which is expected to reduce drug prices for top selling drugs and impact the profitability for manufacturers. For platform technologies, this will effectively reduce the commercialisation window, making early decisions for indication sequencing and market access strategy even more crucial for these products.     💡 Our recommendation for platform technology manufacturers is to seek support from experienced partners to inform their early market access and HEOR strategy     An experienced healthcare consultancy can bring together scientific rigour and a strong knowledge of the access landscape to provide a holistic understanding of the manufacturer’s needs. In the coming weeks, we will be focusing on some of our case studies relating to market access and HEOR strategy for platform technologies, culminating in an analysis of the current macro trends in both the US and European healthcare landscapes and how this can impact revenue potential for prospective investors and biotechnology companies alike. Stay tuned for more! For more information or to schedule an introductory meeting with our expert teams, please contact Abbey Child (abbey.child@cogentia.co.uk).  #Pharma #MarketAccess #platformtechnologies #PharmaceuticalIndustry #HealthcareInnovation #Cogentia  

We’re heading to the World Orphan Drug Congress in Barcelona later this month. Matias Ricci will be attending and is looking forward to discussing the hottest industry trends, latest innovations and challenges in the rare disease space. Catch up with Matias to hear more about our expert services in health economics, market access, and value communications can help you achieve your drug development goals. #WorldOrphanDrugCongress #WODC #RareDiseases #OrphanDrugs #MarketAccess #HealthEconomics #CellAndGeneTherapy #ValueCommunications

To welcome the new season, we will review the NICE published guidance during the last month of summer. In September, NICE recommended the largest number of treatments since October last year, totalling 11 treatments (10 pharmaceuticals and 1 Interventional procedure). Oncology, Haematology, and Metabolism & Endocrinology were the disease areas with the largest number of treatments reviewed last month.   In Summary:  📆 In September 2024, NICE published 12 sets of guidance: 11 single technology assessments and one Interventional procedural guidance.   (graph icon) NICE published across 6 different therapy areas: Oncology, Haematology, Ophthalmology, Orthopaedics, Urology/Nephrology and Metabolism/Endocrinology. 🌐 11 treatments were recommended: 7 with patient access schemes (simple discounts) and two with commercial access arrangements.  #NICE #pharma #HTA #metabolism #endocrinology #haematology #oncology #neurology #ophthalmology #orthopaedics #urology 

🏃♂️ A big congratulations to our two Cogentia teams who recently participated in the Chariots of Fire race around historic Cambridge, all in support of Magpas Air Ambulance! 🚁 Despite the challenging and horrible weather conditions, both teams gave their best and crossed the finish line in very respectable positions. We’re thrilled to announce that we not only reached, but doubled our fundraising target, raising an incredible £1,145! 🎉 A huge thank you to everyone who supported us and donated—your generosity helps keep the Magpas Air Ambulance flying and saving lives. 💙 Our fundraising page is still open… https://lnkd.in/eQUSwWYy #Charity #ChariotsofFire #Fundraising #TeamCogentia #Community #Cambridge Abbey Child David Alderson Bishal Mohindru, MSc, PhD oscar wright Hope Sheppard Evie C. George Hale Mark Orchard Neil Davies

Last week, NICE hosted a webinar titled ‘Reviewing and refining our highly specialised technologies (HST) criteria’, in which they discussed their plans to refine & revise the 4 HST criteria. It was abundantly clear from attending this session that NICE do not plan to open up HST routing to a greater number of technologies, but instead want to provide additional clarity, and remove ambiguity around qualification. In doing so, the aim is to ensure that manufacturers are better able to determine whether or not HST might be applicable to their technology. As part of Cogentia’s White Paper exploring HST vs STA routing, the theme of subjectivity in HST eligibility criteria was clear, with terms such as ‘significant’, ‘severe’, and even ‘the disease’ open to interpretation. By intentionally keeping these subjective terms in their criteria, NICE permitted the topic selection team to apply discretion. For instance, where 2-3 criteria were considered strongly met, a fourth that was less clear may be given the benefit of the doubt. However, this discretion also opened the topic selection process up to appeals. As captured in the accompanying table, since the 4 HST criteria were adopted, there have been 6 appeals across 5 topics, with the manufacturer appealing twice in ID3941. Notably, of these appeals, only one was successful in overturning an STA routing. The individual criteria successfully overturned include criterion #1, with the definition of ‘the disease’ the subject of ambiguity, and criterion #3, where the definition of ‘severe’ was open to interpretation. As NICE opens up consultation later this year into a more objective set of HST criteria, with qualifying statements to further remove ambiguity, a key consideration will be whether in doing so, they remove the discretion permitted by the current criteria, resulting in even fewer HST routings. Download our White Paper >> https://lnkd.in/es48uuNm #NICE #marketaccess #HEOR #healthtechnologyassessment #HST

In our recently published white paper, we take a deep dive into NICE’s topic selection decision making, with specific focus on the four criteria required to achieve HST routing. These criteria were introduced in 2022 following a review of the initial 7 routing criteria (Figure 2 below). According to our analysis, the most challenging criterion to satisfy is #1, as a result of challenges interpreting “the disease”. Where the indicated subpopulation is not considered clinically distinct or well defined, our thematic analyses show that the topic selection team use the full population to inform their prevalence estimate. There are several trends emerging over time as NICE’s topic selection team become more familiar with the updated criteria. ➡️ Topic selection often ruled a criterion ‘partially met’ early on, with four partially met decisions in the first five rulings. However, for the subsequent 18 assessments, there have been no further partially met decisions, suggesting more confidence in the application of each criterion ➡️ Of the first 12 topic selection decisions, only two satisfied criterion #4. For the final 11, ten satisfied this criterion, suggesting NICE have better tailored referrals to drive efficiency ➡️ Finally, and most interestingly, of the first 16 decisions, only one of 16 was routed to HST. For the most recent seven, three have been routed to HST. The final two points support the notion that NICE are improving their process for filtering HST vs STA referrals to the topic selection team, resulting in a higher proportion of products achieving a HST routing over time. To delve into our White Paper >> https://lnkd.in/es48uuNm #marketaccess #HEOR #NICE #HST #STA #healthtechnologyassessment 

In our recent Whitepaper, we consider NICE’s topic selection process for appraisal routing. NICE’s Topic Selection Oversight Panel has considered 23 distinct products for a potential HST routing since January 2022. Only 4 of these 23 were successful in achieving a routing to HST, and for the other 19, there was a substantial negative impact on the ultimate appraisal outcome. For the 31 total appraisals routed and published via HST to date, 30 (96.7%) have resulted in a positive decision. This is in comparison to 6 positive recommendations from 16 appraisals (37.5%) routed to STA where sufficient time has elapsed to draw conclusions. For the other 10 appraisals: ➡ 2 of 10 have been terminated by the manufacturer, with both manufacturers explicitly stating at the time of termination that the STA process presents significant challenges to value demonstration (TA923, TA941) ➡ 1 of 10 has resulted in a negative final recommendation from NICE (ID3988) ➡ 1 of 10 has been suspended by NICE (ID3767) ➡ 4 of 10 are awaiting further developments following the decision to route via STA, with these decisions taking place between September 2023 and January 2024 ➡ 2 of 10 have faced extensive delays, with one delayed pending further update and the other delayed primarily due to 2 unsuccessful routing appeals The challenge for these products is summarised well by AstraZeneca is a statement on the termination of TA941: “Assessment of rare disease medicines through the STA process, presents significant challenges to demonstrate the value a product delivers in the treatment of rare conditions.” There is a clear negative impact of routing to STA for rare disease medicines that could be considered as candidates for HST. There are plausible reasons for this, such as small target patient populations resulting in uncertainty in clinical trials. As such, appraisal via STA – the same route used for treatments for prevalent conditions – is likely to pose considerable challenges to rare disease manufacturers. Therefore, making the strongest case possible for HST routing is a critical step in UK market access for manufacturers developing rare and ultra-rare medicines. Download our White Paper ➡ https://lnkd.in/es48uuNm #marketaccess #HEOR #NICE #HST #STA #healthtechnologyassessment

In a webinar on Monday, NICE’s chief medical officer stated that NICE will be working on an update to its current Highly Specialised Technology criteria, with the intention to open consultation in December 2024, and to adopt the new criteria by April 2025. Companies have previously been vocal about the strictness of criteria, in particular relating to the criterion that “no more than 300 people in England are eligible for the technology in its licensed indication and no more than 500 across all indications”, noting that orphan medicines may be approved in multiple diseases. Although it has been confirmed in the webinar that this criterion will be under review, our recent analysis based on a Freedom of Information request to NICE indicates that this particular criterion (#2 below) was met more often than those relating to the disease rarity and availability of treatments (#1 and #3). Furthermore, the most challenging criterion to satisfy was in fact #1, with the interpretation of 'the disease' often resulting in Topic Selection often considering a larger population than the specific indication, resulting in >1,100 patients in England. For a detailed look at our analysis on the topic, you can access our article here: https://lnkd.in/es48uuNm What do you think NICE will look to adjust in the planned update? #NICE #marketaccess #HEOR #healthtechnologyassessment #HST

NICE’s Highly Specialised Technology (HST) route is a key part of a successful market access strategy for orphan/ultra-orphan manufacturers in the UK. Benefits include higher willingness to pay and a greater tolerance for uncertainty, which has led to positive outcomes in 30 of 31 published HSTs to date. However, HST routing is reserved for very few medicines. Only 31 HST appraisals have been published, compared to 1006 standard single technology appraisals. Routing decisions are taken as part of NICE’s topic selection process. Cogentia have conducted the most comprehensive review of NICE topic selection decisions to date, based on data obtained through a Freedom of Information request. Key objectives of our analysis include: ➡ To explore the impact of routing decisions on the ultimate appraisal outcome ➡ To establish the key contributing factors to treatments being routed via HST or STA ➡ To better understand the topic selection decision-making process, including the interpretation of each criterion and the use of external sources to inform it ➡ To provide recommendations to manufacturers with orphan medicines that they believe may be eligible for HST routing. In 23 cases where the Topic Selection Oversight Panel was required to make a determination (i.e. where routing to HST was a plausible option), the overwhelming majority were routed to STA, with just four medicines achieving HST routing. Outcomes for the 19 routed to STA have been largely negative, resulting in a number of terminations, suspensions, or protracted processes. Our findings support the conventional wisdom that a crucial step in the UK for rare disease manufacturers is to secure a routing to HST. You can read the full article here: https://lnkd.in/es48uuNm #marketaccess #HEOR #NICE #HST #STA #healthtechnologyassessment