Payers and manufacturers both want to provide patients with quick access to new healthcare interventions. However, getting there can be difficult, not least when there is a mismatch between manufacturers’ evidence and payers’ expectations. This can cause unnecessary delays that do not only increase the cost to manufacturers but, crucially, compromise patient care by delaying access to new technology.

For the past nine years, NICE has provided early scientific advice to manufacturers to help guide their data collection strategies and improve their chances of reimbursement. However, improving health is not just about pharmaceuticals – medical device, diagnostics and other tech manufacturers are increasingly important players in the provision of healthcare. In recognition of this, NICE launched on 3 July 2017 their new Medtech Early Technical Assessment (META) tool, designed especially for the medtech industry.

The META Tool aims to provide manufacturers with affordable advice that will help them develop an evidence base that aligns with payers’ expectations, ultimately leading to quicker access for patients. The tool follows a Health Technology Assessment (HTA) structure and allows manufacturers to either gain advice from NICE or a specialist organisation. Non-NICE facilitators are organisations with experience in business development for SMEs, cost-effectiveness evaluations and NHS healthcare structures that have been trained by NICE on the HTA and META Tool process.

Following completion of an online application where the manufacturer describes their problem and specifies which facilitator they wish to engage with, they have a telephone discussion with the facilitator of their choice who would then review their data and produce a report with advice on what the evidence gaps are and how the manufacturer should best address them in order to produce an argument that is convincing to payers and commissioners. The report also contains information on which other organisations and HTA bodies the manufacturer should approach, such as the High Cost Devices Portal, the Office for Market Access or other related research organisations.

Feedback from NICE’s initial user testing has been very positive with manufacturers in particular highlighting the value of understanding what the gaps in their evidence base are, how they should best address these gaps and understanding the questions payers are likely to ask and being able to prepare for these. Feedback also included comments on how the advice has helped manufacturers make better use of limited resources by not investing in the wrong tests, understanding who their optimal market is and helping inform their value proposition.

The launch of the META Tool not only recognises the importance of medical device and diagnostics manufacturers to improving patients’ health but is also a sign of the ever-increasing collaboration between payers and manufacturers, which will ultimately benefit patients and manufacturers alike.  

The BOBI Awards are a set of highly prestigious awards given to business intelligence professionals through the BHBIA, and the only healthcare-specific business intelligence awards in the UK.

The 2017 BOBI Challenge (sponsored by MSD) consisted of a one day business simulation competition which focused on analysing and advising on the commercial opportunities for a fictional, innovative health monitoring technology.

In their announcements, the judges stated that the winning team “presented logical, balanced and persuasive arguments that told a story and inspired confidence at each stage of the challenge. Their projections and recommendations were backed up by strong rationale. They displayed strong, supportive teamwork”.

Have a look at our case studies for a few examples of how we have previously helped clients refine their strategy, make portfolio decisions and create bespoke data tools to support their field teams. For more information on our business intelligence solutions, please contact [email protected]

CCGs are, among other things, responsible for developing and maintaining regional formularies. These are either managed by an individual CCG’s formulary group or, in some instances, by a joint formulary group working across two or more CCGs and/or acute trusts. A drug that has received a positive technology appraisal (TA) by NICE should automatically be included in CCG formularies within three months of NICE’s decision. However, CCGs can conduct their own appraisals of drugs that have not undergone a TA and that are considered relevant to the local population. As such, CCG formulary groups function as gatekeepers to the uptake of drugs that have not undergone a national level assessment.

How should they operate?

NICE’s guidelines for how CCGs should manage regional formularies recommends that regional formulary groups involve a mix of locally relevant stakeholders in their decisions. Stakeholders that NICE recommends including are clinical networks, patient groups, local people and communities and relevant manufacturers. If CCGs conduct local appraisals and evidence synthesis, the guidelines further state that CCGs should ensure there are individuals with the specialist skills necessary to undertake these activities available. Such specialist skills include literature searching, critical appraisal and interpreting and contextualising evidence.

What did we do?

We wanted to find out how local formulary groups actually work, what stakeholders they involve in their formulary decisions and what data they consider and prioritise during decision making. To this end, we surveyed 32 selected commissioners from across England.

What did commissioners tell us?

• Clinical groups are part of (97%), or consulted by (84%), almost all CCGs’ formulary groups. Conversely, patients and patient representative groups, who NICE guidelinesrecommend are included in decision making, are only part of, or consulted by, a minority of local formulary groups (22% to 41%)
• Most CCGs (73%) require both budget impact (BI) and cost-effectiveness (CE) data when evaluating drugs for inclusion on the local formulary. Overall, CCGs are more likely to require CE estimates that are based on national, than on CCG specific, data (75% versus 50% of CCGs). An opposite trend is seen for BI estimates, for which local formulary groups are more likely to request estimates based on CCG specific (58%), rather than national data (33%), data
• Most formulary groups conduct an in-house critical appraisal of clinical data in submissions (75%) and over half conduct their own BI or CE estimates (58%)
• Most CCGs have at least one member on their formulary group with formal training in how to conduct a critical appraisal of clinical data (83%). Conversely, despite the importance of health-economic data to formulary decisions, only 25% of CCGs surveyed had a member of the formulary group with formal training in how to appraise such data.

What does this mean?

• There is demand for CCG specific data in submissions. Most CCGs require both BI and CE data in formulary submissions and, when BI estimates are requested, CCGs prefer for these to be based on local data. If assisting a local champion with preparing a formulary submission, manufacturers and consultancies working with them should ensure they clearly state the economic impact that uptake of the product would have on local services
• CCGs may require support in developing in-house expertise. Despite the importance of health-economic data for formulary submissions two-fifths of surveyed CCGs do not conduct their own CE or BI analyses and only one one-quarter has a person on their formulary group with expertise in how to appraise such data. To ensure funding decisions are made to the highest standards, CCGs may therefore require further support from NHS England in developing and retaining professionals with the necessary skills to conduct a critical appraisal of formulary submissions
• Patients may be underrepresented in formulary decision making. Despite recommendations to involve patients and patient representatives when developing and reviewing local formularies, these groups are only included or consulted by between one-fifth and two-fifths (22% to 41%) of surveyed CCGs’ formulary groups. As a result, important user views could be missed during decision making

The data described above were included in a conference poster presented at ISPOR’s 19th Annual European Congress. For a copy of the poster, please email [email protected]

We therefore analysed general practice prescribing data from England and Wales and identified the key prescribing trends of 2015.

Click here to access the full report

Overall trends

We found that the total net ingredient cost (NIC) associated with primary care prescriptions had increased from £9.16 billion in 2014 to £9.58 billion in 2015. Similar to what we found in our 2014 prescribing review, the drug types associated with the highest total NIC spend were diabetes drugs, respiratory corticosteroids, analgesics, antiepileptics and oral nutrition products, in descending order.

Opioids

Opioids are effective and common forms of pain relief. However, they are associated with a known risk of dependence and addiction. It is therefore interesting that, for the second year in a row, there was an increase in the prescription of strong opioids. Specifically, the quantity of strong opioids tablets and capsules prescribed in English and Welsh general practices had increased by a staggering 10% relative to 2014.

Diabetes drugs

Ohe total NIC spend on diabetes drugs in 2015 was £992 million. Interestingly, the highest spend was seen in CCGs that were described as deprived urban areas with younger people and ethnic diversity, particularly with Asian and Black minorities. The finding that demand for diabetes drugs is much higher in certain sociodemographic and ethnic groups implies that cost-savings could be achieved if targeted campaigns were conducted in these groups. This was also noted by Dr Ahmad, Clinical Director of Dementia and Diabetes in Merton CCG and Diabetes UK Clinical Champion, who commented that the data beg the question why more is not done to address the problem of diabetes in ethnic minorities.

Antiepileptics

Analysis of antiepileptic prescribing data also revealed interesting findings. It has previously been argued that demonstrating bioequivalence to an originator antiepileptic drug is not sufficient to guarantee clinical equivalence because of the narrow therapeutic window of some antiepileptics and that, as a result of this, switching patients to different manufacturer’s drug could result in therapeutic failure.  Against this background, the MHRA has previously recommended that patients on certain antiepileptics (Category 1 antiepileptics) are maintained on the same version of the drug that they began treatment with. However, in spite of this, our analysis of prescribing data showed that approximately half of all category 1 antiepileptics were still prescribed generically in 2015.

Top-performing brands

We also identified the branded pharmaceuticals with the highest performance in 2015. For the second year in a row, the respiratory corticosteroid Seretide® was the branded pharmaceutical with the highest total NIC spend (£164 million). However, both the total number of Seretide® units prescribed, and the associated total NIC, had decreased between 2013 and 2015. Considering the recent introduction of cheaper generic versions of the drug in the UK it seems likely that Seretide®’s market share will continue decreasing over the coming year.

Other branded pharmaceuticals to note are Lyrica® and Incruse® Ellipta®, identified as the branded pharmaceuticals with the greatest numerical increase in total NIC and the greatest percentage increase in total NIC, respectively, relative to 2014.

The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK. The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.

The workshop brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and Health Technology Assessment decision-making, aspirations for the use of this evidence in a regulatory context, challenges to the acceptability and steps to overcome these.

The report summarises the presentations and discussions from the meeting, which highlighted the potential of real world evidence to significantly impact how medicines are evaluated.

Click here to download the workshop report, and further information on the meeting can be found on the Academy’s policy project page.

Media and marketing services company Cogora has analysed 2014 general practice prescriptions from England and Wales to identify the year’s biggest movers and shakers, and set out its findings in a new report. General Practice Prescribing Trends in England & Wales, 2014 Annual Review.

Key overall findings in the report include:

• The total cost associated with prescriptions issued by general practices in England and Wales rose from £8.91 billion in 2013 to £9.16 billion in 2014. This increase (2.9%) far exceeded the 2014 inflation (0.5%) indicating a real increase in cost to the NHS
• There were large regional variations in the cost of prescription per registered patient. The highest cost per registered patient in 2014 was observed in Wales (£183.24 per registered patient) while the lowest cost per registered patient was observed in London (£111.19 per registered patient)
• In terms of drug categories, the highest total cost associated with general practice prescriptions was for diabetes drugs, respiratory corticosteroids, analgesics, antiepileptics and oral nutrition products, in descending order. Together, these five drug categories accounted for just over one third of the total NIC associated with all English and Welsh general practice prescriptions in 2014
• The branded pharmaceuticals with the highest total cost associated their prescriptions in 2014 were Seretide, Symbicort and NovoRapid, in descending order. Conversely, the greatest number of prescriptions was issued for Ventolin, Adcal D3 and Clenil Modulite

Therapy area specific findings in the report include:

• The cost for diabetes prescriptions issued in English and Welsh general practices increased by 7% between 2013 and 2014, with the total spend in 2014 being £902 million
• The cost of corticosteroid prescriptions issued in English and Welsh general practices was over £754 million in 2014. Comments from a therapy area expert suggest the increased prescribing may, in part, be due to over-prescribing of inhaled corticosteroids rather than an increased clinical need
• Between 2013 and 2014, there was an increase in the number of prescriptions issued for opioid analgesics. This increase was much higher for strong opioids (+10%), which are associated with increased risk of addiction, than for weak opioid (+2%) analgesics.
• In line with official prescribing guidelines, the data showed lower levels of generic prescribing for certain types of antiepileptics (51% generic prescribing) than when analysing data from all therapy areas together (82%). However, medical charities are advocating higher branded prescribing due to concerns relating to clinical equivalence of some branded and generic products
• There was a 12% increase in the cost of prescriptions issued for oral nutrition products such as nutritional supplements and paediatric milk formulae between 2013 and 2014

For more information please contact:

Ellen Murphy

Head of Insight

Cogora

T: 44 (0) 20 7214 0576

[email protected]
About Cogora

Cogora is an integrated media and marketing services company that sits at the heart of a community of 220, 000 highly-engaged healthcare professionals.

For over 25 years we have produced inspirational and incisive content via a range of brands and channels. These in turn provide the data and insight that gives us a deep understanding of what our audiences want.

We combine these resources to create innovative, flexible solutions for clients looking to access and influence Commissioners, Primary and Community Care Nurses, GPs, Practice Managers, Hospital Pharmacists and Hospital Managers across the UK and Western Europe.