For a long time, agencies have considered information from “comparable” markets when making their own technology decisions. However, recently, collaboration between health technology assessment (HTA) agencies has notably increased and not only do they share HTA results, but they also share their assessment methodologies. These collaborations have led to the formalization of three major international networks, the main one being the European Network for Health Technology Assessment (EUnetHTA). Their objective is to enhance the collaboration among European HTA agencies in order to contribute to the sustainability of healthcare systems. Here we discuss three reasons why the pharmaceutical industry should be mindful of international HTA agency collaboration:
1. EUnetHTA’s tools improves efficiency for HTA agencies
The main EUnetHTA output is the HTA Core Model®. It consists of a nine-module methodology for individual agencies to conduct subparts of an HTA, which are populated in a database made exclusively available to EUnetHTA’s members (agencies). The tool allows reference to the work previously conducted on the same product within the network. As a result, it provides some degree of standardization and prevents agencies from reinventing the wheel, thus improving efficiency.
2. EUnetHTA is not a European HTA agency – it’s a network of agencies
Collaborating is not merging. A closer look at the HTA and market access decision value chain helps to identify some of the limits of a pan-European HTA and market access approach. Apart from some well-documented exceptions (hepatic metabolism specificities in Asian populations involving particular cytochrome isozymes), the biomedical science is universal; what is valid in one country generally holds for another.
The context starts to play a role as soon as the sponsor pharma company wishes to design a clinical trial that compares their new drug to the standard of care which may differ between countries. As a result, outputs from relative effectiveness studies also vary. Even when assessed against the same comparator, cost-effectiveness analysis, which assesses economic data, also varies greatly. It depends on the proposed price of the new drug, the healthcare settings involved, clinical practices and guidelines and the funding system. Therefore, one cost-effectiveness analysis won’t suit all. A similar reasoning also supports country-specific budget impact models.
Thus, the access decision (yes or no) and the conditions applied (indication, price and reimbursement status) remain specific to the market being considered. Interestingly though, Belgium and the Netherlands have announced their intention to jointly negotiate the price for orphan drugs and other medicines of high value or with a high budgetary impact/a high cost-per-patient with individual pharmaceutical companies. This pilot project is expected to launch in 2016, in an effort to improve patient access by increasing their bargaining power in price negotiations.2
Avoiding the political sphere, EUnetHTA restricts its role to the most easily generalizable aspects of HTA: science and methodologies.3 EUnetHTA members benefit from the scientific assessments already carried out by another agency via the HTA Core Model; however the final HTA report, intended to inform access in a given country, will be made specific to the country’s context by the national agency itself, not the network.
3. The pharma industry should consider EUnetHTA’s approach in order to better align their operations
There is an opportunity for pharma to account for EUnetHTA’s approach in their operations: Roche has looked closely at EUnetHTA’s methodology, module by module, to identify which elements could be relevant to its activities.4 This project, which involved many affiliate representatives and benefited from EUnetHTA guidance, led to the deployment of new evidence and value-generation procedures within the firm.
This is a pioneering initiative that some observers question. However, even though the long-term benefit of such a commitment remains to be quantified, pharmaceutical companies should not overlook EUnetHTA. It’s becoming an influential player in the HTA and market access arena. Expect EUnetHTA’s work to be more systematically considered in the future, possibly informing joint price negotiations such as the recent Belgian-Dutch initiative.
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1. EUnetHTA, Work package 4 – HTA Core Model for Medical and Surgical Interventions. December 2008
2. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Position on joint price negotiations for Medicines. June 2015
3. STAMP European Commission expert group. EU cooperation on HTA – latest developments. PowerPoint presentation. May 2015
4. Roche Pharma. Roche Pharma Report Relating to EUnetHTA HTA Core Model® Applications for Pharmaceuticals. December 2014
Colds and coughs are the most common health conditions experienced by consumers all over the world in the past 12 months, but the number of sufferers in China and Hong Kong, at 57 percent and 55 percent are even higher than the global average which stands at 51 percent. These findings were revealed from a recent GfK online survey which asked over 27,000 people in 22 countries which health conditions from a given list1 they have experienced in the past 12 months.
Leading market research group GfK announced today the agreement to sell its global animal & crop health division to a consortium consisting of Inflexion, a private equity investor, and the current management led by Stephen Hearn.
Will 2016 be the year of the smart home?
With technology and digital information sources advancing rapidly, to be effective marketers, it is important to understand the complete market dynamic a consumer faces when searching for disease or treatment information. While extensive data about their quest traditionally have been obtained using surveys, the data are recall-based and therefore are subject to the reliability and validity issues inherent in self-reported methods.
Digital tracking technology has advanced beyond cookies to apps that can capture every search term and URL-click a person makes on their devices (PC, laptop, tablet or mobile). This tracking, used for research purposes and with the permission of respondents, enables us to change our measurement strategy. Thereby, we can capture attitudes as well as passively observe behavior as it occurs. Importantly, researchers can link survey data with behavioral data, allowing for a deeper and more robust understanding of the intentions behind individuals’ behavior.
So how can we best exemplify the significance of understanding the patient’s digital experience and then leveraging that knowledge? In this article we will share the methodological details of a GfK study that examines how, in this case, diabetes-focused marketers can be more patient-centric in their digital strategy in the following areas:
The study objective was to use an observational approach to better understand the journey of people with diabetes through evaluating their buying, navigation and search behavior. People with diabetes were recruited from our US panel and downloaded our proprietary tracking app onto their PC or laptop. The app then monitored the respondents’ web use for three weeks, collecting data on all URLs they went to, the duration of their visits, search behavior and other information. Respondents completed a diary survey two times /week for the first two weeks, where they described their online and offline experiences. Certain high-profile websites were pre-programmed with short entry and exit surveys. We assigned a task for week three – half of the respondents were to research blood glucose meters and half were to research weight management.
Data from multiple sources were integrated into this study, including:
Combining the behavioral tracking data with the other data streams enriched our understanding of their digital journey, including:
The key learnings from the study that comprise the core components to optimizing digital strategy using a data-driven approach included:
o Most search topics are centered on managing weight and blood sugar levels; insurance topics are also popular.
o General health sites generate higher audience reach, more repeat visits and longer visit duration than diabetes-specific sites.
An accurate view that minimizes patients’ recalled experiences is crucial to unlocking the digital experience that so many marketers seek. This view requires an approach that does not solely rely on self-reported methods, which is why the use of an observational approach to evaluate behavior is crucial to answer these questions. This helps us to evaluate the total patient experience.
Of course, validity and reliability are the keystones of observational methodology. In a situation where a patient self-reports, the resulting data is subject to many variables. By using the observational method, the patient’s behavior is an undisputed matter of record.
This article was co-authored by Art Rome of Health.
For further information, contact Natasha Stevens.
We asked over 27,000 people in 22 countries which health conditions from a given list they had experienced in the past 12 months.
The Cancer Drugs Fund (CDF) was launched in 2011 to enable patients to access drugs that would not otherwise have been routinely available from the NHS in England.
In September 2015, the National Audit Office reported that to date the fund had cost nearly £1billion, having funded the treatment of over 74,000 patients. However, for over 50% of these patients, this has meant funding drugs that have been appraised but not recommended by the National Institute for Health and Care Excellence (NICE), largely on the basis of cost-effectiveness.
This had led some independent observers to suggest that the fund does more harm than good in that it diverts limited funds away from more cost-effective therapies and, therefore, reduces the overall health gain that could be achieved within the NHS.
Against the background of a cost-constrained NHS, the cost of the CDF has risen by over £200 million to £416 million for the two years leading up to March 2015. The budget for this period was £280 million.
Figure 1. Cancer Drugs Fund costs
It is hardly surprising then that NHS England has had to take action in an attempt to control these spiraling costs.
In March, we saw 25 drugs removed from the national CDF list following a review of clinical effectiveness and cost, while a number of other drugs remained only as a result of discounting by manufacturers.
On October 4, a further 16 medicines used for 27 indications were expected to be delisted, in a move which has been met by outrage from the lay press and cancer charities alike.
One high-profile casualty of the latest review is Avastin (bevacizumab) [for breast and bowel cancer], which accounted for 19% of patients supported by the CDF between April 2013 and March 2015. Other delisted therapies include Celgene’s Imnovid (pomalidomide) and Revlimid (lenalidomide) for patients with myeloma who have failed on two prior therapies. Roche’s secondary breast cancer therapy, Kadcyla (ado-trastuzumab emtansine) has avoided the chop on appeal, but has come under pressure from the charity Breast Cancer Now, because of the cost, with the full list price estimated to be around £90,000 per patient. [For the full National Cancer Drugs Fund List, including those being unlisted in November visit www.england.nhs.uk/wp-content/uploads/2015/09/ncdf-list-sept15.pdf].
Well, the Cancer Drug Fund Working Party, which is chaired by the National Clinical Director for Cancer and includes representatives from the department, NHS England, NICE, cancer charities, the Ethical Medicines Industry Group and the Association of the British Pharmaceutical Industry, has been set up to “create a better way forward for appraising and commissioning new cancer drugs”.However, in July 2015, NHS England announced that the work of the group would be “paused” while it considered how the work should progress.
This coincided with the publication of the Independent Cancer Taskforce’s report on “Achieving world-class cancer outcomes – a strategy for England 2015–2020“. The taskforce noted that the CDF had “enabled some pharmaceutical companies to bypass NICE cost-effectiveness assessments” and advocated a solution that allowed access to new cancer drugs while managing within a defined budget and aligning with NICE appraisal processes.
NHS England has in principle accepted this recommendation and proposed that the CDF should become a “Managed Access Fund”, with clear entry and exit criteria.
In theory, this would see funding for a set period prior to the availability of NICE guidance, plus additional time for the generation of “real-world evidence” to support a more informed NICE appraisal process. The critical difference for this Managed Access Fund is that it would no longer fund drugs that have been appraised but not recommended by NICE.
NHS England is planning to implement the new arrangements beginning April 2016, following a period of consultation this autumn.
For further information, please contact Tim Fitzgerald.
National Audit Office. Investigation into the Cancer Drugs Fund. Published September 17, 2015.
A survey by GfK revealed that one in four Canadians have experienced depression, anxiety or mental health issues in the past year.
Top five most common conditions that people say they have experienced in the past 12 months are a cold, problems sleeping, muscle or joint pain due to injury or over exertion, weight problemsand migraines or severe headaches.
Top five most common conditions that people say they have experienced in the past 12 months are a cold, problems sleeping, muscle or joint pain due to injury or over exertion, weight problems and migraines or severe headaches.
What is the justification for high drug prices for niche markets that include orphan drugs with annual price tags of more than €200,000 and the growing number of targeted therapies for well-defined, relatively small patient populations? No doubt, many of the recently launched products would not have achieved their high prices if their product features, such as efficacy and safety, were the sole criteria considered.
Indication-specific factors, such as prevalence, number of competitors, characteristics of the target population, as well as the opinions and preferences of stakeholders – payer, physicians, patients and society – are playing an increasingly significant role for the pricing opportunity of new drugs.
Multi-criteria decision analysis (MCDA) has become a way to capture those different factors. And a growing number of health technology assessment (HTA) and payer organizations have started to implement MCDA in their decision-making process for coverage and/or pricing decisions.
Several studies have shown that, for example, prevalence (or rarity) of a disease is a strong price-driver, as well the severity (seriousness) of the disease, and the age (vulnerability) of the affected patient population. In other words, the smaller the patient population, the younger the patients and the more serious the disease, the higher is the payer’s (and society’s) willingness-to-pay. Conversely, a treatment for a mild form of a disease, which affects primarily elderly people and which is caused by smoking for instance, has less chance to be valued by society and is unlikely to achieve a commercially attractive price.
So, how can the value of a product be determined, considering all the different factors which have varying importance for decision-making?
As the term implies, MCDA is a methodology which explicitly considers multiple criteria for decision-making. Thus, in the pharmaceutical world, MCDA means not only considering the therapeutic benefit of the new drug, but also elements, such as disease-related factors (burden of illness), innovation level, the evidence provided and the socio-economic impact of a new drug.
A crucial first step in an MCDA is to identify the factors which are (at least potentially) relevant for the decision-making process. These factors can be collected by a literature search and ideally complemented by primary research with experts. The second and equally important step is the weighting of the factors, in terms of their relevance, for decision-making. Expert interviews can achieve this either by a simple point allocation exercise or more sophisticated methodologies, such as conjoint approaches or the hierarchical analytical process – all methodologies based on trade-off tasks to determine relative importance of criteria. In the third step, the product performance has to be assessed against the relevant factors to derive a (competitive) product performance score.
A complicating factor in applying MCDA for HTA assessments is that the relevant decision criteria, as well as their weighting, can vary significantly by indication, which makes a standardized approach, and therefore a cross-indication comparison, very challenging. Another unsolved problem is a universal way to translate the derived MCDA value score(s) into a monetary value for pricing and reimbursement decisions.
Despite the challenges with MCDA, it is increasingly used by many HTA organizations and for pricing and reimbursement decision making. Although not many HTA and P&R bodies are currently using MCDA as a formal part in their decision-making, there is a clear trend suggesting that the importance of MCDA will increase over the coming years.
For example Quebec’s HTA organization, the National Institute for Excellence in Health and Social Services (INESSS) has already adopted a multi-criteria approach as part of their appraisal process of new therapies.1 Similarly, the National Institute for Health and Care Excellence (NICE) in the UK and Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) have also adopted elements of the approach.
The English National Health Service uses an MCDA process for deciding which oncology medicines will be funded by the national Cancer Drugs Fund 2 and the German Institute for Quality and Efficiency in Healthcare ( IQWiG) has piloted two projects to validate the use of conjoint 3 and analytic hierarchical process to compose a multi-factor patient preference score4
Another clear indicator of the increasing role of MCDA is the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Vision 2020 Implementation Research Working Group, which identified “Good Practices for Using a Multi-Criteria Decision Analysis in Health Care Decisions” as one of the top priority methods for task force development.5
For further information, contact Marco Rauland or Tim Fitzgerald.
 Aenishaenslin C, Hongoh V, Cissé HD, et al. Multi-criteria decision analysis as an innovative approach to managing zoonoses: results from a study on Lyme disease in Canada. BMC Public Health. 2013 Sep 30;13:897.
 NHS England. Cancer Drug Fund decision summaries. Available at: www.england.nhs.uk/ourwork/pe/cdf/cdf-drug-sum. Accessed October 2015.
 IQWiG. Choice-based Conjoint Analysis – pilot project to identify, weight, and prioritize multiple attributes in the indication “hepatitis C”. 23 July 2014.
 IQWiG. Analytic Hierarchy Process (AHP) – Pilotprojekt zur Erhebung von Patientenpräferenzen in der Indikation Depression. Article in German. 8 May 2013.
 ISPOR. Multi-criteria decision analysis in health care decision making emerging good practices task force. Available at: www.ispor.org/taskforces/multi-criteria-decision-analysis-bgr.asp. Accessed October 2015.
There is no disputing the value of social media insights in health, though it is still generally not embedded and utilized in the daily business of most health companies. Primarily, companies stay away from the internet to avoid becoming aware of adverse events regarding their own products. And if they do listen to what is said on the internet, they have another challenge: getting the best out of the discussions and then turning those insights into actions. That is a missed opportunity, as online postings and discussions in the social media domain can be a great source of real-world data that is so valuable in the evolving health landscape.
For instance, older consumers (50+), who are more vulnerable to diseases, are quickly adopting social media (e.g., 70% is already connected to Facebook).1 We also know that most adults trust medical information shared by peers in their social media networks. Blogs, forums and online platforms have evolved into trusted sources for sharing personal experiences related to medical conditions and diseases and for discussions on unmet needs, treatments and drug-related topics.
The big advantage is that social media data add insights from unprompted discussions that are missed in traditional survey research. It is real-time and contextual. It is rather flexible, not having the constraints of sampling and study design. And it is ideal for discovering, isolating and tracking issues as they emerge. So, when interpreting and structuring the data, you might well be gaining valuable real world-evidence insights.
However, most health companies are still struggling to harvest and activate the insights from social media. The issue is that while you might expect the yummy chocolate cookie in the form of a comprehensive perspective, often you will get just the crumbs and a fragmented picture. That is because social media is fraught with unstructured big data Insights. Although health issues are one of the most-discussed topics on the web, it is still like looking for the needle in the haystack. The importance of data relevance and accuracy is underestimated. Data and research integration are crucial to add value and industry-specific information is needed to put things in context.
Let us outline three examples of integrated ways how we apply social media research and answer specific health-related business issues:
Health companies need to understand the strategic landscape first, before starting operational planning. We use network analysis to follow the connections between people, brands and media.
By mapping stakeholder groups and influencers, identifying and segmenting audience interests and affinities as well as tracking and evaluating health-related public debates, network analysis brings health companies strategic insights into the whole social ecosystem.
Nowadays, digital media provides you with the ability to interact with and communicate about brands whenever you like. Brands are no longer created, managed and controlled solely by brand-directed activities, but they are also shaped through the communication between consumers, also patients and HCPs, in the digital world. Only by integrating social media information and tracking data do you get complete insights into managing your brand in an interactive world. A pre-condition for this exercise is an integrated research framework with harmonized KPIs to connect survey-based and unstructured social media data to finally make sense of both worlds.
Monitoring social media to identify potential key safety issues enables health companies to act quickly and early on safety issues discussed on the internet. It is not only about getting access to this real-world data on drug performance, but also having a structured and referenced approach for coding, interpretation and classification in order to get the full picture.
It’s important for healthcare companies not to relinquish the value of social media in the process of avoiding the potential risks of discovering adverse events regarding their brands. If you find yourself in such a social media dilemma, you don’t have to make the choice. Actively monitoring social media, including early signaling of any potential safe issues, can help you to securely embrace real-world discussions in social media forums that can help strengthen your brand.
1 Roper Reports US – Fall Core 2014 Study; Interview Dates: September 23 – October 27, 2014
This article was co-authored by Christian Waldheim of Social Media Intelligence.
For further information, contact Jan Guse.