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Despite the challenges with the implementation of managed entry agreements, the debate involving these complex market access routes is not abating. Speakers at the International Society for Pharmacoeconomics and Outcomes Research Europe meeting in Milan on 7–11 November 2015 discussed current experiences with such agreements across Europe, as they are about to make a bigger showing across the Atlantic. 


Economic pressures drive MEAs in Spain

In the past, Spain did not present a fertile ground for managed entry agreements (MEAs), but economic pressures are changing attitudes. For payers, reduced ability to pay for new treatments that are coming onto the market and, in many cases, the uncertainty regarding their real-world performance are key drivers for the willingness to engage in innovative financing schemes. According to Antoni Gilabert-Perramon, managing director of pharmacy and medicines at the Catalan Health Service, the way of thinking within pharma companies is also changing rapidly as they “see the opportunity to win in terms of access and fair financing.” As part of its Harmonization program within the autonomous community of Catalonia, the region has entered into 17 risk-sharing agreements, involving nine drugs, 29 hospitals, and nine pharma companies.

Gilabert-Perramon sees the following as the basis of forming sustainable models for financing healthcare innovations: firstly, evaluation – for whom, when, and how the new drug should be used; secondly, monitoring of real-world performance through establishment of registries and evaluation of data; and thirdly, financial co-responsibility and risk-sharing between the payer and the pharma company. The infrastructure allowing monitoring is critical; in the last five years 60,000 registries have been set up in Spain covering diseases such as HIV, rheumatoid arthritis, hepatitis C, cancers, and orphan diseases, according to Gilabert-Perramon. The implementation of MEAs requires investment on the part of the payer, as Gilabert-Perramon stated that in Catalonia “the payer pays for the monitoring but the company pays too.” In addition to co-financing, the data analysis process is also a shared responsibility as “the payer has set up a committee in which the company, hospitals, and the Catalan Health Service participate, to monitor and decide which treatments have success or not.”

Should CEDs replace MEAs?

Not everyone is convinced that MEAs are sustainable or have great potential to be successful. Risk-sharing schemes have been in place in Italy for a number of oncology products, but there is scant evidence pointing to any beneficial results for the payers. According to Professor Livio Garattini of the Mario Negri Institute of Pharmacological Research, such schemes are very plausible for politicians as a means of allowing access, instead of denial of access to new treatments, but there are difficulties when it comes to defining the response and also in implementing the schemes into reimbursement contracts. Professor Mondher Toumi from the Department of Public Health at Aix-Marseille University in France concurred, highlighting that in Italy there were several practical issues, including difficulties in ascertaining what the costs are for patients and also in ensuring that the money is being paid back to the healthcare system. Toumi sees coverage with evidence development (CED) as a more appropriate way to deal with situations which so far have led to pay-for-performance deals. He highlighted the high administrative burden as one of the key drawbacks of MEAs, with many deals being too complex and expensive to manage. In addition, the lack of clear vision as to where the payback would stop makes such deals unsustainable. CEDs would instead have the advantage of data collection being designed to answer specific questions regarding uncertainty surrounding the drug, and therefore could be more specific and effective in the long run.

Despite Toumi’s reservations, others still remain open to MEAs and do not necessarily view them as being very different from CEDs. Spain’s Gilabert-Perramon agreed that payers are looking for simplicity with MEAs and also consider them as a means to answering the question of a drug’s real-world effectiveness, which could be used to negotiate rebates. For example, if a hepatitis C drug has shown cure rates of 90% in clinical trials but in the real world it is closer to 80%, the rebates could be constructed in a way that compensates for the lower effectiveness in the covered patient population. However, Garattini asserted that in the case of hepatitis C, the key question was not whether payers should pay for the 80% versus 90% responders, rather they should focus on the high price and the resulting budget impact, arguing that in such instances, price-volume agreements were more appropriate.

Omar Ali, pharmacy director and Quality, Innovation, Productivity and Prevention adviser for the Commissioning Payer Network of the UK’s National Health Service (NHS) suggested that CEDs can be attractive for payers and that many are open to the co-creation of such studies with pharma companies. He asserted that emulating the NHS’s commissioning through evaluation approach used for medical devices and procedures may be one way to do it, whereby local or regional payers would reimburse the treatment at the same level as standard of care and then collect the data that can be used to negotiate the price. While the industry may not have been too keen to engage in such experiments so far, changes in the standard drug lifecycle that are occurring with the introduction of adaptive pathways will necessitate changes in established processes with pharma and payer communities alike.

When used wisely, MEAs can benefit both parties

Despite the criticism of many past MEAs, especially in the UK and Italy, previous examples provide both payers and pharma with lessons on what does and does not work in practice. Francois Lucas, principle consultant at Pope Woodhead, a market access consultancy, shared his company’s experience in advising clients on MEAs. According to Lucas, MEAs are most appropriate to use for drugs that treat diseases with high unmet need, with potential to significantly change the way the disease is managed, and where the standard evidence route is not sufficient to convince payers of the value the treatment brings. Furthermore, MEAs are most suitable with drugs that have high costs but do not treat many patients, and where it is possible to identify easy-to-measure outcomes that can be captured within a short timeframe. This last point was echoed by Swati Mehta, associate director of pricing and market access at Bristol-Myers Squibb in the UK. According to Mehta, payers will not be willing to wait two years (for example) to see the outcome and potentially get their money back; six months is typically the longest timeframe they will accept.

Mehta also shared the lessons from her company’s experience of dealing with the UK’s National Institute for Health and Care Excellence Patient Access Scheme Liaison Unit (PASLU). Companies need to be certain that a simple discount is not the best way forward, which is a route that PASLU has preferred over more complex agreements in recent years. Mehta asserted that MEAs are appropriate in scenarios where a treatment works well in some patient populations and not in others, but it is difficult to estimate the percentage of the responder population in advance, making it impossible to define an appropriate discount. Mehta also highlighted that outcomes-based MEAs require investment of resources from the company’s perspective, and they do not enter them lightly.

Is the US the one to watch for more MEAs?

The US has already seen some outcomes-based MEAs over the past few years, but there are signs that further interesting developments in this area are still to come. There are numerous challenges with the implementation of such deals in the US, including legal challenges (Medicaid Best Price rule compliance and the Anti-Kickback Statute) and misalignment of incentives (eg for pharmacy benefit managers who work on behalf of insurers), but despite this the appetite for such deals has certainly grown among the pharma industry. For now, MEAs will still be used sparingly, and only among a select group of innovative insurers and those more keen to experiment with real-world analytics, but the confluence of new expensive treatments and budgetary pressures will mean that they will not be ultra-rare sightings, as payers and pharma experiment with new payment models.

Commenting on Amgen’s deal with Harvard Pilgrim Health Care for an outcomes-based deal for its proprotein convertase subtilisin/kexin type 9 inhibitor Repatha (evolocumab) announced only two days earlier, Kathleen Hughes, vice president of Avalere Health, predicted that more MEAs will occur in the US, but due to the different healthcare system and payer environment compared to Europe “we can expect to see some Wild West situations happening.” Hughes added that there was a rumor that Amgen proposed a couple of different deal options to Harvard Pilgrim, indicating that companies and payers alike will experiment with how such deals are structured as they seek to find the optimal approach for a given drug. Hughes also explained that keeping deals simple will be critical, and that from the payers’ perspective, any outcomes that can be “taken off a claim form are easier to administer, anything that requires sourcing from medical forms makes them more difficult.”

The details of Amgen’s deal with Harvard Pilgrim have not been released, but what is known is that there is a performance-based element to it, linked to the decrease in patients’ low-density lipoprotein levels. As these data are collected in medical forms, rather than claim forms, this example may be a test case for how feasible it is to collect and analyze such data in practice. Hughes suggested that drugs to treat chronic heart failure (CHF), such as Novartis’s Entresto (valsartan/sacubitril), may be more amenable to outcomes-based deals if rebates are linked to hospitalization events which can be extracted out of claim forms. However, they may also not be easy to implement in practice – for example there may be some confounding factors, such as for non-CHF-related causes of hospitalization, and it is not clear whether such information can be readily accessed by the insurers.

In the US, as in Europe, the payers are responsible for data collection and analysis, but the nature of the diseases where these deals have been made so far differ between the two regions. US payers seem to find MEAs attractive for drugs that can treat many patients, with a substantial budget impact, whereas European payers prefer to resort to them only in situations where a small number of patients are involved. It remains to be seen to what extent the takeaways from the European experience with outcomes-based deals will be taken on board by both payers and pharma as the US gets to grips with such deals.

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