In the interview to Interfax-Ukraine Martin Verschlan, General Director of Roche Ukraine LLC, Member of the Board of Directors of American Chamber of Commerce in Ukraine (ACC), Member of the Board of Directors of Association of Innovative Medicines (APRaD) told how Roche company sees the Ukrainian pharmaceutical market, how to make innovative drugs accessible to Ukrainians and how to provide expensive treatment for patients with orphan diseases, in particular, patients with CMA.

Text: Anna Levchenko

 

How would you evaluate Ukraine’s pharma market? How did COVID-19 influence the country’s healthcare system?

This market has great potential if proper reform mechanisms are used. However, its structure remains largely unreformed, and the legacy of the USSR healthcare system is still apparent. In the private sector for example, there are no sustainable financing mechanisms and too much of the healthcare costs come out of the patients’ pocket, including quite costly oncology and orphan diseases treatments. It’s quite unusual to see the near complete absence of private medical insurance in Ukraine, despite the fact that around 10% of the population could afford medical insurance if it were accessible and attractive, but it’s not being developed here. In the public sector, the allocation of resources is still largely driven by the size of the hospital infrastructure and the state procurement system focuses on procurement of siloed input components without much consideration to efficiency, evidence, quality, and outcomes.

On the positive side, the first steps in healthcare reforms have been made and the 2nd stage has been initiated. With the intended stage 2 healthcare reforms, healthcare service providers will have a much stronger incentive to operate with quality and efficiency and I would say that this reform is one of the most meaningful changes I’ve seen during my last several years in Ukraine.

What conclusion can be made from the first year of COVID-19? Ukraine understood quite quickly that this pandemic poses a serious problem, and that the healthcare system does not have the capacity to deal with a massive outbreak. Hence, I believe the decision to lock down even when we had few cases won us a lot of time and helped us to balance the limited capacity and the demand on the healthcare system better. For the pharma market, on the other hand, the pandemic has a twofold impact. On the one hand many patients struggled to see their doctors and we know that many treatments and diagnosis have been delayed due to the pandemic. The impact of this can be felt in a decline on healthcare outcomes - in the fact that we now have more metastatic cancer cases for example, and it had an impact on our global business as well. On the other hand, due to the pandemic many people also realized the need to invest more in healthcare and in a country with low overall level of investment and standards of care, such as Ukraine, this is opening up new opportunities.

As for the plans for 2021, I can say there are new areas of healthcare reform and new procurement mechanisms being implemented in Ukraine. Particularly, we are talking about managed entry agreements (MEA) – a new, but effective procurement mechanism, providing access to innovative medicines to patients in Ukraine. MEA also allows the government to spend budget funds wisely and to procure integrated healthcare solutions based on medicines with clinically proven effectiveness. Such an instrument has been in use in the USA and Europe for years, including the countries neighboring Ukraine.

In your opinion, should the pharmaceutical companies participate in shaping the country’s healthcare system or should they accept the terms and conditions set by the government?

Pharma companies cannot remain silent observers. Companies like ours have a vast experience of cooperating with government healthcare systems in numerous countries of the world. We understand what legislative changes are necessary to provide expedient patient access to costly innovative medicines. We have a clear vision of what needs to be changed and done to fully launch private medical insurance in Ukraine. You see, such a mechanism can take some of the financial load off the government and people who can afford it, can invest in healthcare through buying insurance when young and then, in case of illness, they receive treatment.

It’s important to change the government healthcare’s approach to patient treatment – from process to the quality of results. Here we can offer the government a solution that allows for the procurement of a defined result for a defined patient population – e.g. those with a certain type lung cancer. We define the expected results for patients and offer the cost of therapy, based on those results. This is another example of our company being actively involved in the process of Ukraine’s healthcare modernization.

Also, pharma companies have already been helping Ukraine’s healthcare system to improve the level of public awareness which is very low in the country overall. We see it in our lung cancer awareness campaigns: 75% of all patients with lung cancer turn to doctors at its late stages when it’s quite difficult to get a positive result. In Western Europe this figure is around 25%. Many Ukrainians have no culture of regular doctor visits and annual medical exams.

What healthcare areas Roche considers to be the most promising in Ukraine?

Roche is sharply focused on research and targeted therapy. Life expectancy in Ukraine is quite low. If we determine the proper treatment for a patient and prolong their life – it’s very valuable. We are ready to present the new diagnostics technologies in Ukraine that allow obtaining the best result of the properly tailored treatment. We know that not all treatments work equally well for all patients and our aim is therefore to match the right patient to the right treatment. This is a so-called personalized treatment or personalized healthcare approach (PHC).

Another area where a lot of innovation has occurred during the last years is in cancer biology and the ability of science to activate the human immune system to attack tumor cells. This is why cancer immunotherapy is a very promising area. We can observe a long duration of the response of these treatments and it’s taking us one step closer to eventually cure this disease. We are very much interested to provide patients in Ukraine with access to these innovations.

Many innovations are also being implemented in the area of rare genetic diseases. In this area we can also change patients’ lives. We hope Ukraine is interested in that because we see many patients here with rare nosologies whose treatment is not covered by the government as it’s done in other countries.

In your opinion, can personalized medicine be made cheaper in Ukraine because it’s quite expensive for us now.

I wouldn’t necessarily agree with posing the question as ‘cheap or expensive’. I don’t think cheap healthcare exists, and COVID-19 has demonstrated just that. Because the capacity of the system is low we had to close down our economy even though we did not have many cases of COVID, and we may end up remaining in lockdowns much longer than we should because we cannot vaccinate fast enough. So our low level of investment in health care in the end cost us quite a lot. If more investment had been made in Ukraine’s healthcare, it would be stronger today. Healthcare is an investment, not an expense. And our role is to make this investment effective, ensure the money is not lost, but invested and gives us productive healthy people at the end.

As for personalized medicine, I believe the challenge is not in its cost, quite the contrary. Due to the personalized approach, the patient can receive treatment that’s effective specifically for them and will not be a waste of resources on expensive medicines that don’t help and are not losing time on ineffective therapy. So personalized health care is cost effective.

This is one of the biggest challenges in Ukraine’s healthcare system because too much money is being spent with no base in evidence and no rational effect. The state should be using the available resources effectively. And personalized medicine is the answer to the question of the return on investment in healthcare. I think it’s not about making treatment cheaper or more expensive, we just need a different, a value based approach.

How would you evaluate the existing state procurement mechanisms in Ukraine? What problems are currently acute?

State procurement mechanism in Ukraine, overall, is quite outdated. It’s reassuring to see the government considering making a change. Currently the government makes policy, decides what to pay for, which patients’ treatment to cover, provides funding, conducts procurement procedures, procures and allocates medicines, and organizes treatment. However, in Ukraine, as in other countries with similar procurement logistics, we see it’s not the most effective mechanism. Even despite the approved budget, the patients are not receiving treatment because the tender failed or something went wrong with the paperwork.

I believe the government should focus on what its role is. As a private business, we are convinced the government should define policy and rules, assume a controlling role and regulate. But the procurement itself, allocation and shipment of medicines is something private businesses can do more effectively and that cooperation between government and business can be fruitful. Ukraine’s procurement mechanisms can be better. For instance, the second stage of medical reform is based on the establishment of defined reimbursement amounts for the cost of medical services, allowing both private and public institutions to treat patients funded by the National Health Service of Ukraine (NHSU). I am glad to see such plans being hatched. I hope the movement in this direction will continue and more effective procurement mechanisms and funding allocation for patient treatment are implemented.

Are you ready to sign managed entry agreements?

Of course, we’d like to be the first to sign a MEA in Ukraine. We’d like to provide outcome assurances and a return for investment to the payer. We are ready to sit down and negotiate the terms, based on the government’s objectives. For instance, in treating breast cancer we can determine the specific expected treatment outcome, and the government signs the agreement to achieve it. This allows the government investing effectively in treatment and paying not for a vial of a drug, but for a defined outcome for a patient.

Will the first MEAs be signed in the area of oncology?

Possibly. We hope and are now ready to sign such agreements. But it can happen in other areas as well, for instance, in orphan diseases, but we believe there are oncology areas that are very suitable for such a format.

Let’s talk about the lack of innovative medicines in Ukraine. How can Ukrainians be provided with access to effective treatment?

First of all, we need to understand and accept the fact that most governments around the world cannot always fully provide patients with such medicines. The financial burden should be shared by the public and the private sectors. If we look at the existing healthcare system, it’s obvious that patients are paying out of pocket for too often. This is also because people see healthcare as a cost and not as an investment and essentially, Ukrainians begin spending money on healthcare only in the moment they get sick. But it’s difficult to pay out of pocket for an innovative treatment. Serious disease is a catastrophe in itself for the patient and their family and, additionally, there is a burden of thinking where to get the money for treatment. A financial catastrophe is added to the human one. It’s necessary to help people understand the necessity to invest in their health while still being young and healthy. This means to invest in a healthy lifestyle but also to make financial provisions in time, such as through medical insurance and insurance products. I believe this can help to create a more stable private sector and relieve financial pressure on the government – in the long term. The government cannot pay for everything, but there are people in the country who can pay for themselves and they should have an opportunity to do that.

I see that many people in Ukraine do not understand that. There is no practice of being insured in Ukraine and people falsely believe that it is a matter of affordability. I strongly challenge that notion as I have seen medical insurance work in many developing countries around the world. However, there are structural flaws in our legislation and market practice which make medical insurance unattractive both for the customer and the insurer. For example, medical insurance agreements are signed for one year without the right of automatic renewal. This means that at the end of each year the insurance company has the right to deny me coverage. This is fundamentally different from what’s happening in any other market. Patients should have a right to remain insured as long as they comply with their obligations in the insurance contract. Insurance companies have a right to refuse patients at the beginning or to make certain exclusions based on past history but not at the end of every single year. And this right to remain insured should not end when I turn 65, when people retire in Ukraine. People after 65 get sick more often, but if you know that at this age you will be deprived of insurance, why would you get insured at 30 years old? This looks much like an umbrella that starts leaking when it starts raining. This needs to change. Proper insurance coverage is one of the things that can help provide access to innovative treatment in the private sector.

For the public sector, more focus of the government should be on quality and results. The government should not spend funding on therapies without evidence and unproven effectiveness and in order to give the government an incentive to invest in quality and outcomes, we are ready to sign these risk-sharing agreements mentioned above. Then treatment will become more accessible, its coverage will be wider and investing in infrastructure will become possible.

What instruments of pharma producers and government interaction can improve Ukraine’s healthcare system – besides insurance?

We have a lot of expertise, information, and data we could share with the government. Part of the reason why the allocation of healthcare funds is not optimal and why there is a lack of good insurance products in the market is the absence of solid data. We can help the authorities to improve this through our capacity in Real World Data evidence and through the use of leading-edge technology which involves programmers in the Ukraine as well, such as blockchain enabled and encrypted patient registries. It’s evident that there is a lot of value in health care data and digital health and I believe that Ukraine as a country is in a good position to play in this field through its strong IT sector and openness to digital innovation.

How do you see the solution to the problem of providing medicines for patients with orphan diseases in Ukraine and improving treatment access?

Firstly, diagnostics – such diseases frequently have genetic origin and are difficult to diagnose. Several experts and lots of knowledge is needed to make a correct diagnosis. Our company supports screening and diagnostics programs, as well as projects focused on doctors’ education and awareness.

Secondly, the lack of single register of such patients – the government does not always know the real number of orphan patients. Usually, difficulty of diagnostics is the reason. Sometimes it’s unclear how many people such diseases affect, so the government has difficulties making decisions about their treatment.

Also, patient-government dialogue is important. For the government, among the key needs is understanding the number of patients and the treatment they receive, in order to control spending. We can provide a solution for transparently managing this proves and know exactly whom the government is paying, for what result, and how it impacts the budget.

Our company is directly involved in organizing patient access to treatment in many countries. We invest in improving patient registers allowing to create the foundation for making decisions. We see the problem of personal and medical data control in Ukraine. Many attempts have been made to misuse user data, especially if you are a patient with a difficult condition. However, there are technologies that can help protect patient data. We invest substantially in developing such registers in Ukraine.

Lately, collecting money to treat children with SMA abroad has become a frequent occurrence. Several families left for other countries (e.g. Poland) where their children can get the necessary treatment free of charge. At the same time, your company provided 55 SMA children in Ukraine with medicines for free, under the pre-registration access project. In Ukraine, such patients are not treated, there is no government program. How can we expedite such program implementation and how much, do you think, it can cost?

It’s important to understand that treatment for SMA patients exists. Currently, two SMA treatment medicines are registered in Ukraine. Clinical effectiveness of both medicines registered in Ukraine has been proven via multi-center international trials. They provide significant improvement of patient life expectancy, breathing and movement function, as well as quality of life. There is also a genetic therapy medicine that’s not currently registered in Ukraine.

All these medicines are different. One of them is administered via injection into the spinal cord and has limitations, e.g. it is not recommended in babies and patients with scoliosis. The medicine our company produces is administered orally (drops in the mouth), which significantly expands the treatment opportunities, it’s convenient and safe. Genetic therapy medicine is declared as a single injection and is most effective in infants when applied before the first symptoms, requires normal liver function and blood tests.

Families initiate collection of funds for expensive treatment, with no consideration of the risks, hoping that on injection will cure their child’s SMA. Such sentiment is well understood since there is no government SMA treatment program in Ukraine today.

In 2020, to expedite access to life-saving treatment of children with SMA, our company included 55 Ukrainian patients into the international pre-registration access program. These are children with the most difficult SMA types – 1 and 2. However, these patients need for their treatment to continue.

Collecting money and participating in the international programs is a temporary fix. The problem needs to be addressed on the global level. How it’s done in other countries – e.g. Poland, where all patients with SMA receive treatment funded by the government and last year a total newborn screening was launched for early SMA detection. This is why a holistic improvement of medical assistance to patients with SMA is important. It’s necessary to implement modern global innovative technologies in Ukraine’s healthcare. The government needs to create the effective treatment model to decrease child mortality and disability of SMA patients.

Treatment cost depends on many factors. In case of SMA, there are different types of this disease, whose treatment and support vary in cost and logistics. The government needs to evaluate the number of patients and establish the standard cost of treatment for them. Determining whom to treat – and if everyone, the investment will be substantial. If the government were to focus on the most difficult cases, the cost decreases. It depends on the government focus and the part of patient’s state funding covers. It’s difficult to specify the cost, but it you’d like to have good coverage for these patients, it requires investment.