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Experts point to how innovative market access agreements will be applied to high-value drugs in China in the future

 Last Update: 2022-11-05
 Source: Internet
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As the world embraces rapid medical innovations, it is also under pressure
to pay high fees.
The payment problem of breakthrough innovative drugs has also become a global challenge
.
Especially under the current situation that China's medical insurance financing channels are relatively single and there is still a lack of more targeted evaluation tools and innovative access channels, how to further refine the access management of basic medical insurance, explore access methods for high-value and breakthrough innovative drugs, and do a good job in risk management and control? Professor Chen Yi, market access instructor of Qipu University, professor and researcher of the Institute of Hospital Management of Tsinghua University, and co-head of the Biomedical Innovation Center of Shanghai Chuangqi Health Development Research Institute, tried to learn from the development practice of the European medical insurance reimbursement system, and sorted out the innovative market access agreement (Market) on the basis of summarizing relevant international literature Access Agreement, MAA) development background, driving factors, protocol categories, implementation conditions, evaluation criteria, relevant cases and development trends, aiming to help medical and health colleagues have a more systematic understanding of international practical experience, and bring inspiration and thinking
on how to establish high-value drug access payment methods suitable for China's national conditions in the future.
This article is quoted from: Professor Chen Yi's report "High-value Innovative Drug Medical Insurance Reimbursement Risk Management - International Experience: Innovative Payment Agreements from Concept to Case", the purchase report is shown at the end of the
article.

Chen Yi

Professor and researcher of the Hospital Management Research Institute of Tsinghua University, co-head of the Biomedical Innovation Center of Shanghai Chuangqi Health Development Institute

1 Background on the development of innovative MAA

The standard of market access is defined as the relevant policy management regulations and rules
of pharmaceutical enterprises in promoting the commercialization of drugs involving the main links of market access.
There are two main types of market access rules: the first is a general rule that is suitable for all pharmaceutical market access; The second is a targeted, separate market access rule
designed to optimize and accelerate access to a new drug among patient populations.

Our country's medical insurance department in 2017 Before the formal negotiation of the drug catalogue is launched, the first general rule is mainly used, according to the generic name of the drug, and according to the market price of drugs of different manufacturers of the same generic name, the reimbursement ratio is based on the reimbursement ratio stipulated by medical insurance, that is, the inclusion of new drugs in reimbursement does not require exclusive negotiation to reduce the price
.
This report mainly introduces the second, that is, under the market access rules, the market access agreement between pharmaceutical companies and medical insurers for a new drug, also known as the innovative market access payment agreement (Market).
Access Agreement, MAA）
。

Innovative MAA in various countries since 2010 With rapid development, especially in European countries, under the government-led social insurance financing model, new market access payment agreements have gradually become the main mode for
high-value drugs to be included in national medical insurance.
With the emergence of high-value, high-value innovative drugs, coupled with the budget constraints of medical insurance funds, a variety of innovative access payment agreements have been developed
internationally.
According to incomplete statistics Since 2009, at least dozens of medical insurance departments in various countries around the world have reached different MarketAccess Agreements with pharmaceutical companies every year.

These include: Price-Volume Agreement (Discount) ◆ Utilization of Medicare Reimbursement Limit (Utilization Capitation, Fee for Capitation, Outcome-based and Performance-based）

It is worth noting that between 2010 and 2012, the development of MAA in European countries accelerated, and in addition to European countries, other countries such as Australia, New Zealand, Poland, Belgium and Hungary began to adopt MAA agreements
.

According to the international research literature, the main reasons for the rapid development of innovative MAA are several aspects:

◉ First, the pricing of new drugs has changed from the lack of evidence in the early 90s, subjective price assessment, simple and extensive price control to the establishment of a set of objective and clear evaluation standards, that is, health economic and technical evaluation methods
.
However, the results of health technology evaluations will be eligible for reimbursement for high-value drugs because Price factors such as ICER value are excluded from health insurance reimbursement, resulting in some good drugs losing market
access.

◉

In addition, the technical requirements and process of health technology assessment are time-consuming and labor-intensive, and there are still many uncertainties
in how the results and recommendations of health technology assessment will be applied to specific pricing.
therefore Both the medical insurance department and pharmaceutical companies hope to benefit patients in a timely manner for the access of new drugs, and actively explore a compromise solution acceptable to both sides, that is, to form a new drug market access agreement
through the results of negotiation and negotiation.

Second, for a long time, before the emergence of MAA, there was no specific written agreement
between pharmaceutical companies and medical insurance departments on how to share the risks of drug development and post-marketing commercialization.
generally speaking Pharmaceutical companies bear all R&D expenses and the risk of R&D failure before the new drug is launched Risk), but once a new drug is approved for marketing and obtains the medical insurance price and reimbursement eligibility, the medical insurance must bear all the risks of the drug reimbursement (post-approval risk).

Hence 2010 Around and after that, the gradual application of MAA changed this practice, and its goal was to reduce all the risks borne by the medical insurance party after the new drug is launched, that is, the possible risks that may arise after the new drug is launched, part of which should be borne
by the pharmaceutical company.

◉

2 The logic behind the development of innovative MAA

Since the mid-2000s, MAA has been driven by the increasing number of expensive therapeutics (such as tumor-targeted drugs) approved for marketing, limited health insurance fund budget constraints, and lack of effective evaluation tools and fund overruns for Medicare payment for expensive drugs
on the other.
Therefore, medical insurance puts forward more stringent requirements and expectations
for the evaluation of high-value and high-priced innovative drugs, whether they are really effective, and whether they have the best cost performance.

In the practice of new drug pricing and medical insurance reimbursement in various countries, the evidence shows that many new drugs after they are approved for marketing, especially those that are conditionally approved for marketing, have a "real" world clinical trial value (Actual).
benefit) did not meet the clinical value "expected" by the health care department benefit), leading the health care department to challenge
a series of questions such as whether the new drugs it buys are "value for money".

Therefore, when there is a large gap between the value of new drugs expected by medical insurance and the true value of drugs, to a large extent, medical insurance parties require companies to provide real-world drug clinical data to prove the value of
new drugs.

In other words, the medical insurance department believes that the safe and effective data obtained from the clinical trials of new drugs prescribed by the drug regulatory authorities is mainly due to the responsibility of the drug regulatory department, and rarely considers the need of medical insurance parties to obtain evidence of additional or differentiated clinical value of drugs （Anticipated Added Value）
。

Furthermore, the value evaluation of drugs by medical insurance is different from that of the NMPA, that is, in addition to the safety and effectiveness of drugs, medical insurance also considers economy, that is, the cost performance of drugs, and medical insurance pays more attention to real-world data, especially to evaluate the impact
of drugs on the budget of medical insurance funds.
Therefore, clinical trial data is a necessary condition for new drugs to obtain medical insurance reimbursement, but it is not the most sufficient condition
.

Therefore, clinical trial data is a necessary condition for new drugs to obtain medical insurance reimbursement, but it is not the most sufficient condition
.

Because even if the clinical trial data shows that the control drug can bring additional clinical value, it is still limited to the data of the pre-market clinical trial of the new drug, and there is great uncertainty
as to whether the new drug will produce additional clinical value as scheduled in the later stage of marketing.

In addition, the medical insurance department also believes that the results of clinical trials will also affect its true clinical value judgment
due to some factors.
For example, the institution conducting clinical trials, the conditions for enrolling patients, refer to the selection of drugs, and the endpoint of mid-term clinical trials Uncertainties in factors such as the determination of intermediate endpoints and the time frame for conducting clinical trials can affect the results of
clinical trials.

Based on the rationality and rigor of the above views, since the mid-2000s, there have been innovations
in exploring access agreements between many health insurance and pharmaceutical companies, mainly in European countries.

It is worth noting that both medical insurance and pharmaceutical companies believe that the negotiated market access payment agreement is an innovation and a win-win solution, because:

First, for the medical insurance sector, MAA can reduce the payment risk
of uncertainty about the efficacy of new drugs just on the market.
Meanwhile, MAA It can solve the crisis of trust in medical insurance to pharmaceutical companies (The Trust).
Crisis), especially if the payment of efficacy results depends on real-world clinical results, and the medical insurance department can adjust its reimbursement price in time based on real-world data, or disqualify for reimbursement, with decision-making flexibility
.

First, for the medical insurance sector, MAA can reduce the payment risk
of uncertainty about the efficacy of new drugs just on the market.

In addition, by requiring pharmaceutical companies to collect post-market clinical data of drugs, it helps medical insurance understand the performance of the drug market and serves as a reference for
other new drug negotiations.

Second, for pharmaceutical companies, due to the uncertainty of the additional clinical efficacy of new drugs and concerns about the risk of international reference prices, the discounts negotiated through agreements are usually confidential and do not affect the published prices of the agreed drugs (List).
Price）
。

Due to the uncertainty of additional clinical efficacy, there are two commonly used methods for medical insurance providers in actual negotiation operations:

First, the simple approach is that health insurance usually requires companies to give a discount directly during negotiations, in which case the discount price of the agreement already includes the risk
due to uncertainty about efficacy.

First, the simple way is that health insurance usually requires companies to give a discount directly during negotiations.

Second, the medical insurance first signs an agreement with the pharmaceutical company and pays the drug at a premium, but the condition is that the company must collect the efficacy data promised by the company within a certain period of time after the drug is launched, and then submit real-world data for the medical insurance to carry out the economic and technical evaluation of the drug and determine the final reimbursement qualification and price
.

Second, medical insurance first signs an agreement with the pharmaceutical company and pays the drug at a premium.

3 Innovative MAA definition

Review MAA Regarding the development of innovative access payment agreements, the industry has given different definitions for different understandings, and there are also some controversies
.
Some are named "risk-sharing agreements" and some are named "innovative payment agreements"
.
Some mistakenly equate it with a "cost-sharing" financial risk management agreement or a efficacy risk management agreement, but in practice, it is innovative MAA market access agreements are often used in different forms of financial risk management agreements or efficacy risk management agreements, and both
.

De Pouvourville first proposed innovative payment protocols in one of his papers, arguing that innovative payment agreements primarily refer to risk sharing Agreement
).
The idea of risk-sharing schemes is that there is a difference between the validity of clinical trial data and real-world data and needs to be further confirmed and evaluated
.

Adamski et al.
give a broader definition
of a payment agreement for risk sharing.
That is, in addition to the payment risk involving the uncertainty of the true clinical value of drugs, the more critical risk for the medical insurance department is the risk
that the medical insurance cost exceeds the budget of the medical insurance fund after the new drug is included.

In other words, as the pressure on the budget of the health insurance fund is increasing, the health insurance department will actively consider how to reduce the risk of underbudget payment and avoid the double risk
of real-world clinical efficacy being lower than clinical trial efficacy.
Therefore, the evaluation of medical insurance pays more attention to the risk of impact on fund budgets, while researchers pay more attention to the risk of
uncertainty in clinical efficacy.

As the pressure on the budget of the health insurance fund gradually increases, the health insurance department will actively consider how to reduce the risk of insufficient budget payment and avoid the double risk
of real-world clinical efficacy being lower than clinical trial efficacy.

In addition, compared with the medical insurance department, the former involves the risk assessment of the impact of the fund budget, which is relatively easy to operate, while the latter involves clinical evaluation results and program design, and the cost and specific process of collecting clinical efficacy data will be more complicated
.

To be precise, so far, there is no consensus definition
of the MAA protocol.
But most of them put MAAs are classified as risk-sharing agreements, even though some MAAs do not have risk-sharing functions, such as cost-sharing agreements
.
PAS（Patient Access Scheme) is an additional MAA, more widely used in the UK, with the aim of improving the cost performance of drugs and improving patient access to new drugs
.
Most often, however, PAS results in more restrictions on patient accessibility than optimized access
.

In general, risk sharing, cost sharing, and pay-for-efficacy are all classified as innovative access payment agreements, or risk sharing payment agreements
.
Below we will give further explanations and explanations of the classification (see Table 1).

◉First, Risk Sharing agreements: Risk sharing agreements refer to the transaction between the health insurance department and pharmaceutical companies.
Regardless of the final value of the new drug, the contract is for both parties to sign the contract in the face of uncertainty about the true clinical value of the new drug, and bear certain risks
for each other.
Despite this, pharmaceutical companies have full confidence in the safety and efficacy of the drugs they sign in the real world and are willing to accept rewards and punishments
according to the promised efficacy of the drugs agreed upon in the agreement.
For example, incentives would mean premiums and contract renewals for drugs, and penalties would mean lower prices and loss of eligibility for
Medicare reimbursement.

◉First, Risk Sharing Agreements◉◉◉◉

◉ Second, Cost Sharing Agreement: The cost-sharing agreement is a commercial agreement signed between the medical insurance department and the pharmaceutical company, divided into two types, the purpose of which is to reduce the cost of drugs
.
The first agreement is that the cost of drugs for treating all patients is shared
between health insurance and the company.
Another agreement is that Medicare pays for patients who treat patients who have an effect, and the cost of patients who do not work is borne by
the company.
The latter can also be understood in a certain sense as paying
for efficacy.

◉ Second, Cost Sharing Agreement◉◉◉◉

◉Third, Payment for Performance (P4P): It is a pay-by-efficacy agreement, that is, the price and profit of a new drug by a pharmaceutical company are linked to the performance of the efficacy results of the
drug in the subsequent real-world clinical use.

◉Third, Payment for Performance (P4P)◉◉◉◉

Conclusion: According to the above, MAA is defined as "2 or more Parties.
" Conditional pricing and reimbursement agreements for access to a new drug", which refers to the specific financial and efficacy-related commitments
that pharmaceutical companies need to fulfill with Medicare.
Although different countries are interested in MAA The definitions are interpreted differently, but mainly cover Risk-Sharing, Cost-Sharing Agreement, and P4P Agreement
.

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