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Financing and Payment of Innovative Drugs: How to reach a consensus among medical/insurance/medicine/patient parties?

 Last Update: 2022-06-13
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Abstract: Applying stakeholder theory, analyzes the relationship between patients, medical insurers, medical providers, and drug manufacturers in the field of innovative drug financing and their respective difficulties, and draws on international experience to put forward suggestions for building a multi-funding system for innovative drugs in China: Coordinate various To meet the interests of all parties, take medical insurance as the entry point, build a multi-level medical security system, at the same time enrich medical insurance products, increase income and reduce expenditure medical insurance funds, establish a drug research and development incentive and compensation mechanism, encourage early talks and pilot projects, and gradually solve the financing and payment of innovative drugs puzzle

mind Mapping

text

Innovative drugs refer to "new chemical entities oriented by clinical application, with independent intellectual property rights, and new drugs with new targets or new mechanisms to produce new therapeutic effects; or those with outstanding clinical treatment advantages in diseases for which there is no effective treatment.

theoretical basis

Research on innovative drugs is both a frontier and a hot topic.

Stakeholders refer to "people who can influence the achievement of an organization's goals, or are affected by the process of an organization's achievement of its goals" [7]

Figure 1 Belgium's National Health and Disability Insurance Agency (NIHDI) Massachusetts Institute of Technology established the US Therapeutics Funding and Reimbursement Project

The realistic dilemma of financing and payment of innovative drugs from the perspective of stakeholders

01 patients

Patient coverage and access to the medical insurance drug catalog will directly affect the availability of innovative drugs

02Insurer _

Due to the lack of relevant evidence and limited understanding of some innovative treatments, innovative drugs are uncertain in terms of real-world efficacy, long-term efficacy, and adverse reactions.

03Medical prescription

As a provider of innovative drug treatment, medical institutions will fully consider the cost and benefit of using innovative drugs, and are driven by both treatment effects and benefits

04 Pharmaceutical manufacturers

Pharmaceutical companies tend to use high retail prices to ensure the recovery of huge R&D investment before the expiration of innovative drug patents.

International Experience in Diversified Financing of Innovative Medicines

The financing and payment difficulties of innovative drugs seriously affect the accessibility of patients, the sustainability of medical insurance fund reimbursement, the enthusiasm of medical institutions to apply, and the continuous investment of pharmaceutical companies

See Table 1

01Patients ' Financing Improvement Path

In order to reduce the economic burden, the patient side usually adopts consumer loans and installment payment to share the pressure of medical out-of-pocket expenses, but the actual effect is not good, and the financing model links disease treatment to the patient's income and personal credit , which may lead to moral hazard

Consumer loan installments Linking disease treatment to patient income and personal credit may trigger moral hazard Patient assistance program RxAssit data platform to obtain free, low-cost medicines Share co-payments

02Insurer 's financing improvement path

Insurers usually respond to the impact of high-value drugs on medical insurance funds by means of merger financing, the establishment of national special funds, and reinsurance mechanisms.

National Special Funds Australian Drug Welfare Portfolio Complex Authoritative Demands Special Medicines Project Funds 34 special medicines to prove that the condition can be fully improved American Rare Disease Reinsurance and Benefit Management Office ORBM The affordability of pharmaceutical companies Insurance companies Strong medical network and medical management capabilities, professional pharmacies The delivery capacity is shown in Figure 2

03The financing improvement path of the medical party

In order to reduce the management costs of innovative drugs and the costs of obtaining accreditation, medical institutions can enhance their bargaining power through joint efforts.

Medical parties can reduce inventory risks and improve medical service efficiency by joining ORBM

04The financing improvement path of pharmaceutical companies

With the diversification of medical insurance payment methods for innovative drugs, drug manufacturers may delay payments, reduce payments or even non-payment due to lower-than-expected drug efficacy, resulting in cash flow burdens that are not conducive to continued investment in R&D

Maturity Guarantee Instrument Hedging Instrument Biopharmaceutical Copyright Payment

Thoughts on multiple financing paths for innovative drugs in my country

01 General idea

"Expanding financing channels, innovating financing methods, and participating in multiple subjects" has become an international consensus to balance the interests of all parties and solve the problem of innovative drug financing

02 Specific path

See Figure 3

The first level is the national medical security, which is borne by the social security fund and financed , including social medical insurance and medical assistance , and provides basic medical security to all citizens equally
.

The first level is the national medical security, social medical insurance and medical assistance , which is undertaken by the social security fund and financed.

The second level is the supplementary medical insurance that emphasizes collective responsibility .
Under the support of specific policies, the employer and the employees jointly contribute and raise funds, which is an important supplement to the basic medical insurance
.

The second level is supplementary medical insurance that emphasizes collective responsibility

The third level is commercial health insurance , including special drug insurance, critical illness insurance, urban inclusive insurance, critical illness insurance, mutual health insurance and other insurance products.
Individuals sign insurance contracts with insurance institutions to encourage and regulate commercial insurance suitable for innovative drug characteristics.
The product has become a key project to improve the level of patient financing
.

The third level is commercial health insurance , special drug insurance, critical illness insurance, urban inclusive insurance, critical illness insurance, and mutual health insurance.

The fourth level is social charity and mutual medical assistance , drawing on international experience to try various forms of assistance such as charitable medicine donations, patient membership, special funds, and patient assistance , and relying on social forces to solve the drug problems of extremely difficult groups [16]
.

The fourth level is social charity, medical mutual aid , charitable medicine donation, patient membership, special fund, and patient assistance.

2.
Multi-pronged approach to improve the affordability of medical insurance funds

The financing of medical insurance funds should be "open source and reduce expenditure".
On the one hand , part of the state-owned capital should be transferred to enrich the social security fund , and at the same time, the payment standard should be appropriately adjusted according to the level of regional economic development ; The normalization of centralized procurement and other work will improve the bargaining power of official negotiation, prompting pharmaceutical companies to reduce prices, thereby improving the affordability of medical insurance funds to pay for innovative drugs .
In the access of innovative drug medical insurance, refer to international experience and try risk-sharing agreements, performance-based payment, health technology assessment and other approaches to avoid budget expenditure risks caused by uncertain evidence and clinical efficacy, thereby reducing the financial burden of payers and improving patient outcomes.
access to medicines .
In addition, in order to prevent collusion and moral hazard in the application process of innovative drugs, according to the "Regulations on the Supervision and Administration of the Use of Medical Insurance Funds", the responsibilities of relevant subjects are clarified, fund use behaviors are regulated, fund supervision is strictly implemented, and the security of medical insurance funds is effectively guaranteed .

On the one hand , transfer some state-owned capital to enrich the social security fund ;

3.
Establish a drug R&D incentive and compensation mechanism

Establish a special fund to stimulate the development of the pharmaceutical innovation industry .
First , while the financing method remains unchanged, it will be allocated and established proportionally from the existing medical insurance fund ; the second is voluntary payment by the insured and part of the financial subsidy from the financial department.
Form an independent innovative drug reimbursement fund; thirdly, refer to international experience and enrich the fund by taxing specific transactions and seeking support from relevant international
funds[17] .
Through the establishment of a medical insurance innovative drug development fund to support the reimbursement of innovative drugs with outstanding clinical effects, so that they can quickly open the market within a limited patent period, recover R&D costs, and conduct secondary R&D, thereby guiding the R&D direction of drug manufacturers
.
At the same time, it actively supports the overseas authorization of innovative drugs independently developed by China , and obtains profits through various forms such as "down payment + mileage + sales commission" , and recovers the cost of research and development .
In addition, the priority approval system for innovative drugs should be further optimized, green channels for registration and approval should be unblocked, property rights protection should be strengthened, and innovative drugs with high clinical value should enter the market as soon as possible .

The special fund is firstly allocated and established from the existing medical insurance fund.
Second , the insured is voluntarily paid by the insured and some funds are subsidized by the financial department .
Authorize "down payment + mileage + sales commission"

4.
Encourage early talks and pilot projects for innovative drug financing

Whether the international experience of innovative drug financing can play the greatest role in China's national conditions still needs further discussion and verification
.
Therefore, various stakeholders should be encouraged to conduct early conversations , explore important factors affecting the implementation of innovative drug financing methods, and reach a consensus on building the best financing path framework
.
Early dialogue can enable various stakeholders to gain insight into product uncertainty earlier, and take relevant measures to reduce risks as early as possible.
For example, drug manufacturers can understand the financing challenges of other stakeholders before innovative drugs enter Phase III clinical trials , ensuring clinical trials.
The trial design incorporates the considerations of other stakeholders, improves the rationale for the evidence collection plan, and maximizes the chances of the drug being included in the Medicare Drug List
.
At the same time, pilot projects for financing innovative drugs are encouraged to explore the best financing models for different types of innovative drugs
.
When conditions permit, the results and experience of pilot projects will be shared in a timely manner to further optimize the financing path for innovative drugs
.

Various stakeholders conduct early conversations Drug manufacturers can learn about funding challenges from other stakeholders before innovative drugs enter Phase III trials Funding pilot projects

references

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