Amarin Corp Plc (AMRN)

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French Transparency Committee to adopt Vazkepa opinion 12/15/21

https://www.investorvillage.com/uploads/87669/files/FrenchMeeting-12-15-21.pdf


These three aspects of a Committee Opinion represent its main conclusions, and answer the five questions posed by the decision-makers, which are:

» Should this medicinal product be reimbursed by French national insurance, in hospitals or in community practice, yes or no?

» What level of contribution should be made by the person insured?

» What is its added clinical value, i.e. the improvement in treatment (or diagnosis) contributed by the medicinal product compared with existing products, in the context of current optimal care?

» What is the size of the population for which reimbursement is justified or in which the medicinal product represents added value?

» What impact (or even benefit) does this medicinal product have on public health?

These conclusions are aimed at a number of stakeholders:

» Decision-makers: CEPS which sets the price; the Chief Executive of UNCAM9 which sets the level of reimbursement; the Minister of Health, who takes the final decision on reimbursement.

» Stakeholders involved in the proper use of the medicinal product: the company that markets the product; health professionals, particularly the doctors who prescribe it and the pharmacists who dispense it; the patients and citizens (for preventive therapies) who use it.

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In France marketing authorization for drugs can be obtained at the national or European level. The French regulatory agency for drugs is the National Agency for the Safety of Medicine and Health Products (ANSM).

There are 3 key bodies involved in the process of approving a product and agreeing pricing and reimbursement levels:

The Transparency Committee (Commission de la Transparence, or CT)

The Economic Committee on Healthcare Products (Comité Economique des
Produits de Santé, or CEPS)

The National Healthcare Insurances (Union Nationale des Caisses d’Assurance Maladie, or UNCAM)


Simply put:

The CT is in charge of assessing the medical benefit (known as SMR) and the improvement of medical benefit (known as ASMR) of a new medicine for which a pharmaceutical company submits a request for inclusion in the reimbursable drugs formulary.

Drug price setting is established by CEPS after negotiation with the drug company. The ASMR is one of the key items taken into account during price setting.

The reimbursement rate is fixed by a decision from UNCAM, primarily based on SMR. The HAS (Haute Autorité de Santé) then makes the final decision regarding whether or not the drug will be registered on the list of reimbursable medicines. This registration is valid for 5 years. At the end of this period or at any time when significant new information becomes available, the CT reevaluates the SMR and ASMR levels.


It is important to note that the ASMR is mainly driven by the effect size of the benefit of the drug. Although the effect size concept is a well-defined and standardized measure of the benefit over a comparator, in France, the effect size is considered by the CT as a very subjective endpoint that relies on the expert assessment of the CT members. The lack of decision analysis framework leaves some unpredictability.


The Transparency Commission considers the level of innovation the drug brings to the market, as well as how important it is to the health of French citizens. It determines the drug’s improvement of medical benefit or amelioration du service medical rendu (ASMR) compared to the current standard of care, and assigns a rating from 1 to 5:

ASMR V: no improvement

ASMR IV: minor improvement

ASMR III: moderate improvement

ASMR II: important improvement

ASMR I: major improvement. This is reserved for an extremely few drugs that have demonstrated effect on mortality in a severe disease.

The ASMR answers the question: does the drug improve patients’ clinical situation as compared to existing therapies? Consequences of ASMR rating and level of price are as follows:

ASMR V – the drug can be listed only if the costs are less than the comparators for cost savings to the French National Health Insurance (NHI). Discounted pricing for the new drug is typical.

ASMR IV: the target population for the new drug is relevant. If the new drug targets the same population as the comparator drug, then a parity price is best possible outcome. Price can be higher than a comparator if the new drug has better effect in a more restricted population.

ASMR I, II or III: Faster access (price notification instead of negotiation) and price consistency with rest of Europe. However, it is increasingly rare to secure ASMR I – III ratings.

The Transparency Commission also determines the product’s medical benefit or service medical rendu (SMR). The SMR answers the question: should the drug be reimbursed? Is the drug clinically differentiated (interesting)? The SMR considers five criteria:

Severity of the disease to be treated and its impact on morbidity and mortality

Clinical efficacy/effectiveness and safety of the medicine

Aim of the drug: preventive, symptomatic or curative

Therapeutic alternatives? Positioning in treatment strategy for the disease, indication or condition?

Public health considerations – burden of disease, health impact at the community level, transposability of clinical trial results etc.

The CT assigns each drug a rating of 1 to 5 corresponding to its medical benefit, referred to as the “medical service rendered” (service médical rendu, or SMR), which determines the percentage of price that NHI reimburses. The CT considers the gravity of the problem, the medication’s effects, and its public health impact. NHI reimburses 100 percent of medicines for afflictions that lead to death if untreated and for grave, long-term illnesses, such as diabetes. It reimburses other medications as follows:

65 percent for drugs awarded a major or important SMR
30 percent for drugs with a moderate SMR
15 percent for low SMR drugs
0 percent for drugs receiving an insufficient SMR.


The ASMR and SMR ratings described above, are determined concurrently. Once they are determined, the manufacturer enters negotiations with The Comité Economique des Produits de Santé (CEPS) to establish the reimbursement price and rate for innovative ambulatory (retail) drugs. The ASMR level determined by the TC and the expected annual sales volume are key considerations for the CEPS when establishing price.


For each new medication, the CEPS negotiates a five-year contract with the manufacturer that specifies the price and anticipated sales volume. This discourages the marketing of drugs for indications that are approved by the European Medicines Agency (EMA) but not reimbursed by health insurance, as well as the marketing of drugs for off-label uses. The agreement on price and anticipated sales volume constitutes a cap on revenue. When sales exceed the contract cap, manufacturers pay rebates of between 50 percent and 80 percent.

The CEPS has the option of employing a performance contract under which the manufacturer refunds a portion of the price if the drug does not produce specified clinical results.

Negotiated Discounts and Market Competition

Once a list price has been set based on the value of the drug, CEPS negotiates a confidential discount (typically 10% to 30%), which is paid as a rebate to the Central Agency for Social Security Organizations.14 This is similar to negotiations between manufacturers and insurers in other European Union (E.U.) nations (see box below). Hospitals in France can sometimes obtain additional discounts through a competitive bidding process and price negotiations when competing drugs exist.

Impact on Innovation

Critics often contend that capping prices will eliminate or slow access to new medicines. It hasn’t in France, where manufacturers sell the full spectrum of innovative drugs available in the E.U. In fact, France explicitly rewards innovation by requiring the CEPS to pay more for new products that offer an important therapeutic improvement and to set prices that are consistent with reference prices in other E.U. countries. This system provides incentive to bring drugs to market that offer significant therapeutic improvement, rather than “me too” drugs.

However, industry critics note that the process of evaluating the added benefit of new drugs and reaching a price agreement is slower in France than in some other European countries. A European Commission directive set a goal for completing such work in 180 days. In 2017 it took France 168 days to complete this process, with another 45 days until the price was published in the official journal.2

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Marking the conclusion of intense negotiations between Leem and CEPS, this framework agreement introduces profound revisions to some of the rules governing the setting and regulation of prices for medicines with the aim of achieving five key goals: shortening lead times, promoting patient access to innovation, boosting investment and exports, facilitating supplies of medicines addressing public health needs, and improving transparency, in accordance with the engagement letter sent to the Chairman of the Economic Committee on 19 February 2021 by the ministers supervising the CEPS. Provisions include:

Fast-track Access within 15 days for medicines given an ASMR 1-3 rating dominant in terms of efficiency, medicines given an ASMR 4 rating dominant in terms of efficiency and saving, and medicines given an ASMR 5 rating priced below the comparator

Price stability and predictability - The 5-year stability period for the Europe-wide price of medicines given an ASMR 1-3 rating with a valid health economic assessment covers both the face value cost and the net price

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