Confidentiality of reimbursement prices should be tightened

Confidentiality of reimbursement prices should be tightened

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Berlin – The members of the government parties have persuaded the Federal Ministry of Health (BMG) to soften the controversial plans to introduce confidential reimbursement amounts for newly introduced drugs. This is evident from the amendments to the Medical Research Act (MFG), which the German Medical Journal In addition, manufacturers should be allowed to charge higher prices if a drug has been partially tested in Germany. The law is to be passed by the Health Committee tomorrow and in the Bundestag plenary session on Thursday.

The plan to give companies the option of confidentiality of the reimbursement amounts negotiated with the National Association of Statutory Health Insurance Physicians (GKV-SV) when introducing new active ingredients has met with widespread criticism in recent weeks – not only from most associations in the healthcare sector, but also from the governing coalition of the SPD, the Greens and the FDP.

“As MPs, we had to renegotiate a lot of this law because the government draft was extremely unbalanced,” explained Paula Piechotta, rapporteur for pharmaceuticals and medical devices for the Green parliamentary group. “As MPs, we had to protect the interests of the insured in the country and that is what we did.” Piechotta had already announced during the hearing that she wanted to achieve a removal of the confidential reimbursement prices in particular.

It did not manage to do that, but the BMG now wants to address the criticism with a series of improvements to the planned regulation. Among other things, an automatic price reduction is to be provided and doctors are to be able to comply with the cost-effectiveness requirement without insight into the actual prices.

Compulsory discount for confidentiality

In addition, manufacturers will no longer be able to choose confidentiality of the reimbursement amount before negotiations with the GKV-SV, as previously planned. Instead, they will only be able to do so after the price agreement or determination by the arbitration board, by submitting a corresponding declaration to the GKV-SV within five days of the agreement or determination.

If they opt for confidentiality, this will necessarily lead to a price reduction of nine percent. In doing so, BMG and the governing coalition are responding to criticism that there is no evidence that confidential reimbursement prices would actually lead to higher discounts.

The GKV-SV in particular had expressed concerns that it could ultimately lead to higher prices if companies entered into reimbursement negotiations with confidentiality agreed in advance. The adjustment should now ensure that the granting of confidentiality is actually accompanied by a specific discount.

“This ensures that the benefits of preventing external price referencing do not remain with the pharmaceutical company alone, but are at least partially passed on to the cost bearers and thus ultimately to the contributors,” the amendments state.

The price referencing of the German market in other health systems was cited as one of the main reasons why confidential reimbursement prices make sense. If a higher discount in Germany does not lead to price reductions in other markets, companies could grant higher discounts here, that is the logic behind it.

A nine percent discount appears appropriate in view of the confidential discounts granted in other countries, according to the justification for the amendment.

Subjects in Germany as a prerequisite

In addition, a prerequisite for granting confidentiality is to be introduced: the pharmaceutical company must have a drug research department and relevant own projects and cooperations with public institutions in preclinical or clinical drug research in Germany.

This not only serves to promote research and development in Germany. The statutory health insurance system also benefits if the data collected can be particularly well transferred to the German healthcare context.

The GKV-SV should examine the pharmaceutical company’s documents within seven days and then decide whether the required evidence is available. If the GKV-SV makes a negative decision, the arbitration board should also decide within a further seven days based on the pharmaceutical company’s documents. This is to ensure that the final decision is made no later than fourteen days after receipt of the pharmaceutical company’s documents.

In order to give companies greater security in advance, they should be allowed to submit the documents proving research and development in Germany as early as six months after the medicinal product has been placed on the market.

The final decision will then be valid for one year so that the manufacturer does not have to submit the evidence again after the reimbursement amount agreement has been concluded. This way, the manufacturer will know whether it meets the requirements for a confidential reimbursement amount before the reimbursement amount negotiations have been concluded.

Expiry clause for confidentiality option

A so-called sunset clause is to apply to the entire procedure: it will initially only be introduced for a three-and-a-half-year trial period, namely until June 30, 2028. Whether it will be extended or made permanent after that is up to the legislature.

However, in the event that the procedure is discontinued after this date, confidential reimbursement prices already agreed upon will continue to apply until the data protection for the respective medicinal product ceases.

The BMG is to be obliged to submit an evaluation of the effects of the new confidentiality option to the Bundestag’s Health Committee by December 31, 2026. This will discuss whether it has achieved its objectives in the pharmaceutical sector of avoiding market waivers or withdrawals with regard to the financial consequences of external price referencing and of achieving savings through specific discounts for granting confidentiality.

Any unintended effects such as unexpectedly high processing costs for the actors involved or unforeseen changes in drug expenditure should also be taken into account. The evaluation could form the basis for a later decision on whether to continue or end the rule.

Transparency requirements for doctors

In order to mitigate downstream, undesirable effects, the MPs negotiated further improvements to the draft law. Previously, many had criticized the fact that doctors would hardly be able to comply with the principle of cost-effectiveness if they did not know the actual price of a drug.

This is now to be addressed by guidelines for providers of practice management systems (PVS) and other primary systems. They are to be obliged to include “information and instructions” on the drugs in question as a mandatory component in their systems.

These must “present the cost-effectiveness of the prescription in relation to competing drugs or other therapies in the relevant indication area in such a way that the doctor is able to make an economical and appropriate choice of drug therapy even without knowing the specific treatment costs,” states the justification for the amendment proposal. How exactly this is to be done is not explained.

Generic drug manufacturers, on the other hand, should be granted more rights to information, as a certain degree of insight into the reimbursement amounts is ultimately relevant for them in setting their own competitive market entry price.

The right of generic drug manufacturers to information should not be available until at least twelve months before the expiry of the data protection period and should require proof that they themselves have submitted an application for the authorisation of a generic drug and refer to the documents for the drug with a confidential reimbursement amount as a reference drug.

Exception from AMNOG guard rails

The BMG and members of parliament want to accommodate the manufacturers of patented drugs with another regulation: For almost two years now, pharmaceutical companies and their associations have been criticizing the so-called guard rails that were included in the AMNOG procedure with the GKV Financial Stabilization Act (GKV-FinStG).

One of these guidelines provides three negotiating guidelines to reduce the costs of newly introduced medicinal products: If no additional benefit is proven for the new medicinal product and the appropriate comparator therapy (ABT) is no longer patent-protected, the reimbursement amount should not exceed that of the ABT.

In the case of a patent-protected ZVT, the reimbursement amount for the new active ingredient should be ten percent below its price; in the case of a low additional benefit in combination with a patent-protected ZVT, the maximum price of the ZVT should also apply.

This regulation is to be suspended if the clinical trials carried out for the approval of the drug are at least partially carried out in Germany. Then, in future, for drugs without proof of an additional benefit, with little or non-quantifiable additional benefit in the case of patent- or document-protected appropriate comparative therapy, “the framework conditions that applied before the GKV Financial Stabilization Act came into force are to be restored,” it continues.

A hurdle of five percent of the test subjects who were treated at German trial centers should apply. Those test subjects who took part in the clinical trial were cared for at the expense of the pharmaceutical company rather than at the expense of the insured community, according to the statement on the amendment.

The value of five percent is therefore sufficiently high to justify the additional burden on statutory health insurance and other cost bearers that comes with the regulation.

The finding that five percent of the test subjects actually come from Germany is to be integrated into the benefit assessment procedure at the Federal Joint Committee (G-BA). To this end, the company is to provide information on the number of test participants in its dossier and the proportion of test subjects at German test sites in relation to the total number.

Only clinical trials will count and other non-interventional clinical studies such as observational studies will not be taken into account. The G-BA can check the plausibility of the manufacturer’s information based on the study documents submitted, but it is not obliged to carry out official investigations.

Piechotta sees success in negotiations

Piechotta is satisfied with the results of the negotiations. “From now on, even drugs with little added value can be paid for better if the company conducts research in Germany,” she explains. “At the same time, we have significantly curtailed the unspeakable proposal of secret drug prices, which the entire health care system, including the majority of manufacturers, has rejected.”

The incentives now agreed would keep the interests of the insured better in mind and would be much more targeted in attracting pharmaceutical investments to the country for companies than the ideas from the Chancellery and the Federal Ministry of Health, she stresses: “I hope that the next draft laws from the Federal Government will reach Parliament again with a higher quality than we have experienced with this law.” © lau/aerzteblatt.de

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