A weapon in the fight against the great pharma

Medications are becoming too expensive and threaten to become an unsustainable expense for the national budget, so that they can not always be reimbursed for patients.

In the Netherlands, we spend more than 5 billion euros on drugs, more than the entire budget of the Ministry of the Interior. A large part of these costs is borne by a group of very expensive drugs intended for specific patient groups.

The Inspectorate of Health and Youth (IGJ) on Wednesday issued a surprising statement, which gives hospitals the opportunity to financially impede pharmaceutical companies by copying their own resources.

Why can manufacturers charge such high prices?

As soon as a drug is admitted to the European market by the EMA regulator, manufacturers often get the exclusivity of the market and can claim as much money as they wish. The Dutch Institute of Health determines whether a drug is reimbursed from basic packaging, but as manufacturers refuse to provide information on the price structure of their resources, trading is virtually impossible.

A market exclusivity was designed to stimulate the development of new drugs. Such surveys are very expensive and often fail, so it is sometimes correct to ask for high prices. But sometimes manufacturers charge exorbitant prices that they can not justify. For example, the price of CDCA, a drug against a serious metabolic disease, has been increased by the leading manufacturer, from 28 cents to 140 euros per tablet in ten years. According to the government adviser Zorginstituut Nederland, the manufacturer could not rely on expensive research costs multiplied by five

.

The health insurers were divided in two: they did not want to pay so much for this drug, but did not want to leave their patients in the cold. The Ministry of Health, Welfare and Sports (VWS) recognizes this struggle and has been trying to negotiate with manufacturers since 2013 to lower the price of their drugs. Last year, 130 million euros were saved. But the outcome of negotiations is usually secret. For example, with Spinraza, a medicine for patients with SMA muscle disease. The manufacturer charged six injections of half a million euros per patient during the first year of treatment. Too expensive to repay, health insurers were found. After negotiations between the ministry and the manufacturer, the drug will be reimbursed for a portion of patients from August 1, but we do not know how much it costs.

Why pharmacy preparation can be a solution

Hospitals can sometimes take drugs in their own pharmacy to make a lot less money than the manufacturer. Officially, this is called "magistral preparation". Minister Bruno Bruins (Public Health, VVD) considers that, as a solution to the expensive problem of drugs, he wrote this summer in the House of Representatives: "A preparation in pharmacy can be an alternative to registered medicines, for example in case of excessive price ".

Amsterdam UMC was able to manufacture CDCA in its own pharmacy at the price of 25,000 euros per patient per year, while Leadiant put it on the market between 160,000 and 220,000 euros. A bold step, because the hospital has crossed the marketing authorization of the main manufacturer, it does not pay him anything. The manufacturer has signed a protest with the Inspectorate of Health and Youth (IGJ)

He made a remarkable statement Wednesday: despite the mistakes made by Amsterdam UMC in the process of preparation, according to the law, it is allowed, under certain conditions, to copy expensive drugs, even if the manufacturer still has an exclusive marketing authorization.

Five percent of drugs are already manufactured in pharmacies, but this usually involves one or two patients. All Dutch patients were informed by their therapists that they could get a product magically prepared in Amsterdam UMC. They had to register at the pharmacy of the Amsterdam hospital (the magistral preparation is only allowed if the pharmacist does it for the "own patient"). With the decision of the IGJ, it is now possible to apply pharmacists for a larger number of drugs. This method also constitutes a much harsher attack on the profits of the pharmaceutical company.

What does the Inspection say?

Drug manufacturers are under pressure to charge acceptable prices for their pills, powders and beverages. For the first time, the ministry and health insurers have a real instrument to force them to control their prices. Leadiant can not therefore "find" in the statement. "The basis of our European drug system is affected if we allow the replacement of registered drugs with unregistered pharmaceutical preparations solely for financial reasons," the company said in a statement

Will hospitals now produce all medicines? ?

are suitable for hospital pharmacy, says pharmacist Marleen Kemper of Amsterdam UMC. Large manufacturers can greatly simplify jackpots and often require an acceptable price. Inhibitors of paracetamol or stomach acid will not be produced suddenly in the hospital. According to Kemper, masterful drug preparation is also "very laborious".

So it is best that the Dutch Institute of Health, which assesses whether drugs are eligible for the core package, works with drugs manufactured by the industry. These have also been the subject of extensive admission tests, in accordance with European directives.

Pharmacy preparation in the hospital is an option if a manufacturer demands an unreasonable price and if the preparation of the drug is practically possible. We do not know how many funds that apply. It is expected that this can be done in special cases and that it is mainly used as a weapon in the fight against major pharmaceutical companies

The Antoni van Leeuwenhoek Hospital announced in he might make a cure for lymphoma two to three hundred Dutch patients. So, like Amsterdam UMC, the pharmaceutical industry was bypassed

Is a homemade medicine as safe as a registered product?

It must be, and it is possible. In the decision regarding Amsterdam UMC, the Health and Youth Inspectorate added a chart explaining what a home-made drug must comply with. This can be read as a plan for hospitals that also want to attack the compensation model of [pharmacie] . Raw materials must be used in accordance with strict European directives and the preparation itself must also comply with strict regulations.

Amsterdam UMC bought raw materials (an acid) from China for CDCAs and tested them by a certified laboratory in Belgium. This was done in accordance with European directives and the product was also safe according to these tests. But when the inspection tested the same substance, it turned out that there were two impurities. Amsterdam UMC is currently investigating whether these impurities could have been harmful to patients. Hospital pharmacist Kemper: "We have strong indications that it was completely harmless, but we do not say anything until the end of the investigation."