When Karl Lauterbach (SPD) announced the first delivery of Pfizer’s anti-corona drug Paxlovid at the end of 2021, the Federal Minister of Health sounded downright euphoric. The drug, which is intended to help prevent a severe course of the disease, is "extremely promising" and, in combination with the vaccines, could help make the Covid pandemic less frightening, Lauterbach praised the newly approved drug.
Similar to the Sars-CoV2 vaccines before, the federal government acted boldly and ordered one million packs of the virus inhibitor.
In the meantime, it has become apparent that this was obviously too bold: just over a year after the market launch in Germany, only 380,000 packs have been ordered, according to a request from WELT am SONNTAG to the Federal Ministry of Health.
The remaining 620,000 are still in stock at pharmaceutical wholesalers. It is not known how many of the delivered therapy units were actually prescribed to patients, because not only pharmacies, but also family doctor's surgeries, hospitals and care facilities can provide the drug in limited quantities. According to industry estimates, there are still around 120,000 packs of five daily doses in pharmacies, clinics and doctor's offices.
For the Federal Association of Pharmaceutical Wholesalers (Phagro), Paxlovid has long become a nuisance. "Due to the lack of medical prescriptions for Paxlovid, there is no need in the pharmacies, and the pharmaceutical wholesale trade is left with the Paxlovid procured by the federal government," it says there.
This initially also applies in the event that the drug reaches its expiry date. Because the federal government makes the decision about taking back or destroying the goods: "Pharmaceutical wholesalers are currently storing Paxlovid on a large scale free of charge and without remuneration for the federal government."
At least in view of the impending end of shelf life, relief is now looming. The Federal Ministry of Health announced that a “possible further extension to a total of 24 months” had been announced. The manufacturer Pfizer is informed that "since February 15, 2023, Paxlovid has a shelf life of 24 months".
The basis for this is the evaluation of further stability data, which is why the extension “also applies retrospectively to batches that have already been produced”. An official communication with a list of the corresponding batches and new expiry dates is currently being coordinated with the authorities and the Federal Ministry of Health.
Emanuel Wyler works at the Max Delbrück Center for Molecular Medicine in Berlin. The molecular biologist comments on a possible approval of Paxlovid in the WELT talk.
Source: WORLD / Nele Würzbach
In September 2022, the shelf life of Paxlovid in the EU was retrospectively extended from a year earlier to 18 months. Without another change, the first packs would have reached their expiry date at the end of May 2023.
It is not known how much the virus inhibitor has cost the federal government so far. The ministry announced that it had been agreed with the manufacturer not to disclose the purchase price.
In the USA, however, where the government ordered a total of 20 million packs in 2021, the price is known: It is around 530 dollars, the equivalent of 500 euros. However, Pfizer boss Albert Bourla had emphasized at the time that the USA would receive a special price because of the size of their order. For countries with smaller orders, the price is more in the order of around $700. If you apply these values, the federal government would have spent between 500 million and 660 million euros just for the purchase of Paxlovid.
The fact that the drug is only rarely used in Germany, despite sufficient availability, is primarily due to the reluctance of doctors to prescribe it. "Paxlovid is a highly effective drug for risk groups, but - just like any other preparation - should only be prescribed if there is a medical indication for it," says the German Association of General Practitioners. "For healthy, vaccinated people in their mid-40s, for example, a prescription is usually not necessary." Rather, as with any drug, the benefits and risks must be carefully weighed.
"Basically, over-therapy, which can potentially cause serious damage, should be avoided, as well as under-therapy, which could withhold possible help," confirms Martin Scherer, President of the German Society for General Medicine and Family Medicine (DEGAM). In addition, the list of possible interactions with other drugs is long, and clinical studies on this have so far been lacking.
In view of these restrictions, a significant increase in demand for Paxlovid is therefore unlikely, especially since the number of new infections has recently declined - even if the number of unreported cases has been high since the end of compulsory testing. "Basically, in the current situation, the higher the immunity in the population and the lower the number of infections in the risk groups, the less often Paxlovid has to be used," says the General Practitioners' Association. "Of course, how many units were ordered and whether they expire soon or not must not play a role in the prescription."
In retrospect, the neighboring country of Switzerland, with its approximately 8.7 million inhabitants, proceeded much more skilfully. Originally, 12,000 packs were ordered, of which around two-thirds have been delivered so far, according to the Federal Office of Public Health. And emphasizes, despite the small order quantity: "The supply of the Swiss population with Paxlovid was secured at all times."
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