Public hospitals pay 307,2000 euros (without VAT) for each treatment of Kymriah, a novel CAR-T therapy, developed by Novartis, for two types of blood cancer. Although the Ministry of Health had published the figure of 320,000 euros, as confirmed in a resolution of the Transparency Council, that is the maximum price set for each individual treatment, but it is not the actual price Administrations pay. The effective price of 307,200 euros is lower and only comes to light today for the first time due to the opacity that continues to characterise relations between the government and the pharmaceutical industry.
What is CAR-T therapy?
The treatment consists of the extraction of a type of immune cells, T lymphocytes, from the patient, which are then genetically modified in the laboratory and reintroduced into the patient. Clinicians add a kind of key (called CAR) to the outside of the T lymphocytes so that they recognise locks on the surface of the patient’s malignant cells and can attack them in a targeted manner. There are currently two CAR-T therapies approved in the European Union: Kymriah and Yescarta. Novartis produces Kymriah, whose active ingredient is tisagenlecleucel. This CAR-T therapy is authorised for the treatment of children and young people with leukaemia and adult patients diagnosed with a type of lymphoma, but only if they have first undergone other treatments and suffered a relapse.
In order to find the real cost of Kymriah, Civio obtained three different public contracts showing the same unit price. The contracts are from the Gregorio Marañón Hospital in Madrid, which will spend about three million euros total to treat nine patients between 2019 and 2021; the Management of the Health Sector of Zaragoza 1, which also includes VAT, bringing the unit cost from 307,200 euros to 319,488 euros; and the Consorci Hospital Clínic de Barcelona, which awarded a contract to Novartis for about 1.6 million euros with VAT for five therapies.
Opacity in drug prices
A few months ago, the Ministry of Health began publishing the maximum price it is willing to pay for all new drugs, but not the actual price paid to providers, which it usually negotiates downward, behind the scenes. In other words, there is no official data from the government about what it actually pays for drugs, including CAR-T therapies. But the multiple purchasing agencies, which include state entities, autonomous regions and the health platforms of autonomous regions contract their acquisitions separately. Some of the contracting documents, whether by conviction or by mistake, reveal the actual prices paid to pharmaceutical companies. The unit cost is the same in the three cases we know: 307,200 euros without VAT for each Kymriah treatment. In 2015 Civio resorted to similar disparities in regional contracting transparency to reveal the price of Sovaldi medicine for hepatitis C.
In negotiations with pharmaceutical companies, it is normal to hide the actual price paid for medications
Opacity is often the usual tonic in the relations between public administration and industry: the most common is that the real price paid for medicines is hidden. A very frequent way is to publish the total amount of the contract, but not the effective price paid for each treatment or the number of units that will be administered. For example, the government of the Basque Country published on its public procurement platform a resolution of adjudication to acquire Kymriah, detailing the total budget without VAT (about 16 million euros), but without breaking down the cost of each individualised treatment or the number of therapies included. Asked by Civio, the Euskadi Corporate Pharmacy Service refused to confirm if Kymriah’s unit price was 307,200 euros. The reason? The signing of a non-disclosure agreement with Novartis, which prevents public administrations from publishing the prices negotiated.
What is the price of Yescarta, the second CAR-T therapy?
The Ministry of Health decided to include Yescarta, another CAR-T therapy, after Kymriah, so there is not as much information about its price. In this case, the treatment developed by the pharmaceutical company Gilead, whose active ingredient is axicabtagene ciloleucel, is used for adult patients diagnosed with two other types of blood cancer (lymphomas). The maximum price set for Yescarta is 327,000 euros, although this is not the price administrations pay. At the moment we have only been able to locate one contract with the actual price paid for each Yescarta therapy. The contract is with the Hospital Clínic de Barcelona, which will pay just over eight million euros to treat 26 patients with Yescarta. That is, the unit price of Yescarta, in this case, is 313,920 euros (without VAT).
CAR-T treatments are very expensive, but they have also been a real turning point in medicine. Both Kymriah and Yescarta are intended as last resorts for patients whose previous therapies have failed. Still, CAR-T therapies are not risk-free, as reported by the independent publication Prescrire. Kymriah or Yescarta can lead to serious and even life-threatening side effects. So the Ministry of Health has designated a limited network of centres in Spain that can administer these personalised treatments while monitoring their impact.
According to the plan published by the central government, the maximum prices of Kymriah in other countries are similar to those set in Spain. According to this document, in France it is 320,000 euros, after the approval of a temporary authorisation for the use of the medicine. In the United Kingdom, Kymriah costs 282,000 pounds per patient (approximately 328,000 euros). That is, the figures are very similar despite the different wealth of the different countries. That contradicts a mantra repeated by the pharmaceutical industry: one European industry representative said a few weeks ago that secret negotiations allows the poorest regions to pay less for medications. Our evidence, at least in cases such as these CAR-T therapies, Sovaldi and several vaccines, says otherwise.
The prices for treatment of Kymriah (tisagenlecleucel) appear in contracts published by the health systems of the Community of Madrid (Hospital Gregorio Marañón), Aragon (Health Sector Management of Zaragoza 1) and the Generalitat de Catalunya (Hospital Clínic de Barcelona). The Kymriah supply contract of the government of the Basque Country is available on its public procurement website, although it does not break out the price of individual treatments. In the case of Yescarta (axicabtagene ciloleucel), the price for treatment without VAT appears in a contract published by the Generalitat de Catalunya (Hospital Clínic de Barcelona). We used the exchange rate estimated by the European Central Bank for October 21, 2019 to convert British pounds to euros. Finally, Civio has also made several public information requests to various administrations for the real prices they pay for CAR-T. None of the administrations have made a satisfactory reply yet.