Waits of between two and four years to access drugs in Spain

The 661 days on average that it took Health to finance innovative medicines in 2023 are just that, a sock. The 43 drugs whose financing was approved by the Interministerial Commission on Drug Prices (CIMP) last year They were included in the National Health System (SNS) 599 days (1 year and a half) after the pharmaceutical company that developed them expressed its interest in marketing them in Spain and requested financing, and 696 days (1 year and nine months) after its authorization by the European Commission, according to public data from the European Medicines Agency (EMA), Bifimed (information search engine on the financing situation of medicines in Spain) and the Medicines Information Center (CIMA) of the Aemps.

But there was 10 medications that reached record waiting times, between 2 and 4 years, as this newspaper has investigated. Let us remember that both European and Spanish legislation establish that the Maximum time should be 180 days. These drugs came to multiply that number by 10. Half of them are cancer patients and 3 are orphans. Furthermore, as we will see, they faithfully represent what the 2023 WAIT report indicates: that More than half of the medicines (52%) that obtain financing in Spain do so with restrictions regarding the indications for which they can be prescribed.

The first on the list is larotrectinib (Vitrakvi), whose inclusion in the SNS occurred this month, with a delay of 1,473 days (more than 4 years). Of course, with restrictions. This medication has been shown quadruple life expectancy – from 10 to 40 months (almost 4 years) – in adult and pediatric patients with solid tumors with locally advanced, metastatic disease or whose surgical resection is likely to generate high morbidity, and with the absence of satisfactory therapeutic options. The Ministry of Health had been rejecting its financing for three years, alleging, on the one hand, that the efficacy and safety data were “preliminary” and that its approval by the EMA was provisional and, on the other, criteria for the rationalization of public spending and the budgetary impact of the SNS.

It follows very closely gilteritinib (Xospata)a molecule that stops the growth of cancer cells to treat acute myelogenous leukemia (AML). Nothing less than 1,316 days (3 years and 6 months) have passed since the pharmaceutical laboratory that markets it requested its financing until the recent approval, a few days ago. The drug is indicated as monotherapy for the treatment of adult patients with relapsed or refractory AML with FLT3 mutation, but excludes patients with unfavorable cytogenetic risk and in maintenance treatment after allo-transplantation of hematopoietic stem cells.

The next is Nustendi (ezetimibe)a medication for patients who are not meeting their goals cholesterol c-LDL marked by clinical guidelines with the usual treatments (around 65% in Spain) and, therefore, has a exponentially higher risk of suffering a heart attack or stroke. This innovation has taken time to be financed in Spain 3 years and 4 months (1,253 days). Something similar has happened with another active ingredient, bempedoic acid (Nilemdo), considered the first of a new generation of drugs that reduce cholesterol in people at high cardiovascular risk, covering a need for which there were no oral alternatives. This one took a while 3 years and 3 months (1,248 days) to be included in the SNS, and also with restrictions.

No therapeutic alternative

Fifth on the list is entretinib (Rozlytrek) an innovative targeted therapy indicated in both tumor agnostic as in lung cancer, that It has been delayed about 3 years (1,218 days) for Spanish patients. Therapies with a tumor-agnostic indication, independent of the location and/or histology of the cancer, are a type of oncological treatment aimed at treating the tumor according to its genetic and molecular characteristics, without taking into account the affected organ. These options represent a significant change in cancer treatment.

It follows luspatercept (Reblocyl)with 1,163 days late. This drug is an erythroid maturation agent (EMA), the first of its kind, indicated for the treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate risk myelodysplastic syndromes. It has been shown to improve the bone marrow’s ability to produce red blood cells and, in this way, increase the level of hemoglobin in the blood.

The cholesterol “vaccine”

The seventh on the list, with 1,057 days late in Spain, It is a revolutionary drug that allows you to reduce “bad” cholesterol levels by half with just two injections a year.Inclisiran (Leqvio) It was unofficially called “the cholesterol vaccine” and has been a before and after for people with atherosclerotic cardiovascular disease, in whom it achieves a powerful and sustained reduction in LDL-C of up to 54%.

Oncology innovation

As shown by the In the 2023 WAIT report, Spanish patients’ access to innovative cancer therapies is the one with the worst results: it takes 725 days to be financed, 256 more than in 2022.

The last three positions are occupied three oncological drugs for highly prevalent tumors and with well-identified biomarkers. The first, with a delay of Approximately 2 years and two months (861 days) is Phesgo (generic name for three combined drugs: pertuzumab, trastuzumab and hyaluronidase) against early and metastatic HER 2 positive breast cancer, in combination with chemotherapy. It follows tucatinib (Tukysa)a tyrosine kinase inhibitor indicated, in combination with two other drugs in the treatment of adult patients with HER 2-positive, locally advanced or metastatic breast cancer, who have received at least 2 previous lines of anti-HER 2 treatment. Its financing It was approved in April 2023, after a long wait of 840 days. Finally, selpercatinib (Retsevmo)the first and only selective inhibitor of the RET gene in non-small cell lung cancer and thyroid cancer, whose funding was approved at the end of June 2023, with more than 26 months late (809 days).

Madrid calls for urgent changes in the CIMP

The Community of Madrid once again demanded this week from the Ministry of Health for “urgent changes” in the operation of the CIPMattached to the General Secretariat of Health and Consumer Affairs, before the delays of 661 days in financing medicines. Changes in this body, said the Minister of Health of the Community of Madrid, Fatima Matute, “who neither need nor can wait for a law.” “All administrations are going to align themselves to be able to obtain these drugs in less time, precisely to achieve that equity, that sustainability and that equal access to our National Health System,” he added.

The priority medicines program (Prime, for its acronym in English) includes 26 medicines, “of which in Spain we have 15,” said Matute, and pointed out that we must reach these 26 “for that precision and personalized medicine.”