The Ministry of Health has decided to tighten for the first time the Red button that allows you to veto the price increase of a drug not subject to public financing. It has done so with the Fortasec, a popular antidiarrheal that since 2012 has multiplied 3.2 times its price and that Johnson & Johnson intended to apply a new increase. A box of 20 capsules of the drug was worth 2.81 euros in 2012, and today costs 8.95 euros. That of 10 pills has risen in this same period from 1.89 to 5.95 euros. 2.2 million units of Fortasec are sold in Spain every year.
The Interministerial Commission for Drug Prices held on February 8 rejected the increase proposed by Johnson & Johnson to consider that it goes against "the need to ensure equal access to medicines by patients." The company now has a deadline to submit claims. "We are studying the following steps internally, we have not yet made any decision," says a company spokesman.
Fortasec is part of the so-called "underfunded" drugs, the 417 medicines that the Ministry of Health decided to exclude from public financing in 2012. The measure was justified by the need to save 450 million euros per year in full cuts due to the crisis, although it was also alleged that many of them had stopped presenting a favorable benefit-risk profile. Most of them are well-known medicines, such as cough syrups (Flutox, Mucosan, Fluimicil ...), anti-inflammatories in ointment (Voltarén, Calmatel ...), antacids (Almax) and antidiarrheals such as Fortasec. Health only kept public funding in a few indications, such as mucolytics in patients with chronic bronchitis and laxatives in cases of diverticulosis (protuberances inside the colon).
These drugs, also called "price notified", were in an intermediate situation between the financed - regulated price - and over-the-counter, such as vitamins. The name "notified" is due to the fact that the laboratories must inform the ministry of any price change that they wish to apply. Health had given the green light so far to all requested increases, admits a spokesman. The ministry assures that "each proposal of the laboratories is studied in detail" and does not specify if the veto of the Fortasec is a change of policy. Several sources in the sector do interpret this decision as a sign that "the price increases of underfunded drugs may be touching ceiling".
The Fortasec has been part of the backpack of millions of travelers during the last decades and, after a holiday without intestinal incidents, has ended up entering as new in the first aid kits of many Spanish homes. "Traveler's diarrhea is precisely one of its indications, although obviously it is not a priority to finance it with public funds in these cases," says Eulàlia Ruiz, family doctor and member of the Board of the College of Physicians of Barcelona. "It is a drug that can be very useful in some patients with colon cancer, for example, but it should be taken with great caution. Its main function is to stop intestinal transit and if taken improperly it can end up causing serious intestinal occlusions, "he adds.
For Ruiz, the "Fortasec is a good example of medication that should be sold in much smaller boxes, almost by pills." "Most of the time with one or two shots is enough. It does not make much sense that it is sold in boxes of 20 pills, "he says.
The sales data of this drug show that, by far, it is the largest (and most expensive) boxes that are most consumed in Spain. According to the consultant IQVIA, last year 2,174,045 boxes of Fortasec were sold in Spanish pharmacies. Of these, 1,887,447 units (86.8%) correspond to the presentation of 20 capsules and only 286,598 to that of 10 capsules.
Many medicines have played an authentic escalation between 2012 and 2018 (see graphic attached). Five have quadrupled their cost to the patient; in another 17, the increase exceeds 200%; in 46 it is above 100% and in 54 it exceeds 50%. In contrast, 139 presentations continue to cost the same and one has dropped in price.
These increases have allowed laboratories to increase billing significantly in recent years. At the retail price, Fortasec's business volume has tripled from 6.6 million euros in 2012 to 18.2 million euros in 2018, according to IQVIA.
The health veto has caused concern in the Association for Health Self-Care (Anefp, the pharmaceutical employers' association of non-financed presentations). Jaume Pey, its CEO, sees it as "incomprehensible". "De facto is to intervene again a price that you no longer finance. If the ministry does not want to pay for these drugs, it does not want to, but does not introduce unnecessary distortions in the market, "adds Pey. The Anefp recalls that part of the increases are explained because "many drugs had suffered significant declines imposed by the reference prices when they were financed".
The price increases have reached the Congress of Deputies repeatedly in recent years. Socialist deputy Jesus Maria Fernandez has been the one who has warned of "an escalation that puts at risk vulnerable groups, as chronically ill and elderly." "The problem is that the 2012 decree established very few exceptions so that patients could continue to have the medicines funded. This has created a great inequality, "he laments.
Eulàlia Ruiz, family doctor and member of the Board of the College of Physicians of Barcelona, illustrates it with an example: "The Fortasec is not funded in any case and in some, as colon cancer patients, I think it should be "
Juan Gabriel García Ballesteros, coordinator of the Medication Working Group of the Spanish Society of Primary Care Physicians (Semergen) believes that "we should consider expanding the list of drugs financed, especially in chronically ill patients." "They should be included in all cases the treatment of symptoms that appear in especially fragile patients, such as laxatives in the elderly. "Ruiz and García Ballesteros agree that" apart from some exceptions, most of the drugs underfunded in 2012 already have little therapeutic use. "
María Rubio-Valera, researcher in Health Economics of the Prism group of the CIBER in Epidemiology and Public Health, confirms that "to date there is no evidence in the scientific literature that has shown that the defunding of 2012 had a significant impact on the health of the population. "