The drug against metastatic pancreatic cancer is available again after Health forced its exit

• Testimony Seven years surviving pancreatic cancer: "In my case, the prognosis was two to six months to live"

Commercially it is called Onivyde and belongs to Servier laboratories, although it responds to the active principle of pegylated liposomal irinotecan and is used to treat

.

From this tumor, one of the most lethal, 7,427 Spaniards died in 2020.

In addition, it is considered an orphan drug, a topoisomerase inhibitor (enzyme that acts on DNA), indicated for a disease with

It arrived at

in Spain in July 2018 with public funding at a notified price of 800 euros per vial.

But it was withdrawn at the end of 2019 and, now,

, it is available again in the national market.

Behind these comings and goings there is an erroneous interpretation of European legislation by the Ministry of Health -as stated in a Supreme Court ruling- and a refusal by the laboratory to sell a medicine below its production price, as confirmed by the

, owner of the formulation.

It all started when, after the drug's marketing report, in July 2018, the Ministry of Health included

in the 2019 reference price order. It placed the formula with the set of drugs based on the classic irinotecan active ingredient,

The decision stunned members of the lab.

The astonishment from the legal point of view is explained by Servier's legal area: "

has been classified by the EMA (European Medicines Agency) as an orphan drug, a consideration that is obtained by community regulation (

) and gives the drug protection for its commercialization, which is basically summarized in a 10-year marketing exclusivity. On this issue, the authorities of each member country have little to say, because it is an exclusive competence of Europe".

Orphan drug situation

This "special protection" is interpreted as the pharmaceutical industry as a mandate to exclude

from the reference price order, which is published every year by Health and where it sets the price of medicines with a downward trend in search of a higher price. sustainability of the health system.

However, the Ministry of Health included

in the general marketing prices because its active ingredient is irinotecan, like that of other drugs in the group.

The laboratory's defense to such an argument was that the uniqueness of the drug and its effect is due to

's unique

formulation .

Servier filed an administrative appeal against the 2019 reference price order, which received no response

.

The

vial went from a notified price of 800 euros to a reference price of 11.70 euros,

, they clarify from Servier and add that "admitting that price in Spain could influence that of other European markets".

Servier withdrew Onivyde

from the Spanish market

.

But he allowed patients who were being treated with his drug to continue.

He donated the remaining vials so as not to interrupt the treatments.

The singularity of orphan drugs is that they do not have a therapeutic alternative.

Consequently, patients with

who were eligible for

were left without a drug that would allow them to maintain a good quality of life.

And the doctors, without a therapeutic option.

What did the oncologists do in this situation?

Well, some eliminated the possibility of dealing with

and others assumed the long bureaucracy that the new access route to the formula entailed.

Because to respond to these claims,

opened a program for the use of medicines in special situations so that

could be imported from Germany.

Onivyde

, like other cancer drugs, has a double price: the notified one, which is public, and the one paid by the hospitals of the National Health System, which is lower than the notified one and is the result of the laboratory's negotiations with the ministry.

"Health was benefiting from a price of oncological drugs that was significantly lower than what it had to pay when bringing it from

as foreign medication at a cost to the Spanish health system that was even higher than the notified price of 800 euros per vial," Servier points out.

Less patients and more expense

Demand for the drug fell and the cost increased

.

The patients treated with

went from 209 in 2019 to 130 in 2020 and 109 in 2021, these last two years they came via foreign medication.

Thus, while the number of patients treated fell by more than 40%, the cost of public hospitals for this drug rose by more than 30% in the same period.

In addition, the access route as a

entails a bureaucratic overload for the entire system.

Parallel to the hospital battle to access

, the administrative and judicial battle took place.

And in this context, a meeting of the

2020, which changed the regulation that affected Servier's drug, because it established the economic regime for orphan drugs, under article 3.3 of the Law on guarantees and rational use of medicines (RDL 1/2015, of July 24).

"This decision was totally unnecessary because there is a community regulation on orphan drugs that already establishes the rights of protection of orphan drugs and from which it can be deduced that they cannot be within the reference prices," they point out from the laboratory's legal services. .

In any case, the Council of Ministers adopted that agreement days before declaring the state of alarm, which delayed its publication in the

until June 2020. And in the final text "a tagline" was added that says:

.

At this point, Servier points out that the concept of a valid therapeutic alternative is very broad and is subject to the clinical criteria of the professional and that was not in the decision of the

", they clarify from the laboratory.

Servier once again filed an appeal with the Ministry of Health, this time against the 2020 drug price reference order, because

was once again collected with

, less than 11 euros.

Health did not respond to the appeal.

And a similar situation occurred in 2021, with a new resource from the laboratory to order and silence by Health.

Appeal before the Supreme

From this action it can be deduced that the Ministry of Health considered that

had a therapeutic alternative for the treatment of pancreatic cancer.

However, "how can a drug classified as orphan by the EMA have a therapeutic alternative?"

Finally, the laboratory resorted to contentious-administrative proceedings.

They sued the Council of Ministers before the

, for the agreement on orphan drugs.

And the Supreme Court agreed in part with the laboratory on a very specific issue: "The agreement of the Ministerial Council is inconsistent", since it reasons that orphan drugs have no therapeutic alternative with the same indication.

For this reason, the Supreme Court magistrates in the

ruling annulled the aforementioned agreement, in its First point, the expression "when there is no therapeutic alternative in the pharmaceutical provision of the National Health System."

From that ruling that partially admitted Servier's appeal and from other rulings of the Madrid High Court in response to demands made by Farmaindustria for the inclusion of orphan drugs in the

, Servier and the Ministry of Health approached positions.

Several

have led to

Onivyde being available again in hospital pharmacies of the National Health System as

And in the latest reference price order from the Ministry of Health, published in November 2022, orphan drugs are not included.

According to the criteria of The Trust Project

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• Pharmacology

• cancer