This is how a laboratory manages to multiply the price of a drug by 1,000 | Society

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Chenodeoxycholic acid () in 2011 had been in the market for more than 30 years for the treatment of some types of gallstones. The box of 48 capsules cost 6.96 euros (14 cents each). Since the end of the nineties, in addition, the drug had also begun to be used off-label for a very rare and serious genetic disease, cerebrotendinous xanthomatosis (XCT), which causes neurological impairment that can be fatal.


Acid

quenodesoxycholic

(AQ)

Acid

quenodesoxycholic

(AQ)

Treatment

off indication

Acid

quenodesoxycholic

(AQ)

Symptoms of CTX can include diarrhea, cataracts, tendon problems, and progressive neurological problems.

Paula Pérez-Torre, from the Neurology service of the Ramón y Cajal Hospital (Madrid), estimates that in Spain there are between 40 and 50 affected by XCT, although it is an “underdiagnosed disease and there may be more.”

The gallstones what was the AQ about ()

They are a common ailment that affects 4% of the population, although most will not develop symptoms (intense pain, inflammation …). But the advancement of minimally invasive surgical techniques (such as laparoscopy) and other drugs with fewer side effects (such as ursodeoxycholic acid) they left the AQ outdated (), according to Lucas Ilzarbe, assistant doctor of the Digestive System service at Hospital del Mar (Barcelona).


This is the reason that made the AQ () was gradually being abandoned as a treatment for calculations and will be left alone as therapy in front of the XCT.


But due to low demand and low price, the AQ loses interest for laboratories. Zambon, which sold it under the Quenocol brand, stopped doing so in 2001. Estedi lasts another decade with Quenobilan. “We were hardly able to cover the costs,” recalls Álvaro Calzada, Estedi manager. “The policy of drugs not considered innovative in Spain only seeks to lower prices over and over again. This has the serious problem that the economic viability of some drugs is not assured, which is interesting for them to continue on the market ”, he criticizes. In 2010, only 2,411 boxes of Quenobilan were sold, according to consultancy Iqvia. After this withdrawal, the sick of XCT run out of treatment and it is the hospital pharmacy services that have to produce it.


The situation is repeated throughout Europe. In most countries, it is local manufacturers that are gradually discontinuing production of AQ for economic reasons. But a company called Leadiant Biosciences (Sigma-Tau Pharmaceuticals until February 2017) comes on the scene and buys licenses for the AQ-based drugs that are still on the market in places like Belgium and the Netherlands. With these movements, Leadiant manages to remain as the sole holder of the AQ in Europe.

The company takes another step that allows it to consolidate the monopoly situation. Between 2014 and 2017, it succeeded in getting the European Medicines Agency (EMA) to declare AQ as an “orphan drug” and that the European Commission granted it authorization to market it for the treatment of CTX exclusively until 2027. This means that hospitals they can no longer produce it.

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Monopoly achieved, Leadiant Biosciences begins to demand 14,000 euros from governments for each box of medicine.


420 euros

the treatment

Diary of

3 pills


153.300 euros the
single cost
patient in one year

(1,095 pills)

153.300 euros the
single cost
patient in one year

(1,095 pills)

Spain is opposed to the price increase and has tried to negotiate a discount since 2017. In October 2020 there is still no agreement and the Interministerial Drug Price Commission (CIPM), the body that must approve the public financing of drugs, refuses to regularize the price of the drug imposed by the laboratory.

With regard to this medicine, the Commission agrees to propose to the General Directorate the non-inclusion of the medicine in the pharmaceutical service of the SNS since it is a classic medicine for which the proposed price has not been justified and generates a high budgetary impact.

Interministerial Commission on Drug Prices

But while the negotiations last, Health must agree to Leadiant’s claims “due to the need to offer treatment to patients.” As there is no agreement, the purchase is made through “special situations”. In 2020, the public health will spend 6.6 million on pills that need a quarantine of patients. 10 years ago, the cost would have been just 6,600 euros. Health takes the case to Competition and has now obtained a discount of 72%, which will take effect this December. The CIPM therefore agreed to finally finance the Chenodeoxycholic Acid Leadiant in the session of last September 30th. The official price is still 140 euros per pill, but with the discount the real price is 39.2 euros. Even so, it is still 280 times more expensive than in 2011 and the annual cost per patient amounts to almost 43,000 euros.

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Summary of the session of September 30, 2021 of the Interministerial Commission on Drug Prices.
Summary of the session of September 30, 2021 of the Interministerial Commission on Drug Prices.

Leadiant Biosciences has received numerous complaints in Europe for abusive practices due to these events. In the Netherlands, the competition authority has imposed a fine of 19.1 million euros. In Spain, Competition opened an investigation in December 2020 after a complaint from the Organization of Consumers and Users (OCU) to which the information sent by Health has been added.

In 2008, the ministry authorized Estedi to stop manufacturing chenodeoxycholic acid, a mandatory step when a drug is going to disappear from the market. The reason is that its official indication was the treatment of gallstones, for which there were already better therapeutic alternatives.

José Luis Poveda, coordinator of the Working Group on Rare Diseases and Orphan Drugs of the Spanish Society of Hospital Pharmacy (OrPhar-SEFH) considers that “the system should reflect on how it is possible that an already known and very cheap chemical formulation of produce ends up having these costs for the system ”.

“The regulatory framework must guarantee the patient access to medicines with a favorable risk-benefit balance. And funding deals should reward investment made in technology and clinical trials to generate evidence. What does not seem reasonable is that there are companies that can take advantage of legal frameworks for their own benefit ”, adds Poveda.

To achieve the qualification of orphan drug for the treatment of CTX, Leadiant did not present clinical trials promoted by the company in 2014, but used studies already published in the scientific literature, according to official information from the European Medicines Agency (EMA , for its acronym in English). Neither has it carried out them to date and the only published work is a small observational study, which has a much lower cost than trials.

Ángel María Martín, former Head of Pharmacy of the Castilla-La Mancha Health Service and today a member of the Association for Fair Access to Medicine, considers that these practices “are totally rejectionable and are carried out by some companies that take advantage of the cracks of the legislation to appropriate well-known drugs and obtain millionaire benefits with hardly any investment ”.

Leadiant Biosciences and Deco Pharma, its distributor in Spain, have declined to answer the questions posed by EL PAÍS.

The precedent

The Aspen Pharma company was involved in a similar controversy in 2018 when it recalled five cancer drugs from the Spanish market. All of them lacked a therapeutic alternative, were cheap and had been on the market for many years. For five years, Aspen managed to force hospitals to buy the drugs in third countries, where the company had managed to impose prices up to 30 times higher.


Aspen drug prices

* Also sold by Silver Pharma SL

for 41.37 euros

Source: Ministry of Health.

Aspen drug prices

* Also sold by Silver Pharma SL for 41.37 euros

Source: Ministry of Health.

Aspen drug prices

* Also sold by Silver Pharma SL for 41.37 euros

Source: Ministry of Health.

The dispute was not resolved until the European Commission became involved in the case and its Competition authorities threatened the company with a multi-million dollar fine. Finally, Aspen Pharma relented and agreed to cut the price of its drugs by 73%. This percentage is very similar to the discount that Leadiant has now agreed to apply.

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George Holan

George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.

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