Press review

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First-ever Spanish publicly-owned drug to cost €21,500

MADRID, 8 Nov (APM) - The first-ever drug to have been completely developed in a public Spanish hospital is a cell therapy for partial medullary lesions that will cost the system €21,577 per patient, daily newspaper El Mundo reported on Tuesday.
The drug has been successfully used to increase mobility, improve sphincter control, sexual health and sensitivity, with a significant effect on patients’ quality of life, El Mundo reported.
The therapy, called NC1, was developed by a research team at Puerta de Hierro Hospital in Madrid, led by Jesús Vaquero. Vaquero told the newspaper that it was not in anybody’s plans that such a therapy could be developed by a public hospital exclusively.
He said: "It has taken months to design a pricing system for this particular treatment." A pricing scheme was mandatory to administer NC1 across the country as for any other drug, according to Encarnación Cruz, head of advanced therapies in Madrid region.
Cruz told El Mundo: "Even the methodology to estimate the cost of the drug was specifically designed for NC1. Now it will be used for other non-industrially produced advanced therapies."
The novelty in this case is that research costs, estimated at approximately €2.2 million over a period of two decades, were not considered in the assessment. Instead, only direct production costs were taken into account, with a small incentive to the hospital which generated this innovation, she added.
Eventually, the decision on price was made by the pharmacy commission of the Council of Regions, a panel of regional health chiefs and the minister which coordinates policies. The cost of manufacturing NC1 will be paid by the administering hospitals to Puerta de Hierro Hospital, the only one with authorisation to produce it.
Vaquero said there have been offers by many pharmaceutical companies to buy the therapy, but all were rejected because they intended to use allogenic cells from donors, whereas trials had showed that the best option was to use the patient’s own cells (autologous).

CAR-T prices under scrutiny

On Thursday, daily newspaper El País carried a lengthy story scrutinising the prices of the two CAR-Ts approved for reimbursement in Spain - Novartis' Kymriah (tisanlecleucel) and Gilead's Yescarta (axicabtagene ciloleucel).
The article also touched upon Novartis’ litigation to protect the confidentiality of pricing talks and difficulties in access. (APMHE 64909, 64889, 64597)
El País explained that the two CAR-Ts available in Spain have been approved for reimbursement following risk-sharing agreements with the ministry of health. (APMHE 63570, 61052)
The newspaper quoted a study published in Health Affairs magazine as saying that producing a dose of CAR-T does not cost more than €36,000 euros, whereas they have both been approved for reimbursement at more than €300,000. Health Affairs estimates that adding together R&D investment and revenue for the owner companies does not total more than €144,000, El País added.

Amgen’s China venture costs $2.7 billion

At a critical moment for the firm, Amgen is to pay $2.7 billion for China’s biotech BeiGene in an attempt to gain rapid access to the country’s cancer market, financial newspaper Cinco Días reported on Saturday. (APMHE 64961)
With BeiGene’s poor results, however, investors "have reasons to question the move," the financial said.
Loses are not an unusual thing in biotech. However, accusations of sales tampering cast a shadow on the Chinese firm. Even though they were convincingly refuted by the board, fraud biotech companies are no strangers to fraud, and the accusations can be confusing, Cinco Días added.
The move can be a success still, with Amgen’s competitors like AstraZeneca entering the Chinese market, it reported.

Branded pharma’s demands for the next Spanish government

Representatives of branded pharma lobby group Farmaindustria have made public their demands to the government formed following this Sunday’s general election, it was widely reported on Wednesday. (APMHE 65027)
Financial Expansión quoted Farmaindustria president Martín Sellés as saying that pharma’s contribution to the Spanish economy should be acknowledged in order to implement policies which attract investment to the country.
The need for political stability, the inclusion of generics and biosimilars manufacturers in the agreement to curb drug spend and other demands made by Sellés at a meeting with journalists on Tuesdacy were also reported by daily newspapers La Vanguardia, El Español, ABC and a number of medical journals on Wednesday.
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