PARIS, Oct 13 (APM) - Les Echos on Tuesday reported on new government measures to curb the growth of spending on drugs in hospitals in France.
The government has raised the maximum growth rate of medicines spending at the hospital to 3% from 2% to accommodate the expected arrival of several innovations, the paper said.
But if the growth is higher than this ceiling, the pharma companies will have to refund France’s public payer, Assurance maladie, it said.
Among the expected new innovative products, Les Echos cited the extension of indications of BMS’ Opdivo and Merck & Co’s Keytruda in lung cancer, as well as new therapy combinations in HIV and Hepatitis C.
The newspaper also pointed out another measure, which will see foreign patients receiving medicines that are reimbursed within the 'liste-en-sus' having to pay for the products out of their own pockets.
The 'liste-en-sus' is a list of innovative drugs that is reimbursed to hospitals on top of their annual budget by Assurance maladie.
In addition, the government wants to have more control on rebates offered by companies on their products sold at the hospitals through tender offers.
Les Echos said that too often, when a firm wants to launch a generic on the hospital market, it has to face important rebates made by the originator, leaving the former with no margin to make further rebates in order to win the tender offer.
To prevent this situation, the government has created a unique reimbursement price for medicines of the same class with similar efficacy in hospitals.
Furthermore, when a pharma gains an indication extension for a product that is already approved and used in hospitals, its price could be lowered, while currently the price settled for the first indication is generally maintained.
Pharma spent 600 million euros on contracts with healthcare professionals over five years
On Friday, Le Monde published an investigation concluding that pharma has spent more than 600 million euros in five years through contracts and presents to healthcare professionals.
The newspaper said this figure shows little has changed in the way the relationships between companies and healthcare professionals are regulated since the Mediator scandal, despite the promises made by authorities then.
Bioequivalence studies under fire in Levothyrox crisis
On Wednesday, Le Monde (Science and Medicine supplement, p7) published a piece saying that the main causes of the Levothyrox crisis is the way new formulations of medicines are approved, through bioequivalence studies.
The newspaper noted that according to the conclusions of the studies concerning the new formulation of Merck & Co’s product, "no change on the tolerance profile of the product" was expected.
The article severely criticised the attitude of French drug watchdog ANSM in the approval process, saying it should have been much more careful and demanding, as the drug’s therapeutic window is small, and as more than three million person take the product in France.
On Thursday, Libération (p14) and Le Figaro (brief p9) reported more than 14,600 cases of side effects have been reported to date in connection with the new formulation of the product, among which more than 5,000 are severe.
But on Friday, Le Monde (p11) carries the conclusions of a new official report on the case, concluding the side effects are linked to a "thyroid imbalance" caused by the change in the way patients are treated, and not by the new formulation itself.
California against drugs' price hikes
Thursday’s Le Monde (p5) reported on the decision made by Californian authorities to force pharma companies to justify the price increases of their products.
Starting in January 2018, pharma companies will have to give notice of their raises to authorities two months in advance, and in 2019, they will have to justify the reasons behind those increases.
The measure applies to all prescription medicines of more than $40 and whose price is raised by more than 16% over two years.
Efficacy of cancer drugs questioned
Monday’s Les Echos (p32) reported on the study published in the BMJ (British Medical Journal) concluding that only half of cancer drugs approved in Europe between 2009 and 2013 are able to bring an effect on life quality or survival of patients.
As the price of cancer drug is under the spotlight, the study showed these results are mainly the consequence of evaluation methods used in trials, with only a little share of them using survival gain as their main endpoint, the others being limited to evaluating survival without progression of the disease.
The study also judged the huge hope placed on the new wave of personalised treatments, and their very high prices on the market, call for a radical change in the way cancer drugs are evaluated and judged by authorities.
Teva faces headwinds on Copaxone exclusivity loss
Also on Tuesday, Les Echos (p20) published an article on the difficulties Teva is facing after the loss of the exclusivity on its flagship product Copaxone for multiple sclerosis.
The newspaper said Mylan has gained U.S. approval for a generic of the product, leading the market value of the Israeli company to reach historical low levels, though the news was long expected. Les Echos noted this approval came earlier than anticipated.
The article cited an analyst from IBI Investment House, Steven Tepper, who pointed out "all the problems are coming in at the same time for Teva", with higher pressure on prices on the U.S. generics market, a massive restructuring plan and a change of its higher management.
Tepper also noted it will take at least four or five years for the company to compensate for this loss with new products.
Health minister says healthcare professionals insufficiently vaccinated
Tuesday’s Libération (p19) reported on French health minister Agnès Buzyn criticising the level of vaccination among healthcare professionals.
As the extension of the number of mandatory vaccines is about to come to force in January, Buzyn judged this low level "is not acceptable", reminding that vaccination is also a means to protect others.
In a separate piece on Thursday, Le Parisien (p8) also announced around 40 medical associations have publicly expressed their support to the extension of mandatory vaccines.
Sanofi invests 170 million euros in vaccine manufacturing in France
Friday’s Les Echos (p19) reports that Sanofi has pledged to invest 170 million euros to extend its vaccines manufacturing site of Val-de-Reuil in Normandy.
The extension will allow the company to supply Vaxigrip Tetra flu vaccines to around 70 countries, compared to 24 currently.
The new building will be fully operational in 2022. No jobs will be created by this project as the new facilities will be highly automated.
Boehringer opens new French headquarters in Lyon
Tuesday’s Les Echos (p27) announced Boehringer Ingelheim has opened its French headquarters in Lyon.
The company plans to invest 125 million euros in France in the near future, with a new R&D building in Saint-Priest near Lyon, as well as biomanufacturing capabilities and soluble tablets manufacturing units.
The French subsidiary plans to create 125 new posts alongside those projects.
Pfizer might sell OTC business
Wednesday’s Les Echos (p19), Le Figaro (brief p21) reported that Pfizer has asked a private consulting firm to lead a strategic review of its OTC business, which could lead to a sale.
Though the company has declined to make any comment on the matter, the choice could be made as early as next year, added Les Echos.
Biotech Theranaxus plans to raise 18 million euros
Wednesday’s Les Echos (p28) noted French biotech Theranaxus has launched a stock market flotation that aims to raise around 18 million euros.
The company is specialising in the discovery of neurological diseases treatments, targeting glial cells.
With the funds, Theranaxus wants to finance four clinical trials, notably two Phase II trials of its lead compound THN102 in Parkinson's and narcolepsy.