by Edouard Hubert
PARIS, Dec 1 (APM) - Bristol-Myers Squibb (BMS) is not changing the temporary authorisation (ATU) price of its hepatitis C (HCV) drug Daklinza (daclatasvir) despite the arrival on the market, also under ATU, of a direct competitor at a very competitive price, a BMS spokesman told APM.
Following the recent publication in the Official Journal (JO) of the price at which the first direct-acting antiretroviral (DAA) for HCV, Gilead’s Sovaldi (sofosbuvir), can be dispensed, the company announced it had obtained an ATU for its designated successor, Harvoni (sofosbuvir+ledipasvir) (APMMA 40512).
Gilead also said at the time Harvoni’s temporary authorisation price will be 48,000 euros for a 12-week course.
Following pricing and reimbursement negotiations with the French economic committee for health products (CEPS), Sovaldi can now be dispensed by hospital pharmacists to out-patients at 41,000 euros for a 12-week course. In face value terms, the addition of ledipasvir in the Harvoni combination therapy costs 7,000 euros.
In parallel, the two other DAAs that can each be used in combination with Sovaldi, BMS's Daklinza and Janssen’s Olysio (simeprevir) have ATU prices of around 35,000 euros per course.
Consequently, the Harvoni fixed combination marketed at 48,000 euros is in competition with other drug combinations such as sofosbuvir+daclatasvir or sofosbuvir+simeprevir that cost around 76,000 euros per course.
Questioned by APM on Wednesday over a possible fall in the ATU price of Daklinza, a BMS France spokesman said it would remain at 35,000 euros, whether for 12 or 24 weeks of treatment.
“We await the end of the evaluation of our drug; we have not yet begun negotiations with the French economic committee for health products (CEPS),” he added.
Daklinza is currently under examination by the Transparency Commission (CT) and the economic and public health evaluation commission (CEESP). The CT opinion should be known before the end of the year, according to BMS.
Questioned on Friday on the same subject, a spokesman for Janssen France (of the Johnson & Johnson group) said the pharma company has “no official position” on the matter for the moment.
The subsidiary is also waiting for the opinions to be issued by the CT and CEESP and “depends on decisions external to the pharma company”.
An industry source admitted to APM that “Gilead played a master stroke” by announcing an ATU price for Harvoni only 20% higher than the price negotiated with CEPS.
“However, there are two things to bear in mind. On the one hand, opinion leaders, prescribers do not like to see a monopoly forming. And, on the other, they are not all in favour of fixed combinations. In HCV there are various genotypes and it may be that Harvoni is not the best choice for all these genotypes,” the source continued.
Questioned by APM on Thursday, the head of the French association for the study of the Liver (AFEF) professor Victor de Lédinghen, said, however, that Harvoni would “be prominent” in the updated recommendations it plans to issue this week. He added that these recommendations were exclusively on scientific criteria and they do not cover financial aspects at all (APMMA 40624).
The head of AFEF underlined that the efficacy of the fixed combination has been studied in highly diverse populations and consequently has a substantial level of proof “higher than that of the other combinations”.
However, Gilead’s dominant position could be contested in some specific indications by a new player likely to reach the market in the short term - AbbVie.
The U.S. pharma company has developed a combination therapy comprising two drugs, Exviera (dasabuvir) to be taken twice a day and Viekirax (ombitasvir+paritaprevir boosted with ritonavir) to be taken once a day, that were recently backed by the European Medicines Agency’s scientific committee. (APMMA 40540)
To access the French market early on, AbbVie is trying to obtain a group temporary authorisation (ATU de cohorte) for its combination (APMMA 39790). The pharma company has submitted a request to the national agency for medicinal product safety (ANSM) “in all the indications for which we have robust data,” a spokesman for the French subsidiary told APM on Wednesday, without wishing to specify the indications involved.
AbbVie hopes to make its product available in France early in January. Questioned by APM, ANSM confirmed the fact that the ATU request was under evaluation. Its scientific committee for temporary authorisations (CSST) may deliberate on the matter in its next meeting, due on December 4.
Importantly, AbbVie has suggested that if it obtains the ATU, its combination therapy will be free of charge until the packaging is changed, due within three months of the European marketing authorisation (AMM), expected at the end of January.
On the payer side, a source that has participated in CEPS meetings told APM that the ATU price of Harvoni had “weighed quite a lot” in the negotiation of the ATU price of Sovaldi. “Gilead has a substantial advantage. It is ahead of the others, and this allows it to capture a significant market share,” the source said.
“This agreement allows us to influence the price of second agents (taken in combination with sofosbuvir) - that of AbbVie treatment to come in 2015 and, if it obtains a marketing authorisation, Merck and Co’s in 2016. It is even possible to hope to secure a fall, though only modest, in the price of Harvoni when it switches from the ATU to the AMM,” the source added.
Gilead has had to agree to “highly substantial rebates” on the price of Sovaldi and on a performance contract whose indicators will be drawn from the Hepather database, assessing hepatitis drugs and outcomes, of the French National Agency for AIDS and Hepatitis Research (ANRS).
Finally, a widening of the reimbursed indications of HCV agents does not seem to be on the agenda, a payer told APM. The indications currently reimbursed for Sovaldi involve 70,000 to 80,000 patients (APMMA 40548). It seems the French health system can treat 15,000 to 20,000 HCV patients per year. “We’ll need another three years to treat the patients concerned. After that, we shall” widen the reimbursed indications.
eh/aki/hlc
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