More DAAs, More Controversy - Applied Clinical Trials


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More DAAs, More Controversy

Source: Applied Clinical Trials

The storms raging across Europe—and beyond—over the pricing of new hepatitis C treatments have been intensified by the European Union's approval this week of the latest directly-acting antiviral, Bristol-Myers Squibb's Daklinza (daclatasvir). Just two months after the European Medicines Agency gave a positive opinion on the drug, the formal authorization was delivered for use in combination for the treatment of chronic infection in adults.

The company will now start negotiations with each of the national pricing and reimbursement authorities in the EU countries where it wants to launch the product—and those negotiations will be conducted amid the turbulence created by arguments over the price for Gilead's Sovaldi (sofosbuvir), which won EU approval in January this year to become the first of the directly-acting antivirals into the market. Italy's medicines agency has been taking the lead in demanding that Gilead reins in its pricing ambitions for Sovaldi, even attempting to create a "coalition of the willing" among other European authorities. The medicines agency's head, Luca Pani, has described Gilead's pricing strategy as "morally unacceptable."

French parliamentarians have been demanding explanations of the price charged, and German insurance agencies are reviewing their decision to reimburse the product. Janssen's directly-acting antiviral Olysio (simepravir) is also available only in limited indications and only in a few EU countries, with reimbursement authorities remaining hesitant over its cost.

But Sovaldi has won crucial support from the UK's health technology assessment body, NICE, during August, which concluded that in terms of a quality-of-life calculation, the medicine was more cost-effective, at some $60,000 for a short course, than current treatments. It added that in Europe, hepatitis C is the leading cause of liver transplant.

The NICE assessment has not satisfied health campaigners in Europe, who are echoing the high-profile criticisms from the US, where Sovaldi's $84,000 cost is accused of putting the product beyond the reach of those who need it most. The European AIDS Treatment Group—whose members feel particularly vulnerable because of the close links between HIV and HCV in liver cancer—is threatening to demand compulsory licensing of the drug if Gilead does not adjust its European pricing policies to seek deals that would allow high-volume lower-price marketing.

In a late-August statement—allied with other major European activist groups—it called on the CEOs of Abbvie, BMS, Gilead, Janssen, and Merck/MSD to "ensure universal access to state of the art treatment to everyone living with hepatitis C."  This should be done in a way that is sustainable and affordable to different health systems in Europe according to their individual capacity "and in consideration of the overall financial constraints that they face," the statement concedes. But it insists that dual and triple combinations of directly-acting antivirals should be made available at no cost  "to the small percentage of people living with hepatitis C that are in life-threatening condition." It concluded: "If all bona fide negotiations fail, we believe that, as a last option, countries have the right to use compulsory licenses."

Daklinza's approval also provoked health campaigners to issue an immediate call for wide access to treatment with the drug. Médecins Sans Frontières insisted that pricing should allow its use in poorer populations. Dr. Jennifer Cohn, medical director of the MSF Access Campaign, said: "We must ensure that people living with hepatitis C in low- and middle-income countries can actually access this important drug, so that it can have the greatest impact on hepatitis C globally in helping to cure people." MSF highlights daclatasvir's demonstrated action in genotype 3, which, it says, has proven difficult to treat with other drugs in this class, and is highly prevalent among people living with hepatitis C in India and Pakistan. 

MSF points to patent problems that could impede access. “Intellectual property barriers for daclatasvir, unless they are overcome, could keep affordable versions out of reach of people and may also prevent the development of an optimal fixed-dose combination that can provide simple, highly effective treatment for all people with hepatitis C, regardless of genotype," said Cohn.

“Patent barriers that prevent affordable access to daclatasvir and the new directly-acting antivirals must be addressed by governments," she said. This will, she argued, "promote robust generic competition, which will enable price reductions, facilitate the development of a pan-genotypic combination, and accelerate availability in all developing countries that are bearing the brunt of the hepatitis C epidemic.”

According to MSF, development and testing of sofosbuvir/daclastavir combination treatment was delayed when Gilead (the owner of sofosbuvir) stopped collaboration with BMS in favor of Gilead's proprietary sofosbuvir/GS-5816 combination.  "Only now is BMS able to undertake Phase III trials of this combination with commercially available sofosbuvir," said MSF. It also remarks that BMS has not yet announced any access plans for low- and middle-income countries, where, it says, the majority of the hepatitis C burden lies. “Bristol-Myers Squibb must rapidly register daclatasvir in those countries with a high burden of hepatitis C, especially in those countries with a high prevalence of genotype 3. We urge BMS to ensure daclatasvir is affordable in those countries with a high burden of hepatitis C," said Cohn.

The volume and intensity of debate prompted by this class of drugs could prove to be a game-changer in the broader discussion of drug pricing in Europe—and beyond. The tough choices about measuring a medicine's value either in absolute terms of its cost, or in terms of its impact on healthcare spending more widely, are being brought into clearer focus than ever before, and in a very public manner.



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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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