Monday, November 3, 2014

MSF responds to BMS commercial strategy for hepatitis C drug daclatasvir in developing countries

Bristol-Myers' 91-country hep C access plan still draws fire from price critics
November 3, 2014 | By Carly Helfand
Bristol-Myers Squibb ($BMY) is taking Gilead's ($GILD) lead when it comes to developing-world access for its hepatitis C drug, offering up a tiered pricing strategy and licensing agreements with generics makers. But according to some critics, that's not enough.
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Bristol-Myers Plan to Widen Access to its Hep C Drug, But Meets Criticism
A Bristol-Myers spokeswoman would not comment on the criticism or the study, but did send a note saying “our prices in developing countries will take into consideration several factors that include economic development and the burden of disease within a country, as well as the commitment of the government to holistically address hepatitis C, including treatment and care. We are currently engaged in discussions with several high disease burden developing-countries on their plans to address hepatitis C, and the role that Bristol-Myers Squibb can potentially play.”

HCV Developing World Strategy
Bristol-Myers Squibb recognizes the significant public health challenge that hepatitis C (HCV) presents worldwide, including the substantial burden of the disease in the developing world. With more than 80% of the global HCV patient population living in low- and middle-income countries, there is great need for hepatitis C treatment options in these countries. The significant challenges facing many of these countries are not homogeneous, in particular the need for governments, non-governmental organizations, civil society and industry to form coalitions.

As part of our Company-wide commitment to increasing access to medicines for patient populations in need, we have initiated discussions with government health authorities and other stakeholders in a number of developing countries to facilitate access to daclatasvir. Bristol-Myers Squibb’s HCV developing world access approach will utilize tiered pricing, licensing agreements and working in collaboration with other stakeholders who share in our commitment to working toward the eradication of hepatitis C.

Our tiered pricing model for daclatasvir will take into consideration several factors, including countries’ economic development and burden of disease, as well as the commitment of the government to holistically address hepatitis C, including treatment and care. The lowest pricing tier will apply to all low-income and least developed countries. In addition, in 90 countries (see list at right), Bristol-Myers Squibb will work with licensed generic manufacturers to supply licensed versions of daclatasvir. We are eager to leverage our considerable experience in developing world access to our HIV medicines in order to bring daclatasvir to the developing world as soon as possible.

MSF responds to BMS commercial strategy for hepatitis C drug daclatasvir in developing countries


Pharmaceutical company Bristol-Myers Squibb (BMS) has recently revealed a restrictive commercial strategy for sales of its new direct-acting antiviral (DAA) hepatitis C drug daclatasvir in developing countries. This new generation of drugs to treat hepatitis C is giving hope to the 185 million people infected with the disease today, as these drugs are expected to improve treatment and provide significantly higher chances of cure.

But the prices of these drugs are of grave cause for concern. Gilead’s sofosbuvir, the first DAA which received USFDA approval, is priced at US$84,000 per three-month treatment course in the United States, and nearly $95,000 per treatment when used in combination with another DAA, ledipasvir. These prices will hinder any attempt to scale up treatment of the disease.

But studies have suggested that the cost to produce these drugs is just a tiny fraction of the price of the drug; sofosbuvir costs just $68 - $136 per treatment to produce. One of these studies, from Liverpool University, suggests daclatasvir could cost as little as $10 - $30 to produce for a 12 week course of treatment. BMS has not yet announced the price for developing countries for daclatasvir, but the company has announced that it will create a tiered pricing strategy for the drug. Tiered pricing is a marketing strategy that sets different prices for different countries, most often based on macroeconomic factors; the effect is that middle-income countries – where nearly three-quarters of the world’s poor, and over 70 percent of people with hepatitis C, live – are required to pay high prices that are unaffordable to treatment providers such as MSF, government health programs, and patients who must pay for medicines out of pocket.

BMS also announced its intention to negotiate voluntary licenses – which allow selected generic manufacturers to market cheaper versions of a drug – but with a geographical coverage of only 90 developing countries. Restrictive licensing terms can prevent generic competition where it is needed most: the BMS policy could mean that many middle-income countries with a significant burden of hepatitis C, including China, Egypt and Ukraine, are excluded from access to more affordable generic versions of daclatasvir and will have to pay higher prices. The ability to produce or import generic versions of daclatasvir will be critical to significantly reduce prices of these drugs, as well as to develop or sell fixed-dose combinations that are expected to provide the best treatment outcomes for patients.

Registration of daclatasvir in all countries will also be key; BMS has indicated that it does not have plans to register the drug worldwide, which will seriously hinder access in those countries where BMS chooses not register the drug.

Finally, BMS has largely decided their plans in secret, sharing very few details on plans for registration, price and access ahead of the announcement, an approach that is reminiscent of industry approaches in the early years of the AIDS epidemic and unacceptable by any standard today. Details shared ahead of the announcement have been purposefully vague and BMS has not yet committed to publishing any licence agreement it signs with generic manufacturers in the future, or its tiered pricing structure for developing countries.

BMS’ secrecy and very restrictive commercial plans for developing countries is of grave concern, given the medical importance of daclatasvir; studies have shown it to have high rates of cure when used in combination with other DAAs. Daclatasvir is also pan-genotypic, showing it is effective for genotype 3, which has proven difficult to treat with other DAAs and is highly prevalent among people living with hepatitis C in India and Pakistan.

Médecins Sans Frontières (MSF) responds to the news of BMS’s plans on access and licencing for daclatasvir:
“Unfortunately, history seems to be repeating itself with BMS, who haven’t learnt from the company’s poor track record responding to the HIV epidemic; it is disappointing that BMS is choosing to lock out millions of people from gaining affordable access to daclatasvir, and will not commit to registering the drug in all countries that have a hepatitis C burden, even those that do not represent a commercial opportunity for BMS.
“Once again, people in middle-income countries – where nearly three-quarters of the world’s poor, and over 70 percent of people with hepatitis C, live – are the ones left empty-handed. Affordable access to daclatasvir has been intentionally blocked from most middle-income countries, with BMS keen to extract as much profit as it possibly can.  MSF hopes that excluded governments will take all relevant measures available under global trade rules and national patent laws to secure access to low-cost generic versions of these medicines.
“BMS’ secrecy portends an unwelcome approach that does not respond to the urgent need for affordable access to hepatitis C drugs for millions of people across the developing world.”
- Rohit Malpani, Director of Policy and Analysis, Médecins Sans Frontières Access Campaign.


Updated November 3, 2014
Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir) and Sovaldi.
An index of articles & research weighing the pros and cons over the high price of hepatitis C drugs.

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