Amid healthy sales and bountiful approvals, a pricing conundrum impedes patient access to medicines in 2014
Within a week of publication of C&EN’s 2013 Pharmaceutical
Year in Review, a new drug called Sovaldi was introduced. Like others
before, it came with a backstory and kicked off a new adventure for the
firm that developed it and the patients, physicians, and payers that
populate the market. In the case of Sovaldi, a highly effective
treatment for hepatitis C, the narrative illuminates the key issues and
dilemmas characterizing the drug industry in 2014.
The active ingredient in Sovaldi, sofosbuvir, was discovered by
Pharmasset, a Princeton, N.J.-based biotech firm with fewer than 100
employees. Seeing potential, Gilead Sciences
acquired Pharmasset in 2011 for a surprising $11 billion. The bet,
although big, has already paid off: Sovaldi sales were $8.5 billion in
the first nine months of this year.
For Gilead, a fast-growing drug company with a portfolio of
successful therapies in areas such as HIV/AIDS and oncology, Sovaldi
exemplified the kind of product most highly prized in drug discovery and
development: one that has a novel and positive impact on an intractable
LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) has finally
fixed price of the ‘blockbuster’ oral drug – Sovaldi – after its
registration in Pakistan, giving a good news to hepatitis C patients.
decision was taken in a meeting of DRAP’s Drug Price Committee presided
over by Pricing Director Mr Amanullah in Islamabad on Thursday, a
senior official in the authority told Dawn.
He said the Ferozsons
Laboratories is the sole company which was granted rights to sell and
market this much-awaited drug in Pakistan at a price approximately
Rs1,940 for each tablet. The company will make available a pack of 28
tablets for total price Rs55,000 [$890 US] after final approval by the federal
While highlighting the
significance of the new life-saving drug, Technical Advisory Group (TAG)
Member Prof Dr Ghiasun Nabi Tayab said presently approximately 10
million people in the country were living with chronic hepatitis C virus
In a bid to widen access to its hepatitis C drug, Bristol-Myers Squibb has begun talks with health authorities in 90 countries and generic
drug makers, according to a brief statement posted on the drug maker’s
web site late last week.
Bristol did not offer many specifics, other than to say it is
pursuing licensing and tiered pricing, which refers to offering a drug
at a different price in different countries.
The move comes as pricing over hepatitis C treatments – notably, a pair of medications sold by Gilead Sciences – has helped to fuel a growing controversy
over the cost of medicines. In the U.S., for instance, the Sovaldi
treatment costs $1,000 a pill, or $84,000 for a 12-week regimen, while a
newer treatment called Harvoni is priced at roughly $95,000. The prices have alarmed Medicaid and private insurers.
After shaking up the health care industry with a $1,000 hepatitis C
pill, Gilead Sciences of Foster City won approval Friday for a new
version of that treatment that works faster, drops the usual injections
and boasts an already-controversial $1,125 price tag.
The new daily pill Harvoni costs $94,500 for 12 weeks and $63,000 for
eight weeks — both cheaper than some existing hepatitis C treatments,
according to the drugmaker. But some patient advocates are already upset
about the price after nearly revolting against Gilead’s first hepatitis
C therapy, Sovaldi, which became the best-selling new drug ever when it
hit the market late last year at $84,000 for 12 weeks.
Harvoni, which combines Sovaldi and a new drug called ledipasvir, is
expected to push Gilead’s overall hepatitis C drug sales to $12 billion
this year and more than $15 billion next year, said Michael Yee, a biotechnology analyst at RBC Capital Markets.
Globally it is estimated that around 170,200 million individuals around
the world are currently living with the Hepatitis C virus (HCV), with an
additional 3-4 million becoming infected every year and 350,000+ deaths
annually. HCV is clearly one of the greatest public health threats of
this century and possibly even the next. Unlike HIV, HCV is curable.
In Malaysia, it is estimated that as at 2010 the HCV infections were at 397,515. According to a report in The Star dated
June 8, 2014, the present rate of infection is likely to be much higher
as often many infected with hepatitis C are not aware of their status.
In this context, new oral medicines bring significant new hope for many
people infected with the Hepatitis C virus with its better cure rates
and lesser side effects. However, hopes for universal affordable curable
treatment were dashed with Gilead’s announcement on Sept 15 of a
voluntary licence on two direct-acting oral antivirals (DAAs) used to
treat HCV infections, sofosbuvir (Sovaldi®) and ledipasvir.
Gilead Sciences of San Francisco is under investigation by the U.S.
Senate Finance Committee for charging $84,000 for a 12 week course of a
new drug to treat hepatitis C. Gilead sells the exact same course for
$900 in poor countries like Egypt and India.
Sovaldi – the brand name for sofosbuvir – was approved last December
by the U.S. Food and Drug Administration, to treat hepatitis C, a viral
infection that can cause fever, fatigue, cirrhosis and deadly liver
cancer. Some 150 million people around the world are estimated to be at
risk, often many years after receiving contaminated blood tranfusions. (Body Shop founder Anita Roddick died from such a transfusion).
Sovaldi has been described as a breakthrough drug because of its
ability to cure victims in just three months, with few side effects.
A new study by Express Scripts, a pharmacy benefits firm, estimates
that U.S. government healthcare programs alone will have to spend $55
billion to buy Sovaldi. “Should the states be compelled to pay for everyone?”
Dr. Steve Miller, medical director for the firm, asked NBC News.
“You’re going to have to figure out if you’re going to have to go back
to your voters and ask for more funding.”
This the 185 million people worldwide
living with chronic Hepatitis C (HCV) and their loved ones ought to be
celebrating a major medical accomplishment: the release of sofosbuvir, a
new medication which cured 90%
of HCV-infected patients in clinical trials. It is too soon to
celebrate, however, as this life-saving drug remains financially out of
reach for most of those affected.
Gilead Sciences, the manufacturer, has
decided to sell the medication, named Sovaldi, at a cost of $84,000 per
twelve-week treatment regimen. Raymond Schinazi, one of the scientists
who helped formulate the drug, estimates that this same treatment
regimen costs only $1,400
to produce. At this price, insurance companies and government programs
will be reluctant to cover the medication, and it will be inaccessible
for most people living in low- and middle-income countries, who account
for 90% of HCV cases worldwide.
The prohibitive cost has put health advocates in a bind. Alan Franciscus, of the HCV Advocate, an organization that publishes an HCV-focused newsletter on www.hcvadvocate.org and runs 40-60 trainings
each year with public health workers, patients and doctors, is one
example. He has found that Gilead has had good patient assistance
program for uninsured patients in the past, which he has encouraged
people to use. Yet in spite of this he has remained concerned about
how the cost will affect insurance companies’ willingness to cover the
medications, and has felt that he has had to “be silent on the question
“We must learn from the HIV epidemic and ensure that affordable prices are in place so that the millions with Hepatitis C infection can get new drugs that appear to be a cure.”
Médecins du Monde, in a new report, says we must learn the
lessons from HIV. “New Treatments for Hepatitis C virus: Strategies for
Achieving Universal Access” looks at the need and what companies like
Gilead say they will do about it. The authors are not, as yet,
Françoise Barré-Sinoussi, virologist, winner of the
Nobel prize for her early work on the HIV virus and president of the
International Aids Society, specifically makes the link with HIV in a
quote in the report:
“We are witnessing a revolution in the treatment of hepatitis C virus
with powerful molecules capable of curing the infection. There is no
question that these treatments that can save millions of lives must be
made universally available at an affordable price.”