March 21, 2014

Coffee Is Probably Good For Your Liver

Provided by International Business Times

By Nat Rudarakanchana
on March 21 2014 1:39 PM

coffee

Mounting scientific evidence has shown that coffee prevents and mitigates liver disease, even among the thousands of Americans who may not realize they have the disease, according to the Canadian Liver Foundation.

Several studies from the late 1990s to date have shown that coffee helps prevent liver inflammation, which is often related to hepatitis C, cirrhosis and liver cancer. One April 2013 overview study showed that 16 studies, which surveyed more than 500,000 subjects over several years, all demonstrated coffee’s benefits on the liver.

But awareness among the general public about coffee’s benefits for the liver remains “very poor,” Canadian Liver Foundation Chairman Dr. Morris Sherman told IBTimes on Thursday, at a New Orleans coffee conference.

That holds true of the coffee industry itself, which may not know much about the scientific connection, Sherman added.

It’s unclear if caffeine or other ingredients in coffee are responsible for the health benefits, Sherman said at an industry presentation called “Coffee and Liver Health: A Growing Nexus.” One study in Japan showed that green tea failed to help those suffering from liver diseases, Sherman said. Other evidence indicates that tea has little effect on liver diseases.

“Tea doesn’t seem to have any benefit” on the liver, Sherman said.

Still, coffee alone can hardly treat liver disease, and more solid scientific data in coming years is needed to strengthen the evidence of its health benefits. “It is unclear whether any of these benefits [from drinking coffee] are significant enough to 'treat' patients with chronic liver disease,” the 2013 overview study concluded. “In the interim, moderate daily unsweetened coffee ingestion is a reasonable adjunct to therapy.”

Obesity is a leading cause of nonalcoholic fatty liver disease, which many Americans have but don't know it. The disease may affect up to 25 percent of U.S. adults, though the actual figure may be closer to 10 to 15 percent. But if 5 percent of those with a liver disease were aware of it, that would be a significant improvement over the status quo, Sherman said.

Liver diseases don’t cause any symptoms until the liver actually fails, he said.

“The evidence has been slowly building," Sherman said. "These studies are not easy. It’s not easy to find a population large enough, and where someone has had the foresight to ask them about their coffee consumption.”

Coffee’s other health benefits may be dubious, however. The federal Food and Drug Administration (FDA) on Wednesday warned consumers against buying Vitaccino Coffee, which contains harmful substances, despite labelling claiming that the coffee can help drinkers lose weight safely.

Seven coffees that claim to boost weight loss have been found to contain harmful ingredients since 2011, according to the FDA's website.

Mortality rates for liver cancer are rising faster than many other cancers, though the Center for Disease Control and Prevention's data show that liver cancer isn't among the 10 most common cancers in the United States.

Source

New HCV Guidance: Rapid Updates for Clinicians

Medscape Gastroenterology

Laura A. Stokowski, RN, MS, Helen W. Boucher, MD, Paul Martin, MD
March 21, 2014

HCV Science Catching Up to Medical Need

In just 2 or 3 years, the pace of progress in the treatment of hepatitis C virus (HCV) infection has been fairly dramatic. A swift and steady stream of new drugs has challenged clinicians to keep up with the latest recommendations for therapy, and the pipeline is far from dry. The next wave of direct-acting antivirals will continue to target the HCV life cycle from different angles, and combining molecules with different mechanisms of action, different resistance profile, and high antiviral activity will be the name of the game.[1]

Safer, shorter, and more durable treatments are anxiously awaited by many patients already infected with HCV, who have been forestalling treatment or retreatment while waiting for all-oral, interferon-free regimens that will cure their infections without the adverse effects associated with previous drugs. For the rest of the estimated 2-3 million individuals infected with HCV in the United States, all the new drugs in the world are of scant worth if these infections remain undiagnosed.

The recommendation to add a 1-time HCV birth cohort screening for "baby boomers" to exposure risk-based screening[2] is expected to identify more than 800,000 new cases of chronic HCV infection in the United States.[3] Many clinicians -- from those on the frontlines of primary care to the specialists who are experienced in managing HCV and its complications -- will be needed to cope with the burgeoning newly diagnosed population.

The rapid advances in the field of HCV prompted the Infectious Diseases Society of America (IDSA) and the American Association for the Study of Liver Diseases (AASLD), in collaboration with the International Antiviral Society-USA (IAS-USA), to sponsor an effort to synthesize the current evidence in the field, from which was derived a set of expert-developed recommendations for the management of HCV infection, a feat that was accomplished remarkably quickly. The first phase of the HCV guidance, available online at HCVguidelines.org, details the methodology used to develop the guidance, and covers the following sections related to diagnosis, referral, and management:

  • HCV Testing and Linkage to Care;

  • Initial Treatment of HCV Infection in Patients Starting Treatment;

  • Retreatment of Persons in Whom Prior Therapy Has Failed; and

  • Unique Patient Populations (HIV/HCV coinfection, cirrhosis, transplantation, renal impairment).

Sections ("coming soon") that are now being developed for updates of the guidance include:

  • In Whom and When to Initiate Treatment;

  • Monitoring Patients Who Are On or Have Completed Therapy; and

  • Management of Acute HCV Infection.

Clinicians will appreciate the color-coded treatment guidance within the report, allowing them to distinguish at a glance "recommended" (outlined in green) from the "not recommended" (outlined in red) treatment regimens. Each section of the report ends with a quick reference summary of recommendations, and useful resources are provided at exactly the point they might be needed. For example, the section on testing includes a table of commercially available, US Food and Drug Administration-approved anti-HCV screening assays, and a simple algorithm of the recommended sequence for screening, testing, and linking patients to care for ongoing evaluation and management.

Medscape Talks to Paul Martin, MD, and Helen W. Boucher, MD, for Perspectives on New HCV Guidance

Medscape recently spoke with Dr. Paul Martin, a hepatologist and member of the guidance writing panel, and Dr. Helen W. Boucher, an infectious diseases specialist, about the new HCV guidance, including key points of emphasis about the content of the guidance, the implications for clinical practice, and what clinicians can expect in the way of updates.

Medscape: HCV treatment is still in flux -- it almost seems impossible to settle on treatment guidelines. How did the HCV guidance first come about?
Dr. Boucher: The HCV guidance was sponsored by the IDSA and the AASLD, with IAS-USA as the collaborating partner. The 2 societies have decided that the best way forward with the treatment of hepatitis C infection is to collaborate, and I think what is so exciting about this new guidance is the partnership behind it. We have recognized the need to provide up-to-date information, and that is what our societies have done with this guidance. The speed with which the guidance document was achieved was extremely noteworthy.

Medscape: You refer to the HCV guidance as a "living document." How does this differ from the model that we are accustomed to in medicine?

Dr. Martin: The whole area of hepatitis C treatment is evolving so rapidly that we felt that it was crucial that treating healthcare providers have access to up-to-date information. The more traditional practice guidelines go through a detailed process and take some time to appear in print. Clearly, however, this whole field is moving so rapidly that we felt that it was best to have our recommendations online as soon as possible. As far as updating it, the same panel will be involved, and additional experts may be invited to participate for specific topics. The idea is that this will be updated on a regular basis. We plan to add additional sections later on. Clearly, however, the HCV guidance reflects treatment options in the United States, as these new drugs may not yet be licensed in other countries where different standards of care exist.

I think this is probably going to be the wave of the future, because we are all now so dependent on the Internet for information. We use the Internet in the office to research clinical questions when a patient is being seen, and I think practice guidelines in the future will reflect what we have done and mirror this sort of model. Speed and completeness are going to be the watchwords of the future.

Medscape: Is it significant that the document is called "HCV Guidance" rather than "HCV Guidelines"?

Dr. Martin: Yes. We view it that guidelines are typically developed after a protracted process, and the word "guidance" reflects the need to make recommendations available to potential treaters in a relatively short period. The recommendations are still based on a combination of review of the literature and consensus of expert opinion, but we view guidance as reflecting an up-to-date process.

Dr. Boucher: We were (and still are) experiencing an explosion of information about how best to treat patients with HCV, similar to what happened with HIV years ago The IAS-USA has done something similar, in a very high-quality way, for HIV/AIDS.

Medscape: With the recommendation to test all "baby boomers" (people born between 1945 and 1965) in addition to risk-based screening, the numbers of individuals with active hepatitis C infection are going to climb in the near future, and concerns have been raised about having enough healthcare providers to evaluate and treat all of these individuals.

In the section on testing and linkage to care, it says, "All patients with current HCV infection and a positive HCV RNA test result should be evaluated by a practitioner with expertise in assessment of liver disease severity and HCV treatment." Does this mean that primary care/internal medicine practitioners should refer all newly diagnosed patients to liver specialists?

Dr. Martin: We didn't restrict management of HCV to any particular discipline. The key thing is in managing hepatitis C is that although you are managing a viral disease, you are also managing the liver disease. We didn't seek to preclude any type of healthcare practitioner from caring for these patients, but we wanted to recommend that patients be seen by somebody who can not only treat the viral infection but also understands that the severity of the liver disease needs to be addressed -- because ultimately that is going to determine, or be an important component of determining, the patient's prognosis.

Dr. Boucher: The important point is that the patient ends up with a healthcare practitioner who is expert in managing his or her disease. Many physicians are expert in treating HCV. Some are infectious diseases trained, and some are gastroenterology/hepatology trained. It differs by medical center; there are no absolutes.

Medscape: In the section about initiating treatment, as written today, what would you most like to draw clinicians' attention to?

Dr. Martin: The most important point is endorsing the use of the combination of sofosbuvir and simeprevir in the treatment of hepatitis C and discouraging the use of telaprevir- and boceprevir-containing regimens. These drugs are still approved for use, although they are associated with higher rates of adverse effects, such as rash and anemia.

Medscape: If a patient has already been started on a regimen involving either telaprevir or boceprevir, would you switch to a different combination, or allow the patient to complete the treatment?
Dr. Martin: If a patient is already doing well on treatment, there is no need to switch therapy.

Medscape: How important is genotyping in tailoring treatment to the patient?

Dr. Martin: Genotyping is key to picking the optimal regimen.

Medscape: Can you speak a little about the progress toward an all-oral, interferon-free treatment for hepatitis C?
Dr. Martin: In my mind, it has already arrived. We are in the first phase of it already. Obviously, interferon is still part of a number of regimens, but as we speak, many patients are receiving all oral therapies

It depends on the genotype. For patients with genotype 1, we have the COSMOS protocol, which is a combination of simeprevir and sofosbuvir. For patients with some non-genotype 1 infections, there is the option of using sofosbuvir with ribavirin, for instance.

In general, therefore, we are seeing an increased use of these all-oral regimens. This reflects what has been approved as of the date that the guidance was generated. A drug such as the NS5A replication complex inhibitor daclatasvir will be part of the revised treatment strategy if and when it has been approved.

Medscape: We hear talk of an "avalanche" of drugs in the HCV pipeline, and that some of the drugs are pan-genotypic: For example, a drug such as the NS5A replication complex inhibitor daclatasvir might become part of a revised treatment strategy if approved. Can we really expect this many new drugs, and how will you keep this manageable for clinicians who must keep up to date with new drugs all the time?

Dr. Martin: "Avalanche" might be overstating it. I would describe it as a very good developmental pipeline, and I think we are going to see continued advances related to the licensing of new drugs. We will probably see several more drugs licensed in the next 1-2 years. It will certainly be challenging to help clinicians keep them all straight, but that is one of the reasons we were interested in developing these guidelines and, in fact, the reason that they are called hepatitis C "guidance" rather than "guidelines." It is a huge amount of information, and it needs to be updated frequently.

Medscape: How much concern do you have about the development of resistance to these drugs?

Dr. Martin: When we are seeing sustained virologic response rates now routinely in excess of 90%, clearly resistance is going to be substantially less of a concern, because most patients are going to be cured by a single course of treatment. That being said, I don't think anybody thinks resistance is going to go away. However, the key to managing or preventing resistance is to very effectively treat the infection with the best drug combination available and to eradicate the infection the first time around.

Medscape: In the guidance document, you don't mention cost of treatment at all. It is understandable that you wouldn't want to get into that, but would you be willing to comment on the reports about the high cost of these drugs?

Dr. Martin: It is fair to say that the more treatment options that there are, the more price pressure there will be on the individual companies to license or sell their drugs at a competitive price. It is very expensive to take care of a patient with advanced liver disease -- not just the cost of a liver transplant, but a patient with advanced liver disease who is in and out of hospital with one complication after another is enormously resource-intensive for the system. If we can abort the progression of liver disease, we are ultimately going to have a major impact on healthcare costs related to hepatitis C. Many patients with hepatitis C may elect to wait for less expensive regimens if their liver disease is mild.

Medscape: Is there anything else practice-changing about the guidance document, as it stands today, that you would like to mention?

Dr. Martin: It is critically important that patients are seen by practitioners who are comfortable managing and treating hepatitis C. We don't want to restrict anyone from taking care of these patients, but we want to make sure that patients have the appropriate work-up. Patients with advanced liver disease who may need additional consideration, such as a liver transplant, should be referred for specialty care. Another group of patients who might need referral are those who are coinfected with HIV, who might need expertise in HIV management.

Dr. Boucher: We hope that primary care practitioners will use the guidance to help them decide who needs a referral and when.

Medscape: How do you plan to disseminate the guidance to clinicians, both now and when there is updated guidance that you want to make them aware of?

Dr. Boucher: I believe that the plan is to use the Website www.hcvguidelines.org as the major point of dissemination.

Source

Gilead offers Egypt new hepatitis C drug at 99 percent discount

By Maggie Fick and Ben Hirschler
CAIRO/LONDON  Fri Mar 21, 2014 4:10pm EDT

(Reuters) - Gilead Sciences, facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.

While the drug will still cost $900 for a 12-week course of treatment, that is a fraction of the $84,000 charged for a course of treatment in the United States.

The high price tag in America prompted questions from U.S. lawmakers on Friday, after U.S. health insurers said they were seeking help from state health officials to foot the bill.

Gilead said it was "pleased to have finalized an agreement" for the introduction of Sovaldi in Egypt, which has the highest prevalence rate of hepatitis C in the world.

"We believe Sovaldi could have a major impact on public health in Egypt by significantly increasing the number of people who can be cured of hepatitis C," Gregg Alton, head of corporate and medical affairs at Gilead, said in an emailed statement.

Egyptian health minister Adel El-Adawi said Cairo had struck a deal with U.S.-based Gilead for the government to buy Sovaldi for $300 for a one-month box, according to a recent report on the state news agency MENA.

That would imply a cost of $900 if Sovaldi is used as part of a 12-week drug regimen, although the cost would be higher if it was used for 24 weeks, which is also an option based on different drug combinations.

El-Adawi said Gilead's offer would apply to Sovaldi supplies used in government clinics, adding that access programmes would start in the second half of 2014, following completion of registration procedures in Egypt.

Sovaldi is in the vanguard of a wave of pills which could cure the liver-destroying disease in millions of people worldwide, or even eradicate it entirely. But that will only happen if the new therapies are affordable enough to allow widespread use.

Nowhere is the problem more acute than in Egypt, which has the world's highest prevalence of the virus, following the use of poorly sterilized needles in campaigns dating back to the 1970s to stamp out the parasitic disease schistosomiasis.

Like HIV, hepatitis C (HCV) can be spread through blood, often via contaminated needles.

The World Health Organization estimates that more than 150 million people worldwide are chronically infected, most of them in developing countries, putting them at risk of cirrhosis and liver cancer.

Other companies such as Johnson & Johnson, AbbVie, Bristol-Myers Squibb and Merck & Co are also developing oral treatment regimens for HCV that have shown dramatic results in clinical trials, while reducing the need for debilitating interferon injections.

Doctors and industry analysts believe the new drugs will transform HCV treatment - and prove hugely profitable. In the developed world, they are tipped to become major blockbusters, with consensus sales forecasts for Sovaldi alone standing at $9.1 billion in 2017, according to Thomson Reuters Pharma.

But the risk of a gulf in access between patients in the rich and poor parts of the world is causing alarm among health campaigners who warn of a potential re-run of the battle over HIV drugs in Africa more than a decade ago.

Medecins du Monde, a non-profit group that provides medical care around the world, highlighted Egypt as a country in dire need of the new hepatitis C drugs in a report this week.

Gilead has also said it plans to license Sovaldi to a number of Indian generic pharmaceutical manufacturers, which would be able to sell lower-priced copies of the medication.

(Additional reporting by Deena Beasley; Editing by James Dalgleish)

Source

Journal of Hepatology
Volume 60, Issue 4 , Pages 741-747, April 2014

Zobair M. Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M. Jacobson, Eric Lawitz, David Nelson, Fatema Nader, Sharon Hunt

Zobair M. Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M. Jacobson, Eric Lawitz, David Nelson, Fatema Nader, Sharon Hunt

Received 17 September 2013; received in revised form 29 November 2013; accepted 4 December 2013. published online 11 December 2013

Abstract

Background & Aims

Treatment for CH-C contains interferon with substantial associated side effects and health-related quality of life (HRQL) impairment. Currently, there is no published data assessing the impact of interferon-free regimens on HRQL. The aim is to report the HRQL of patients who participated in clinical trials of sofosbuvir (SOF) for CH-C.

Methods

CH-C patients were treated with sofosbuvir (SOF), pegylated interferon (PegIFN), ribavirin (RBV), or placebo in different combinations and duration (POSITRON, FISSION, FUSION, and NEUTRINO phase III trials). HRQL was assessed using SF-36 at baseline, during treatment, at the end of treatment, and at follow-up, and compared between treatment arms.

Results

HRQL scores decreased over the course of treatment for all treatment arms in all studies; however, patients returned to their baseline score by the end of follow-up. Compared to placebo, SOF and RBV was not associated with HRQL impairment (POSITRON). Compared to SOF and RBV, HRQL was significantly more impaired in the PegIFN and RBV arm (FISSION). For those treated with SOF and RBV, there was no difference in HRQL between 12weeks or 16weeks of treatment (FUSION). Multivariate analysis demonstrated that depression, fatigue, and insomnia were important predictors of patients’ HRQL prior, during or after treatment. Additionally, anemia and receiving interferon were predictors of HRQL impairment during treatment. Achieving sustained virologic response after 12weeks of follow-up (SVR-12) with SOF and RBV was associated with improvement in HRQL scores from baseline.

Conclusions

Treatment-related HRQL impairment during SOF and RBV regimen is mild, and does not increase with longer treatment duration. Achieving SVR-12 with SOF and RBV is associated with an improvement in HRQL.

Keywords: Quality of life, Clinical trials, Hepatitis C

Source

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Positive opinion for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

“The recommendation is one additional step in the global strategy that our partner Janssen has for simeprevir, to offer a new and efficacious treatment option to the many hepatitis C patient groups suffering from this devastating disease” said Maris Hartmanis CEO, Medivir.

Simeprevir is a new generation, NS3/4A protease inhibitor administered as a once daily 150 mg capsule with pegylated interferon (PegIFN) and ribavirin (RBV) offering proven efficacy across a range of different HCV patient types.

The CHMP opinion was based on positive and consistent results from three pivotal phase III studies in patients with GT1 HCV; QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients (who have relapsed after previous interferon-based therapy). QUEST-1 and QUEST-2 included 785 treatment-naïve patients with chronic HCV GT1 infection. PROMISE included 393 relapsed patients with chronic HCV GT1 infection. All three studies met their primary end points and demonstrated simeprevir in combination with PegIFN/RBV achieves superior cure rates when compared with PegIFN/RBV alone, in treatment naïve and relapsed patients.

Hepatitis C in the European Union
Hepatitis C is a major health problem in the European Union, where nine million people are living with the disease. The current standard of care is not always tolerable due to significant side effects of interferon based therapy and improvements in efficacy for difficult to treat patients, such as prior null responders, represent a high medical need. Treatment of HCV is complex because of the heterogeneous population of patients it affects and that treatment efficacy is highly dependent on the genotype of the virus.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 15.45 CET on 21 March 2014.


About Simeprevir

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

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Mar 20, 2014

Today Ranking Member Henry A. Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette sent a letter to Gilead Sciences Inc. Chief Executive Officer John C. Martin to request a briefing on pricing of the company’s recently approved Hepatitis C drug, Sovaldi.  Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment, which will affect coverage for patients with public or private insurance. 

FDA approved Sovaldi in December 2013 after the drug received an FDA Priority Review and Breakthrough Therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions.

The full text of the letter is available below and online here.

                                                                                             March 20, 2014

Dr. John C. Martin, PhD
Chief Executive Officer
Gilead Sciences Inc.
333 Lakeside Drive
Foster City, CA 94404

Dear Dr. Martin:

We are writing to request a briefing from Gilead Sciences Inc. to answer important questions about the pricing of the company's recently approved Hepatitis C drug, Sovaldi. 
A breakthrough treatment for Hepatitis C could result in significant public health benefits.  Approximately 3.2 million Americans have a chronic Hepatitis C infection, and the illness causes approximately 15,000 deaths in the United States annually.  There is no vaccine for Hepatitis C, which causes fatal cirrhosis or liver cancer in up to 5% of affected individuals.

There is evidence that Sovaldi could be a breakthrough treatment.  According to FDA, “Sovaldi was effective in treating multiple types of the hepatitis C virus. … demonstrat[ing] efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.”

Our concern is that a treatment will not cure patients if they cannot afford it.  Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment.  In cases where Sovaldi is prescribed with other treatments the costs could be even higher.  According to a recent Reuters report, “many doctors are requesting a $150,000 combination of Sovaldi … and Olysio.”

These costs are likely to be too high for many patients, both those with public insurance and those with private insurance.  Because Hepatitis C is “concentrated in low-income, minority patients,” the affordability problems are likely to be particularly acute for state Medicaid programs and those patients served by these programs.  Colorado and Pennsylvania have already announced that their Medicaid programs will be limiting use of the new drug to “only the sickest patients,” such as those already suffering from liver disease.  California’s Medicaid program is still considering how and when to reimburse for the drug.  The large pharmacy benefit manager Express Scripts has said it is “encouraging some doctors in its networks to delay prescribing Sovaldi.”  Even in cases where public or private insurers pay for the medication, it will impose substantial costs on taxpayers and could cause premium increases for those with employer or individual coverage.

The extraordinarily high cost of your drug raises additional concerns because of the role of the federal government in speeding its approval.  In April 2013, Gilead submitted a New Drug Application to the Food and Drug Administration for approval of Sovaldi for the treatment of Hepatitis C.  As part of the request, Gilead filed for and received a Priority Review and Breakthrough Therapy designation, which reduces the FDA review goal date from ten to six months.  This designation is awarded to medicines that meet certain criteria, including “that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.”  The FDA approved Sovaldi on an expedited basis on December 6, 2013.

This history raises many questions about Gilead's approach to pricing this drug and the impact the high cost may have on public health.  In order to address these issues, we ask that you brief Committee staff on a number of key questions, including:

(1)        The methodology used by Gilead to establish Sovaldi's pricing.
(2)        The extent to which Gilead is providing discounts to low-income patients and to key government or private-sector purchasers of the drug.
(3)        The value to the company of the expedited review provided under the Priority Review and Breakthrough Therapy designation and how any savings provided by the expedited review factored into pricing decisions for the drug.
(4)        The public health impact of insurers’ and public health programs’ decisions not to cover Sovaldi for all patients with Hepatitis C.

We ask that you provide this briefing no later than April 3, 2014.  Please contact Brian Cohen of the Committee staff at (202) 225-3641 if you have any questions.

Sincerely,

Henry A. Waxman
Ranking Member

Frank Pallone, Jr.
Ranking Member
Subcommittee on Health

Diana DeGette
Ranking Member
Subcommittee on Oversight and Investigations

Related Documents:

Letter to Dr. John C. Martin, CEO, Gilead Sciences Inc., from Ranking Members Henry A. Waxman, Frank Pallone, Jr., and Diana DeGette (March 20, 2014) .

Source