Tuesday, March 10, 2015

Expensive new hepatitis C therapies drive prescription-drug cost

U.S. Prescription Drug Spending Increased 13.1 Percent in 2014, Driven by Hepatitis C and Compounded Medications

ST. LOUIS, March 10, 2015 /PRNewswire/ -- New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1 percent increase in U.S. drug spending in 2014 – a rate not seen in more than a decade – according to new data released today in the 2014 Express Scripts (NASDAQ: ESRX) Drug Trend Report.

Hepatitis C and compounded medications are responsible for more than half of the increase in overall spending. Excluding those two therapy classes, 2014 drug trend (the year-over-year increase in per capita drug spending) was 6.4 percent.

Specialty medications – biologic and other high cost treatments for complex conditions, such as multiple sclerosis and cancer – accounted for more than 31 percent of total drug spending in 2014. As Express Scripts forecasted last year, specialty drug trend more than doubled in 2014, to 30.9 percent. Hepatitis C medications accounted for 45 percent of the total increase in specialty spend despite having the second lowest prescription volume among the top 10 specialty conditions. Medicare plans – required to follow Medicare Part D formulary guidelines – were the hardest hit, as their annual specialty drug spend increased 45.9 percent.

"For the past several years, annual drug spending increases have been below the annual rate of overall healthcare inflation in the U.S., but that paradigm is shifting dramatically as prices for medications increase at an unprecedented and unsustainable rate," saidGlen Stettin, M.D., Senior Vice President, Clinical, Research and New Solutions at Express Scripts. "Now, more than ever, plans need to tightly manage the pharmacy benefit, implement smarter formularies, control compounded medication use and offer the right clinical support to ensure all patients are able to achieve the best possible health outcomes at a price our country can afford."

The U.S. spent nearly 743 percent more on hepatitis C meds in 2014 than it did in 2013. Express Scripts' hepatitis C solution, which makes Viekira Pak™ (ombitasvir/paritaprevir/ritonavir packaged with dasabuvir) available to all hepatitis C patients and guarantees successful completion of therapy through Accredo, is expected to save our clients $1 billion in 2015.

New treatments for hepatitis C are just one example of non-orphan drugs with orphan-drug price tags. Future pharmaceutical innovations, such as new cancer drugs and PCSK9 inhibitors for high blood cholesterol, will continue to challenge payers. Projected to command an annual cost as high as $10,000 per patient, and potentially reaching a patient population eventually as large as 10 million Americans, PCSK9 inhibitors alone could one day cost the U.S. healthcare system an estimated $100 billion per year.

Closely Managed Plans Mitigate Spend Increases

Express Scripts' solutions, including formulary and utilization management programs, and use of Express Scripts' home delivery pharmacy, help payers improve patient care and benefit affordability. More than 15 percent of Express Scripts' clients spent less, per capita, on prescription drugs in 2014 than in 2013.

A sub analysis of the Drug Trend Report found that, compared to payers with less managed pharmacy plans, payers that implemented four or more cost-management programs achieved nearly zero drug trend and spent nearly 30 percent less per member on traditional (non-specialty) medications, those which treat common chronic conditions, such as diabetes.

A similar analysis shows that the annual increase in specialty spending is 32 percent less for employers with a tightly managed specialty pharmacy benefit compared to employers with an unmanaged benefit. The study – which examined 851 clients, 20 percent of which employed no utilization management programs for specialty – also revealed that tightly managed programs saw higher average medication adherence rates in top specialty therapy classes, such as multiple sclerosis and pulmonary conditions.

Formulary Design Delivers Cost Savings with Low Member Impact

Many plan sponsors countered brand-drug price inflation by implementing the 2014 Express Scripts National Preferred Formulary, which excluded 48 products from coverage, achieved a 3.9 percent decrease in drug spending among the affected therapy classes, more than $750 million in savings. The excluded products represented only about 1 percent of all the products on the market, and in all cases, patients had safe and effective alternatives covered by their plan. Drug costs in those same therapy classes increased 7.2 percent among plan sponsors who did not adopt the new formulary.

Plans participating in the National Preferred Formulary in 2014, and continuing in 2015, have seen the number of patients impacted by formulary exclusions decline significantly, while realizing cumulative savings of more than $2.2 billion.

Compounded Medications Drive Increased Spending on Traditional Medications

Spending on traditional classes of medications continues to rise as a result of compounded drugs, which emerged in the top 10 traditional therapy classes for the first time. Despite having the least number of prescriptions among the top 10 classes, compounded medications accounted for 35 percent of the increase in spending, the most of any traditional therapy class of drugs.

However, Express Scripts expects spend on compounded medications to decline sharply in 2015 due to widespread adoption of ourcompound utilization management solution. Implemented in mid-2014, this program will save clients more than $1.9 billion in 2015 that would have otherwise been wasted on compounded medications that do not provide a proven clinical benefit.

"Express Scripts' actions to close the compound loophole provided our clients with a swift and effective solution to this costly concern," said Dr. Stettin. "There is no charge to clients for this new solution, only the benefit of a 95 percent reduction in waste associated with this category of medications. We ensure that patients who need compounds can access them; and where clinically appropriate, we ensure that patients who do not need these compounds can receive effective, more affordable alternatives."

Additional Key Findings
Drugmaker consolidation and drug shortages also led to increases in traditional drug trend, which rose to 6.4 percent in 2014.
Diabetes remains the leading traditional therapy class for a fourth straight year based on total costs; Express Scripts expects double-digit increases in spend in this class over the next three years due to once-weekly oral and injectable drugs in the pipeline.
Cost for medications to treat pain increased 15.7 percent in 2014, due in part to new tamper-resistant formulations for opiates.
Inflammatory conditions, which include treatments for rheumatoid arthritis and psoriasis, maintained their position as the costliest specialty drug class due to expanded indications and increased prevalence of treatment.

As it has for the past two decades, the Express Scripts Drug Trend Report examines annual changes in utilization, unit costs and overall prescription drug spending, based on the pharmacy claims data from Express Scripts, the nation's largest pharmacy benefit manager. The full report is available online at http://Lab.Express-Scripts.com.

Related:
Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir)/Sovaldi/Viekira Pak.
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Monday, March 9, 2015

$10 copy of Gilead’s blockbuster Sovaldi appears in Bangladesh

$10 copy of Gilead’s blockbuster Sovaldi appears in Bangladesh

By Ketaki Gokhale and Makiko Kitamura / Bloomberg News

March 8, 2015 11:27 PM

MUMBAI, India — A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesn’t have patents.

Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said managing director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.

Saturday, March 7, 2015

Experts Discuss: Cost-Based Treatment Decisions,Comparing Adverse Events of HCV Drugs And More...



Managed Care Minute: March 7, 2015
March 7, 2015

The American Journal of Managed Care’s convened a panel of experts to discuss the role of formulary management in the changing dynamics for hepatitis C.

The approval of Sovaldi (sofosbuvir) in December 2013 to treat hepatitis C revolutionized the treatment landscape for the condition. While cost debates followed—with widespread criticism of the 12-week $84,000 regimen of Sovaldi—Medicare and some private payers came up with a plan to ration treatment to the more advanced-stage patients. As Sovaldi sales reached $2.8 billion in the third quarter of 2014, Gilead announced the launch of Harvoni, a combination of sofosbuvir with ledipasvir, priced at $94,500 for 12 weeks. And then at year end in December, Abbvie announced the FDA approval of its regimen, Viekira Pak.

As formulary exclusivity deals have begun for these molecules, The American Journal of Managed Care convened an expert panel to discuss formulary decisions by pharmacy benefit managers and their influence on rational drug use.

The panel included Ed Cohen, PharmD, FAPhA, Senior Clinical Director, Walgreens; Matthew D. Harman, PharmD, MPH, Director, Clinical Pharmacy Strategies, Employers Health; Keith Hoffman, Phd, VP, Scientific Affairs, Adverse Events; and Steven Miller, MD, MBA, Senior Vice President and Chief Medical Officer at Express Scripts

Listen to the panel discussion here.
Segment 1: Formulary Exclusivity Deals
The panelists discuss the evidence that is weighed when determining whether or not to include a particular therapy on their regimens.

Segment 2: Rational Drug Use

While formularies should provide physicians the ability to treat any patient that walks into the office, there also need to be clinical exceptions that allow patients with mitigating circumstances to get any product clinically necessary.

Segment 3: Saving More Than $4 Billion in 2015

After Viekira Pak was approved, Express Scripts kicked off a spree of exclusivity deals with pharmacy benefit managers and health plans picking Harvoni or Viekira Pak. Steven Miller, MD, MBA, estimates this will save the US market $4 billion in 2015.

Segment 4: Making Cost-Based Treatment Decisions

Harvoni has shown results within the first 8 weeks of treatment, which would save costs, Matthew D. Harman, PharmD, MPH, does not think many patients or providers will be making cost-based hepatitis C treatment decisions.

Segment 5: Alleviating Adherence Concerns

The panelists discuss potential adherence issues considering Harvoni is a once daily pill while Viekira Pak is a 2-pill combination. Steven Miller, MD, MBA, explained that at 84 days, the treatment period is relatively short no matter what, which makes adherence less of an issue.

Segment 6: Setting the Bar for Hepatitis C Treatment Costs

Even with 2 drugs competing with one another and more coming soon, Ed Cohen, PharmD, FAPhA, does not believe additional competition in the marketplace will significantly drive down costs for a hepatitis C cure.

Segment 7: Comparing Known Adverse Events of HCV Drugs
A recent report from Adverse Events suggests that based on the pre-approval adverse events listed for Viekira Pak that Harvoni and Sovaldi may be safer, according to Keith Hoffman, Phd.

Segment 8: Putting Patient Safety and Outcomes First in HCV Decisions
Although the Adverse Events report found Viekira Pak may not be as safe as Sovaldi and Harvoni, Express Scripts complimented that information with its own real-world data from 85 million patients before choosing Viekira Pak.

The idea has been floated that the government should try buying the patent rights for Harvoni from Gilead Sciences in an attempt to improve access, but even if such a move was feasible, no one seems to think it’s a good idea.

Segment 10: Hepatitis C Costs in the Spotlight
In the last year the hepatitis C drug market has gained a lot of attention in the healthcare industry despite the fact that oncology as a specialty drug market has been very expensive for years now.

Segment 11: High Cost Trends Trickling Into Other Disease Areas
Although the marketplace has managed to come to a temporary solution for the high cost of hepatitis C drugs, Steven Miller, MD, MBA, expects to see more examples of similar high-cost drugs in other categories.

The situation with hepatitis C drug costs is setting an interesting precedent for the rest of healthcare and one that needs to be watched closely, according to Keith Hoffman, PhD.

Segment 13: Making HCV Care Sustainable for All Patients
Looking at the situation in hepatitis C and its potential impact on other conditions from a provider standpoint, Ed Cohen, PharmD, FAPhA, offers up many questions to which there may not be answers just yet.

Friday, March 6, 2015

NIH-led study to assess community-based hepatitis C treatment in Washington, D.C.

NIH-led study to assess community-based hepatitis C treatment in Washington, D.C.

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

The study, called ASCEND, is co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), with additional support from the NIH Office of AIDS Research. The study is being conducted as part of the D.C. Partnership for HIV/AIDS Progress, a program that aims to reduce the burden of HIV/AIDS and associated diseases, such as hepatitis C, in the District of Columbia.

More than 3 million people in the United States are infected with HCV. If left untreated, the infection can lead to cirrhosis (liver scarring), liver cancer and eventual liver failure. Chronic HCV infections contribute to thousands of deaths each year, and hepatitis C is a leading cause of death for people co-infected with HIV. In the United States, hepatitis C infection is largely centered in urban areas and disproportionately affects minority, low-income and marginalized populations, such as the homeless and people who inject drugs.

In the past, hepatitis C treatment involved long-term use of oral and injectable medications, some of which had unpleasant side effects, including flu-like symptoms and depression. Because of the complexity of these regimens, hepatitis C treatment has largely been provided by specialist physicians, such as infectious disease specialists and hepatologists. New oral direct-acting antiviral drugs may offer more effective, shorter-duration, curative treatments. In October 2014, the U.S. Food and Drug Administration approved a new, once-daily antiviral drug for treatment of hepatitis C infection that combines ledipasvir and sofosbuvir (trade name Harvoni). Gilead Sciences, based in Foster City, California, manufactures the drug and is providing it free-of-charge for use in the ASCEND study.

“The recent advent of direct-acting antiviral medications has offered promising new treatment options for people who are chronically infected with hepatitis C,” said NIAID Director Anthony S. Fauci, M.D. “These therapies have yielded high cure rates in clinical trials led by specialized care teams. The ASCEND study will help determine whether these medications are similarly effective when administered in an urban, community-based setting.”

Led by principal investigator Henry Masur, M.D., chief of the NIH Clinical Center’s Critical Care Medicine Department, and lead associate investigator Sarah Kattakhuzy, M.D., of the University of Maryland’s Institute of Human Virology, the Phase 4 (post-marketing) ASCEND study aims to enroll approximately 600 D.C. clinic patients with HCV infections or HCV and HIV co-infections. Of those enrolled, 350 participants will continue treatment with their current specialist, and 250 participants will be assigned to a primary care physician, physician assistant or nurse practitioner for treatment. All participants will take a daily pill of combination ledipasvir (90 milligrams) and sofosbuvir (400 milligrams) for two to six months. Study volunteers will be treated at 11 D.C.-based clinics operated by Unity Health Care, Inc., and one D.C. clinic run by Family and Medical Counseling Services. Both D.C. health care organizations are active collaborators in the D.C. Partnership for HIV/AIDS Progress.

Participants will be monitored over a 10-year period for short-term and long-term treatment outcomes, including viral response to the drug and evidence of liver damage. The researchers aim to determine whether the type of health care provider administering the treatment influences outcomes. They also will assess the safety of the drug, how well it is tolerated and whether there are differences in outcomes for people infected with both HCV and HIV compared with those with HCV alone. According to the investigators, this study will help advance scale-up of the use of direct-acting antivirals for elimination of chronic HCV infections in certain at-risk groups. The ASCEND study is expected to be completed in 2025.

“This study demonstrates the benefit that research can have on the community,” Dr. Masur said. “NIH, community clinics and the D.C. Department of Health are working collaboratively to reduce the impact of a lethal viral disease, hepatitis C, on the population of our nation’s capital.”

More information about the Study to Assess Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia (ASCEND) can be found at ClinicalTrials.gov using the identifierNCT02339038.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available at http://www.niaid.nih.gov.

The NIH Clinical Center is the clinical research hospital for the National Institutes of Health. Through clinical research, clinician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation's health. More information: http://clinicalcenter.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Thursday, March 5, 2015

Clinical Liver Disease - New Treatments for Hepatitis C

Clinical Liver Disease - New Treatments for Hepatitis C

New Treatments for Hepatitis C
Guest Edited by Donald M. Jensen, M., FACP

New therapies for hepatitis C: Latin American perspectives (pages 8–10)
Rafael Claudino Botero and Martin Tagle
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.438
Watch a video presentation of this article
Watch the interview with the author

Los nuevos tratamiento de hepatitis C: Perspectivas latinoamericanas (pages 11–13)
Rafael Claudino Botero and Martín Tagle A
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.466
Watch a video presentation of this article

Treating HCV infection in children (pages 14–16)
Christine K. Lee and Maureen M. Jonas
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.439
Watch a video presentation of this article
Watch the interview with the author 

New treatments for HCV: Perspective from Asia (pages 17–21)
Ming-Lung Yu and Wan-Long Chuang
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.442
Watch a video presentation of this article
Watch the interview with the author 

Access to new direct-acting antiviral agents against HCV infection: A view from Spain (pages 22–23)
Santiago Tomé and Esteban Otero
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.444
Watch a video presentation of this article
Watch the interview with the author 

Accesibilidad a los nuevos agentes antivirales directos contra la infeccion por VHC. Un punto de vista desde España (pages 24–25)
Santiago Tome and Esteban Otero
Article first published online: 4 MAR 2015 | DOI: 10.1002/cld.467
Watch a video presentation of this article

View the complete index, here

Ending an Epidemic: Overcoming the Barriers to an HCV Free Future

Global Health Justice Partnership calls for action to lower drug prices
BY AMAKA UCHEGBU
STAFF REPORTER
Thursday, March 5, 2015
Yale’s Global Health Justice Partnership has released a report warning the international community that scientific discoveries will not be enough to prevent the over 500,000 deaths that occur every year from Hepatitis C.
Last week, in partnership with the AIDS policy think tank Treatment Action Group and the Initiative for Medicines, Access and Knowledge, which aims to increase access to medicines worldwide, the GHJP cautioned that despite the development of Sovaldi — a Hepatitis C drug, marketed since 2013, with a 96 percent efficacy rate in some patients — there are numerous remaining hurdles to ending the “silent epidemic” of Hepatitis C, especially in low- and middle-income countries. In their report, “Ending an Epidemic: Overcoming the Barriers to an HCV Free Future,” the four lead student authors advocated for legal, economic and political solutions to the challenge.
“The bottom line takeaway is that if you make a breakthrough, there is no guarantee that it will get to everyone,” said co-author Kyle Ragins MED ’15 SOM ’15 . “You need innovation in your intellectual property law, your financing and the way care is delivered.”

Continue reading.... 

Report - Ending an Epidemic: Overcoming the Barriers to an HCV Free Future


Wednesday, March 4, 2015

Sovaldi - Attacking the Patent System for Pricing Issues Is a Non-Starter

Sovaldi - Attacking the Patent System for Pricing Issues Is a Non-Starter

Mar 4th, 2015
by Richard Bergström

Gilead Sciences’ hepatitis C treatment, Sovaldi, has been a regular feature in healthcare news of late, not least because it offers that most elusive of gifts: a cure. There has been much discussion about its price, but also a recognition of the value that this drug offers to society. If a patient is successfully treated with Sovaldi, ongoing treatment costs are nullified, including significant expenditure on care, and that patient may return to work delivering further economic benefits to society.
However, on 10 February, Médecins du Monde (Doctors of the World – MdM) filed a challenge against the patent for Gilead’s drug. The NGO maintained that while the medicine clearly represented a real breakthrough in the treatment of hepatitis C, it was not innovative enough to warrant a patent, particularly at the price that Gilead was charging. MdM argues that if they win the patent challenge, this would open the gates for generic companies to enter the field, copy the drug and sell it for a considerably lower price.

Continue reading... 

Utility of Hepatitis C Viral Load Monitoring On Directly Acting Antiviral Therapy.

Clin Infect Dis. 2015 Mar 2. pii: civ170. [Epub ahead of print]

Utility of Hepatitis C Viral Load Monitoring On Directly Acting Antiviral Therapy.

Sidharthan S1, Kohli A1, Sims Z1, Nelson A2, Osinusi A3, Masur H1, Kottilil S2.

Author information

1Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland.
2Institute of Human Virology, University of Maryland, Baltimore, Maryland Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
3Gilead Sciences Inc., Foster City, California.

Abstract

BACKGROUND: Hepatitis C (HCV) viral loads aided as predictors of treatment response during interferon-based therapy. We evaluated the predictive ability of HCV RNA levels at end of treatment (EOT) for sustained virologic response (SVR12) during interferon-sparing directly acting antiviral (DAA) therapies.

METHODS: HCV genotype 1, treatment naive patients were treated with sofosbuvir and ribavirin for 24 weeks (n=55), sofosbuvir and ledipasvir for 12 weeks (n=20), sofosbuvir, ledipasvir, and GS-9669 for 6 weeks (n=20), or sofosbuvir, ledipasvir, and GS-9451 for 6 weeks (n=19). Measurements of HCV RNA were performed using the Roche COBAS TaqMan HCV test and the Abbott RealTime HCV assay. Positive and negative predictive values (PPV, NPV) of HCV RNA less than the level of quantification (<LLOQ) at EOT for SVR12 were calculated.

RESULTS: All patients treated with sofosbuvir and ribavirin (55/55) had HCV RNA <LLOQ at EOT by the Roche and Abbott assays, but only 38 achieved SVR12 (PPV: 69%). Among patients treated with sofosbuvir, ledipasvir, +/- GS-9669 or GS-9451, 100% (59/59) had HCV RNA <LLOQ by Roche and one relapsed (PPV: 98%). By Abbott, 90% (53/59) had HCV RNA <LLOQ out of which one patient relapsed (PPV: 98%). Notably, six patients with HCV RNA ≥LLOQ at EOT (range: 14-64 IU/mL) achieved SVR12 (NPV: 0%). Quantifiable HCV RNA (range: 15-57 IU/mL) was measured two weeks post-treatment in four individuals, and four weeks post-treatment in one (14 IU/mL).

CONCLUSIONS: Contrary to past experience with interferon-containing treatments, low levels of quantifiable HCV RNA at EOT do not preclude treatment success.

Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.