State restrictions for hepatitis C drug may go too far
(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.
"We had this idea that there were restrictions in place, but we didn't anticipate the breadth of these restrictions," said study author Robert Greenwald of the Center for Health Law and Policy at Harvard Law School in Jamaica Plain, Massachusetts.
About 3.2 million people in the U.S. are infected with hepatitis C, but many do not feel ill or know they have the disease, according the Centers for Disease Control and Prevention (CDC). There are about 17,000 new infections each year.
Without treatment, the hepatitis C virus can lead to liver failure, liver cancer or even death.
In 2013, the U.S. approved a new drug known as sofosbuvir, which is marketed here as Sovaldi by Gilead. Given in combination with other drugs, sofosbuvir achieves very high cure rates in patients with the difficult to treat infection.
But sofosbuvir costs about $1,000 per day, which adds up to about $84,000 for a 12-week course, the researchers write in Annals of Internal Medicine.
For the new study, Greenwald and his colleagues searched the Medicaid websites of each state and the District of Columbia in 2014. Medicaid, the state-run health insurance for the poor, is partly funded by the U.S. government.
Overall, 42 state Medicaid programs put restrictions on payments for sofosbuvir. About three quarters only allow the drug to be used when hepatitis C has already caused liver damage known as fibrosis or an even later stage of damage known as cirrhosis.
The vast majority of states include drug- and alcohol-based restrictions on payments for the drug, including abstinence and drug screening.
About two thirds of states restrict who may prescribe the medication, the researchers write. In a third of states, for example, it can only be prescribed by a specialist. In the other third, nonspecialists can prescribe it but they have to consult a specialist first.
About a quarter of states have restrictions based on the person's HIV status.
"I think the restrictions have significant personal and public health implications," Greenwald told Reuters Health.
"I think anybody with a communicable disease or other medical condition should be taking this extremely seriously, because this gets to how our country responds to a cure," he added.
What's more, the researchers found many of the restrictions vary by state and do not correspond with the recommendations of medical organizations like the Infectious Diseases Society of America and the American Association for the Study of Liver Disease.
Also, the researchers say, the restrictions may violate a federal regulation that says state Medicaid programs must provide coverage for drugs consistent with the labels from the U.S. Food and Drug Administration if the manufacturer has a rebate agreement with HHS.
"What we’re really seeing here is this huge push back and frankly the insurer ruling the day so that the focus has been really on cost," Greenwald said.
The researchers caution that they only examined traditional Medicaid fee-for-service programs, and not managed care organizations, which may impose additional restrictions not cataloged in their results.
SOURCE: bit.ly/SQRXAa Annals of Internal Medicine, online June 29, 2015.
HCV New Drug Research
State restrictions for hepatitis C drug may go too far
BY JONATHAN STEMPEL
The Food and Drug Administration was sued by two advocacy groups seeking to force the faster disclosure of clinical trial data that helped Gilead Sciences Inc win approval for two blockbuster hepatitis C drugs.
In their June 25 lawsuit, Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors and patients deserve more information about the "enormously costly" drugs Harvoni and Sovaldi to make informed decisions about whether to use them.
Public health advocates and groups such as the World Health Organization have called for the broad release of clinical trial data, even if it were to compromise patient confidentiality or proprietary research.
According to the complaint filed in a federal court in New Haven, Connecticut, Harvoni and Sovaldi cost a respective $94,500 and $84,000 for 12-week regimens, straining state budgets and prompting insurers to restrict patient access.
The plaintiffs said Gilead ignored its request for the trial data, while the FDA said it would need 1-1/2 to two years to decide merely whether disclosure was proper to begin with. That's too slow, the groups said.
"Unless defendants disclose the requested information, hundreds of thousands more patients will be treated with drugs whose safety, efficacy, and cost effectiveness cannot be fully studied or understood," the complaint said.
Harvoni and Sovaldi accounted for $4.55 billion, or 60 percent, of Gilead's revenue from January to March.
The FDA is part of the U.S. Department of Health and Human Services, which is also a defendant. Gilead is based in Foster, City, California, and was not sued.
Neither the FDA nor Gilead immediately responded to requests for comment on Monday. The Wall Street Journal reported the lawsuit earlier in the day.
Hepatitis C is a liver infection often caused by the sharing of needles or other means to inject drugs. It affects about 150 million people worldwide, and kills roughly half a million annually.
Gilead won FDA approval for Sovaldi in December 2013 and Harvoni in October 2014. Sovaldi's chemical name is sofosbuvir, while Harvoni contains sofosvubir and ledipasvir.
In May, the WHO added new hepatitis C treatments to its "essential medicines" list.
The case is Treatment Action Group et al v. FDA, U.S. District Court, District of Connecticut, No. 15-00976.
(Reporting by Jonathan Stempel in New York; Editing by Richard Chang)
FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data
By ED SILVERMAN
File this under ‘Show me the data.’
A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.01%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.
Here’s what happened...
AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario
Ontario is the second province in Canada to reimburse HOLKIRA PAK
In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hepatitis C virus patients; additionally, 98 percent of patients completed treatment
MONTREAL, June 29, 2015 /CNW/ - AbbVie, a global biopharmaceutical company, today announced that the Common Drug Review (CDR) has posted the Canadian Drug Expert Committee (CDEC)'s positive recommendation1of HOLKIRA PAK for listing with provincial drug formularies. HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets) is an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
During their review, the CDEC clearly recognized the clinical value that HOLKIRA PAK brings to people living with hepatitis C and recommended that the treatment be covered under minimal conditions: liver fibrosis stage of ≥2, and treatment should be initiated by physicians with experience in the management of hepatitis C.
Following the positive CDR recommendation announcement, Ontario is the second province to reimburse HOLKIRA PAK on its public formulary through its Exceptional Access Program (EAP) as of June 29, 20152. In Ontario, HOLKIRA PAK will be covered under the following EAP criteria: for treatment-naïve and treatment-experienced adult patients with GT1 chronic HCV infection, with compensated cirrhosis.
"We finally have the tools to address hepatitis C. Although this disease is sometimes overlooked, it is the infectious disease that causes the most years of life lost in Canada. With new, extremely well-tolerated treatments, cure rates are now above 95 per cent," said Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "Now that we can access these life-saving therapies for those who need them most, we have the possibility to actually eliminate hepatitis C from Canada."
HOLKIRA PAK combines three direct-acting antivirals to attack the virus at three separate stages of its replication process. In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of GT1 HCV patients, and 98 percent of patients completed treatment.
"Most patients with hepatitis C have been living with the disease for years or even decades," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation. "And after such a long duration of infection they are rapidly running into problems with liver failure and liver cancer. Having therapies that are both highly effective and accessible is critical to curing these individuals and preventing these complications."
According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C.3 A significant number of the estimated cases in Canada remain undiagnosed, although the exact proportion is unclear.4There are six different genotypes of hepatitis C; two-thirds of Canadians living with hepatitis C have genotype 1 – either subtype 1a or 1b – which are the most difficult to cure.5
"AbbVie is committed to providing the best solution to Canadians living with hepatitis C. With this milestone, we are getting closer to fulfilling this ambition," said Stéphane Lassignardie, general manager, AbbVie Canada. "Furthermore, Canadians prescribed HOLKIRA PAK will have the opportunity to be enrolled in AbbVie Care, our signature care program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support for health care professionals and people living with genotype 1 hepatitis C."
HOLKIRA PAK was approved by Health Canada on December 22, 2014. The approval of HOLKIRA PAK was supported by a robust clinical development program that was designed to study the safety and efficacy of the regimen in six pivotal Phase 3 studies, including one trial exclusively in subjects with compensated cirrhosis, with more than 2,300 patients across 25 countries.
About HOLKIRA PAK
HOLKIRA PAK consists of the fixed-dose combination of ombitasvir/paritaprevir/ritonavir, taken once daily, and dasabuvir taken twice daily. HOLKIRA PAK is administered with or without ribavirin, depending on the type of hepatitis C virus in cause, the treatment history of the patient and the presence/absence of cirrhosis. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response across different patient populations.
The complete HOLKIRA PAK Product Monograph is available at the following location on Health Canada's website (http://hc-sc.gc.ca/index-eng.php); the manufacturer's website www.abbvie.ca, or by calling 1-888-704-8271.
Additional information about AbbVie's chronic hepatitis C clinical program can be found on www.clinicaltrials.gov.
Important Safety Information6
To help avoid possible side effects and ensure proper use, talk to your health care professional before you take HOLKIRA PAK. Talk about any health conditions or problems you may have, including if you:
are using a medicine containing ethinyl estradiol for contraception or for other reasons. You must not use medicines that contain ethinyl estradiol while taking HOLKIRA PAK. Your doctor will ask you to stop or consider changing to a different type of contraceptive medicine during your treatment.
have liver problems other than hepatitis C infection.
have any other medical condition.
have had a liver transplant.
are breastfeeding or plan to breastfeed. It is not known if HOLKIRA PAK passes into your breast milk. You and your health care provider should decide if you will take HOLKIRA PAK or breastfeed. You should not do both.
Other warnings you should know about:
Let your health care provider know if you develop nausea, vomiting, loss of appetite, yellowing of your skin or eyes, or darkening of your urine while on treatment with HOLKIRA PAK.
If HOLKIRA PAK is administered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen. Refer to the ribavirin Patient Medication Information for a full list of the warnings and precautions for ribavirin.
It is not known if taking HOLKIRA PAK is safe and effective in children under 18 years of age.
Your doctor may do blood tests before you start your treatment and regularly during your treatment. These blood tests are done to help your doctor to check if the treatment is working for you.
Tell your health care professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
HOLKIRA PAK should not be administered with other ritonavir-containing medicines (NORVIR®, KALETRA®). When co-administered with HOLKIRA PAK, atazanavir or darunavir should be taken without ritonavir.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.ca and www.abbvie.com. Follow @abbvie on Twitter or view careers on ourFacebook or LinkedIn page.
Accessed on June 26, 2015
2 Ontario Ministry of Health and Long-Term Care. http://www.health.gov.on.ca/en/pro/programs/drugs/edition_42.aspx
Accessed on June 26, 2015
3 Public Health Agency of Canada. Hepatitis C Quick Facts. http://www.phac-aspc.gc.ca/hepc/index-eng.php.
Accessed on June 26, 2015
4 An update on the management of chronic hepatitis C: Consensus guidelines from the Canadian Association for the Study of the Liver, Canadian Journal of Gastroenteroly, Vol 26 No 6, June 2012
5 Hepatitis C Online. http://www.hepatitisc.uw.edu/go/treatment-infection/treatment-genotype-1/core-concept/all
Accessed on June 26, 2015
HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film coated tablets) Product Monograph. Date of Revision: December 22, 2014
Accessed on June 26, 2015
SOURCE AbbVie For further information: Eileen Murphy, AbbVie Canada, 514-832-7788, firstname.lastname@example.org
The new detection method for a key drug resistant hepatitis C virus mutation
HCV is a major cause of chronic liver disease, liver cirrhosis, and hepatocellular carcinoma, affecting up to 180 million people worldwide. HCV often acquires resistance against direct acting antiviral agents. Presence of the Y93H mutation prior to treatment has been reported as an important predictor of virologic failure. Direct sequencing is a commonly used method to detect this mutation. However, it is only capable of detecting viral subpopulations with frequencies of at least 10% to 20%. Next generation sequencing has recently been applied as a more sensitive method to analyze viral mutations, but it is still complex to perform and expensive for widespread clinical use.
By combining nested PCR and the Invader assay with well-designed primers and probes, the Y93H drug resistant mutation can be detected with a high success rate of 98.9% among a total of 702 Japanese HCV genotype 1b patients.
"Our assay system also showed a much lower detection limit for Y93H than using direct sequencing, and Y93H frequencies obtained by this method correlated well with those of deep-sequencing analysis." Professor Kazuaki Chayama, the principle investigator of this study at Hiroshima University, explained.
The proportion of the patients with the Y93H mutant strain estimated by this system was 23.6%, and this rate is comparable with that assayed by real-time PCR and ranked between those of deep sequencing and direct sequencing reported in the Japanese population, presumably reflecting the lower detection limit of Y93H.
This new system attained a high assay success rate and was more sensitive in detecting Y93H than direct sequencing. The evaluation of Y93H strain may provide important information for prediction of disease progression in HCV genotype 1b patients.
More information: "Rapid, Sensitive, and Accurate Evaluation of Drug Resistant Mutant (NS5A-Y93H) Strain Frequency in Genotype 1b HCV by Invader Assay."
Weekend Reading - Natural history of hepatitis C: An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation
To date the natural history of hepatitis C remains controversial. Among HCV-infected individuals progression to advanced liver disease generally requires decades but is influenced by several host factors, the following offers an update on the natural history of hepatitis C using information found online at Medscape, NATAP, and the interactive website Hepatitis C Online.
Cirrhosis and the Incidence of Decompensation
The projected public health burden of HCV is based on old natural history studies. One presentation suggested a need to reexamine the natural history of HCV because the current patient cohort is older and confounded by a higher prevalence of obesity, and other comorbid conditions that may affect the outcome of the disease. Therefore, investigators conducted a retrospective cohort study at Kaiser Permanente Southern California.
From 2002-2013, 60,338 adults had an HCV diagnosis code or a positive HCV RNA lab test. Of these, 33,124 HCV cases met inclusion criteria and were matched with 164,221 controls. Mean age of the HCV cases and non-HCV controls was 54 years. Among case-patients, 41% were white and 27% were Hispanic; among controls, the respective proportions were 46% and 28%.
Prevalent cirrhosis was found in 19% of the HCV-infected cohort and 1.4% of the non-HCV controls. The incident decompensation rate among previously compensated HCV patients with cirrhosis was 47%, which was almost twice the incident decompensation rate among non-HCV cirrhotic controls. Of note, 23% of HCV cases were diagnosed with cirrhosis after a median follow-up of 2 years, which indicates that the rates of development of HCV-related cirrhosis and decompensation are higher than previously reported. The authors attributed this to aging of the HCV cohort and associated comorbidities, such as obesity. Multivariable analyses to explore the relationship between baseline comorbid conditions and the incidence of cirrhosis and decompensation are ongoing.
- Nyberg LM, Li X, Chiang K, et al. The natural history of chronic hepatitis C. An updated look at the rate of progression to cirrhosis and the incidence of decompensation in a large U.S. health maintenance organization. Program and abstracts of Digestive Disease Week; May 16-19, 2015; Washington, DC. Abstract 809.
Hepatitis C Online is a free educational web site from the University of Washington.
The site is a comprehensive resource that addresses the diagnosis, monitoring, and management of hepatitis C virus infection.
In 2014 The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.
The "guidelines" have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time. Yesterday the AASLD announced updates for the use of hepatitis C drugs with a summary published in the AASLD journal, Hepatology.
Australian Journal of Pharmacy
The report by the House of Representatives Standing Committee on Health, The Silent Disease – Inquiry into Hepatitis C in Australia has been welcomed by the peak body representing more than 230,000 Australians living with hepatitis C.
Ford is the vice president of pharmacy services for Blue Cross and Blue Shield of Louisiana. He spoke with The News-Star Thursday about the rising cost of specialty drugs, which are used for cases of hepatitis C, cancer, rheumatoid arthritis, multiple sclerosis and more.
When Pearland resident John Rocks went into the hospital in 2012, the last thing he expected was to be diagnosed with Hepatitis-C(HEP-C) [an inflammation of the liver due to virus or bacteria], yet that's exactly what the doctor told him. “I had a ...
Various cannabinoid compounds did not improve nausea, vomiting, or appetite, and only slightly improved chronic pain and spasticity, in patients with various long-term health conditions, a review of randomized clinical trials found.
The greatest reductions in chronic pain were reported by patients who smoked tetrahydrocannabinol (THC) in eight of the trials, but the majority of the 79 trials in the meta-analysis demonstrated cannabinoids had little effect on HIV/AIDS patients with low-appetite and actually worsened chemotherapy-related nausea and vomiting, Penny F. Whiting, PhD, of University Hospitals Bristol NHS in England, and colleagues reported in the Journal of the American Medical Association.
BMS TO DROP ANTIVIRAL RESEARCH IN SHAKE-UP OF R&D
BMS is stopping early-stage discovery work in virology as part of a reshuffle in its R&D operations, pmlive.com reports.
The company stressed that the decision will not affect projects that have already reached the clinical development stage, which include beclabuvir for hepatitis C virus (HCV) in phase III and two HIV drugs in phase II, or indeed its marketed antiviral drugs including new HCV therapy Daklinza (daclatasvir).
The decision will mainly affect early programmes in hepatitis B and HIV, said the company, which said around 100 positions will be lost as a result. It will organisation will continue to focus on research in immuno-oncology as well as heart failure, fibrosis, genetically defined diseases and immunoscience.
Meanwhile, structural changes caused by the reshuffle include the opening of a facility in Cambridge, Massachusetts, due to open in 2018, as well as a the closure of its sites in Wallingford, Connecticut, and Waltham, Massachusetts, in 2018.
Around 200 workers from the two closing units and BMS’ New Jersey operations will relocate to the new unit, which will focus on discovery efforts in genetic diseases, molecular discovery technologies and discovery platform chemistry, said the company.
26 Jun 2015 | PharmaBusiness Daily
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of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Dates: May 18 - June 1, 2015
MedPage Today invited specialists from leading medical institutions to weigh in on the latest advancements in hepatitis C with one question each day for 10 days.
Hepatitis C News Of The Day
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HepCBC presents the March release of Peppermint Patti's Hepatitis C FAQs - version 10.
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These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences and more.
CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.
Lucinda K. Porter, RN, the author of "Free from Hepatitis C" has graced the HCV community with a second book "Hepatitis C Treatment One Step at a Time" available now on Amazon.
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