Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials
click here

Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.


Alan Franciscus

Editor-in-Chief

HCV Advocate



Showing posts with label Sovaldi. Show all posts
Showing posts with label Sovaldi. Show all posts

Tuesday, September 29, 2015

The True Cost of an Expensive Medication

It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.

There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.

Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.

Read more....

Friday, June 19, 2015

China rejects patent linked to Gilead hepatitis C drug

China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at $1,000 per pill in the United States or $84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe.

The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said.

Read more...

Monday, May 4, 2015

India: Mylan launches hepatitis-C Sovaldi tablets in India

HYDERABAD: Pharma giant Mylan NV today said its subsidiary Mylan Pharmaceuticals has launched Gilead Sciences' Sovaldi (sofosbuvir 400mg tablets) in the country.

Sovaldi is used for the treatment of chronic hepatitis-C infection as a component of a combination anti-viral treatment.

It is estimated that around 12 million people are chronically infected with hepatitis-C in India, Mylan said in a release.

In February this year, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India.

Read more at: http://economictimes.indiatimes.com/articleshow/47148108.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst


Egypt: Locally manufactured Sovaldi to be released soon

CAIRO: The Egyptian market will receive a new batch of the hepatitis C treatment medication Sovaldi next June after being manufactured locally, Youm 7 reported Sunday.

Pharmed Healthcare Executive Director, Mohamed Mabrouk, said that his firm will deliver 500,000 bottles after being manufactured with local chemical materials.

“This step will give the Egyptian market an unprecedented motive,” he said.

Read more...

Wednesday, April 22, 2015

U.S.A-$373.9 Billion Spent on Drugs in 2014

“Drug spending in the United States last year was one for the record books. Pharmacists filled a record 4.3 billion prescriptions in 2014 that cost nearly $374 billion, according to a new report issued by the IMS Institute for Healthcare Informatics. 

The 13.1% increase in drug spending in 2014 was mainly driven by two things: the availability of new hepatitis C [HCV] treatments and very few products losing patent protection,” said Murray Aitken, IMS Health senior vice president and the executive director of the IMS Institute for Healthcare Informatics. “Sovaldi [sofosbuvir; Gilead] was the biggest drug launch in history and accounted for about $8 million, or 2%. of the 13% increase.

As for patent protection, the health system saves money when drugs move from branded products to generics. Typically, there has been a savings of between 15 [billion] and 30 billion a year due to patent expiries. But in 2014, that figure was only $12 billion,” he said”.

Friday, March 27, 2015

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C

-- Sovaldi Part of First All-Oral Treatment Regimen for Genotype 2 Patients in Japan --
-- 96 Percent Cure Rates and Shortened, 12-Week Course of Therapy --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.

“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” said Masao Omata, MD, Yamanashi Prefectural Hospital Organization.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.

Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-naïve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.

“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”

Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.

- See more at: http://gilead.com/news/press-releases/2015/3/japans-ministry-of-health-labour-and-welfare-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-genotype-2-chronic-hepatitis-c#sthash.tfSV7EEB.dpuf

Saturday, March 21, 2015

FDA Hepatitis Update - Important safety information: Harvoni , and Sovaldi



IMPORTANT DRUG WARNING

Subject: Serious and Life-Threatening Cases of Symptomatic Bradycardia as well as One Case of Fatal Cardiac Arrest Reported with Coadministration of Amiodarone With Either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or With Sovaldi® (sofosbuvir) in Combination with Another Direct Acting Antiviral.



On March 20, 2015, FDA approved changes to the Harvoni (ledipasvir/sofosbuvir fixed dose combination) and Sovaldi (sofosbuvir) labels to update the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DRUG INTERATIONS sections of the labeling and the patient package insert with information on post-marketing cases of symptomatic bradycardia when co-administered with amiodarone. Additionally, Gilead Sciences has issued a Dear Healthcare Provider letter (below):

Dear Health Care Provider,
The purpose of this letter is to inform you of new important safety information for Harvoni and Sovaldi.

·       Harvoni is indicatedfor the treatment of chronic hepatitis C genotype 1 infection in adults.

·       Sovaldi is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.
Serious Risk of Symptomatic Bradycardia With Co-Use of Amiodarone with Either Harvoni or With Sovaldi in Combination with Another Direct Acting Antiviral (DAA)
·       Postmarketing casesof symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported in patients taking amiodarone and Harvoni, or amiodarone and Sovaldi in combination with another DAA.
·       Bradycardia was observed within hours to days of starting Harvoni, or Sovaldi in combination with another DAA, but cases have been observed up to 2 weeks after initiating HCV treatment.
·       Risk factors for the development of symptomatic bradycardia in patients receiving amiodarone may include coadministration of a beta blocker, or those with underlying cardiac comorbidities and/or advanced liver disease.
·       Similar cases have not been reported in patients receiving Sovaldi with ribavirin or with pegylated interferon and ribavirin.

Warning and Precaution
Coadministration of amiodarone with either Harvoni or with Sovaldi in combination with another DAA is not recommended.

Further Information
Ninecases of symptomatic bradycardia have been reported during postmarketing in patients receiving amiodarone with either Harvoni, or Sovaldi in combination with another DAA (daclatasvir, an investigational DAA, or Olysio (simeprevir)). Seven patients were also receiving a beta blocker.
·       Sixcases occurred within the first 24 hours and the remaining 3cases occurred within the first 2-12 days following HCV treatment initiation.
·       One case was a fatal cardiac arrest and 3 cases required pacemaker intervention.
·       In 3cases, rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia.

·       Inone case discontinuation of amiodarone followed by rechallengeof HCV treatment after 8 weeks did not result in recurrent bradycardia.
·       Three of the 9 cases were in patients receiving Harvoni, 5 cases were in patients receiving Sovaldi plus an investigational agent (daclatasvir) and 1 case was in a patient receiving Sovaldi with Olysio (simeprevir).
The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA is unknown.
Because the number of patients taking amiodarone who have been exposed to Harvoni or Sovaldi in combination with another DAA is unknown, it is not possible to estimate the incidence of occurrence of these events.
Prescriber Action
For patients taking amiodarone who have no other alternative, viable treatment options and who will be co-administered Harvoni, or Sovaldi in combination with another DAA:
·       Counsel patients about the risk of serious symptomatic bradycardia
·       Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Patients who are taking Harvoni or Sovaldi in combination with another DAA who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac monitoring as outlined above.
Due to amiodarone’s long half-life, patients discontinuing amiodarone just prior to starting Harvoni or Sovaldi in combination with a DAA should also undergo similar cardiac monitoring as outlined above.
Tell your patients if they develop signs or symptoms that might suggest symptomatic bradycardia they should seek medical evaluation immediately. Symptoms may include:
·       Near-fainting or fainting
·       Excessive tiredness
·       Dizziness or lightheadedness
·       Shortness of breath
·       Malaise
·       Chest pains
·       Weakness
·       Confusion or memory problems

Patients should not stop taking any of their medicines without talking to their healthcare provider.
This information is based on currently available data and recommendationsmay change. Additionally, the product labeling will be updated.
Reporting Adverse Events
Please report all adverse events, following or coincident with the use of Harvoni or Sovaldi, to Gilead Global Drug Safety at 1-800-GILEAD-5, option 3; or to FDA's MedWatch program by telephone at 1-800-332-1088; by fax at 1-800-332-0178; via www.FDA.gov/medwatch; or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857 (use postage-paid FDA Form 3500).
Please refer to the accompanying full prescribing information and approved patient information for a complete description of the risk profile for Harvoni or Sovaldi.
Contact Gilead Medical Information at 1-800-GILEAD-5, option 2 if you have additional questions.

This information is being sent in agreement with the FDA.

Sincerely,
John McHutchison, MD
Executive Vice President, Clinical Research
Gilead Sciences, Inc.

Thursday, March 19, 2015

Advocates Urge Easier Access To Expensive Drug For Medicaid Patients

Advocates for those living with Hepatitis C are urging the state Department of Social Services to ease new criteria patients must meet in order to have an expensive medication covered by Medicaid.

DSS has issued a bulletin to medical care providers, notifying them that patients with Hepatitis C who are enrolled in HUSKY A, HUSKY C or HUSKY D — parts of the state’s Medicaid program — must have “prior authorization” in order for prescriptions for the medication Sovaldi to be covered.

Prior authorization typically is required by insurers when they want to make sure certain prescription drugs are appropriately used. In essence, it requires enrollees to meet a higher threshold of criteria before insurers will agree to cover the medication’s expense.

Read more....

Wednesday, March 18, 2015

Charity attacks Gilead over hepatitis C drug restrictions

(Reuters) - Charity Medecins Sans Frontieres has accused U.S. drugmaker Gilead Sciences Inc GILD.O of restricting access to its breakthrough hepatitis C drug Sovaldi in developing countries as it tries to protect profit margin in wealthier nations.

MSF, also known as Doctors Without Borders, said Gilead's restrictions aimed to stop discounted supplies of Sovaldi being diverted to patients from rich countries, but that the effort had resulted in "multiple restrictions and demands" on people receiving treatment in poor countries.

It said Gilead was excluding people without national identity documents, a move that hurts migrants, refugees and marginalized patients.

Read more...

Wednesday, March 11, 2015

Hepatitis Pills Contributed to 13 Percent Spike in Drug Spending

Costly new hepatitis pills helped drove a 13 percent increase in drug spending last year among insurer-managed plans in the United States, a rate not seen in more than a decade, according to a report from the pharmacy benefit manager Express Scripts.
A course of therapy to treat the liver-damaging hepatitis C virus could cost as much as $150,000 with the approvals of medicines such as Gilead Sciences Inc.’s Sovaldi and Harvoni and Johnson & Johnson’s Olysio, Express Scripts said in the report, released Tuesday. Driven as well by higher costs of specialty and compounded medicines, the estimated drug spend in general for each person in commercial-insured plans was $980 in 2014.
The new hepatitis C medicines are particularly challenging for government health plans and programs.

Gilead Sciences (NASDAQ:GILD) and AbbVie (NYSE:ABBV) Trying to Make the Most from Market Share

Gilead Sciences (NASDAQ:GILD) share prices are dropping as a result of the FDA giving the approval to AbbVie (NYSE:ABBV) of its hepatitis C drug, Viekira Pak. Through drastic price cuts, Gilead Sciences (NASDAQ:GILD) is facing a tough time trying to become market leader. Both companies have confirmed that the price reductions are so that they can attract more customers yet investors may not consider this a positive sign.
After Gilead Sciences (NASDAQ: GILD) launched Sovaldi, its drug for oral hepatitis C, it revolutionized the treatment. Before this, patients of hepatitis C had to be treatment with cures that had significant side effects like ribavirin and peg interferon that lasted nearly 48 weeks and had only 50%-80% cure rates.
However, Sovaldi’s treatment doesn’t eliminate ribavirin from the core, but it does put aside peg interferon and gives cure rates of 90%. This is why doctors embraced the drug with open arms and turned it into the quickest drug to achieve such successful levels of treatment. It made nearly $10.3 billion sales in the previous year. However, Gilead Sciences (NASDAQ: GILD) strengthened its drug back in October, when it won the approval by the FDA for its drug Harvoni.

Thursday, March 5, 2015

State OKs new Hep C drug for Medicaid patients

Two drugs now available, but cost difference unclear

During the latter portion of 2014, Oregon officials and Hepatitis C patient advocates debated who would be able to receive a new, highly effective yet prohibitively expensive drug under the state’s Medicaid program.

Officials approved criteria that restricted the drug, Sovaldi, to very sick patients, with the caveat that they’d take up the issue again once new, perhaps more affordable drugs hit the market.

That appears to have happened sooner than expected. The director of the Oregon Health Authority, which oversees the state’s Medicaid program, the Oregon Health Plan, approved new criteria this month that permits some OHP beneficiaries with Hepatitis C to access a new drug: Harvoni. Hepatitis C is a disease that causes inflammation of the liver and can lead to liver failure or liver cancer.  


Wednesday, March 4, 2015

New Cigna, Catamaran Hep C Pacts Put Gilead Drugs to the Test

"Since the December 2014 approval of AbbVie Inc.’s hepatitis C treatment Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets), at least 10 companies have disclosed exclusive or semi-exclusive deals with Gilead Sciences, Inc. that feature the manufacturer’s hepatitis C agents, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir). But Catamaran Corp. and Cigna Corp. this month unveiled the first outcomes-based arrangements with Gilead that industry observers say could open the door for more value-based deals around hepatitis C and other specialty agents".
"Catamaran on Feb. 3 said it would offer a new hepatitis C patient management program through its specialty pharmacy, BriovaRx, that features Gilead’s Harvoni and Sovaldi as exclusive hepatitis C treatment options (DBN 2/6/15, p. 1). Similarly, Cigna Corp., a long-term Catamaran customer, on Feb. 4 said it would offer Harvoni as the only preferred brand drug treatment for customers with hepatitis C genotype 1 infection as well as develop an outcomes-based incentive program".
"While both companies declined to provide specifics on how the deals are structured, other outcomes-based pharmaceutical arrangements between manufacturers and insurers or PBMs have tied rebate payments to agreed-upon outcomes achieved by the payers’ members. Cigna, for instance, in 2010 embarked on an outcomes-based partnership with Merck & Co. in which the drugmaker provided rebates to Cigna when its members with type 2 diabetes met goals for adherence to prescribed medications and low blood sugar levels (DBN 12/17/10, p. 1). And Prime Therapeutics LLC in 2012 signed an outcomes-based contract with EMD Serono, Inc. for its multiple sclerosis drug Rebif (interferon beta-1a) through which the drugmaker promised to pay rebates to the PBM if its members taking Rebif had a higher total cost of care than people on other MS medications. Adherence levels were also considered. Cigna inked a similar deal with EMD Serono in 2011".

Thursday, February 26, 2015

NICE guidance recommends sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) for treating hepatitis C

Healthcare guidance body NICE has today published final guidance recommending sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen) as treatment options for some people with chronic hepatitis C.


Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to, the liver, preventing it from working properly.

About a third of people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small number of people with chronic hepatitis C and cirrhosis also go on to develop liver cancer.

The aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Sofosbuvir and simeprevir are oral antiviral drugs used to prevent hepatitis C viral replication in infected cells.

Sofosbuvir has a marketing authorisation in the UK for use in combination with other medicinal products for treating chronic hepatitis C in adults. The guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C.[1]

Simprevir has a marketing authorisation in the UK for use in combination with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C. The guidance on simeprevir recommends its use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

More data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who can’t tolerate or aren’t eligible for treatment with interferon is due to become available soon. Therefore recommendations on this treatment combination will now be developed in separate guidance.

Commenting on today’s guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Poor diagnosis rates - estimates suggest around 50% of people with the condition in England remain undiagnosed - combined with a high number of new infections annually make hepatitis C a major public health challenge. But even when people are diagnosed, the long duration and potentially unpleasant side-effects of current interferon-based treatments can discourage people with the disease from completing the full course, or even from seeking treatment in the first place.

“New treatments, like sofosbuvir and simeprevir, can shorten the length of interferon-based therapy and in some situations don’t need to be taken with interferon at all. Both drugs can also be given to people who have previously been treated but did not clear the virus, in people whose condition has relapsed, or in people who have become re-infected after treatment.

“Sofosbuvir and simeprevir could therefore be valuable treatment options for people with chronic hepatitis C. This is good news, not just for people with chronic hepatitis C, but also because having more effective treatments for the condition could reduce the spread of the virus.”
 
Following a request from NHS England and consultation with stakeholders, the period during which NHS England has to comply with the recommendations for sofosbuvir is extended to 31 July 2015. The period during which NHS England has to comply with the recommendations for simeprevir has not been extended.

Ends
For further information, please contact the NICE press office on 0300 323 0142 / pressoffice@nice.org.uk or out of hours on 07775 583 813.


About the guidance on sofosbuvir
  1. The guidance on sofosbuvir is available from the NICE website (from 00:01 on 25 February 2015).
  2. The guidance states that:
1.1  Sofosbuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1.
1.2  People currently receiving treatment initiated within the NHS with sofosbuvir that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Table 1 Sofosbuvir for treating adults with chronic hepatitis C

Sofosbuvir in combination with peginterferon alfa and ribavirin
Sofosbuvir in combination with ribavirin
GenotypeTreatment historyRecommendationTreatment historyRecommendation
Adults with genotype 1 HCVAllRecommendedAllNot recommended
Adults with genotype 2 HCVAllNot licensed for this populationTreatment- naiveOnly recommended for people who are intolerant to or ineligible for interferon
Treatment- experiencedRecommended
Adults with genotype 3 HCVTreatment-naiveOnly recommended for people with cirrhosisTreatment-naiveOnly recommended for people with cirrhosis who are intolerant to or ineligible for interferon
Treatment-experiencedRecommendedTreatment-experiencedOnly recommended for people with cirrhosis who are intolerant to or ineligible for interferon
Adults with genotype 4, 5, or 6 HCVAllOnly recommended for people with cirrhosisAllNot recommended
HCV – hepatitis C virus
Treatment-naive – the person has not had treatment for chronic hepatitis C
Treatment-experienced – the person’s hepatitis C has not adequately responded to interferon-based treatment

About sofosbuvir
  1. Sofosbuvir (Sovaldi, Gilead Sciences) is an antiviral drug used to prevent hepatitis C viral replication in infected cells. It is administered orally.
  2. Sofosbuvir has a UK marketing authorisation for use ‘in combination with other medicinal products for treating chronic hepatitis C in adults’. The recommended dose is one 400mg tablet daily. The summary of product characteristics for sofosbuvir states that peginterferon alfa and ribavirin, or ribavirin only, are the recommended co-administered medicinal products for use with sofosbuvir.
  3. The duration of treatment is 12 or 24 weeks depending on the patient’s hepatitis C virus genotype and history of prior treatment with interferon.
  4. The cost of sofosbuvir is £11,660.98 per 28-tablet pack of 400 mg tablets (excluding VAT, ‘British national formulary’ [BNF] May 2014). The cost of a 12-week course of treatment is £34,982.94 and a 24-week course is £69,965.88 (both excluding VAT), not including the cost for ribavirin and peginterferon alfa. Costs may vary in different settings because of negotiated procurement discounts.
Summary of Appraisal Committee’s key conclusions on cost effectiveness
Genotype 1
  1. The ICER for treatment with sofosbuvir plus peginterferon and ribavirin compared with peginterferon and ribavirin was £17,500 per QALY gained in treatment naïve patients.
  2. The Committee also considered sofosbuvir plus peginterferon and ribavirin to be cost effective compared with boceprevir plus peginterferon and ribavirin, and telaprevir in combination with peginterferon and ribavirin (ICERS of approximately £10,300 and £15,400 per QALY gained respectively).
  3. The Committee considered sofosbuvir plus peginterferon and ribavirin to be cost effective in treatment experienced patients compared with peginterferon and ribavirin, boceprevir plus peginterferon and ribavirin, and telaprevir plus peginterferon and ribavirin with ICERs of approximately £12,600, £700 and £8200 per QALY gained respectively.
  4. Sofosbuvir plus ribavirin was not recommended in people for whom interferon was unsuitable (regardless of previous treatment) because of the higher ICER compared with standard care (no treatment) which was in excess of £47,500 per QALY gained in the combined population of people with and without cirrhosis .

Genotype 2
  1. The ICER for sofosbuvir plus ribavirin compared with peginterferon and ribavirin in people who were treatment experienced was £12,500 per QALY gained. However, in the treatment naïve group the treatment was not recommended because of the high ICER of £46,300 per QALY gained.
  2. The Committee considered sofosbuvir plus ribavirin to be clinically effective and cost effective compared with no treatment in people for whom treatment with interferon was unsuitable regardless of treatment experience (with ICERs of approximately £8200 and £8600 per QALY gained respectively).

Genotype 3
  1. The Committee considered the extended treatment duration (24 weeks) of sofosbuvir plus with ribavirin to be clinically effective compared with peginterferon alfa and ribavirin. The Committee considered sofosbuvir plus peginterferon alfa and ribavirin to be cost effective in people with treatment-naive HCV with cirrhosis (with an ICER of approximately £6600 per QALY gained) but not in people with treatment-naive HCV without cirrhosis (with a high ICER of approximately £40,600 per QALY gained). Treatment was recommended in people with treatment-experienced HCV regardless or cirrhosis status with ICERs of below approximately £19,000 per QALY gained
  2. The Committee considered the cost effectiveness of sofosbuvir plus ribavirin to be acceptable in people with cirrhosis who were not eligible for peginterferon alfa regardless of previous treatment with ICERs of approximately £10,500 per QALY gained for treatment-naive HCV and £19,200 per QALY gained for treatment-experienced HCV. The Committee did not consider sofosbuvir in combination with ribavirin to be cost effective in people without cirrhosis with ICERs of approximately £28,000 and £31,400 per QALY gained in treatment-naive and experienced HCV respectively.

Genotypes 4, 5 and 6
The Committee considered sofosbuvir in combination with ribavirin with or without peginterferon alpha to be clinically effective compared with peginterferon and ribavirin in people with treatment naïve and experienced HCV genotypes 4, 5 and 6.
  1. The Committee noted that the ICER for sofosbuvir plus peginterferon alfa and ribavirin compared with peginterferon and ribavirin in the combined cohort of people with treatment naive genotype 4, 5 and 6 HCV was £39,100 per QALY gained. The Committee did not consider sofosbuvir plus peginterferon alfa and ribavirin to be cost effective in people with genotype 4, 5 or 6 HCV without cirrhosis. The Committee considered that ICERs in the population with cirrhosis are consistently lower than in people without cirrhosis and that considering the high unmet need in the population of people with genotype 4, 5 and 6 with cirrhosis, the Committee could consider sofosbuvir plus peginterferon alpha and ribavirin to be cost effective in the treatment naive or experienced populations with ICERs that could be between £20,000 and £30,000 per QALY gained. In addition the Committee did not consider sofosbuvir plus ribavirin in people who were not eligible for interferon to be cost effective. 

About the guidance on simeprevir
  1. The guidance on simeprevir is available from the NICE website (from 00:01 on 25 February 2015).
  2. The guidance states that:

    1.1  Simeprevir, in combination with peginterferon alfa and ribavirin, is recommended within its marketing authorisation as an option for treating genotype 1 and 4 chronic hepatitis C in adults.
  3. As part of this appraisal the Committee originally considered the effectiveness of simeprevir in combination with sofosbuvir. In the appraisal consultation document the Committee concluded that the true magnitude of the effect of simeprevir in combination with sofosbuvir could not be robustly estimated in people who cannot tolerate or are not eligible to have interferon treatment. At its second meeting, the Committee heard that mature observational data for simeprevir in combination with sofosbuvir would become available in the near future, and that this would include data on people who cannot tolerate or are not eligible to have interferon treatment. The Committee considered that it would be more appropriate to postpone making a decision on this combination until the more mature data become available. To avoid postponing the recommendations for the combination of simeprevir with peginterferon alfa and ribavirin for treating genotype 1 and 4 hepatitis C, the Committee recommended that this appraisal be split. Therefore, this appraisal no longer includes a recommendation for simeprevir in combination with sofosbuvir with or without ribavirin for treating people with genotype 1 and 4 HCV who are intolerant or ineligible for treatment with interferon.
  4. Following a request from NHS England to extend the period during which funding must be made available, NICE consulted on a proposal to grant an extension to the deferred funding period until 31 July 2015. Following consideration of comments received during the consultation on a decision to amend the deferred funding, the NICE Guidance Executive decided that no extension to the normal period was required for simeprevir in combination with peginterferon alpha and ribavirin.  This is because simeprevir will be used in the same way as boceprevir and telaprevir. Both these interventions have been funded by the NHS since the publication of NICE appraisal guidance in early 2012. The resources and arrangements for safe delivery of treatment are already in place as a result of the availability of telaprevir and boceprevir.  Therefore, additional resources or training are not required to support the implementation of simeprevir. In addition, simeprevir treatment is less complex to administer than telaprevir and boceprevir, and the additional small patient population with genotype 4, for whom simeprevir is licensed is not expected to constitute a substantial challenge to the implementation.  Consequently, section 5 of the FAD states that clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities are required to comply with the recommendations in this appraisal within 3 months of its date of publication.
About simeprevir
  1.  Simeprevir (Olysio, Janssen) is a protease inhibitor; it inhibits the NS3/4A enzyme that the hepatitis C virus (HCV) depends on to replicate. Simeprevir is administered orally.
  2. Simeprevir has a UK marketing authorisation in the UK for use in combination with peginterferon alfa and ribavirin or in combination with sofosbuvir (with or without ribavirin) for treating adults with genotype 1 or 4 chronic hepatitis C, including people with or without cirrhosis, and people with HIV.
  3. For people who have not had previous treatment or whose disease has responded to previous treatment but subsequently relapsed, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 12 weeks of peginterferon alfa and ribavirin alone.
  4. For other people, the course of simeprevir is the same, but the course of pegylated interferon and ribavirin is longer than 24 weeks; specifically, for people whose disease did not respond to previous treatment, and for people with HIV who also have cirrhosis, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 36 weeks of peginterferon alfa and ribavirin alone.
  5. Simeprevir costs £1866.50 per pack of 7x150 mg tablets (excluding VAT, MIMS online, accessed July 2014). A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 24 weeks) costs £27,220. A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 48 weeks) costs £32,155.
  6. For treating genotype 1 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone was between £14,200 and £9800 per QALY. Simeprevir dominated both telaprevir and boceprevir (both with peginterferon alfa and ribavirin), that is simeprevir was less expensive and provided more QALYs.
  7. The Committee noted that, in all scenarios for genotype 4 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin remained below £20,000 per QALY gained. 
About chronic hepatitis C
  1. 15 to 20% of people infected with the hepatitis C virus naturally clear their infections within 6 months, the remainder develop chronic hepatitis which can be life-long.
  2. Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time.
  3. About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue.
  4. A small percentage of people with chronic hepatitis C and cirrhosis also develop liver cancer.
  5. For people with mild disease, a ‘watchful waiting’ approach may be agreed, on an individual basis, between the patient and clinician.
  6. Current NICE guidance (NICE technology appraisal 75 and NICE technology appraisal 106) recommends that standard treatment for the majority of people with chronic hepatitis C is peginterferon alfa and ribavirin combination therapy. Monotherapy with peginterferon alfa-2a or peginterferon alfa-2b is recommended for patients who are unable to tolerate ribavirin or for whom ribavirin is contraindicated.
  7. Other NICE guidance on hepatitis C (NICE technology appraisal 200) also recommends that people who have been previously treated with peginterferon alfa and ribavirin or with peginterferon alfa monotherapy have an option to receive further courses of peginterferon alfa and ribavirin.
  8. Shortened courses of peginterferon alfa and ribavirin are also recommended as an option for certain patient subgroups (NICE technology appraisal 200).
  9. For people with genotype 1 chronic hepatitis C, who have not been previously treated or who have been previously treated, NICE guidance also recommends telaprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 252) or boceprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 253).


[1] There are 6 major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically. Genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43% respectively). People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.
                           
 
 

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.
To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.

Wednesday, February 25, 2015

India: Mylan to distribute both Sovaldi and Harvoni for HCV

"Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

Read more...

Friday, February 20, 2015

Canada: New Hepatitis C drug Sovaldi needed in B.C., say desperate patients

Hepatitis C patients in B.C. are fighting to get access to new drug Sovaldi, which could cure them, but could also cost the provincial government up to $2.75 billion.

There are currently up to 25,000 British Columbians living with the contagious liver disease, which begins as a mild viral infection lasting a few weeks but can lead to a chronic, lifelong illness.

Desmond McKilligan of Kaslo, B.C., who contracted hepatitis C after receiving tainted blood 45 years ago, says going through life with the virus is exhausting.

Read more...

Wednesday, February 11, 2015

Pakistan: Waiting for hepatitis drug

AN estimated 10 million hepatitis C patients in the country may hear the good news soon. A life-saving drug to be administered orally to such patients is expected to be cleared for distribution next week, long after it got the approval of the Drug Regulatory Authority of Pakistan. The matter has been pending with the Federal Ministry of Health Services Regulations and Coordination for the last three months, which somehow could not take out the time to give a formal nod to the medicine called Sovaldi. Whereas doctors have prescribed the tablet to a few thousand suffering Pakistanis in anticipation of its availability on the local market, one distribution company has been selected for its supply. The company is going to buy it from the United States. It was initially in competition with many other aspiring distributors, but managed to convince DRAP that it had the right combination of price and quality.

Read more...

New drugs, price war provide hope for hepatitis C patients

Sallie Wickens’ life followed a death-defying narrative that traced the medical arc of hepatitis C:

A blood-transfusion infection after a car accident in 1959, when she was 5; a positive test for the virus when she was 30; 10 years of deteriorating health; a debilitating course of interferon drug treatments that didn’t work; a liver so damaged she needed a transplant.

And then, her doctor, hepatologist Laura Alba, walked into an exam room last month at St. Luke’s Hospital and gave Wickens, 60, a big smile.



Tuesday, February 10, 2015

Pa. considering moving away from costly Hepatitis C treatment

(Harrisburg) -- Pennsylvania might move away from a stunningly expensive prescription drug treatment for Medicaid patients with Hepatitis C, but the Commonwealth won't save as much as other states.

Missouri is one of the first states to move away from Sovaldi, which costs $1,000 a pill.

Pennsylvania might do the same, but the state's Medicaid program is waiting on final offers from two competitors that provide other drugs recently approved by the FDA for Hepatitis C treatment.

Read more...

Monday, January 26, 2015

EnvisionRx and Gilead Sciences Sign Exclusive Agreement to Help in the Fight Against Hepatitis C

TWINSBURG, Ohio, Jan 26, 2015 (BUSINESS WIRE) -- EnvisionRx®, a national, full-service pharmacy benefit management (PBM) company, today announced a partnership with Gilead Sciences Inc., a pioneer in the treatment of the Hepatitis C virus (HCV), to provide availability to HCV infection treatments Sovaldi® and Harvoni™ for EnvisionRx patients on an exclusive basis.

“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”

Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Read more...