HCV Treatment Access
Some Payer Groups (medicaids-public/private-commercial) try to Hold Patients Hostage.....but what will happen in the fall when the FDA approves several interferon-free regimens with 95% SVR rates! Below are various groups & govt statements: Orgeon Paper, French, UK NICE, German, CTAF(California group)
from Jules: HCV+ Patients deserve access to HCV treatments. It should be the patient's decision if they want to be treated, HCV itself can cause liver disease but also extra-hepatic manifestations including cancers, fatigue, quality-of-life affects, diabetes etc. But various countries & groups appear to want to hold patients hostage, prevent access to therapy, lets see if this persists in the Fall when the FDA is expected to approve new HCV therapies: daclatasvir, asunaprevir, sofosbuvir+ledipasvir & Abbvie 3D, & the supplemental indication request for simeprevir+sofosbuvir. Various countries & groups have made statements about Sovaldi on whether the drug is useful for patients, astonishingly the Oregon Paper said the sofosbuvir data is not good enough, the AASLD Guidelines were not good because they written by people with conflicts of interest & the FDA was wrong to NOT have comparator arms in Sovaldi studies. NOTHING could be further from the truth. If the sofosbuvir data is not good either is the data from Merck, Abbvie, BMS & others, put all together we have thousands of patients from all these studies & they all show 95%+ SVR rates, poor SVR rates were 65-70% for telaprevir & boceprevir & was used with interferon & was for 48 weeks for many patients. The AASLD Guidelines were very well done! The FDA decision not to require comparator groups was the CORRECT! decision, it was unethical to randomize patients, they would not have enrolled & to require buying & studying treatment for comparator groups would have been a waste of resources that could be better used. Medicaids & commercial payers have expressed support for the Oregon Paper & it appears that some state medicaid's may have provided funding for the paper, so it appears they have a conflict of interest, the paper supports their notion that HCV drugs, Sovaldi, do not have adequate evidence to provide for patients, pretty laughable!.
According to this paper just published the annual healthcare HCV expense has been $15 billion for the last 10 years, up to 2010, and authors suggest this was an underestimate. State medicaid's are required by law to pay for HCV treatments but they can obstruct barriers, like prioritizing F3-4 for treatment & delaying treatment for F0/1/2. In their arguments these payers fail to say they receive discounts from drug companies, medicaid 23% I think & commercial payers negotiate behind the scenes I think. Not to mention this is disingenuous, when they just quote the retail sofosbuvir price of $84,000. Oregon apparently has an exemption from having to provide treatment, apparently the only state with such an exemption. As well recently UK NICE committee did not support sofosbuvir although the UK was providing sofosbuvir compassionate access as well as for daclatasvir, sounds to me that they do believe the therapy is crucial for sick patients! The French supported access to Sovaldi. NYS medicaid is paying for all treatments, & so are many medicaids (I hear 15), medicare & commercial payers, and they are also paying for simeprevir+sofosbuvir because it is a highly effective interferon-free therapy, at this time the most potent, which is cost-effective, it is cost-effective to cure patients & the payers realize this!
"Medicaid Evidence-Based Decisions Project at OHSU" Report Questions Sofosbuvir Research & the AASLD Guidelines & Medicaid Director (NAMD) Comments - (06/01/14)
"Annual inpatient charges among HCV-infected persons with a liver-related complication totaled $463 million for the younger cohort, $5.8 billion for the baby boomer cohort and $1.3 billion for the older cohort........Inpatient stays totaled 2.8 million days and cost over $15 billion annually. Non-whites, uninsured individuals, and individuals receiving publicly funded health insurance were disproportionately affected in all healthcare settings"
Germany IQWIG Issues Sovaldi Statement
"the CTAF Panel voted that the two new drugs are likely superior in terms of clinical effectiveness for most patients and offer clinical benefits beyond current treatments. However, a majority of the CTAF Panel rated the new treatments as "low value" compared with older drugs due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens.......consider prioritizing treatment with the new drugs for patients who need urgent treatment and are expected to benefit the most from immediate treatment."
California Technology Assessment Forum (CTAF) Issues Final Report and Action Guides on New Treatments for Hepatitis C
San Francisco, Calif., May 20, 2014 - The California Technology Assessment Forum (CTAF), a core program of the Institute for Clinical and Economic Review (ICER), has released a final evidence report and three Action Guides (one each for patients, clinicians, and payers/ policymakers) on new treatments for hepatitis C. The final report and Action Guides are based on a March 2014 CTAF public meeting where the evidence on effectiveness and value of different drug treatment options was reviewed and recommendations made to guide practice and policy. The key findings of the review and the votes of the CTAF Panel were that the evidence was adequate to demonstrate that the new drugs are clinically superior to existing therapies, yet they represent a "low value" to the health care system due to the high potential cost of treating such a large number of patients with very expensive medication. The CTAF Panel is an independent committee of medical evidence experts from across California, including practicing clinicians, methodologists, and leaders in patient engagement, all of whom meet strict conflict of interest guidelines.
"The CTAF process of conducting a systematic review of the evidence, analyzing the economic impact of different treatment options, and convening independent thinkers to deliberate on the findings, is the bedrock of producing actionable, trustworthy information for health care stakeholders," stated Steven D. Pearson, MD, MSc, President of ICER. "CTAF's judgment of the low comparative value of these new drugs compared to existing treatments highlights the importance of ongoing discussions concerning the high costs of medical treatments and the trade-offs inherent in our health care system. Provider groups, state Medicaid agencies, pharmacy benefit managers, and patients alike are all joining the conversation to create a more efficient and effective health care system; we hope this report and these Action Guides help stakeholders make the best use of available resources based on the current state of the evidence."
The final report, "The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection," compares these two drugs to the previous standard of care. The report includes a clinical evidence review as well as supplemental information on regional and national payer coverage policies, practice guidelines, and cost models for California.
Chronic hepatitis C is a common infection that is a major cause of chronic liver disease, liver failure, and liver cancer. Some 3-5 million individuals in the US are believed to be infected with the hepatitis C virus, and only about half are aware of their infection. In 2013, the FDA approved two new drugs to treat chronic hepatitis C that were easier for patients to take and had fewer side effects; several other drugs with similar profiles are currently in late-stage clinical trials. However, information on treatment-related side effects and how the drugs work in some patient populations is still emerging. The costs for initial treatment regimens including the two drugs range from approximately $88,000 to $175,000 per patient, depending on the drugs selected and the duration of initial treatment.
At its March 2014 public meeting, the CTAF Panel voted that the two new drugs are likely superior in terms of clinical effectiveness for most patients and offer clinical benefits beyond current treatments. However, a majority of the CTAF Panel rated the new treatments as "low value" compared with older drugs due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens.
The clinical advantages of the newer treatment regimens would come with a substantial impact on health care budgets if large numbers of patients are treated. If only patients with advanced liver fibrosis are started on the new treatment regimens, drug expenditures are estimated to increase by $7 billion in the first year for the population of California, one-third of the estimated $22 billion needed to treat all infected patients. At 20 years, cost offsets due to avoided liver transplants and other savings from higher cure rates are estimated to produce a net savings to the statewide health care system of about $1 billion if only patients with advanced liver fibrosis are treated. No such net savings are seen at 20 years if all patients are treated.
Because the financial impact of using these new drugs to treat all eligible patients with hepatitis C is untenable, the CTAF Panel and several clinical experts in hepatology serving on a policy roundtable at the meeting stated that it is reasonable to consider prioritizing treatment with the new drugs for patients who need urgent treatment and are expected to benefit the most from immediate treatment. The policy roundtable included clinical experts in liver disease, a patient advocate, payer representatives, and a representative from a manufacturer of one of the new drugs who were selected for their expertise on the specific meeting topic and did not vote at the meeting.
The Action Guides for patients, clinicians, and payers/policymakers are companion materials to the full report. The Action Guides provide a practical list of evidence-based action steps and resources tailored to help individuals or organizations interpret and apply the best available evidence regarding new treatments for hepatitis C to policy and practice. The final report and Action Guides are available for download on the CTAF website.
The California Technology Assessment Forum (CTAF) - a core program of the Institute for Clinical and Economic Review (ICER) - produces objective evidence reports and holds public meetings to develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about CTAF, please visit www.ctaf.org.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit health care research organization dedicated to improving the interpretation and application of evidence in the health care system. ICER directs two core programs: CTAF, and the New England Comparative Effectiveness Public Advisory Council (CEPAC). For more information about ICER, please visit ICER's website, www.icer-review.org.
from Jules: These NICE recommendations below merely defer the major decision until after the approval for the sofosbuvir/ledipasvir fixed dose combination & the other approvals expected in the Fall of 2014 for the Abbvie 3D regimen, daclatasvir/asunaprevir & the simeprevir+sofosbuvir supplemental submission to the FDA. Plus what about the use of daclatasvir+sofosbuvir, EU is providing compassionate access programs for this combination but will it be available more widely?? This week BMS announced studies of 4 & 6 weeks with a 4-drug regimen: daclatasvir+sofosbuvir plus 2 BMS drugs - protease asunaprevir & BMS non-nuc BMS325.
4 weeks/4 Drugs-Daclatasvir/Sofosbuvir/Asunaprevir/BMS325 - (06/23/14)
This week Merck & Idenix agreed for Merck to buy Idenix for their HCV drugs, 2 sofosbuvir-like nucleotides & NS5A samatasvir:
Merck to Acquire Idenix - (06/09/14)
In the USA NYS Medicaid is covering for HCV medications & by law HCV medications are required to be covered by Medicaid but they can impose restrictions on use.
USA AASLD/IDSA Guidelines:
New Recommendations for Testing, Managing, and Treating Hepatitis C from AASLD/IDSA Panel. And newer developments in HCV therapy - (01/31/14)
Today (6/6) France's health technology assessment agency, Commission de la Transparence, issued a positive recommendation for Gilead's Sovaldi.
The Committee voted unanimously for Sovaldi to be assigned SMR rating of "Important" and ASMR rating of "II"; both ratings together, we believe, should give GILD high negotiation leverage to secure premium pricing in France.
We note that historically, ASMR's rating of "II" is assigned only to agents considered to have made an "important" improvement to the standard-of-care and such agents have been able to command strong pricing power (e.g., Soliris).
Dr Miller is the chief medical officer for Express Scripts, America's biggest pharmacy-benefit manager (PBM), hired by insurers and employers to control the drugs costs for the patients they cover. In America a melanoma drug from Bristol-Myers Squibb costs nearly $120,000 for a course of treatment. And it is not just cancer treatments that are worrying.
www.fiercepharma.com - It's an early guidance, with final word expected in October. In the realm of NICE's "not minded to" decisions, it's fairly positive. Chances are that Gilead can sway the outcome with additional evidence and number-crunching. But NICE's evaluation could spur price negotiations; often, the agency presses drugmakers for discounts or other cost-cutting schemes, and successfully. Already, Gilead has priced Sovaldi much lower in the U.K. than in the U.S., at about $57,000.
Meanwhile, in the U.S., pharmacy benefits managers are casting about for ways to limit Sovaldi use, at least until the FDA approves other drugs in a much-anticipated new generation of hep C treatments. Some payers figure they can pit rival drugmakers against one another to gain price concessions.
In the meantime, they're trying to reserve the drug for the sickest patients. Medicaid providers are demanding more state funding to cover the drug. But Sovaldi sales are flooding in, with more than $2 billion in the first quarter, and probably more than that for Q2.
Analysts are skeptical that U.S. payers can squeeze big cost concessions out of hep C drugmakers even after competition heats up. But the fact that FDA is on the verge of approving a raft of new drugs is giving some PBMs a bit of a reprieve: ....... evidence is mounting that doctors are "warehousing" patients till the newest meds hit the market. Of course that's a temporary respite for payers--but it might give them time to strike deals with AbbVie and Bristol-Myers, if not Gilead.
Read more: U.K. gatekeepers nix hep C drug Sovaldi till Gilead ponies up more evidence - FiercePharma
....draft guidance, "This is draft guidance; NICE has not yet issued final guidance to the NHS".......NICE wrote that the agency "is minded not to recommend" that the U.K.'s National Health Service cover the cost of Sovaldi........ NICE estimates there are 160,000 people with hepatitis C, has not been disclosed.
The interim view from NICE is not surprising, though. The agency is known for taking a hard line on pharmaceutical costs and frequently ties drug makers in knots as they attempt to provide data that will persuade the agency to issue positive recommendations. By contrast, the equivalent agency in France earlier this month backed the use of Sovaldi.
Just the same, the move underscores the willingness of some government agencies to push back on Sovaldi pricing, when the opportunity presents itself. The Oregon Health Authority, for instance, is considering restricting coverage since the program can do so thanks to a special waiver that allows it to make such decisions based on cost and efficacy.
NICE - Hepatitis C (chronic) - sofosbuvir: appraisal consultation document
NICE consults on draft guidance on the drug sofosbuvir (Sovaldi) for treating hepatitis C
In draft recommendations published today healthcare guidance body NICE is asking Gilead Sciences for more information on its product sofosbuvir (Sovaldi), for the treatment of chronic hepatitis C.
Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, usually as a result of using contaminated needles for injecting drugs. The virus can cause inflammation of, and damage to the liver, preventing it from working properly.
Although 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.
Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in the England. More than half of people with chronic hepatitis C do not know they are infected because often, they only have mild symptoms or no symptoms at all for a long period of time.
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.
A small percentage of people with chronic hepatitis C and cirrhosis also 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 is an oral antiviral drug used to prevent hepatitis C viral replication in infected cells.
Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "Poor diagnosis rates, combined with a high number of new infections annually means that chronic hepatitis C presents a major public health challenge.
"The problem is made worse because the potential side-effects of current treatments, such as interferon, which often needs to be given for a long period of time, mean that many people with the disease either don't complete the full course, or are reluctant to seek treatment in the first place.
"The availability of new treatments, like sofosbuvir, that can shorten the duration of interferon-based therapy or which in some cases don't need to be taken with interferon at all, would potentially encourage more people to seek treatment.
"The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer. The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources."
Consultees are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee at the next meeting, and following this meeting the next draft guidance will be issued. The closing date for comments on the draft guidance is 4 July 2014.
This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the draft guidance
1. The draft guidance on is available from the NICE website. Consultation on the draft guidance closes on 4 July 2014.
2. The draft guidance states that:
1.1 The Committee is minded not to recommend sofosbuvir within its marketing authorisation for treating chronic hepatitis C in adults.
1.2 The Committee recommends that NICE requests further analyses from the manufacturer for sofosbuvir in combination with ribavirin, with or without peginterferon alfa compared with peginterferon alfa and ribavirin in people with genotype 1 and genotype 3 chronic hepatitis C, to be made available for the second Appraisal Committee meeting, as follows:
About chronic hepatitis C
1. There are 6 major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically.
2. Genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43% respectively).
3. People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.
4. For people with mild disease, a 'watchful waiting' approach may be agreed, on an individual basis, between the patient and clinician.
5. 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.
6. 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.
7. Shortened courses of peginterferon alfa and ribavirin are also recommended as an option for certain patient subgroups (NICE technology appraisal 200).
8. 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. 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 average 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. Sofosbuvir combination treatment regimens without peginterferon alfa for patients with genotype 1, 4, 5 and 6 hepatitis C virus infection have not been investigated in phase 3 studies. According to the summary of product characteristics for sofosbuvir, treatment regimens without peginterferon alfa should only be used for patients with genotype 1, 4, 5 and 6 hepatitis C virus infection if they are intolerant to or ineligible for peginterferon alfa therapy and are in urgent need of treatment.
5. The summary of product characteristics for sofosbuvir also states that for all genotypes, consideration should be given to potentially extending the duration of therapy from 12 weeks up to 24 weeks especially for subgroups of people who have one or more factors historically associated with lower response rates to interferon-based therapies (such as people with advanced liver fibrosis or cirrhosis, high baseline viral concentrations, prior unresponsiveness to peginterferon alfa and ribavirin combination therapy, or a non-CC nucleotide polymorphism near their IL28B gene [that is, people without the CC genotype IL28B polymorphism]; or for people of African and Caribbean family origin).
6. 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.
7. In April 2014 NHS England issued an interim clinical commissioning policy stating that it would commission sofosbuvir in combination with daclatasvir or ledipasvir with or without ribavirin for patients who meet specific criteria and are considered to be at significant risk of death or irreversible damage within the next 12 months, irrespective of genotype. The combination of sofosbuvir and daclatasvir or ledipasvir with or without ribavirin is not being considered in this ongoing appraisal.
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.
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This page was last updated: 16 June 2014