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Post Info TOPIC: Access to drugs


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Access to drugs

Medscape - News > Reuters Health Information - By Reuters Staff - November 01, 2017


MSF Charity Secures Generic Hepatitis C Drugs for $1.40 a Day

LONDON (Reuters) - Medecins Sans Frontieres, the international nonprofit medical charity, said on Tuesday it had struck deals with generic manufacturers to buy hepatitis C drugs for as little as $1.40 a day, a dramatic reduction on original prices.


U.S. drugmaker Gilead Sciences created storm in 2013 when it launched sofosbuvir at $1,000 per pill in the United States, under the brand name Sovaldi.


Since then, increased competition has pushed prices lower for the modern medicines, which have cure rates of up to 95% for the liver-destroying disease.


The big drugmakers have offered discounts on their products for poor countries, but MSF has long complained that the medicines are still too expensive.


MSF said the deals with generic companies meant it was now able to provide a 12-week course of treatment for around $120, against $1,400 to $1,800 available through Gilead and BMS access programs for poorer nations.


Nearly three-quarters of the estimated 71 million people living with chronic hepatitis C infection worldwide are in low- and middle-income countries.


Reuters Health Information © 2017 

Cite this article: MSF Charity Secures Generic Hepatitis C Drugs for $1.40 a Day - Medscape - Oct 31, 2017. 

 Helio - MEETING NEWS - November 2, 2017

Generic HCV treatments could cost $50, as effective as branded drugs

Generic direct-acting antiviral regimens for hepatitis C can be manufactured for $50 and are as effective as branded medicines, according to data presented at the World Hepatitis Summit 2017 in São Paulo, Brazil.

"As there are around 70 million people infected with hepatitis C worldwide, the basic cost of the drugs to treat everyone infected globally, at $50 each, would be around U.S. $3.5 billion", Andrew Hill, PhD, from the University of Liverpool, United Kingdom said in a related press release. "Much more must be done to enable all countries - but especially developing countries - to produce or buy drugs for these lower prices. Without significant changes to pricing structures, the battle against the global hepatitis C epidemic simply can't be won."

According to Hill and colleagues, the 12-week course of sofosbuvir combined with daclatasvir ranges from $78 in India, to $174 in Egypt, $6,000 in Australia, $77,000 in the United Kingdom, up to $96,404 in the U.S. However, the basic cost of the active ingredients, formulation and packaging costs is less than $50 per course, including a small profit margin for the generic companies.

The researchers also analyzed the efficacy of generic DAAs in 1,160 patients. Results showed sustained virologic response rates over 90%, comparable with branded products.

"In 2016, for every person cured of hepatitis C globally (1.76 million), another person was newly infected (1.5 million)," Hill said. "We simply cannot eliminate this epidemic unless we treat more people. And we can only do this if the prices of the drugs come down." - by Talitha Bennett


Hill A, et al. What price for what drug: is there a science to it? Presented at: The World Hepatitis Summit 2017; Nov. 1-3, 2017; São Paulo, Brazil.



Medscape - News > Reuters Health Information

U.S. Drug Pricing Watchdog Gets Funding to Expand Efforts

By Bill Berkrot - November 01, 2017


(Reuters) - A U.S. independent nonprofit organization that evaluates the clinical and cost effectiveness of new medicines said on Tuesday it has received significant new funding that will enable it to greatly expand its work.


The Boston-based Institute for Clinical and Economic Review (ICER) announced a three-year, $13.9 million grant from the Laura and John Arnold Foundation, which follows its initial two-year $5.2 million award from the foundation in 2015.


The new funding comes at a time of increased scrutiny among politicians and insurers over the high cost of new prescription medicines in the United States, especially in comparison with other countries, and steep price hikes of some older generic medicines faced with little competition.


ICER has previously issued reports outlining what it believes to be an appropriate cost for new medicines to treat high cholesterol, lung cancer, hepatitis C and other conditions, typically suggesting a value to patients that is a fraction of prices set by drugmakers.


The new funding will enable ICER to evaluate all newly approved medicines, rather than select high profile drugs.


Pharmacy benefit managers, insurers and government agencies have all used ICER reports in negotiating pricing and preferred formulary placements with manufacturers, ICER President Steven Pearson said in an interview, mentioning Express Scripts, CVS Health, the U.S. Department of Veterans Affairs and others.


Pearson said he had been informed by Express Scripts that it used ICER's report in aggressively negotiating discounts on prices for new curative hepatitis C drugs with Gilead Sciences.


"Veterans Affairs have used our reports to inform their thinking and price negotiations," Pearson added.


Drugmakers argue that list prices do not reflect what is actually paid after discounts and rebates, but that has done little to quell criticism over high costs.


Rather than working from list prices as it did initially, ICER now attempts to "come up with a more precise estimate incorporating average net prices, taking rebates into account, to determine what it considers fair value-based pricing," Pearson said.


Some drugmakers, such as Allergan and AbbVie , have pledged to limit annual price increases on prescription medicines in an effort to head off more drastic government measures to rein in costs.


The infusion of new funds will also enable ICER for the first time to assess price increases for existing medicines.


"We want to come up with an approach at . . . determining when price increases are or aren't justified," Pearson said.


Reuters Health Information © 2017 

Cite this article: U.S. Drug Pricing Watchdog Gets Funding to Expand Efforts - Medscape - Oct 31, 2017.


-- Edited by Canuck on Monday 6th of November 2017 04:43:19 AM


HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.




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Posts: 2458

A shortened version - a look at why (in part) in 2014 certain people were not getting treated in North America. Gee, is it because they are not sick enough? Some things are are changing ... but too slowly. cry C.



Disparate Access to Treatment Regimens in Chronic Hepatitis C Patients

Data From the TRIO Network

Z. M. Younossi; B. R. Bacon; D. T. Dieterich; S. L. Flamm; K. Kowdley; S. Milligan; N. Tsai; A. Nezam

J Viral Hepat. 2016;23(6):447-454. 



Despite the clinical success in the real-world of all oral hepatitis C virus (HCV) therapy with response rates approaching that seen in the clinical trials, access has been limited by many payers with discussion of prioritization of treatment based upon AASLD guidelines. We evaluated patients in the TRIO network who were prescribed sofosbuvir (SOF)-based regimens to determine reasons for not starting treatment. Trio Health is a disease management company that works in partnership with academic medical centres, community physicians and specialty pharmacies in the United States to optimize care for HCV. Data for 3841 patients prescribed a sofosbuvir-containing regimen between December 2013 and September 2014 were obtained through this programme. Of the entire group, 315 (8%) patients did not start the prescribed sofosbuvir-containing therapy. A total of 141 (45%) of the nonstart patients had a commercial plan as their primary insurance, 137 (44%) were primarily covered by Medicaid, 17 (5%) were primarily covered by Medicare, and 20 (6%) were either without coverage or coverage was not specified. Reasons for nonstarts were varied and overlapping. Only 15 patients (5% of nonstarts) did not start because they were unreachable or failed to complete required testing. Another 39 patients who did not start (12%) were following their physicians' direction to either wait for new treatment options or to hold treatment for an unspecified reason. Insurance-related processes and financial reasons accounted for 254 (81%) of the 315 nonstarts. The remaining 7 (2%) patients did not have a specified reason for not starting treatment. Nonstart rates were highest in the Medicaid-covered population at 35%. Medicare and Commercial nonstart rates were 2% and 6%, respectively. In a matched comparison, patients with commercial coverage were 6.5 times as likely to start SOF-based therapy compared to patients with Medicaid. Despite high SVR rates of SOF-based regimens in clinical practice, there are still barriers to access to care. In fact, almost half of the nonstart patients had advanced fibrosis scores (F3 or F4) and should have been prioritized to start treatment. As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high nonstart rate in the Medicaid-covered group, must be resolved.

Reasons for Nonstart of Sofosbuvir-based Treatment

A total of 315 (8%) of the 3841 patients did not start the intended sofosbuvir-based treatment. Primary nonstart reasons were broadly grouped as financial or insurance related (254 of 315 patients, 81%), patient actions (15 of 315 patients, 5%), physician directed (39 of 315 patients, 12%) or unspecified (7 of 315 patients, 2%) (Table 2). A total of 141 (45%) of the 315 nonstart patients were primarily covered by commercial insurance, 137 (44%) by Medicaid, 17 (5%) by Medicare, and 20 (6%) by a mix of patient assistance, self-pay and no or unspecified coverage. Within the commercial-covered group, financial or insurance related accounted for 109 (77%) of the 141 nonstarts. In the Medicaid-covered group, financial or insurance related accounted for 116 (85%) of the 137 nonstarts.

Medicaid Start Rates by State

Although the study sample included patients from 19 states, Medicaid-covered patients were only represented in 6 states, with the majority in Missouri (231/395, 58%), Illinois (98/395, 25%) and Oklahoma (49/395, 12%) (Table 4). Of these states, Illinois had the lowest start rate at 42% (41/98). The start rates for Missouri and Oklahoma were 70% (162/231) and 86% (42/49), respectively.


These data show that between December 2013 and September 2014, 3841 HCV patients received a written prescription for a full course of sofosbuvir-based treatment. As expected, the majority of these patients were genotype 1 (69%) and the most common treatment regimen was SMV + SOF +/- RBV (47%). Primary insurance coverage for the majority of patients (61%) included in this study was commercial-based with Medicaid accounting for 10% of patients, Medicare for 18% of the patients, and a mix of Government, patient assistance, self-pay and no or unspecified coverage for 10% of patients.

Of the 3841 patients, 8% (n = 351) of the patients did not start their treatment with the primary reason being financial. Upon a subanalysis of this group, patients who received Medicaid assistance were the least likely to start their treatment. In fact, those who had commercial insurance were 6.48 times as likely overall to receive treatment when compared to a propensity score-matched group of Medicaid patients. This disparity was most striking when the intended regimen was SMV + SOF +/- RBV, where commercial-covered patients were >15 times as likely to start this regimen compared to Medicaid-matched patients. This divergence occurred despite the presence of characteristics aligned with prioritization of treatment; the majority of the patients were GT 1 with a fairly high viral load, a Fibrosis score of 3 or 4 and were treatment naïve. This is a disturbing finding as the Medicaid population makes up 10% of the study population yet comprise 43% of nonstarts, with 85% of Medicaid nonstarts due to financial/insurance issues. It is also important to note that prevalence of HCV is highest in subjects in lower socio-economic level who may be more likely to need Medicaid. As such, this disparity in providing HCV treatment may affect the most vulnerable population with the highest prevalence of HCV.[12]

While new regimen costs may have been anticipated, the high volume of medically eligible covered patients may not have been considered by legislators when setting state Medicaid budgets. Medicaid managed care firms are given a set amount per member per month by the state to cover all their medical costs. In traditional Medicaid, states must cover FDA-approved drugs marketed by companies that have negotiated rebates with the federal Medicaid drug rebate programme, but states have flexibility to manage their Medicaid drug costs using preferred drug lists and requiring prior authorizations for some treatments. The impact of Medicaid eligibility criteria was evident in our analyses even with the smaller sample size of nonstarts. The most stringent criteria (Illinois) were associated with the lowest start rate. These limitations of the Medicaid programmes have continued with the availability of newer regimens, resulting in negotiations with drug manufacturers for drug pricing as well as adjusted budgets to attempt parity in access to treatment for their patients.

In summary, our real-world data from TRIO network shows significant barriers to access the new regimens to treat HCV. In fact, almost half of the nonstart patients with liver histology data had advanced fibrosis scores (F3 or F4). Medicaid was the primary insurance for almost half of nonstarts. Furthermore, 81% of nonstarts were due to financial reasons (which included loss or change of insurance) or insurance denials and processes. As better treatment for HCV with high efficacy and low side effects rates becomes available, the Medicaid budget barrier to treatment must be resolved. Future studies will focus on the newer genotype 1 treatment regimens to see whether an increase in the competitive landscape has changed the access issues identified by this study.




HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 62 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.



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