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Canuck


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RE: Access to drugs
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Slipping a couple more articles in here about access to drugs/access to treatment, and the removal of barriers. This study is a bit longish, so it's not posted in it's entirety - but you can google search up the whole of the article and read all the pages (and it's appendices) at your leisure - some of the important article-highlights centre on reducing barriers - many countries (and not just Australia that happens to be the focus in this article) have been quietly growing utilization of GP's and not just specialists, to be more employed in winning this hepc war. This study examines performance of this GP utilization. 

As well, of interest to me, in this Aus. based info, was that (in 2016) when Aus. remained doing pre-treatment VL's but dropped some of the on-treatment VL's to be done instead at physician discretion, especially the EOT VL, they have seen a slight problem not doing the EOT VL's, it seems for stats there is some needed reliance on the EOT VL's, as folk can become lost to subsequent follow-ups (past EOT) - ie SVR12 or SVR24.

Aus. has drafted up some nice user-friendly paper-form tools for GP's to use (as we have seen done in North America too, algorithms and such), that makes the transition for the GP to be the HCV care provider easier versus the heavy singular reliance on specialists-only for primary HCV care. We will be seeing more and more of these kinds of performance reviews coming out from countries all over the world and not just Australia, as using GP's has been quite a quiet push all over the place to improve access to treatment. It's an evolution in the kill-hepc revolution.

 

 MEDSCAPE - Journal of Viral Hepatitis

Aiming for Elimination: Outcomes of a Consultation Pathway Supporting Regional General Practitioners to Prescribe Direct-acting Antiviral Therapy for Hepatitis C

A. J. Wade; A. McCormack; C. Roder; K. McDonald; M. Davies; N. Scott; M. Wardrop; E. Athan; M. E. Hellard

DISCLOSURES 

J Viral Hepat. 2018;25(9):1089-1098. 

 

 

Abstract and Introduction

Abstract

To increase access to treatment, the Australian government enabled general practitioners (GPs) to prescribe direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV)in consultation with a specialist if inexperienced in HCV management. This study describes the establishment and outcomes of a remote consultation pathway supporting GPs to treat HCV. Key stakeholders from primary and tertiary healthcare services in the Barwon South Western region developed and implemented an HCV remote consultation pathway. Pharmaceutical Benefits Schedule prescription data were used to evaluate GP DAA prescription 12 months pre-and post- pathway implementation. A retrospective review of patients referred for remote consultation for 12 months post- pathway inception was undertaken to determine the care cascade. HCV treatment initiation by GPs increased after implementation of the remote consultation pathway. In the 12-month study period, 74 GPs referred 169 people for remote consultation; 114 (67%) were approved for GP DAA treatment; 48 (28%) were referred for specialist assessment. In total, 119 (71%) patients commenced DAA; 69 were eligible for SVR12 assessment. Post-treatment HCV RNA data were available for 52 (75%) people; 37 achieved SVR12; 15 achieved SVR ranging from week 5 to 11 post-treatment. No treatment failure was detected. Collaborative development and implementation of a remote consultation pathway has engaged regional GPs in managing HCV. Follow-up post-treatment could be improved; however, no treatment failure has been documented. To eliminate HCV as a public health threat, it is vital that specialists support GPs to prescribe DAA ...

...

Discussion

Our remote consultation pathway resulted in a high DAA treatment uptake rate of over 70% in a cohort of people living in regional Victoria. A collaborative approach between the primary and tertiary health sectors resulted in a remote consultation pathway used by 74 GPs, and increased access to DAA treatment in primary care, in the Barwon South Western region. Providing hepatitis C treatment in the local community, within an established healthcare provider relationship, may overcome both travel and trust-related barriers to accessing tertiary care.

Although the initial listing of DAA on the PBS on 1 March 2016 required all medical practitioners to prescribe DAA in consultation with a hepatologist, gastroenterologist or infectious disease physician experienced in the treatment of hepatitis C, this was revised on 1 October 2016 to require only medical practitioners not experienced in the treatment of hepatitis C to seek consultation.[7] The Pharmaceutical Benefits Advisory Committee has not defined "experienced," but national guidelines suggest that clinical experience should be gained by attending a formal training session and treating ten people living with hepatitis C in consultation.[6] Therefore, the remote consultation pathway should function as a remote training programme for GPs and create links between GPs and specialist services.

Of the 69 people who are eligible for SVR12 assessment, 52 (75%) have had blood taken, 37 have documented SVR12, and 15 had an HCV RNA negative result after the end of treatment, but before their SVR12 time point. Day 1 of DAA therapy was presumed to be the date the script was written, but it is possible that the treatment course was commenced at a later date, which would impact on when the patient was eligible for SVR assessment. This study did not investigate reasons why SVR12 blood tests were not completed. Failure to have SVR12 blood tests after DAA treatment has been observed in other cohorts.[1012] These findings demonstrate that there is an opportunity to improve follow-up post-DAA treatment. In response to this finding, the significance of waiting 12 weeks after DAA completion to assess for cure has been emphasized in GP education sessions, within the referral HealthPathway and in the revised remote consultation response letter (Appendix 3). Of note, national hepatitis C management guidelines from 1 March 2016 recommended testing for HCV PCR at the end of treatment, but the updated guidelines published in January 2017 simplified follow-up by removing the end of treatment HCV PCR.[6]

 

As injecting status did not influence hepatitis C management, injecting history was not requested on the remote consultation referral. Therefore, the proportion of active injectors in this cohort is unknown. However, to achieve hepatitis C elimination, it is critical to increase treatment uptake amongst this population. In Melbourne, Victoria, the annual hepatitis C treatment rate in PWID prior to the introduction of DAAs was estimated to be 3 per 1000.[13]Recent modelling data have suggested that increasing treatment uptake to 59 per 1000 PWID annually could achieve the WHO incidence target.[14]Cohort studies and one small randomized controlled trial conducted in the era of pegylated interferon-based hepatitis C treatment have demonstrated that when compared to treatment in tertiary centres, provision of treatment in the community results in higher treatment uptake rates, particularly in PWID.[15,16] To determine the effect of providing DAA treatment in the community on treatment uptake and SVR outcome, a large, randomized controlled trial is underway in Australia and New Zealand (The Prime Study NCT02555475), in which participants recruited at primary healthcare centres are randomized to receive DAA treatment at their primary healthcare centre or a tertiary hospital.

In conclusion, this study demonstrates that collaborative development and implementation of a remote consultation pathway have engaged regional GPs in hepatitis C treatment. Although follow-up post-treatment could be improved, no treatment failure has been documented. It is vital that specialists and the tertiary system support GPs to prescribe curative DAA, to stop people dying of hepatitis C, and eliminate hepatitis C as a public health threat...

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 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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Canuck


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More "access to drugs/access to treatment" and removal of barriers - it's an evolution. More and more docs and not just specialists but regular GP's, family docs, are helping win this war. Easy to relax fibrosis/sobriety/provider rules - harder to solve the $ problem.

Quite a novel state-budgetary contemplation going on in Lousianna, in how they will succeed in getting the most of their people treated by perhaps the lions share of one big pharma over another - interesting. Reminds me of Iceland (sorta).

 

Helio - HCV Next 

FEATURE

Louisiana developing Netflix style subscription plan for HCV treatment

 
 
September 18, 2018

The Louisiana Department of Health is currently developing a subscription style payment plan with pharmaceutical manufacturers to provide state residents with access to hepatitis C treatment.

 
 
Pete Croughan, MD
Pete Croughan

HCV Next spoke with the departments chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

Hepatitis C is definitely an epidemic here, like it is in many places, and equally tied to the opioid epidemic due primarily to transmission through reuse of needles, Croughan told HCV Next. National data has shown that rates of acute infections tripled in the last 5 years. This corresponds with our own internal data on increased rates of infection.

While the state has adequate data on the number of individuals infected with HCV through Medicaid, Croughan explained that the health department is focused on improving surveillance in correctional facilities, which is significantly lacking. National data, he said, place HCV prevalence in correctional facilities between 15% and 40%. Until screening is expanded in Louisiana, were not going to know how many people are infected with HCV in our justice system, he said.

Prior authorization criteria had also presented a barrier to treatment for state residents. Like many states, prior authorization initially restricted treatment based on at least 1 year of sobriety, prescriber specialty and the patients fibrosis score. However, cost-effective data that followed the introduction of new DAAs led the health department to evaluate what criteria was the most restrictive and least evidence-based with the help of the physician community and health advocates in New Orleans.

We wound up changing our sobriety restriction to only needing a provider access statement that the patient is able to complete treatment, we removed the provider specialty restriction, and we eliminated fibrosis scores for HCV and HIV-coinfected individuals, Croughan said. Our hope is to eliminate this disease thats been our goal from the beginning but the challenge has been how to pay for it. Were among the poorer states and were trying to find space to treat large numbers of people. Thats where we think the subscription model in a win-win-win, for patients, the state and potentially pharmaceutical partners.

Working with Rebekeh Gee, MD, Secretary of the Louisiana Department of Health, Croughan and colleagues developed the concept of a subscription payment model that has been described by some as the Netflix model.

We want to go from Blockbuster where youre paying per rental to Netflix where youre paying a subscription amount for unlimited streaming, Croughan explained. Or in this case, the streaming would be access to medication.

The model would take the states annual Medicaid and correctional facilitys budget for HCV treatment and offer the lump sum to a partnered pharmaceutical manufacturer for a specific duration. Currently, the department has discussed a period of 3 years to 5 years.

It would then be incumbent on the state, the public health community and the provider community to get as many people screened, linked to care and treated as much as possible, he said. For one company in a competitive space, they now expand their reach into a market that previously did not exist because the rate of access for corrections and Medicaid has been so low. In our mind, this wouldnt cut into the more lucrative bottom line, its only adding to it.

The department estimates that this plan could increase treatment from approximately 3% of people on Medicaid and in correctional facilities up to nearly 60%.

Weve actually had conversations with all three hepatitis C manufacturers AbbVie, Gilead and Merck and all three have expressed interest in potentially partnering with us, he said. The plan is to ultimately select a partner through a request for proposal process, but were willing to work with any company that gives us the best deal.

Croughan said that this has been a rare policy project as they have not experienced any pushback. Patients, providers and pharmaceutical companies are in support, he said. Additionally, while there are some potential regulatory barriers, Croughan said that the federal government has otherwise expressed interest in the model, so its really a matter of details at this point.

Regarding the next steps, the department is continuing to review request for information submissions for ideas and solutions as to how to structure the final model.

Were developing our concept paper and materials that we need to have that conversation with the federal government, Croughan said. We need to figure out whether we need to start drafting waivers or if can we get it done with just some regulatory guidance from CMS. So, its a little bit of a back and forth over the next few months.

Croughan explained that the department expects to have a clear sense of the regulatory path by early 2019 and have drafted a request for proposal that will be released to selective pharmaceutical partners with the hope of beginning the program in mid-2019.  by Talitha Bennett

Disclosure: Croughan reports no relevant financial disclosures.

 

 



-- Edited by Canuck on Thursday 20th of September 2018 03:30:39 AM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 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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Canuck


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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

Reference:

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. 64 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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Canuck


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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. 

 

Abstract

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.

Discussion

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. 64 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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