Showing posts with label Sofosbuvir/Cost. Show all posts
Showing posts with label Sofosbuvir/Cost. Show all posts

Friday, March 1, 2019

Companies, states interested in Louisiana Netflix-style hepatitis C plan

Companies, states interested in Louisiana hepatitis C plan
By MELINDA DESLATTE Associated Press

Three drug companies are interested in Louisiana's plan to use a Netflix-style subscription model to buy access to hepatitis C drugs for Medicaid patients and prisoners, a treatment concept being watched by other states, the state health department announced Friday.

Health Secretary Rebekah Gee wants Louisiana to pay a fee to a drug manufacturer for unlimited access to its hepatitis C medication. The state will treat as many people as it can during the access period, rather than pay a per-patient treatment price
Continue reading:
Read more here:

Friday, February 15, 2019

Hepatitis C and HIV/AIDS Medications Costliest Group of Outpatient Prescription Drugs for Medicaid

Kaiser Family Foundation
Analysis Finds that Medications for Hepatitis C and HIV/AIDS Are the Costliest Group of Outpatient Prescription Drugs for Medicaid, While Diabetes Drugs Have Posted the Sharpest Rise in Costs 
Chris Lee
Published: Feb 15, 2019
Antiviral medications, including those that treat hepatitis C and HIV/AIDS, cost the Medicaid program more money (before rebates) than any other group of outpatient prescription drugs for each year from 2014 to 2017, according to a new KFF analysis.

The analysis of utilization and spending trends finds that antivirals accounted for more than 13 percent of the $63.6 billion in Medicaid outpatient drug spending pre-rebates in 2017 — a level disproportionate to their utilization and a reflection of the high cost of these drugs. Drugs for diabetes were the second most costly group that year, accounting for 10 percent of Medicaid outpatient drug spending before rebates. Spending for diabetes drugs rose faster than for any other group, nearly doubling from 2014 to 2017 — largely due to the rising price of insulin.

On This Blog 
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions implemented by private insurers/Medicaid/Medicare and the effectiveness, safety and availability of generic versions of hepatitis C medications. 

Thursday, February 14, 2019

Netflix Model -Countries Use Novel Strategies to Tackle Price of HCV Drugs

Countries Use Novel Strategies to Tackle Price of HCV Drugs
Roxanne Nelson, RN, BSN
February 14, 2019
A recent study suggests that the WHO's goal of eliminating HCV infections worldwide by 2030 is potentially feasible but faces some daunting challenges, including the cost of DAAs.
To help overcome some of the barriers to treatment access, Australia and Brazil are each exploring innovative methods to circumvent the cost. Two perspective articles published February 14 in the New England Journal of Medicine outline how they hope to accomplish this goal.
The healthcare system in Australia is complex but is generally funded by the government. Drugs that are on the national formulary are usually paid for by the government. To help make DAAs more affordable to patients and the healthcare system, the Australian government has rolled out a strategy, nicknamed the "Netflix" plan because it is similar to the movie subscription service, in which payment is for bulk access.
Read more: 

New England Journal of Medicine
Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C
Suerie Moon, M.P.A., Ph.D., and Elise Erickson, M.A.
High prices can restrict access to medicines in rich and poor countries alike. Australia’s approach to providing direct-acting antivirals (DAAs) for patients with hepatitis C virus (HCV) suggests that, under certain conditions, innovative approaches to payment can remove price as a barrier to access. In Australia, medicines on the national formulary are largely paid for by the government. In 2015, the authorities negotiated an agreement to spend approximately 1 billion Australian dollars (U.S.$766 million) over 5 years in exchange for an unlimited volume of DAAs for HCV from suppliers. This approach has been called the “subscription” or “Netflix” model, and the state of Louisiana announced in January 2019 that it was pursuing a similar approach for HCV. The Australian agreement is confidential, though the basic information above has been publicly reported..
Read more: 

New England Journal of Medicine
Brazil’s strategy for addressing hepatitis C, which combines evidence-based treatment protocols and innovative initiatives for local production of generic direct-acting antiviral drugs, needs to be considered in light of ongoing conflicts over pharmaceutical patents.
Payment may be required to view article. 

Thursday, February 7, 2019

Impact of Hepatitis C Virus and Insurance Coverage on Mortality

The American Journal of Managed Care February 2019
Impact of Hepatitis C Virus and Insurance Coverage on Mortality
Haley Bush, MSPH; James Paik, PhD; Pegah Golabi, MD; Leyla de Avila, BA; Carey Escheik, BS; and Zobair M. Younossi, MD, MPH

View Full-text Article Online

Takeaway Points
Hepatitis C virus (HCV) prevalence is significantly higher among patients with Medicaid compared with patients with private insurance and Medicare. 

Medicaid patients who are infected with HCV have a higher risk of all-cause mortality than HCV-positive patients with private insurance coverage. 

Policy makers should consider providing additional resources to Medicaid to cover all HCV-infected individuals.

The Medicaid population has significantly higher hepatitis C virus (HCV) prevalence and mortality rates than patients with private insurance. These data must be considered when policy makers assess providing additional support to Medicaid programs for HCV elimination.

Objectives: To assess the association of payer status and mortality in hepatitis C virus (HCV)–infected patients.

Study Design: For this retrospective observational study, we used the National Health and Nutrition Examination Survey from 2000 to 2010. Adults with complete data on medical questionnaires, HCV RNA, insurance types, and mortality follow-ups were included.

Methods: We used Cox proportional hazards models to evaluate independent associations of insurance type with mortality in HCV-infected individuals. These models were rerun in the subset of HCV-positive subjects to determine the association of insurance type with mortality. The data used in this study predated the implementation of the Affordable Care Act.

Results: Among 19,452 eligible participants, 311 (1.4%) were HCV positive. HCV-positive patients were older, were more likely to be non-Hispanic black and male, and had higher prevalence of hypertension (all P <.001). HCV-positive patients were also less likely to have private insurance and more likely to be covered by Medicaid or be uninsured relative to HCV-negative patients (P <.001). Among HCV-positive patients, after adjustment for confounders, those with Medicaid coverage had an increased risk of mortality compared with those with private insurance (hazard ratio [HR], 6.31; 95% CI, 1.22-29.94) and uninsured individuals (HR, 8.83; 95% CI, 1.56-49.99).

Conclusions: Patients who have HCV are more likely to be uninsured or covered by Medicaid. HCV-positive patients with Medicaid have an increased mortality risk compared with those with private insurance. Given the high burden of HCV infection and adverse prognosis among individuals covered by Medicaid, policy makers must prioritize funding and supporting Medicaid programs.

Source Full-text article:
Am J Manag Care. 2019;25(2): In Press

Wednesday, February 6, 2019

HCV Special Conference - Worldwide HCV Epidemiology and Impact of Treatment

February 1-2, 2019 
The goal of the conference is to promote global elimination of hepatitis C infection. World leaders in the related disciplines will assemble to establish the current state of the science and public health challenges. The experts will then formulate the most effective future steps toward elimination.

Executive Director - Publisher, Editor, Reporter: Jules Levin

View slides and commentary from the HCV special conference over at (NATAP), here are a few presentations to get you started:

Baby Boomers; Is There a Need to Re-Focus our Efforts for Hepatitis C Screening Away from Baby Boomers? 23% HCV+ in Rural Drug Users Pennsylvania

Worldwide; HCV Epidemiology and Impact of Treatment 

What Is The Value Of HCV Treatment?
The Cost of HCV Elimination

Begin here:

Monday, February 4, 2019

Gilead's hepatitis C generics are on their way, but Epclusa's getting TV ads anyway

Gilead's hepatitis C generics are on their way, but Epclusa's getting TV ads anyway 
by Beth Snyder Bulik | Feb 4, 2019 
Gilead Sciences isn't letting a few of its own generics interfere with advertising its pan-genotypic hep C drug Epclusa. The Big Biotech is turning to TV again to promote its hep C franchise, this time with a commercial that highlights Epclusa's versatility across different strains of the disease.

The TV commercial features multiple patients disclosing details about their individual hep C infections, such as whether the viral strain was rare or common, whether they are symptomatic, and whether they're newly diagnosed or long knew they had the disease.
Read more: 

On This Blog
HCV-treatment: cost, access and generic versions 
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions implemented by private insurers/Medicaid/Medicare and the effectiveness, safety and availability of generic versions of hepatitis C medications.

Sunday, February 3, 2019

Interferon-free hepatitis C therapies: barriers to adherence and optimizing treatment outcomes

Research Article
Experiences with interferon-free hepatitis C therapies: addressing barriers to adherence and optimizing treatment outcomes 
Avy A. Skolnik, Amanda Noska, Vera Yakovchenko, Jack Tsai, Natalie Jones, Allen L. Gifford and D. Keith McInnes
Received: 24 August 2018
Accepted: 14 January 2019
Published: 1 February 2019

Despite medications with increased efficacy and effectiveness, and few onerous side-effects, there is much to be learned about achieving high rates of SVR while delivering positive patient treatment experiences. Newer HCV medications carry considerable financial costs, and are not without context-related adherence barriers, side effects, and potential for complex dosing. This suggest that even amidst optimism about dramatically reducing rates of HCV, patient access to medications, treatment adherence and treatment completion remain critical issues in combatting HCV.

Millions of Americans are living with hepatitis C, the leading cause of liver disease in the United States. Medication treatment can cure hepatitis C. We sought to understand factors that contribute to hepatitis C treatment completion from the perspectives of patients and providers.

We conducted semi-structured interviews at three Veterans Affairs Medical Centers. Patients were asked about their experiences with hepatitis C treatments and perspectives on care. Providers were asked about observations regarding patient responses to medications and perspectives about factors resulting in treatment completion. Transcripts were analyzed using a grounded thematic approach—an inductive analysis that lets themes emerge from the data.

Contributors to treatment completion included Experience with Older Treatments, Hope for Improvement, Symptom Relief, Tailored Organized Routines, and Positive Patient-Provider Relationship. Corresponding barriers also emerged, including pill burden and skepticism about treatment effectiveness and safety.

Despite the improved side-effect profile of newer HCV medications, multiple barriers to treatment completion remain. However, providers and patients were able to identify avenues for addressing such barriers.

Continue to full-text article available online:

Saturday, February 2, 2019

Hepatitis C - Generic DAAs achieve excellent cure rates in Egypt

Source: infohep
Treatment Outcomes

Generic DAAs achieve excellent cure rates in Egypt matching those of branded drugs at a fraction of the cost
Michael Carter / 01 February 2019
Generic direct-acting antivirals (DAAs) are just as effective and safe as their branded equivalents for the treatment of chronic hepatitis C virus (HCV) infection, according to Egyptian research published in Liver International. Generics achieved...


On This Blog
Controversy and barriers over hepatitis C drugs
Link to news articles addressing barriers to hepatitis C treatment, for instance insurance restrictions of these therapies by private insurers Medicare or Medicaid. In addition review research articles on the effectiveness, safety and availability of generic versions of hepatitis C medications.

Friday, February 1, 2019

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas

In case you missed it

DOI: 10.1200/JOP.18.00525
Journal of Oncology Practice
Published online before print January 22, 2019
PMID: 30668219

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas 
Laura Tenner, MD, MPH12; Trisha V. Melhado, MPH2; Raudel Bobadilla2; Barbara J. Turner, MD, MSED2; and Robert Morgan, PhD3

Source - Journal of Oncology Practice 

Mortality rates for hepatocellular carcinoma (HCC) are increasing faster than those of any other cancer, nearly doubling since the 1980s.1 Only one in five individuals diagnosed with HCC will survive 5 years after diagnosis despite the improvements in treatment.1 One of the top three contributing factors to HCC deaths is the high prevalence of hepatitis C virus (HCV) infection.1,2 The number of US residents currently infected with HCV is estimated at approximately 3.5 million.3 Baby boomers account for 81% of all new HCV diagnoses, and this cohort has the highest rates of HCV-related liver transplantation secondary to the development of HCC.4 Connecting patients infected with HCV to care has been problematic because approximately half of individuals with HCV are asymptomatic and are not seeking treatment.5,6

The need for HCV screening has increased significantly as a result of the development of highly effective direct-acting antiviral (DAA) treatments, which can cure more than 90% of patients.7 Curing HCV offers long-lasting, substantial health benefits including reduction in the incidence of liver cancer.7 A consensus committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) has proposed a strategy to decrease the prevalence of HCV by 2030.5 Their models predict that, if 260,000 patients can be treated annually, the incidence of HCV would be reduced by 90% relative to 2015 levels. This model presumes that all patients with chronic HCV infection would be treated, regardless of their level of fibrosis. In an effort to increase capacity to meet these treatment goals, the NASEM committee recommended using primary care as a result of the limited number of specialists to meet the high demand for HCV treatment.5 Moreno et al8 reported that expanding coverage to patients regardless of their fibrosis level was highly cost effective and saved a net social benefit of $500 billion at a $150,000 per quality-adjusted life-year valuation. The study found that the benefits of treatment extended beyond immediate improved patient health by decreasing the pool of individuals who can transmit the infection and by decreasing future health care expenditures related to end-stage liver disease.8

However, treating this population has significant challenges. For example, Texas has one of the highest liver cancer death rates in the nation.1 South Texas, specifically Region 11, encompasses a 19-county area in the Rio Grande Valley and has the highest prevalence of liver cancer in the state.9 Over the course of implementing screening and treatment guidelines, significant challenges to addressing the HCC epidemic have been identified in this region. Up to a third of individuals live in poverty, well above the state average of 17.5%, and up to a third of individuals are without health insurance (state average of 24.8%).10 This population tends to be less educated with less health care literacy.11 Furthermore, this region is more than 50,000 square miles, and access to health services is limited by lack of transportation and poor proximity to care.10 These factors all present major challenges to screening and treatment of HCV. There is a significant need for health policy to increase funding or reimbursement for social services in this region and regions like these around the United States.

Yet even privately insured individuals can experience significant cost barriers to care if they are found to be chronically infected with HCV. Because screening is a US Preventative Services Task Force recommendation,12 HCV tests and supporting laboratories are covered by insurance, but treatment can be difficult to afford. It is not unusual for HCV antiviral therapies that have previously ranged from $60,000 to $80,000 for a 12-week course of treatment to require a 20% to 30% cost-sharing responsibility by the patient.13 AbbVie recently released glecaprevir/pibrentasvir (Mavyret; AbbVie, North Chicago, IL), which has a significantly lower cost than other DAAs on the market at a cost of $13,200 per month or $39,600 for the 12-week treatment.13 This may help decrease the out-of-pocket cost, although the expense of treatment is still sizeable, especially in a region where a significant number of individuals live in poverty. A study of patients seeking treatment for HCV showed significant disparities in accessing these drugs.14 Many insurance companies as well as government-sponsored insurance are striving to decrease spending by limiting access to these medications. Up to 46% of Medicaid, 10% of private insurance, and 5% of Medicare beneficiaries have been denied treatment of HCV.14 This high cost sharing can cause significant financial toxicity to privately insured individuals, and many are faced with the decision to pursue treatment with a significant financial risk or refrain from treatment until they have irreparable damage to their liver. Sadly, it is easier for uninsured individuals to obtain DAAs due to medication assistance programs that provide the drugs for free.15 Health policy change is needed to decrease the out-of-pocket expenditures for insured patients for DAAs.

Texas Health and Human Services reports that more than 4 million individuals in the state rely on Texas Medicaid for their health insurance.16,17 There are particular concerns, however, that Texas Medicaid poses significant challenges for access to HCV care. The National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation of Harvard Law School developed the “Hepatitis C: The State of Medicaid Access” report card for each state.17 Texas was rated poorly, receiving a D+.17 The report identified severely restricted access to HCV medications as a cost-containment measure, citing requirements such as severe liver damage, a prescription written by or in consultation with a specialist, and 90 days of sobriety as the main barriers to medication access. Overall, the report cites restrictions that limit treatment to persons with severe fibrosis as one of the primary barriers to receipt of HCV medication, not just in Texas but across all state Medicaid programs.17

To the first restriction, as emphasized by the NASEM, the benefit of prevention of end-stage disease is greatly diminished or lost with restricting treatment to individuals who already have severe fibrosis. Although immediately cost effective for the organization, the pool of individuals who can transmit the infection will be not substantively decreased, so this measure does not create long-term cost savings. Legislation across all state Medicaid programs is needed to open treatment to all infected individuals.

To the second restriction, Texas Medicaid requires that a board-certified specialist must prescribe the DAA.18 Patients often face transportation challenges for specialist care as a result of the limited number of specialists in rural areas of Texas. Although telehealth programs such as Project ECHO (Extension for Community Healthcare Outcomes),19 which helps to connect primary care providers with specialists using telecommunication, are in existence in South Texas, most clinics serving vulnerable populations lack access to this consultation. More funding is needed for telehealth programs because remote specialist to primary care consultation could play a larger role for Texas Medicaid HCV treatment in South Texas.

Finally, there are restrictive requirements by Texas Medicaid concerning drug and alcohol addiction for treatment of HCV.16 If a patient has a history of illicit drug use, the patient must have initiated a substance use disorder program for 6 months before becoming eligible for treatment.16 In addition, the patient can be denied treatment if he or she consumes alcohol.16 Access to substance use disorder programs in South Texas is a significant barrier for HCV treatment because of the limited availability of treatment programs and transportation concerns.20 Data show no difference between the high rates of sustained viral response for individuals consuming alcohol while on DAAs and those who are abstinent.21 Physicians should lobby Texas Medicaid to remove this restriction. In addition, further funding to support substance abuse treatment is needed across the state.

Medical oncologists have an ethical obligation to advocate for health interventions that aid in the prevention of cancer, especially in settings where there are limited effective cancer treatment options. Although cancer death rates are decreasing in almost every other cancer, they continue to increase in liver cancer. Treating HCV infection could slow the rate of increase of HCC, yet the high price tag on curative treatments for HCV creates significant barriers to patient access, especially in areas with low socioeconomic status. Payers trying to control spending by only treating the sickest patients may undermine the benefit that might be achieved in HCV control and liver cancer prevention. Until these challenges are addressed through effective health policy reform in a collaborative effort between specialists and primary care physicians, not only on a local but also a national level, the serious impact of HCV and HCC on morbidity and mortality will not be mitigated.

Copyright © 2019 by American Society of Clinical Oncology

Hepatitis C: Out-of-Pocket Cost Burden for Specialty Drugs in Medicare Part D in 2019

Published: Feb 01, 2019 
The Out-of-Pocket Cost Burden for Specialty Drugs in Medicare Part D in 2019
Juliette Cubansk, Wyatt Koma, and Tricia Neuman

Medicare Part D enrollees without low income subsidies can expect to pay thousands of dollars out of pocket for a single specialty tier drug in 2019. For many specialty tier drugs, the majority of these costs will occur in the catastrophic phase of the benefit.

Part D enrollees can face thousands of dollars in annual out-of-pocket costs if they take expensive drugs, despite having catastrophic coverage. Expected annual out-of-pocket costs in 2019 average $8,109 across the 28 specialty tier drugs covered by some or all plans in this analysis. For 28 of the 30 studied specialty drugs used to treat four health conditions—cancer, hepatitis C, multiple sclerosis (MS), and rheumatoid arthritis (RA)—expected annual out-of-pocket costs for a single drug in 2019 range from $2,622 for Zepatier, a treatment for hepatitis C, to $16,551 for Idhifa, a leukemia drug. Two of the 30 drugs are not covered by any plan in our analysis. (See Tables 1 and 2 for drug-specific cost and coverage information.)

Figure 3: While out-of-pocket costs for some hepatitis C drugs have decreased since their introduction, Part D enrollees still pay thousands of dollars for these medications

Wednesday, January 16, 2019

No-haggle policy on drug pricing cost Medicare at least $14.4B

Becker's Hospital Review

No-haggle policy on drug pricing cost Medicare at least $14.4B, study finds
Written by Alia Paavola | January 15, 2019
Medicare Part D could have saved $14.4 billion on the top 50 medications covered in 2016 if the program had been able to pay the same prices as the Department of Veterans Affairs, which often negotiates discounts...
In particular, the VA spent $1.7 billion of Gilead's Harvoni hepatitis C treatment in 2016, compared to Medicare Part D, which spent $3 billion on the drug...

Saturday, January 12, 2019

HCV requires serious policies and affordable insurance coverage

Of Interest
Q&A: DAA restrictions impact patient care
January 14, 2019
Infectious Disease News spoke with Breskin about why DAAs restrictions were enacted, the current state of treatment denials and how DAA policies should be changed.

The paper draws on participant interview data from a qualitative research study based on a participatory research design that included a peer researcher with direct experience of both hepatitis C DAA treatment and injecting drug use at all stages of the research process.

The role of insurance providers in supporting treatment and management of hepatitis C patients
Masoud Behzadifar, Hasan Abolghasem Gorji, Aziz Rezapour, Meysam Behzadifar and Nicola Luigi Bragazzi

BMC Health Services Research201919:25

Excerpt from the article:
In order to cope with the high costs of the new DAA regimens, some insurers are restricting access to medications, establishing selective criteria for reimbursement. Gowda and collaborators performed a prospective cohort study among American HCV patients (Open Access Published online 2018 Jun 7). Authors found that absolute denials of DAA regimens by insurers have remained high and increased over time.

Received: 24 April 2018
Accepted: 4 January 2019
Published: 10 January 2019

Full-text article
Read Online
Download PDF

The role of insurance providers in supporting treatment and management of hepatitis C patients
Today, one of the most important global public health challenges is represented by hepatitis C virus (HCV), which imposes relevant costs. Globally speaking, the median cost of HCV-related complications ranges from $280 for an uncomplicated hepatitis to $139,070 for a liver transplantation. There are effective therapies for HCV patients worldwide, which has increased the hope of improving the process of managing and curing these patients. The adherence of patients to the pharmacological treatment and the use of effective drugs in the management of HCV disease are of crucial importance for health policy- and decision-makers. Studies show that, globally, insurance coverage for patients with HCV is not adequate in that still many patients are not covered by insurance programs. This issue as well as the economic conditions of countries are very serious challenges for ensuring an effective treatment. The most important and greatest help currently available to ensure HCV treatment is to implement plans to reduce costs and support patients. Some studies have shown that the expansion of coverage by private payers seems able to generate positive spillover benefits to public insures. Insurers, in addition to maintaining and increasing their own interests, are trying to increase their social status as a sponsor of patients. In conclusion, HCV disease requires serious policies and affordable insurance coverage.

Read the full article:

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications. 

Friday, January 11, 2019

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain
Starting this month more hepatitis C patients can qualify for care under Iowa Medicaid. But some doctors and advocates argue the remaining restrictions are immoral and illegal.

Previously, only Iowans with more advanced liver disease, a fibrosis score of F3 or above, would qualify for treatment. As of January 1, 2019, those with a score of F2 and above can request the treatment from their doctor through a process known as prior authorization, which requires they meet certain criteria beyond their need for the treatment.
Continue reading: 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs

Washington Post: To Your Health - January 10, 2019 

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs
Louisiana will use the 'Netflix' model, with the goal of treating 10,000 people with hepatitis C in its Medicaid and prison population by 2020.
By Carolyn Y. Johnson January 10 at 5:49 PM

Instead of paying for each prescription individually, Louisiana Gov. John Bel Edwards (D) said the state would essentially pay a subscription fee to a drug company, an alternative payment arrangement that has become known as the “Netflix model.” The state would then get unlimited access to the drug, similar to how consumers pay a monthly fee to stream unlimited television shows and movies.
Continue reading: 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Sunday, January 6, 2019

Medicaid patients in Puerto Rico don’t get coverage for drugs to cure hepatitis C

Medicaid patients in Puerto Rico don’t get coverage for drugs to cure hepatitis C
By Carmen Heredia Rodriguez
January 4, 2019
Drugs that can cure hepatitis C revolutionized care for millions of Americans living with the deadly liver infection. The drugs came with a steep price tag — one that prompted state Medicaid programs to initially limit access to the medications to only the sickest patients. That eased, however, in many states as new drugs were introduced and the prices declined.

But not in Puerto Rico. Medicaid patients in the American territory get no coverage for these drugs.

The joint federal-territory health care program for the poor — which covers about half the island’s population — does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail.

The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV but expanded the program later to those with only hepatitis C. However, according to the Office of Patient Legal Services, an official territorial agency that advocates for consumers, the program ran out of funding and is no longer accepting patients only with hepatitis C.

The Puerto Rico Health Insurance Administration (ASES), which oversees Medicaid, said it is working with a pharmaceutical company to create a cost-effective system to provide these medications.

“Definitely, they need to be given coverage,” said ASES director Angela Ávila Marrero. “They need to be given care.”

Hepatitis C, a bloodborne infection, increases the risk of cirrhosis, liver cancer and death. Poor screening led many to contract the disease through tainted blood and organ transplants into the early 1990s. Today, intravenous drug use drives most of the new cases in the United States.

William Ramirez, executive director of the American Civil Liberties Union of Puerto Rico, said he is considering filing suit against Puerto Rico for failing to cover the cost of these medications for people enrolled in Medicaid.

“You’re holding back medication and thereby allowing certain people to die,” Ramirez said.

That reality is clear for Hector Marcano, 62, who stopped working roughly six years ago because of the illness. After recovering from a drug addiction, he was a case manager who worked to connect drug users to health resources.

His liver disease is leading to overall deterioration. He struggles with walking. A bout of pneumonia that left him hospitalized lingers in his racking coughs. He spends his days reading, listening to the radio and praying for the strength to keep searching for the cure.

He doesn’t understand why the government does not provide hepatitis C medications, he said, especially as there are so many people in need of them.

“So what are we waiting for?” asked Marcano. “For a pandemic to happen?”

Medicaid Costs Drive Island’s Debt Crisis

Hepatitis C afflicts approximately 3.5 million people in the United States. The virus can silently corrode the liver for years without causing symptoms.

Because of the condition’s stealthy nature and the absence of recent data, the number of people in Puerto Rico living with the virus is uncertain. Researchers on the island in 2010 estimated 2.3 percent of 21- to 64-year-old residents had the virus.

Documents provided by the Center for Health Law and Policy Innovation of Harvard Law School show medical providers reported more than 11,000 hepatitis C cases to the Puerto Rico Department of Health from 2010 to September 2016.

Cynthia Pérez Cardona, an epidemiology professor at the University of Puerto Rico and an author of multiple studies involving hepatitis C in Puerto Rico, said she is uncertain of how widespread the virus is on the island. But other statistics present a worrisome sign: A report from the island’s cancer registry found the number of new liver cancer cases increased an average of 2.1 percent annually among men and 0.7 percent among women from 1987 to 2014. Hepatitis C can cause such cancers.

Despite these warnings, Puerto Rico has fewer resources than most of the nation to care for its impoverished.

Unlike states, Puerto Rico’s federal funding for Medicaid is capped. Historically, these federal dollars have fallen far short of covering the program’s costs on the island. The territory’s crushing Medicaid expenses helped drive the island into its $70 billion debt crisis.

Under these financial constraints, said Matt Salo, executive director of the National Association of Medicaid Directors, Puerto Rico’s officials are left with a difficult choice when considering covering hepatitis C drugs.

“Rather than blowing through their cap in six months,” Salo said, “they’d blow through their cap in one month.”

Pilot Project Falls Short
In the health department’s pilot project, patients with certain conditions like uncontrolled diabetes or an active mental health condition or those who could not prove they had been sober for six months were barred.

Such restrictions rankle patients and their advocates. “You know, we do not deny lung cancer treatment for a person who smokes or diabetes treatment to a person that doesn’t eat well,” said Robert Greenwald, a professor at Harvard Law School and faculty director of the Center for Health Law and Policy Innovation.

Dr. José Vargas Vidot, a member of Puerto Rico’s Senate and a physician, submitted a petition in 2017 to various territorial agencies questioning Medicaid’s coverage of hepatitis C medications.

The Office of Patient Legal Services responded to Vargas Vidot in a letter this year confirming that the island’s Medicaid program did not cover these drugs. It also noted the health department pilot project closed its wait list after reaching 100 patients because of a lack of funding. In November, Vargas Vidot submitted legislation to require that hepatitis C medication and treatment be part of basic coverage for insurance plans and Medicaid.

Ávila Marrero said ASES is in talks with a drugmaker to create a network separate from the Medicaid program to provide medications to the patients. She said she hopes the arrangement will allow the government to get lower prices for the drugs. But no agreements have yet been reached for such a program.

Despite its success in states, suing to get coverage may not be the best option for Puerto Rico because the debt rescue package passed by Congress in 2016 includes a provision that bars creditors from taking legal action to collect from the territory.

That could apply to a lawsuit filed against the territory for not covering hepatitis C treatment in its Medicaid program, said Phillip Escoriaza, a health and federal grants law attorney in Washington, D.C., who practiced in Puerto Rico. And even if the case can go forward, it would enter the docket for a special bankruptcy court with more than 165,000 other claims, as of Dec. 14. It may be in the Puerto Rican government’s interest for things to take a long time, said Escoriaza. Once there, it could stall for years — time hepatitis C patients such as Marcano might not have.

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions.

Wednesday, December 5, 2018

Appeal lodged against decision to uphold Gilead’s patent on hepatitis C drug

Video - The story of sofosbuvir illustrates how research and development for new prescription drugs really works: When Big Pharma plays for keeps, who wins and who loses?

Appeal lodged against decision to uphold Gilead’s patent on hepatitis C drug
Press Release
5 December 2018
Paris – Six organisations, including Médecins Sans Frontières (MSF), have just appealed the European Patent Office’s September decision to uphold US pharmaceutical corporation Gilead Science’s patent on the key hepatitis C drug sofosbuvir.

The appeal – filed by Médecins du Monde (MdM), MSF, AIDES (France), Access to Medicines Ireland, Praksis (Greece) and Salud por Derecho (Spain) – states that the European Patent Office (EPO) should revoke Gilead’s patent because it does not meet the requirements to be a patentable invention from a legal or scientific perspective.

The appeal comes exactly five years after sofosbuvir was first approved for use, in the US, where Gilead launched the drug at US$1,000 per pill, or $84,000 for a 12-week treatment course.

The corporation has made more than $58 billion from sales of the drug and its combinations in the last five years.

In March 2017, civil society organisations from 17 European countries filed a challenge against Gilead’s patent on the base compound of sofosbuvir, stating that Gilead’s patent claims were not legitimate, primarily because they lack inventiveness. 

Out-of-control drug prices 
Gilead’s monopoly on sofosbuvir in Europe has allowed the corporation to charge excessive prices for the drug.

In some European countries, Gilead charges as much as €43,000 for a 12-week treatment course, when generic versions of the same course can be purchased for less than €75 outside Europe.

"What is the point of medical innovation if people and health systems cannot afford the products coming out of it? Gaëlle Krikorian, head of policy at MSF’s Access Campaign"

These exorbitant prices have forced health systems to ration sofosbuvir, leaving thousands of people in Europe with hepatitis C without treatment.

Despite compelling arguments presented by the organisations opposing the patent, on 14 September 2018 the European Patent Office (EPO) decided to uphold Gilead’s patent, thereby making it impossible to produce or sell affordable generic versions of the drug in Europe.

“The EPO is being too lenient with pharmaceutical corporations, giving them a free pass,” said Olivier Maguet of MdM’s drug pricing campaign. “There needs to be much greater scrutiny in Europe when it comes to determining whether pharmaceutical corporations deserve patents or not; otherwise, unmerited monopolies will continue to result in out-of-control drug prices.”

The appeal aims to put an end to pharmaceutical corporations’ abuse of medicines patenting systems to increase their own profits – including in countries outside Europe, where patent offices often follow the EPO’s decisions when they decide whether to grant a patent to a pharmaceutical corporation or not.

As some new patented drugs – such as those to treat cancer – come to market with price tags reaching €400,000 per person, there is an urgent need to reform patent systems so that people have access to the medicines they need to stay alive and healthy.

“Unmerited patents in Europe are giving pharmaceutical corporations the monopoly power that allows them to charge exorbitant prices for many lifesaving drugs,” said Gaëlle Krikorian, head of policy at MSF’s Access Campaign.

The excessive prices Gilead is charging for sofosbuvir have kept this breakthrough medicine away from millions of people with hepatitis C in Europe and around the world. What is the point of medical innovation if people and health systems cannot afford the products coming out of it?”

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, as well as addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Tuesday, November 27, 2018

Wall Street - Curing diseases like Hepatitis C just doesn’t pay

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

In The News
Wall Street Wants the Best Patents, Not the Best Drugs
Curing diseases like Hepatitis C just doesn’t pay.
Joe Nocera
‎November‎ ‎27‎, ‎2018‎ ‎8‎:‎00‎ ‎AM‎ ‎EST 
It’s probably unfair to start a column about the new drugs that are curing Hepatitis C by referencing Jonas Salk and the discovery of the polio vaccine, but I’m going to do it anyway. It’s worth remembering what the world used to look like as we contemplate what it looks like now.

In the late 1940s and early 1950s, there was nothing that scared American parents more than polio, a disease that a) caused partial paralysis, b) was easily transmitted, and c) primarily affected children. Salk, who had worked on flu vaccines during World War II, joined the University of Pittsburgh in 1947 and soon began working on a possible polio vaccine. In 1953, he announced — on a national radio broadcast, no less — that he had developed a vaccine that prevented the disease; two years later, once its efficacy had been proven, the country undertook a national inoculation program, paid for by the federal government.
Read More:

Sunday, November 25, 2018

In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)

In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)
Jorge Mera, MD, Brigg Reilley, MPH, Jessica Leston, David Stephens, RN


The American Journal of Medicine
Publication History
Published online: November 24, 2018

Recent advances in Hepatitis C Virus HCV treatment could be described as revolutionary: for uncomplicated patients, treatment is nearly 100% effective, oral-only, has a low pill burden, minimal side effects, and results in a cure.1 Comparisons we have heard from clinicians are that HCV is now easier to treat than either diabetes or hypertension. Unfortunately for many patients, their state of residence is the decisive factor for whether they will receive lifesaving treatment. As part of a tribal telehealth network for HCV, we support several rural clinics successfully treating HCV and see this dilemma all too frequently.

Consider a patient with chronic HCV infection who presents with a recent history of marijuana use and has been late picking up hypertension medication. The patient has cirrhosis and is at high risk of HCV related mortality. He is enrolled in state Medicaid and highly motivated for treatment. What is the treatment plan? It depends on the state. A resident of New Mexico can start treatment without delay. If instead the patient lives in Montana, a state that determines treatment eligibility based on advanced liver fibrosis, documented sobriety, and compliance with existing medications, the consultation is effectively moot; treatment will be denied. Montana is far from alone in its HCV treatment restrictions. Patients in South Dakota, Oregon, and several other states we serve face similar hurdles …

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Current Issue
November 2018
Volume 131, Issue 11 

Saturday, November 24, 2018

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks

Hepatitis C treatment can be shortened in 50 percent of patients, study finds
Shorter treatment times could significantly reduce costs of the expensive therapy

Slides available online @ NATAP

AASLD The Liver Meeting 2018

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks
Last Updated: 2018-11-23
By Lorraine L. Janeczko

NEW YORK (Reuters Health) - In about half of patients with hepatitis C virus (HCV) infection, response-guided therapy with oral direct-acting antiviral agents (DAAs) can be reduced from the standard 12 weeks to as little as six weeks and still be effective, according to a new pilot study.

DAAs have revolutionized hepatitis C treatment, eliminating the virus and enabling a cure with minimal side effects in over 90% of patients treated. But the high cost, which can exceed $50,000 per patient, limits patient access and burdens the insurance industry, researchers write in a press release.

"Implementing response-guided therapy as standard of care may lead to significant cost savings on the expensive hepatitis C treatment," senior author Dr. Amir Shlomai of Beilinson Hospital in Petah-Tikva, Israel, told Reuters Health by email.

The team enrolled 22 HCV patients with compensated liver disease and genotypes 1 to 6, who were either treatment naive or interferon experienced. Participants were treated with one of four DAA regimens chosen by the investigators.

Viral load was measured at baseline, at day 2, and at weeks 1, 2, and 4 after the start of treatment. The primary endpoint was the proportion of patients with sustained virologic response at 12 weeks (SVR12) post-treatment, with undetectable HCV RNA (<15 IU/mL).

The researchers presented the preliminary proof-of-concept results in a late-breaking abstract poster session on November 12 at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in San Francisco.

Participants averaged roughly 50 years of age, 11 were female and 9% had METAVIR scores of F3-4. The most common genotypes were G1b (59%) G3 (27%), G1a (9%), and G2 (5%).

The drug combinations sofosbuvir/velpatasvir, elbasvir/grazoprevir, sofosbuvir/ledipasvir and glecaprevir/pibrentasvir were administered to 41%, 31%, 23% and 5% of participants, respectively.

Mathematical modeling of viral kinetics was performed during weeks 2-4 to project time to cure, and model projections were used to individualize each participant's treatment duration.

Modeling predicted that treatment duration could be shortened to 10 weeks in one patient (5%), eight weeks in eight (36%) and six weeks in two (9%).

Of the 19 participants who completed therapy, 100% had undetectable viral load at the end of treatment. Of those, 18 (95%) remained HCV-undetectable four weeks after treatment.

Of the 15 patients who reached post-treatment week 12, 14 (93%) achieved SVR12.

One treatment-naive G3 patient with F1 fibrosis who was treated with sofosbuvir/velpatasvir for six weeks relapsed. Virus sequencing did not detect resistance-associated substitutions at baseline or in response to treatment, and no significant side effects were found among the DAA-treated patients.

"A shorter treatment may lead to improved compliance to treatment, especially in special populations, including hepatitis C patients with limited health insurance benefits," Dr. Harel Dahari of Loyola University Chicago in Maywood, Illinois, who also worked on the study, told Reuters health by email.

Dr. Dahari estimates that the shorter treatment may potentially decrease the cost of HCV drugs by up to 20%.

Now that the proof-of-concept pilot study has shown that response-guided therapy can potentially reduce treatment times, a large multicenter trial to validate the results is underway in Israel, the authors say.

Clalit Health Services in Israel and the United States National Institutes of Health helped support the study. The authors state that they have no conflicts of interest.

SOURCE: LB-34 Response-Guided Therapy with Direct-Acting Antivirals Shortens Treatment Duration in 50% of HCV Treated Patients

AASLD The Liver Meeting 2018.

Thursday, November 22, 2018

Blogging About Liver Disease: Reasons To Be Grateful

Happy Thanksgiving! This year, and every year, I am grateful for a small group of talented bloggers who continue to keep us informed about all types of viral hepatitis.

In the spirit of the holiday, each blog has featured many reasons to be thankful this year; from curing HCV to improving the treatment of HIV.

Latest Articles 
Some of the following blogs are published by support organizations, healthcare professionals or physicians, while others are written from a patients perspective, offering us healthy tips about each stage of liver disease.

New @ HIV and ID Observations
Paul E. Sax, MD
As noted here before, I’m a big fan of Thanksgiving, a great excuse to get together with family and friends, and to eat a gargantuan amount of food.*

Hepatitis B Foundation
Holidays with Hepatitis B: How to Tell Your Family
As the holidays approach, families are planning parties and dinners and preparing to spend time with their loved ones. In such a merry atmosphere, the idea of discussing hepatitis B – whether its a recent diagnosis or the first time that you are ready to disclose your status – may be intimidating. However, it doesn’t have to be! In honor of National Family Health History Day – which falls on Thanksgiving – we put together some tips to help you start the conversation.

Joseph Galati, M.D.
Tips for a Healthier Holiday
Ahh, the holidays. A time to celebrate all the good that has come our way during the previous year. First up: Thanksgiving. What better way to begin the year-end wrap-up than to sit down at a hearty meal with family and friends? But the holidays are arguably the toughest time of the year to eat..

Hep Blogs
Finding Gratitude in Sickness, Health and Hepatitis 
By Lucinda K. Porter, RN
Some good news in the hepatitis C realm, plus a look at the practice of gratitude.

Mavyret versus Epclusa
By Greg Jefferys
Both Mavyret and Epclusa give cure rates above 97% for all genotypes of Hepatitis C except for G3 where both give a cure rate of around 95%.

The End Times
By Grace Campbell
Who gave cirrhosis such a catchy generic title? End stage liver disease. There’s a name sure to invoke confidence.

Liver Meeting 2018 Wrap-Up: Vaccines, Diet, and an Increasing Liver Menace 
By Lucinda K. Porter, RN
Ending the week with summaries of research from the 2018 Liver Meeting. I cover hepatitis B vaccination, diet and alcoholic liver disease.
Options for Treatment with Liver Cancer
By Karen Hoyt
After my diagnosis of liver cancer, I had to find out what options for treatment were available.

ADRLF (Al D. Rodriguez Liver Foundation)
Who says a fantastically delicious Thanksgiving spread can’t be healthy? This year, make your Thanksgiving feast even more special with these liver-healthy options that won’t give you or your family that post-holiday guilt; nor will they keep you stuck in the kitchen for hours on end! Check out these appetizing recipes for a healthy, scrumptious, easy-to-prep (or time-saving) Thanksgiving meal!

Finding Hope in Affordable Hepatitis Screening
Screening remains to be the best defense against detecting the hepatitis virus in its earliest stages, and potentially developing life-threatening complications, later down the line. Dubbed as the “silent killer,” hepatitis doesn’t exhibit obvious symptoms in many people, who may live, comfortably, with the virus for years and only discover their condition at its advanced, acute stage. Noting the importance of the timeliness of testing, Texas-based Link2Labs is making affordable hepatitis C tests available to uninsured and underinsured people.

HCV News
Weekly Review
Catch up on what you missed this week, read HepCBC's - Weekly Bull.

FYI - Lettuce Recall 
“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

AGA Journals - Blog
Dr. Kristine Novak
Persistent drinking of very hot coffee can cause exfoliative esophagitis due to thermal injury, researchers report in the November issue of Clinical Gastroenterology and Hepatology. Florian Schertl et al describe the case of a 55-year-old woman with new retrosternal pain upon swallowing. She had been receiving continuous and successful proton pump inhibitor.

Fatty Liver Disease
Canadian Liver Foundation
It Happened To Me | My Fatty Liver Journey
Melanie was all too familiar with fatty liver disease, with her husband being diagnosed 5 years earlier. But, she never thought it would happen to her.

The Flu & You
Canadian Liver Foundation
What’s intended to help shouldn’t hurt
Before you head to the cabinet for medication, there are a few things you should know to ensure that what you take will help, not hurt.

One Medical blog
So you’ve come down with a nasty bug that’s been making the rounds.

This Blog
Flu Activity Updated Nov 10/News Articles Nov 16
Weekend Reading - Baby Boomers and the Flu

Recommended Blogs
Dr Paul Gow talks all things the liver and answers call-in questions on ABC Nightlife 

Source - Hepatitis Victoria

On Twitter
Shared by @HenryEChang 

Just Because
Matthew Kaskavitch
CU Anschutz Medical Campus experts share Thanksgiving health insights
Thanksgiving is almost here, and that means two things: 1) time spent with family and friends around the television watching football, and 2) eating turkey. Lots and lots of turkey. At this time of year, we often overindulge and loosen our belt and wonder how we fit all that stuffing and gravy into our stomach. Don’t worry. We asked leading health experts from the University of Colorado Anschutz Medical Campus a few of the Thanksgiving questions you’ve always wanted to know the answer to.

Happy Thanksgiving!