Monthly Archives: September 2018

3rd Annual National Monitoring Report on HIV/HCV Co-Infection Recap

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The Community Access National Network (CANN) hosted its 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection on Wednesday, September 19th in Washington, DC, at PhRMA Headquarters. Presenters included Marcus  J. Hopkins (the author), Amanda Bowes (National Alliance of State and Territorial AIDS Directors – NASTAD), Jack Rollins (National Association of Medicaid Directors), and Ayesha Azam (Patient Access Network – PAN – Foundation).

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

I presented on the progress that’s been made in expanding access to Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) in state Ryan White AIDS Drug Assistance Programs (ADAPs), Medicaid programs, and the Veterans Administration. In addition, I discussed some of the issues facing Harm Reduction measures (e.g. – Syringe Services Programs, Doctor Shopping laws, Prescriber Education requirements, et cetera), as well as CANN’s foray into Correctional Healthcare.

One key finding is that, as of September 2018, 39 state ADAP programs (most recently, Mississippi) have expanded their formularies to include coverage for HCV DAAs. By comparison, when the HIV/HCV Co-Infection Watch (CANN’s monthly report) began in January 2015, only 7 states offered expanded coverage. In addition, on the correctional healthcare front, there are currently at least 16 HCV-related lawsuits active in 14 states.

You can find my presentation at the following link:

Amanda Bowes, a Manager on NASTAD’s Health Care Access Team, presented on NASTAD’s work with Ryan White programs to expand access to treatment, as well as previewing a forthcoming PDF and web-based consultation tool – “Strategies to Increase Access to Hepatitis C (HCV) Treatment within ADAPs: Provider Decision Tree”– for providers to consult when determining how their patients living with HCV can pay for treatment.

In addition to this fantastic resource, Amanda also presented statistics about HIV/HCV Co-Infection within Ryan White programs. In calendar year 2016, over 1,000 (2%) across 15 ADAPs were reported as being co-infected with HCV at some point during the year. Of those, 336 (32%) of these clients received treatment for their HCV, and of those who were treated, 160 (48%) were reported as cured.

You can find Amanda’s presentation at the following link:

Jack Rollins, Senior Policy Analyst with the National Association of Medicaid Directors, presented on some of the opportunities to lower the costs of prescription drugs within state Medicaid programs. One of the most popular methods of controlling prescription in European markets is through the use Value-Based Purchasing (VBP), a concept that the U.S. has been loath to adopt in our traditional Fee-For-Service healthcare market.

The general idea behind “Value-Based Purchasing” (at least in nations with universal healthcare) is that purchasers – the buyer of the drugs prior to distributing them to patients – pay for drugs only when they prove “effective.” As that relates to HCV, the payor would only pay for the cost of the DAA if the patient achieves Sustained Virologic Response (SVR) – if the patient is cured of HCV.

VBP, as it’s currently being discussed in the U.S., looks much different. Currently, Oklahoma is the only state whose Medicaid program has an approved VBP, but the details of that are largely unavailable to the public due to existing trade secrets laws – a consistent sticking point with healthcare advocates that allows pharmaceutical companies and payors to “hide” the actual cost of medications.

Jack also mentioned two more states, Louisiana and Massachusetts, the latter of which recently had their VBP proposal denied by the Centers for Medicare and Medicaid Services (CMS). Massachusetts’s proposal was proposed to be limited in scope, proposing limited coverage for certain therapeutic drug classes with a robust exceptions process and would be tied to coverage decisions made by a Pharmacy Benefits Manager (PBM) and/or state employee benefits. Although this proposal was denied by CMS, several other states are interested in this idea.

Louisiana is looking at VBP policies specifically targeted at HCV DAA drugs, terming it the “Netflix for HCV.” Their idea would pool Medicaid and state Corrections populations under a model that would pay a flat amount to a drug manufacturer (say, Gilead) in exchange for unlimited access to their drug (say, Gilead’s Epclusa). Essentially, Louisiana would play a flat fee and be able to prescribe as much (or as little) of the drug as needed to treat patients and inmates with HCV.

You can find Jack’s presentation at the following link:

Ayesha Azam, Senior Director of Medical Affairs at the PAN Foundation, presented on the important of Co-Pay Assistance in underinsured populations. In defining who is considered “underinsured,” PAN goes by the following descriptors:

  • Individuals who spend more than 10% of their annual income on out-of-pocket medical expenses
  • Individuals who spend more than 5% of their annual income on deductibles
  • Individuals whose income is less than 200% of the Federal Poverty Level and medical expenses are greater than 5% of annual income
  • Seniors who do not have funds or who fall into the “donut hole” (where they have outspent their annual benefit, but have not reached the Medicare catastrophic coverage level)

So, using those descriptions, I’ll present my own information:

My health insurance through Highmark West Virginia BlueCross/BlueShield has a deductible of $4,000, which for me is around 12% of my annual income. My Out-of-Pocket Maximum is $5,000, around 15% of my annual income. With that in mind, let’s look at my Out-of-Pocket costs for the first quarter of 2018:

Doctor Visit Co-Pays (01/18 – 03/18): $246.34

Blood Work (single visit on 02/06/18): $1,785.00

HIV Meds (01/18 – 03/18): $768.00

Endoscopy (02/28/18): $278.68

Anesthesia (02/28/18): $440.50

TOTAL: $3,518.02

Add on a couple more months of the medications, and another volley of blood work in June, and I’ve hit both my deductible AND my out-of-pocket maximum before I’ve ever reached half-way through the year.

Using PAN’s definitions, I am critically underinsured; what’s worse is that the vast majority of plans made available through West Virginia’s health insurance marketplace are shifting further towards high deductible plans that tack on co-insurance after the deductible has been met (mine is 10% co-insurance), and I’m looking at spending nearly 1/3 of my annual income justfor my healthcare.

Without the West Virginia Ryan White Program, I would likely be so far underwater with medical bills (which I am), that I couldn’t even see to swim to the surface. Worse, still, is that, for HCV patients, there is noRyan White-type program to provide them with that level of financial assistance, leaving them to essentially fend for themselves.

This is where organizations like the PAN Foundation step in with Patient Assistance Programs (PAPs). In order to qualify for assistance with PAN, a client must be underinsured and make below 400%-500% (depending upon the fund-specific guidelines) of the Federal Poverty Level (FPL). PAN receives specific funding streams for individual conditions (e.g. – HIV, HCV, diabetes, arthritis, et cetera) and assist with the out-of-pocket costs associated with treatment. They will assist with Co-Pays, Travel to and from doctor appointments, and Insurance Premium payments.

The downside is that the demand for this assistance far outstrips the supply, and because each condition/disease has a specific funding stream, each fund has its own number of clients that can be helped before funds are exhausted. With most HCV drugs be shunted into Specialty Tiers, co-pays for each fill can be $250+ depending upon the insurance plan. To be clear – one member of the PAN Foundation stated, recently, that research indicates any co-pay over $50 to be “unreasonable.” Using that analysis, a single visit to my HIV doctor will set me back $60+, depending upon whether or not I’m assessed a clinic fee on top of my specialist co-pay.

This is where PAN Foundation (and other charitable assistance programs) are vital. Moreover, the vast majority of patients in the U.S. – already a low-healthcare-literacy nation – have no idea that these resources exist, which is a mixed blessing, for PAN: fewer patients knowing about the program means that funds will not be so quickly exhausted; the other side of that coin is that fewer patients will receive the critical financial assistance they need.

You can find Ayesha’s presentation at the following link:

 

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Research Indicates Nearly 30% of Opioid Prescriptions Lack Medical Justification

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

HEAL Blog posts frequently discuss the impact the opioid epidemic has upon the spread of HIV, Hepatitis B (HBV), and Hepatitis C (HCV). One aspect that we’ve discussed – prescribing habits – has recently received further study. According to new research published in Annals of Internal Medicine, 28.5% of opioid prescriptions have no record of either pain symptoms or pain-related conditions justifying their prescription (Scutti, 2018).

The study authors go out of their way to suggest that various causes may contribute to this lack of justification – failure to submit documentation, time constraints, clinic workflows, or complicated documentation systems (Scutti). In recent decades, doctors and nurses, alike, have complained about the complicated and seemingly never-ending amount of paperwork involved in providing even the most basic of care. Much of this is related to the Electronic Medical Record (E.M.R.) – software programs that are designed to account for virtually everything that can, does, or should occur with a patient. Recent studies indicate that doctors spend a little more than half of their work hours doing administrative work, rather than in face-to-face time with patients (Ofri, 2017).

Rx bottle with medicine on top of an Rx order

Photo Source: MedScape

Essentially, any time an insurer, new law, regulation, or threat of legal action appears, new field (or more) pops up in E.M.R. software that requires input on behalf of the doctor. So, realistically, it is possible that the justifications for at least some of the 28.5% of unjustified opioid prescriptions could just have been lost in the shuffle. Doctors are, after all, only human. Very well-trained, highly educated humans, but humans, nonetheless.

The other side of this argument, however, is that “doctors are human.” Doctors, like every human, are susceptible to poor influences – deals made with pharmaceutical companies to prescribe certain medications that highly addictive in lieu of other medications, for example. Or addiction; manipulation by patients; under the table dealing. At least once a week, I read an article about a doctor whose license is being suspended or revoked because they’ve been illicitly prescribing opioids or other narcotics in exchange for [x], or they’ve been selling them on the side. But, even those instances can’t account for all of 28.5%.

Yet another angle is that these drugs have become increasingly regulated since 2006 (the scope of the Annals study is 2006-2015). Since 2015, even more restrictions have been placed upon opioid prescribing, and in most states, this has resulted in dramatic decreases in the number of prescription per capita. In 2017, the opioid prescribing rate had fallen to the lowest it had been in 10 years (Centers for Disease Control and Prevent, 2017). But, even that comes with additional problems: patients turning to “street” sources for prescription opioids; patients moving off of opioids to heroin (often cut with fentanyl or carfentanil), because heroin is easier and cheaper to obtain; the resultant overdoses and increased risk of infection with HIV, HBV, and HCV.

There is no single solution to curbing the opioid epidemic. Doing so is going to require multiple approaches working in conjunction to defeat the problems. Outside of just prescriber education about opioid addiction and increase prescribing restrictions, we must also include and incorporate patient-focused harm reduction measures, such as increasing access to legal Syringe Services Programs (needle exchanges that also provide screening and testing for diseases and linkage to treatment programs for disease and addiction) and increasing access to addiction treatment programs by expanding the number of available beds.

For far too long, we have attempted to deal with these problems with siloed responses – just syringe exchanges; just prescribing restrictions; just prescriber education. This strategy is not working, and moreover, it is more expensive, in the long-run, to continue funding multiple single-focus initiatives that don’t work in tandem with one another, than it would be bring all of these resources and initiatives into one large effort. But, that will require cooperation and a lot of money up front; it’s far more palatable to fund smaller, less effective initiatives because the “ask” is lower on up-front costs. Realistically, though, it needs to be done.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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3rd Annual National Monitoring Report on HIV/HCV Co-Infection

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The Community Access National Network (CANN) will be hosting its 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection on Wednesday, September 19th, beginning at 2:00 p.m. EST. This annual report provides valuable information on the state of Hepatitis C (HCV) treatment coverage, harm reduction measures to prevent transmission of HIV and HCV, and, new to this year, a brief focus on HIV and HCV testing and treatment for individuals currently incarcerated and post-incarceration.

Returning this year are yours truly (as the Project Director for the HIV/HCV Co-Infection Watch and Medicaid Watch), and Amanda Bowes, Manager on the National Alliance for State and Territorial AIDS Directors’ (NASTAD) Health Care Access Team. New presenters for 2018 include Ayesha Azam, Senior Director of Medical Affairs at the Patient Access Network (PAN) Foundation, and Jack Rollins, Senior Policy Analyst at the National Association of Medicaid Directors.

At last year’s National Monitoring Report, I focused on the increase in coverage options for both the Ryan White and Medicaid programs, showing how treatment options have expanded across the country since 2015 (when the HIV/HCV Co-Infection Watch began). Mrs. Bowes provided more detailed information available about coverage, as well as NASTAD’s efforts to expand coverage for Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) within the nation’s AIDS Drug Assistance Programs (ADAPs).

This year’s event is sponsored by the ADAP Advocacy Association, Gilead Sciences, Merck, Quest Diagnostics, Walgreens, and the Pharmaceutical Research and Manufacturers of America (PhRMA).

The 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection can be attended either in person at PhRMA Headquarters in Washington, DC, or remotely for non-DC residents. Registration is free and can be done online. While registration is free, there is limited seating for those attending in person and advanced registration is required to attend.

Learn more at http://www.tiicann.org/events.html#091918cr.

3rd Annual National Monitoring Report on HIV/HCV Co-Infection

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Lower-Priced HCV Drugs Haven’t Improved Treatment Approvals

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

“The Free Market will work! Competition in the Hepatitis C drug market will force prices down, and everything will be okay!”

This has been the mantra of pharmaceutical companies and market watchers since the 2013 introduction of the highly-effective, but extremely expensive Direct-Acting Agents (DAAs) to treat and cure Hepatitis C (HCV). And, in point of fact, prices for treatment have decreased significantly since Sovaldi hit the market with a Wholesale Acquisition Cost (WAC) of $84,000 for twelve weeks of treatment. The latest (and cheapest) drug to hit the market – AbbVie’s Mavyret – sells for “just” $39,600 for twelve weeks of treatment. But, that twelve-week treatment period is for the most aggressive HCV cases; the recommended treatment for most patients is eight weeks, for which Mavyret goes for $26,400.

Curiously enough, however, healthcare payors have done their damnedest to not cover these drugs for patients. A study published in June of this year (2018), insurance companies deny coverage in 35.5% of cases (over 1/3 of the time); for patients with commercial insurance, the denial rates are even higher (Kaltwasser, 2018).

$100 bill with prescription medicine on it

Photo Source: Consumer Reports

As Kaltwasser points out in his MD Magazine article, previous studies published in 2016 indicated that the approval rate was much higher, and that Medicaid denial rates were higher. While Medicaid approval rates have improved (after a 2015 letter from the Centers for Medicare and Medicaid Services to state Medicaid directors informing that denials based on the cost of treatment violated Federal law), that does little to help the 56% of Americans with commercial insurance.

When patients are denied coverage, there are options – Patient Assistance Programs (PAPs) are designed to aid patients who are either underinsured or whose insurance plans deny coverage of certain drugs. Manufacturer-provided PAPs, like those offered by Gilead Sciences and AbbVie, pay for most (if not all) of the out-of-pocket expenses for purchasing the drug, whereas private PAPs, such as the PAN Foundation, provide assistance for patients whose insurance company agrees to pay for treatment and patients need assistance with the out-of-pocket costs.

Another, more common route is the appeals process, which can take weeks, if not months, and requires a lot of extra groundwork from all parties. Some patients have gone through numerous rounds of appeals and denials, just to get an approval. This process is exhausting, and frankly, it’s not good for the health of patients who go through unnecessary stress just to get the treatment they need (and pay).

Worse, still, is that, while the cost to payors has decreased along with WAC prices, the price to consumers has not.  In fact, for many patients, those costs have increased as insurers place HCV DAA drugs in “Specialty Tiers” or the highest payment tiers in their policy, meaning that patients will pay $100+ out-of-pocket for co-pays.

HIV medications – the newer ones, at least – often fall into this “Specialty Tier” as well. My monthly co-pay for my HIV medications, for example, sets me back $250/month on top of the $285+ monthly premium, for a total of over $500/month. Were these costs not covered by West Virginia’s Ryan White program, nearly ¼ of my monthly income would be dedicated solely to treating my HIV, and that leaves out the up to $500 that each of my biannual doctor visits cost me, including the $75 co-pay, plus the cost of the bloodwork, any X-Rays, or procedures I need done.

HCV patients get to go through all that, and worse, without the benefit of a Ryan White-style program that helps to cover the cost of treatment. And the cost of treatment is higher for HCV on an annual basis.

I know I’ve beaten this drum, before, but the fact is this: until such time as the U.S. joins the rest of the modern world and begins offering Universal Healthcare, patients are going to be the ones getting screwed at every turn, in addition to being nickeled and dimed for every cost a provider can cobble together every time they visit a doctor. Insurance company, pharmaceutical company, and for-profit hospital profits will soar, while patients will continue to struggle to afford even poor-quality healthcare that would be unacceptable in every other First World nation, never mind quality, comprehensive healthcare.

In the meantime, patients living with chronic illnesses are just going to have to suffer through denials, appeals, and ever-mounting medical debt that will leave us scraping by from month to month, just to make ends meet. But, hey! At least we won’t have to suffer the indignities of “Socialized Medicine,” where Conservatives insist that, as David Sedaris once put it, “…patients [will] lie dirty cots waiting for aspirin to be invented.”

Lucky. Us.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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