Monthly Archives: November 2015

Paying the Piper

By: Marcus J. Hopkins, Blogger

In the past two installments of HEAL Blog, we’ve discussed the process of Prior Authorization (PA) procedures for patients whose payers – the organization or company who pays for medical services and treatments – require prerequisite paper work and diagnostic tests as qualifiers for treatment. We’ve followed the process through the initial phase of simply qualifying to qualify on through the actual procedural bureaucracy between prescribing physicians, pharmacists, and payers. This week, we’re going to take a new look at some potential alternative forms of payment – Patient Assistance Programs (PAPs).

I say “new” because, as a rule, HEAL Blog has covered the topic of PAPs several times over the last two years. Relatively recent developments in the world of Patient Assistance and payer relations have warranted a new look at the issue, particularly through a far less rosy lens.

Image of a prescription gel cap split open, with money flowing out of it

Photo Source: The Arthritis and Infusion Center

Since Sovaldi (Gilead) first hit the market, back in 2013, it has faced no small amount of controversy. With a Wholesale Acquisition Cost (WAC) averaging around $87,000 for twelve-weeks of treatment, it quickly earned the moniker of “The $1,000-A-Day Pill.” Advocates, activists, patients, physicians, and payers, alike, were all seemingly horrified at this asking price – so much so that Congress held an official hearing specifically related to the drug. What they could not argue with, however, were two things: (1.) the drug’s efficacy at attaining a Sustained Virologic Response (SVR), and (2.) the considerable generosity offered through Gilead Science’s Support Path Patient Assistance Program.

When HEAL Blog initially began reporting on Sovaldi (and its complementary drug, Olysio) in October 2013, the details of Gilead’s PAP had not quite fully been laid out for the public. I spent hours on the phone with Gilead customer service representatives attempting to find out more details about the program, getting shuffled around to various departments, before they finally were ready to put forth their comprehensive plan: Support Path.

Initially, Support Path was open to virtually anyone whose income virtually prohibited them from having access to this life-saving medication. This was prior to the first year of mandated health insurance coverage under the Affordable Care Act (ACA) and the expansion of Medicaid eligibility in all but 19 states, and most insurers and public payers simply didn’t offer coverage under their respective Preferred Drug Lists (PDLs) or formularies. This essentially meant that only those with the best of the best insurance coverage (or those with barges of money floating in their castle moats) had access to the drug. So long as you made little enough money, were uninsured or underinsured, and had tested HCV-Positive, the incredibly generous PAP could likely cover you.

By May of 2014, payers of all stripes, however, were balking at the cost of the drug. Scathing articles were penned, angry releases were rushed to press, and government-funded public programs across the country were predicting calamitous tidings, should neither Gilead, nor Congress do something about the price of this medication. Mind you, the moderately less expensive Olysio – coming in at around $50,000 as the companion drug to Sovaldi – received markedly less scrutiny, largely because it could be substituted for the far more cost-friendly ribavirin (RBV) alternative. People all around the world were raising flags, both red and white, at what they felt was price gouging on behalf of Gilead Sciences. The Pharmaceutical Pied Piper had come through on his promise of a greater, greener SVR pastures, but the government of Hamlin was objecting to his price.

Unlike the famed Piper Pied, however, Gilead still managed to maintain arguably the most generous PAP program on record – a $1,000-a-day pill for a very small fee, or no fee, at all. And so, this trend continued, even after the release of their $94,500 follow up, Harvoni (Gilead). Support Path continued to offer a relatively easy alternative to having to slog through the Prior Authorization bogs created by Hamlin’s other 3rd Party payers. But, as with every tale of the faerie variety, something wicked this way came.

The Hamlet of Hamlin began to include coverage for Sovaldi and Harvoni, Olysio (Janssen) and Viekira [Pak] (AbbVie), but only under the strictest of conditions. “We’ll pay you, Piper,” said the payers, “But, only in the direst of circumstances.” You see, these payers had gotten wind of the Piper’s generous offer to rid the poor of their HCV on his own dime, and the payers decided to play a dangerous game.

All alliterative allegorical aphorisms aside, I managed to speak with an insurance claim processor in California who, under the cloak of anonymity, stated verbatim: “Most of the time, we don’t even bother to process the claim; we just call and tell the client to go get it for free from Gilead.”

And this, unfortunately, is what many of the payers in Hamlin seemed to be doing. By the time 2015 rolled around, with the healthcare mandate going fully into effect, what seemed to be a trend was developing, and the Piper, named Gilead, started to notice that they were seeing far more applications from patients whose insurers ostensibly offered coverage for his SVR services. And lo, in the month of July, in the year 2015, the Piper exacted his price on both the payers and their redirected patients, effectively cutting off all access to his PAP to anyone who had government-funded insurance (Medicaid or Medicare).

This is where Gilead has landed: Insurance Assistance and the Co-Pay Coupon.

Gilead is now taking a more proactive step in interacting with private payers, promising to help patients navigate the Prior Authorization process, as well as to help provide assistance to patients whose cases require appeals to their insurers. Essentially, Gilead is saying to the payers, “You have this drug listed on your PDL/formulary – it’s time to pony up and pay for it.”

For patients on government-funded programs, however, the waters are murkier. Gilead’s Financial Assistance page under their Support Path tab makes very clear that these patients are not eligible for the Co-Pay Coupon program, and then goes on to say:

If you are enrolled in a government healthcare prescription drug program, do not have insurance, or have private insurance that does not cover HARVONI, other financial assistance may be available.

They then go on to provide no additional links to said potential financial assistance options.

A more concerning trend, in my opinion, is developing tradition of Gilead paving the way for other pharmaceutical companies to follow suit. Certainly, with so many treatment options – okay…five treatment options, depending on the HCV genotype – competition is growing in the world of HCV treatment. That competition has yet, however, to deliver substantially lower prices for these treatment regimens, and likely won’t until even more options exist…or a Federal mandate addressing the issue is passed.

In a spot of good news for Medicaid patients, as of November 5th, 2015, the Centers for Medicare and Medicaid Services (CMS) released its newest guidance regarding HCV coverage:

This guidance essentially informs Medicaid programs that they need to start opening up their formularies to cover these treatments in accordance with Federal law.

Luckily, there are other organizations who have stepped up to provide links to these programs:

There are most certainly several more options that I have failed to list in this post; that said, there are other options, and while they may not all be the right fit for everyone, they do exist.

Given the new Medicaid guidance, it will be interesting to see how states respond in the coming months, and hopefully, 2016 will bring about a better, cheaper way to deal with the burgeoning HCV crisis. Despite the very high WAC prices for all of the newer HCV therapies, these drugs are now offered to almost all payers at incredibly significant discounts, either through pricing agreements or through rebate programs. That said, payers are still balking at even the discounted prices, some paying as little as 50% percent of the WAC prices. This raises another issue tied to all three parts of this triptych – approval.

Although many state Medicaid programs pay significantly less than the WAC prices for these drugs and coverage is ostensibly offered for them, that doesn’t guarantee that patients will be approved for treatment. Texas’ Medicaid program is rumored (I say “rumored,” because pricing negotiations are not publicly available, thanks to private contracts and disclosure clauses) to be paying that 50% of WAC price; they have, however, only a very small number of treatments – perhaps fewer than 20. This type of expense dodging is exactly what the new CMS recommendations are designed to address.

The past two years have seen great strides in treating and curing HCV, and as with every big leap, there are going to be complications and snags along the way. No new technology or advancement comes, however, without great expense. That said, there is little political will to force pharmaceutical companies to explain, justify, or detail their pricing process or decisions. Until such time, pharmaceutical companies can essentially name whatever price they want, and payers are going to either accept them and pay up, or patients are going to pay the price of payers refusing to cover their treatments.
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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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Procession of the Foibles

By: Marcus J. Hopkins, Blogger

In last week’s HEAL Blog, we discussed in detail the prerequisites required to qualify a patient for coverage under the State of Illinois Department of Healthcare and Family Services’ new HCV drug Prior Authorization (PA) process. This was a basic checklist that includes questions about how far along (i.e. – how “sick”) a patient is, as well as whether or not they’ve modified any deleterious behaviors for long enough to even be considered for treatment. This week, we are focusing not so much on the criteria required to begin the process, but on the process, itself.

Cartoon image of an explosion with the words, KA-POW!

Photo Source: Armchair Chef

I’ll begin this post with an anecdote:

This past summer, I was privileged to attend the National Viral Hepatitis Roundtable (NVHR) session, hosted by the National Alliance of State and Territorial AIDS Directors (NASTAD). During one of the afternoon segments, we were addressed (via telephone) by two officials from the Centers for Medicare and Medicaid Services (CMS), and the conversation quickly became tense.

During this conversation, several of the participants voiced their concerns and frustrations regarding the PA process for the newer HCV drugs. This included a representative from Walgreen’s pharmacy. When this particular person mentioned how cumbersome the process had become, one of the gentlemen from CMS responded, “You work for Walgreen’s? I’m not certain why you’re complaining. Isn’t filing PAs part of your job?”

What was striking about this exchange to virtually everyone in the room was the level of incredulity and annoyance this response implied – a sense that CMS has heard enough of this type of grousing, so he should just shut up and get on with doing his job. In researching the PA process with other Medicaid representatives, I encountered a similar level of exasperation from numerous employees – that they already know the process is beleaguered, and they’re tired of hearing about it.

The implications of this type of reaction are seemingly stark – the process is what it is, and no one is likely to come along and change it, so you might as well suck it up, and do the paperwork. This is the way bureaucracy works, and it’s just the price everyone has to pay if they someone else to pay the piper.

Anecdotal experiences aside, the reality is that there isn’t just one way to establish a PA process; each payer (private or public) has its own way of doing things, which means that each provider (physician or pharmacist) may have to do each step of the process differently, depending on who’s going to be paying. There is little standardization, when it comes to HCV drug PAs.

The PA process is essentially broken down into several steps filled out and filed by each provider along the way. It usually begins with the prescribing physician, who starts the ball rolling by ensuring that each patient individually meets the prerequisites to even begin the PA process. Once that is established, they begin to fill out paperwork, such as this version from Illinois’ Medicaid program. This is form provides the payer with basic information about the prescribing physician and the patient, and requires the submission of documentation showing the following – METAVIR or equivalent fibrosis score, long-term and recent test results showing that the patient has tested negative for drug screenings for the last year and fifteen days prior to beginning the regimen, and whether or not the patient is committed to treatment (which I assume means that the doctor must vouch for the patient in writing). After the physician submits the initial PA request, the payer will determine whether or not they will agree to pay for the treatment.

But, the paperwork doesn’t stop, there; the process continues with the next provider patients see – their pharmacist. In order to ensure that they are allowed to fill the prescription for each HCV-infected patient, they must be provided with the approved PA form from the physician, and then, submit their own form that again requests a guaranteed payment before the drugs are dispensed.

If a PA request is denied during any step along the way, each person must file an appeal to the decision, and potentially a second appeal, all in an effort to provide their patients with the treatment their physicians have deemed necessary.

In states that require proof of “Medical Necessity” – meaning all other treatment regimens have failed the patient – the process can take even longer, as the patient will have to attempt each regimen, including those whose side effects so negative and tolerability are so low, failure is essentially guaranteed. This places a burden on both physicians and patients, as both parties have to confront and cope with the outcomes of each failed attempt to cure HCV.

So, the question becomes, “Is there any respite in sight?” Honestly, until prices for these drugs drop significantly, it’s very unlikely. The PA process is designed to ensure that payers aren’t doling out money for therapies that are going to go to waste, either from a patient’s refusal to comply with the regimen or if they require a second round of treatment. Regardless of how fabulously these drugs do their job in attaining a Sustained Virologic Response (SVR – “cure”), they are simply too expensive for payers to simply approve and pay for treatment for everyone who seeks coverage.

In next week’s HEAL Blog, we’ll explore some of the options that some patients may utilize in lieu of coverage from a 3rd party payer – Patient Assistance Programs (PAPs).

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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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Filed under Uncategorized