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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