New HCV Medications (Part 2): Patient Assistance Programs

By: Marcus Hopkins, HEAL blogger

To read Part One, CLICK HERE.

Continuing from last weeke, HEAL Blog will be posting a two-part series discussing the cost of new Hepatitis C regimens and what pharmaceutical companies are doing to help defray the expense of these drugs. As such, I must place the following disclaimer: Any personal views expressed on HEAL Blog are not the views of the organization; rather, they are the observations and opinions of the blogger. That having been established, I will do my best to remain objective and less editorialized.

In Part Two of our series about the price of HCV treatments, HEAL Blog looks into Patient Assistance Programs (PAPs) provided by both Gilead and Janssen Pharmaceuticals.

Patient Assistance
Part One of this series provided information on the high costs associated with the two new treatment options, Sofosbuvir and OLYSIO™ (Simeprevir), as well as the efficacy of these treatments versus that of previous treatment options.  While both of these drugs are highly effective, the high cost of treatment has many in the healthcare community worried that those most in need of treatment will be largely unable to access the drugs due to the prohibitive pricing model.

This is where PAPs come into the equation.  Patient Assistance Programs are designed to provide reduced co-pays or free medications to those who qualify as having an economic burden preventing them from paying the full cost, including lack of access to affordable health insurance coverage.  An interesting component of this issue is that several of these patients (particularly those who qualify for Medicaid under the new Medicaid Expansion in those states who have agreed to accept said expansion) are unaware of PAPs, either because they have not sought treatment or have not been informed of the programs by their healthcare provider.

Since Part One of this series was published, Sofosbuvir (now given the geographically neutral name “Sovaldi”) has been approved by the FDA, and the price of treatment has reportedly increased from the previously listed price of $60,000 to roughly $84,000, a roughly 35% increase.  This introductory price point is a shock to those of us who had provided information that Solvadi would be the cheaper of the two new HCV drugs

In another twist in the pricing war that will inevitably begin between Janssen and Gilead, Express Scripts, a company that manages prescription benefits for many insurance providers, has suggested that they are more than willing to substitute lower priced competitors’ drugs, even if those treatments come with less friendly dosing schedules and side effects.

So, what does this mean for consumers?  At this point…likely very little.  Once again, without a trial production run, the final price points for these medications cannot be firmly established.  That said, the fears based on pricing remain relevant as public perception helps to inform reality – if consumers are afraid that they cannot afford to treat a disease, they are less likely to seek treatment in the first place.

In an attempt to gather more information from Gilead Sciences about PAP coverage for Sovaldi, I placed a call to their U.S. Advancing Access hotline.  I would like to say that my experience with the company was satisfactory, but in reality, the process of even obtaining basic information about the program was confusing, at best.  After finally reaching a representative, I was met with outright confusion as to what drug I was referencing, and was then transferred no fewer than five times between various departments.  One employee even suggested since Gilead Sciences was not producing Sovaldi (which it is), they would not be offering a PAP for it.  When I clarified that Sovaldi was, in fact, a Gilead product, she said that the program was already in place.  The same employee, when asked about how PAPs work with Gilead, provided only the most basic information – in order to qualify for the program, patients much be “lower income” with no insurance, underinsured, or have plans that, while otherwise excellent, do not have the drug on the formulary.

Were I not a seasoned veteran at dealing with healthcare providers and pharmaceutical companies, I would have given up by that point.  What I gleaned from this experience is that, while PAPs for HIV medications is something about which pharmaceutical company employees are very well versed, even they are unsure of what is going on in terms of this coverage.

This, of course, is my perception of the matter, primarily because Gilead’s Advancing Access website does not provide information about coverage for anything other than HIV drugs.

Update:

After a bit more searching, I discovered that Gilead does, in fact, have a patient portal for Sovaldi that is separate from their Advancing Access website, called “Support Path.”  It is a wholly different support team, each of whom are dedicated to providing information, education, and support to people living with HCV.

Support Path offers PAPs for people, who do not have insurance, are underinsured, or who otherwise need financial assistance to pay for the drug.  The Sovaldi Co-Pay Coupon Program provides co-pay support for eligible patients with insurance coverage to ensure that they pay no more than $5 co-pay per script.  This is an excellent assistance program, and for me to say that is something of a blessing, given that I am quite the skeptic when it comes to Big Pharma.

There is, as always, the reality that Sovaldi will likely have to be taken with other prescriptions, which creates a regimen whose cost is more than the base $84,000 for Sovaldi.  Whether or not these other drugs will come with assistance from Gilead is, at this time, unknown.

The Janssen PAP website is far more informative.  The Access2Wellness website (sponsored by Johnson & Johnson Health Care Systems, Inc.) in incredibly user-friendly, providing consumers with the ability to search drugs by name to see if coverage or assistance is offered.

OLYSIO™ has its own portal for information, providing a wealth of access to information about assistance, and a specific benefits program that lays out how the program works:

“OLYSIO™ Savings Program may provide instant savings on your out-of-pocket medication costs for OLYSIO™. Once eligible patients qualify and activate their OLYSIO™ Savings Card, patients pay only $25 per fill, with a maximum annual benefit of $25,000, 12 months after activation or 3 fills (12-week supply), whichever comes first. Not valid for patients enrolled in Medicare, such as Medicare Part D, or Medicaid. Other restrictions apply (http://www.janssenprescriptionassistance.com/olysio-cost-assistance).”

This information is far more helpful for patients and healthcare professionals, as it allows them to give specific answers, whereas Gilead’s program provides only a number to call, and as I experienced, several transfers until an adequate answer is received.

Even with the availability of PAPs, the question remains the same – will the pricing of these treatments instill enough fear in patients and potential patients to prevent them from seeking access to these drugs, therefore staying with older, less patient-friendly regimens?  The proof of the pudding, as they say, will be in the eating (a rather clever pun, given the all-oral nature of one of these drugs).

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