Monthly Archives: December 2013

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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New HCV Medications (Part 1): The high cost of treatment

By: Marcus Hopkins, HEAL blogger

To read Part Two, CLICK HERE.

Over the next two weeks, 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 the first part of this series, I will be discussing the cost of the newest medications, Sofosbuvir and OLYSIO™ (Simeprevir). One of the major things to note is that neither of these drugs have hit the market, yet, which makes locking down a specific price point for consumers and insurers a difficult proposition. As such, we can only theorize as to the price of these regimens, and any speculation of such price structures should be taken as just that – speculation.

Photo of Sofosbuvir Pills

As with any new medication, the cost to consumers is of paramount concern. Whenever doctors prescribe medications to patients, rarely is the factor of cost taken into consideration, the prevailing thought process being that if the patient is seeing the doctor in the first place, they must be covered by some sort of medical insurance. Unfortunately, this is not always the case.

As I’ve discussed in previous posts, current estimates suggest that roughly 52% of people living with HIV/AIDS fall at or below the poverty line, which very clearly correlates to the CDC’s estimation that over 54% of the HIV/AIDS population is not currently seeking treatment. When factoring in the analyses suggesting that HCV has a higher incidence in lower income individuals, the likelihood that those living with both HIV and HCV will seek treatment is brought further into question.

In October 2013, an FDA panel unanimously endorsed Sofosbuvir, which is made by Gilead Sciences; it had Wall Street virtually bursting with glee, as the drug is expected to have a price point of $80,000 to $90,000 per patient. Regardless of the cost of this medication, it is highly effective, offering a higher cure rate with both less toxicity (meaning that patients experience fewer negative physical side effects) and a shorter duration for treatment than the pair of medications approved two years ago by the FDA.

Sofosbuvir is slated for approval for use in patients with HCV genotypes 2 and 3 in combination with Ribavirin, an older medication long prescribed in treatment regimens. If it is approved in 2014, it will provide patients with the first all-oral treatment for these two strains. The panel also endorsed its usage for genotypes 1 and 4 in combination with Ribavirin and Interferon in patients who have not already received therapy. It should be noted that the vast majority of HCV cases involve genotype 1.

OLYSIO™ (Simeprevir), which is made by Janssen Therapeutics, is set to have a WAC (Wholesale Acquisition Cost) of $66,360 for a single twelve-week treatment. Once again, regardless of the price point, OLYSIO™ is extremely effective in treating patients who are treatment naïve or in those who have failed prior interferon-based therapy. OLYSIO™ is a NS3/4A protease inhibitor, and it is designed in combination with 24- to 48-weeks of a pegylated interferon and ribavirin treatment regimen, and provides an excellent treatment option for patients struggling with HCV.

What neither of these price points takes into account are the additional cost of the additional medications with which they are designed to be taken, nor is the cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating OLYSIO™ therapy. Current WAC costs of interferon and ribavirin sit at roughly $18,000, making the combined cost of treatment for Sofosbuvir between $98,000 and $108,000; for OLYSIO™, the cost of treatment will be around $84,360.

Both drugs, while expensive, provide exciting and highly effective treatment options for patients, particularly those who are treatment naïve or in whom previous treatments have not been effective. Despite their efficacy, the true test of whether or not these therapies will be accessible to patients will be in the cost.

These pricing structures have many in the healthcare and medical community worried that the exorbitant cost of treatment will put treatment far out of the reach of the estimated 3.2 million people affected in the U.S., not to mention those patients in developing countries. According to Gilead Sciences, fewer than 60,000 of those patients in the U.S. are currently being treated, which makes the severity of situation all the more pressing.

The burgeoning rate of infection suggests that demand for treatment is expected to mushroom, setting up a potential clash over the availability of these drugs to patients and to doctors faced with greater numbers of patients in need of treatment now that the US Preventive Services Task Force has recommended screening for HCV. If the price of these drugs is not lowered, the potential exists that very few people will be treated and the HCV epidemic in the U.S. will continue unchecked.

While the cost of these treatments is of great concern to healthcare professionals and patients, Gilead and Janssen both stand to profit from keeping the price points high, providing little incentive to lower the cost of treatment to accommodate those who need, but cannot afford, HCV therapy. With the implementation of the Affordable Care Act mandating coverage for all U.S. citizens, whether or not these drugs will be covered on their formulary will largely depend on the level of coverage purchased by the consumer, which may leave many people without affordable treatment options.

That also raises the question of whether or not state ADAPs and the Medicaid Expansion will include these treatments on their formularies. Currently, 23 state ADAPs offer the existing FDA-approved treatment, so whether or not to add the new treatment options is optional for me. These formularies are usually updated monthly, but with the admittedly high cost of both OLYSIO™ and Sofosbuvir, it is not certain that these programs will initially cover them until the price decreases.

It should be noted at this point, however, that any price analyses of these products are imprecise – more precise estimates of production costs require pilot production batches and more detailed analyses of process chemistry for both drugs. Additionally, access to these drugs at minimum prices in developing countries will depend on the level of enforcement of patent restrictions.

That having been said, pharmaceutical companies have been forthcoming in stepping up to provide Patient Assistance Programs (PAPs) for those who don’t qualify for public assistance or who have limited private coverage. These programs, as well as other cost-related issues, will be discussed in Part Two of our series to be released later this month.

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December 17, 2013 · 8:09 pm