Gilead’s US patient access programs for Sovaldi

This is a note on Gilead run or funded programs that are available for patients residing in the United States.

Recently, Gilead’s new hepatitis C drug, Sovaldi, has received much attention and criticism for its high price of $1000 a day.

This is not unexpected given the 3.2 million people estimated to be infected in the United States and the miraculous cure rates that Gilead is claiming for a 12-week course of treatment.

But with a record high number of Americans now covered by health insurance, how does access to Sovaldi actually play out?

Despite pricing Sovaldi at $1000 a day and refusing to lower this price, Gilead claims to “believe that cost should not be a barrier to receiving treatment.” In line with this statement, they offer a program called Support Path for hepatitis C patients who lack insurance, are underinsured or need financial assistance in affording Sovaldi.

The Gilead Support Path includes several programs.

Gilead’s Co-Pay Coupon Program

One program of Support Path is the Co-pay Coupon Program, through which Gilead will cover up to $16,800 of out-of-pocket expenses for Sovaldi provided that the patient pays $5 per prescription fill. The $16,800 is the cumulative amount of co-pay coupons available from Gilead, and can be used for up to 6 prescription fills of 28 x 400 milligram tablets each. Most patients will require 3 or 6 fills, under current treatment guidelines. If the $16,800 co-pay limit is reached before the end of treatment, the patient becomes responsible for paying the remaining cost.

The Gilead run Co-pay Coupon Program is not available for patients who receive any type of reimbursement from federal or state insurance. Patients must be commercially insured.

Assistance from the Patient Access Network (PAN) Foundation

In addition to Support Path, Gilead says they contribute to the Patient Access Network (PAN) Foundation, which helps privately-insured and federally-insured patients cover out-of-pocket expenses. The PAN foundation offers subsidies (referred to as awards or grants by the PAN foundation) of up to $10,000 per year to go towards co-pay costs. This option is available to patients who have exhausted benefits from the Gilead co-pay coupons, or who were not eligible for the Gilead co-pay coupons.

The PAN Foundation requires the patient to be insured, and earn less that 500% of the federal poverty level.

Gilead’s Patient Assistance Program

Another element of Gilead’s Support Path is the Gilead Patient Assistance Program (PAP). Through the PAP, Gilead pledges to provide Sovaldi for free to patients with no other insurance options, and who meet certain income eligibility requirements.

The Patient Assistance Program is available to households of up to three individuals with an annual income below $100,000 or for larger households that have an income below 500% of the federal poverty level.

Report from one California health clinic

In Gilead’s own backyard, KEI has received reports that there is difficulty in obtaining this pricey but effective drug. At one clinic, doctors have yet to see a single uninsured patient receive Sovaldi. Even among insured patients, not all have received the drug and those who do, often have to jump through several hoops to get there. For insured patients who are prescribed Sovaldi, there are often four outcomes:

First, it can be approved by the patient’s insurance and the patient is able to afford the co-pays and therefore begins treatment.

Second, it can be approved by the patient’s insurance but the patient is unable to afford the co-pay and therefore appeals to Gilead for assistance. The guidelines for receiving such assistance are explained above.

Third, Sovaldi reimbursement may be denied entirely by the patient’s insurance. The patient then sends the request denial letter to Gilead in hopes of receiving treatment free of charge. In some cases, Gilead provides the drug and the patient begins treatment.

Lastly, the insurance company neither denies or approves treatment and instead requests further verification, for example, a second opinion or additional consults. In this scenario, the patient is unable to appeal to Gilead in any way and is forced to jump through endless hoops in order to obtain treatment. Insurance companies often employ this practice in order to keep the number of denied patient requests low for appearance and monitoring reasons.

Further data needed to evaluate access

It will be useful to have more details regarding the following questions:

1. What measures have been undertaken by state governments to limit access to Sovaldli, and how have these measures limited access?

2. How timely are requests for insurance coverage and patient assistance programs for Sovaldi resolved?

3. What standards do insurance/reimbursement entities have for determining coverage, how many patients meet these standards, and how many patients would be treated if the prices were lower, and standards for access were also lower?

Other concerns

Access is clearly one important issue for Sovaldi. Separate from the issue of access is the reasonableness of the price and the overall cost of reimbursements for Sovaldi.