21 July 2015
In a bid to push back against payers, Gilead Sciences is limiting enrollment to its patient assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni treatments when they lack sufficient insurance coverage or the financial wherewithal to get the medicines otherwise.
The drug maker is taking this step after finding that some payers, despite receiving discounts in recent months, have continued to restrict patient access to its hepatitis C medicines. As a result, Gilead has been picking up the cost of the medicines for more people it would like seeking patient assistance, according to a July 1 letter sent to patient groups and community health providers, among others.
A Gilead spokeswoman declined to say how many people are enrolled in its Support Path assistance program, how many may be affected by the change or provide actions taken by specific payers.
The move is likely to add another level of controversy surrounding the Gilead drugs, which are poster children in the national debate about the cost of prescription medicines. By restricting access, Gilead appears to be counting on patients to complain to payers about a lack of access, but the tactic may also raise questions about the extent to which patient assistance programs are easily manipulated.
“This is a way of applying more pressure on payers to expand their coverage criteria,” says Roger Longman of Real Endpoints, a research firm that tracks reimbursement issues.
Meanwhile, Randy Vogenberg, a partner at Access Market Intelligence, a consulting firm that specializes in managed care, says “unfortunately, such a strategy places the patient in the middle as the pawn.”
The Gilead spokeswoman wrote us that the drug maker “supports open access to hepatitis C therapies… We continue to work with payers to provide information that conveys the profile of our hepatitis C medications and the benefit of curing individuals living with the virus.”
Here is the genesis: Gilead began offering discounts last winter to payers in response to deals that AbbVie struck with some payers while launching a rival hepatitis C medicine. At the time, Gilead dominated the field with Sovaldi, which cost $84,000 for a 12-week regimen, and then began selling Harvoni, which cost from $63,000 to $94,500, depending upon the duration of the regimen.
Seeking to maintain market share, the Gilead discounts averaged 46%. But the drug maker did not require payers to provide coverage for Sovaldi and Harvoni on a wide basis, Longman says. The Gilead spokeswoman says it is not always that simple. “Payers ultimately make their own decisions about the level of access they are willing to provide, and they may reject any discount offered,” she explains.
Nonetheless, payers are free to place restrictions on the drugs, thus lowering their own costs. So while some payers have since provided coverage for the Gilead drugs without restrictions, others still maintain restrictions, according to the Gilead letter.
“While many payers responded to these discounts by opening access broadly, some payers have continued to restrict access despite the discounts,” wrote Coy Stout, a vice president of managed markets at Gilead in the July 1 letter. “As a result, our [program] criteria enabled continued restrictions by some payers by providing a generous route for them to deny access and refer patients they have chosen not to cover. “
“While we have approved many of these patients in the past, we feel it is necessary to establish more specific guidelines for patient eligibility. Our [program] was designed to help uninsured patients with the most need, and changes are necessary to remain true to that mission. We believe these changes also will help increase access among those payers who continue to restrict access.”
And so, Gilead is limiting enrollment in its program if payers restrict access to the drugs for several reasons. These include patients with less severe hepatitis C or if a plan prefers or offers exclusive coverage to another drug on its formulary, or list of preferred medicines. An obvious example would be the AbbVie drug, known as ViekiraPak.
Gilead also cites these reasons: A plan that limits access to the medicines for a specific length of time or denies subsequent treatment after a patient has failed therapy. What else? Gilead will limit enrollment if plans require step therapy, which involves using one treatment before trying another. And enrollment will be limited if plans restrict access to the drugs based on alcohol testing, among other clinical criteria.
HERE IS THE LETTER…
Wednesday, July 1, 2015
Dear Community Partner,
Gilead has always been an advocate for patient access to therapies in the areas in which we work. I am writing to provide you with an update regarding Support Path, our patient support program for individuals living with chronic hepatitis C.
As you may be aware, Support Path is designed to help patients in the U.S. with high co- pays or who lack adequate insurance access to Sovaldi or Harvoni. The Support Path program provides assistance to patients who are uninsured or who need financial assistance to pay for the medicine.
Key components of the program include:
In the interest of facilitating patient access in the period immediately following the launch of Sovaldi and Harvoni, the Gilead Patient Assistance Program (PAP) made these medications available to virtually all patients who met financial and other program requirements. Gilead also implemented significant discounts for its HCV therapies across different payer groups. While many payers responded to these discounts by opening access broadly, some payers have continued to restrict access despite the discounts.
As a result, our PAP criteria enabled continued restrictions by some payers by providing a generous route for them to deny access and refer patients they have chosen not to cover. While we have approved many of these patients in the past, we feel it is necessary to establish more specific guidelines for patient eligibility. Our PAP was designed to help uninsured patients with the most need, and changes are necessary to remain true to that mission. We believe these changes also will help increase access among those payers who continue to restrict access.
With that in mind, effective July 1, 2015, the following changes will be implemented. Gilead anticipates these changes will not impact the majority of patients helped by our patient support programs.
Specifically, patients who are insured and who do not meet their payers coverage criteria will no longer be eligible for support via Gileads Patient Assistance Program. Patients who fall within the category of Insured and Did Not Meet Payer Criteria are patients whose insurance providers limit access to Sovaldi/Harvoni based on, but not limited to, the following:
Fibrosis score restrictions
Preferring or exclusively covering another product on formulary (i.e., Viekira Pak preferred)
Limiting coverage to a maximum treatment duration or denying subsequent treatment after a patient has failed therapy
Clinical criteria (e.g., psychiatric requirements, drug and alcohol testing)
It is important to note that a very small number of patients fall into this category. Support Path experts will continue to treat each patient case individually and consider a number of variables when assessing patients for our free drug program.
The Sovaldi and Harvoni Co-pay Coupon Program, which minimizes monthly out-of-pocket costs for eligible patients* to as little as $5 per month
The Support Path Patient Assistance Program, which will provide Sovaldi or Harvoni at no charge for eligible patients
*You are not eligible if you are enrolled in a government healthcare prescription drug program such as Medicaid or Medicare Part D
For Sovaldi and Harvoni patients who are insured and have been denied coverage by their payer, Support Path can assist patients with the requirements for submitting appeals, peer reviews and understanding the process for in-person hearings if required.
Gilead continues to support open access to hepatitis C therapies with prescribing decisions made by a physician in partnership with his or her patient. We will continue to work with payers to provide information that conveys the profile of our hepatitis C medications and the benefit of curing individuals living with the virus. We believe that payers should take the responsibility to provide coverage for their insured patients based on the treatment decisions of their healthcare providers.
Through Gileads Support Path Program, which provides a comprehensive suite of patient assistance resources, we are committed to our mission of helping patients in financial need access our products, and to ensuring our patient assistance program reaches eligible uninsured patients.
As always, we appreciate the ongoing dialogue with our community partners and look forward to continuing to collaborate with you on efforts to expand access to life-saving therapies.
Vice President, Managed Markets Gilead Sciences, Inc.