Fair Pricing Coalition

On May 23, 2011, the FDA approved Vertex’s Incivek (telaprevir), the second new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years.   Merck’s Victrelis (boceprevir) was approved by the FDA on May 13, 2011.  The United States Department of Health and Human Services estimates that there are between 2.7 to 3.9 million people in the United States living with HCV and that approximately 20,000 people are newly infected with HCV every year.

“While this new drug approval is another very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is appalled at the price set by Vertex for Incivek,” said FPC member Lynda Dee.  “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $49,200 per 12 week course of Incivek treatment will adversely affect the ability of people with HCV to access this new drug and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline.

“Merck’s Victrelis costs $48,400 for 48 weeks of treatment.  Now Vertex has set a price approximately four times greater than Victrelis for twelve weeks of Incivek treatment.  While we welcome a shorter course of Incivek treatment, both price points are outrageous.  What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek.  What a terrible way to begin!”

Like Victrelis, Incivek is a drug from the protease inhibitor family that is relatively easy and uncomplicated to make.  “We understand that drug development costs a lot of money, and we commend Vertex for their excellent Incivek drug development program, but there is no reason for a drug from the protease inhibitor class to be so expensive,” said Dee.

The FDA label recommends that 12 weeks of Incivek be taken with pegylated interferon and ribavirin for either 24 or 48 weeks, depending on a patient’s response to the regimen.  The WAC price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $30,000.  The $49,200 WAC price for 12 weeks of Incivek will more than double the already exorbitant 48 week price of pegylated interferon and ribavirin.

“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current US healthcare crisis,” said Dee.

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner.  “An encouraging number of these drugs are currently in development.  It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future.  Future HCV drugs will invariably be more expensive than Victrelis and Incivek.

“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future.  This is unsustainable and will unacceptably limit access to the regimens.”

A recent paper presented at the American Association for the Study of Liver Diseases conference indicates that there will be a 30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs.  “These increased costs must also be considered in the equation,” said Penner.

“Many people with HIV are also co-infected with HCV,” said Bill Arnold of the FPC.  “The cost of HIV drugs which must be taken over the entire course of a patient’s life, plus a course of this new HCV treatment is unreasonably excessive.  At this time, there are over 8,300 people on waiting lists for federally funded AIDS Drug Assistance Programs (ADAPs).  I am very concerned that these people will never gain access to promising new HCV therapies.  Many may die as a result.”

Many individuals with HCV also have other medical conditions such as diabetes and bleeding disorders, and people with bleeding disorders pay as much as $150,000 each year for their clotting factor drugs alone.  While many do have private insurance, the cost of co-pays and caps on insurance coverage may make these promising new therapies unaffordable for many people with private insurance, resulting in the inability of even people with insurance to access promising new HCV therapies.

“We were very disappointed by the cost set by Merck for Victrelis earlier this month.  Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” said Dee.  “How will this all end?  We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP).  Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word.  We have kept a tight watch on HIV drug manufacturers in this regard.  We intend to do the same thing in the viral hepatitis arena.”

FOR IMMEDIATE RELEASE

May 17, 2011—On May 13, 2011, the FDA approved Merck’s Victrelis (boceprevir), the first new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years.  The United States Department of Health and Human Services estimates that there are between 2.7 to 3.9 million people in the United States living with HCV and that approximately 20,000 people are newly infected with HCV every year.

“While this new drug approval is a very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is very disappointed at the price set by Merck for Victrelis,” said FPC member Lynda Dee.  “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $1,100 per week will adversely affect the ability of people with HCV to access Victrelis and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline.  You can bet that no future HCV drugs will be priced less than Victrelis.  This is a very bad start.”

Victrelis is a drug from the protease inhibitor family that is relatively easy and uncomplicated to make.  “We understand that drug development costs a lot of money, but there is no reason for a drug from the protease inhibitor class to be so expensive,” said Dee.

Two other drugs, pegylated interferon and ribavirin must be taken with Victrelis, and the WAC price for HCV treatment with these two drugs is approximately $30,000.  The FDA label recommends that Victrelis be taken with pegylated interferon and ribavirin for either 24, 32 or 48 weeks, depending on a patient’s response to the regimen.  The WAC price for Victrelis is $26,400 for 24 weeks, $35,200 for 32 weeks and $48,400 for 48 weeks of treatment.

“These amounts added to the already high $30,000 cost of pegylated interferon and ribavirin make the cost of the new Victrelis containing regimen astronomical,” said Dee.  “Although the addition of Victrelis to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current US healthcare crisis.”

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner.  “An encouraging number of these drugs are currently in development.  It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future.  Future HCV drugs will invariably be more expensive than Victrelis.  If each of the new drugs costs approximately $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future.  This is unsustainable and will unacceptably limit access to the regimens.”

A recent paper presented at the American Society of Liver Diseases conference indicates that there will be a 30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs.  “These increased costs must also be considered in the equation,” said Penner. “Many people with HIV are also co-infected with HCV,” said Bill Arnold of the FPC.  “The cost of HIV drugs which must be taken over the entire course of a patient’s life, plus a course of this new HCV treatment is unreasonably excessive.  At this time, there are over 8,100 people on waiting lists for federally funded AIDS Drug Assistance Programs (ADAPs).  I am very concerned that these people will never gain access to promising new HCV therapies.  Many may die as a result.”

Many individuals with HCV also have other medical conditions such as diabetes and bleeding disorders, and people with bleeding disorders pay as much as $150,000 each year for their clotting factor drugs alone.  While many do have private insurance, the cost of co-pays and caps on insurance coverage may make these promising new therapies unaffordable for many people with private insurance, resulting in the inability of even people with insurance to access promising new HCV therapies.

“We are very disappointed by the cost set by Merck for Victrelis and are even more concerned that Vertex’s Incivek (telapravir) which will probably be approved by the FDA later this month may be even more expensive,” said Dee.  “How will this all end?  We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word.  We have kept a tight watch on HIV drug manufacturers in this regard.  We intend to do the same thing in the viral hepatitis arena.”

For Immediate Release
February 1, 2011 – Washington, DC

Contact:
Lynda Dee (410) 332-1170
Murray Penner (202) 725-6762

For additional background information, click here.

The Fair Pricing Coalition (FPC) today announced that it has brokered agreements that will allow approximately 6,500 Floridians to continue to receive their HIV medications during a budget crisis in that state. Partners in the agreement include Welvista, a non-profit pharmacy; major manufacturers of HIV medications; and the State of Florida’s AIDS Drug Assistance Program (ADAP). Florida’s ADAP was expected to exhaust all available funds and shut down in early February if an emergency solution was not implemented. With these agreements, the state of Florida projects having enough funds to provide medications to its remaining 3,500 ADAP clients for the remainder of the ADAP fiscal year (through March 31, 2011). The plan will be final when the state of Florida and Welvista sign their operational agreement, expected to occur in the next several days.

Under the plan, Florida’s ADAP will transition approximately 6,500 of their nearly 10,000 active clients to Welvista beginning February 14, 2011. Welvista will provide up medications to these clients as a “transition” to the next ADAP fiscal year which begins April 1, 2011, when Florida’s renewed allocation of federal Ryan White/ADAP funds becomes available. Clients will then again receive their medications from Florida’s ADAP program.

Abbott Laboratories, Bristol-Myers Squibb (BMS), Gilead Sciences, Merck and Co., Tibotec Therapeutics and ViiV Healthcare already participate with Welvista to expedite access to HIV medications for ADAP clients on waiting lists. Abbott, BMS, Gilead and Merck and ViiV have agreed to participate in the plan brokered by the FPC and will provide medications to Welvista for these additional clients in Florida on a one-time, emergency basis. The FPC is still negotiating with Tibotec Therapeutics about this situation.

“None of us are happy with the Florida fiasco,” remarked Lynda Dee, spokesperson for the FPC. “It will result in a drain on limited funds from drug company patient assistance programs (PAPs). This inequitable use of industry PAPs could have a very significant, negative impact on the ability of other patients from other states to utilize these PAPs,” Dee warned.

“We are nonetheless grateful to the companies and Welvista for their willingness to step in to provide medications for Florida patients,” said Dee. “We clearly recognize this is a one-time, emergency rescue of a program that cannot be repeated or duplicated by Florida or any other state. We therefore implore the federal government and all state governments, especially Florida, to provide adequate funding to state ADAPs to meet the medication needs of its uninsured and underinsured people living with HIV,” she concluded.

Nationally, state ADAPs are situated in the eye of a “perfect storm.” Thousands continue to enroll in state ADAPs each year due to the effects from the economic recession, and other factors are contributing additional pressure. These include rising drug prices on already-expensive medications (some companies have agreed to price freezes for ADAPs while others continue to take price hikes, limited by law for ADAPs to be no more than the rate of inflation); minimal increases in federal appropriations (the federal ADAP contribution has shrunk from approximately 70 percent to 50 percent of the overall national ADAP budget in recent years) and significant state budget cuts; and larger client caseloads due to HIV-positive individuals living longer. Positive developments such as national efforts to significantly expand HIV testing and linkages into care and new HIV treatment guidelines calling for earlier therapeutic treatments have further pushed ADAPs to a fiscal tipping point from which recovery will be difficult.

The National Alliance of State and Territorial AIDS Directors (NASTAD) reports that as of January 27, 2011, there are 5,779 individuals on ADAP waiting lists in ten states. Twenty states have instituted, or anticipate instituting cost containment measures other than ADAP waiting lists before the end of the ADAP fiscal year ending in March 2011. Florida has the greatest number of individuals on its waiting list (3,008) which will continue into the next fiscal year. Those individuals are, for the most part, already receiving medications through other pharmaceutical patient assistance resources, and are not affected by this plan. To see a list of states with access restrictions, please visit NASTAD’s website at www.NASTAD.org.

The FPC remains concerned about the fiscal health of Florida’s and many other state ADAPs. Moving forward, the FPC will work with local advocates to push Florida for additional state appropriations and to seek drug rebates that should have been applied for heretofore. In addition to working on this stopgap measure to ensure uninterrupted medications for 6,500 Floridians, the FPC will also continue to work with all stakeholders and ADAPs on long-term solutions to the national ADAP crisis.

About the Fair Pricing Coalition (FPC): The FPC is a group of community treatment activists advocating for fair and sustainable pricing of HIV and viral hepatitis drugs in the United States. The FPC also works with manufacturers of HIV medications to ensure adequate co-pay and patient assistance programs are in place to help ensure all Americans living with HIV have access to life-saving medications.

About Welvista: For over 17 years, Welvista, a nonprofit organization located in Columbia, South Carolina, has been providing access to prescription medications to the uninsured and underserved throughout South Carolina. Welvista partners with 12 branded pharmaceutical companies who donate medications and a network of over 3,000 health care providers, making them one of the largest mail-order pharmacies for the uninsured in the nation. In 2009, Welvista filled and dispensed more than 135,000 prescriptions to the uninsured valued at over $47 million. With a grant from the Heinz Family Philanthropies and Abbott Laboratories, Welvista began serving ADAP waiting list clients as part of its mission in August, 2010. For more information, visit www.welvista.org.