Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

Download the press release: Harvoni_FPC_101314_FINAL

The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni (sofosbuvir and ledipasvir) should be extended to 12- and 24-week curative treatment durations.

The Fair Pricing Coalition (FPC) today applauded the October 10, 2014, U.S. Food and Drug Administration (FDA) approval of Harvoni, a combination tablet containing the direct acting antivirals (DAAs) sofosbuvir and ledipasvir for the curative treatment of genotype 1 hepatitis C, and called upon Gilead Sciences to establish a uniform price per cure, regardless of the length of therapy.

The FPC, a coalition of HIV and viral hepatitis treatment activists, recognizes the significant advance in treatment success and convenience of Harvoni, but is disappointed at the Wholesale Acquisition Cost (WAC) of $1,125 per once-daily tablet, or $63,000, $94,500, and $189,000 for an 8-, 12-, and 24-week course of treatment, respectively.

The FPC maintains that these costs, particularly for the 12- and 24- week courses of treatment, are exorbitant. Since they are now published, however, FPC concludes that the WAC of $63,000 for eight weeks of Harvoni, which is projected to be the most common duration of treatment as more people living with genotype 1 hepatitis C learn of their infection and seek care, should be made the uniform cost per cure, regardless of the length of therapy.

Harvoni’s FDA approval follows that of Sovaldi® (sofosbuvir) on December 3, 2013, the price of which was denounced by FPC. The $84,000 WAC ($1,000 per pill) of Sovaldi has since brought rebukes from insurers, activists, government officials, health care providers, and people living with hepatitis C.

While Gilead has contended that the total price for a course of treatment with a Sovaldi-containing regimen was a modest increase compared with previous standards of care, this is an invalid argument based on the incorrect premise that these regimens were appropriately priced to begin with. So, although an eight-week course of Harvoni will result in a lower cost-per-cure than previous regimens, the $1,125 WAC per pill means that coverage for the 50 percent or more of people living with genotype 1 hepatitis C who require 12 or 24 weeks of therapy will be unreasonably costly and therefore potentially unattainable.

“Harvoni is a remarkable breakthrough in hepatitis C treatment,” explained FPC Co-Chair Lynda Dee. “It is easy to take, is associated with cure rates between 94 and 99 percent, is safe and effective in advanced liver disease, is much less toxic than older regimens, and has a manageable drug interaction profile. Yet its price sours our appreciation of these long-awaited agents, particularly now that we have examples that curative treatment is inaccessible to many because of out-of-control escalator drug pricing.”

Gilead’s pricing of Sovaldi, and now Harvoni, puts these medications on a par with the pricing of pharmaceuticals that are much more costly to manufacture and often for rare diseases, despite the fact that Sovaldi and Harvoni are relatively inexpensive to produce, and that at least 3.5 million people are estimated to be living with hepatitis C in the United States. These costs are putting unprecedented pressure on public and private insurers, and stripping patients and providers of the required autonomy to make treatment decisions based on need.

The FPC recognizes that Gilead Sciences is maintaining their free medications program for low-income, uninsured patients, and expanding subsidies that greatly minimize out-of-pocket expenditures, such as co-payments and co-insurance costs, associated with the placement of Harvoni and Sovaldi in specialty drug tiers. Yet these programs are unable to address all disparities of access to treatment due to excessive pricing, resulting in a two-tiered system of care based on insurance coverage and ability to pay.

“Many resource-constrained programs, such as Medicaid, have only been covering Sovaldi-containing regimens for patients with advanced liver disease, despite the fact that people with early stages of disease can transmit the virus to others and may suffer health consequences if treatment is delayed,” said Murray Penner, FPC Co-Chair. “People living with hepatitis C who seek access to these medications are also being required to undergo degrading evaluations related to drug and alcohol use, factors which have not been scientifically substantiated as determinants of the success or failure of treatment. It remains unclear if the reduced cost associated with eight weeks of Harvoni treatment will mollify these programs and we fear these restrictions will be extended, particularly for those requiring 12 or 24 weeks of treatment.”

“A remarkably safe, effective, and easy-to-take tablet means that if it is financially accessible to the many millions of people who desperately need it, we can actually imagine eliminating this insidious disease nationally and globally,” said Dee. “Gilead has failed to comprehend that pricing its curative treatments beyond what the market can bear is a shortsighted business tactic and a failed public health opportunity, both to the detriment of people living with hepatitis C.”

Fair Pricing Coalition Highlights Major Barriers to Life-Saving Treatment in Affordable Care Act Health Insurance Marketplace Plans

New report offers short- and long-term solutions to minimize out-of-pocket expenses and maximize access to treatment for all Qualified Health Plan beneficiaries living with HIV and/or hepatitis C

For Immediate Release
February 6, 2014
Contact: Lynda Dee 410-332-1170 or lyndamdee@aol.com

Discriminatory practices by Qualified Health Plans (QHPs) in the health insurance marketplaces, exorbitant drug pricing by the pharmaceutical industry, and a lack of clear guidance from the federal government regarding the legality of co-payment assistance programs for QHP beneficiaries are proving to be major barriers to affordable treatment for HIV and hepatitis C, according to a new policy guide produced by the Fair Pricing Coalition (FPC).

“The QHPs mandated by the Affordable Care Act are good news for many people living with HIV and/or hepatitis C, as it means they can’t be denied health insurance, because of pre-existing conditions,” explained FPC Co-Chair Lynda Dee. “This ensures the provision of essential health benefits, including important primary care services, access to specialists, and prescription drug benefits.”

“However, many plans are proving financially disastrous for people living HIV, hepatitis C, and other chronic diseases,” Dee added. “This situation is made worse by high drug prices being set and increased annually by manufacturers, along with an inexcusable lack of direction from the U.S. Department of Health and Human Services regarding co-pay assistance programs for people receiving care under ACA-mandated plans.”

According to FPC’s policy guide, Health Insurance Marketplace Plans and People Living with HIV and/or Viral Hepatitis: The Success of the Affordable Care Act Requires Fair Drug Pricing and Access, numerous drug pricing and access issues are becoming increasingly apparent:

  • Some health insurance companies are not including certain standard-of-care HIV medications in their formularies, essentially circumventing the non-discrimination backbone of ACA.
  • Many QHPs are placing prescription medications for HIV and hepatitis C in “specialty drug” tiers (Tier 4 or 5), which impose extremely high out-of-pocket costs.
  • High prices of drugs used to treat HIV and hepatitis C are a key driver of QHPs placing standard-of-care medications in the highest tiers, resulting in prohibitive out-of-pocket costs.
  • QHPs are failing to be transparent regarding their drug formularies and the associated cost sharing, thereby prohibiting people living with HIV and/or hepatitis C from making educated plan choices.
  • Some manufacturers and not-for-profit payers have indicated that they are unwilling to extend their co-payment assistance programs to QHP beneficiaries because of conflicting government guidance.

“These are major barriers to life-saving treatment, when in fact we need to be making access to affordable treatment as easy as possible,” said Tim Horn, an FPC member. “Nationally, only 25 percent of people living with HIV are receiving HIV treatment and keeping the virus in their blood in check. This is essential in terms of protecting their own health and preventing ongoing transmission of the virus. We need to get more people on treatment, not fewer, which won’t be possible if they cannot afford their costly medications.”

Among the possible short- and long-term solutions offered by the FPC:

  1. Require access to all U.S. Department of Health and Human Services (HHS)- preferred and HHS-alternative antiretrovirals for HIV and all FDA-approved treatments for hepatitis C.
  2. Monitor tiering of HIV and hepatitis C drugs for discriminatory practices, such as placing all recommended treatment options on the highest cost-sharing or specialty tiers.
  3. Mandate QHP benefits and drug formulary transparency.
  4. Confirm Secretary of Health Kathleen Sebelius’ indication that manufacturers and non-profit payers may help defray out-of-pocket costs for medications under ACA through co-payment assistance programs.
  5. Lower the out-of-pocket spending caps for individuals and families with incomes up to 250 percent of the federal poverty level.
  6. Insist that insurance companies include HIV and hepatitis C expertise on their pharmacy and therapeutics committees or that they consult disease experts regarding formulary and tiering decisions.

“The problems outlined in the policy report are not insurmountable,” said Dee. “The FPC believes that the Affordable Care Act, while not perfect, has tremendous potential to redress disparities for U.S. residents whose access to healthcare has previously been at the whim of conflicting political and economic forces. This applies not only to HIV/AIDS and viral hepatitis, but also to many other chronic, debilitating, and costly health challenges beyond the capacity of individuals to manage on their own.”

The FPC supports urgent attention to these matters for all U.S. residents at this moment of new hope for achieving universal, affordable, quality health care.

The FPC policy guide can be accessed here:

http://fairpricingcoalition.org/wp-content/uploads/2014/02/FPC-QHP-Policy-Guide-Feb-2014-1.pdf

_______________

The Fair Pricing Coalition (FPC), founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured.  The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals.

 

 

Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C

The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir), a once-daily, first-in-class nucleotide polymerase inhibitor approved by the U.S. Food and Drug Administration on December 6, 2013, for the treatment of chronic hepatitis C, including those co-infected with HIV. While FPC believes that all hepatitis C virus (HCV) drugs are priced too high, the coalition of HIV and viral hepatitis treatment activists is especially dismayed by the wholesale acquisition cost (WAC) of $84,000 for a 12-week course of Sovaldi™. For comparison purposes, the FPC notes the 12-week WAC for the recently approved NS3/4A protease inhibitor Olysio™ (simeprevir) is $66,360.

“Sovaldi™ is a very safe and highly effective drug that will significantly shorten HCV therapy and either reduce or eliminate the need for injected pegylated interferon,” explained FPC Co-Chair Lynda Dee. “However, this does not give Gilead unconscionable pricing carte blanche, particularly when considering that Sovaldi™ still needs to be combined with ribavirin for the treatment of HCV genotype 2 for 12 weeks or genotype 3 for 24 weeks. Twelve weeks of therapy with Sovaldi™ plus both pegylated interferon and ribavirin is required for the treatment of HCV genotype 1, the most common genotype in the US, and HCV genotype 4.”

The WAC for 12 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $9,000, resulting in a combined WAC of $93,000 for a Sovaldi™-inclusive regimen to effectively treat a single person living with HCV genotypes 1 or 4. To treat HCV genotype 3, 24 weeks of Sovaldi™ plus ribavirin is required, resulting in a Sovaldi™ WAC of $168,000.

Price Portends an Ominous Future

“Gilead has set the bar dangerously high as other companies determine prices for similar hepatitis C drugs as they enter the market,” Dee said. The effectiveness of Sovaldi™ as a component of future pegylated interferon-free regimens for the treatment of HCV will ultimately depend on co-administration with other DAAs currently in development, and are anticipated to come with their own high price tags.

“Sovaldi™ is expected to transform the curative landscape for hundreds of thousands of people living with hepatitis C in the U.S. who require therapy or responded poorly to previous treatment,” said Lorren Sandt, FPC Co-Chair. “Yet the high price will result in significant barriers to treatment access, particularly in limited and fixed-budget programs, such as Medicare and state Medicaid programs, AIDS Drug Assistance Programs, the Veterans Administration, and in correctional systems.”

The high price may also lead to access challenges imposed by private insurance plans and Qualified Health Plans in the new Affordable Care Act (ACA) Marketplaces, notably those with high co-payment and other out-of-pocket requirements.

“There may be reluctance to add Sovaldi™ to formularies quickly and payers may force people living with HCV to engage in step therapy in which they are first required to try less expensive options that are less effective,” Sandt added. “These options take longer to complete and are associated with serious side effects, which present a serious impediment to adherence and, ultimately, to being cured of hepatitis C.”

Concessions Where They Count

Although Gilead refused FPC’s demand for fair pricing of Sovaldi™, the company has agreed to all FPC requests for concessions regarding Sovaldi™ access programs. These include:

The SupportPath™ (www.mysupportpath.com) patient assistance program (PAP), with a $100,000 maximum income allowance for a household of three and 500% of the federal poverty level (FPL) eligibility criteria for larger households.

  • The SupportPath™ Sovaldi™ co-pay coupon program will provide co-pay assistance for eligible patients with private insurance, including ACA Marketplace exchange patients, who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay. Co-pay assistance of up to 20% ($16,000) of the WAC price for Sovaldi™ can also be applied toward prescription deductibles and co-insurance obligations.
  • Gilead has made a contribution to the Patient Access Network (PAN) for co-pay assistance for Medicare Part D clients.
  • Gilead has initiated an emergency Sovaldi™ supply program for patients that may lose their prescriptions.
  • Gilead has agreed to ensure access to its PAP and co-pay assistance programs for AIDS Drug Assistance Program (ADAP) patients who are co-infected with HIV, even in states with ADAP programs that will not include Sovaldi™ on their formularies.

The FPC urges Gilead to widely disseminate the details of its SupportPath™ PAP and co-pay coupon program, which must include providing written SupportPath™ information for prescribers, prominently featured SupportPath™ information in its professional and direct-to-consumer advertisements, and clear links to www.mysupportpath.com via the Gilead and Sovaldi™ websites.

Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)

The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients.  Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360.  Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

“While we are very excited to have more effective and more tolerable treatment options for people living with hepatitis C, we are concerned about the overall cost of treatment,” said FPC HCV Co-Chair Lorren Sandt. “Janssen did price Olysio comparatively with other HCV PIs, but the bar previously had been set too high.  We strongly urged Janssen to price Olysio lower than current regimens to help address the overall cost of therapy, which continues to spiral out of control.”

The FPC is gravely concerned about the continued precedent this pricing has on the future of HCV therapy.  Industry experts have stated their expectations that Gilead Sciences’ new direct acting antiviral, sofosbuvir, will be approved by the FDA in the next few weeks.  While the cost of sofosbuvir is not yet known, patients and doctors may look to combine these therapies (off label), resulting in an expected doubling of the current price of therapy.

“We know that this is just the initial price,” said Sandt.  “Other HCV protease inhibitor manufacturers quickly increased prices after their initial 2011 launch. For example, a 12-week course of Vertex’s PI Incivek (telaprevir) had a WAC price of $49,000 at launch, but is now priced at $66,155.  We caution Janssen not to continue this unacceptable trend. Treatment is just too costly for the majority of people living with chronic HCV,” concluded Sandt, “and we fear that barriers to patient access will be inevitable as a result.”

Anticipating the price of Olysio, the FPC urged Janssen to expand their access programs to ease the fiscal challenges that patients will face when trying to purchase Olysio. The FPC acknowledges that the Johnson & Johnson Patient Assistance Foundation agreed to expand the eligibility criteria for Olysio from 200% to 500% of the Federal Poverty Level (FPL). While this is a step in the right direction, it is not as generous as the program Vertex established for their PI, which is a maximum household income of $100,000 per year. The FPC also applauds Janssen’s intent to initiate a $25,000 per course of treatment co-pay program for Olysio.  Unfortunately, the legal status of such programs for the Qualified Health Plans in the new Affordable Care Act Exchanges remains in question, possibly making Olysio access out of reach for many ACA patients.

“We thank Janssen for responding to our requests to increase the eligibility level of their PAP for Olysio and for developing a generous co-pay assistance program,” said Murray Penner, a member of the FPC.  “We know that co-insurance costs will be very high for patients.  Despite the access programs Janssen has in place, we are very concerned that the high price of Olysio, coupled with high co-insurance costs for patients, will result in limited access to Olysio.”

FPC DENOUNCES PRICING OF GILEAD’S NEW QUAD ANTIRETROVIRAL STRIBILD™

BALTIMORE, August 28, 2012 — While the Fair Pricing Coalition (FPC) applauds the Food and Drug Administration’s (FDA) approval of Gilead’s new 4-in-1 anti-HIV/AIDS single tablet regimen, Stribild™, we strongly protest the $28,500 annual Wholesale Acquisition Price (WAC) price announced by Gilead Sciences, Inc.

“This is a long-anticipated addition to the options available to people living with HIV/AIDS and their healthcare providers”, said Lynda Dee, FPC spokesperson. “However, in pricing the new drug more than 35% above the $21,000 per year WAC price of its own best-selling single-tablet regimen, Atripla™, Gilead has created an environment of restricted access and financial hardship for patients impacted by current dire economic conditions and US healthcare costs and whose very lives depend on access to more convenient treatments,” Dee added.

Gilead appears to be pricing cobicistat, its own booster component of Stribild™, comparably with Abbott Laboratories’ Norvir™ which includes Abbott’s unconscionable 400% price increase while its closest competitor Merck & Co.’s integrase inhibitor Isentress™, plus Truvada™ needs no booster and has an annual WAC price of $26,200. Thus, Stribild’s™ booster component cobicistat is more like excess baggage than an achievement worth $2,000 above the only other approved integrase inhibitor combination. There may also be a greater risk of kidney side effects with Stribild™ than with the Merck integrase inhibitor combination.

“Gilead asked for community input in setting the price of its new product, and invited the FPC to the negotiating table in June for discussions,” said Dee. “We thought we had reached a reasonable understanding with Gilead, but evidently the company is more interested in filling its coffers than in reasonable and fair pricing. I’m shocked at the price they have set, and would call this a betrayal of the spirit of our negotiations“, she added. “We will now consult with our community partners, government allies as well as public and private payers to determine the best course of action to take,” she concluded.

Protest Gilead Price Increases

The Fair Pricing Coalition has written in protest of Gilead’s constant and excessive price increases for their HIV drugs and is asking others to sign onto our protest letter. The letter and signatories as of 3/19 are below. If you’d like to add your voice click here.

Letter to Gilead:

March 19, 2012
John Martin
James Meyers
Gregory Alton
Coy Stout
David Poole
Amy Flood
Cara Miller
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404

RE: Recent Gilead Drug Price Increases

Ladies and Gentlemen:

We are writing in response to your latest antiretroviral price increases. We are dismayed that Gilead has imposed a 7.9% price increase on Truvada and agreed to a 7.3 % increase on Complera and a 6.6% increase on Atripla in January of 2012.  Because the Fair Pricing Coalition (FPC) has been unable to convince Gilead to take no more than one annual price increase in line with the Consumer Price Index (CPI), we have enlisted the assistance of the larger HIV community in this effort.

We have been urging Gilead to refrain from taking more than one annual price increase no greater than the CPI for many years.  In October of 2009, the FPC wrote to our industry partners, including Gilead, about the crisis in access to HIV medication, resulting, in part, from repeated industry price increases taken continuously over a short period of time. Gilead has constantly been one of the worst offenders in this regard.

While we salute Gilead for its commitment to AIDS Drug Assistance Programs (ADAPs) as well as its co-pay and Patient Assistance Programs (PAPs), we are astounded at how Gilead diminishes the benefit of its philanthropy with these continuous price increases.  It is essential that you understand the negative impact of your actions on people living with HIV/AIDS (PLWHAs).  Since our original 2009 letter, Gilead has raised prices three times each for Viread and Truvada for a total of 22.1% and 24.5% respectively; twice for Emtriva for a total of 15.3%,and agreed to four price increases on for Atripla, totaling 21%, and agreed to a 7.3% price increase for Complera.  These increases are dramatically higher than the rate of inflation. They also come at a time when many people with HIV have lost their jobs, their employer-based insurance coverage and, in many instances, their ADAP coverage, all resulting in desperate patients attempting to access HIV drugs on the open market, a market plagued with constantly increasing drug prices.

As U. S. economic stagnation persists, PLWHAs continue to lose jobs, income, health care benefits and ADAP coverage.  At the same time, third party payers are imposing higher premiums as a direct result of escalating drug prices. Some patients have abruptly stopped treatment because they can no longer afford their medications. Although PAPs exist to help people who cannot afford medication, barriers to access are significant. Many people are unaware of the existence of PAPs. Others cannot cope with the labyrinth of multiple forms and requirements.  Even with Gilead’s PAP eligibility at 500% of the Federal Poverty Level, a PLWHA earning $56,000.00 annually is not PAP eligible and will have to pay $20,000.00 or more to purchase Atripla at retail prices.  This figure represents at least two-thirds of their net income.

The pharmaceutical industry’s extravagant price increases reverberate throughout the healthcare industry.  They come at a time when many ADAPs are covering private insurance payments for their clients and result in ADAPs paying significantly increased premiums as a result of exorbitant price increases.  This policy also results in higher premiums for people with HIV who are insured at a time when more and more people have less and less income due to unemployment, underemployment, reduced wages and reduced hours.  Moreover, higher healthcare costs mean higher co-pays and pharmacy deductibles for people with private insurance and high share-of-cost plans which also result in increased costs to patients as well as decreased benefits.  More restrictive access within insurance plans affects the cost of drugs, but also ancillary services, such as mental health, prevention healthcare, rehabilitation and substance abuse services.

Escalating costs for private and employee healthcare plans occasioned by continuous drug pricing increases will undoubtedly have a deleterious effect on the states as they design their health care exchanges in preparation for the 2014 implementation of the Affordable Care Act (ACA).  Many states are likely to set a minimum standard for drug coverage for their “essential health benefits” package that requires only limited coverage of antiretrovirals and other higher cost drug classes. Additionally, with non-preferred generic antiretrovirals entering the marketplace we are concerned that higher drug prices will increasingly result in key coverage decisions being driven by cost rather than the standard of care for HIV treatment.

From our perspective, much of this crisis is occasioned by irresponsible pharmaceutical industry behavior. We firmly believe that Gilead’s price increases are particularly egregious because Gilead currently has the lion’s share of the antiretroviral market.We believe that the best way to begin to address these issues is for industry to change its price increase practices and agree to the following:

  • Gilead must agree to take no more than one CPI consistent price increase annually.
  • Gilead must use its sales force to disseminate information regarding its PAP and co-pay programs.
  • Gilead must contribute to foundations that provide co-pay program access to Medicare Part D clients.
  • Gilead must cooperate with the FPC and other stakeholders in designing and implementing a seamless, industry-wide standardized PAP criteria and enrollment process.

Now is the time for Gilead to reconsider its price increase policy and rescind its latest unreasonable price increases. We sincerely hope that Gilead will agree to the above and we look forward to your immediate response.

Yours truly,
The Fair Pricing Coalition and the Undersigned Organizations

AIDS Action Baltimore, Baltimore, MD
AIDS Treatment Activists Coalition, New York, NY
Community Access National Network, Washington, DC
HIV Prevention Justice Alliance, Chicago, IL
Program for Wellness Restoration, Houston, TX
ADAP Advocacy Association (aaa+), Washington, DC
Queerocracy, New York, NY
Treatment Action Group, New York, NY
Positive Life, Palm Springs, CA
Nightsweats & T-cells, Co, Cleveland OH
Positive Outreach Women’s Education & Resources (POWER)
ACT UP –New York,   NYC, NY
ADAP Educational Initiative, Columbus, OH
SAVE ADAP Inc.   Columbus, OH
AIDS Treatment News
Aspirations, Baton Rouge, LA
AIDS Foundation of Chicago, Chicago, IL
International Foundation for Alternative Research in AIDS, Portland, OR
HIV Empowerment & Action League (HEAL), Nashville, TN
Zephyr LTNP Foundation, Inc., Sacramento, CA
Global Network of People Living with HIV, North America
LIGHT Health & Wellness Comprehensive Services, Inc., Baltimore, MD
GALAEI, Philadelphia PA
Community Information Center, Inc., Portland, OR
AIDS Healthcare Foundation, Los Angeles, CA
TAPWA-(Tennessee Association of People with AIDS) Knoxville, TN
Miami Valley Positive for Positives, Dayton, OH
The Church of Christ in Thailand AIDS Ministry
People Living with HIV/AIDS Members, Of Thai Network of People Living with HIV/AIDS TNP+
Children’s Hospital Boston, Neuro-epidemiology, Boston, MA
HIV-AIDS ADVOCACY POLICY & PROCEDURE CONSULTING SERVICE MILWAUKEE WI 53211
Most at Risk Populations’ Society in UGANDA (MARPS in UGANDA)

 

 

The Fair Pricing Coalition Expresses Disappointment at the Price of Vertex’s Newly Approved Hepatitis C Drug

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.”

THE FAIR PRICING COALITION EXPRESSES DISMAY AT THE PRICE OF MERCK’S NEWLY APPROVED HEPATITIS C DRUG

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.”

Fair Pricing Coalition Brokers Rescue of Troubled ADAP; Nearly 6,500 Floridians Will Continue to Receive HIV Medications

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.