Fair Pricing Coalition Blasts HIV Pharmaceutical Manufacturers for Unjustified 2015 Drug Price Increases

Community requests for price freezes to strengthen affordable access to life-saving treatments go ignored

The Fair Pricing Coalition (FPC) today expressed its dismay and frustration at manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV, citing exorbitant Wholesale Acquisition Cost (WAC) price increases ushered in with the new year. The WAC price increases implemented by these industry leaders show complete disregard for an annual FPC year-end appeal calling for a two-year price freeze, with several companies setting 2015 prices that far exceed the typical rise in the Consumer Price Index (CPI).

“The FPC firmly believes that upwardly spiraling drug prices are already at the upper limit of any conceivable justification, are unsustainable, and will continue to hinder patient access to life-saving HIV treatment and prevention options, as well as recently approved curative hepatitis C virus (HCV) regimens,” said FPC Co-Chair Lynda Dee. “We made this point, plainly and clearly, to executives at the major pharmaceutical companies again in 2014, yet we are once more looking at WAC increases that are generally between 7 and 10 percent over last year’s already indefensible prices.”

Though the January 2015 CPIs—measures of inflation—have not yet been announced, the 2015 WAC price increases for leading antiretrovirals are two to three times higher than the ten-year CPI average of 2.5 percent; they are also higher than all medical CPI categories, which average 2 to 3 percent and are driven in part by unrestrained drug pricing.

“Several companies are, once again, guilty of unsubstantiated price gouging, with Bristol-Myers Squibb (BMS) being the most egregious example,” said FPC Co-Chair Murray Penner. “Despite that BMS was recently granted a reprieve on the anticipated 2014 loss of patent exclusivity for Sustiva, allowing it to reap an additional two years of exclusivity on U.S. sales of the drug, the company decided that this windfall occasioned by endless patent evergreening was not enough, and increased the 2015 WAC for Sustiva by nearly 10 percent—the largest price increase reported thus far this year. And this followed two 2014 increases, totaling 16.7 percent, contributing to a total price increase of approximately 150% since the drug was approved in 1998.”

 

Starting January 1, the annual WAC price for Sustiva (efavirenz) increased from $9,352 to $10,260. Importantly, this price increase directly impacts the WAC of the efavirenz-containing single-tablet regimen Atripla, which is now $25,874 per year, compared with $24,965 at the end of 2014. The 2015 Atripla annual WAC is also more than 85% higher than its 2006 launch price of approximately $13,800 per year.

Other notable WAC price increases reported on January 1 include Janssen Therapeutics’ Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine) (7.9% each); a 6.9% increase in the WAC price for Merck’s Isentress (raltegravir), and a 7.9% increase in the WAC price for BMS’s Reyataz (atazanavir). WAC price increases for ViiV Healthcare’s HIV drug products are anticipated during the first quarter of 2015. AbbVie is not expected to increase the price on its drug products, at least not this quarter.
Shielded by claims of legal proscriptions, the companies notify FPC and the general public of price increases only after they have already been decided. As there is rarely an opportunity for comment or other public input into these price determinations, the FPC submitted letters to all of the major HIV drug manufacturers in December 2014, demanding a price freeze or, if absolutely necessary, no more than one price increase annually (some antiretroviral prices have been raised twice in one year), not to exceed the overall increase in the medical CPI for the preceding year. Letters also reiterated the need for more robust company patient savings programs to offset skyrocketing out-of-pocket (OOP) costs associated with these expensive medications being placed in specialty drug tiers.

“We commend many companies for complying with our requests for more generous assistance programs to help cushion the blow associated with exorbitant OOP costs, but we have been unambiguous in noting that ever-increasing drug prices only encourage payers to place all HIV and HCV medications in specialty tiers, and raise cost sharing requirements, and establish even more draconian prior authorization restrictions,” explained Dee. “Our demands that major HIV companies refrain from compounding the average consumer’s economic hardship and inflating prices beyond the brink of what health care delivery under the Affordable Care Act can reasonably bear have been ignored. The time has come to inform and mobilize the public regarding the pharmaceutical industry’s reluctance to heed reasonable requests regarding its unjustified pricing policies.”

Contact:
Lynda Dee
(410) 332-1170
lyndamdee@aol.com

Fair Pricing Coalition Applauds AbbVie/Express Scripts Deal for Viekira Pak, Urges Similar Price Negotiations Across Payer Landscape to Maximize Access to Curative Hepatitis C Treatment

For Immediate Release
Contact: Lynda Dee (410) 332-1170 or lyndamdee@aol.com

In addition to welcoming U.S. Food and Drug Administration (FDA) approval of Viekira Pak™ (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) for hepatitis C virus (HCV) genotype 1 infection on December 19, 2014, the Fair Pricing Coalition (FPC) applauds manufacturer AbbVie’s deal with pharmacy benefit management (PBM) organization Express Scripts to ensure access to the co-packaged curative regimen for all people living with hepatitis C virus (HCV) for whom treatment is indicated.

“Viekira Pak is an important addition to the expanding curative treatment armamentarium for hepatitis C, with its documented 91 to 100 percent cure rates in Phase III clinical trials involving people with HCV genotype 1, the most common form of the infection in the United States,” said FPC Co-Chair Lynda Dee. “No less exciting is the recently announced pricing deal between AbbVie and Express Scripts, which will make highly curative therapy available to many people with HCV genotype 1 unable to access other combination regimens, such as Gilead Science’s Harvoni® (ledipasvir and sofosbuvir), due to cost-containment restrictions.”

Under the terms of the deal announced Sunday, December 21, AbbVie will offer a substantial discount on the co-packaged regimen’s Wholesale Acquisition Cost (WAC) price of $83,300. In exchange, Express Scripts will make Viekira Pak the preferred option to its clients living with HCV genotype 1, regardless of disease severity or the prescriber’s specialty. In the absence of this deal, curative therapy may have been limited to those with advanced fibrosis (stage F3 or F4) and those receiving care from a liver disease specialist—both of which are among some of the prior authorization requirements in place for Gilead’s Sovaldi® and Harvoni.

Harvoni and emerging options will likely be covered by Express Scripts for patients for whom Viekira Pak is not recommended, such as patients with advanced (decompensated) cirrhosis or for those who cannot tolerate ribavirin (a requirement for individuals with HCV genotype 1a or for patients who have undergone a liver transplant).

The AbbVie/Express Scripts deal is expected to be a game changer in the arena of treatment access, in which manufacturers will no longer be able to charge what they believe the U.S. market will bear, but rather what PBMs and cost-cutting insurance carriers will actually pay for. “Though Express Scripts is the largest PBM in the U.S., it is by no means the only payer covering people living with hepatitis C” said FPC Co-Chair Murray Penner. “We need to see AbbVie continue its good-faith negotiations with other payers, including state Medicaid programs.  It will behoove other drug manufacturers to do so as well.”

“Maintaining provider and patient choice is critical to advocacy work focusing on treatment affordability and access,” explained David Evans, an FPC member. “In a landscape where HCV drugs have adopted ever-escalating prices and payers are limiting choice to contain costs, any deal that dramatically expands the number of people who can receive curative therapy must be applauded.”

For qualified individuals living with hepatitis C who have financial difficulties accessing Viekira Pak, the AbbVie Patient Assistance Program provides medication at no cost. A co-pay assistance program will also be available for commercially insured patients being treated with Viekira Pak. Out-of-pocket costs for eligible patients will be as little as $5.00 per month for most patients. Additionally, AbbVie has launched a patient support program, called proCeed™, which is intended to provide a broad range of patient support options. The proCeed program can be accessed at www.viekira.com or by calling 1-844-2-PROCEED.

Download the full press release here: FPCPRViekiraPakv_FINAL

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The Fair Pricing Coalition, 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. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalition.org

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

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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.”