[Ip-health] Gilead's blackmail/Insurers' rationing

leena menghaney leenamenghaney at gmail.com
Mon Jul 20 09:15:55 PDT 2015


Dear Brooke,

BMS too has limited CU/name patient access for daclatasvir to a few
countries and to make it worse, it is making no moves to register in high
burden countries like India.

Leena

On 20 July 2015 at 21:22, Baker, Brook <b.baker at neu.edu> wrote:

>  I'm sure many may have seen the WSJ article below detailing Gilead's
> effort to limit enrollment in its compassionate care program in an effort
> to blackmail insurers into providing broader coverage for people with Hep C
> whose insurers are currently employing treatment eligibility requirements
> that limit treatment to patients with advance liver disease.  Poised
> between Gilead's blackmailing efforts to increase sales of its
> super-expensive medicines and insurers' craven decisions to ration
> treatment until people are seriously ill are millions of patients whose Hep
> C infections could be cured with benefits not only for their health but
> with prevention benefits as well if Gilead were to adopt more pro-access
> pricing and if insurers, including Medicare/Medicaid, provided guaranteed
> prompt treatment to their insureds.
>
>  This deadly contest between behemoth pharmaceutical and so-called
> "health" insurers does have a body count and disastrous public health
> implications.  It's hard to weigh whether Gilead or insurers' approaches
> are more cynical, but when access to medicines is left to the deadly logic
> of profit-maximizing monopolist and oligopolists this kind of standoff is
> inevitable.  In a more rational health system, binding treatment guidelines
> would require access and direct acting antivirals would be more affordable
> either as a result of generic competition or real price controls.
>
>  Brook
>   Professor Brook K. Baker
> Northeastern U. School of Law
> Affiliate, Program on Human Rights and the Global Economy
> 416 Huntington Ave.
> Boston, MA 02115 USA
> Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
> Senior Policy Analyst Health GAP (Global Access Project)
> NGOs Board Member UNITAID
> (w) 617-373-3217
> (cell) 617-259-0760
> (fax) 617-373-5056
> skype: brook_baker
> b.baker at neu.edu
>
>
> http://blogs.wsj.com/pharmalot/2015/07/16/gilead-limits-enrollment-in-its-hep-c-patient-program-to-pressure-insurers/tab/print
> /
>
>    Gilead Limits Enrollment in its Hep C Patient Program to Pressure
> Insurers
>    ByEd Silverman  July 16, 2015
>
> In a bid to push back against payers, Gilead Sciences
> <http://online.wsj.com/public/quotes/main.html?type=djn&symbol=GILD> is
> limiting enrollment to its patient assistance program for hepatitis C
> drugs, which helps people obtain the Sovaldi and Harvoni treatments when
> they lack sufficient insurance coverage or the financial wherewithal to get
> the medicines otherwise.
>
> The drug maker is taking this step after finding that some payers, despite
> receiving discounts in recent months, have continued to restrict patient
> access to its hepatitis C medicines. As a result, Gilead has been picking
> up the cost of the medicines for more people it would like seeking patient
> assistance, according to a July 1 letter sent to patient groups and
> community health providers, among others.
>
> A Gilead spokeswoman declined to say how many people are enrolled in its
> Support Path assistance program, how many may be affected by the change or
> provide actions taken by specific payers.
>
> The move is likely to add another level of controversy surrounding the
> Gilead drugs, which are poster children in the national debate about the
> cost of prescription medicines. By restricting access, Gilead appears to be
> counting on patients to complain to payers about a lack of access, but the
> tactic may also raise questions about the extent to which patient
> assistance programs are easily manipulated.
>
> “This is a way of applying more pressure on payers to expand their
> coverage criteria,” says Roger Longman of Real Endpoints, a research firm
> that tracks reimbursement issues.
>
> Meanwhile, Randy Vogenberg, a partner at Access Market Intelligence, a
> consulting firm that specializes in managed care, says “unfortunately, such
> a strategy places the patient in the middle as the pawn.”
>
> The Gilead spokeswoman wrote us that the drug maker “supports open access
> to hepatitis C therapies… We continue to work with payers to provide
> information that conveys the profile of our hepatitis C medications and the
> benefit of curing individuals living with the virus.”
>
> Here is the genesis: Gilead began offering discounts last winter to payers
> in response to deals that AbbVie struck
> <http://blogs.wsj.com/pharmalot/2014/12/22/the-hepatitis-c-price-wars-begin-what-the-express-scripts-move-means/> with
> some payers while launching a rival hepatitis C medicine. At the time,
> Gilead dominated the field with Sovaldi, which cost $84,000 for a 12-week
> regimen, and then began selling Harvoni, which cost from $63,000 to
> $94,500, depending upon the duration of the regimen.
>
> Seeking to maintain market share, the Gilead discounts averaged 46%. But
> the drug maker did not require payers to provide coverage for Sovaldi and
> Harvoni on a wide basis, Longman says. The Gilead spokeswoman says it is
> not always that simple. “Payers ultimately make their own decisions about
> the level of access they are willing to provide, and they may reject any
> discount offered,” she explains.
>
> Nonetheless, payers are free to place restrictions on the drugs, thus
> lowering their own costs. So while some payers have since provided coverage
> for the Gilead drugs without restrictions, others still maintain
> restrictions, according to the Gilead letter.
>
> “While many payers responded to these discounts by opening access broadly,
> some payers have continued to restrict access despite the discounts,” wrote
> Coy Stout, a vice president of managed markets at Gilead in the July 1
> letter. “As a result, our [program] criteria enabled continued restrictions
> by some payers by providing a generous route for them to deny access and
> refer patients they have chosen not to cover. “
>
> “While we have approved many of these patients in the past, we feel it is
> necessary to establish more specific guidelines for patient eligibility.
> Our [program] was designed to help uninsured patients with the most need,
> and changes are necessary to remain true to that mission.  We believe these
> changes also will help increase access among those payers who continue to
> restrict access.”
>
> And so, Gilead is limiting enrollment in its program if payers restrict
> access to the drugs for several reasons. These include patients with less
> severe hepatitis C or if a plan prefers or offers exclusive coverage to
> another drug on its formulary, or list of preferred medicines. An obvious
> example would be the AbbVie drug, known as ViekiraPak.
>
> Gilead also cites these reasons: A plan that limits access to the
> medicines for a specific length of time or denies subsequent treatment
> after a patient has failed therapy. What else? Gilead will limit enrollment
> if plans require step therapy, which involves using one treatment before
> trying another. And enrollment will be limited if plans restrict access to
> the drugs based on alcohol testing, among other clinical criteria.
>
> *HERE IS THE LETTER…*
>
> Wednesday, July 1, 2015
>
> Dear Community Partner,
>
> Gilead has always been an advocate for patient access to therapies in the
> areas in which we work.  I am writing to provide you with an update
> regarding Support Path, our patient support program for individuals living
> with chronic hepatitis C.
>
> As you may be aware, Support Path is designed to help patients in the U.S.
> with high co- pays or who lack adequate insurance access to Sovaldi or
> Harvoni.  The Support Path program provides assistance to patients who are
> uninsured or who need financial assistance to pay for the medicine.
>
> Key components of the program include:
>
> In the interest of facilitating patient access in the period immediately
> following the launch of Sovaldi and Harvoni, the Gilead Patient Assistance
> Program (PAP) made these medications available to virtually all patients
> who met financial and other program requirements.  Gilead also implemented
> significant discounts for its HCV therapies across different payer groups.
> While many payers responded to these discounts by opening access broadly,
> some payers have continued to restrict access despite the discounts.
>
> As a result, our PAP criteria enabled continued restrictions by some
> payers by providing a generous route for them to deny access and refer
> patients they have chosen not to cover.  While we have approved many of
> these patients in the past, we feel it is necessary to establish more
> specific guidelines for patient eligibility.  Our PAP was designed to help
> uninsured patients with the most need, and changes are necessary to remain
> true to that mission.  We believe these changes also will help increase
> access among those payers who continue to restrict access.
>
> With that in mind, effective July 1, 2015, the following changes will be
> implemented.  Gilead anticipates these changes will not impact the majority
> of patients helped by our patient support programs.
>
> Specifically, patients who are insured and who do not meet their payers
> coverage criteria *will no longer be eligible* for support via Gileads
> Patient Assistance Program.  Patients who fall within the category of
> Insured and Did Not Meet Payer Criteria are patients whose insurance
> providers limit access to Sovaldi/Harvoni based on, but not limited to, the
> following:
>
> Fibrosis score restrictions
>
> Preferring or exclusively covering another product on formulary (i.e.,
> Viekira Pak preferred)
>
> Limiting coverage to a maximum treatment duration or denying subsequent
> treatment after a patient has failed therapy
>
> Step-therapy requirements
>
> Clinical criteria (e.g., psychiatric requirements, drug and alcohol
> testing)
>
> It is important to note that a very small number of patients fall into
> this category.  Support Path experts will continue to treat each patient
> case individually and consider a number of variables when assessing
> patients for our free drug program.
>
> The Sovaldi and Harvoni Co-pay Coupon Program, which minimizes monthly
> out-of-pocket costs for eligible patients* to as little as $5 per month
>
> The Support Path Patient Assistance Program, which will provide Sovaldi or
> Harvoni at no charge for eligible patients
>
> *You are not eligible if you are enrolled in a government healthcare
> prescription drug program such as Medicaid or Medicare Part D
>
> For Sovaldi and Harvoni patients who are insured and have been denied
> coverage by their payer, Support Path can assist patients with the
> requirements for submitting appeals, peer reviews and understanding the
> process for in-person hearings if required.
>
> Gilead continues to support open access to hepatitis C therapies with
> prescribing decisions made by a physician in partnership with his or her
> patient. We will continue to work with payers to provide information that
> conveys the profile of our hepatitis C medications and the benefit of
> curing individuals living with the virus.  We believe that payers should
> take the responsibility to provide coverage for their insured patients
> based on the treatment decisions of their healthcare providers.
>
> Through Gileads Support Path Program, which provides a comprehensive suite
> of patient assistance resources, we are committed to our mission of helping
> patients in financial need access our products, and to ensuring our patient
> assistance program reaches eligible uninsured patients.
>
> As always, we appreciate the ongoing dialogue with our community partners
> and look forward to continuing to collaborate with you on efforts to expand
> access to life-saving therapies.
>
> Best regards,
>
> Coy Stout
>
> Vice President, Managed Markets Gilead Sciences, Inc.
>
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-- 
Leena Menghaney
Mobile: 9811365412



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