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By Lauren
Flynn Kelly, Editor
January 9, 2015Volume
16Issue 1
Following last month’s approval of
AbbVie Inc.’s hepatitis C therapy Viekira Pak (ombitasvir, paritaprevir and
ritonavir tablets; dasabuvir tablets), both Express Scripts Holding Co. and CVS
Health’s CVS/caremark PBM made bold but expected moves that are setting a new
paradigm in formulary management of specialty drugs.
Express Scripts on Dec. 22 unveiled
what Chief Medical Officer Steve Miller, M.D., calls a “game-changing
agreement” through which Viekira Pak will be the exclusive genotype 1 hepatitis
C treatment option for members that are on the National Preferred Formulary at
a “significant discount” to clients.
And after conducting a “comprehensive
clinical review” of Viekira Pak and Gilead Sciences, Inc.’s Harvoni (ledipasvir
and sofosbuvir), CVS/caremark chose the latter as the preferred agent for its
2015 standard formulary, CVS Health explained in a Jan. 5 fact sheet outlining
its hepatitis C therapy strategy for clients and consultants.
Viekira Pak on Dec. 19 became the
fourth oral agent in the hepatitis C class to receive FDA approval since November
2013. The new agent can be used with or without ribavirin, and is approved to
treat patients with chronic genotype 1 hepatitis C virus infection, including
those with compensated cirrhosis. It is not recommended for patients with
decompensated liver disease. The FDA approved Olysio (simeprevir) in November
2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni in October 2014 (DBN
10/24/14, p. 1).
Express, CVS Cut Hep C Deals
For commercial clients that adopt the
CVS/caremark standard formulary with exclusions, Viekira Pak will be considered
non-formulary and available only by a medical exception or prior authorization
for patients who have not yet begun therapy, explained CVS. Both Harvoni and
Sovaldi are included on the second tier of that formulary, with Sovaldi
designated as a preferred agent for the treatment of other genotypes. Olysio,
meanwhile, is on the third tier for commercial plans and non-formulary for
exchange plans that use the standard formulary. Harvoni is also recommended as
a preferred agent on Medicare Part D and managed Medicaid template formulary
clients, said CVS. The changes went into effect Jan. 7.
In its fact sheet, CVS pointed out
once-daily treatment with Harvoni is “extremely well tolerated, facilitating
the completion of a full course of therapy,” which for some patients may last
only eight weeks compared to typical 12-week regimens with its competitors. The
recommended dosing for Viekira Pak, which combines three distinct mechanisms
that combat the hepatitis C virus at three separate stages of the disease
lifecycle to keep it from reproducing, is two fixed-dose
ombitasvir/paritaprevir/ritonavir tablets once a day in the morning and one
dasabuvir 250 mg tablet twice daily with a meal.
Express Scripts Favors AbbVie Drug
Meanwhile, Viekira Pak was added to
Express Scripts’ exclusionary formulary on Jan. 1 as the preferred, covered
alternative for all clinically appropriate plan members, regardless of their
disease stage. The National Preferred Formulary now excludes Sovaldi, Harvoni
and Olysio, unless patients had already begun treatment regimens with those
agents. Sovaldi, however, will still be covered for patients with other
genotypes. Express Scripts also has preferred select antivirals and interferons
that may be used with the covered agents.
“We want all hepatitis C patients to
receive the best care our health care system can deliver,” Miller explains to DBN.
“At the same time, we have been vocal throughout 2014 that Gilead’s price for
Sovaldi and Harvoni was unsustainable for our plan sponsors, and that U.S.
payers should not have to pay orphan-drug prices for non-orphan drugs.”
A 12-week course of Sovaldi is priced
at $84,000, or $95,000 per patient when used with ribavirin and interferon,
while the same length of treatment with Harvoni costs roughly $94,500. The
AbbVie drug is set at $83,319 for the typical 12-week treatment. While most
patients will qualify for the 12-week course, the recommended dosing for
genotype 1a-infected patients with cirrhosis is 24 weeks with ribavirin,
according to the prescribing information. The treatment is also indicated for
patients who are co-infected with HIV or who have had liver transplants.
Based on data from the Viekira Pak
clinical trials, Express Scripts anticipates there being very few instances
where it wouldn’t be clinically appropriate for a genotype 1 patient, adds
Miller. But if, for example, a patient has an allergy to one of the treatment’s
ingredients, the patient would be able to receive coverage for one of the
excluded products, he explains.
Moves by both of the big PBMs came as
no surprise to industry analysts, given that Express Scripts had been vocal
throughout 2014 about its plans to pit hepatitis C drugmakers against each
other for better discounts, and an exclusive Gilead partnership seemed
inevitable for CVS following the Express Scripts news.
In a Dec. 22 research note, Evercore
ISI Senior Managing Director and Partner Ross Muken pointed out that Express
Scripts has “historically not been afraid to take bold steps when it comes to
wielding its position with the [supply] chain relative to branded drug
manufacturers.” He pointed to when the PBM moved Lipitor (atorvastatin) to the
third tier of its national formulary in early 2012 after the first generic
version of Pfizer Inc.’s blockbuster cholesterol-lowering drug was launched.
“Ultimately, specialty trend has been
and remains a major problem for customers, and decisions like this (assuming a
reasonable discount with much of the rebate passed back to customers) will be
increasingly necessary in order to control spend and should help to set the
stage for the treatment of biosimilars in the future,” wrote Muken.
Will New Exclusions Help PBMs’ Sales?
During a Dec. 22 webinar to discuss the
Express Scripts news, Evercore Managing Director Michael Cherny suggested that
it may be the “one shot that could help accelerate the move to more restrictive
formularies.” Cherny also asked whether the deal could enable the company to
win back business it’s lost in recent years to competitors.
Muken suggested in a Jan. 5 note that
the CVS/Gilead alignment may be perceived as “less bold” than the Express
Scripts/AbbVie deal and “potentially appealing to a broader segment of the
employer market” because it involves two drugs that are “more advantaged,”
given the potentially shorter regimen, more convenient dosing and fewer
drug-to-drug interaction issues.
“By rolling their new hepatitis C
formulary exclusions into their broader National Preferred Formulary strategy,
[Express Scripts] will likely get decent client uptake on this,” predicts Josh
Golden, practice leader, employer consulting at Pharmaceutical Strategies
Group, LLC, in an interview with DBN. “The hope is that most or all of
the incentives that are created by these new exclusions would flow back to the
plan sponsor — but in reality the PBM often retains some of that value. What’s
less predictable is the client uptake of ESI’s new Hepatitis Cure Value
Program.”
That new program, launched alongside
the hepatitis C formulary update, provides additional discounts on Viekira Pak
for plan sponsors that elect to treat all their genotype 1 patients (including
those with early stages of the disease) and use the Express Scripts-owned
Accredo Specialty Pharmacy.
“It’s basically a way for [Express Scripts]
to capture more volume through exclusive Accredo distribution,” suggests
Golden. “Clients that already have an exclusive Accredo arrangement will
probably jump on this one. Others will likely take a more measured look before
leaping.”
Golden adds that he was “not surprised”
to see CVS/caremark follow up with an exclusionary strategy for the hepatitis C
class. “Gilead was obviously hungry to negotiate after the [Express Scripts]
decision,” he remarks. “In the long run, this will hopefully provide some competitive
price relief for this class. It’s becoming a hallmark of our heavily
consolidated PBM industry: cost containment through back-room deals and supply
chain alliances, instead of good, old-fashioned open market price competition.”
While several health plans and PBMs
recently polled by DBN say they are hopeful that increased competition
in this expensive category will create opportunities for manufacturer
contracting, many indicated it is too soon to make coverage determinations on
Viekira Pak.
Prime Therapeutics LLC reports that it
is “actively engaged” with both Gilead and AbbVie and is “working closely” with
its Blue Cross and Blue Shield plan owners to finalize a hepatitis C strategy.
The PBM declined to say whether it would have an exclusive arrangement to
prefer one agent over others.
“We will review the newly released
product, [but there is] no urgency to do so since this newer product has a pill
burden compared to existing therapy and complexity of treatment regimen without
any clinical advantage,” observes Mesfin Tegenu, R.Ph., president of PerformRx,
which is a wholly owned subsidiary of the AmeriHealth Caritas Family of
Companies. Viekira Pak will remain off the PBM’s formulary, while Harvoni,
Sovaldi and pegylated interferons are covered.
When asked if Express Scripts has any
concerns about the potential “pill burden,” Miller responds, “AbbVie has
created a very elegant packaging solution that effectively mitigates any
potential challenges posed by Viekira’s twice-a-day dosing regimen.” Moreover,
clinical trial data shows “very high medication compliance” and cure rates of
up to 100%.
Contact Golden at jgolden@psgconsults.com,
Miller via David Whitrap at dwhitrap@express-scripts.com, Tegenu via
Cynthia Arnold at carnold@performrx.com, and Cherny and Muken at
rossandmichael@evercoreisi.com.
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