Express Scripts News Flash Harvoni

[flyinlynn]

October 10th, 2014
HARVONI – New Hep C Drug FDA Approved
On Oct. 10, 2014, Gilead received U.S. Food and Drug Administration (FDA) approval for Harvoni® (ledipasvir / sofosbuvir) for the treatment of genotype 1 chronic hepatitis C virus (HCV) in adults. Harvoni is a single tablet that is dosed once daily for 12 weeks in treatment-naïve patients with or without cirrhosis; eight weeks of treatment may be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA < 6 million IU/mL. In treatment-experienced patients without cirrhosis, the duration of treatment is 12 weeks. In treatment-experienced patients with cirrhosis, the duration of treatment is 24 weeks. Gilead plans to launch Harvoni early next week. It will be available through open distribution- not limited to specific pharmacies. Full prescribing information is available at: www.gilead.com.
 At a Glance
 Brand (Generic) Name: Harvoni (ledipasvir / sofosbuvir)
 Manufacturer: Gilead
 Date Approved: October 10, 2014
 Indication: Treatment of genotype 1 chronic hepatitis C virus (HCV).
 Dosage Forms Available: Single-tablet containing 90 mg of ledipasvir and 400 mg of
sofosbuvir.
 Launch Date: Week of October 13, 2014.
 Estimated Annual Cost: Harvoni is expected to cost approximately $95,000 for 12 weeks
of treatment and $63,000 for 8 weeks of treatment.
 Specialty Status: Harvoni will be added to Express Scripts’ specialty drug list.
 Approximately 3.2 million Americans are infected with HCV. Genotype 1 represents nearly
75% of cases. Genotype 1a is more common in the US and is more difficult to treat than genotype 1b. It is a viral disease that causes inflammation in the liver. Ultimately, HCV infection can lead to liver failure and liver cancer.
 Harvoni contains ledipasvir, the first NS5a inhibitor to gain FDA approval and Sovaldi® (sofosbuvir), a nucleotide analog polymerase inhibitor that was approved in Dec. 2013.
 AbbVie and Enanta are expecting approval of their all-oral regimen for genotype 1 hepatitis C by Dec. 21, 2014. This regimen contains ABT-450, a protease inhibitor that is boosted with ritonavir and is co-formulated with ombitasvir, an NS5a inhibitor. That tablet is taken once daily. This regimen is also given with dasabuvir, a non-nucleoside polymerase inhibitor that is taken twice daily. Patients with genotype 1a will also likely need treatment with ribavirin twice daily. This all-oral regimen is taken for 12 weeks.
 Bristol-Myers Squibb’s daclatasvir, an NS5a inhibitor that is taken once daily, is expected to be approved sometime after Dec. 7, 2014, for patients with the less common genotype 1b hepatitis C. Bristol-Myers Squibb recently announced it is no longer pursuing approval of asunaprevir, a protease inhibitor that was expected to be used in combination with daclatasvir. Other all-oral regimens are expected to compete in the hepatitis C market in 2015 and 2016.

https://www.afspa.org/home/pdfs/Clinical-Matters-October-10.pdf

[somuchmore2]

Oh! I forget must be brain fog.

"May you always do for others
And let others do for you"--B Dylan

[somuchmore2]

Appears to be much talk about expense to the insurance companies and their approval.

It seem to me that insurance is the reason insurance companies exist.

$200k is much less expensive that transplant and meds which follow after transplant.

Peace comfort and love to all of you.....let's beat this disease out of your lives.

[Pamelajean1]

Catamaran also has Harvoni listed. They ran a test claim for me and it came back as paid with a $250 copay but with Gilead assistance only $5.

Because I've already been approved for Sovaldi there was NO clinical criteria...great news if I were to relapse...and it made me think of you! You've got Express right? Call them back and ask them to run a test claim for you. :)

[Dee1956]

This is great news! With Express Scripts adding to their list the others will follow.
When Incivek was approved May 2011, there were people treating within a month or two.
I hope the same for this

[hepcandme]

That's an excellent point Guy

Something I had been thinking about all afternoon

So, it's not like your doc is even being a big hero or anything by going "off label"

Gives me hope that Kaiser will come through although I don't know if I am able to access what drugs are covered like with Express Scripts

[flyinlynn]

I checked on the web site for my prescription coverage Express Scripts and they do now list Harvoni 90-400 Mg Tablets.

Under the coverage notes it says:
"Your plan provides coverage for this medication in certain situations. To determine if coverage is available, your doctor may request a coverage review by calling the toll-free number, 1-800-753-2851."

So getting closer

[sue4hula]

Thanks for the post!  I'm glad to see Express Scripts is approving.  That is my plan.  Hope I won't need it, but if so, bring it on!

[hrsepwrguy]

One thing to remember, the S/O combo was (actually still is but recommended for inf ineligible by the EASL) completely off label, with only a small trial to prove it works, insurance co's don't like that and that gave them a good reason to fight having to pay for it, harvoni will be used exactly as recommended by the FDA  (not off label) with lots of data to show it works, so IMHO I think you see a lot less denials by the ins co's or at least I hope so, it bums me out to watch guys have to fight for something you basically prepaid for

[hepcandme]

Trying to be patient here but I am at the mercy of my insurance company to hear how they will proceed

Last time out, Sovaldi/Olysio approved in December, my 12 week treatment began in March

So, just waiting for all the stars to align on this one but trying to be realistic

[hrsepwrguy]

Gilead is well aware that Abbvie is set for approval on Dec 14 and could possibly be rolled out by Jan 1, with the amount of money at stake do you really think they are going to dilly dally around rolling out harvoni which they already have approval for, I think not, I think you will be seeing real soon, it is all about the money

just sayin

[keepingOnkeepingOn]

I'd give it 5-6 more months before people are getting treatment from Sofie/Ledi combo in most areas of the country. By then AbbVie will have their medicine out on the market for all geotypes and at a much lower cost. The Pharmacist says the unveiling for it will be Jan 1.

[Sarah1949]

That's the problem with taking things too literally. Know it well. The drug was approved on October 10. Do people not think that there is still a ton of things to be done, one of which is for the insurance companies to add the drug to their formularies.

I thought this post was just to show that Express Scripts recognizes the approval of Harvoni is all.

[flyinlynn]

well not yet but soon. gotta get the pill machine pumping out the meds, get them in the bottles and out the the pharmacies

[somuchmore2]

Great read....

Thank you....

[Idyllic]

Thanks for this post ★☆

Hey there was just a post on here with someone saying Oct 10 has come and gone and Harvoni is no where.