How to get Harvoni.. denied on all fronts

[rabbitfluff]

So my doctor wants me to go through the Harvoni treatment, but unfortunately I am on Medicaid (since I have followed my passion of being a snowboard and climbing instructor and love my life, I subsequently make no money). I was denied from Medicaid, I appealed that decision but was told that it is too expensive and I am not 'sick enough'. I have tried going through 'My Support Path' but they won't help anyone on federally funded insurance (i.e. Medicaid). I am so frustrated that there is a potential cure just out of reach. Anyone have any advice for getting my hands on this medication without paying $94,000?

Backstory:: I was born with Hep C, thanks mom, I have no side affects to speak of and stage 1 fibrosis. I'm 25, live a very healthy lifestyle and want to keep it that way, which is why I am desperate to be treated before anything gets worse. In 2012 I was treated with interferon, riba, and victrelis, for 24 weeks. Total hell, I can't do interferon again. I was undetectable after 4 weeks, and relapsed 8 weeks after treatment ended.

[gnatcatcher]

rabbitfluff, one much less expensive route that some people on this forum have been talking about is in this thread: http://forums.hepmag.com/index.php?topic=3128.0

Sorry you (and others in that thread) are facing such obstacles. Sending you good thoughts and best wishes,

Gnatty

[Farron1]

It took me 7-months before BC would approve, I did not give up. Email appeal after appeal, once I asked for the qualifications of the internal and external reviewers, I started getting more of a response. I went though 7 internal and 4-external appeals. 

SHERNOFF BIDART
ECHEVERRIA BENTLEY LLP
has a lawsuit filed see below;

Lawsuit Alleges Unreasonable Insurance Denial Puts Health at Risk
June 10, 2015, 03:30:00PM. By Heidi Turner

Bad faith insurance lawsuits, alleging insurance companies have unreasonably denied disability claims, are nothing new. But now lawsuits are being filed against insurance companies alleging policyholders are being wrongfully denied potentially life-saving treatment on the basis they are not sick enough for treatment to be medically necessary.

One such lawsuit was filed by Shima Andre against Blue Cross of California, alleging breach of good faith, breach of contract and intentional infliction of distress.

Andre was diagnosed in late 2011 with hepatitis C, a contagious liver disease that can cause liver complications - including liver damage, liver cancer and death. Until October 2014, there was no consistent cure for hepatitis C (there was a three-drug treatment, but the cure rate was only 70 percent and there were severe side effects). In October 2014, the US Food and Drug Administration (FDA) approved a drug called Harvoni. Harvoni has been shown in studies to be 95 to 99 percent effective in curing hepatitis C, with few complications or side effects. Even better, it only requires treatment lasting between 8 and 12 weeks.

The catch? Harvoni is expensive, costing up to $99,000 for a 12-week treatment.

In the years following her diagnosis, Shima reportedly suffered diminished health. She experienced severe liver pains and had to delay having a child because childbirth could result in her offspring having hepatitis C, as well.

Once Harvoni was approved, Shima’s doctor reportedly requested the okay from Blue Cross to treat Shima. Blue Cross allegedly refused, finding the medication was
“‘not medically necessary’ for her because her liver had not sufficiently deteriorated.”
Shima’s doctor appealed the denial, and the appeal was also denied.

According to court documents, Shima’s doctor attempted to contact Blue Cross reviewers directly to push for treatment, but Blue Cross refused to speak with him. The doctor again wrote an appeal, citing information from the American Association for the Study of Liver Diseases that all patients with hepatitis C - not just those with a certain level of liver damage - should be treated. Blue Cross again denied Shima’s complaint.

“Again Blue Cross told Shima that she would have to live with daily pain, depression, chronic fatigue, and wait until her liver drastically worsened before it would approve the medication. Blue Cross prefers that its insureds get much worse before paying for treatment almost guaranteed to cure their disease,” Shima’s lawsuit alleges.
In addition to forcing her to live with daily pain, Shima alleges she has had to continue delaying pregnancy out of concern for passing on hepatitis C to her offspring. Despite repeated communications from her doctor that the Harvoni treatment was medically necessary, Blue Cross has allegedly determined that is not the case.

Notably, the lawsuit also alleges there is no scientific backing for Blue Cross’s stance that the liver must be sufficiently damaged to approve treatment, nor is there evidence that the doctors reviewing Shima’s application have any experience in dealing with hepatitis C patients.

The lawsuit is Andre v. Blue Cross of California et al., case number BC582063 in Superior Court for the State of California for the County of Los Angeles.

[gnatcatcher]

Blue Cross of CA is worse than Anthem on this. In late June, Anthem added as a reason to approve Harvoni (for the genotypes for which it works) that the patient is female, of child-bearing potential, and wishes to become pregnant (because of the ribavirin contraindication in pregnancy). Such female still has to be at least Grade/Class A on the Child Pugh-Turcotte (CPT) classification scoring system, but that's an easier standard than having to be F3/F4, as so many insurers require, and as Anthem still requires with the exceptions of the above pregnancy status or one of a few other things.

Anthem's pharmacy benefits manager Express Scripts made an exclusive deal with AbbVie to use Viekira Pak (whereas pharmacy benefits manager CVS Health struck a deal with Gilead to make Harvoni and Sovaldi the exclusive option for patients on its commercial drug list as well as for patients it manages on health care exchanges, Medicare Part D and Medicaid). Since Viekira Pak requires ribavirin for all G1a patients as well as G1b patients without cirrhosis, that pregnancy exception may be Anthem's attempt to avoid a similar lawsuit.

It stink that insurers make patients wait until their livers worsen, and it stinks that insurers, just because they use a particular pharmacy benefits manager, get away with refusing to approve the other product even if the doctor deems it better. Understandably, the lawsuit press release doesn't say whether Blue Cross of CA was willing to treat Shima Andre with a competing product (if one with as good a cure rate exists for her genotype), but Blue Cross of CA will probably make such an argument if it can.

Farron1, please keep this forum updated on the status of the lawsuit. Thanks.

[rabbitfluff]

Thanks for the responses everyone, I am hopeful that I will find some way to get this medicine soon.. or those lawsuits will make insurance companies actually cover their patients. if not then maybe I have a good reason to fly to India next year!

[Farron1]

Found this on-line.....

Prior Authorization Protocol

Harvoni (sofosbuvir-ledipasvir)

HNMC

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

1. FDA Approved Indications:
◦Indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.


2. Health Net Approved Indications and Usage Guidelines:
◦Diagnosis of hepatitis C virus (HCV) genotype 1, 4 or 6 infection confirmed by detectable serum HCV RNA by quantitative assay. Baseline viral load by quantitative assay including genotype and treatment status of patient (treatment naive or treatment-experienced) are required.


AND
◦Patient is 18 years of age or older



AND
◦Any of the following clinical states identify candidates for treatment:
◾Evidence of Stage 2 or greater hepatic fibrosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater OR Transient elastography (FibroscanR), score greater than or equal to 7.5 kPa; OR FibroSure (also known as FibroTestR) score of greater than or equal to 0.48; OR APRI score greater than 0.7; OR FIB greater than 3.25.

◾Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end- organ manifestations (e.g. vasculitis), or kidney disease (e.g., proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis).
◾Persons with hepatocellular carcinoma with life expectancy greater than 12 months
◾Pre- and post-liver transplant, or other solid organ transplant
◾HIV-1 co-infection
◾Hepatitis B co-infection
◾Other coexistent liver disease (e.g. nonalcoholic steatohepatitis)
◾Type 2 diabetes mellitus (insulin resistant)
◾Porphyria cutanea tarda
◾Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease)
◾Men who have sex with men with high-risk sexual practices
◾Active injection drug users
◾Persons on long-term hemodialysis
◾Women of childbearing age who wish to get pregnant
◾HCV-infected health care workers who perform exposure-prone procedures



Criteria for Reauthorization/Continuation of Therapy:
◦Initial authorization criteria have been met, and
◦Evidence of lack of adherence may result in denial of treatment reauthorization.
◦Missed medical appointments related to the hepatitis C virus may result in denial of treatment authorization.


3. Coverage is Not Authorized For:
◦Dual therapy (Harvoni+(Sovaldi, or Olysio)
◦Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature


4. General Information:
◦Treatment-experienced patients have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin.
◦Treatment-naive patients have no prior exposure to peginterferon alfa, ribavirin or an HCV protease inhibitor.
◦METAVIR Fibrosis Scores:
o F0 = No fibrosis
o F1 = Portal fibrosis without septa
o F2 = Portal fibrosis with few septa
o F3 = numerous septa without cirrhosis
o F4 = Cirrhosis
◦FibroSure (aka FibroTest) Scoring:
o <0.21 = Stage F0 = No fibrosis
o 0.21 - 0.26 = Stage F0 - F1
o 0.27 - 0.30 = Stage F1 = Portal fibrosis
o 0.31 - 0.47 = Stage F1 - F2
o 0.48 - 0.57 = Stage 2 = Bridging fibrosis with few septa
o 0.58 - 0.71 = Stage F3 = Bridging fibrosis with many septa
o 0.72 - 0.74 = Stage F3 - F4
o >0.74 = Stage F4 = Cirrhosis
◦Treatment with Harvoni for 8 weeks can be considered in treatment-naive patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL. In the ION-3 trial, patients with a baseline HCV viral load of <6 million IU/mL and were treated with Harvoni for 8 weeks achieved SVR-12 at a rate of 97% versus 96% of those treated with Harvoni for 12 weeks.

◦Based on information presented as abstracts at the 2014 American Association for Study of Liver Disease (AASLD), this organization had made recommendation for the use of Harvoni outside of the approved indication. The AASLD treatment guideline include dosing recommendation for use in patients with decompensated cirrhosis, in patients with compensated cirrhosis who have relapsed following liver transplant and in patients who have failed previous treatment with a Sovaldi (sofosbuvir) based therapy.



◦There are currently neither published studies nor AASLD guidelines supporting the use of Harvoni in patients with hepatocellular carcinoma (HCC). Sovaldi (sofosbuvir) is currently approved by the FDA for patients with HCC.



◦Serious symptomatic bradycardia may occur in patients taking Harvoni with amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Harvoni:


◾Counsel patients about the risk of serious symptomatic bradycardia


◾Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.




◦Patients should be evaluated for readiness to initiate treatment. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. Caution should be exercised with patients who have a history of treatment failure with prior hepatitis C treatment due to non-adherence with treatment regimen and appointments. Patients should be educated regarding potential risks and benefits of hepatitis C virus therapy, as well as the potential for resistance and failed therapy if medication is not taken as prescribed.




◦Evidence of lack of adherence may result in denial of treatment reauthorization.

◦Lost medications will not be replaced and may result in denial of treatment authorization. Replacement of stolen medications will require documentation and will be adjudicated on a case-by-case basis.
◦Missed medical and lab appointments may result in denial of treatment authorization.

◦Retreatment may be considered where there is evidence that such retreatment will improve patient outcomes according to AASLD guidelines.


◦HIV/HCV-coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications


◦Investigational services are not covered except when it is clearly documented that all of the following apply:

◾Conventional therapy will not adequately treat the intended patient's condition;


◾Conventional therapy will not prevent progressive disability or premature death;


◾The provider of the proposed service has a record of safety and success with it equivalent or superior to that of other providers of the investigational service;


◾The investigational service is the lowest cost item or service that meets the patient's medical needs and is less costly than all conventional alternatives;


◾The service is not being performed as a part of a research study protocol;


◾There is a reasonable expectation that the investigational service will significantly prolong the intended patient's life or will maintain or restore a range of physical and social function suited to activities of daily living;


◾All investigational services require prior authorization. Payment will not be authorized for investigational services that do not meet the above criteria or for associated inpatient care when a beneficiary needs to be in the hospital primarily because she/he is receiving such non-approved investigational services.



◦There is no dosing recommendation for patients with severe renal impairment (estimated glomerular filtration rate < 30mL/minute/1.73m 2 or with end stage renal disease due to higher exposures (up to 20 fold) of the predominant sofosbuvir metabolite.



5. Therapeutic Alternatives:


Drug

Dosing Regimen

Dose Limit/ Maximum Dose

This field intentionally left blank. This field intentionally left blank. This field intentionally left blank.
* Requires Prior Authorization

6. Recommended Dosing Regimen and Authorization Limit:


Drug

Dosing Regimen

Authorization Limit


Harvoni
 
Genotype 1 CHC:

400 mg / 90 mg PO QD 



Treatment naive patients without cirrhosis AND whose HCV viral load is less than 6 million IU/mL:

8 weeks

May be filled in quantities up to 28 days at a time






Treatment naive patients without cirrhosis AND whose HCV viral load is greater than or equal to 6 million IU/mL: 12 weeks

May be filled in quantities up to 28 days at a time






Treatment naive patients with compensated cirrhosis:

12 weeks

May be filled in quantities up to 28 days at a time





Treatment-experienced without cirrhosis:

12 weeks

May be filled in quantities up to 28 days at a time






Treatment-experienced with compensated cirrhosis:

24 weeks

May be filled in quantities up to 28 days at a time






Treatment-experienced with compensated cirrhosis in combination with ribavirin:

12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Genotype 1 or 4 CHC with decompensated cirrhosis: 400 mg/90 mg QD plus ribavirin
 
12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Genotype 1 or 4 CHC with decompensated cirrhosis and anemic or intolerant to ribavirin: 400 mg/90 mg QD
 
24 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Patients who have advanced fibrosis, in whom a previous sofosbuvir-containing regimen has failed: 400 mg/90 mg QD with or without ribavirin
 
24 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Genotype 1 or 4 CHC with decompensated cirrhosis for patients in whom a prior sofosbuvir based therapy has failed: 400 mg/90 mg QD plus ribavirin
 

24 weeks

May be filled in quantities up to 28 days at a time




 

Harvoni
 
Treatment-naive and -experienced patients with Genotype 1 or 4 infection post liver transplantation, including compensated cirrhosis: 400 mg/90 mg PO QD plus ribavirin
 
12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Post liver transplant treatment-naive patients who are intolerant to RBV or RBV ineligible with HCV genotype 1 or 4 infection in the allograft, including compensated cirrhosis: 400 mg/90 mg QD
 
24 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Treatment naive patients without cirrhosis AND HIV co-infection with Genotype 1 CHC:
400 mg / 90 mg PO QD 

12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Treatment naive patients without cirrhosis with Genotype 4 CHC:
400 mg / 90 mg PO QD 

12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Treatment-naive or treatment experienced patients with CHC genotype 4 infection

400 mg / 90 mg PO QD 

12 weeks

May be filled in quantities up to 28 days at a time


Harvoni
 
Treatment-naive or treatment experienced patients with CHC genotype 6 infection

400 mg / 90 mg PO QD 

12 weeks

May be filled in quantities up to 28 days at a time



7. Product Availability:

Harvoni (sofosbuvir/ledipasvir) tablets: 400 mg/90 mg


8. References:

1. Harvoni [Prescribing Information]. Foster City, CA: Gilead Sciences, Inc.; March 2015.

2. Afdhal N, Zeuzem S, Kwo N et al. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. NEJM May 15, 2014 370;19: 1889-1898

3. Afdhal N, Reddy KR, Nelson DR et al. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. NEJM April 17,2014 370;16:1483-1493

4. Kowdley KV, Gordon SV, Reddy KR et al. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. NEJM May 15, 2014 370;19:1879-1888

5. American Association for the Study of Liver Disease Recommendations for Testing,Managing, and Treating Hepatitis C; June 2015. (accessed at: http://www.hcvguidelines.org)

6. European Association for Study of the Liver treatment guidelines April 2014 accessed at: http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C/index.html#p=4

7. WHO guidelines for treatment of hepatitis C April 2014 accessed at: http://apps.who.int/iris/bitstream/10665/111747/1/9789241548755_eng.pdf?ua=1&ua=1



The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.