Legal Threats to Connecticut Removes HCV Restrictions
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Download the PDF here
Download the PDF here
from Jules: the threat of a real lawsuit convinced Connecticut state authorities to drop HCV treatment access restrictions. In this report are letters to the Connecticut State authorities from the lawyer and from a Connecticut community group raising that the Connecticut policy regarding access to treatment was illegal. Pdfs of the letters are attached and the applicable federal law regarding medicaid coverage.
Connecticut is making a new class of hepatitis C drugs more accessible to those on Medicaid - (05/20/15)
From: Sheldon Toubman [mailto:SToubman@nhlegal.org]
Subject: Hepatitis C Drugs Under Medicaid: Suggested Template for Gaining Access
We have obtained success regarding access to the new (expensive) Hepatitis C virus drugs under the CT Medicaid program, compared to the severe restrictions on access to the drug Sovaldi which prevailed from December of 2014 until three weeks ago. I provide a summary of what happened, our strategies, and some of our documents, to the extent these might help you in your state-I believe that almost every other state has some illegal substantive or procedural restrictions on access to Sovaldi/Harvoni (made by Gilead) at the moment. If you are in a state without such a problem, please hit "delete" now!
Like most states, our state issued a bulletin severely restricting access to the new curative drug Sovaldi (reported to have a sticker process of $84,000 per 12 week course of treatment), attached. Not only did the document set forth highly restrictive criteria which violate state and federal law in many ways, particularly by denying the drug to individuals for whom it was FDA approved (including by requiring end organ damage, which is not referenced in the FDA labeling), but what was particularly odious was the requirement that the provider had to first certify that those narrow, illegal criteria were met before he or she could even submit the request for prior authorization (PA). This ensured that valid requests for treatment would not even be received, so the Medicaid agency would not have to deny the requests -- with information about hearing rights which could result in challenges to its policies.
But on May 13th, the CT Pharmaceutical and Therapeutics (P and T) Committee accepted our Medicaid agency's recommendation that all of the new Hepatitis C drugs be included on the state's preferred drug list (PDL). And more importantly, at the same time, the agency made available a proposed new PA request form, also attached, applicable to all HCV drugs and going into effect by July 1st but hopefully earlier, which is substantially streamlined and contains no such restrictive criteria and no onerous certification requirement. I note that this occurred in a miserable state budget climate, with the legislature facing a $1.3 billion deficit for the coming year and tremendous pressure to cut costs.
The four strategies we used to get there were:
(1) a demand letter from lawyer types spelling out why what they were doing was illegal;
(2) a broader sign-on letter from CT advocates addressing the policy reasons why these restrictions were counter-productive (and ultimately more expensive for the taxpayers);
(3) respected specialists who treat people with HCV separately communicating with the agency's medical staff about the medicalreasons why their restrictive criteria should be reversed; and
(4) media attention to the cost/public health/moral reasons why this was a bad policy.
The two advocate letters mentioned, both issued in February, also are attached.
Ultimately, three things probably came together to make this work:
· the pressure from a possible lawsuit;
· the acceptance by the state Medicaid agency, after internal research they were motivated to do, that, even at the then approximately $60,000 state cost of this treatment, it still saved money, on average, in other Medicaid line-items; and
· a still better deal having been obtained from Gilead by the state publicly making noise before the P and T Committee recommendation that they might only put the new drug Viekira Pak, made by competitor Abbvie, on the PDL
The better deal made the cost/benefit argument even stronger, but the argument was already there that covering these drugs saved money for the taxpayers because of (1) avoided hospital-based treatments with interferon, (2) avoided complications from those treatments; and (3) the realities that the older treatments have had only very mediocre cure rates-versus 90% plus for these new drugs - so these individuals would probably otherwise still need years of expensive treatment and possibly very expensive cancer care and transplants.
I cannot verify if this is correct or not, but a Gilead representative also claimed that, nation-wide, its rebates to state Medicaid agencies range from 46 to 52% of the $84,000 sticker price, so it is more like $40,000 a course of treatment. He also claimed that they are finding that 8 weeks is an adequate course in some cases, instead of the recommended 12 weeks, reducing the cost still further. Both of these claims warrant further research, as, if confirmed, they would facilitate the cost/benefit argument for reasonable access to the company's drugs (a provider in CT has confirmed the 8 week regimen for Harvoni for certain genotype 1 patients).
The remaining problem with the new PA request form is its maintenance of the requirement that patients must go to the pharmacy every 2 weeks to get another supply, vs. the 30 day supply available for all other drugs (if the course is for 30 days or more), putting a burden on patients who have difficulty getting to the pharmacy and potentially causing compliance problems. But, other than that, when tied to our strong state medical necessity statutory definition, Conn. Gen. Stat. 17b-259b(a), which specifically includes "preventative services" and which they agreed to cite on the PA request form, the new form seems to have undone all of the harmful substantive and procedural restrictions on access to these critical medications.
Finally, if you are hearing in your state (or from your state's MCOs) that they will make Viekira Pak readily available for all FDA-approved purposes but not Sovaldi/Harvoni, because Abbvie is making better deals, please note that for many, but not all, patients, Sovaldi/Harvoni is superior because it requires only one pill a day and no adjuncts. Abbvie's product may have greater compliance problems because it requires multiple pills twice daily, and the adjuncts required for some patients could have adverse reactions. It is all great if the state can get a better deal with a cheaper product, and we should encourage this-so long as individuals who have a specific medical need for the more expensive FDA-approved product still have access to it.
I hope that the attached materials are helpful. Please let me, or my colleagues in legal services in CT, Sue Garten and Kristen Noelle Hatcher (both on this list), know if you have any questions. But I think that the take away here is that, as expensive as these curative drugs are- and they certainly are expensive -- they nevertheless save money, including when you treat individuals with no organ damage, because you now can reliably cure these people and avoid other, even more expensive treatments, and can dramatically reduce the ability to transmit this virus to others. Doesn't mean we shouldn't beat up on the manufacturers to get better prices - their pricing is abusive and we need to address that-but, in the meantime, providing these remarkable new drugs wherever medically necessary is already a win-win for Medicaid enrollees and the taxpayers.
P.S. Here is some of the press about this in CT, including an unfortunate newspaper editorial which I responded to with a letter to the editor (also linked below):
Sheldon V. Toubman
New Haven Legal Assistance Association
426 State Street
New Haven, CT 06510
ph: (203) 946-4811, ext. 148
Some of you have raised the important question whether the analysis in our attached letter to CT DSS applies to individuals enrolled in Medicaid MCOs as well, such as permeate NY and other states. My position has always been "effectively, yes," despite the purported express exception for MCOs to all of the federal Medicaid statutory requirements re outpatient drug access in 42 USC 1396r-8(j) -- because if the MCOs were not on the hook for the drugs, the state would have to be since IT is not exempt from that provision, and the whole point for states contracting with MCOs is to avoid any obligation to directly provide drug coverage (among other services).
There is good news on this front: the proposed new Medicaid managed care regulations, issued on June 1st, state, under 42 CFR 438.3(s), that the MCO must "provide coverage of covered outpatient drugs as defined in 1927(k)(2)." (Section 1927 = 1396r-8) Available at http://www.gpo.gov/fdsys/pkg/FR-2015-06-01/pdf/2015-12965.pdf
Moreover, the preamble to these proposed regulations, at page 31115, confirms my long-time understanding:
"In paragraph (s)(1), we propose that the MCO, PIHP, or PAHP must provide coverage of covered outpatient drugs (as defined in section 1927(k)(2) of the Act) as specified in the contract and in a manner that meets the standards for coverage of such drugs imposed by section 1927 of the Act as if such standards applied directly to the MCO, PIHP, or PAHP. This is intended to clarify that when the MCO, PIHP, or PAHP provides prescription drug coverage, the coverage of such drugs must meet the standards set forth in the definition of covered outpatient drugs at section 1927(k)(2) of the Act. The MCO, PIHP, or PAHP may be permitted to maintain its own formularies for covered outpatient drugs that are under the contract, but when there is a medical need for a covered outpatient drug that is not included in their formulary but that is within the scope of the contract, the MCO, PIHP, or PAHP must cover the covered outpatient drug under a prior authorization process. This proposal is based on our authority under section 1902(a)(4) of the Act to mandate methods of administration that are necessary for the efficient operation of the state plan. Furthermore, if an MCO, PIHP, or PAHP is not contractually obligated to provide coverage of a particular covered outpatient drug, or class of drugs, the state is required to provide the covered outpatient drug through FFS in a manner that is consistent with the standards set forth in its state plan and the requirements in section 1927 of the Act." (emphasis added).
So everything we said in our letter to CT DSS about federal law applies equally in any state, whether it contracts with MCOs not at all, some or entirely. I would just address any demands directly to the state Medicaid agency, rather than the MCOs, noting that 1396r-8(j) helps them not at all -- though you should feel free to copy the recalcitrant MCOs.
Sheldon V. Toubman
New Haven Legal Assistance Association
426 State Street
New Haven, CT 06510
ph: (203) 946-4811, ext. 148
letter pdf attached
NEW HAVEN LEGAL ASSISTANCE ASSOCIATION, INC.
426 STATE STREET
NEW HAVEN, CONNECTICUT 06510-2018
TELEPHONE: (203) 946-4811
FAX (203) 498-9271
February 3, 2015
Department of Social Services
55 Farmington Avenue
Hartford, CT 06106
Re: Access to Medications to Treat and Cure Hepatitis C Virus
Dear Commissioner Bremby:
The undersigned organizations, which represent clients at risk for and living with the hepatitis C virus (HCV), are gravely concerned about the new clinical criteria for HCV treatment under Connecticut's Medicaid program, as announced in the department's bulletin to providers issued on November 24th, entitled "New Hepatitis C Prior Authorization Criteria - Sovaldi™", which went into effect on December 10, 2014, as amended via a new Sovaldi prior authorization request form circulated on or about January 22, 1015.
We would like to illustrate our specific concerns with the policy under federal and state Medicaid law. We are optimistic that we can find agreement around this issue and our hope is the policy can be revised to achieve our mutual priorities.
As we're sure you know, under federal Medicaid law, notwithstanding cost, if a drug is FDA-approved, subject to a rebate agreement with the manufacturer, and not in one of the few categories in which a state is allowed to exclude coverage (for adults only, none of which are applicable here), the drug must be made available wherever medically necessary, although prior authorization (PA) may be imposed. Solvaldi, being FDA-approved, subject to such a rebate agreement, and not within one of those excluded categories, must be covered by every state that has an optional Medicaid pharmacy program, including Connecticut.
A state may, of course, limit payment for a drug to (1) FDA-approved uses plus (2) other medically accepted indications, i.e., off-label uses, specified in one of three compendia set forth in the federal Medicaid statute. Sovaldi has been broadly approved by the FDA to treat patients with HCV genotypes 1 through 4, and it is, to our knowledge, not yet being prescribed for any other purposes.
Federal law requires that all Medicaid-covered services be furnished with "reasonable promptness." Federal regulations under this provision require that a person be able to apply for Medicaid services without delay. Federal law also requires that a hearing be offered to anyone denied specific services, with a written notice to the enrollee explaining the reason for the denial and providing information about the means to access a hearing.
These strict federal requirements are reinforced by state Medicaid law. Under the Connecticut Medicaid statutory definition of medical necessity, Conn. Gen. Stat. 17b-259b(a), a state must pay for any kind of covered treatment under Medicaid, at least where "[c]onsistent with generally-accepted standards of medical practice," provided the requested treatment is "not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results." (emphasis added). The statute also requires that medical necessity determinations be "based on an assessment of the individual and his or her medical condition." 17b-259b(a)(5)
The new policy codified in PB 2014-83, issued on November 24, 2014, and the revised prior authorization request form issued about two weeks ago, violate state and federal Medicaid law by declaring that Sovaldi can not be provided under Medicaid if the specific clinical criteria in the bulletin are not met. There is no exception process whereby the treating provider can explain why individual medical need is established, under the long-standing state statutory definition of medical necessity, regardless of the result when applying the bulletin's clinical criteria. The statute requires that "[c]linical policies, medical policies, clinical criteria or any other generally accepted clinical practice guidelines used to assist in evaluating the medical necessity of a requested health service shall be used solely as guidelines and shall not be the basis for a final determination of medical necessity." C.G.S. 17b-259b(b)(emphasis added). Several of the restrictive criteria provided in the bulletin and prior authorization request form are quite harmful, as well as illegal. We will provide some select examples below.
The most straightforward example is the metavir 3 or 4 requirement. Medical need under the Medicaid medical necessity standard has never been limited to individuals with organ damage, even before the statutory codification. That definition mandates coverage of "health services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition, including mental illness, or its effects, in order to attain or maintain the individual's achievable health and independent functioning." Critical to invalidating the cost-motivated policies in the bulletin, the statute provides that an alternative treatment can be substituted only if it is "not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the individual's illness, injury or disease."
The metavir 3 or 4 requirement, which is a test for a high level of organ damage, does not meet any of these standards. It also does not meet the federal statutory and regulatory requirements which prohibit categorical limitations on treatment with an FDA-approved drug, especially when consistent with what is set forth in the FDA's labeling requirements. It does not meet the narrow circumstances set forth in the Medicaid Act where coverage can be excluded for an identified population with a particular disease, namely, where a covered drug, based on information from both the manufacturer and in the recognized compendia of off-label usages, "does not have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome of such treatment for such population over other drugs included in the formulary." Completely apart from recognized off-label uses, the manufacturer of Sovaldi says nothing in its labeling about excluding from treatment the population with HCV who have metavir scores under 3, who have malignancies, who are pregnant (except if they are also taking ribavirin or peginterferon alfa/ribavirin), etc. The restriction also violates the general Medicaid scope of service regulations.
The second example is the prohibition on treatment if the patient previously had either a full or incomplete course of Sovaldi. This exclusion violates the state medical necessity statutory definition because it attempts to exclude all patients who have already started and not completed a regimen with Sovaldi, or completed this therapy but did not get a cure, which is called a "sustained virologic response" (SVR). There are now reports in the literature of patients who took Sovaldi and Olysio together who eventually showed continued HCV infection, and some of them are now being re-treated. In addition, a few patients fail to complete a course of treatment, due to losing Medicaid coverage, severe illness or other issues not the fault of the patient -- perhaps the individual has already had his or her access to further treatment blocked due to the Sovaldi policy change in December. Whether individuals should be re-treated in these cases is a medical and ethical question, and one which must be assessed on a case by case basis applying the medical necessity definition to each patient, if a treating provider, weighing all of the factors, chooses to request prior authorization.
The criteria barring patients who are taking other products believed to reduce the effectiveness of Sovaldi, while perhaps appearing reasonable on their face, also violate state and federal law. While there are known drug interactions with sofosbuvir-based regimens which should be avoided, there are gray areas in which there is some interaction but the drug is not contraindicated -- this holds true for a number of other antiretroviral regimens. For example, the FDA labeling for Sovaldi says only that "Coadministration is not recommended" with anticonvulsants, compare label regarding St. John's wort ("Sovaldi should not be used with St. John's wort"). It will be for the treating provider to decide whether to follow this advice and, if so, which drug(s) to drop, subject to DSS's review of a request for prior authorization for the particular patient.
Similarly, while the FDA label recommends taking Sovaldi with ribavirin or peginterferon alfa/ribavirin, it is only the latter drugs, not Sovaldi, which are contraindicated for pregnancy. In addition, since that label was produced, interferon is no longer the standard of care even for Genotype 1 of Hepatitis C. And, in the case of ribavirin, since November, 2014, there is now an FDA-approved combination which can be used instead, Sovaldi plus Olysio, avoiding entirely the use of interferon or ribavirin. The provider may, in the case of a patient who is pregnant or may become pregnant but has an urgent need for Hepatitis C treatment, prescribe the primary medication, Sovaldi, without the adjuncts which are contraindicated for pregnancy. But in the absence of an opportunity for an individualized review of the patient, his or her various medical conditions, the need for treatment of each of them and possible changes in prescriptions to accommodate any contraindication, as mandated under state law, it is impermissible to apply these categorical exclusions on coverage and declare across the board that approval will never even be considered in these situations.
In addition to the above examples, the requirement that the "patient must undergo treatment with SovaldiTM for an FDA approved indication and [it must be] prescribed with FDA approved combination therapy," is inconsistent with federal Medicaid law. Federal law mandates that other medically accepted indications, i.e., off-label uses specified in one of the three compendia specified in the federal Medicaid statute, must also be covered. The development of indications beyond the FDA-approved therapies has already occurred in the case of Sovaldi: while the label recommends interferon as an adjunct for Genotypes 1 and 4, this is no longer the standard of care at least for Genotype 1; Sovaldi with ribavirin alone (or a substitute for ribavirin) is recommended. See American Association for the Study of Liver Diseases/Infectious Diseases Society of America Guidelines, at www.hcvguidelines.org (updated January 25, 2015). And there will very likely be new usages as providers innovate. For example, although the FDA labeling says "[a]vailable data on subjects with genotype 5 or 6 infection are insufficient for dosing recommendations;" this could soon become a recognized off-label use. A policy that categorically limits coverage to only FDA-approved uses is stagnant and dangerous, and runs afoul of the federal Medicaid requirements; it should be removed.
Apart from the above examples, the policy allowing only a handful of kinds of specialists to provide a written consult as a prerequisite for approval of Sovaldi conflicts with the "reasonable promptness" requirement in the federal Medicaid statute, 42 U.S.C. 1396a(a)(8). Medicaid patients have extreme difficulty in obtaining access to specialists in Connecticut, for a variety of reasons, including reimbursement rates and specialist preferences. Most of the federally qualified health centers do not have an ID specialist on staff. By contrast, there are many experienced prescribers who have long been treating HCV patients and are fully qualified to make the assessment about the appropriateness of prescribing this drug, or any other HCV drugs, often with much more experience treating HCV than the designated kinds of specialists. This includes but is not limited to HIV specialists, whom we understand you are now considering to be qualified specialists. Limiting the prescribing of Sovaldi to providers who are, or who have obtained written consults from, board-certified gastroenterologists, hepatologists, liver transplant specialists, or infectious disease or HIV specialists will greatly reduce access to treatment. The long delays before such appointments can occur will mean long delays before essential treatment begins, in some cases causing irreparable harm, in violation of federal Medicaid law.
Lastly, under federal Medicaid law, an enrollee is entitled to request any services under Medicaid and to appeal any denial of services, and "[t]he agency may not limit or interfere with the applicant's or beneficiary's freedom to make a request for a hearing." The right to a hearing, as also provided in both the Due Process Clause of the Fourteenth Amendment and the federal Medicaid Act, at 42 U.S.C. 1396a(a)(3), necessarily includes the right to a written notice informing a Medicaid enrollee of the denial and of the means to appeal it.
Sovaldi must be submitted through a treating provider, but the providers also are instructed in the bulletin and both the original and revised prior authorization request forms that they must use the specific PA request form included with the bulletin, and that form expressly declares that the provider must "certify that use of SovaldiTM for this patient is consistent with the above criteria/guidelines," i.e., they are not allowed to request PA on behalf of a patient who does not meet those narrow criteria, which are not consistent with the FDA labeling or state law and are rapidly becoming seriously outdated. Accordingly, the filing of a request for PA is completely blocked whenever a provider with a patient who does not meet these narrow and illegal criteria seeks treatment with Sovaldi for that patient, with the result that no denial notice is issued and no hearing is offered in these situations, in violation of the Medicaid regulations and the Due Process Clause.
We respectfully request that your agency immediately remove the restrictive clinical criteria provisions as absolute requirements, remove the certification requirement, and indicate in a revised bulletin that all requests for prior authorization for Sovaldi will be individually assessed for medical need pursuant to C.G.S. 17b-259b. We would be more than happy to discuss this matter with you further or offer our assistance in these revisions.
We thank you in advance for your prompt response.
Sheldon V.Toubman, Staff Attorney, New Haven Legal Assistance Ass'n
Kristen Noelle Hatcher, Managing Attorney, Benefits Unit, Conn. Legal Services
16 Main Street
New Britain, CT 06051
Susan L. Garten, Managing Attorney, Greater Hartford Legal Aid
999 Asylum Avenue, 3rd floor
Hartford, CT 06105-2465
Gregg Gonsalves, Amy Kapczynski, Alice Miller
Global Health Justice Partnership
Yale Law School-Yale School of Public Health
P.O. Box 208215
New Haven, CT 06520-8215
cc: Kate McEvoy, Medicaid Director, Dr. Robert Zavoski, DSS Medical Director
 42 U.S.C. 1396r-8(d)(4)(D), see 42 C.F.R. 440.230(d).
 42 U.S.C. 1396r-8(d)(4)(C); see 42 U.S.C. 1396r-8(d)(1)(B)(i).
 Beyond these pharmacy-specific statutory provisions, the long-standing set of general federal Medicaid regulations related to "amount, duration and scope," at 42 C.F.R. 440.230(b) and (c), provide that "[e]ach [type of] service must be sufficient in amount, duration and scope to reasonably achieve its purpose" and that "[t]he Medicaid agency may not arbitrarily deny or reduce the amount, duration or scope of a required service under 440.210 and 440.220 to an otherwise eligible beneficiary solely because of the diagnosis, type of illness, or condition." There is extensive case law under 440.230, including drug cases, which make clear that categorical declarations of non-coverage or of non-coverage based on the extent of disease are not permissible. See Weaver v. Reagan, 886 F.2d 194 (8th Cir. 1989)(invalidating under 440.230(b) state rule limiting AZT for individuals with AIDS to those with certain symptoms, including a CD4 count under 200). See also Ledet v. Fischer, 638 F.Supp. 1288 (M.D. La. 1986)(state refusal to pay for eyeglasses, an optional category of benefits, except for post-cataract surgery patients, invalidated under 42 C.F.R 440.230(b)).
 42 U.S.C. 1396a(a)(8).
 42 C.F.R. 435.906.
 42 U.S.C. 1396a(a)(3); 42 C.F.R. 431.200, et seq.
 C.G.S. 17b-259b(a)(emphasis added).
 C.G.S. 17b-259b(a)(4)(emphasis added).
 42 U.S.C. 1396r-8(d)(4)(C).
 42 C.F.R. 440.230(b) and (c), see Weaver v. Reagan, 886 F.2d 194 (8th Cir. 1989)(invalidating state rule limiting AZT for individuals with AIDS to those with certain symptoms, including a CD4 count under 200).
 42 U.S.C. 1396r-8(d)(4)(C); 42 U.S.C. 1396r-8(d)(1)(B)(i).
 42 C.F. R. 431.221.
pdf of letter attached
February 19, 2015
Department of Social Services
55 Farmington Avenue
Hartford, CT 06106
Re: Access to Hepatitis C Virus Cure
Dear Commissioner Bremby:
The undersigned organizations, which serve or advocate for individuals living with the hepatitis C virus (HCV), or individuals with other chronic medical problems, are very concerned about the new clinical criteria for HCV treatment under Connecticut's Medicaid program, as announced in the department's bulletin issued to providers on November 24, 2014, entitled "New Hepatitis C Prior Authorization Criteria - Sovaldi™", both in and of themselves and as a dangerous precedent potentially restricting access to any kind of expensive drug. This bulletin, which went into effect on December 10, 2014, and which was somewhat modified in January 2015, bars treating providers from even requesting prior authorization for Sovaldi if narrow substantive criteria are not met.
The severe restrictions in Sovaldi (sofosbuvir) violate state and federal law and are unwise public health policy. They will significantly restrict access to this new curative drug, which will dramatically improve, and in some cases save, the lives of individuals living with HCV, and can also save tens of thousands of dollars (or more) in future treatment costs, as well as substantially slow transmission of this life-threatening disease. While we recognize the high cost of some of the newer HCV treatments, and in fact some of us are involved with the Fair Pricing Coalition which is working to address this problem right now, in the meantime, Connecticut may not respond to this cost issue through the denial of access to medically necessary medications.
A. Rationing Solvadi for Medicaid Enrollees Harms Public Health, Exacerbates Health Disparities, and Generates Higher Costs for the Medicaid Program
HCV is a transmissible disease which, if untreated, has a high likelihood of resulting in very expensive medical complications, including the development of cirrhosis, hepatocellular carcinoma, the need for liver transplantation and death. Below are some of the reasons why the newly-announced policies are unwise and bad medicine, and will ultimately cost the taxpayers more, as vulnerable individuals with this disease who could be cured of it are forced to go untreated.
1. The new policy will inappropriately restrict access to medically necessary treatment through Sovaldi in at least the following ways:
· Requiring a Metavir score of 3 or 4 will mean that only people with advanced liver disease can get this curative drug, blocking access to treatments which might prevent expensive, life-threatening conditions from developing and even provide cure and avoid transmission
· Authorizing only five specific kinds of specialists to provide a written consult as a prerequisite for approval of Sovaldi will severely restrict access because Medicaid enrollees have extreme difficulty securing timely consults with specialists
· Forcing patients with Genotype 1 hepatitis C to use interferon instead of Sovaldi if they are "interferon-eligible" even though this is no longer the standard of care
· Excluding individuals with any malignancy, whether or not the malignancy is related to HCV status, Sovaldi will have any effect on treatment for the malignancy or the cancer treatment will impair effectiveness of the Sovaldi treatment
· Barring pregnant women or women who might become pregnant from access to Sovaldi, based on purported FDA restrictions, when the FDA contraindication for pregnancy applies not to Sovaldi itself but to adjuncts (ribavirin or peginterferon alfa/ribavirin), which adjuncts are only (previously) recommended to be taken with Sovaldi and can be replaced with another drug for a particular patient
· Barring patients from access if they previously had a full or "incomplete" course of treatment, when some patients will need more than one course and the failure to complete a course may not have been the patient's fault (such as becoming otherwise ill or losing their Medicaid coverage mid-treatment)
· Limiting access to the medication even after it has been approved by DSS, by prohibiting the patient from getting more than a 14 day supply at a time and categorically prohibiting early refills (before 85% of a 14 day supply used up) even through special request, causing patients to be non-compliant with their approved regimens because of inability to timely obtain a refill.
2. This new policy undermines the public health imperative to identify, treat, and cure people living with hepatitis C, and will result in preventable infections.
Increased transmission of HCV among young adults has been reported in at least 30 states. With thousands of Connecticut residents living with HCV and HCV the primary cause of hepatocellular carcinoma, the fastest growing cancer in the nation, now is the time to act aggressively against HCV-not to slow down the fight. This new policy is far too restrictive given the health crisis caused by HCV and the tremendous opportunity HCV treatments provide to improve health and save lives, by curing the majority of people living with HCV and reducing transmission. Patients who develop advanced cirrhosis and other complications due to lack of early treatment will require ongoing medical treatment, even after they are cured, whereas early treatment prevents liver damage and liver cancer and improves quality of life, while stemming the tide of onward transmission of the virus. Without treatment, women of childbearing age who do not meet the strict F3/F4 criteria in the new policy will be unable to avoid perinatal transmission to their future children. Limiting treatment with Sovaldi in the various ways set forth in the bulletin ensures that Connecticut is committing unnecessarily to treating thousands of individuals with hepatitis C for many years to come.
3. The new policy ignores the economic benefits of providing Sovaldi early on.
Identifying and treating everyone with hepatitis C in the United States has been estimated to net a $1.4 trillion benefit to society over time. Economic analyses have demonstrated that sofosbuvir-based regimens specifically are highly cost-effective even at the wholesale acquisition cost (which Medicaid does not pay). In fact, the cost of a treatment regimen with interferon and ribavirin and with one of the older direct acting agents (which were toxic and caused a lot of complications) was comparable to current treatment costs with Sovaldi. Depending on the duration of treatment, dual therapy with pegylated interferon alfa and ribavirin can vary between $18,000 and $36,000. Adding telaprevir or boceprevir (Victrelis) (these were the older generation of direct acting agents before Sovaldi) to the other two drugs more than doubles the cost of therapy to a range of $48,000 to $85,000. This does not factor in the much lower cure rate (less than 60% even for those able to tolerate interferon's severe side effects, vs. the Sovaldi cure rate of 95%), such that there are inevitably additional costs for treating the half of individuals unable to be cured with the expensive interferon regime. Hepatitis C treatment with Sovaldi is in the vast majority of cases a one-time expense, and it accrues savings many years into the future.
The need to reduce expenditures further should be addressed by negotiating pricing with the manufacturer of drugs, not by denying effective and medically indicated treatment to indigent low-income individuals. Restricting cost-effective care - especially safe, quick, easy, nontoxic treatment for a life-threatening communicable infection - is not a rational approach to reducing expenditures.
4. The new policy will result in inappropriate rationing of care for Medicaid patients.
The Department's restrictive policies regarding Sovaldi apply only to Medicaid enrollees. But Medicaid enrollees already suffer barriers to healthcare access due to patient, provider, and systemic factors that restrict their ability to access treatment relative to the general population, particularly in terms of accessing specialists. These new policies will severely exacerbate these barriers. Whatever justifications might be set forth for rationing of life-sustaining health care generally, rationing such health care for vulnerable low-income Medicaid patients, who already have serious health care access problems, is particularly inappropriate.
5. The policy undermines our ability to address health inequities and disparities, particularly among communities of color, which have disproportionally higher HCV prevalence.
The Centers for Disease Control and Prevention have found that African American "Baby Boomers" (those born between 1945 through 1965) are twice as likely to have HCV as Baby Boomers in general. Latinos experience some of the highest rates of hepatitis C infection in the U.S., with an estimated overall prevalence rate of 2.6%, and incidence appears to be rising. Since people of color are disproportionately represented within the Medicaid program, this policy will stifle efforts to achieve health equity and could increase the disparate outcomes for HCV in communities of color.
6. The New Policy Undermines the HCV Public Health Legislation Enacted in 2014.
The department's Sovaldi policy undermines the important public health legislation passed by the General Assembly last year requiring all primary care physicians to offer hepatitis C testing to all Connecticut residents capable of consent (except in an emergency situation). Public Act No. 14-203. The testing mandated in this new law underscores the urgent need to diagnose infected individuals and get them into early treatment. These provisions, which just went into effect on October 1, 2014, mean that health care providers are now required to test thousands of asymptomatic patients born between 1945 and 1965. But, under the bulletin, those same providers would then have to inform those testing positive that Connecticut will not allow them to be treated for this serious and potentially life-threatening medical condition because they are on the Medicaid program unless they already have suffered organ damage from the disease.
Indeed, it would be cruel not to encourage people to be tested for a life-threatening and curable disease, but, if they test positive for it, they should be entitled to treatment. It would be far crueler to deny them the available treatment. The legislative history makes clear that this was clearly not the legislature's intent. See Public Health Committee, Joint Favorable Report on SB 257, available at http://www.cga.ct.gov/2014/JFR/S/2014SB-00257-R00PH-JFR.htm (summarizing testimony). See also Statement of Sen. Olsten from Joint Favorable Report ("I am in favor of SB 257.ÉI am emphasizing that this test will ultimately save the Connecticut's healthcare system many millions of dollars by providing early diagnosis and treatment.)(emphasis added).
7. The supply limitations in the bulletin will needlessly restrict access even where the need for treatment is confirmed, threatening ineffectiveness of the Sovaldi regime.
The bulletin provides extreme limitations on access to Sovaldi even after it has been approved by DSS, by prohibiting the patient from getting more than a 14 day supply at a time (versus 30 days for all other drugs with a course of 30 days or more) and categorically prohibiting early refills (before 85% of a 14 day supply is used up, allowing a fixed two-day window), even through special request.
These two limitations, uniquely applicable to Sovaldi, will cause treatments to be missed within already approved regimens, because it is far more difficult for Medicaid enrollees than others to get to the pharmacy to obtain a supply of a medication due to transportation and other barriers. Medicaid rules allow a 30 day supply in part because of this reality. Requiring a return to the pharmacy every 14 days increases the chances that treatments will be missed, threatening the efficacy of the entire regimen and causing state expenditures to have been wasted when they could have effectuated a total cure.
Similarly, not allowing a Medicaid enrollee even to request an exception to the 85% early refill bar, as allowed for all other medications, increases the chances that critical treatments will be missed if the individual is unable to make it to the pharmacy, due to illness, a family obligation or otherwise, during the very short (two day) window for picking up refills allowed under the highly restrictive new policy. Both of these policies undermine access to treatments already found by the department to be medically necessary for the individual.
B. The Policies Set Forth in the Bulletin Are Illegal.
Under federal Medicaid law, notwithstanding the cost, states must cover Sovaldi under their Medicaid programs and do not have the discretion to deny or delay anyone Solvaldi where this drug is prescribed by a treating provider for an individual with Hepatitis C and there is a specific medical need for it, as defined in our state's statutory definition of medical necessity, Conn. Gen. Stat. 17b-259b(a). This state law also declares that "[c]linical policies, medical policies, clinical criteria or any other generally accepted clinical practice guidelines used to assist in evaluating the medical necessity of a requested health service shall be used solely as guidelines and shall not be the basis for a final determination of medical necessity." C.G.S. 17b-259b(b)(emphasis added). DSS may use more restrictive criteria such as those specified in its new bulletin, but only if DSS makes clear to all providers that treatment requests for individuals who do not meet those criteria will be individually assessed based on the statutory definition of medical necessity, and so long as no one is denied any requests for Sovaldi under those more-restrictive criteria.
DSS's bulletin violates these requirements, as well as federal coverage, timely access and due process requirements. The bulletin states unequivocally that the criteria specified in the bulletin must be met and reinforces that point by requiring any provider requesting prior authorization to sign the PA form and "certify that use of SovaldiTM for this patient is consistent with the above criteria/guidelines," blocking all providers from even requesting prior authorization if the guidelines are not met. All of the criteria in the new Sovaldi bulletin are therefore illegal unless changed to being recommended criteria for quick review and approval. This, and the many other violations of state and federal law contained in the bulletin, are discussed in detail in the February 3, 2014 letter to you from legal advocates (three Connecticut legal services programs and the Global Health Justice Partnership of the Yale Law School and the Yale School of Public Health).
We respectfully request that your agency immediately remove these harmful and illegal barriers to access to appropriate treatment for Medicaid patients living with hepatitis C. Our immediate suggestion for doing so is to issue a corrective bulletin (1) stating that the November bulletin and January PA Form are only "guidelines" and that all requests for prior authorization for Sovaldi will hereinafter be individually assessed for medical need pursuant to C.G.S. 17b-259b (and removing the requirement of certifying on the PA request form that the narrow criteria are met), and (2) changing the 14 day supply to a 30 day supply (up to the end of the course of treatment) and allowing requests for PA for early refills, while the Department begins a process to engage the advocacy, patient and provider communities in the collaborative development of replacement recommended guidelines.
We welcome the opportunity to engage with your agency in developing a replacement policy of recommended guidelines, through a cooperative process involving all stakeholders. We also welcome the opportunity to join forces with your agency and other state Medicaid agencies to address the high cost of the various new HCV drugs directly with manufacturers. We share your goal of reducing the per treatment costs of these drugs and believe that, through education of providers, we can put downward price pressure on the manufacturers.
Please contact us if you have questions or require additional information. We look forward to your response to our concerns and to working with you in the manner outlined above.
Thank you for your attention to this matter of critical importance to the individuals we serve.
Shawn Lang, Deputy Director, AIDS CT
Evelyn Barnum, Chief Executive Officer
Community Health Center Association of CT
Kyle Ragins, State Director, Doctors for America, Connecticut
Luis B. Perez, President and CEO, Mental Health Ass'n of CT, Inc.
Eileen Healy, Executive Director, Independence Northwest
Jan Van Tassel, Executive Director, Connecticut Legal Rights Project
Global Health Justice Partnership
Yale Law School-Yale School of Public Health
Kristen Noelle Hatcher, Managing Attorney, Benefits Unit, Connecticut Legal Services
Judith Stein Executive Director, Center for Medicare Advocacy
Susan L. Garten, Managing Attorney, Greater Hartford Legal Aid
Kate Mattias, Executive Director, NAMI Connecticut
Sheldon V. Toubman, Staff Attorney, New Haven Legal Assistance Ass'n
Kathi Liberman, Ellen Cyr, Co-Chairs, Conn. Ass'n of Resident Services
Coordinators for Housing (CARSCH)
Stephen A. Karp, Executive Director, National Association of Social Workers, CT Chapter
Kevin Galvin, Chairman, Small Business For A Healthy Connecticut
cc: Honorable Dannel P. Malloy
OPM Secretary Benjamin Barnes
Kate McEvoy, Medicaid Director
Dr. Robert Zavoski, DSS Medical Director
Dr. Jewel Mullen, DPH Commissioner
Senator Marilyn Moore
Rep. Catherine Abercrombie
Senator Terry Gerratana
Senator Beth Bye
Rep. Toni Walker
 While we appreciate the Department expanding PA eligibility from only F4 to F3 and F4, F3 is still a very high standard, requiring organ damage to receive treatment.
 We understand that HIV specialists are an additional kind of specialist allowed to provide prescriptions for Sovaldi, in addition to the four kinds specified in the bulletin.
 There appears to be an error in the bulletin, even as intended, in that the FDA label for Sovaldi, which this criteria presumably is based on, refers to individuals with Genotype 1 being appropriate for just Sovaldi and ribavirin, instead of these two in combination with interferon, as would historically be prescribed for Genotype 1 if the person is "interferon ineligibile." Nothing in the label even suggests that in order to be prescribed Sovaldi the person must be "interferon ineligible." And there appears to be an erroneous word "not" in this criteria in the bulletin. In addition, as discussed below, since the Sovaldi label was approved by the FDA, interferon is no longer the standard of care even for Genotype 1.
Suryaprasad AG, White JZ, Xu F, Eichler BA, Hamilton J, Patel A, Hamdounia SB, Church DR, Barton K, Fisher C, Macomber K, Stanley M, Guilfoyle SM, Sweet K, Liu S, Iqbal K, Tohme R, Sharapov U, Kupronis BA, Ward JW, Holmberg SD. Emerging Epidemic of Hepatitis C Virus Infections Among Young Nonurban Persons Who Inject Drugs in the United States, 2006-2012. Clin Infect Dis 2014. PMID: 25114031.
 Dana Goldman, Economist, University of Southern California. Presentation to Brookings Institute, "Are New Breakthrough Treatments Worth Their Price? Assessing the Social Costs and Benefits of Biomedical Innovation," during event The Cost and Value of Biomedical Innovation: Implications for Health Policy, October 1, 2014. Webcast accessed October 3, 2014 at http://www.brookings.edu/events/2014/10/01-cost-and-value-biomedical-innnovation-hep-
Saab S, Gordon SC, Park H, Sulkowski M, Ahmed A, Younossi Z. Cost-effectiveness analysis of sofosbuvir plus peginterferon/ribavirin in the treatment of chronic hepatitis C virus genotype 1 infection. Aliment Pharmacol Ther 2014;40(6):657-75. PMID: 25065960.
 http://blog.aids.gov/2013/05/latino-community-rallies-to-generate-awareness-of-viral-hepatitis.html, accessed October 3, 2014