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VA covering Sofosbuvir Treatment?
Does anyone know if the VA is going to make treatment for Hep C with Sofosbuvir available to veterans?
Update I talked to my VA Gastro MD today unofficially. I live a mile away and caught up with him as he was leaving afternoon clinic.
He told me he just got word the the VA has made arrangements with the company/distributor to get Sovaldi at a much cheaper price. He is hoping that two of his patients that are in bad shape can get it within the next week. My appointment is in two weeks. He hopes I can start treatment in about a month or so after my appointment.. I should know more then.
FYI for veterans
Information on VA Health Benefits
http://www.va.gov/opa/publications/benefits_book/benefits_chap01.asp
http://www.va.gov/healthbenefits/apply/veterans.asp
I qualify for VA health care because veteran low income and not service connected.
Some veterans may have acquired HCV when in service via Jetgun Injections Blood Transfusions, Medical Procedures or other. If not qualified for VA health care as listed in Basic Eligibility link above
You would have to apply and proof that you qualify for service connection. It will be denied in most cases and you will have to file an appeal and many of those are nenied but some have been approved. This site has a lot of info links to claims and court decisions etc.
http://www.hcvets.com/
Recognized service connected transmission methods for the Hepatitis C virus and other bloodborne pathogens. If a veteran applies for benefits and does not have "other" risk factors, or can prove service was a "greater risk" for infection with Hepatitis C, qualify for service connection.
He told me he just got word the the VA has made arrangements with the company/distributor to get Sovaldi at a much cheaper price. He is hoping that two of his patients that are in bad shape can get it within the next week. My appointment is in two weeks. He hopes I can start treatment in about a month or so after my appointment.. I should know more then.
FYI for veterans
Information on VA Health Benefits
http://www.va.gov/opa/publications/benefits_book/benefits_chap01.asp
http://www.va.gov/healthbenefits/apply/veterans.asp
I qualify for VA health care because veteran low income and not service connected.
Some veterans may have acquired HCV when in service via Jetgun Injections Blood Transfusions, Medical Procedures or other. If not qualified for VA health care as listed in Basic Eligibility link above
You would have to apply and proof that you qualify for service connection. It will be denied in most cases and you will have to file an appeal and many of those are nenied but some have been approved. This site has a lot of info links to claims and court decisions etc.
http://www.hcvets.com/
Recognized service connected transmission methods for the Hepatitis C virus and other bloodborne pathogens. If a veteran applies for benefits and does not have "other" risk factors, or can prove service was a "greater risk" for infection with Hepatitis C, qualify for service connection.
I found this in a manual for VA health providers So if your situation might apply you could ask your doctor about a non-formulary request
q. A non-formulary request process must exist at each VA medical center. This process needs to ensure that decisions are evidence-based and timely. Routine requests for non-formulary agents are reviewed and the requestor notified of the decision within 96 hours of receipt of a completed non-formulary request. Emergency requests for non-formulary agents are immediately addressed by individual(s) identified in local VA medical center policy. NOTE: If the degree of urgency or emergency is in question, the drug needs to be provided immediately and the nature of the urgency or emergency reviewed afterwards.
r. Non-formulary drugs that have received FDA approval are only to be approved when:
(1) A documented contraindication exists to the formulary agent(s);
(2) A documented adverse reaction occurred to the formulary agent(s);
(3) A documented therapeutic failure to formulary therapeutic alternatives exists;
(4) No formulary alternative exists;
(5) The patient has previously responded to a non-formulary agent and serious risk is associated with a change to a formulary agent; or
(6) Other circumstances having compelling evidence-based clinical reasons.
s. All physician-initiated appeals of a non-formulary drug request are received and adjudicated by the facility Chief of Staff.
q. A non-formulary request process must exist at each VA medical center. This process needs to ensure that decisions are evidence-based and timely. Routine requests for non-formulary agents are reviewed and the requestor notified of the decision within 96 hours of receipt of a completed non-formulary request. Emergency requests for non-formulary agents are immediately addressed by individual(s) identified in local VA medical center policy. NOTE: If the degree of urgency or emergency is in question, the drug needs to be provided immediately and the nature of the urgency or emergency reviewed afterwards.
r. Non-formulary drugs that have received FDA approval are only to be approved when:
(1) A documented contraindication exists to the formulary agent(s);
(2) A documented adverse reaction occurred to the formulary agent(s);
(3) A documented therapeutic failure to formulary therapeutic alternatives exists;
(4) No formulary alternative exists;
(5) The patient has previously responded to a non-formulary agent and serious risk is associated with a change to a formulary agent; or
(6) Other circumstances having compelling evidence-based clinical reasons.
s. All physician-initiated appeals of a non-formulary drug request are received and adjudicated by the facility Chief of Staff.
NOTE: This link i posted here Dec 15, 2013 is not available as of this reply
VA Formulary Process
A description of the process and timeline for adding newly approved drugs to the VA National Formulary, December 12, 2013
http://www.hepatitis.va.gov/provider/hcv/va-formulary-process.asp
This was a a Google cashe It is a snapshot of the page as it appeared on Dec 19, 2013 23:52:42 GMT
VA Formulary Process
After a drug is approved by the FDA, the following process is required for the drug to be on the VA National Formulary.
USUALLY TAKES BETWEEN 1-6 MONTHS
Drafting of Drug Monograph and Criteria of Use
Pharmacy Benefits Management Clinician* conducts literature review and drafts a VA Drug Monograph (this is a document that is similar to the FDA package insert). *In the case of Hepatitis C medications, this is usually created in consultation with the VHA Office of Public Health.
For medications that have very specific indications, and/or require intensive monitoring, and/or have serious or unknown safety profiles, and/or are high cost, (i.e. hepatitis C direct-acting antivirals) medication specific criteria for use (CFU) are developed to promote appropriate drug therapy and reduce variability in use across VA. The CFU are created so that all medical centers can use the medication in the same way for any patient that meets these criteria. This process usually begins after the drug is approved and takes between 1-6 months.
Medical Consultation
Consultation with Medical Advisory Panel (MAP), VHA Medical Consultants, Field Advisory Committees (i.e. Hepatitis C Treatment Advisory Group (TAG), as indicated
Review by VA Formulary Committees
Drug monograph and Draft CFU are presented to VA Formulary committees (MAP and VISN Pharmacy Executives). Sometimes committees have questions or edits to add to the documents. Both committees must vote to approve documents for dissemination to the front-line field providers who may be using the drug, for comment.
USUALLY TAKES 1 MONTH
Review by Field Providers
Draft documents are disseminated to front-line field providers, e.g., relevant specialty providers (i.e. hepatitis C providers) primary care providers, clinical pharmacists, Chief Medical Officers). These providers can submit comments to the VA Formulary committees. They have 2 to 4 weeks to submit their comments.
PBM Review of Field Comments
Field comments are collected and reviewed by the PBM Clinician. Any comments and any changes that are suggested by the field providers are discussed with the Formulary committees before they are incorporated into the documents. It is at the discretion of the formulary committees to decide which changes to incorporate.
USUALLY TAKES 1 MONTH
Formulary Committees Vote on Formulary Status
Both Formulary committees (MAP and VISN Pharmacy Executives) review final documents and vote on formulary status and/or approval of Drug monograph and CFU documents.
Formulary decisions are evidence-based, not preference-based.
A drug can be approved to the formulary without criteria, approved for formulary with criteria, made non-formulary with criteria, or made non-formulary. Any non-formulary drug can still be requested for a patient by a provider; the request is sent to the local PBM where a decision of approval for that particular patient is adjudicated locally in accordance with the non-formulary request process at that facility.
USUALLY TAKES 2 WEEKS
Changes Made to VA National Formulary
Changes are made to the VA National Formulary as indicated; documents are generally posted to the PBM Intranet site within 2 weeks. Notification via email is sent to field providers and to relevant specialty providers (i.e. hepatitis C providers)
VA Formulary Process
A description of the process and timeline for adding newly approved drugs to the VA National Formulary, December 12, 2013
http://www.hepatitis.va.gov/provider/hcv/va-formulary-process.asp
This was a a Google cashe It is a snapshot of the page as it appeared on Dec 19, 2013 23:52:42 GMT
VA Formulary Process
After a drug is approved by the FDA, the following process is required for the drug to be on the VA National Formulary.
USUALLY TAKES BETWEEN 1-6 MONTHS
Drafting of Drug Monograph and Criteria of Use
Pharmacy Benefits Management Clinician* conducts literature review and drafts a VA Drug Monograph (this is a document that is similar to the FDA package insert). *In the case of Hepatitis C medications, this is usually created in consultation with the VHA Office of Public Health.
For medications that have very specific indications, and/or require intensive monitoring, and/or have serious or unknown safety profiles, and/or are high cost, (i.e. hepatitis C direct-acting antivirals) medication specific criteria for use (CFU) are developed to promote appropriate drug therapy and reduce variability in use across VA. The CFU are created so that all medical centers can use the medication in the same way for any patient that meets these criteria. This process usually begins after the drug is approved and takes between 1-6 months.
Medical Consultation
Consultation with Medical Advisory Panel (MAP), VHA Medical Consultants, Field Advisory Committees (i.e. Hepatitis C Treatment Advisory Group (TAG), as indicated
Review by VA Formulary Committees
Drug monograph and Draft CFU are presented to VA Formulary committees (MAP and VISN Pharmacy Executives). Sometimes committees have questions or edits to add to the documents. Both committees must vote to approve documents for dissemination to the front-line field providers who may be using the drug, for comment.
USUALLY TAKES 1 MONTH
Review by Field Providers
Draft documents are disseminated to front-line field providers, e.g., relevant specialty providers (i.e. hepatitis C providers) primary care providers, clinical pharmacists, Chief Medical Officers). These providers can submit comments to the VA Formulary committees. They have 2 to 4 weeks to submit their comments.
PBM Review of Field Comments
Field comments are collected and reviewed by the PBM Clinician. Any comments and any changes that are suggested by the field providers are discussed with the Formulary committees before they are incorporated into the documents. It is at the discretion of the formulary committees to decide which changes to incorporate.
USUALLY TAKES 1 MONTH
Formulary Committees Vote on Formulary Status
Both Formulary committees (MAP and VISN Pharmacy Executives) review final documents and vote on formulary status and/or approval of Drug monograph and CFU documents.
Formulary decisions are evidence-based, not preference-based.
A drug can be approved to the formulary without criteria, approved for formulary with criteria, made non-formulary with criteria, or made non-formulary. Any non-formulary drug can still be requested for a patient by a provider; the request is sent to the local PBM where a decision of approval for that particular patient is adjudicated locally in accordance with the non-formulary request process at that facility.
USUALLY TAKES 2 WEEKS
Changes Made to VA National Formulary
Changes are made to the VA National Formulary as indicated; documents are generally posted to the PBM Intranet site within 2 weeks. Notification via email is sent to field providers and to relevant specialty providers (i.e. hepatitis C providers)
Does anyone know if when you print out the payment coupon from Gilead if there is an expiration date on it?
Does anyone know what the procedure is to get the VA to pay for it. I went through boot camp in the mid 80's in San Diego and they used those same air guns for innoculations and it was soon after that that I volunteered to donate some blood that they caught it. I wonder if it's just a matter proving the time period you were in, or if there is extensive paper work?
The VA will offer Sofosbuvir but the biggest issue right now is the cost. It is estimated to cost $1000 per pill in the regular market. The VA will negotiate with the pharmaceutical company for a lower contract price but this takes time (1-3 months). Right now is the time to make sure you are established with a provider who can prescribe the treatment so that when it is available you are ready to go. Normally the VA limits the prescription of HCV medications to only select providers experienced in HCV treatment, such as Gastroenterology. Treatment with Sofosbuvir for Genotype 1 even with the Peginterferon will have less side effects overall than the treatment regime with a Protease Inhibitor (Incivek/Victrelis). Also need to consider that the length of treatment with a Protease Inhibitor can be as short as 24 weeks but it can also be 48 weeks - and this is not known until you are in treatment and it is determined how the virus responds to treatment. The treatment length for the Sofosbuvir regime is only 12 weeks no matter what. Of course the best is to talk directly to your HCV provider.
They should offer it because their inoculation protocol in the 70's spread HCV to so many baby boomers.
Treatment time is shorter with the new FDA approved treatment drugs. Also, less pills. I took Incivek treatment. I would welcome better, shorter treatment.
Thanks to both of you. This is so discouraging. Wondering if the wait is worth it since it includes Interferon for Type 1 anyway. Maybe son should just start old protocol if time frame is so long. What are advantages for waiting for new med?
Thanks for the info
Anticipating New Regimens with Direct Acting Antivirals for Hepatitis C
Summary of current research into HCV treatments, including clinical trials, updated December 11, 2013
http://www.hepatitis.va.gov/provider/hcv/DAA-update.asp
in part
...It is too early to know exactly which drugs will be FDA approved, and when. However, for now, it is most important to realize that many DAAs have been showing Phase 2 and Phase 3 trials with increased SVR rates, shortened durations of treatment, and acceptable adverse event profiles, creating intriguing possibilities for patients who have not been candidates for hepatitis C treatment because of the toxicities caused by interferon. But, it is also important to know that these results have been obtained in carefully selected clinical trial populations and that effectiveness in the real-world is unlikely to be as high. In addition, the relatively small numbers of patients treated in these trials mean that these new drugs may show unexpected side effects.
VA Formulary Process
A description of the process and timeline for adding newly approved drugs to the VA National Formulary, December 12, 2013
http://www.hepatitis.va.gov/provider/hcv/va-formulary-process.asp
After a drug is approved by the FDA, the following process is required for the drug to be on the VA National Formulary.
It looks like a total of 3.5 to 8.5 months to complete the process
I go to the VA and my doctor is hoping the process goes quickly and be able to start by next April. I am genotype 2a/2c and been putting off treatment for the past 6 years. Had hep c for 32 years
Anticipating New Regimens with Direct Acting Antivirals for Hepatitis C
Summary of current research into HCV treatments, including clinical trials, updated December 11, 2013
http://www.hepatitis.va.gov/provider/hcv/DAA-update.asp
in part
...It is too early to know exactly which drugs will be FDA approved, and when. However, for now, it is most important to realize that many DAAs have been showing Phase 2 and Phase 3 trials with increased SVR rates, shortened durations of treatment, and acceptable adverse event profiles, creating intriguing possibilities for patients who have not been candidates for hepatitis C treatment because of the toxicities caused by interferon. But, it is also important to know that these results have been obtained in carefully selected clinical trial populations and that effectiveness in the real-world is unlikely to be as high. In addition, the relatively small numbers of patients treated in these trials mean that these new drugs may show unexpected side effects.
VA Formulary Process
A description of the process and timeline for adding newly approved drugs to the VA National Formulary, December 12, 2013
http://www.hepatitis.va.gov/provider/hcv/va-formulary-process.asp
After a drug is approved by the FDA, the following process is required for the drug to be on the VA National Formulary.
It looks like a total of 3.5 to 8.5 months to complete the process
I go to the VA and my doctor is hoping the process goes quickly and be able to start by next April. I am genotype 2a/2c and been putting off treatment for the past 6 years. Had hep c for 32 years
"Hepatitis.va.gov" gives information about new treatments, releases of new treatments and availability. I saw info on the new drug releases on that site.
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