Aetna Krystexxa Coverage

[Anonymous]

http://www.aetna.com/products/rxnonmedicare/data/2011/ENDO/gout_2011.html

I.Precertification Criteria
Under some plans, including plans that use an open or closed formulary Krystexxa is subject to precertification. If precertification requirements apply Aetna considers Krystexxa to be medically necessary for those members who meet the following precertification criteria:

The documented treatment of symptomatic gout when both of the following criteria are met:

At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and non-steroidal anti-inflammatory drugs(such as ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis; AND
Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day or when xanthine oxidase inhibitors are contraindicated.


II.Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Uloric is subject to step-therapy. Aetna considers Uloric to be medically necessary for those members who meet the following step-therapy criteria:

A documented trial of one month of the preferred generic alternative allopurinol

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below).

III.Medical Exception Criteria
Krystexxa is currently listed on the Aetna Formulary Exclusions list.* Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Krystexxa to be medically necessary for those members who meet the criteria specified below:

Uloric is currently listed on the Aetna Formulary Exclusion and Step-Therapy list.* Therefore, Uloric is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers Uloric to be medically necessary for those members who meet the criteria specified below:

For Krystexxa

A documented treatment of symptomatic gout when the following criteria are met and at least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and non-steroidal anti-inflammatory drugs (such as ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis;

AND

Contraindication to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Intolerance to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Allergy to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day.
For Uloric

A documented:

Contraindication to the preferred generic alternative allopurinol OR
Intolerance to the preferred generic alternative allopurinol OR
Allergy to the preferred generic alternative allopurinol OR
Failure of a one month trial of the preferred generic alternative allopurinol

Place of Service:

Outpatient

The above policy is based on the following references:
1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
6. Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies including Therapeutics (ESCISIT). Am Rheum Dis. 2006;65:1312-24.
7. Schumacher HR Jr, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized,double-blind, parallel-group trial. Arthritis Rheum. 2008;59(11):1540-8.
11.
8. Eggebeen AT. Gout: An update. Am Fam Physician 2007;76:801-8.
9. Chen LX, Schumacher HR. Gout: an evidence-based review. J Clin Rheumatol. 2008;14(5 Suppl):S55-62
10. Hair PI, McCormack Pl, Keating GM. Febuxostat. Drugs 2008;68:1865-74.



Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2011

 

[Anonymous]

Completely reasonable. This is exactly the patient population and I see nothing in this policy that is an issue for access.

With all the vitrol that one particular person on this site is spewing, lets not forget that these are advanced patients with a high burden of disease, at high risk for CV events. They have a diminished quality of life. Krystexxa works for these patients with no alternatives.

Don't forget about patients !

 

[Anonymous]

Completely reasonable. This is exactly the patient population and I see nothing in this policy that is an issue for access.

With all the vitrol that one particular person on this site is spewing, lets not forget that these are advanced patients with a high burden of disease, at high risk for CV events. They have a diminished quality of life. Krystexxa works for these patients with no alternatives.

Don't forget about patients !

and don't forget to use the proper spelling when you want to present yourself with credibility. the proper S.A.T. word that you're trying to use in your posts on 2 threads is VITRIOL, with an i. It's not vitrol.

 

[Anonymous]

Completely reasonable. This is exactly the patient population and I see nothing in this policy that is an issue for access.

With all the vitrol that one particular person on this site is spewing, lets not forget that these are advanced patients with a high burden of disease, at high risk for CV events. They have a diminished quality of life. Krystexxa works for these patients with no alternatives.

Don't forget about patients !

Completely reasonable???? Try completely UNREASONABLE, ARE you on crack? This will apply to less than 1% of eligible patients that you are going to be "calling on".

You do not sustain profitability on with these restrictions, step edits, labor intensive protocol;s and a 60 person sales and marketing team. You just don't..... this is a massive failure and you know it, I know it, and Savient knew this years ago.....

Is vitrol a new drug? Pass me some of that vitrol and crack that you are smoking. NO coverage, medically unnecessary after cost is discovered and patient goes through the entire work up process, which is unlikely to happen. 99% of gout patients will not go through the entire REMS and connections program enrollment to fight for reimbursement, they will stick to the gold standards and alternative treatment even if they are not at 100% goal with remission and are experiencing flares. You are one delusional fella.

 

[Anonymous]

You are one sick S.O.B.

You have no idea what you are talking about. The drug is for patients who failed other therapies...aetna's coverage reflects exactly what is in the PI.

Go away, you are a hateful, twisted loooooooser.

 

[Anonymous]

http://www.aetna.com/products/rxnonmedicare/data/2011/ENDO/gout_2011.html

I.Precertification Criteria
Under some plans, including plans that use an open or closed formulary Krystexxa is subject to precertification. If precertification requirements apply Aetna considers Krystexxa to be medically necessary for those members who meet the following precertification criteria:

The documented treatment of symptomatic gout when both of the following criteria are met:

At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and non-steroidal anti-inflammatory drugs(such as ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis; AND
Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day or when xanthine oxidase inhibitors are contraindicated.


II.Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Uloric is subject to step-therapy. Aetna considers Uloric to be medically necessary for those members who meet the following step-therapy criteria:

A documented trial of one month of the preferred generic alternative allopurinol

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below).

III.Medical Exception Criteria
Krystexxa is currently listed on the Aetna Formulary Exclusions list.* Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Krystexxa to be medically necessary for those members who meet the criteria specified below:

Uloric is currently listed on the Aetna Formulary Exclusion and Step-Therapy list.* Therefore, Uloric is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers Uloric to be medically necessary for those members who meet the criteria specified below:

For Krystexxa

A documented treatment of symptomatic gout when the following criteria are met and at least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and non-steroidal anti-inflammatory drugs (such as ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis;

AND

Contraindication to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Intolerance to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Allergy to two xanthine oxidase inhibitor alternatives – allopurinol [Zyloprim] and febuxostat [Uloric] OR
Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day.
For Uloric

A documented:

Contraindication to the preferred generic alternative allopurinol OR
Intolerance to the preferred generic alternative allopurinol OR
Allergy to the preferred generic alternative allopurinol OR
Failure of a one month trial of the preferred generic alternative allopurinol

Place of Service:

Outpatient

The above policy is based on the following references:
1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
6. Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies including Therapeutics (ESCISIT). Am Rheum Dis. 2006;65:1312-24.
7. Schumacher HR Jr, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized,double-blind, parallel-group trial. Arthritis Rheum. 2008;59(11):1540-8.
11.
8. Eggebeen AT. Gout: An update. Am Fam Physician 2007;76:801-8.
9. Chen LX, Schumacher HR. Gout: an evidence-based review. J Clin Rheumatol. 2008;14(5 Suppl):S55-62
10. Hair PI, McCormack Pl, Keating GM. Febuxostat. Drugs 2008;68:1865-74.



Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2011

"If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below").


This is the only take away from this Aetna posting. Remember there are thousands of Aetna PBM's and umbrella plans, all based on the negotiations with the employer will have a different clinical map for a product like Krystexxa, and 99.9% of them will deny the coverage or pay a very small co insurance usually, less than 20%, which still makes this reach to think in this economy even at an orphan disease designation that this will even be a blip on the radar for a Rheumatologist. Highly unlikely this will be used even in the most refractory subsets of gout patients. Very limited usage. How long will this justify your jobs? Not long. Many of you or least the guy posting seems to have very little understanding of what a medically necessary product or test looks like and the bazillion step edits that have to be met in order for reimbursement to be offered, which it will not for KX until they prove its utility to Medicare, which is a long process and all claims will be denied up front and the patient will pay severely, this will not fly with the doc's. Been there done that.

 

[Anonymous]

"If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below").


Almost all biologics where other meds are avail have this same criteria. Did you see even Takeda's Uloric (non-biologic) have III. Medical Exception Criteria?


Check Aetna MS drugs...how many have Medical exception criteria? Get it now? Very common

http://www.aetna.com/products/rxnonmedicare/data/2010/INJ2010/multiple_sclerosis_2010.html

 

[Anonymous]

"If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below").


This is the only take away from this Aetna posting. Remember there are thousands of Aetna PBM's and umbrella plans, all based on the negotiations with the employer will have a different clinical map for a product like Krystexxa, and 99.9% of them will deny the coverage or pay a very small co insurance usually, less than 20%, which still makes this reach to think in this economy even at an orphan disease designation that this will even be a blip on the radar for a Rheumatologist. Highly unlikely this will be used even in the most refractory subsets of gout patients. Very limited usage. How long will this justify your jobs? Not long. Many of you or least the guy posting seems to have very little understanding of what a medically necessary product or test looks like and the bazillion step edits that have to be met in order for reimbursement to be offered, which it will not for KX until they prove its utility to Medicare, which is a long process and all claims will be denied up front and the patient will pay severely, this will not fly with the doc's. Been there done that.

LImited usage is right. this is nothing but a smoke and mirror routine. this launch is for the investors and the street. the reps will be disposed of in 3 months after the debacle of no coverage sinks in and Savient takes a huge beating by the board and street for the unnecessary expense of the "new sales team"... its all happening. Get with the program bucko!

 

[Anonymous]

do you even understand what TFG is?

the market is small. ever heard of orphan drugs?

and insurance will cover it. treating TFG patients and keeping them out of the hospital makes more sense than patients (and insurance) incurring much larger expense by hospitalization.

and for you bozos who claim insurance won't cover it -- better go educate all the analysts who cover SVNT.

 

[Anonymous]

do you even understand what TFG is?

the market is small. ever heard of orphan drugs?

and insurance will cover it. treating TFG patients and keeping them out of the hospital makes more sense than patients (and insurance) incurring much larger expense by hospitalization.

and for you bozos who claim insurance won't cover it -- better go educate all the analysts who cover SVNT.

Hey clowns shoes, analysts are ALWAYS RIGHT, RIGHT? What a pure douche bag statement above. If you knew anything about this market, it is a no brainer that insurance will not cover this enormous cost. orphan disease drugs are notorious for breaking the patients piggy bank and doc's, especially RhU have been burnt by this game before, there will be no takers.....face it. The misconception that simply because a drug is in a Orphan designation by the FDA that it will be "covered" or even partially reimbursed is a huge myth and misguided thought. Trust me. We would know. In Kystx's case, the PI are even more skeptical and pessimistic about it, the black box warnings, weak clinical footprints, and COST is all they need to red flag and block this little engine that couldn't. Savient bulls were very optimistic prior too the admission and discovery that NO BODY would partner with them and now they are left holding the bag! Do your diligence!!

 

[Anonymous]

Post #10 is correct. Unfortunately.

Launched Uloric with Takeda and marketing got it wrong. They dogged allopurinol and stated that "the medical community has waited 2 years for this drug". Maybe so but they soon forgot to write it where they could- limited places. Bottom line: after the optins are exhausted so you will be as well. Long sales cycle spells MUCH impatience on the part of upper management. The next step you ask? They will blame the sales force and reduce it accordingly after about 9 months or until the next appraisal process. Sorry for the negative news but that is remains the reality for that division of Takeda.