HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

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Trevor Shields
6 years ago
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1 Generic Brand HICL GCN Exception/Other EFINACONAZOLE JUBLIA TAVABOROLE KERYDIN GUIDELINES FOR USE 1. Does the patient have a diagnosis of onychomycosis of the fingernail or toenail? If yes, continue to #2. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, is only covered when prescribed for fungal infection of the fingernail or toenail. Your physician did not indicate that you are being treated for this condition and therefore your request was not approved. 2. Is the requested medication being prescribed by a podiatrist, dermatologist or infectious disease specialist? If yes, continue to #3. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, is only covered when prescribed by a podiatrist, dermatologist or an infectious disease specialist. Your physician did not indicate that he or she specializes in one of these areas, and 3. Has the patient received ONE complete course of covered therapy with Jublia or Kerydin within the last 24 months as indicated on the MRF or by claims history? If yes, do not approve (additional courses can be prescribed at a cost to the patient). Please use status code #238 and the denial text provided. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, your plan covers one course of therapy within a 24-month period. Our records indicate that you have received coverage of a topical onychomycosis agent (such as ciclopirox, Jublia, or Kerydin) within the previous 24 months and If no, continue to #4. Page 1

2 4. Does the patient have diabetes, peripheral vascular disease (PVD), or immunosuppression? If yes, continue to #6. If no, continue to #5. 5. Does the patient have pain surrounding the nail or soft tissue involvement? If yes, continue to #6. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, this medication is only covered in situations where there are complicating factors such as pain surrounding the nail, diabetes, or a suppressed immune system. Your physician did not indicate that you have any of these complicating factors and 6. Has the prescribing clinician provided documentation that the diagnosis was confirmed within 6 months of initial treatment date by at least ONE of the following? Positive KOH test Positive fungal culture Pathology report If yes, continue to #7. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, your plan requires confirmation of a positive laboratory analysis (culture, KOH, etc.) within the past 6 months, prior to approving coverage for the requested medication. Your physician did not provide confirmation of a positive laboratory analysis performed within the past six months and 7. Is the request for Jublia or Kerydin for a patient less than 18 years of age and/or for the treatment of onychomycosis of the fingernails? If yes, do not approve. Please use status code #238 and the denial text provided. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, this medication is only covered for [select appropriate denial reason(s): patients 18 years of age and older or the treatment of onychomycosis of the toenails]. Your physician did not indicate that you meet this requirement and If no, continue to #8. Page 2

3 8. Is treatment with oral terbinafine AND itraconazole contraindicated because of ONE of the following medical conditions? Renal impairment Pre-existing liver disease Evidence of ventricular dysfunction such as congestive heart failure (CHF) or history of CHF. If yes, continue to #10. If no, continue to # Has the patient failed a previous treatment with both oral terbinafine AND itraconazole within the past 12 months? If yes, continue to #10. Please enter a proactive PA for itraconazole 100 mg by GPID as follows: Fingernails: o 100mg (for 200 mg BID dosing): Total of #56 capsules in 8 weeks Toenails: o 100mg (for 200mg): Total of #168 capsules in 12 weeks) AND o 100mg (for 400mg): Total of #336 capsules in 12 weeks. NOTE: Do not communicate itraconazole PA to the prescriber. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, a trial with both terbinafine (Lamisil) tablets AND itraconazole (Sporanox) capsules, or a documented reason why treatment with these medications would be inappropriate [such as kidney or liver disease, or congestive heart failure (CHF)] is required prior to approving coverage of the requested medication. Your physician did not indicate that you were previously treated with both terbinafine tablets AND itraconazole capsules, or indicate why treatment with either agent would be inappropriate, and 10. Has the patient failed a trial with ciclopirox 8% topical solution (Ciclodan, Penlac)? If yes, continue to #11. DENIAL TEXT: Per your health plan's Topical Onychomycosis Agents guideline, a trial with ciclopirox 8% topical solution is required prior to coverage of the requested medication. Your physician did not indicate that you were previously treated with ciclopirox topical solution, and Page 3

4 11. Approve for 48 weeks by GPID. Please use status code #056 (for Jublia) and #057 (all other requests) (The quantity limit is hard coded for Jublia). Requests for products on formulary with a restriction, please use the approval text provided. JUBLIA APPROVAL TEXT: Jublia has been approved for your condition for a quantity of 4mLs per 28 days for a 48-week period. KERYDIN APPROVAL TEXT: Kerydin has been approved for your condition for a 48-week period. Requests for products not on formulary, please use the approval text provided. JUBLIA APPROVAL TEXT: Jublia has been approved for your condition for a quantity of 4mLs per 28 days for a 48-week period at your highest cost-share tier. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on that tier. KERYDIN APPROVAL TEXT: Kerydin has been approved for your condition for a 48-week period at your highest cost-share tier. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on that tier. May approve unused portion of a previously approved course of Jublia or Kerydin up to a total of 48 weeks of combined treatment, if not used in the original approval timeframe. NOTE: If the patient meets criteria for approval of PA, but the prescriber is requesting quantities and/or directions different than those listed above, please use status code #056 and/or #057 to indicate on the approval letter the limitations of the PA, (which will be stated in the free text area of the same letter). Page 4

5 RATIONALE A significant number of cases for which topical onychomycosis agents [ciclopirox, Jublia, or Kerydin] are prescribed are cosmetic in nature. Treatment with ciclopirox, Jublia, and Kerydin is lengthy, has a low cure rate, and is costly. Prior authorization ensures that Jublia, and Kerydin are approved in cases which are medically necessary. FDA APPROVED INDICATIONS Jublia is an azole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophyte. Kerydin is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. REFERENCES Jublia [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; September Kerydin [prescribing information. Palo Alto, CA: Anacor Pharmaceuticals, Inc.; March Created: 12/04/01 EC Effective: 01/01/18 Client Approval: 10/19/17 P&T Approval: 09/11/17 Page 5

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other BLOOD SUGAR DIAGNOSTIC DIABETIC TEST STRIPS 25200 NOTE: Requests for preferred blood glucose (diabetic) test strips manufactured by Abbott Diabetes Care (such as