HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

Transcription

1 Generic Brand HICL GCN Exception/Other SELEXIPAG UPTRAVI TREPROSTINIL ORENITRAM ER If the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request for prior authorization. All requests for high-impact medications require review by a pharmacist prior to final approval. GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the patient 18 years of age or older? If yes, continue to #2. Vasodilators guideline, this medication is only covered for members 18 years of age and older. Your physician indicated that you are under the age of 18 and therefore your request was not 2. Has the requested medication been prescribed by, or in consultation with, a cardiologist or pulmonologist? If yes, continue to #3. Vasodilators, this medication is only covered when prescribed by or in consultation with a cardiologist or pulmonologist. Your physician did not indicate that he or she specializes in one of these areas or has consulted with a specialist and therefore your request was not 3. Does the patient have documented confirmatory PAH-WHO Group 1 diagnosis, based on right heart catheterization? If yes, continue to #4. Vasodilators guideline, this medication is only covered for patient's that have documented confirmation of pulmonary arterial hypertension. Your physician did not indicate that you have a diagnosis of pulmonary arterial hypertension and therefore your request was not Page 1

2 INITIAL CRITERIA (CONTINUED) 4. Does the patient have NYHA - WHO Functional Class II - III symptoms? If yes, continue to #5. Vasodilators guideline, this medication is only covered for patients that have symptoms of pulmonary arterial hypertension with ordinary physical activity or at rest. Your physician did not indicate that you have symptoms of pulmonary arterial hypertension with ordinary physical activity or at rest and therefore your request was not 5. Is the patient currently taking an alternative prostacyclin, such as inhaled treprostinil (Tyvaso), iloprost (Ventavis), oral treprostinil (Orenitram ER) or selexipag (Uptravi)? If yes, continue to #6. If no, continue to #7. 6. Will the requested medication replace the patient's current prostacyclin therapy? If yes, continue to #8. Vasodilators guideline, this medication is not covered when used in combination with another prostacyclin such as [current prostacyclin]. Your physician indicated that you will continue your prostacyclin while taking [requested medication] and therefore your request was not 7. Is the patient currently taking, tried and failed therapy with, or have a contraindication to a phosphodiesterase-5 inhibitor (PDE5I) [i.e., sildenafil (Revatio) or tadalafil (Adcirca)] or an endothelin receptor antagonist (ERA) [i.e., bosentan (Tracleer), ambrisentan (Letairis), or macitentan (Opsumit)]? If yes, continue to #8. Vasodilators guideline, this medication is covered for pulmonary arterial hypertension in patients who are currently taking, tried and failed therapy with, or have a contraindication to first line medications such as sildenafil (Revatio), tadalafil (Adcirca), bosentan (Tracleer), ambrisentan (Letairis), or macitentan (Opsumit). Your physician did not indicate that you are on, have tried and failed, or have a contraindication to any of these agents and therefore your request was not Page 2

3 INITIAL CRITERIA (CONTINUED) 8. Please approve for 6 months with the following quantity limits: [PAC NOTE: Please enter proactive prior authorization(s) to allow for dose titration.] Please use status code #056. Requests for products on formulary with a restriction, please use the approval text provided. APPROVAL TEXT: Your request for [requested medication] has been approved for a 6-month period with a quantity limit of [one pack per 6 months/[x] tablets per day]. Requests for products not on formulary, please use the approval text provided. APPROVAL TEXT: Your request for [requested medication has been approved for a 6-month period with a quantity limit of [one pack per 6 months/ [X] tablets per day] at your highest costshare tier. Uptravi Dose Approve Quantity Limits Titration pack (GPID: 40378) by GPID 1 pack per 6 months 200 mcg tablets (GPID: 40355) by GPID 8 tablets per day 400 mcg tablet (GPID: 40356) 600mcg tablet (GPID: 40357) 800 mcg tablet (GPID: 40358) 1,000mcg tablet (GPID: 40359) 1,200 mcg tablet (GPID: 40374) 1,400 mcg tablet (GPID: 40375) 1,600 mcg tablet (GPID: 40376) One strength by HICL Orenitram Dose Approve Quantity Limits mg ER tablet (GPID: 35799) by GPID 3 tablets per day 0.25 mg ER tablet (GPID: 35798) 1 mg ER tablet (GPID: 35803) 2.5 mg ER tablet (GPID: 35804) 5 mg ER tablet (GPID: 43521) RENEWAL CRITERIA One strength by HICL 1. Has the requested medication been prescribed by or in consultation with a cardiologist or pulmonologist? If yes, continue to #2. Vasodilators guideline, this medication is only covered when prescribed by or in consultation with a cardiologist or pulmonologist. Your physician did not indicate that he or she specializes in one of these areas or has consulted with a specialist and therefore your request was not Page 3

4 RENEWAL CRITERIA (CONTINUED) 2. Does the patient have documented confirmatory PAH-WHO Group 1 diagnosis, based on right heart catheterization? If yes, continue to #3. Vasodilators guideline, this medication is only covered for patient's that have documented confirmation of pulmonary arterial hypertension. Your physician did not indicate that you have a diagnosis of pulmonary arterial hypertension and therefore your request was not 3. Has the patient experienced an improvement while on therapy, i.e., stabilization or improvement in functional class symptoms or no change or improvement in 6MWD (6-minute walk distance)? If yes, approve for 12 months with the following quantity limits: [PAC NOTE: Please enter proactive prior authorization(s) to allow for dose titration.] Please use status code #056. Requests for products on formulary with a restriction, please use the approval text provided. APPROVAL TEXT: Your request for [requested medication] has been approved for a 12- month period with a quantity limit of [x] tablets per day. Requests for products not on formulary, please use the approval text provided. APPROVAL TEXT: Your request for [requested medication] has been approved for a 12- month period with a quantity limit of [X] tablets per day at your highest cost-share tier. Uptravi Dose Approve Quantity Limits 200 mcg tablets (GPID: 40355) by GPID 8 tablets per day 400 mcg tablet (GPID: 40356) 600mcg tablet (GPID: 40357) 800 mcg tablet (GPID: 40358) 1,000mcg tablet (GPID: 40359) 1,200 mcg tablet (GPID: 40374) 1,400 mcg tablet (GPID: 40375) 1,600 mcg tablet (GPID: 40376) One strength by HICL Orenitram Dose Approve Quantity Limits mg ER tablet (GPID: 35799) by GPID 3 tablets per day 0.25 mg ER tablet (GPID: 35798) 1 mg ER tablet (GPID: 35803) 2.5 mg ER tablet (GPID: 35804) 5 mg ER tablet (GPID: 43521) One strength by HICL Page 4

5 RENEWAL CRITERIA (CONTINUED) Vasodilators guideline, authorization for renewal requires documentation of improvement of symptoms while on therapy with [requested medication]. Your physician did not indicate that your symptoms have improved with [requested medication] therapy and therefore your request was not RATIONALE Ensure appropriate utilization of the prostacyclin vasodilators based on FDA approved indication and appropriate clinical criteria FDA APPROVED INDICATIONS ORENITRAM: Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. UPTRAVI: Treatment of pulmonary arterial hypertension (PAH) (World Health Organization Group I) to delay disease progression and reduce the risk of hospitalization for PAH. ORENITRAM DOSING Starting dose: 0.25 mg BID or mg TID. Titrate by 0.25 mg or 0.5 mg BID or mg TID, not more than every 3 to 4 days as tolerated. Maximum dose is determined by tolerability. UPTRAVI DOSING Increase by 200 mcg twice daily usually at weekly intervals to the highest tolerated dose. If a dose is not tolerated, reduce dose to previously tolerated dose. REFERENCES Uptravi (selexipag) [prescribing information]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; July Orenitram (treprostinil extended-release tablets) [prescribing information]. Research Triangle Park, NC: United Therapeutics Corp; January Created: 11/17 Effective: 01/01/18 Client Approval: 11/06/17 P&T Approval: 12/04/17 Page 5