2016 Drug Blockbusters and Patent Expiration Review
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1 February 23, Drug Blockbusters and Patent Expiration Review Nicolle Rychlick, PharmD Director, Clinical Integration and Implementation 1
2 Disclosure Nicolle Rychlick, Pharm.D., has nothing to disclose. 2
3 Objectives Identify key drug patents anticipated to expire in 2016 Summarize the impact of new branded drug launches Analyze potential clinical strategies to manage new branded drug products 3
4 Generic Availability HealthTrust vendor conversations days for generic launch and distribution availability Generally no less than 30% savings Weekly newsletter announcements Contract change report 4
5 2016 Patent Expirations Infectious Disease Cubicin Tygacil Ambisome Tamiflu Cardiology Crestor Benicar Multaq Aggrastat Respiratory Advair Diskus Combivent Respimat Other Lupron depot Entereg Gleevec Sensipar Nexium 5
6 6 Infectious Disease
7 Cubicin Indicated for complicated skin and skin structure infections and Staphylococcus aureus bacetermia Patent expires June 2016 Hospira likely to come to market first Teva a possible competitor 7
8 Tygacil Indicated for complicated skin and skin structure infections, complicated intraabdominal infections and communityacquired bacterial pneumonia Patent expires April
9 Ambisome Indicated for empirical therapy for presumed fungal infection in febrile, neupropenic patients, Cryptococcal meningitis in HIV patients and Aspergillus, Candida or Cryptococcus species and treatment of visceral leishmaniasis Patent expires October
10 Tamiflu Indicated for treatment of acute, uncomplicated influenza patients who have been symptomatic for no more than two days Patent expires December 2016 Litigation could delay expiration and launch till
11 11 Cardiology
12 Crestor Indicated for treatment of hyperlipidemia Patent expires May 2016 Multiple generic entrants expected 12
13 Benicar Indicated treatment for hypertension Patent expires October
14 Multaq Indicated to reduce the risk of hospitalization for atrial fibrillation Patent expires July 2016 Litigation has delayed launch till at least
15 Aggrastat Indicated to reduce the rate of thrombotic cardiovascular events in patients with non-st elevation acute coronary syndrome Patent expires October
16 16 Respiratory
17 Advair Diskus Indicated for the treatment of asthma and maintenance treatment for chronic obstructive pulmonary disease Patent expires August
18 Combivent Respimat Indicated to reduce the rate of thrombotic cardiovascular events in patients with non-st elevation acute coronary syndrome Patent expires October 2016 Over 20 patents that could delay release 18
19 19 Other drugs
20 Lupron depot Indicated for palliative treatment of advanced prostate cancer, endometriosis, uterine leiomyomata (fibroids), and in children with central precocious puberty (CPP) Patent expires December
21 Entereg Indicated to accelerate the time to upper and lower gastrointestinal recovery following surgery Patent expires March
22 Gleevec Indicated for treatment of chronic myeloid leukemia, acute lymphoblastic leukemia and other blood cancers Patent expired February 2016 Sun Pharma launched February 1 Six-month exclusivity for generic 22
23 Sensipar Indicated for secondary hyperparathyroidism in patients with chronic kidney disease and treatment of hypercalcemia Patent expires December
24 Nexium Indicated for treatment of gastroesophageal reflux disease, risk reduction of NSAIDassociated gastric ulcer, H. pylori eradication Patent expires May
25 Blockbusters
26 Pulmonary arterial hypertension Sample of available therapies Vasodilators/prostacyclin pathway agonists Flolan (epoprostenol) Orenitram (treprostinil) Ventavis (iloprost) Endothelin receptor antagonists Tracleer (bosentan) Letairis (ambrisentan) PDE5 inhibitors Revatio (sildenafil) Adcirca (tadalafil) High-dose calcium channel blockers Cardizem (diltiazem) Adalat (nifedipine) Norvasc (amlodipine) 26
27 Uptravi (Selexipag) Indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH MOA: Oral prostacyclin receptor (IP receptor) agonist; structurally distinct from prostacyclin that selectively binds to the IP receptor 27
28 Uptravi (Selexipag) No renal or hepatic dosing required Significant drug interactions with CYP2C8 inhibitors (e.g. gemfibrozil) causing an increase in drug exposure Most common adverse reactions reported were headache, diarrhea, jaw pain and nausea (>20%) 28
29 Uptravi (Selexipag) Manufacturer: Actelion Starting dose of 200 mcg per day, increasing dose by 200 mcg twice weekly to maximum dose of 1600 mcg twice daily Non-contracted WAC Cost: $ /60 count bottle (200mcg tablet) Available in eight strengths, all different colored tablets 29
30 Anticoagulation Praxbind (idarucizumab) Manufacturer: Boehringer Ingelheim Indicated for emergency surgery/urgent procedures or life-threatening or uncontrolled bleeding reversal of dabigatran Recommend dose is 5 grams WAC cost: $3,500 per 5 gram dose Will continue to complete safety studies to maintain approval 30
31 31 HealthTrust Member Portal
32 Anticoagulation Andexanet alfa Phase II Manufacturer: Portola Pharmaceuticals For the reversal of direct and indirect Factor Xa inhibitors BLA application accepted by FDA 2/17/2016, with a target FDA action by 8/17/2016 Phase III trial ANNEXA published November 2015 All primary and secondary endpoints were met Study participants received a bolus followed by a 2-hour infusion Third agent developed by Perosphere in Phase II 32
33 Oncology Opdivo (nivolumab) Manufacturer: Bristol-Myers Squibb Indications for metastatic melanoma, metastatic nonsmall cell lung cancer, advanced renal cell carcinoma Dosing as a single agent is 3mg/kg every two weeks Non-contracted WAC Cost: $ mg/4mL single dose vial Phase III trials showed extended survival 33
34 Critical Care Bridion (sugammadex) Manufacturer: Merck Indication for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide Recommended dose of 2-4 mg/kg; 16 mg/kg for high dose rocuronium WAC cost: $ mg/mL 2mL vial 34
35 Endocrinology Basaglar (insulin glargine) Manufacturer: Lilly Indication to improve glycemic control for patients with type 1 or 2 diabetes mellitus Launch December 15, 2016 Launching with pen only 35
36 Anti-infectives Drugs to watch Dalvance, Teflaro, Avycaz, Zerbaxa Cardiology Entresto, Kengreal, serelaxin Biosimilars infliximab, peg-filgrastim, epoetin-alfa 36
37 Management of blockbusters Review products as soon as possible Clinical and patient need Is it an improvement? P&T committee review of drug pipelines Identify physician champions Determine formulary status Formulary, restricted? Non-formulary Contact your GPO for resources or questions 37
38 Resources ASHP daily newsletters FDA weekly updates AMCP Dossier Clinicaltrials.gov Vendor press releases FDA Orange Book Law360.com FiercePharma newsletters MPR Drugs (empr.com) 38
39 39 Questions
HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
Generic Brand HICL GCN Exception/Other SELEXIPAG UPTRAVI 42922 TREPROSTINIL ORENITRAM ER 40827 If the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request
1. Phosphodiesterase Type 5 Enzyme Inhibitors: Sildenafil (Revatio), Tadalafil (Adcirca)
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic
PULMONARY ARTERIAL HYPERTENSION AGENTS
Approvable Criteria: PULMONARY ARTERIAL HYPERTENSION AGENTS Brand Name Generic Name Length of Authorization Adcirca tadalafil Calendar Year Adempas riociguat Calendar Year Flolan epoprostenol sodium Calendar
Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date:
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date: 07.01.16 Last Review Date: 02.19 Revision Log See Important Reminder at the end of this policy for important
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Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date:
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date: 07.01.16 Last Review Date: 02.18 Revision Log See Important Reminder at the end of this policy for important
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Drug Class Monograph Class: Pulmonary Arterial Hypertension Agents Drugs: Adcirca (tadalafil), Adempas (riociguat), Flolan (epoprostenol), Letairis (ambrisentan), Opsumit (macitentan), Orenitram (treprostinil),
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Revatio) Reference Number: CP.PHAR.197 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Revatio) Reference Number: CP.PHAR.197 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM*, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Flolan, Veletri) Reference Number: CP.PHAR.192 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Medicaid Coding Implications Revision Log See Important Reminder
2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2020-10 Program Prior Authorization/Medical Necessity PAH Agents Medication Adcirca (tadalafil), Adempas (riociguat), Letairis
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Ambrisentan (Letairis) Reference Number: CP.PHAR.190 Effective Date: 07.01.18 Last Review Date: 01.12.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the
Coding Implications Revision Log. See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Ventavis) Reference Number: CP.PHAR.193 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Coding Implications Revision
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Opsumit) Reference Number: CP.PHAR.194 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
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Coding Implications Revision Log. See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM*, Medicaid Description (Orenitram, Remodulin,
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM*, Medicaid Coding Implications Revision Log
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Coding Implications
National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008
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See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 07.01.18 Last Review Date: 01.12.18 Line of Business: Oregon Health Plan Coding Implications Revision
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Adcirca) Reference Number: CP.PHAR.198 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tracleer) Reference Number: CP.PHAR.191 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Letairis) Reference Number: CP.PHAR.190 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Health Insurance Marketplace, Medicaid Revision Log See Important Reminder at the
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tracleer) Reference Number: CP.PHAR.191 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Letairis) Reference Number: CP.PHAR.190 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
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Clinical Policy: Ambrisentan (Letairis) Reference Number: ERX.SPMN.84 Effective Date: 07/16
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