Drug Utilization and the Pharmaceutical Pipeline: Correctional Health Care Formulary Considerations. October
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1 Drug Utilization and the Pharmaceutical Pipeline: Correctional Health Care Formulary Considerations October
2 Objectives Overview the drug utilization trends of the top traditional therapy classes within the community and assess their impact on drug utilization within correctional systems. Identify new agents in development and compare them with currently available treatment options by therapeutic class as well as summarize first time generic dates of availability of commonly used agents over the next 24 months. Assess the impact of new medications and newly approved generic formulations will on correctional health care and their formularies 2
3 Notes Dr. Hamel does do not have any relevant financial relationships with commercial interests nor any affiliation with products presented Medications presented in late-phase studies Not an all inclusive review of pharmacy pipeline Generic names are provided and proposed trade names when available Actions by FDA cannot be speculated nor inferred Presenter cannot guarantee correct pronunciation of generic names in all cases 3
4 Generic Pipeline: Cardiovascular Product Name Anticipated Generic Entry 2011 US Sales (In millions) Clopidogrel (Plavix ) 5/2012 $5,020 Valsartan (Diovan /Diovan HCT ) Candesartan (Atacand /Atacand HCT ) 9/2012 $1,585/$1,431 12/2012 $95/$46 Fenofibrate (Tricor ) 1/2013 $1,111 Niacin (Niaspan ) 9/2013 $954 Accessed September 25, 2012
5 Cardiovascular: Market Trends Cholesterol and hypertension #2 and #3 in traditional drug class spend in 2011 Market spending expected to decrease HTN and cholesterol generic entry s JNC 8 and ATP IV expected in 2012 Expected broader recommendations for statin use Top Medications by market share 2011: Cholesterol-simvastatin, rosuvastatin, atorvastatin HTN-lisinopril, metoprolol, amlodipine, valsartan
6 Cardiovascular: Pipeline Trends Continued development on oral anticoagulants with improved safety and efficacy over warfarin Robust lipid-lowering pipeline Novel molecule investigations as well as reformulations of old standbys Approvals may hinge more on safety concerns than demonstration of efficacy Significant cost saving opportunities with generic entries
7 Cardiovascular: Anticoagulant Factor Xa inhibitors Orally administered with predictable effect, does not require frequent monitoring Fewer known drug interactions FDA-Approved Rivaroxaban (Xarelto ) Apixaban (Eliquis ) Prevention of stroke in AF and VTE prevention and treatment, twice daily AVERROES comparison vs. ASA 50% reduction in stroke and embolism risk ARISTOTLE comparison vs. warfarin Superior stroke and embolism prevention with lower major bleeding risk CRL in 6/2011. Decision date 3/17/2013 Edoxaban (Lixiana ) Stroke prevention in AF and VTE prevention post surgery, once daily STARS J-V significant reduction in DVT ( 65%) vs. enoxaparin Ongoing studies ENGAGE-AF TIMI-largest AF study with 21,000 participants HOKUSAI VTE-largest study of VTE with 7,500 participants
8 Cardiovascular: Lipid-Lowering Mipomersen (Kynamro ) Apo-B inhibitor dosed weekly as SQ injection LDL and Apo-B reductions demonstrated ~30% added to statin Increase benign and malignant neoplasms noted Review by FDA advisory panel set for 10/2012 and decision by 1/29/2013 Laropiprant + niacin (Tredaptive, formerly Cordaptive ) Co-formulated extended-release niacin with laropiprant, novel flushing inhibitor D/C due adverse reactions ~10% vs. 22.2% with niacin Non-approvable letter from FDA in 2008, resubmission expected 2012 following completion of HPS2-THRIVE Cardiac outcomes trial with 25,000 patients 10
9 Cardiovascular: Lipid Lowering Icosapent ethyl (VASCEPA, formerly AMR101) Prescription grade omega-3 fatty acid for dyslipidemia and very high TG ( mg/dl) MARINE 20-33% TG reduction in patients with very high TG (already on statin) ANCHOR 10-21% TG reduction dyslipidemia (already on statin) without raising LDL FDA approved 7/2012, but still not available on market 11
10 Generic Pipeline: Infectious Disease Product Name Anticipated Generic Entry 2011 US Sales (In millions) Valganciclovir (Valcyte ) 3/2013 $224 Moxifloxacin (Avelox ) 2/2014 $376 Nelfinavir (Viracept ) 4/2014 $44 Efavirenz (Susteva ) 3/2015 $141 Ritonavir (Norvir ) 1/2015 $422 Linezolid (Zyvox ) 5/2015 $271 Accessed September 25, 2012
11 Infectious Disease: Market Trends Increased generic formulations with stagnant pipeline Generic levofloxacin Increased generic options for azithromycin, ciprofloxacin and amoxicillin/clavulanate Increased rifaximin utilization Generic entry of lamivudine in 2012 Cost savings opportunity in HIV regimens Anticipated generic moxifloxacin (2014) and ceftibuten (2014) not expected to impact market
12 Infectious Disease: Pipeline Trends Continued development of novel direct-acting oral antivirals for hepatitis C Protease inhibitors and polymerase inhibitors Movement toward all oral combination regimens utilizing 3-4 drug regimens Development of new integrase inhibitors for HIV New once-daily one-pill combination formulations for HIV
13 Infectious Disease: Hepatitis C Simeprevir (formerly TMC 435) Once-daily protease inhibitor weeks PILLAR-SVR=76-84% in treatment naïve genotype 1 Phase II underway with GS-7977 QD polymerase inhibitor and ribavirin 3 Phase III trials currently underway and combo w/ daclatasvir Fast-tracked by FDA July 2011 and global filings expected 1 st half 2013 Sofosbuvir (Formerly GS-7977 and PSI-7977) Once-daily polymerase inhibitor Phase II-88% undetectable in treatment naïve (interferon free) Prior null responders, 8/9 patients with undetectable VL relapsed (interferon free) Three interferon free phase III trials underway in genotype 1,2,3,4 NDA expected in second half 2013
14 Infectious Disease: Hepatitis C Faldaprevir (Formerly BI ) Once daily protease inhibitor weeks Phase II-Genotype I SILEN-C1=SVR ~84% in treatment naïve with SOC 48 weeks SILEN-C2=SVR~35%(null) + 50% (partial) with SOC 24 weeks SILEN-C3=SVR ~80% and 82% in treatment naïve with SOC (12 and 24 weeks) Phase III SOUND-C2 5-arm study with IFN free regimen with RBV and polymerase inhibitor-interim results--38%-68% SVR Fast-tracked April 2011 (SOC and INF-free) and launch expected 2014 Daclatasvir (Formerly BMS ) Once daily NS5A inhibitor given weeks with SOC Phase II SVR~83% in treatment naïve genotype 1 vs. 25% placebo Phase III-COMMAND-3 daclatasvir vs telaprevir (+ifn/rbv) Phase III in treatment naïve patients co-infected HIV
15 Infectious Disease: HIV Dolutegravir (GSK ) Oral, once-daily, unboosted, integrase inhibitor Continued activity in raltegravir-resistant strains (Q148) SPRING II 88% undectable VL vs. 85% with raltegrevir SINGLE 88% undectable VL vs. 81% with tenofovir/emtricitabine/efavirenz Combination product with abacavir/lamivudine (572-Trii) Filing expected end of 2012 GS-7340 Prodrug of tenofovir Higher potency and lower median effective concentration compared to tenofovir Dosed 10 times lower than tenofovir Intracellular concentrations ~4-33x greater but blood concentrations lower than tenofovir Combination product with darunavir, cobicistat, FTC HIV: human immunodeficiency virus
16 Generic Pipeline Central Nervous System (CNS): Product Name Anticipated Generic Entry 2011 US Sales (In millions) Duloxetine (Cymbalta ) 12/2013 $2.891 Aripiprazole (Abilify ) 4/2015 $4,077 Quetiapine (Seroquel XR ) 6/2016 $1,003 Accessed September 25, 2012
17 CNS: Market Trends Generic entry of olanzapine, quetiapine and ziprasidone expected to have large impact Despite availability brand use still increasing Aripiprazole largest cost driver New atypical antipsychotics aim to reduce unfavorable side effect Top Medications by market share 2011: Mental Health-Quetiapine, aripiprazole, donezepril, risperdone
18 CNS: Antipsychotics Loxapine (Adasuve Staccato ) Inhaled, typical antipsychotic Rapid treatment of agitation in patients with schizophrenia or bipolar disorder (onset~10 minutes) 08/2010 and 05/2012 FDA issued CRL Re-filing expected 12/2012 Bitopertin (Formerly RG1678) First in class glycine reuptake inhibitor (GRI) Adjunct for negative symptoms in schizophrenia and suboptimally controlled symptoms Phase III trials initiated in early 2011 Filing anticipated in 2014
19 CNS: Antipsychotics/Antidepressants Cariprazine (RGH-188) Atypical antipsychotic, D3/D2 antagonist for schizophrenia, bipolar II and MDD Low potency on 5-HTC2, H1, muscarinic, and adrenergic receptors Phase III-Significant improvement in symptoms in acute manic episodes vs. placebo Filing anticipated in 2012
20 Generic Pipeline: Pain Management Product Name Anticipated Generic Entry 2011 US Sales (In millions) Lidocaine (Lidoderm ) 11/2012 $1,125 Oxymorphone (Opana ER ) 1/2013 $405 Duloxetine (Cymbalta ) 12/2013 $3,434 Celcoxib (Celebrex ) 5/2014 $1,497 Accessed September 25, 2012
21 Pain Management: Market Trends US accounts for 80% of worldwide Rx opioid use Pain management products focus on abuse deterrence New products available-opana ER, Oxycontin Older formulations removed from market 2011 FDA requirement to reduce APAP content to 325 mg in combination products within 3 years Top Medications by market share 2011: Pain-Hydrocodone/APAP, oxycodone/apap, tramadol, amitriptyline, oxycodone
22 CNS: Pain Management Little in the development of new molecular entities Increase in reformulated pain products New Combinations New Controlled-Release Matrix New Routes of Administration Abuse Deterring Agents Strategy Up-armor, Gel, Antagonize, Punish
23 Pain Management New/Reformulations (Phase III-Preregistration) Tamper Resistance/Abuse Deterrence Oxycodone ER (Remoxy ) Oxycodone IR (Acurox ) Hydrocodone ER(CEP-33237) Extended/Immediate Release Hydrocodone (Zohydro SODAS ) Combinations Morphine/oxycodone (MoxDuo IR and CR)
24 Pain Management New Routes of Administration Fentanyl sublingual spray (Subsys ) Morphine nasal spray (Rylomine TM ) Cannabidiol/tetrahydocannabinol oral spray (Sativex ) Intranasal ketamine (Ereska TM ) Buprenorphine SC implant (Probuphine) Oral transmucosal buprenorphine BEMA Dihydroergotamine (Levadex) inhaler 26
25 Generic Pipeline: Respiratory Product Name Anticipated Generic Entry 2011 US Sales (In millions) Levalbuterol (Xopenex )* 8/2012 $415 Montelukast (Singulair ) 8/2012 $4,420 Sildenafil (Revatio ) 9/2012 $180 Mometasone (Nasonex ) 7/2014 $1,122 Ipratropium/Albuterol (Combivent ) * Not HFA formulation 12/2015 $889 Accessed September 25, 2012
26 Respiratory: Market Trends Community market expected to grow ~30% in next 3-4 years Inhaled steroids market driver New combination ICS/LABA inhalers Generic entry of leukotriene inhibitors Generic versions of current inhaled steroids and combination inhalers?????? 28
27 Respiratory: Pipeline Trends Strong pipeline for COPD compared to asthma New long-acting antimuscarinic agents (LAMA) and long-acting beta agonists (LABA) New combination inhalers with shift toward LAMA + LABA New inhaler devices security concerns Generic versions of current inhaled steroids?
28 Respiratory: Combination Products Class Agents Indication Long-acting muscarinic antagonist and Long-acting beta agonist GSK573719/Vilanterol Tiotropium/Olodaterol Glycopyrronium /Indacaterol Aclidinium /Formoterol COPD Long-acting beta agonist and inhaled steroid Fluticasone/Vilanterol COPD and Asthma
29 Respiratory Aclidinium (Tudorza Pressair ) Twice daily long-acting antimuscarinic agent for COPD Lower systemic exposure vs. tiotropium Combination formulation with formoterol in development NDA filed July 2011, FDA approved 7/2012 Glycopyrronium (Seebri ) Once daily long-acting antimuscarinic agent for COPD Development of combination formulation with indacaterol NDA filed in 2011, FDA response requesting additional clinical data
30 Respiratory Fluticasone/vilanterol (Breo ) Once daily LABA with inhaled steroid for COPD and asthma Phase III-Significant FEV1 improvement vs. placebo and fluticasone monotherapy, but not vilanterol monotherapy Large16,000 patient COPD study currently underway NDA filed 7/2012. Response expected 05/12/2013 Glycopyrronium/Indacaterol Once daily LAMA/LABA for COPD ILLUMINATE-phase III vs. salmeterol/fluticasone. Greater FEV1 after 12 hours SHINE-phase III vs. monotherapy tiotropium, glycopyrronium and indacaterol. Significantly greater FEV1 after 12 hours vs. monotherapies US filing anticipated end of 2014
31 Generic Pipeline: Diabetes Product Name Anticipated Generic Entry 2011 US Sales (In millions) Rosiglitazone (Avandia ) 3/2012 $286 Rosiglitazone/Metformin (Avandamet ) Rosiglitazone/Glimepiride (Avandaryl ) 3/2012 $161 3/2012 $35 Pioglitazone (Actos ) 8/2012 $2,830 Pioglitazone/glimepiride (Duetact ) Pioglitazone/metformin (Actos Met ) 12/2012 $31 12/2012 $426 Accessed September 25, 2012
32 Diabetes: Market Trends Top Traditional Drug Class in 2011 Highest per member/month spend ~10% of traditional market GLP-1 and DPP-4 inhibitors driving spending Metformin use still increasing Sharp decreases in TZD utilization Top Medications by market share: Metformin, Insulin glargine,pioglitazone, glipizide 34
33 Diabetes: GLP-1 Analogs Albiglutide (Syncria ) Once weekly GLP-1 analog Fuses human GLP-1 analog with human albumin Current recruitment evaluating usefulness in heart failure Dulaglutide Once weekly GLP-1 analog Phase III studies Dulaglutide vs. insulin glargine (6/2015) Dulaglutide vs once-daily liraglutide (6/2014) Filing expected 4 th quarter 2012 Lixisenatide (Lyxumia ) Once weekly GLP-1 analog Additional ~ HgbA1c when added on to metformin Filling anticipated in 4 th quarter 2012
34 Diabetes: Insulins Inhaled Insulin (Afrezza ) Inhaled insulin with ultra rapid acting onset (~10 minutes) Comparable HgbA1c reduction to insulin aspart and insulin lispro Two different inhaler devices utilized in clinical trials 1/2011 FDA 2 nd Complete Response Letter requesting 2 additional trials 8/2011 Design confirmed for requested trials results expected 2013 Degludec (Tresiba ) Ultra long-acting insulin (duration ~40 hours), Once daily or 3x weekly dosing Comparable HgbA1c reduction to insulin glargine with lower overall and nocturnal rates hypoglycemia Combination product with insulin aspart (Novolog ) NDA filed 9/2011. FDA advisory panel set for 11/8/2012
35 Diabetes: Sodium Glucose Co- Transporter 2 Inhibitors (SGLT2) Dapagliflozin (FORXIGA ) Once daily SGLT2 inhibitor indicated as add-on therapy Additional HgbA1c reduction -0.32% vs % SU add-on Weight loss ~3.7 kg after 24 months vs kg with SU add-on 07/2011-FDA panel concerns surrounding bladder and breast cancer risk 01/2012-CRL from FDA requesting benefit-risk assessment Canagliflozin Once daily SGLT2 inhibitor as add on HgbA1c reduction -0.93% vs % (glimepiride) as met add-on HgbA1c reduction of 0.65%-0.73% as add-on to insulin HgbA1c additional reduction -0.37% vs. sitagliptin as add-on to met/su NDA submitted 5/2012
36 Trends Middle of Patent Cliff Several blockbuster medications lost patent protection ~Estimate $30 Billion 2012 Significant new molecule developments in cardiovascular, hepatitis C, and central nervous system Stagnant oral antibiotic pipeline Strong COPD pipeline Reformulations of existing molecules for pain management to be more tamper resistant
37 Questions Erik Hamel, Pharm.D, BCPS 333 South St Shrewsbury MA Tel # [email protected]
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