drugs in development CuraScript Specialty Pharmacy Management Guide & Trend Report

Transcription

1 CuraScript Specialty Pharmacy Management Guide & Trend Report

2 Drugs in Development There are currently more than 324 drugs in development for nearly 150 disease states. These potential new medications and indicated uses, all of which are currently in clinical trials, will continue to expand the list of available specialty drugs and the approved indicated uses of those already available on the market (Exhibit 21). Exhibit 21 Specialty Pipeline ROUTE OF BRAND GENERIC COMPANY PROPOSED USE APPROVAL ADMINISTRATION abatacept (CTLA4-Ig) Bristol-Myers Squibb (BMS) Rheumatoid arthritis (RA) 2005 IV Myozyme alglucosidase alpha Genzyme Pompe disease 2005 IV Xinlay atrasentan Abbott Prostate cancer 2005 oral Vaprisol conivaptan Yamanouchi Hyponatremia 2005 IV Pulminiq cyclosporine, inhalation Chiron Allogeneic lung transplant 2005 inhalation Dacogen decitabine Supergen Myelodysplastic syndrome (MDS) 2005 IV Aryplase galsulfase BioMarin Mucopolysaccaridosis (MPS) VI 2005 IV lapatinib GlaxoSmithKline Breast cancer 2005 oral Revlimid lenalidomide Celgene MDS / multiple myeloma 2005 oral SomatoKine mecasermin rinfabate Insmed Growth hormone insensitivity syndrome 2005 SQ Revatio sildenafil Pfizer Pulmonary arterial hypertension (PAH) 2005 oral Zarnestra tipifarnib Ortho Biotech Acute leukemias and RAS-dependent tumors 2005 oral ambrisentan Abbott/Myogen PAH 2006 oral Provenge APC8015 Dendreon Prostate cancer 2006 IV iduronate-2-sulfatase Transkaryotic Therapies MPS II 2006 IV Advexin INGN-201 Introgen Advanced squamous cell carcinom a of the head/neck 2006 IV ixabepilone BMS Breast cancer 2006 IV Cerovive NYX-059 AstraZeneca/ Renovis Acute stroke 2006 IV panitumumab (ABX-EGF) Amgen/Abgenix Metastatic colorectal cancer 2006 IV Xyotax paclitaxel poliglumex Cell Therapeutics/ Chugai Non-small cell lung cancer 2006 IV Preos parathyroid hormone NPS Osteoporosis 2006 SQ Thelin sitaxsentan Encysive PAH 2006 oral sorafenib (BAY ) Bayer/Onyx Renal cell carcinoma 2006 oral Sutent SU Pfizer Renal cell carcinoma and gastrointestinal stromal tumors (GIST) 2006 oral Telcyta TLK-286 Telik Ovarian and lung cancer 2006 IV AMG-162 Amgen Osteoporosis 2007 SQ LymphoStat-B belimumab CAB/HGS Lupus and RA 2007 IV CDP-870 UCB Pharma RA and Crohn s 2007 SQ LymphoCide epratuzumab Immunomedics Lupus 2007 IV phenoxodiol Novogen Prostate cancer 2007 oral Lucentis ranibizumab Genentech/ Novartis Wet age-related macular degeneration 2007 eye injection vatalanib (PTK-787) Novartis/Schering AG Metastatic colorectal cancer 2007 oral Riquent abetimus La Jolla Lupus 2008 IV AMG-531 Amgen Idiopathic thrombocytopenia purpura (ITP) 2008 IV / SQ apolipoprotein (ETC-216) Pfizer/Esperion Prevention of restenosis, angina and coronary atherosclerosis 2008 IV Mylinax cladribine Ivax/Serono Multiple sclerosis (MS) 2008 oral ICA Icagen/J&J Sickle cell anemia 2008 oral MDX-010 Medarex/BMS Malignant melanoma 2008 IV MEDI-493 MedImmune Respiratory syncytial virus (RSV) in transplant patients 2008 IM laquinimod Active Biotech/Teva MS 2009 oral BMS BMS Chronic myelogenous leukemia (CML) resistant to Gleevec 2010 oral CP Pfizer/Abgenix Advanced solid tumors 2010 IV drugs in development IV = Intravenous SQ = Subcutaneous IM = Intramuscular 41

3 ANTINEOPLASTICS Cancer-drug research has become a leading focus for several pharmaceutical and biotechnology companies. Many new compounds are in development, including some that could alter the course of the disease significantly. In the near future, cancer may be regarded as a chronic disease, much like RA. Like other chronic conditions, certain cancers may soon be kept at bay for years by regular treatments with chemotherapy or biologic agents. In addition, factors such as limited generic exposure and relative ease of reimbursement from plan sponsors make antineoplastics one of the few classes that promise long-term financial viability for the pharmaceutical industry. New drugs are likely to be available in the next few years for several cancers, such as renal cell carcinoma, glioblastoma and non-small cell lung cancer, which currently have limited treatment options. The oncology field contains some of the most promising drugs in the pipeline, with potential treatments for many different kinds of cancer in various stages of development (Exhibits 22 and 23). With new drugs come higher costs, however. As evident in 2004, even a small marketshare for a new product can have a noticeable impact on overall trend in this class. Exhibit 22 Antineoplastics Patent Expirations 42 CuraScript specialty pharmacy management guide & trend report 2004

4 Exhibit 23 Antineoplastics Pipeline drugs in development ROUTE OF ADMINISTRATION A review of the route of administration for drugs in development reveals an important trend that clients may want to monitor. There appears to be a significant number of both oral and intravenous drugs in the drug pipeline. Exhibit 24 shows the breakdown of oral and injectable drugs for the top six therapy classes. Injectable drugs are then further broken down by intravenous, subcutaneous and intramuscular. 43

5 Exhibit 24 Routes of Administration for Specialty Drugs in Development Generally, intravenous and intramuscular injectables require a healthcare provider s assistance to administer, which has implications for delivery settings, cost trend and benefit design. This contrasts to today, where many specialty drugs, with the exception of oncology, can be self-administered and are increasingly covered under the prescription-drug benefit. Many of the orals in development may replace some injectable products, which can result in a shift from being rendered under the medical benefit in a physician s office to the pharmacy benefit and thereby subject to prescription-drug copayments. A recent example of a change in route of administration that impacted both delivery setting and benefit design was the launch of Tysabri for MS. Before its removal from the market, Tysabri had begun to impact clients. For plan sponsors covering self-administered medications through their prescription-drug benefit, the majority of the MS drugs were being provided under the prescription-drug benefit. But Tysabri required administration by a healthcare professional, which for most clients meant it was covered under the medical benefit. 44 CuraScript specialty pharmacy management guide & trend report 2004