Winter 2013 Changing landscapes, pipeline products and plan sponsor impact
Changing landscapes, pipeline products and plan sponsor impact The pharmaceutical landscape is changing as is the profile of blockbuster drugs (i.e. global sales totalling $1 billion dollars or more). Blockbuster drugs historically impacting millions of chronic disease sufferers are remnants of the past, with the future forecasted profile of blockbuster drugs set to come to market teeming with novel therapies aimed at the specialty disease market and its niche a smaller patient population but higher associated price tag. The shift in research and development towards specialized indications, with minimal generic exposure due to a paucity of treatment alternatives, comes hand in hand with another trend: oral medications for diseases previously dominated by treatments requiring injections or infusions. Examples include the approval of the first oral multiple sclerosis drug, Gilenya, in 2011, and the approval of four new oral cancer medications in 2012 alone (Inlyta, Xalkori, Zelboraf and Jakavi). This trend is expected to blossom in the near future and is of importance to plan sponsors with the greying of the line between the public payer and the plan sponsor as to who is responsible for paying. A larger proportion of expenditure for disease treatments once solely encompassed under the public provincial payer umbrella is expected to fall to the plan sponsor. There will also be the inevitable impact of expensive game changers for the rare, but costly speciality disease classes. In continuation with the Spring 2012 issue of Perspective, we present some noteworthy pipeline products. Drug Chemical Name Manufacturer Pipeline Phase Approval Timeline Mechanism of Action Disease Area Commentary Anticipated Impact Based on Disease Class BG 12 Dimethyl Fumarate Biogen Idec Currently under review by the US Food and Drugs Administration (FDA) and European Medicines Agency (EMA). Novel mechanism of action: Nuclear factor E2 related factor 2 (Nrf2) modulator Decreases oxidative stress and inflammatory response Relapsing Remitting Multiple Sclerosis New oral MS drug with promising phase III efficacy and impressive tolerability compared to currently approved therapies. Forecasted to reach blockbuster status due to its favourable efficacy and safety profile in a disease area characterized by treatment with frequent injections of interferons (Avonex, Betaseron, Extavia, Rebif). Although Multiple Sclerosis is considered a rare disease, MS medications accounted for 2.4% of DIN cost paid on the TELUS book of business (2011). The average annual cost of injectable MS medications ranges from $16 000 to $24 000 per patient. Gilenya, the first new oral MS drug launched with an annual price of $37 803.12 per patient and captured 3% of total MS expenditure across the 2011 TELUS book of business. The forecasted potential global spend for BG-12 is $3 billion i Perspective Winter 2013 2
Sofosbuvir Gilead Sciences Inc. Submission for U.S. regulatory approval expected in 2014. Nucleoside Analague Polymerase Inhibitor Antiviral Agent Hepatitis C Conventional therapy for hepatitis C requires a combination of injectable peginterferons (Pegetron, Pegasys) and Ribivirin, an oral antiviral product for as long as 48 weeks. Newer oral agents, Victrelis and Incivek, are approved as ADD ON therapies to the above regimen. Sofosbuvir is the first oral product showing noteworthy efficacy in clinical trials without the co administration of interferons. It presents a rare blockbuster opportunity due to its potential to dramatically improve Hepatitis C therapy. Although Hepatitis C is not a prevalent disease (2007 Canadian estimate: 0.8% ii ), the average cost of currently available Hepatitis C therapies ranges from $22,000 to $50,000 per patient per treatment course. Incivek and Victrelis, the first new oral ADD ON agents for Hepatitis C, launched with a price ranging from $36,000 to $50,000 per treatment course, depending on course duration. The forecasted potential global spend on Sofosbuvir is $3.8 billion. i Apremilast Celegene Corp. Submission for U.S. and European regulatory approval expected in early 2013. Phosphodiesterase 4 inhibitor New mechanism of action for targeting autoimmune and inflammatory diseases. Inflammation: Psoriatic Arthritis (PsA) and Plaque Psoriasis Apremilast is an oral molecule showing notable efficacy for Psoriatic Arthritis (PsA) and Plaque Psoriasis in phase III trials. Management of these diseases is currently dominated by the injectable biologics category (e.g. Enbrel, Humira, Stelara and Remicade). May be one of the first new oral disease modifying agents for PsA and Psoriasis to be marketed in over 10 years. Biologic agents accounted for 17%*of expenditure across the TELUS book of business for 2011 by DIN COST PAID. The cost of biologics for PsA and psoriasis ranges from $20,000 to $30,000 per patient per year. Potential forecasted revenue is $685 million in 2020. iii Fostamatinib AstraZeneca results expected to be released in early 2013 with subsequent submission to regulatory agencies. Spleen tyrosine kinase (syk) inhibitor Blocks cell signaling associated with tissue inflammation and breakdown in Rheumatoid Arthritis Inflammation: Rheumatoid Arthritis (RA) Fostamatinib will likely be the second oral molecule targeting the inflammatory pathway involved in RA. The cost of biologics for RA ranges from $15,000 to $27,000 per patient per year. Forecasted sales of $330 million in 2018. iv * Biological Products as defined by Health Canada National Drug Schedule D Perspective Winter 2013 3
We continue to advise carriers to keep an eye out for noteworthy products first introduced in the Spring 2012 Perspective: XELJANZ (Tofacitinib), the first new oral anti-inflammatory drug for Rheumatoid Arthritis in over a decade, which recently received FDA approval and Dapagliflozin, a first-in-class medication (still under FDA review) targeting a novel pathway to reduce blood sugar levels in diabetic patients. Plan sponsor impact The influx of high-cost specialty drugs, with potential for further cost shifting to the plan sponsor as payer due to the availability of oral formulations, necessitates consideration of strategies to minimize the anticipated impact on plan sponsors. TELUS Health currently offers several drug plan management approaches such as the Enhanced Biologics Formulary and Prior Authorization Program and proactively looks to develop new programs to suit the needs of carriers in light of the changing pharmaceutical landscape. Shazia Syed ACPR BSc.Phm, Pharmacist, Pharmacy Services References i McBride, R and Caroll John. Fierce Biotech 15 top blockbuster contenders October 2012. http://www.fiercebiotech.com/special-reports/top-15-blockbuster-contenders/quad-top-15-blockbuster-contenders ii Public Health Agency of Canada. Hepatitis C in Canada: 2005-2010 Surveillance Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada; 2011. http://www.catie.ca/sites/default/files/1109-0139-hep%20c%20report-en%20final.pdf iii Berstein: Another De-Risking - Apremilast Meets Endpoints; Now Targeting a $1.5bn Market, November 2012. http://www.investorvillage.com/ smbd.asp?mb=341&mn=173312&pt=msg&mid=12302716 iv Decision Resources Updated Rheumatoid Arthritis Report Now Includes Forecast for Rigel Pharmaceuticals Fostamatinib Disodium. http://www.prnewswire.com/news-releases/decision-resourcesupdated-rheumatoid-arthritis-report-now-includes-forecast-for-rigel-pharmaceuticals-fostamatinib-disodium-62170922.html Perspective Winter 2013 4
Information for life TELUS Health is a leader in telehomecare, electronic medical and health records, consumer health, benefits management and pharmacy management. TELUS Health give health authorities, providers, physicians, patients and consumers the power to turn information into better health outcomes. For more information about TELUS Health, please visit telushealth.com. This article printed as part of Perspective - Winter 2013 issue. TELUS 2014. All rights reserved. Printed in Canada.