INDUSTRY OUTLOOK SPECIALTY DRUG REPORT
INDUSTRY OUTLOOK FOR SPECIALTY DRUGS: Specialty drugs are classified in the specialty category when they require special handling, specific administration techniques and/or present side effects that may be difficult for patients to manage. NOVEL DRUG APPROVALS 5 50 40 30 20 U.S. DRUG APPROVAL HITS 21 YEAR HIGH IN 2017 WITH 47 NOVEL MEDS 5 OVER 700 NEW SPECIALTY DRUGS ARE IN DEVELOPMENT ₁ SPECIALTY DRUG PRICES ARE EXPECTED TO INCREASE BY APPROXIMATELY 22% EACH OF THE NEXT 3 YEARS ₄ 10 0 2013 2014 2015 2016 2017 ON AVERAGE THE FDA ONLY APPROVED 25 NEW DRUGS PER YEAR FROM 2005-2013... OVER 40 NEW DRUGS WERE APPROVED PER YEAR IN 2014 AND 2015 2 FDA APPROVAL HIGHLIGHTS POTENTIALLY LIFE LONG MEDICATIONS Multiple Sclerosis Psoriasis High Cholesterol Glatopa (biosimilar to Copaxone) Cosentyx Praulent, Repatha (PCSK9) $2,400 - $4,500 / Prescription 3 $15,000 / Prescription 3 $1,100 - $2,200 / Prescription 3 ** Cost of these drugs may vary depending on pharmacy, strength prescribed and other factors. PCSK9 PRESCRIPTIONS TO CONTROL HIGH CHOLESTEROL COULD COST U.S. HEALTH CARE CONSUMERS AND HEALTH PLANS OVER $1.5 BILLION / YEAR ₁ Sources: 1. Medical Cost Trend: Behind the Numbers 2016; June 2015 Health Research Institute; PWC http://www.pwc.com/us/en/health-industries/behind-the-numbers/high-cost-drug.html 2. Specialty Drug Approvals: 2015 Highlights + 2016 Projections; Diplomat Clinical Services 3. www.goodrx.com 4. http://lab.express-scripts.com/lab/insights/specialty-medications/specialty-medications-in-development 5. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm
HIGHLIGHTS OF WHAT is COMING MORE SPECIALTY AND BIOSIMILAR DRUGS EXPECTED BIOSIMILARS ARE NOT THE SAME AS A TRADITIONAL GENERIC MEDICATION. THESE DRUGS, IN FACT, ARE EXPECTED TO BE PRICED AT 70-90% OF THE COST OF THE ORIGINAL INNOVATOR PRODUCT. ENBREL S BIOSIMILAR IS EXPECTED TO BE APPROVED IN 2016. A NEW PSORIASIS DRUG, Ixekizumab, is expected to generate $600m in revenue in the U.S. by 2020 1 2017 2018 2019 2020 PRICE INCREASES FOR EXISTING SPECIALTY DRUGS 3 New drugs are only a part of the reason behind soaring drug prices. News in the industry reports frequent increases in price for drugs currently on the market. SINCE DECEMBER 2014 the prices for 60 drugs more than doubled and another 20 quadrupled. 4 28% 30% 26% Enbrel 3 HIKES FOR A TOTAL OF 28% INCREASE BETWEEN 11/2014 AND 12/2015 Humira 2 HIKES FOR A TOTAL OF 30% INCREASE BETWEEN 11/2014 AND 1/2016 Xeljanz 2 HIKES FOR A TOTAL OF 26% INCREASE BETWEEN 1/2015 AND 1/2016 Sources: 1. http://www.businessfinancenews.com/26099-eli-lilly-and-co-drug-ixekizumab-shows-improvement-in-phase-iii-study/ published by Camilla Pritchard November 9, 2015 2. The Cost Savings Potential of Biosimilar Drugs in the United States. By Andrew W. Mulcahy, Zachary Predmore and Soren Mattke. https://www.rand.org/content/dam/rand/pubs/perspectives/pe100/pe127/rand_pe127.pdf 3. Medispan 4. Shkreli was right: everyone s Hiking Drug Prices by Robert Langreth and Rebeca Spalding. Bloomberg.com 2016/02/02
CONCERNS ABOUT INDUSTRY TRENDS AND THE STATUS QUO CONCERNS ABOUT INDUSTRY TRENDS AND THE STATUS QUO THE TREND OF RISING PHARMACEUTICAL COSTS WILL CONTINUE, driven by expensive specialty drugs CONFLICTS OF INTEREST ABOUND since Pharmacy Benefit Management companies have financial ties to pharmaceutical manufacturers and many own their own specialty drug pharmacies PRESCRIBING PHYSICIANS CAN BE INFLUENCED by pharmaceutical representatives and rarely have current information regarding the cost of drugs to the member and/or the plan MEMBERS CAN BE INFLUENCED by specialty drug advertising (television, magazines & social media), creating demand for high cost drugs with no knowledge of their cost or less expensive alternatives IS THERE A SOLUTION? YES. IT STARTS WITH FINDING A PARTNER YOU CAN TRUST Partnering with an unbiased vendor who is able to perform additional research on outcomes and manage the administration of specialty drugs continues to be the most cost effective way to mitigate specialty drug risk. For example, RxResults features a joint-collaborative with the University of Arkansas for Medical Sciences Evidence-Based Medicine Center and is led by an independent team of pharmacists, physicians and benefit industry experts. HAVING AN UNBIASED THIRD PARTY PARTNER, SEPARATE FROM YOUR PBM, IS THE ONLY WAY TO ENSURE THE DOLLARS YOU SPEND ON SPECIALTY DRUGS ARE SPENT WITH A WELL THOUGHT OUT PLAN, IMPLEMENTED BY A CLINICAL TEAM WITH ACCESS TO THE MOST UP-TO-DATE PEER REVIEWED, CLINICALLY RELEVANT RESEARCH. The key to managing the costs of these extremely expensive drugs is to proactively make sure the right members meeting the right clinical criteria get the right drugs at the right time in order to achieve the best clinical outcomes. * Many prior authorization requests are withdrawn by the prescriber after being provided educational / clinical information such that the prescriber voluntarily changes the patient s prescription without seeking further approval of the original drug. RxResults PRIOR AUTHORIZATION METRICS APPROVALS DENIALS WITHDRAWALS*
CONTROLLING SPECIALTY DRUG SPEND ACTUAL EXPERIENCE FOR AN RxResults CLIENT WITH APPROXIMATELY 40,000 MEMBER LIVES USING THE SPECIALTY DRUG MANAGEMENT PRODUCT RESULTED IN OVER $790,000 IN COST AVOIDANCE. Drug Requested Common Condition Denial Reason # Denial Avg Cost/Year HUMIRA Rheumatoid Arthritis Did not meet clinical criteria 1 $ 41,370 ENBREL Rheumatoid Arthritis Alternative Medication Recommended 1 $ 41,314 COSENTYX Psoriasis Lack of Information from Prescriber 1 $ 39,687 BOTOX Many Conditions Alternative Medication Recommended 2 $ 30,939 OTEZLA Psoriasis Alternative Medication Recommended 1 $ 26,060 FORTEO Osteoporosis Lack of Information from Prescriber 1 $ 23,244 SYNVISC Osteoarthritis Alternative Medication Recommended 2 $ 18,029 XOLAIR Asthma Inappropriate Diagnosis 1 $ 11,274 MONOVISC Osteoarthritis Not Appropriate for Diagnosis 1 $ 10,901 AVITA Acne Diagnosis/Age 1 $ 1,608 HARVONI * Hepatitis C Stage 1 Disease, did not meet clinical criteria 2 $ 189,814 ZYTIGA * Prostate Cancer Alternative Medication Recommended 2 $ 188,766 SOVALDI * Hepatitis C Stage 1 Disease, did not meet clinical criteria 1 $ 84,372 VIEKIRA * Hepatitis C Stage 1 Disease, did not meet clinical criteria 1 $ 82,915 * Some drugs may not be required on an on-going basis. In that case the full course of therapy costs are represented. 18 $790,291 www.rxresults.com 501.367.8402 320 Executive Court, Suite 201 Little Rock, AR 72205