Tracking tough questions- does bigger mean better? How will pharmacies compete in the future? And what do the key trends mean for you?

 want our readers to be prepared for the future of our business and profession. So who has the proverbial crystal ball? In this month’s publication, Bill Martin discusses the “Eight Mega Trends Shaping the Future of Specialty Pharmacy.”

	I’d add a 9th trend—the potential of the “Mega Specialty Pharmacy.” The Mega Bombshell in the specialty space is the potential of 2 giants coming together with the announced merger of Medco and Express Scripts. Both of these PBMs own vertically integrated, well-established specialty pharmacies&mdash;Accredo and Curascript, respectively. The potential combination of these 2 businesses has received the attention of a consortium of specialty operators through the Independent Specialty Pharmacy Coalition (ISPC), as well as pharmacy associations. Time and the FTC will decide the outcome of this deal, but clearly a new playing field may emerge&mdash;if this merger is approved.

	So with the advent of the Mega Specialty Pharmacy, some folks may ask the follow questions: 

How will pharmacies compete in the future? Does bigger mean “better”? Who determines what is “better”? Is it “better patient outcomes” or “better price”?

	I’ll venture a 10th trend, which may very well be the growing standard of accreditation in specialty pharmacy. In the specialty pharmacy world, we have many definitions that are generally acceptable, but few established standards, either as determined by the payers, patients, providers, or boards of pharmacy, around specialty. Four of the most commonly seen specialty pharmacy accreditation programs are from Accreditation Commission for Health Care (ACHC; www.achc.org), URAC (www.urac. org), The Joint Commission (TJC; www.jointcommission.org), and Community Health Accreditation Program (CHAP; www.chapinc.org). URAC accreditation appears to be the front runner and is often mentioned in RFPs from network providers and manufacturers seeking specialty pharmacy services.

	With accreditation, the playing field of specialty gets leveled—“

” now has metrics that are more generally accepted in the marketplace. Standards get established and specialty pharmacies can establish points of performance that potentially separate them from one another. These become negotiating points, and clusters of specialty pharmacies can be developed with “

”—driving access to products and managed care plans.

	If you are thinking of jumping into specialty pharmacy, you will need to consider making the investment up front with accreditation. Find the right areas of alignment and your competition down the street may end up being your best partner through collaborative practice. In today’s virtual world, systems can build business bridges without bricks and mortar. Think “outside of the box” and that box may be the 4 walls of your new pharmacy.

	We welcome your feedback on this topic and on any topics you would like us to cover in future editions of 

. We also encourage you and your colleagues to subscribe to this unique journal by logging on to 

. Also, watch for us on iPad, coming soon! 

Mr. Steiber is a principal of D2 Pharma Consulting LLC (d2rx. com) and is responsible for commercial operations, trade-supply chain strategy development including 3PL selection, regulatory oversight, and “operationlizing”organizations. Mr. Steiber has served in several senior positions in pharmacy, distribution, and industry over the course of his 35-year career. 

Mr. Steiber is a licensed pharmacist in Texas, Washington, California, and Pennsylvania. He is affiliated with several professional associations and publications and is a frequent speaker on behalf of many professional organizations. Mr. Steiber graduated from Washington State University College of Pharmacy. He has participated in a variety of postgraduate programs in law and business development/ marketing at Harvard University and Northwestern University. Mr. Steiber currently resides in Plano, Texas, with his wife and 2 sons. With accreditation, the playing field of specialty gets leveled.

Articles

Editorial

Are We Ready for Tomorrow?

New rules related to Health Insurance Exchanges as part of the health care reform law are examined, as they signal the potential for a dramatic shift in the insurance market.

	On July 11, 2011, the US Department of Health and Human Services (HHS) published 2 Proposed Rules related to Health Insurance Exchanges that were established under the Affordable Care Act (ACA). The first proposed rule, the Exchange Rule, describes the federal requirements that states must meet if they elect to establish and operate an Insurance Exchange.

 This rule outlines the minimum requirements that health insurance issuers must meet in order to participate in an Insurance Exchange and also details the basic standards that employers must meet to participate in the Small Business Health Options Program (SHOP).

	The second proposed rule addresses standards related to reinsurance, risk corridors, and risk adjustment to assure stability in these newly established markets.

 These policies are designed to stabilize premiums and mitigate potential adverse selection in the individual and small group markets as insurance reforms and Insurance Exchanges are implemented, starting in 2014. These proposed rules are just 2 in a series of proposed rules and other guidance documents that have been issued by HHS. Further guidance documents are expected.

	Taken together, the proposed rules signal the potential for a dramatic shift in the insurance market. With as many as 24 million Americans expected to enroll in the new Insurance Exchanges by 2019, the impact on the specialty pharmacy community could be immense—both in terms of the number of patients served and the new regulatory requirements under which insurers will be operating.

	By way of background, the ACA requires the creation of Insurance Exchanges in all states by January 1, 2014. States have the option to decide not to operate an exchange at all, in which case the federal government will assume this role. These exchanges are intended to facilitate the purchasing of insurance by individuals and small employers, and eventually, large employers.

	Although all legal residents are eligible to purchase insurance through these exchanges, the ACA dictates that individuals with incomes between 138% and 400% of the Federal Poverty Level will be eligible to receive federal subsidies, in the form of tax credits, for the purchase of health insurance through these exchanges. It is expected that these subsidies, increased purchasing flexibility via the creation of exchanges, and the inclusion of an individual requirement to purchase health insurance in the legislation will lead to increased insurance coverage among Americans.

	By and large, the 2 proposed rules signal an increased anxiety by HHS to avoid setting up a Federal Exchange.By allowing states and the federal government to share some duties involved in the administration of the exchanges (“shared business functions eligibility and enrollment,” including “financial management” and “health plan management systems and services”), the federal government is hoping to avoid having to set up and manage Federal Exchanges in countless numbers of states due to what the states perceive as unduly burdensome requirements. As such, the proposed rules also allow for “conditional approval” as an alternative to full approval, allowing a state to move forward with the implementation of a state exchange, even if it is not ready for certification in 2013.

	For specialty, the most dramatic change in the insurance market will likely come from a new requirement imposed on PBMs that participate in exchanges to confidentially disclose information on their pricing mechanisms and savings rate. This controversial provision, which has pitted community pharmacists against representatives of the PBM industry,

 establishes federal disclosure and reporting standards for health plans and entities participating in the exchanges that provide pharmacy benefit management services.

	According to the proposed rule, plans operating in the exchange will be required to report, among other measures, the aggregate amount of types of rebates, discounts, or price concessions that are attributable to patient utilization under the health plan and the aggregate amount of rebates, discounts, or concessions passed through the health plan issuer, and the number of prescriptions dispensed. The proposed rule also requires reporting by the health plan on the aggregate difference between the amount the health plan pays its PBM and the amount the PBM pays retail and mail order pharmacies. HHS anticipates providing additional guidance on the reporting requirements, and seeks comments in the proposed rule on how a health plan whose contracted PBM operates its own mail order pharmacy can meaningfully report on the aggregate differences.

	Will these new reporting requirements on PBMs signal a shift in market power for specialty pharmacies? Will states, based on the new flexibility provided in the proposed rule, move forward in establishing exchanges or will the federal government end up carrying a large burden? Most importantly, as the Congressional Budget Office predicts, will millions of American move into exchanges over the next 5 to 10 years, and what does this mean for specialty pharmacies? No matter the answer, as the regulations roll out over the next several years, specialty pharmacies should expect to see major changes in the marketplace. SPT 

www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17610.pdf

www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17609.pdf

	3. For the National Community Pharmacists Association’s response to the Exchange regulations see: 

http://ncpanet.org/index.php/news-releases/1038-ncpa-commends-inclusion-of-pbm-transparency-provision-in-proposed-rule-for-health-insurance-exchanges

	4. For the response of the Pharmaceutical Care Management Association to the original request for comments on the Exchanges see: 

www.regulations.gov/#!documentDetail;D=HHS-OS-2010-0021-0275

Ross Margulies is a health policy specialist at Foley Hoag LLP with expertise in federal and state health law and policy issues including Medicare and Medicaid, community health, and the impact of health care reform. 

Jayson Slotnik focuses on health policy at Health Policy Strategies LLC. He was formerly the director of medicare reimbursement and economic policy at the Biotechnology Industry Organization in Washington, DC. He is on the Specialty Pharmacy Times Editorial Board. 

Washington Insights

Health Insurance Exchanges: A Boom or a Bust for Specialty Pharmacy?

The debate about who should pay for specialty pharmacy nursing services continues as risks mount without adequate nursing in the infusion/ injection patient experience.

	There continues to be much debate regarding who should pay for specialty pharmacy nursing services. Most manufacturers consider it to be the responsibility of the specialty pharmacy and believe that they will be reimbursed by the patient’s insurance provider. However, that is only partially true. Even if a patient does have a nursing benefit that is covered under their insurance plan, the payment structure for nursing services tends to be only a fraction of the cost of what a specialty pharmacy will have to pay a highly skilled infusion nurse.

	As a result of a poor reimbursement structure, patients could typically receive inadequate nursing care that can lead to an unsatisfactory infusion/injection experience. The risks associated with inadequate nursing care can include some or all of the following:

	• Missed doses due to a nurse not being able to obtain venous access.

	• Wasted drug due to a nurse not being familiar with the proper technique for mixing and administering the drug.

	• Decline in referrals from physician to specialty pharmacy.

	• Increases in the cost of drugs and supplies due to misuse.

	Traditionally, when a specialty pharmacy (SP) has to incur the cost of nursing as an operational expense, they will look to contract with a nurse or a nursing agency that provides the highest level of care at the best available fee. The SP is relying on the nurse/agency to provide the highest level of care but cannot be guaranteed it meets the need of the patient with this specialty drug. Home health care agencies do not usually have high-tech nurses on their staff due to the higher cost of salary for this level of nursing. The agencies that do provide high-tech nursing usually have higher visit fees.

	Some manufacturers have decided to contract out the nursing directly. This way they are covering the higher cost of nursing services to insure patients are receiving quality care and that these patients are not missing the therapies necessary for their health. By contracting for nursing costs directly the manufacturers can also contract directly with limited nursing providers who have the highly skilled nurses on staff and maintain better control and oversight of the nursing services patients are receiving. The result of this type of model may significantly improve the level of patient care while also significantly increasing compliance and adherence.

	The manufacturer not only provides these nurses with the educational tools necessary to properly administer the therapy, they also are offering the opportunity for the highly skilled nurses to grow in an area of expertise. These nurses are very eager and excited to be a part of a specialty therapy, but they have not been recognized for their level of expertise monetarily within the traditional home care reimbursement model.

	Until the payers start to acknowledge the high level of skill required in the home setting to administer these specialty therapies, these highly skilled infusion nurses will not be utilized by the home health care agencies in the home setting. This has proved to be detrimental to the health of patients and may also result in a delay in the start of therapy or even a discontinuation of therapy. SPT

Ms. Gregory, RN, BSN, is founder and president of the Specialty Pharmacy Nursing Network (SPNN). She has more than 30 years of experience as an oncology/infusion nurse and combines her clinical knowledge with an entrepreneurial spirit. SPNN is one of the first specialty pharmacy nursing services to provide a nationwide network of 500 qualified nurses to meet the needs of specialty pharmacies and biotech manufacturers. The organization’s services include coordination of care, drug administration, first dosing, education, clinical outcome data collection and reporting, and on-call coverage for specialty therapies. Visit 

Specialty Pharmacy Nursing

The Payer Dilemma 

The autoimmune diseases represent a growing therapeutic catagory in specialty pharmacy, as the pipeline for biologics that treat inflammatory conditions remains strong. 

	Inflammatory conditions, sometimes referred to as autoimmune diseases, represent a growing therapeutic category in specialty pharmacy. Prior to 2010, there were biologic therapies available to treat rheumatoid arthritis (RA), anklyosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriasis, and psoriatic arthritis.

	With the recent approval of 2 new molecular entities (Savient Pharmaceuticals’ Krystexxa and GlaxoSmithKline’s Benlysta), gout and lupus can now be added to the list of inflammatory conditions that are treated with a biologic therapy approved by the FDA. In addition to the expanding list of autoimmune diseases that are treated with a biologic, the pipeline for biologics that treat inflammatory conditions currently being investigated in Phase III remains strong.

 is an infusion of adult human mesenchymal stem cells from healthy volunteer donors. The cells do not require any donor—recipient matching and may have both immunosuppressive and healing benefits in CD. The cells appear to migrate specifically to sites of inflammation, so the effects are believed to be local and self limiting rather than systemic. Phase III trials are currently active to evaluate whether or not the adult human mesenchymal stem cells can induce remission in patients with moderate to severe CD.

	Patients in the active comparator arms are receiving either the low-dose protocol, the high-dose protocol, or placebo. Those in the low-dose arm are receiving 600 million cells total over 4 infusions given in 2 weeks and those in the high-dose arm are receiving 1200 million cells total delivered in 4 infusions over 2 weeks. Osiris Therapeutics estimates that the primary completion date of the study will be December 2011.

is an anti-47 Integrin therapeutic antibody currently in Phase III testing for both CD and UC. Millennium and its parent company Takeda are calling the Phase III program GEMINI and plan to enroll nearly 2000 patients. GEMINI-I consists of a placebo-controlled induction and maintenance study in patients with UC which is expected to be complete April 2012; GEMINI-II and GEMINI-III are placebo-controlled induction and maintenance studies in patients with CD expected to collect the final data in July 2012; and GEMINI LTS, an open label long-term safety study in patients with either UC or CD, is expected to be complete in December 2016. Vedolizumab is given as an intravenous (IV) infusion at weeks 0, 2, 6, and then at 4- or 8-week intervals.

(formerly CCX282-B) targets chemokine receptor CCR9, which is expressed selectively on intestinal lymphocytes and dendritic cells. CCR9 mediates migration of immune cells to the intestine, and blockade of the receptor inhibits migration. GSK1605786A is being studied in CD at a dose of 500 mg by mouth once daily or 500 mg by mouth twice daily versus placebo. Final data is anticipated to be collected mid-2012 for a study evaluating efficacy over a 12-week treatment period. A study reviewing maintenance of remission is expected to be complete in July 2014 and a long-term safety study is scheduled for completion in July 2015.

(abatacept), already approved in the United States for RA and juvenile idiopathic arthritis, has gone through Phase III trials to evaluate its use in UC. 

 (ustekinumab), already approved in the United States for moderate to severe plaque psoriasis, is being investigated for use in CD. 

(golimumab), approved in the United States for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylits, is being researched for its use in ulcerative colitis. 

(adalimumab) is approved in the United States for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, CD, and plaque psoriasis; it was announced in May 2011 that Abbott met the primary end point for the Phase III UC study and filed an application with the FDA for the additional UC indication.

, also known as Lupuzor or CEP-33457, is a CD4 T-cell modulator being investigated for the treatment of systemic lupus erythematosus (SLE). In the Phase II trials, Lupuzor was administered subcutaneously at a dose of 200 mcg once a month for 3 months. The Phase III study is anticipated to be complete in September 2012 and will measure the proportion of patients achieving a combined clinical response using the SLE responder index.

, a human monoclonal antibody that neutralizes B-cell activating factor (BAFF), is currently in Phase III trials for evaluation as a treatment for SLE as well as RA. The drug is being studied with a loading dose of 240 mg given 1 time, then 120 mg given subcutaneously every 2 weeks or every 4 weeks. The primary outcome measure is the proportion of patients achieving an SLE responder index response at week 52. The final data collection for the primary outcome measure is anticipated to take place in February 2013.

 is a humanized IgG1 antibody that acts as an antagonist of the CD22 receptor present on B cells. UCB is currently enrolling patients for the 2 Phase III trials, EMBODY-1 and EMBODY-2. The primary objective of both studies is to measure the percent of subjects meeting treatment response criteria at week 48 among those patients with moderate to severe SLE. Epratuzumab is dosed at either 600 mg per week or 1200 mg every other week administered over four 12-week treatment cycles. The cumulative dose for both treatment arms is 2400 mg for each of the 4-week dosing periods. The estimated primary completion date is January 2014 for both EMBODY-1 and EMBODY-2.

	Secukinumab is an anti-IL17A drug being investigated for a number of inflammatory conditions. For AS, Novartis is planning to evaluate a dose of 75 mg subcutaneously or 150 mg subcutaneously compared with placebo. The primary outcome measure of the planned Phase III trial is to evaluate the efficacy of each secukinumab regimen in patients with active AS based on the proportion of patients obtaining an ASAS 20 response. The final data collection for the primary outcome measure is anticipated by July 2014.

 (canakinumab), already approved in the United States for cryopyrin-associated periodic syndromes (CAPS), is also being studied for use in acute gout flares. It is a fully humanized monoclonal antibody that provides selective inhibition of IL-1 beta. The 2 Phase III trials enrolled 228 and 226 patients, respectively. Enrolled patients were required to have experienced 3 or more gouty arthritis attacks in the previous 12 months and were required to have been unresponsive or intolerant to NSAIDs or colchicines. Patients were randomized to receive a single dose of canakinu-mab 150 mg subcutaneously or triamcinolone acetate 40 mg given via intramuscular injection.

	Both studies had primary end points of pain intensity at 72 hours post dose and time to the first subsequent gouty arthritis attack. In both studies, pain intensity met statistical significance in favor of canakinumab and the number of patients with new attacks was significantly reduced with canakinumab compared with triamcinolone acetate. In the first study, 40 triamcinolone acetate patients experienced a subsequent attack during the study compared with 21 canakinumab patients. In the second study, 42 trimacinolone acetate patients experienced a subsequent attack during the study compared with 15 canakinumab patients. There were more adverse events seen in the canakinumab group compared with the triamcinolone acetate group (55.8% vs 38.3% in the first study and 54.5% vs 50.9% in the second study). Novartis filed for FDA approval in the first half of 2011.

	In June 2011, an FDA advisory committee voted 11-1 against recommending approval of the drug for treating attacks of gout. The panel also unanimously voted against Ilaris for delaying and reducing the frequency of future attacks. A final FDA decision is pending.

(rilonacept) is an IL-1 inhibitor and is also already approved in the United States for CAPS. The Phase III trials of rilonacept were designed to study prevention of gout flares rather than reduction of pain in acute flares. In the PRE-SURGE 1 Phase III study, patients who received 80 mg of rilonacept saw a 73% reduction in flares compared with placebo and patients who received 160 mg of rilonacept saw an 80% reduction in flares compared with placebo. The PRESURGE 2 trial showed a 72% reduction of flares per patient both for patients treated with rilonacept 80 mg and rilonacept 160 mg compared with placebo. Regeneron also conducted a Phase III safety study, entitled RE-SURGE, in which treatment-emergent adverse events were generally well balanced between those taking the study drug and those on placebo. Injection site reactions were more prevalent with the treatment group than with placebo (15.2% vs 3.3%) but were generally considered mild. Regeneron is expected to file for FDA approval in mid-2011.

(CC-10004) is an oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition including suppression of TNF-alpha, interleukins 6, 17, & 23, and interferongamma. The Phase III trials that are looking at apremilast’s efficacy in psoriatic arthritis are named the PALACE studies, and those looking into efficacy in plaque psoriasis are called ESTEEM. The PALACE studies to review psoriatic arthritis are reviewing a dose of 20 mg by mouth twice daily or 30 mg by mouth twice daily versus placebo. The final data collection for the PALACE 1, 2, and 3 studies is anticipated in the first half of 2012, with the final data from PALACE 4 to be collected in the second half of 2012. The ESTEEM studies are reviewing a dose of apremilast 30 mg by mouth twice daily versus placebo. ESTEEM-1 is expected to collect final data in October 2011 and ESTEEM-2 is expected to complete data collection in June 2012.

 (CP-690,550) is an oral Janus kinase (JAK) inhibitor. It is being studied versus placebo at a dose of 5 mg orally twice daily or 10 mg orally twice daily. Phase III trials for plaque psoriasis with tofacitinib compared with placebo are expected to collect final data for analysis in the first half of 2013 with a long-term safety study being completed in May 2017. Tofacitinib is also being evaluated at a dose of 5 mg orally twice daily or 10 mg orally twice daily compared with Enbrel (enterecept) 50 mg subcutaneously twice weekly for plaque psoriasis. Final data from that trial are anticipated to be completed in July 2012.

 is an anti-IL17A drug being investigated for a number of inflammatory conditions. For plaque psoriasis, Novartis is planning to evaluate a dose of 150 mg subcutaneously compared with placebo. The primary outcome measure of the planned Phase III trial named ERASURE is to evaluate the efficacy in patients with moderate to severe chronic plaque-type psoriasis. Novartis is also planning to evaluate secukinumab dosed at either 150 or 300 mg versus Enbrel (enterecept) 50 mg in a Phase III trial entitled FIXTURE. Final data collection for the primary outcome measures in both ERASURE and FIXTURE are anticipated by March 2013.

 (ABT-874) targets IL-12 and IL-23. Phase III studies were completed, but following feedback from regulatory authorities indicating the need for further safety analysis and the potential for additional studies, Abbott withdrew its application from the FDA in January 2011.

(ustekinumab), already approved in the United States for moderate to severe plaque psoriasis, is being investigated for use in psoriatic arthritis. 

(certolizumab pegol) is approved in the United States for use in CD and RA and is being investigated for use in psoriatic arthritis. The estimated final data collection for the primary outcome measure of the American College of Rheumatology 20 (ACR20) response is expected to occur around August 2011. Rheumatoid Arthritis 1,17-22 LY2127399, a human monoclonal antibody that neutralizes BAFF, is currently in Phase III trials for evaluation as a treatment for SLE as well as RA. The drug is being studied in RA with a loading dose of 240 mg given 1 time, then 120 mg given subcutaneously every 4 weeks for 24 weeks or a loading dose of 180 mg given 1 time, then 90 mg subcutaneously every 2 weeks for 24 weeks. The primary outcome measure is the proportion of patients achieving an ACR20 response. The final data collection for the primary outcome measure is anticipated to take place mid-2013. A long-term safety study is scheduled for completion in 2018.

is an oral JAK inhibitor. It is being studied for treatment of RA versus placebo at a dose of 5 mg orally twice daily or 10 mg orally twice daily. Tofacitinib is also being evaluated against the active comparators 

 (adalimumab) at a dose of 40 mg subcutaneously every 2 weeks. The Phase III program, named ORAL, consists of 5 pivotal studies and 1 long-term safety study. The pivotal studies were completed in the first half of 2011, with results from the long-term safety study expected in 2015. It is expected to be submitted for FDA approval mid to second half 2011 and may become the first oral disease modifying anti-rheumatic drug approved in more than 10 years. 

 is a spleen tyrosine kinase (Syk) inhibitor. Syk is a key mediator of Fc and B-cell receptor signaling in inflammatory cells, such as B cells, mast cells, macrophages, and neutrophils. The Phase III program to investigate fostamatinib use in RA is referred to as the OSKIRA trials. The regimen being studied is fostamatinib 100 mg by mouth twice daily or 150 mg by mouth once daily. The pivotal trials are expected to wrap up in early 2013, with a long-term safety study planned for completion in 2015.

 is a fully human IgG1 monoclonal antibody directed against the interleukin-6 receptor alpha (IL-6R a). An ongoing Phase III study is evaluating several dosing regimens of SAR153191 (REGN88) in addition to methotrexate compared with placebo plus methotrexate. SAR153191 (REGN88) is being studied at doses of 100 mg subcutaneously every week, 150 mg subcutaneously every week, 100 mg subcutaneously every other week, 150 mg subcutaneously every other week, or 200 mg subcutaneously every other week (all in addition to methotrexate). Data collection is expected to be complete in the second half of 2013 with a longer duration safety study planned for 2015. 

(ofatumumab) is a CD20 directed cytolytic monoclonal antibody marketed by GlaxoSmithKline already approved in the United States for treatment of patients with chronic lymphocytic leukemia. For use in RA, the dose being studied is two 700-mg IV infusions given 14 days apart with a total of 8 infusion cycles given over a 144-week period. Data from the Phase III program was presented at EULAR in late May 2011, but the filing timeline is unknown. GlaxoSmithKline is also in Phase II for development of a subcutaneous version of ofatumumab for use in RA.

	Bristol-Myers Squibb’s Orencia (abatacept) is currently approved by the FDA as an IV infusion for adult patients with moderate to severe RA. On July 29, 2011, a subcutaneous formulation of Orencia was approved for the treatment of adults with moderate to severe RA. After a single IV infusion as a loading dose (dosed per body weight), 125 mg administered by subcutaneous injection should be given within 24 hours, followed by 125 mg subcutaneously once a week. The subcutaneous formulation of Orencia is expected to be commercially available in the United States in September 2011.

Stacey Ness, PharmD, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence and persistency programs, and chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is currently associate director of specialty services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, NJ. 

	1.      Clinical Trials.gov. www.clinicaltr

	2.      The Gemini Studies of vedolizumab for IBD: a journey from early trials to dosing the first phase III patient. Millennium Pharmaceuticals Web site.  

www.millennium.com/inTheNews/VedolizumabGeminiStudies.aspx

	3.      DDW: chemokine inhibitor shows promise for IBD. MedPage Today.  

www.medpagetoday.com/MeetingCoverage/DDW/19981

. Published 2010. Accessed June 18, 2011.

	4.      Abbott’s Humira (adalimumab) meets primary endpoints in phase III ulcerative colitis study. Medical News Today.  

www.medicalnewstoday.com/releases/226094.php

. Published May 21, 2011. Accessed June 18, 2011.

	5.      Positive final Lupuzor trial results. Marketwire. 

www.marketwire.com/press-release/Positive-Final-Lupuzor-Trial-Results-AIM-IMM-1176375.htm

. Published November 19, 2009. Accessed June 18, 2011.

	6.      Cephalon pipeline. Cephalon Web site. 

www.cephalon.com/our-science/pipeline.html

.  Published  2011. Accessed June 18, 2011.

www.ucb.com/rd/pipeline/new-development/epratuzumab

. Published July 10, 2010. Accessed June 18, 2011.

	8.      ACR: anti-IL 17 drug misses endpoint in RA trial. Med Page Today.  

www.medpagetoday.com/MeetingCoverage/ACR/23290

. Published November 10, 2010. Accessed June 18, 2011.

	9.      BSR: canakinumab tames gout flares. MedPage Today. 

www.medpagetoday.com/MeetingCoverage/BSR/25996

. Published April 18, 2011. Accessed June 18, 2011.

	10.  Novartis drug gives pain relief in gouty arthritis. Reuters.  

www.reuters.com/article/2011/05/25/us-novartis-arthritis-idUSTRE74O59220110525

. Published May 25, 2011. Accessed June 18, 2011.

	11.  Novartis says experimental drug quells gout attacks, pain. Bloomberg. 

www.bloomberg.com/news/2011-05-25/novartis-says-experimental-drug-quells-gout-attacks-pain.html

	12.  Novartis data shows ACZ885 for severe gouty arthritis provided better pain relief and reduced risk of new attacks. Fierce Biotech. 

www.fiercebiotech.com/press-releases/novartis-data-shows-acz885-severe-gouty-arthritis-provided-better-pain-reli

	13.  Arcalyst (rilonacept) meets primary and all secondary endpoints in second phase 3 trial for prevention of gout flares in patients initiating uric acid-lowering therapy. Regeneron.  

http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=553068

. Published February 28, 2011. Accessed June 18, 2011.

New Product Pipeline

Surveying the Pipeline of Biologics to Treat Inflammatory Conditions 

The FDA approved Duexis (ibuprofen and famotidine) tablets for the relief of the symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcer.  

	The FDA has approved Horizon Pharma, Inc’s Duexis (ibuprofen and famotidine) for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcer. In clinical trials, upper GI ulcer was defined as gastric and/or duodenal ulcers in patients who were already taking ibuprofen for these indications.

	An estimated 46 million Americans are affected by arthritis, and by 2030, this prevalence is expected to rise by 40%, to 67 million individuals. Although nonsteroidal anti-inflammatory drugs (NSAIDs) are effective pain relief agents, GI side effects often limit their use and may lead to serious complications.

 The patients enrolled in the clinical trials for Duexis were primarily younger than 65 years and had no prior history of GI ulcer. Clinical trials did not last longer than 6 months.

	As with other NSAIDs, the exact mechanism of ibuprofen is unknown. It is believed to exert its analgesic and antipyretic effects through prostaglandin synthetase inhibition. Famotidine inhibits gastric acid secretion through competitive inhibition of histamine H

	The elimination half-life of famotidine is closely related to creatinine clearance; patients with a creatinine clearance less than 50 mL/min should not be given Duexis. The effects of gender, age, and hepatic impairment on the pharmacokinetics of Duexis have not been studied.

	Duexis should be given as 1 tablet (ibuprofen 800 mg/famotidine 26.6 mg) orally 3 times a day. The tablet should be swallowed whole and never cut, chewed, crushed, or divided.

	Duexis was evaluated in 2 multicenter, double-blind, active-controlled, randomized 24-week trials. Patients received either Duexis or ibuprofen 800 mg in approximately a 2:1 ratio.

 The first trial showed a statistically significant reduction in the incidence of gastric ulcers in patients using Duexis (8.7%) compared with patients using ibuprofen alone (17.6%). The second trial showed a statistically significant reduction in the incidence of upper GI ulcers in patients using Duexis (10.5%) compared with patients using ibuprofen alone (20.0%).

Contraindications, Warnings, and Precautions 

	Duexis carries the following boxed warning:

	• NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which may be fatal. This risk may increase with duration of treatment and in patients with cardiovascular disease or risk factors for cardiovascular disease.

	• Duexis is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery (CABG).

	• NSAIDs cause an increased risk of serious GI adverse reactions, such as bleeding, ulceration, and perforation of the stomach or intestines. These reactions may occur at any time, without warning symptoms, and may be fatal. Elderly patients are at greater risk.

	Duexis is contraindicated in patients with a history of asthma, urticaria, or allergic reaction after taking aspirin or other NSAIDs, during the perioperative period of CABG surgery, in pregnant patients at 30 or more weeks’ gestation, and in patients with a known hypersensitivity to other H2 -receptor blockers.

	Duexis should be used cautiously in patients with hypertension, congestive heart failure, or edema. Discontinue Duexis if bleeding, anaphylaxis, or serious skin reactions occur. Long-term use of NSAIDs can lead to renal injury. Discontinue Duexis if abnormal liver tests persist or worsen, if clinical signs and symptoms of liver disease occur, or if systemic manifestations occur. Use caution when concomitantly administering Duexis and the following medications: warfarin, aspirin, angiotensin converting enzyme inhibitors, diuretics, lithium, methotrexate, selective serotonin inhibitors, and cholestyramine. The most common adverse reactions (≥1% and greater than ibuprofen alone) are nausea, diarrhea, constipation, upper abdominal pain, and headache.

Dr. Holmberg is a clinical pharmacist who resides in Phoenix, Arizona. 

	1.  Duexis complete prescribing information. 

www.duexis.com/DUEXIS%20Prescribing%20Information.pdf

	2. Horizon Pharma announces FDA approval of Duexis (ibuprofen/famotidine) for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers [press release]. 

www.horizonpharma.com/ArticleDetail.asp?tid=166.Accessed July 2011

New Drug Review

Horizon Pharma Inc's Duexis

These steps for taking on new contracts and data warehouse projects will save you time and expenses down the road.

	Congratulations! You’ve recently been awarded a fantastic limited distribution contract, or maybe you just joined a small network of specialty pharmacies supporting a large regional managed care organization. Well done! The only problem: you don’t have the capability to support the data requirements associated with your new line of business.

	Because your new client is looking for their reports and the chief executive officer wants a budget, it may be tempting to begin your project by looking at the hardware and software necessary to create the warehouse. But that would be the wrong thing to do.

	First, you need the lay of the land. Speak with the people in the organization who know where the data is and how it moves. Interview those individuals who are currently responsible for creating reports and assisting with analytics. These subject matter experts are key to the success of the project. Most likely, data processes currently exist within the pharmacy that feed financial systems or other processes. Look to leverage these processes. Next gather existing reports and current business requirements. The new data warehouse will need to meet these ongoing needs as well. Finally, you are ready to perform a gap analysis on what you have today and the data you need to meet the requirements of your new managed care organization or Pharma client.

	Nothing will delay the success of or destroy the momentum of the project more than undue deliberation at the outset. Beware—stakeholders will be competing and additional data requirements will be piling on. The data warehouse initiative is a large one, so focus on your prioritized deliverables and don’t take on too much to start with. A phased iterative approach works best. The data warehouse will become an integral part of your pharmacy, and you can always add components later.

	While the selection of hardware and software is outside of our scope here, remember to consider the following items: maturity of the product, ability to implement automation, scalability, and the availability of technical resources which can provide support (and be aware of how expensive they are). The advent of “secure cloud computing,” in a managed environment, means you may not need to maintain and host the servers and ancillary hardware; this could be a low cost scalable option for many pharmacies. In addition, with a hosted environment you will be able to add processing power, disk space, and memory on an as-needed basis.

	Once your data warehouse is in production you will have a data gather system that will regularly pull in large amounts of data from many sources and leave it stored and configured for optimum accessibility and manipulation. The whole point of a data warehouse is to consolidate data that is difficult to pull together. Your design must allow for data acquisition from multiple databases in-house, from remote locations in your companywide area network or WAN, and from external sources. This can be complex.

	If you need to, it’s OK to look for outside help. While it’s prudent to review your in-house resources, if this is your first specialty pharmacy data warehouse project, it’s probably a good idea to hire outside consulting help.

	It’s a certainty that no 2 specialty pharmacies are the same. There are great differences in operational processes, payer requirements, management’s needs, and the quality of data extracted from the fulfillment process. Be certain that your data warehouse partner understands and addresses this uniqueness. Additionally, your data warehouse will more than likely add to the workload of your staff. Be certain that your team has the skills needed to assume the additional responsibility.

	Remember, the data warehouse needs to be maintained. Your analytics will grow in sophistication with time. Data will be refined and configured in new and different ways. In order for your data warehouse to remain relevant, it will have to change as your organization changes. This may be the result of questions needing to be answered, or modifications required due to changes in your fulfillment systems or processes such as therapy management. Lastly, if you selected a vendor partner to help you, that resource should help you to continually and proactively develop a deeper knowledge of specialty pharmacy data integration methodologies and analytical trends.

	Good luck with your data warehouse project! It’s time to roll up your sleeves! Next time, we’ll review data delivery considerations. SPT

Jim Maguire is the chief executive officer of Biomed Intelligence, a firm specializing in health care information technology support solutions. With more than 20 years of experience, Mr. Maguire was formerly the chief information officer of a pharmacy benefit manager and also led information technology operations at a specialty pharmacy. 

Technology

Building Your Specialty Warehouse: Focus on Data Acquisition

Upcoming Fall/ Winter Meetings and Conferences 

	Specialty pharmacists and related health care professionals can chose to attend a variety of meetings, conferences, and special events to enhance their professional practices and understanding of health care issues today. Here are some select upcoming meetings and conferences to consider:

NATIONAL COMMUNITY PHARMACY ASSOCIATION (NCPA)

	113th Annual Convention & Trade Exposition * October 8-12, 2011 * Gaylord Opryland Resort and Convention Center, Nashville, Tennessee

 The NCPA holds meetings to encourage relationships, uphold the profession, and provide educational opportunities for pharmacists. This meeting will bring together national leaders to discuss issues of importance for community pharmacists.

	2011 Scientific Sessions * November 12-16, 2011 * Orange County Convention Center, Orlando, Florida

 These sessions combine information on the significant advances in the prevention, diagnosis, and treatment of cardiovascular disease, and give practitioners the opportunity to see the exhibits showcasing the latest cardiovascular technology and resources.

	The World Congress 2nd Annual Leadership Summit on Accountable Care Organizations & Patient Centered Medical Homes * November 14-16, 2011 * Doubletree Hotel, San Diego, California

 This annual summit centers on the health care reform promotion of the Patient Centered Medical Home as the future of health care delivery in the United States. The meeting will also focus on strategies for participating in an accountable care organization framework.

AMERICAN SOCIETY OF HEALTHSYSTEMS PHARMACY (ASHP)

	2011 Midyear Clinical Meeting & Exhibition * December 4-8, 2011 * New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana

 The ASHP meeting includes workshops, clinical and leadership programs, poster presentations, and continuing education for students, as well as new and experienced practitioners.

	8th Annual American Health Care Congress & Exhibition * December 5-6, 2011 * Anaheim Marriot, Anaheim, California

 This forum is designed to educate health care executives on integration strategies post—health care reform and offer strategies to identify operational changes needed for increased reimbursement, develop aligned incentives across the network, and leverage health care IT.

	Nutrition, Physical Activity and Metabolism/ Cardiovascular Disease Epidemiology and Prevention 2012 Scientific Sessions * March 13-16, 2012 * San Diego, California

 These overlapping conferences focus on population-based research and clinical information that promote the development, advancement, and exchange of new information related to the prevention of heart disease and stroke.

Conference Calendar

Conference Calendar Upcoming Fall/Winter 2011-2012

Adherence for targeted therapies is even more essential now than it ever has been. This case study of services offered at a specialty pharmacy illustrates the impact of hepatitis C patients. 

	As the delivery of pharmaceutical agents evolves, patients will appreciate an increase in autonomy regarding medication administration. Historically, many medications required administration in an infusion suite. However, more and more medications are being formulated or reformulated for oral administration at home. There are even opportunities to increase dosing intervals from daily to weekly.

	Targeted therapies allow for improved medication side effect profiles, affording patients the opportunity to receive once-debilitating treatment regimens for a reduced duration. With this autonomy, however, comes a greater need for patients to maintain medication adherence. In the case of hepatitis C (HCV), adherence is more essential now than it has ever been.

	In May 2011, 2 specialty agents within a new class of medications for hepatitis C (HCV) were approved and quickly adopted as the current standard of care when used in combination with pegylated interferon and ribavirin. This new regimen allows for a shortened course of therapy for patients with HCV genotype 1. Patients expecting 48 weeks of therapy now have an option to be treated for 24 or 28 weeks.

	Despite the allure of the shorter treatment duration, these protease inhibitors are particularly prone to HCV viral resistance when not taken as directed. As little as a single missed dose of the 3-times-daily protease inhibitors can lead to viral resistance and ultimate regimen futility. This is in significant contrast to previous therapies for HCV that have proven reliance on adherence for positive outcomes, as reported in several studies which have shown an improvement in cure rates when patients take more than 80% of their doses for at least 80% of the prescribed duration. 

	While patients are realizing more autonomy with medication administration, providers must focus on preventing barriers to medication adherence. These barriers are present for most, if not all, self-administered medication regimens. The potential influence of acute and chronic side effects on therapeutic outcomes establishes a need for patient education before and during therapy with specialty medications.

	These side effects can be debilitating, ranging from flu-like symptoms to kidney failure. Most specialty medications will carry black-box warnings related to their toxicities and they require frequent laboratory visits and trips to provider offices to monitor the unwanted physical and mental effects of some treatments. The effects on a patient’s quality of life are significant with specialty medications as well. Many patients may alter their work schedule due to fatigue and insomnia, become self-conscious due to hair loss, or seek assisting devices to cope with muscle weakness and bone pain.

	In addition to medication side effect profiles, cost ranks as a significant barrier to adherence. The financial impact on a patient’s life as they initiate a specialty medication regimen can be quite significant. For this reason, many patients will delay treatment until they are financially able to maintain the prescribed duration of therapy. Medicare Part D and private insurances include most specialty pharmaceuticals in their formularies; however, prior authorizations tend to slow medication delivery and the resulting copayments may still prove to be a financial burden.

	Finally, although patients appreciate the option for autonomy when it comes to medication administration, this task can be both challenging and complex for those with physical and emotional barriers, as well as those with deficiencies in health literacy that may interfere with medication administration.

	At Prosperity Specialty Pharmacy, a Community Specialty Pharmacy Network (CSPN) member located in Fairfax, Virginia, services include medication therapy management, drug—drug interaction checks, a refill reminder program, injection trainings, and providing patients access to disease-specific financial assistance. These services have translated into cost-saving outcomes for patients, providers, and the pharmacy.

	With the help of a clinical pharmacy specialist, a pharmacy resident, student pharmacists, and clinically trained pharmacy technicians, the services at Prosperity Specialty Pharmacy have increased adherence rates for many patients. In an observational study conducted by the pharmacy’s community practice resident, entitled “Impact of a Specialty Pharmacy Refill Reminder Program on Hepatitis C Patient Adherence and Incidence of Early Virologic Response,” the impact of the pharmacy’s refill reminder program on rates of HCV patient adherence was assessed.

	The study also aimed to determine the impact of adherence on early virologic response (EVR), an HCV viral load measure predictive of treatment success assessed at the end of the first 12 weeks of therapy with pegylated interferon and ribavirin. The study reported an 81% adherence rate to pegylated interferon and ribavirin over the initial 12 weeks of therapy. This outcome was compared with data from a study by Vincent et al (2009), which concluded that EVR was most common among patients with adherence rates to HCV therapy greater than or equal to 85%. Despite a less than optimal overall adherence rate for patients enrolled in the Prosperity Specialty Pharmacy study, 40% of study participants achieved EVR, while 29% of study participants in the Vincent et al study achieved EVR with an adherence rate of less than 85%. 1 Additional studies at Prosperity Specialty Pharmacy are underway and aim to further examine adherence rates and incidence of EVR and sustained viral load among the HCV patient population in hopes of defining the influence that specialty pharmacy can have on therapeutic outcomes.

	The refill reminder program at Prosperity Specialty Pharmacy is just one of the services provided to patients to ensure optimal treatment outcomes. The following case highlights many of the services available at Prosperity Specialty Pharmacy and other specialty pharmacies like it.

	1. pegylated interferon alpha-2a 180 mcg SQ QW

	3. telaprevir 750 mg PO every 7-9 hours with food

	Upon order receipt, the pharmacy technician sends a fax to the prescribing physician’s office indicating that a prescription for Mr. Smith was received by the pharmacy. The pharmacy technician enters the prescription information into the pharmacy’s computer system, attempting to adjudicate a claim using the provided prescription insurance information. The claim is rejected by the patient’s insurance, with the request that a prior authorization be obtained. The pharmacy technician collects the necessary prior authorization forms from the third-party Web site and faxes them, along with a message to the prescribing physician requesting that the forms be completed and sent in to the third party for processing.

	The pharmacy technician resubmits the claim to see if it can be processed; the claim still can not be processed.

 The pharmacy technician resubmits the claim to see if it will be processed and the claim is paid. Mr. Smith is responsible for a $200 co-pay for a 1-month supply of medication. The pharmacy technician contacts the prescribing physician, letting her know that the claim was successfully processed and that a co-pay is due.

	Next, the pharmacy technician calls Mr. Smith and explains the cost of the medication. Mr. Smith states that he will have a hard time paying $200 every month for his medication. The pharmacy technician informs him about assistance that may be available from the manufacturer and other charitable funding sources. The pharmacy technician is able to enroll Mr. Smith in an assistance program that will reduce his out-of-pocket expense to $50 a month.

	The pharmacy technician goes on to explain the pharmacy’s free medication delivery, refill reminder program, injection training services, and drug—drug interaction check service. Mr. Smith signs up for an injection training session and provides the pharmacy technician with a list of his medications so that the clinical pharmacist can review it.

	The pharmacy technician fills the patient’s order and places it in a queue so that it can be verified by a pharmacist. The patient’s initial shipment includes his medications, a welcome packet with a description of the pharmacy’s services, and an HCV starter kit from the manufacturer of the pegylated interferon. The staff pharmacist verifies the prescription order, ensuring proper dose, duration, and directions. Mr. Smith’s medication order is then set aside in preparation for Mr. Smith’s injection training.

	The pharmacy technician sends a fax to the prescribing physician’s office letting her know when Mr. Smith will receive his medication. The pharmacy technician also provides the clinical pharmacist with the list of medications that Mr. Smith is taking, so that a drug—drug interaction check can be performed. The following list of medications is collected from the patient: amlodipine, lisinopril, St. John’s wort, bupropion, aspirin, and ibuprofen.

	The clinical pharmacist notices 2 drug—drug interactions, which she calls the patient to discuss:

	• Telaprevir amlodipine = increased concentrations of amlodipine

Adherence for targeted therapies is even more essential now than it ever has been. This case study of services offered at a specialty pharmacy illustrates the impact of hepatitis C patients. 


August 2011

Are We Ready for Tomorrow?

Health Insurance Exchanges: A Boom or a Bust for Specialty Pharmacy?

The Payer Dilemma

Surveying the Pipeline of Biologics to Treat Inflammatory Conditions

Horizon Pharma Inc's Duexis

Building Your Specialty Warehouse: Focus on Data Acquisition

Conference Calendar Upcoming Fall/Winter 2011-2012

Hepatitis C Case Study at Prosperity Specialty Pharmacy

Competitive Advantages of Accreditation

Oncology 2011: Today's Payer Strategies and Tomorrow's Market Innovations

8 Mega Trends Shaping the Future of Specialty Pharmacy

Assessing a REMS Strategy: Keep It Simple and Responsible

The Pharmacy Benefit vs the Medical Benefit

A Double-Edged Sword

Rheumatoid Arthritis Watch