Click image to enlarge The impact of specialty drugs continues to increase in both drug utilization and spend. In 2012, specialty drug spend accounted for approximately $87 billion, or about 3.1% of national health spend in the United States. In 2020, the forecasted specialty drug spend is expected to be $400 billion, or about 9.1% of national health spend. In addition, within 4 years, analysts predict that 7 of the top 10 drugs in terms of sales will be specialty products.1 Given this expected growth, the specialty drug pipeline will be of particular interest to patients, prescribers, payers, and pharmacies. New specialty drug approvals As of December 3, 2014, FDA had approved 39 new molecular entities and new therapeutic biologics this year. While there is no universal definition of a specialty drug, approximately 19 of this year’s approvals fit commonly used definitions of specialty products (Table 1).6,7 Of these 19, oncology and rare diseases represented the majority of approvals, a trend that is expected to continue through 2015.2 In The Pipeline
 Oncology Looking ahead to the remainder of 2014 and 2015, the pipeline is again forecasted to have the highest number of approvals in oncology, with approximately one dozen expected approvals for a variety of cancers (Table 2).3 Programmed cell death–1 (PD-1) drugs stand out as an especially promising class of therapy. Pembrolizumab (Keytruda—Merck) was the first of this class to earn FDA approval for the treatment of unresectable or metastatic melanoma. Pembrolizumab, along with fellow experimental PD-1 drug nivolumab (Opdivo—Bristol-Myers Squibb), have earned breakthrough designations from FDA and are likely to see success expanding into other indications. Trials are currently under way with PD-1 agents for a number of cancers, including lung, liver, brain, and solid tumors. Other pipeline drugs are in late stages of development for the treatment of breast, melanoma, non–small cell lung, ovarian, and pancreatic cancers, as well as hematologic malignancies such as leukemia and multiple myeloma. Click image to enlarge Hepatitis C Hepatitis C (HCV) continues to have one of the most intriguing pipelines of any disease state. Within the last year, the approvals of sofosbuvir (Sovaldi—Gilead) and simeprevir (Olysio—Janssen) as individual agents have led to major changes in the treatment of HCV. Gilead’s Harvoni, the combination of sofosbuvir and ledipasvir, was approved in October 2014. In addition, sofosbuvir and simeprevir used together was approved in November 2014. Both of these combination therapies show high sustained viral response rates and are interferon-free, oral regimens. Competition should come from the AbbVie “3D” HCV combination therapy composed of ombitasvir, paritaprevir, and ritonavir (Viekirax) used in combination with dasabuvir (Exviera). An FDA decision for this combination is expected by December 22, 2014. In addition, Merck’s HCV combination of MK-5172 and MK-8742 is also showing good effectiveness in clinical trials. Tough competition from fast-paced innovation in the HCV market has taken a toll on other pipeline agents. Faldaprevir, a late-stage drug from Boehringer Ingelheim, was abandoned. Bristol-Myers Squibb’s daclatasvir and asunaprevir, taken together as a two-drug combination therapy, was…

Why is this document important?  Healthcare marketers are aggressively pursuing new revenue streams to augment lower reimbursements provided under PPACA. Prescription drugs, particularly specialty, are key drivers in the growth strategies of PBMs, TPAs and MCOs pursuant to healthcare reform.  The costs shared below are what our pharmacy actually pays; not AWP, MAC or WAC. The bottom line; payers must have access to "reference pricing." Apply this knowledge to hold PBMs accountable and lower plan expenditures for stakeholders.  Note: This document is updated weekly to reflect changing prices and new products. Did you know that pharmacies (and PBMs) often negotiate discounts on prescription drugs which aren't reflected in AWP, WAC or MAC prices? The only way to be sure you're receiving these discounts is to gain access to invoices. How to Determine if Your Company [or Client] is Overpaying Step #1:  Obtain a price list for generic prescription drugs from your broker, TPA, ASO or PBM every month. Step #2:  In addition, request an electronic copy of all your prescription transactions (claims) for the billing cycle which coincides with the date of your price list. Step #3:  Compare approximately 10 to 20 prescription claims against the price list to confirm contract agreement.  It's impractical to verify all claims, but 10 is a sample size large enough to extract some good assumptions. Step #4:  Now take it one step further. Check what your organization has paid, for prescription drugs, against our pharmacy cost then determine if a problem exists. When there is a 5% or more price differential (paid versus actual cost) we consider this a problem.   Multiple price differential discoveries means that your organization or client is likely overpaying. REPEAT these steps once per month.   -- Tip --   Always include a semi-annual market check in your PBM contract language. Market checks provide each payer the ability, during the contract, to determine if better pricing is available in the marketplace compared to what the client is currently receiving.  When better pricing is discovered the contract language should stipulate the client be indemnified. Do not allow the PBM to limit the market check language to a similar size client, benefit design and/or drug utilization.  In this case, the market check language is effectually meaningless. Click here to register: "How To Slash the Cost of Your PBM Service, up to 50%, Without Changing Providers or Employee Benefit Levels." [Free Webinar]

Many times clients go through great effort putting together an RFP for PBMs to answer in great detail questions about pricing, service level, and others.  Herein lies the problem; little of this pricing information gets put into the contract.  Those 25 pages or more of useless information could've been put to better use by reducing your carbon footprint. If a PBM expects to gain your trust and manage your pharmacy benefit, it is only reasonable they sign a fiduciary contract which reflects their claims to transparency. If the PBM agrees to your terms, it only follows that your plan goals are memorialized in a rock solid contract. RFPs do not bind a PBM to their guarantees, fiduciary contracts do. You must eliminate the RFP process and instead draft an airtight fiduciary contract and put it out for bid. A contract is not a legal agreement until it is signed by all parties involved.  Consider this; Many times financial guarantees are not guarantees unless the client has spelled them out in a fiduciary contract.  All rebates may not be paid unless a fiduciary contract is signed. Full audit provisions generally will not be honored unless you have a signed fiduciary contract and a RFP is not a contract.  However, a signed agreement in a well drafted contract that honors the best that a PBM can offer through the RFP process is worth celebrating with concrete savings. The best type of contract, without question, is a fiduciary contract. Fiduciary contracts provide the highest level of care and deliver perpetual cost reductions to plan sponsors. That being said, why would you settle for anything less? Click here to register for: "How To Slash the Cost of Your PBM Service, up to 50%, Without Changing Providers or Employee Benefit Levels."

As the year winds down, many employers are reviewing 2014 expenses to help plan spending for the new year. One of the main expenses for many organizations is the cost of employees’ health care. These costs seem to go up every year, but why? According to America’s Health Insurance Plans, a national trade association, health care spending nationwide rose at its fastest pace in 10 years in the fourth quarter of 2013. The main reasons are the rising costs of medical services such as hospital care, costly new drugs and medical technologies, and the impact of hospitals and physician offices consolidating, leaving less competition. One of these reasons may surprise employers — the availability of new and costly prescription drugs, also known as specialty drugs. Specialty drugs are used to treat complex conditions such as cancer, cystic fibrosis, hemophilia, multiple sclerosis or psoriasis. You may have seen advertisements or news reports about the drugs Humira for treating inflammatory conditions such as rheumatoid arthritis or Crohn’s disease, and Harvoni for treating hepatitis C. Specialty drugs are usually injected or infused, but also may be taken orally. And many of these drugs show great results in treating complex, chronic conditions and allowing patients to live fuller, longer lives. Specialty drugs are used to treat serious conditions and can be complex to manufacture, the cost can be significant. The 2014 EMD Serono Specialty Digest reports that 3.6 percent of patients who use specialty drugs account for 25 percent of health care costs. Data from Express Scripts, a national pharmacy benefits manager, shows the average cost of filling a specialty drug prescription for one month is $1,800 compared to $54 for other prescription drugs. CVS Caremark also projects that the costs of the entire specialty drug market will reach $402 billion by 2020. Thanks to advanced research, more than 900 specialty drugs are in various stages of development. Knowing that an employee who has a complex medical condition such as cancer now has access to new and better treatments is certainly good news. But employers must understand that when health care costs increase for employees, so do health insurance premiums. The National Institute of Health Care Management Foundation attributes 97 percent of the rise in premium spending between 2006 and 2010 to increased spending by insurers to cover the actual health care costs of members. We encourage employers to be aware of the drivers of health care costs and health insurance premiums and to work with their insurer to help manage those costs. [Publisher Comment:  work with your insurer to better manage rising prescription drug costs, but utilize the services of a PBM expert, internal or external, to hold the insurer/TPA accountable.  Insurers will surely take advantage of gaps in your knowledge in order to maintain their profit.] For example, many health insurers implement utilization management procedures to help ensure that members receive coverage for the right medications to treat the right conditions. Many insurers work with employers to offer workers access to lower…

Source: Pembroke Consulting For decades, generic prescription drugs have been considered the bargains of the pharmaceutical world. An industry group says Americans have saved more than $1.5 trillion in the past 10 years on brand name drugs, thanks to generics. But in recent months, prices on some of the most popular drugs have soared, and experts are trying to figure out why. Buying generic prescription drugs feels like trading on the stock market for Cory Minnick. "Just seems to snowball every month, it gets worse and worse. You see stuff you used to buy for pennies for a hundred, and now you're paying $70 to $80 just to get it in," he says. Minnick, pharmacy manager at Royer’s on Sharp Avenue in Ephrata, Lancaster County, says he’s constantly checking with his three wholesalers to see what it’s going to cost to get a drug in the hands of a customer. The popular antibiotic doxycycline is used to treat common problems like urinary tract infections and pneumonia.  It cost a mere $20 for a 500 pill supply in October 2013. Yet this past April, its price had hit more than $1,800. Don’t do the math on the percentage increase, it could get ugly. By the way, doxycycline has been on the market for 40 plus years, and the formula hasn’t changed. So what’s going on here? Drugs have "life cycles" "These recent drug shortage and price hikes illustrate a third stage of the life cycle of a drug that we haven't really paid much attention to yet," says Jeremy Greene, a Johns Hopkins professor and author of Generics: the Unbranding of Modern Medicine. "What happens when a drug is no longer particularly attractive to generic manufacturers? Or when the interests of the generic marketplace continue to go towards the second pipeline, the pipeline of drugs that are going off patent now and the drugs that have been off for patents for a while are no longer particularly attractive and get neglected," he says. Greene says drugs used to have two cycles – the brand name stage, where the patent protects the work done by companies like Pfizer, and helps them recoup their investment in research. But then the patent expires, and all manufacturers have a shot to make and sell the drug, ideally, at a much lower cost. That what Ralph Neas, President of the Generic Pharmaceutical Association is focusing on. "It may go up 50% or a 100%, whatever it might but you’re still in the pennies and sometimes you get up to a couple dollars. A very few number are more than that," says Neas. Here’s what we know: In 2010, the average cost of one of the 50 most prescribed generics was $13. In 2013, it hit $62. That data comes from Catamaran, which manages pharmacy benefits for 32 million people. Why are prices rising? A lot of theories are floating around, but the most prominent ones deal with raw material shortages and less competition.  To continue reading…

Pharmacy benefit managers generally provide pharmaceutical outpatient plans, which depend on all sorts of financial concessions the PBM extracts from drug manufacturers, pharmacies and other suppliers. Those forms of direct and indirect compensation help the PBMs to keep costs to company health plans low. But the companies are often unaware of whether promised discounts are fully forthcoming because of lack of transparency. The Department of Labor's Employee Retirement Income Security Act Advisory Committee recently approved two recommendations pushing for the department to require disclosure of both direct and indirect compensation.  "We commend the ERISA Advisory Council on its action and we are also excited that U.S. Labor Secretary Thomas Perez has indicated his desire to ensure  those long-overdue changes are implemented," says B. Douglas Hoey, CEO of the Alexandria, Va.-based National Community Pharmacists Association. The NCPA has been locked in numerous battles with the PBM industry over adequate participation of retail pharmacies in PBM networks. "In the past, some council recommendations have led to regulatory projects," says Michael Trupo, a Labor Department spokesman. "The department looks forward to reviewing the council’s final reports when they are submitted." James I. Singer, the issue chairman on PBM disclosure for the ERISA Advisory Committee, says the report should be available at the start of 2015. Three PBMs control the lion's share of the market: Express Scripts, CVS/Caremark and Catamaran. Health plans such as Aetna, Humana and United Healthcare also own PBMs.  Allison Klausner, assistant general counsel for benefits at Honeywell International Inc., says that rebates PBMs receive from drug manufacturers for placing particular drugs on the most attractive formulary "tier" can create "conflicts of interest." That placement, she says, may have nothing to do with a drug's superior effectiveness and everything to do with a higher PBM profit margin. In some instances, she says, plan sponsors may be fine with rebates obtained by the PBM, but may be denied access to auditing them to ensure they are getting the share they contracted for. But Washington, D.C-based attorney William J. Kilberg, a partner at Gibson, Dunn & Crutcher who represents the Pharmaceutical Care Management Association—the PBM trade group—says the rebates PBMs obtain from manufacturers are not "compensation," and should not be subject to DOL regulation. Nor should there be any regulation of any kind of compensation PBMs receive, he adds, as employers have many PBMs to choose from, which gives them leverage to extract whatever information they need from whichever PBM they contract with. Industry experts, such as Patricia M. Danzon, the Celia Moh Professor at the University of Pennsylvania's Wharton School, say that manufacturer rebates to PBMs are generally disclosed and have become less of a profit maker for PBMs as plan sponsors heavily incent the use of generics, where rebates do not come into play ordinarily.  But that trend, experts warn, may also account for the growth of another criticized, opaque practice: PBMs' use of "spread pricing" to boost profits, by which a PBM reimburses pharmacies a lower amount than it charges a plan sponsor.…

Drug therapy is growing more complex and costly! So-called specialty drugs are gradually displacing traditional drugs as the primary component of drug spending. The market is expanding rapidly. Only about 10 such drugs were available 20 years ago but today there are more than 300. These drugs typically treat medical conditions that are life-threatening, chronic and often rare. Cancer treatments are the most common type of specialty drugs, making up one-third of total. Drugs for autoimmune disorders, rheumatoid arthritis, and Crohn's disease, medications for HIV and drugs for multiple sclerosis are responsible for another third of specialty drug spending. Although only about 1 percent of drugs prescribed, specialty drugs now account for more than one-quarter prescription drug spending. This is expected to grow to 50 percent by 2020. Specialty drug therapy costs from at least $15,000 per year, to as much as $750,000 per year. Most have no close substitutes, rendering health plans’ traditional efforts by to control costs by encouraging generic substitution largely ineffective. Due to these medications’ high cost, health plans carefully manage the procurement and administering of these drugs. For instance, health plans are increasingly relying on exclusive preferred pharmacy networks to reduce costs and ensure the quality of specialty drug therapy. When drug plans create preferred pharmacy networks they negotiate for the lowest possible prices. Negotiated prices are the result of bargaining power — the ability of the drug plan to deny business to a firm if their bid isn’t favorable. Bargaining power also strengthens the ability of drug plans to demand quality-enhancing safeguards and patient protections. As you might expect, when a new market segment displaces an old one, stakeholders in the old market understandably don’t want to be shut out. As preferred pharmacy networks have become more common, so too have the calls for lawmakers to enact laws that restrict the ability of health plans to partner with exclusive pharmacy networks. The less competitive drug providers lobby CMS, Congress and state legislatures to restrict the ability of drug plans to effectively negotiate for lower prices. This past January the Centers for Medicare and Medicaid Services (CMS) tried to ban preferred pharmacy networks in Medicare drug plans. CMS had been under pressure from pharmacy interests shut out of Medicare Part D drug plans.  Click here to read the full article by Devon Herrick.

Engineered to treat complex chronic conditions such as cancer, multiple sclerosis, rheumatoid arthritis, Parkinson’s disease, and hepatitis C, specialty prescription drugs represent less than 1% of all U.S. prescriptions yet are growing at an unsustainable rate—and employers are beginning to see their impact on healthcare costs. The Centers for Medicare and Medicaid Services estimates that prescription drug spending was 9.4% of all healthcare spending in 2012, and a large portion of that spending was on specialty drugs. In their 2013 Specialty Drug Trend Insights report, independent pharmacy benefit manager (PBM) Prime Therapeutics places that figure at 30% of total drug costs and predicts it will reach 50% by 2018. Express Scripts’ 2013 Drug Trend Report reveals that for the top traditional therapy classes, spending will likely climb 2% year-over-year for the next three years, whereas spending on specialty medications will increase 16.8% in 2014, 18.0% in 2015, and 18.2% by 2016. It’s no surprise that employers are looking for ways to manage the employee benefit costs of their specialty drug coverage. To help them get a handle on their specialty drugs spend and ensure their employees receive appropriate and effective care, employers—along with their health plans and other healthcare benefits partners—are exploring a combination of tactics: 1.  Integrated Pharmacy and Medical Benefits In their article, Employers Act to Control Prescription Drug Spending, the Society for Human Resource Management (SHRM) cites a 2013 survey by Buck Consultants finding that 71% of U.S. employers spent 16% or more of their total healthcare budget on pharmacy benefits. It can be challenging for employers to estimate their spending on specialty drugs because these drugs are sometimes billed through medical benefits—and other times billed through prescription drug benefits. The inconsistency makes it difficult to get an accurate picture of how much is being spent on specialty medications. When employers move the administration of specialty drugs from the medical plan to the pharmacy program, they can take advantage of better care coordination that’s easier to measure. For example, instead of a doctor ordering and dispensing a specialty drug in their office and billing it as a medical benefit, a prescription drug program can manage the drug’s cost and patient’s care. These tightly coordinated activities can lead to lower costs and easier reporting. 2.  Prior Authorizations Employers may require a prior authorization from a provider before a pharmacy can fill a specialty drug prescription. This added level of control helps making certain that patients are using the most cost-efficient and appropriate therapies. 3.  Cost-Effective Pharmacy Plan Design Many employers are adding a specialty drug tier to pass along at least some of the cost of more expensive drugs to employees and to help track the classes of drugs they’re utilizing. When benefits are tiered, different categories of drugs require different out-of-pocket costs, and categories may be broken up into preferred drugs and non-preferred drugs, generics, and specialty, depending on the needs of the plan sponsor or economics of the formulary. Additionally, plans may include refill policies or…

Notes: (1) Prices are based on a composite of several commonly prescribed brand-name drugs for a typical quantity of pills. For some cells in the table, the relative relationships have been calculated based upon our mail pharmacy and PBM operations and on other relationships widely reported by industry sources. (2) These prices are used for illustrative purposes only and do not represent any type of overall average. (3) Prices reported in this table include both amounts paid by third-party payers and amounts paid by the consumer as cost sharing. (4) Manufacturers generate up to 85% gross margins on brand pharmaceuticals. (5) The HMO column refers only to HMOs that buy directly from manufacturers.

If a pharmacy benefits manager promises a group health plan that there will be no administrative fee for drugs, it actually could be a red flag and not a cause for celebration. It could mean the PBM is “gaming the spread” or not passing rebates through to the plan. Plans can prevent this kind of leakage and contain costs much better if they take more active roles in managing drug benefits, according to Susan Hayes, who founded Pharmacy Outcomes Specialists of Lake Zurich, Ill. If a health plan abdicates all authority, it may end up losing influence and its ability to duck unreasonable price spikes, Hayes told attendees at the International Foundation of Employee Benefit Plans’ Annual Employee Benefits Conference in Boston on Oct. 14. Contracting out drug benefit administration can make it difficult for plans to act in the sole interest of plan participants in certain ways, she said. PBM Rebate Shifts Can Hurt Plans Rebates and discounts between PBMs and  drug makers can reduce drug prices for plans. Several kinds of rebates exist: (1) the drug maker rewards the PBM for putting its product on formulary; (2) the drug maker rewards the PBM for allotting a certain percentage of market share to the product in relation to comparable agents produced by competing manufacturers; and (3) the drug maker pays the PBM for market intelligence on prescribing patterns, Hayes said. But when rebates disappear trouble can start. PBMs might say the sole reasons they rescind preferred status is because: (1) a drug has become a source of wasteful spending; or (2) clinically appropriate alternatives exist. But a drug’s removal from preferred status may be just because the manufacturer stopped paying the PBM rebates, leaving plans wondering what happened, she said. The Spread Is No Game A big source of potential plan waste is “spread pricing.” The “spread” is the difference in what PBMs charge plan sponsors for prescriptions and what they in turn pay pharmacies to dispense those prescriptions. This difference often leads to greater profits for the PBM at the expense of employers. The spread is a prime contributor to why one pharmacy may charge your plan very little and another may charge very much for the same generic medication. According to reporting by Fortune magazine reporter Katherine Eban, Meridian Health System audited its spending on employee medications to learn the scope of spread pricing. For the antibiotic amoxicillin, Meridian was billed $92.53 when an employee filled the prescription, but its PBM paid only $26.91 to the pharmacy to fill the same prescription. That amounted to a spread of $65.62 for only one prescription. In another instance, Meridian was billed $26.87 for a prescription of azithromycin. The PBM paid the pharmacy $5.19 to dispense the prescription, creating a spread of $21.68. While the PBM continually promised savings, Meridian paid $1.3 million in unnecessary prescription benefits costs to this vendor due to the spread, Eban alleged. Dramatic Generic Price Increases But bigger drug cost problems may not be the…