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Serial measurements should be made at the same time of day at the same laboratory order cabergoline online pills. Vertebral Imaging: Once the first vertebral imaging test has been performed to determine prevalent vertebral fractures (indications above) trusted 0.5mg cabergoline, repeat testing should be performed to identify incident vertebral fractures if there is a change in the patient’s status suggestive of new vertebral fracture buy cheap cabergoline 0.5mg online, including documented height loss buy cabergoline 0.5 mg visa, undiagnosed back pain, postural change, or a possible finding of new vertebral deformity on chest x-ray. If patients are being considered for a temporary cessation of drug therapy, vertebral imaging should be repeated to determine that no vertebral fractures have occurred in the interval off treatment. A new vertebral fracture on therapy indicates a need for more intensive or continued treatment rather than treatment cessation. These programs have accomplished a reduction in secondary fracture rates as well as health care cost 100,101 savings. The program creates a population database of fracture patients and establishes a process and timeline for patient assessment and follow-up care. Rehabilitation and exercise are recognized means to improve function, such as activities of daily living. Psychosocial factors also strongly affect functional ability of the patient with osteoporosis who has already suffered fractures. Additionally, progressive resistance training and increased loading exercises, within the parameter of the person’s current health status, are beneficial for muscle and bone strength. Proper exercise may improve physical performance/function, bone mass, muscle strength and balance, as well as reduce the risk of falling. However, long-term bracing may lead to muscle weakness and further de-conditioning. Pain relief may be obtained by the use of a variety of physical, pharmacological and behavioral techniques with the caveat that the benefit of pain relief should not be outweighed by the risk of side effects such as disorientation or sedation which may result in falls. However, many additional issues urgently need epidemiologic, clinical and economic research. For example: • How can we better assess bone strength using non-invasive technologies and thus further refine or identify patients at high risk for fracture? Food and Drug Administration for prevention and treatment of osteoporosis; accumulates and persists in the bone. Studies indicate about a 50 percent reduction in vertebral and hip fractures in patients with osteoporosis. Atypical femur fractures: Low or no trauma fractures which are characterized by distinct radiographic (transverse fracture line, periosteal callus formation at the fracture site, little or no comminution) and clinical features (prodromal pain, bilaterality) that resemble stress fractures. These fractures are thought to be associated with long-term use of potent antiresorptive medications and are distinguished from ordinary osteoporotic femoral diaphyseal fractures. Elevated levels of markers of bone turnover may predict bone loss, and declines in the levels of markers after 3-6 months of treatment may be predictive of fracture risk reduction. Calcitonin (Miacalcin® or Fortical®): A polypeptide hormone that inhibits the resorptive activity of osteoclasts. Calcitriol: A synthetic form of 1,25-dihydroxyvitamin D3, a hormone that aids calcium absorption and mineralization of the skeleton. Calcium: A mineral that plays an essential role in development and maintenance of a healthy skeleton. If intake is inadequate, calcium is mobilized from the skeleton to maintain a normal blood calcium level. In addition to being a substrate for bone mineralization, calcium has an inhibitory effect on bone remodeling through suppression of circulating parathyroid hormone. Cost-effectiveness analysis: As utilized in this Guide, a quantitative analysis that considers the value of treatment by comparing average costs and average health outcomes (quality-adjusted life expectancy) for patients who are treated for osteoporosis relative to untreated patients. Estrogen: One of a group of steroid hormones that control female sexual development; directly affects bone mass through estrogen receptors in bone, reducing bone turnover and bone loss. Indirectly increases intestinal calcium absorption and renal calcium conservation and, therefore, improves calcium balance. Exercise: An intervention long associated with healthy bones, despite limited evidence for significant beneficial effect on bone mineral density or fracture risk reductions. Studies evaluating exercise are ongoing; however, enough is known about the positive effect of exercise on fall prevention to support its inclusion in a comprehensive fracture prevention program. Fluoride: A compound that stimulates the formation of new bone by enhancing the recruitment and differentiation of osteoblasts. Incomplete fractures include stress fractures which are often related to repetitive stress on bones, such as metatarsals and tibia, and are not generally thought to be osteoporosis-related. Most studies of osteoporosis focus on hip, vertebra and/or distal forearm fractures. Ten or more years of use might be expected to decrease the rate of all fractures by about 50 percent. Ibandronate reduces the incidence of vertebral fractures by about 50 percent over three years. Modeling: The term for skeletal processes that occur during growth and fracture repair (e. Non-vertebral fractures: Fractures of the hip, wrist, forearm, leg, ankle, foot and other sites. Osteoporosis: A chronic, progressive disease characterized by low bone mass, microarchitectural deterioration of bone tissue and decreased bone strength, bone fragility and a consequent increase in fracture risk; bone density 2. Peak bone mass: The maximum bone mass accumulated during young adult life (late teens to early 20s). Physiatrist: A physician who specializes in medicine and rehabilitation, or physiatry. Previous fracture: A risk factor for future fractures, defined here as a history of a previous fracture after age 40. The pivotal study indicates a 65 percent reduction in vertebral fractures and a 40 to 50 percent reduction in non- vertebral fractures after 18 months of therapy in patients with osteoporosis. Usually used to assess the lumbar spine, but has been adapted for other skeletal sites. Ultrasound measurements correlate only modestly with other assessments of bone density in the same patient, yet some prospective studies indicate that ultrasound may predict fractures as well as other measures of bone density. It lowers the risk of vertebral fracture by about 30 percent in patients with and about 55 percent in patients without prior vertebral fracture. It lowers the risk of vertebral fracture by about 41-49 percent and non-vertebral fractures by about 36 percent. These readily accessible and commonplace factors are associated with the risk of hip fracture and, in most cases, with that of vertebral and other types of fracture as well. Secondary causes of osteoporosis: Osteoporosis that is drug-induced or caused by disorders such as hyperthyroidism, renal disease or chronic obstructive pulmonary disease. Severe or “established” osteoporosis: Osteoporosis characterized by bone density that is 2. Vitamin D: A group of fat-soluble sterol compounds that includes ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). These compounds are ingested from plant and animal sources; cholecalciferol is also formed in skin on exposure to ultraviolet light. When activated in the liver and then the kidney, vitamin D promotes calcium absorption and bone mass. It lowers risk of vertebral fractures by about 70 percent, hip fractures by about 41 percent and non-vertebral fractures by about 25 percent. The recent prevalence of osteoporosis and low bone mass based on bone mineral density at the femoral neck or lumbar spine in the United States. The contribution of hip fracture to risk of subsequent fractures: data from two longitudinal studies. Clinical review: Clinical applications of vertebral fracture assessment by dual-energy x- ray absorptiometry. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. A simple method for correlative light and scanning electron microscopy of human iliac crest bone biopsies: qualitative observations in normal and osteoporotic subjects. Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the U. Diagnosis of osteoporotic vertebral fractures: Importance of recognition and description by radiologists. Pre-existing fractures and bone mass predict vertebral fracture incidence in women.

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Specialty drugs—1 including those used to treat conditions such as cancer and hepatitis C—represent a signifcant portion of this spending cheap 0.25mg cabergoline mastercard. The high cost of these novel therapies order cabergoline mastercard, which often ofer advancements in patient care purchase cabergoline 0.5 mg mastercard, raises afordability concerns for health plans cheap cabergoline 0.5mg on line, patients, and consumers. The Pew Charitable Trusts defnes specialty drugs as medications with high costs for a course of treatment or a year of therapy. Some health plans also categorize drugs as specialty if they are novel therapies; require special handling, monitoring, or administration; or are used to treat rare conditions. In general, elevated costs are a distinguishing characteristic of specialty drugs. A recent survey found that 85 percent of health plans consider high cost a determining factor in identifying specialty drugs. Patients are often required to pay co-insurance in order to access these medications. Research shows that requiring patients to pay more out of pocket reduces their use of prescription drugs. Step therapy: When multiple treatment options are available for a patient’s condition, plans sometimes require patients to try, and fail, treatment with a cheaper, traditional drug before letting them access a specialty drug. Patients with rheumatoid arthritis, for example, are sometimes required to attempt therapy with traditional oral medications before they can use specialty biologics. Under most prior authorization criteria, clinical information is necessary to verify that a specialty drug is medically appropriate for a patient before coverage is granted. Looking forward Many specialty drugs ofer meaningful therapeutic advances over existing treatments. Pew is focused on identifying and evaluating policy options that balance the need to control overall health care spending with ensuring patient access to appropriate medications. Schulman, “The Impact of Specialty Pharmaceuticals as Drivers of Health Care Costs,” Health Afairs 33, no. However, the various authors do note that drug price or cost is used as part of their respective defnitions of specialty. Joyce, and Yuhui Zheng, “Prescription Drug Cost Sharing: Associations With Medication and Medical Utilization and Spending and Health,” Journal of the American Medical Association 298, no. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and invigorate civic life. Ofcial Medicare Program legal guidance is contained in the relevant statutes, regulations, and rulings. Te information in this booklet describes the Medicare program at the time this booklet was printed. Paid for by the Department of Health & Human Services Table of Contents Section 1: The Basics 7 Medicare prescription drug coverage adds to your Medicare health coverage. Medicare drug plans are ofered by insurance companies and other private companies approved by Medicare. You must also live in the service area of the Medicare health plan or drug plan you want to join. All Medicare drug plans must give at least a standard level of coverage set by Medicare. Medicare drug plans may difer in the prescription drugs they cover, how much you have to pay, and which pharmacies you can use. If you decide to join a Medicare drug plan, compare plans in your Words in area and choose one that meets your needs. If you don’t join a red are Medicare drug plan when you’re frst eligible for Medicare, and defned you don’t have drug coverage that’s expected to pay, on average, on pages at least as much as standard Medicare prescription drug coverage 83–86. Te penalty is in addition to your premium each month for as long as you have a Medicare drug plan. If you don’t use a lot of prescription drugs now, you still may want to think about joining a Medicare drug plan to help lower your drug costs now and help protect against higher costs in the future. If you’re new to Medicare and already have other drug coverage, you have new options to think about. If you aren’t new to Medicare, you may want to look at your options to fnd drug coverage that meets your needs. You can join or switch Medicare drug plans between October 15– December 7 each year, with your coverage beginning January 1 of the following year. Te drug coverage you already have may change because of Medicare drug coverage, so consider all your coverage options. If you have (or are eligible for) other types of drug coverage, read all the materials you get from your insurer or plan provider. Talk to your benefts administrator, insurer, or plan provider before you make any changes to your current coverage. Doctor samples, discount cards, free clinics, or drug discount websites aren’t drug coverage. For details about how Medicare drug coverage may afect other coverage, see Section 4. All plans must cover the same categories of drugs, but generally plans can choose which specifc drugs are covered in each drug category. If you have limited income and resources, you may qualify for Extra Help from Medicare with paying your drug plan costs. Convenience Check with the plan to make sure the pharmacies in the plan are convenient to you. If you spend part of the year in another state, see if the plan will cover you there. You’ll need to join a prescription drug plan to get Medicare coverage for drugs for most chronic conditions, like high blood pressure. Part B covers certain drugs, like injections you get in a doctor’s ofce, certain oral cancer drugs, and drugs used with some types of durable medical equipment—like a nebulizer or external infusion pump. Under very limited circumstances, Part B covers certain drugs you get in a hospital outpatient setting. Generally, Medicare drug plans cover other vaccines, like the shingles vaccine, needed to prevent illness. Note: Medicare Part A (Hospital Insurance) or Part B generally doesn’t cover self-administered drugs you get in an outpatient setting like in an emergency room, observation unit, surgery center, or pain clinic. You’ll likely need to pay out-of-pocket for the entire cost of these drugs and send in a claim to your drug plan for a refund. For more information on how to compare plans and join one that meets your needs, see Section 5. Medicare drug plans have diferent coverage and costs, but all must ofer at least a standard level of coverage set by Medicare. How much you actually pay for Medicare drug coverage depends on which drugs you use, which Medicare drug plan you join, whether you go to a pharmacy in your plan’s network, and whether you get Extra Help paying for your drug costs. Your drug coverage costs are afected by: Monthly premium Words in red are Yea rly deductible defned Copayments or coinsurance on pages Coverage gap (also called the “donut hole”) 83–86. If that amount is more than what’s in your check, you’ll get a bill from Medicare each month. If you don’t pay your entire Part D premium (and the extra amount), you may be disenrolled from your Part D plan. You must pay both the extra amount and your plan’s premium each month to keep Medicare drug coverage. If you have to pay a higher amount for your Part D premium and you disagree, visit socialsecurity. Yearly deductible Te deductible is what you pay for your drugs before your plan begins to pay. Usually, the amount you pay for a covered drug is for a one-month supply of a drug. You might do this if you’re trying a new medication that’s known to have signifcant side efects or you want to get the reflls for all your drugs on the same refll schedule. If you do this, the amount you pay is reduced based on the quantity you actually get. Words in Talk with your prescriber (a health care provider who’s legally allowed to red are write prescriptions) to get a drug for less than a one-month supply. Te Afordable Care Act has made Medicare drug coverage more reasonably priced for people with Medicare with the gradual closing of the coverage gap. You reach the coverage gap afer you and your plan have spent a certain amount of money for covered drugs.

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An estimated In 2015 purchase 0.5 mg cabergoline overnight delivery, 732 000 seizures of cannabis products were 135 tonnes of herbal cannabis was seized in Europe in reported in the European Union including 404 000 of 2015 cheapest generic cabergoline uk, a decrease of 38 % compared with the 217 tonnes herbal cannabis cabergoline 0.5mg, 288 000 of cannabis resin and 19 000 of seized in 2014 generic cabergoline 0.5mg with amex. A similar decrease in the quantity of however, is more than 6 times that of herbal cannabis herbal cannabis seized in Turkey is also evident from 2013. Tis is partially a A number of factors may be behind this overall drop in consequence of cannabis resin being trafcked in volume Europe. Tese may include initiatives to tackle large-scale over large distances and across national borders, making it production in countries outside the European Union, such more vulnerable to interdiction. In the analysis of the as Albania; increased focus on domestic cultivation rather quantity of cannabis seized, a small number of countries than trafcking; changes in the way seizures are registered, are particularly important due to their location on major and changing law enforcement priorities in some cannabis trafcking routes. In the latest data, the quantity of cannabis resin point of entry for cannabis resin produced in Morocco, seized in the European Union has remained relatively reported more than 70 % of the total quantity seized in stable since 2009. Te most recent data suggest that may refect changes in law enforcement priorities, with resin and herb have similar prices, whereas on average, cannabis cultivation more intensively targeted. In 2015, 335 seizures of cannabis oil were reported, with Greece and Turkey seizing the largest quantities. Historically, diverted from legitimate pharmaceutical supplies, while imported heroin has been available in Europe in two forms, others such as the 27 kilograms of morphine powder the more common of which is brown heroin (its chemical seized in 2015, are illicitly manufactured. Far less common is white heroin (a salt form), which in the past Afghanistan remains the world’s largest illicit producer of came from South-East Asia, but now may also be opium, and most heroin found in Europe is thought to be produced in Afghanistan or neighbouring countries. Price and purity of ‘brown heroin’: national mean values — minimum, maximum and interquartile range. However, the discovery of two combined — while the number of seizures rose during the laboratories converting morphine to heroin in Spain and same period (Figure 1. Among those countries reporting one in the Czech Republic in recent years suggests that a consistently, indexed trends suggest that heroin purity small amount of heroin is manufactured in Europe. In addition to heroin, other opioid products are seized in Te two most important are the ‘Balkan route’ and the European countries, but these represent a small fraction of ‘southern route’. Te other opioids most commonly Balkan countries (Bulgaria, Romania or Greece) and on to seized are the medicinal opioids buprenorphine, tramadol central, southern and western Europe. Te southern route, where shipments from Iran and Pakistan enter Europe by air or sea, either directly or transiting through African countries, has gained importance in recent years. Other routes include the ‘northern route’ and a route through the southern Caucasus and across the Black Sea. Following a decade of relative stability, markets in a number of European countries experienced reduced heroin availability in 2010/11. Tis is evident in the number of heroin seizures reported, which declined in the European Union from 2009 to 2014, before stabilising in 2015. Between 2002 and 2013, the quantity of heroin seized within the European Union halved, from 10 to 5 tonnes. Tere are marked regional diferences regarding which stimulant is most commonly seized (Figure 1. Cocaine is the most frequently seized stimulant in many western and southern countries, closely refecting where the drug enters Europe. Amphetamines seizures are predominant in northern and central Europe, with methamphetamine the most commonly seized stimulant in the Czech Republic, Latvia, Lithuania and Slovakia. Cocaine is transported to Europe by various means, including passenger fights, air freight, postal services, private aircraft, yachts and maritime containers. Price and purity of cocaine: national mean values — minimum, maximum and interquartile range. In total, around 87 000 seizures of cocaine were reported in the European Union in 2015. Together, Belgium, Spain, Other coca products were seized in Europe in 2015, France, Italy and Portugal account for 78 % of the including 76 kilograms of coca leaves and 377 kilograms estimated 69. Seizures of coca paste suggest the has remained relatively stable since 2007, although both existence of illicit laboratories producing cocaine the number of seizures and the quantity seized increased hydrochloride in Europe. While Spain date, most of the cocaine laboratories found in Europe (22 tonnes) continues to be the country seizing the most have been ‘secondary extraction facilities’, where cocaine cocaine, Belgium (17 tonnes) and France (11 tonnes) is recovered from materials in which it had been seized very large amounts in 2015, and notable increases incorporated (such as wines, clothes, plastics). However, this control Drug precursors are essential chemicals needed to measure appears to have prompted some innovative manufacture illicit drugs. Tis practice, resumed, with the Netherlands reporting 622 kilograms in however, increases the risk of detection, as more 2015 compared to zero in 2014. Over the last decade, seizures indicate 2015, with Polish authorities seizing 7 000 kilograms in a that the availability of methamphetamine has increased, single shipment linked to production in the Netherlands. Tere are indications that amphetamine mainly from the precursors ephedrine and production mainly takes place in Belgium, the Netherlands pseudoephedrine, which are extracted from medicinal and Poland, and to a lesser extent in the Baltic States, products smuggled chiefy from Poland. In 2015, of the 291 illegal fnal stage of production, the conversion of amphetamine methamphetamine laboratories reported in the European base oil to amphetamine sulphate, is carried out in Europe. Production in that country has shifted from small-scale operations, Some amphetamine is also manufactured for export, involving users making quantities for personal use or local principally to the Middle East, the Far East and Oceania. Te Czech Republic, and more recently, the border areas of neighbouring countries, has long been the source of much of Europe’s methamphetamine. Price and purity of amphetamines: national mean values — minimum, maximum and interquartile range. In dismantled in the European Union in 2015 (3 in the 2015, large quantities of amphetamines were also seized Netherlands, 1 in Belgium). In In many cases, new substances are produced in bulk addition, Belgium seized 1 kilogram of the drug. From there they are shipped to Europe, where they the quantity seized has been fuctuating. Te medicines, which are either diverted from the legitimate estimated 1 300 seizures amounted to 320 kilograms and supply chain or sourced illegally. Te substances may also over 1 500 litres of the drug, with Belgium (33 %) and be produced in clandestine laboratories, either in Europe Norway (35 %) together accounting for two thirds of these or elsewhere. Twelve countries reported around 1 200 seizures illicit laboratories, analysis of dumped synthetic drug of ketamine, amounting to an estimated 130 kilograms of waste and precursor seizures, suggest an increase in this the drug, most of which was accounted for by Denmark, form of production in the last few years in Europe. For example, of the 620 new substances currently being monitored, 423 (almost 70 %) were detected on the drug market during 2015; this 81 compares with 365 in 2014 and 299 in 2013 — illustrating 74 how complex this market has become. In addition, they are sold on darknet markets and on the illicit market, sometimes under their own name and sometimes falsely as illicit drugs such as heroin, cocaine, ecstasy and benzodiazepines. More than 70 % of new substances that were detected through the European Union Early Warning System have been made in the last 5 years. Tis is fewer than in either of the previous 2 years but is similar to the numbers detected in 2012 and 2013. Te causes of this decrease are unclear, but may in part be due to measures taken by national governments in Europe to prohibit new substances, particularly their open sale as ‘legal highs’. In addition, control measures and law enforcement operations in China targeting laboratories producing new substances may be another factor. Together, the synthetic cathinones and synthetic reported for the frst time in 2016. Although currently cannabinoids accounted for over 60 % of all seizures of playing a small role in Europe’s drug market, the new new substances in 2015 (over 47 000). Increases were fentanyls are highly potent substances that pose a serious also observed in the quantities seized in 2015, compared threat to individual and public health. New opioids have been seized in various forms: mainly powders, tablets, capsules, and since 2014, also as liquids. European seizure totals for new substances must be Over 60 % of the 600 seizures of new synthetic opioids understood as minimum values, as data are drawn from reported in 2015 were fentanyls. Reported synthetic opioids was seized in 2015, an increase from the seizures are infuenced by a range of factors such as 240 ml reported the previous year. Fentanyls were found in increasing awareness of new substances, their changing 85 % of the liquids seized. One concern in this respect is legal status, law enforcement capacities and priorities, and the appearance on the market of nasal sprays containing the reporting practices of law enforcement agencies. Refecting their low share of the market as well as their high potency, these opioids account for 0. Tese powders, when exploited this efect by importing bulk powders of the processed into ‘herbal smoking mixtures’, could have been cannabinoids and mixing them with dried plant material in capable of producing many millions of doses. Synthetic cathinones are chemically related to cathinone, which is a naturally occurring stimulant found in the khat In 2015, just over 22 000 seizures of synthetic plant (Catha edulis). During 2015, more than European countries take measures to prevent the supply of 300 000 tablets containing new benzodiazepines such as drugs under three United Nations Conventions, which clonazolam, diclazepam, etizolam and fubromazolam provide a framework for control of production, trade and were seized — almost twice the number reported in 2014. Te Some new benzodiazepines were sold as tablets, capsules rapid emergence of new psychoactive substances and the or powders under their own names.

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The considerable expense of this purchase 0.25 mg cabergoline amex, perhaps coupled with a small market for a new indication buy discount cabergoline 0.5 mg line, often means that a revised application is not made order 0.25 mg cabergoline visa. These prescriptions can be dispensed by pharmacists8 and administered by nurses or midwives cheap cabergoline 0.5 mg. Current legislation on mixing does not extend to controlled drugs, although amendments are under consideration. Meanwhile, existing good practice arrangements should be followed in relation to mixing controlled drugs. It is possible to draw a hierarchy of degrees of reasonableness relating to off-label and unlicensed drug use (Figure 1). The more dangerous the medicine and the more flimsy the evidence the more difficult it is to justify its prescription. Thus, it is important that prescribers (or those authorizing treatment on their behalf) provide sufficient information to patients about the drug’s expected benefits and potential risks (undesirable effects, drug interactions, etc. For off-label prescribing, monitoring can be delegated to another doctor, but not if the drug is completely unlicensed. When current practice supports the use of a drug in this way, it may not be necessary to draw attention to the licence when recommending it. However, it is good practice to give as much information as patients or those authorizing treatment on their behalf, require or which they may see as significant. When patients, or their carers express concern, you should also explain in broad terms the reasons why the drug is not licensed for its proposed use. However, you must explain the reasons for prescribing a drug that is unlicensed or being used off-label when there is little research or other evidence of current practice to support its use, or when the use of the drug is innovative. In palliative care, off-label drug use is so widespread that concerns have been expressed that a detailed explanation on every occasion is impractical, would be burdensome for the patient and increase anxiety, and could result in the refusal of beneficial treatment. However, in situations where there is little evidence and limited clinical experience to support a drug’s off-label use, these figures change to 57% and 7% respectively. A position statement has also been produced by the Association for Palliative Medicine and the Pain Society (Box D). The licence (or marketing authorization) specifies the conditions and patient groups for which the medicine should be used, and how it should be given. In palliative care, medicines are commonly used for conditions or in ways that are not specified on the licence. Your doctor will use medicines beyond the licence only when there is research and experience to back up such use. Medicines used very successfully beyond the licence include some antidepressants and anti- epileptics (anti-seizure drugs) when given to relieve some types of pain. Also, instead of injecting into a vein or muscle, medicines are often given subcutaneously (under the skin) because this is more comfortable and convenient. The information needs of carers and other health professionals involved in the care of the patient should also be considered and met as appropriate. Anti-competitive strategies used by some drug manufacturers, such as “evergreening” and “product hopping,” restrict access to less costly, high-value generics and therapeutic alternatives. Health plans have developed a number of innovative strategies to address unsustainable increases in the prices of specialty drugs. Addressing these cost trends is critical to ensuring a sustainable health care system and achieving affordability for businesses and consumers. While some of these drugs have been groundbreaking in the treatment of cancer, rheumatoid arthritis, multiple sclerosis, and other chronic conditions, the cost of treating a patient with specialty drugs can exceed tens of thousands of dollars a year. The treatment regimen for some of the most expensive specialty drugs can cost $750,000 per year. Historically these drugs have targeted diseases affecting very small populations—sometimes as few as a thousand individuals nationally. But over time and with breakthroughs in the understanding of disease and clinical pathways, these drugs are now used to treat chronic conditions affecting tens of millions of patients. Although these drugs offer tremendous promise when medically necessary, their high costs and use for treatment of chronic conditions in large populations has upended traditional assumptions about prescription drugs and threatens the availability of affordable coverage options nationwide. Health plans, employers, and other stakeholders are searching for innovative, market-based strategies to restrain cost growth while simultaneously maintaining access to safe and effective drugs for patients. This issue brief explores recent trends in the specialty drug market, highlights some of the innovative strategies health plans are adopting to provide patients with access to specialty drugs while managing costs, and recommends additional policy solutions to further promote high-value, high-quality care. Spending on Prescription Drugs, 2014 Prescription Drug Spending in 2014 Prescriptions Written in 2014 1% 32% Specialty Drugs Traditional Drugs 68% 99% Source: The Express Scripts 2014 Drug Trend Report. While the growth rate in spending for Hepatitis C $29,900 (sofosbuvir) traditional medications (non-specialty, small molecules) Olysio Hepatitis C $23,600 in 2014 was just 6. Avastin Metastatic $11,600 (bevacizumab) colorectal cancer Unlike traditional medications made from chemical Revlimid compounds, biologics are complex molecules derived Multiple myeloma $9,300 (lenalidomide) from living or biological sources. Biologic medications Neulasta Neutropenia $5,700 can include vaccines, gene therapies, recombinant (pegflgrastim) protein products, antibodies, and hormones. Advances Source: Adapted from Specialty Medications: Traditional And Novel Tools in the understanding of how these medications work and Can Address Rising Spending On These Costly Drugs, Exhibit 1. Some biologics can be 22 times more expensive Moreover, prices for many existing brand-name and than traditional medications. Prices have been known Unlike their traditional counterparts, spending on to double for dozens of established drugs to treat serious specialty drugs has shown no signs of moderation. An chronic conditions such as diabetes, cancer, and multiple increase of 16% each year is forecast for the 2015–2018 sclerosis, when a single manufacturer produces a number period, with total spending comprising more than 50% of drugs in a specifc therapeutic area. This phenomenon can be more personalized drugs has positioned the specialty drug seen in Medicare spending for Part B drugs, which more market for continued growth. Health plans have developed expertise in using value-based purchasing or cost-sharing designs that provide incentives for prescribers and patients to select high- quality, high-value treatments and care. But when generic or therapeutic alternatives do not exist, the options available for encouraging high-value are limited. There is growing evidence that prescription drug manufacturers have gamed this regulatory process to artifcially prolong the exclusivity period for some drugs and prevent less costly generic versions from reaching the Source: Adapted from Medical Cost Trend: Behind the Numbers 2015,” market. These so called Drug Market “evergreening” schemes do not typically provide any enhanced clinical beneft for consumers—rather they are Unsustainable growth of specialty drug spending is due to aimed at maintaining monopolistic pricing for products many complex factors but can be explained, in part, by the that are just as effective as their less expensive, generic legal and regulatory treatment of these therapies. Strategies like these have While Ensuring Access to resulted in a market for insulin—a drug available for the High-Quality Care last 90 years—with only brand-name versions costing hundreds of dollars per vial. Although the two drugs have been found to be similarly effective at treating age-related macular degeneration, Lucentis costs more than $2,000 per dose, while Avastin Integration and Coordination of Pharmacy (using off-label, intra-ocular injections) costs just $55. An and Medical Benefts analysis of Part B expenditures for these two drugs found Because of their complex nature and their delivery that if providers only prescribed Avastin instead of Lucentis mechanism, some specialty drugs are often covered over the next decade, it would result in nearly $29 billion in through the medical, rather than the pharmacy beneft. This distinction has made it diffcult to get an accurate and complete picture of the prescribing and utilization patterns In the United States, the ability for manufacturers to gain across the two benefts—undermining the use of medical approval to create generic substitutes for expensive biologics evidence that determines the best type of treatments for is still relatively new. Competition and Innovation Act, the legal and regulatory pathways did not exist to bring generic versions of biologics Health plans have begun developing innovative beneft to the market. These generic biologics, or “biosimilar designs recognizing the unique nature of specialty drugs. Biosimilars and collaboration between treating providers and specialty must meet rigorous safety and effcacy requirements, and pharmacists with expertise in medication management must also show no meaningful clinical difference from the for specifc conditions. A Coverage of a specialty drug results in signifcant study conducted in 2013 found that the approval of health care waste, poor outcomes, and higher costs when 11 biosimilars already approved for sale in Europe and patients have poor adherence, or if they discontinue use elsewhere would save approximately $250 billion in health after flling the prescription. Health plans High-Quality, Cost-Effective are also helping patients understand how to take their medications correctly by coordinating with providers Drug Coverage and making sure that patients understand the guidelines for using the medication and any potential side effects. Although health plan efforts to promote access while Condition-specifc care management support teams help lowering the growth of spending on specialty drugs patients adhere to their treatment regimen and work with have shown progress, substantial reforms are still needed providers to coordinate care. The problem facing policymakers is Many health plans now contract with specialty pharmacies urgent—growth in specialty drug prices signifcantly that supply enrollees with the specialty drugs they need outpaced growth in wages and the consumer price index between 2011 and 2013. These pharmacies in Health Affairs modeled the impact of a hypothetical have specialized capabilities to monitor and track the use specialty drug costing $100,000 per treated patient that of specialty drugs and have the necessary training and would increase total health care costs by $250 for every 0. Specialty pharmacies also employ dedicated teams of health care specialists model, such a specialty drug used by just 5% of the that can help enrollees understand how to manage their population would lead to an almost 15% increase in medication and can help ensure that these drugs are premiums (Figure 5). Figure 5: Rate and Percent Increase in Utilization and Pharmacy Management Premiums For A New Specialty Drug By covering specialty drugs for their intended uses and Costing $100,000 PerTreated Patient, monitoring the effectiveness and any side effects that occur Depending on Disease Prevalence during the therapy session, health plans can help to ensure that individuals receive safe, high-value care.

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