Spending on specialty drugs — typically high-cost biologic medications to treat complex medical conditions — is growing at a high rate and represents an increasing share of U.S. pharmaceutical spending and overall health spending.

Absence of generic substitutes, or even brand-name therapeutic equivalents in many cases, gives drug manufacturers near-monopoly pricing power and makes conventional tools of benefit design and utilization management less effective, according to a new qualitative study from the Center for Studying Health System Change (HSC).

Despite the dearth of substitutes, cost pressures have prompted some employers to increase patient cost sharing for specialty drugs. Some believe this is counter-productive, since it can expose patients to large financial obligations and may reduce patient adherence, which in turn may lead to higher costs.

Utilization management has focused on prior authorization and quantity limits, rather than step-therapy approaches — where lower-cost options must first be tried — that are prevalent with conventional drugs.

Unlike conventional drugs, a substantial share of specialty drugs — typically clinician-administered drugs — are covered under the medical benefit rather than the pharmacy benefit.

The challenges of such coverage — high drug markups by physicians, less utilization data, less control for health plans and employers — have led to attempts to integrate medical and pharmacy benefits, but such efforts are still in early development.

Health plans are experimenting with a range of innovations to control spending, but the most meaningful, wide-ranging innovations may not be feasible until substitutes, such as biosimilars, become widely available, which for many specialty drugs will not occur for many years.

High and Rising Specialty Drug Spending

Specialty drugs — typically high-cost biologic medications used to treat a variety of serious, complex conditions ranging from cancer to rheumatoid arthritis to blood disorders — are an increasing concern for employers and other purchasers.

• While specialty drugs are prescribed for only one in every 100 commercial health plan enrollees, these drugs account for an estimated 12% to 16% of commercial prescription drug spending today.
• The monthly spending per patient for a specialty drug typically exceeds $1,200.

Spending on specialty drugs is expected to rise dramatically as drugs currently in development come to market during the next decade and beyond.

Benefit Design Strategies

Mainstream commercial insurance products rarely exclude specialty drugs from their formularies. Once a new specialty drug receives approval from the Food and Drug Administration (FDA) and the health plan’s pharmacy and therapeutics (P&T) committee, its addition to the formulary is typically assured. P&T committee review typically focuses on ensuring safe and appropriate use and preventing off-label use, rather than restricting access to specialty drugs. The rare exceptions to this pattern of comprehensive formulary inclusion are found in the few specialty drug classes where many close substitutes exist — for example, growth hormone — and some niche insurance products aimed at individual and small-group purchasers that provide limited benefits to achieve much lower premiums.

Four-tier pharmacy benefit design. For specialty drugs covered under the pharmacy benefit, some employers choose to transfer a portion of the high costs to patients by adding another, higher cost-sharing tier to the standard three-tier pharmacy benefit design. While it is hard to generalize about the multitude of four-tier designs, the practice of transitioning from flat-dollar copayments in the lowest three tiers to coinsurance, where the patient pays a percentage of the total drug cost, in the fourth tier is quite common.

• A typical design might require a generic copayment of $15,
• a preferred brand copayment of $30,
• a nonpreferred-brand copayment of $60, and
• specialty drug coinsurance in the range of 10% to 25 percent.

Within the fourth tier, some employers — especially large employers — retain a degree of financial protection for patients by applying out-of-pocket maximums per prescription fill — for example, $100 to $250 — or per year — perhaps, $5,000.

Pricing

Obtaining lowest unit price. For specialty drugs covered under the pharmacy benefit, health plans take different approaches to obtain discounted prices from specialty drug manufacturers. It is common for smaller health plans to turn to one of the major PBMs — which all have acquired or developed their own specialty pharmacy divisions — to negotiate unit prices on their behalf, since the largest PBMs are best able to leverage their high volumes to obtain the steepest discounts from manufacturers.

Health plans with high volumes overall — such as the major national plans — or large regional market shares — such as some Blue Cross Blue Shield plans — often find it more advantageous to negotiate prices with manufacturers directly rather than relying on a PBM. Whatever their approach to price negotiations, when it comes to the distribution of specialty drugs to patients, most health plans contract with specialty pharmacies, since these entities have expertise on such matters as special drug handling and patient education.

Some specialty drugs are eligible for rebates on top of the discounted prices. These rebates are typically negotiated by whichever entity — PBM or health plan — is responsible for setting up the formulary and are paid to that entity after the drug has been purchased. Manufacturers are much more likely to offer rebates in drug classes where substitutes are available — for example, rheumatoid arthritis, multiple sclerosis and growth hormone deficiency. The size of rebates typically depends on the PBM or health plan’s willingness to grant the drug preferred-product status and place it in lower cost-sharing tiers.

Utilization and Care Management

Utilization management. Specialty drugs covered under the pharmacy benefit are subject to more pervasive and stringent utilization management (UM) than those under the medical benefit. Prior authorization, for example, is widely practiced — “nearly universal,” according to one respondent — under the pharmacy benefit but far less prevalent under the medical benefit, where retrospective review remains more common. One benefits consultant estimated that specialty drugs under the medical benefit are subject to prior authorization only about 5% of the time.

A major reason is that most contracts between health plans and providers contain no provisions for prior authorization or other UM protocols for specialty drugs under the medical benefit. Health plans are concerned that pushing to add a prior-authorization provision will result in provider resistance and perhaps provider exit from health plan networks. As with provider payment methods discussed previously, respondents suggested that implementing prior authorization under the medical benefit appears to be easier for regional Blue Cross Blue Shield plans whose large market shares give them leverage over providers.

Care management. Experts viewed strong clinical care management as critical to promoting both good health outcomes and cost containment. Key challenges include very sick patients with complex chronic conditions requiring complicated drug regimens, the need to adjust drugs or fine-tune dosage, and strong side effects leading patients to abandon drug regimens. Experts cited cancer and hepatitis C as examples where medications caused such unpleasant, sustained side effects that keeping patients compliant over time was particularly difficult. Several respondents emphasized the importance of a “high-touch” approach to care management, where staff not only has clinical expertise but also the ability to “form personal connections with patients” and motivate them to adhere to demanding drug regimens.

Key Takeaways

Among the common themes that emerged from interviews with industry experts, the following stand out:

Key drug management strategies that have proven effective for conventional drugs often are less applicable to specialty drugs: The lack of close substitutes for most specialty drugs greatly reduces, or eliminates altogether, the ability of tools like cost-sharing tiers and step therapy to steer patients and providers to cost-effective alternatives. It also sharply limits incentives for drug manufacturers to offer substantial price concessions. In contrast, other tools, such as prior authorization and quantity limits — which can help curb unnecessary or inappropriate use, improve patient safety, and reduce waste — are emphasized more in the management of specialty drugs.

Biosimilars are expected to lead to key breakthroughs in specialty drug management, but their impact won’t be seen for many years: The introduction of generic substitutes should allow payers to broaden the use of preferred drug tiers and step therapy, thereby exerting downward pressure on prices. However, achieving therapeutic equivalence — for biosimilar manufacturers — and assessing therapeutic equivalence — for regulators — are likely to be difficult, given the complex nature of biologics. Also, the expensive manufacturing process means that biosimilars may not yield savings as sizable as those achieved by conventional generic drugs. And, it will be an uncertain number of years before biosimilars can make an impact on competition and cost, because (1) innovator products are granted 12 years of market exclusivity and often are protected by patents lasting years beyond that; and (2) the FDA approval process — which has yet to be finalized — is expected to be rigorous and lengthy.

Integration of medical and pharmacy benefits is a goal worth pursuing, but how to achieve it isn’t clear: Efforts to overhaul the currently fragmented benefit structure — which can misalign incentives for patients and providers and result in uncoordinated patient management — are in the early stages of development, and results are uneven at best. Equalizing patient cost sharing for specialty drugs regardless of whether they are covered under the pharmacy or medical benefit is probably the most straightforward dimension of integration. Other aspects of integration present tougher challenges. The ability to track utilization and spending under the medical benefit remains limited, which in turn hinders the ability to manage a large segment of specialty drug utilization. Real-time integration of utilization data remains hampered by limitations in claims and billing systems. Also, as office-administered drugs are moved out of the medical benefit’s buy-and-bill approach, health plans will have to deal with fallout from physicians who see both their margins and clinical autonomy eroding.

Patient adherence is critical to good health outcomes: As one pharmacy consultant observed, “Price tags and performance guarantees [from PBMs] are one thing, but if you [can't achieve] compliance, it’s all a waste.” Both financial factors — high out-of-pocket costs — and nonfinancial factors — strong side effects — pose formidable barriers to patient adherence and positive health outcomes. A combination of non-punitive cost sharing and strong care management may reduce these barriers. One benefit design approach that can help make financial burden more manageable is an income-based cost-sharing structure.

Employers should ensure that their specialty drug strategies are aligned with their overall benefits and business strategies: Decisions on specialty drug coverage require tough trade-offs between cost and access. Which cost-access combination an employer chooses will be heavily influenced by competitive conditions in the industry and the geographic and labor markets where an employer operates. Short-term cost containment can have unintended consequences — for example, increased cost sharing leading to reduced adherence to drug regimen, in turn leading to high-cost complications. Such negative impacts come more into play for employers with low worker turnover and those still offering comprehensive retiree health benefits, as these are the employers likely to be paying the bill in the long term for patients currently taking specialty drugs. Cost-benefit comparisons of different drug coverage options will be more accurate if they are able to account for impact on employee productivity — which is hard to measure — as well as direct medical costs.

PBMs’ interests may not align with employers’ interests: Some employers may be relying heavily on their PBMs to set specialty drug policies, determine specialty drug lists, and pass through discounts from manufacturers, without independently verifying whether their own needs are best served in these arrangements. Employers need to recognize that PBMs’ interests can diverge sharply from their own interests, as PBMs don’t have the same incentives as employers to limit the volume and the prices of drugs. Because the specialty drug sector is complex and the vast majority of employers lack the in-house expertise to deal with PBMs on an equal footing, many employers likely would benefit from having independent experts assess their PBM contract terms and audit compliance with those terms.

Federal contraception coverage mandate raises ire among insurers, may raise premiums for health plan members

The intersection between religion and business is a heated one, with the most recent flare-up sparked by a provision in the Patient Protection and Affordable Care Act that mandates employers cover the cost of contraception in their health plans. Although the Obama administration exempted houses of worship from the rule, it still requires coverage be made available to employees of religiously affiliated organizations such as hospitals and universities.

The administration has said insurers should ultimately make up any initial costs by avoiding expenses associated with unintended pregnancies. But a survey of 15 large health plans shows they are dubious of such savings.

Asked what impact the requirement will have on their costs in the year to two years after it goes into effect, 40% of insurers said they expect the requirement will increase costs through higher pharmacy expenses.

The survey of pharmacy directors at the health plans was conducted by Reimbursement Intelligence, which advises pharmaceutical, medical device and other companies on reimbursement issues. The firm did not name the insurance plans it surveyed.

Of the health plans, 20% said costs would even out because they already budget for contraception in the premium, 6.7% said it would drive up pharmacy costs but decrease medical costs, while 33.3% weren’t sure. None said it would lead to net savings.

“[Insurers] think it will raise pharmacy costs and won’t lower medical costs,” says Rhonda Greenapple, chief executive officer of Reimbursement Intelligence. “The idea that preventive care is going to reduce overall health care costs, they don’t buy it.”

In addition to health insurance companies, lawmakers also have questioned the precedent set by Obama’s plan that would force insurers to pay for coverage with no clear way of recouping the expense. “The idea that insurance companies are going to provide free coverage for items contained in the administration’s order reflects a misunderstanding of the business of insurance,” says Rep. Dan Lungren (R-Calif.). “Under its ‘accommodation,’ the religious employer continues to pay premiums that contribute to the revenues of the insurers. The money paid by religious employers for what will inevitably be higher premiums thereby frees up insurer funds to pay for abortion-inducing drugs, sterilization and contraception in violation of their strongly held beliefs.”

The guidelines require insurers to do away with copayments on coverage of preventive care services for women in all new plans beginning in August. A poll from the Kaiser Family Foundation in February showed nearly two-thirds of Americans favor the policy requiring birth control coverage for female employees, including clear majorities of Roman Catholic, Protestant evangelical and independent voters. Sixty-three percent of Americans overall supported it, according to the data.

But Catholic leaders, Protestant evangelical groups, Republicans and other social conservatives rejected the compromise, saying it still violates religious freedom under the U.S. Constitution and would cause economic hardship for self-insured institutions. The controversy has spawned a rancorous debate in Congress as well as a handful of Catholic lawsuits, including a federal suit in Nebraska joined by seven U.S. states.

Employer response

Some employers have voiced support for the rule, including one reader of EBN’s blog Employee Benefit Views, who said his/her employee population consists mainly of lower-income employees “who make $10 to $15 an hour who may not use birth control – not because of religious reasons, but because they cannot afford the cost of the birth control and keep a roof over their heads. I work for a self-funded employer, and this would create additional costs for us. However, these could possibly be off-set with the savings from births, disability leaves and the like.”

That cost savings may be attractive to employers constantly looking to reduce health care cost burdens. “I understand the issue of ‘religious freedom’ here, but just because this coverage is offered by your insurance company, does not mean that you have to use it,” wrote another EBV commenter. “I would think that each adult can make their own choice on whether or not this is a benefit [they] want to use. But the coverage is there, then, for those individuals who want and need that coverage. Better than the alternative of unwanted pregnancies, abortions and the like.”

Other readers likened the coverage of contraception to coverage to treat chronic conditions. “I do understand the perspective of the employer not wanting to pay for a benefit they do not condone,” a third EBV commenter wrote. “I don’t condone many of the activities that lead to diabetes or heart disease. But I still have to pay for the people that have those habits.”

People who abuse painkillers get their start with pills they received (or took) from friends or relatives according to a study published by Office of National Drug Control Policy.

The ONDCP findings from the Substance Abuse and Mental Health Service Administration’s NSDUH covered the periods 2009 and 2010. The study focused on the growing problem of addiction to prescription opiod (narcotic) drugs. These pills include oxycodone, hydrocodone and others.

Study findings

• 71% of persons used pain relievers in some fashion from friends and family:
  • 55% of persons who used pain relievers non-medically obtained the pain relievers from a friend or relative for free
  • 11% bought them from a friend or relative, and
  • 5% got them from a friend or relative without asking
• The more frequently prescription pain relievers are used, the more likely these pain relievers were obtained from doctors or purchased, rather than by getting them for free.
• 17% were prescribed by one or more doctors, and
• 9% were purchased from a friend, dealer, or the Internet.

The pattern was different for long-term abusers.

• 41% got pills through friends or relatives, and
• 26% through doctors.

www.medtipster.com Source: Healthday.com 3.22.12 – Steven Reinberg

Pregnant women taking the antidepressants known as selective serotonin reuptake inhibitors (SSRIs) face a slightly increased risk of developing dangerously high blood pressure, Canadian researchers report.

This condition, known as preeclampsia, can harm both mothers and their unborn infants, the researchers noted. However, this association may not be cause-and-effect, so women should not just stop taking these medications but should consult with their doctor if they are concerned, they stressed. Two of the most commonly prescribed SSRIs are Paxil (paroxetine) and Prozac (fluoxetine).

“We know that antidepressants should be used during pregnancy, but they should be used with caution,” said lead researcher Anick Berard, director of the research unit of medications and pregnancy at CHU Ste-Justine’s Research Center and a professor with the Faculty of Pharmacy at the University of Montreal.

The association between SSRIs and hypertension is a new finding, she added.

The report was published in the March 22 issue of the British Journal of Clinical Pharmacology.

For the study, Berard and her colleague, Mary De Vera, collected data on women in the Quebec Pregnancy Registry. They looked at more than 1,200 women who had high blood pressure during pregnancy that did or did not result in preeclampsia and who had no history of high blood pressure before pregnancy, and compared them with more than 12,000 healthy women.

They found women taking SSRIs had a 60 percent higher risk of developing high blood pressure. In absolute terms, the risk went up from 2 percent to 3.2 percent.

It appears that all SSRIs are not equal when it comes to risk, however. For instance, for women taking Paxil the risk was increased 81 percent, or to 3.6 percent in absolute terms.

“It’s a big relative increase, but if you look at absolute risk it is 1 percent,” Berard said.

These findings are important because SSRIs are the most common drugs used to treat depression, and of the estimated 20 percent of women who suffer from depression during pregnancy, between 4 percent and 14 percent take antidepressants, the researchers said.

Commenting on the study, Dr. Gene Burkett, a professor of obstetrics and gynecology at the University of Miami Miller School of Medicine, said that “this study has severe limitations. There are a lot of factors in preeclampsia they do not account for, so they don’t show a cause-and-effect relationship.”

However, pregnant women should be concerned about SSRIs for a lot of other reasons, he said. The medications have been linked to lower birth weights, he noted.

“Every physician has to measure the risk of taking an SSRI vs. the risk of not taking it in patients who really need it,” Burkett said.

“If the patient is really in need of it, then you have to give it to them, because the consequences, especially after delivery, of those patients who are depressed can be anything up to suicide or killing their infant; these are the extremes,” he said.

“We do see cases of women whose depression gets worse after delivery and wind up killing their babies,” he said. “Those patients benefit from SSRIs, and the benefits may be greater than the risks of not taking them.”

However, many women with mild depression may be able to cope without SSRIs, Burkett said. “But if you do take a woman off an SSRI during pregnancy, they need to be followed closely,” he noted.

“In some cases you cannot take women off SSRIs; in other cases you can; you have to evaluate each woman individually,” Burkett said.

Research published earlier this month also found risks associated with SSRI use during pregnancy. Dutch doctors reported that the medications were associated with delayed head growth of the fetus.

“Fetal body growth is a marker of fetal health, and fetal head growth is a marker for brain development,” said lead researcher Hanan El Marroun, a postdoctorate fellow in the department of child and adolescent psychiatry at Sophia Children’s Hospital and Erasmus Medical Center in Rotterdam. “We found prenatal exposure to SSRIs was associated with decreased growth of the head, but not decreased growth of the body.”

What GAO Found

Our review identified articles that used varying approaches to estimate the savings associated with generic drug use in the United States. One group of studies estimated the savings in reduced drug costs that have accrued from the use of generics. For example, a series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts, and found that from 1999 through 2010 doing so saved more than $1 trillion. A second group of studies estimated the potential to save more on drugs through greater use of generics. For example, one study assessed the potential for additional savings within the Medicare Part D program—which provides outpatient prescription drug coverage for Medicare—and found that if generic drugs had always been substituted for the brand-name drugs studied, about $900 million would have been saved in 2007. A third group of studies estimated the effect on health care costs of using generic versions of certain types of drugs where questions had generally been raised about whether substituting generic drugs for brand-name drugs was medically appropriate. Unlike the other two groups which focused on savings on drugs only, these studies compared savings from the lower cost of generic drugs to other health care costs that could accrue from their use, such as increased hospitalizations. The studies had mixed results regarding the effect of using these generics in that some found they raised health care costs, while others found they led to cost savings.

Why GAO Did This Study

Prescription drug spending in the United States reached $307 billion in 2010—an increase of $135 billion since 2001—and comprised approximately 12 percent of all health care spending in the country. Until the early 2000s, drug spending was one of the fastest growing components of health care spending. However, since that time, the rate of increase has generally declined each year, attributable in part to the greater use of generic drugs, which are copies of approved brand-name drugs. Generic versions of brand-name drugs become available to consumers when brand-name drugs’ patents and periods of market exclusivity expire and generic manufacturers obtain approval to market their drug. The competition that brand-name drugs face from generic equivalents is associated with lower overall drug prices, particularly as the number of generic manufacturers grows and price competition among them increases. On average, the retail price of a generic drug is 75 percent lower than the retail price of a brand-name drug.

Increased use of generic drugs can partly be attributed to the regulatory framework that was established in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. The Hatch-Waxman Act facilitated earlier, and less costly, market entry of generic drugs, while protecting the patent rights of brand-name drug manufacturers, to encourage continued investment in research and development. When the act was enacted in 1984, the generic utilization rate—which is the share of all drugs dispensed that are generic—was about 19 percent. Today it is about 78 percent for drugs dispensed in retail settings, such as independent, chain, and mail-order pharmacies, as well as in long-term care facilitates. The generic utilization rate is expected to continue to grow over the next few years as a number of blockbuster drugs come off patent through 2015.

For a complete copy of the GAO report, visit: www.gao.gov/assets/590/588064.pdf

We’ve written about some of the most common consumer questions about the newly launched generic version of Pfizer’s cholesterol-lowering Lipitor.

One remaining question is how much money will be saved from the generic iterations of the name-brand blockbuster — the U.S. sales of which were $7.8 billion in the year ended Sept. 30, according to IMS Health.

A group of researchers takes a stab at that issue in a perspective piece published online by the New England Journal of Medicine. Their conclusion: “the overall cost savings from the availability of generic atorvastatin are projected to reach $4.5 billion annually by 2014, equivalent to 23% of total expenditures on statins in that year.” (The aging population could mean another $30 million of cost savings annually by 2014, they note.)

To make their calculations, they looked at what happened after Merck’s Zocor lost patent protection in 2006, and also considered how the aging of the population would drive future demand for statin drugs. They predict that generic atorvastatin will “dominate the statin market as a result of patients’ switching to it from simvastatin [generic Zocor] and from [AstraZeneca's] Crestor, and it will have an estimated market share of 44% by 3 years after market entry.”

The researchers, from institutions including the Western University of Health Sciences and Yale University, project that the price of generic atorvastatin will be 82% of the pre-generic Lipitor at the time of market entry and 49% of the brand-name after the first six months.

However, these projections come with an asterisk: they “estimate what would happen with the rapid availability and timely uptake of generic atorvastatin.” The researchers say “aggressive business tactics” used by Pfizer to keep people using name-brand Lipitor, including deals with pharmacy-benefit managers and discounts to patients, may prevent switches to the generic.

“In order to capitalize on this opportunity for cost savings from the expiration of Lipitor’s patent, there must be a rapid, concerted effort by many players in the health-care system to facilitate awareness of and access to the generic,” they write.

Pharmacy benefit managers (PBMs) are contractors hired by health plans to administer health plan pharmacy benefits, and PBMs that practice spread pricing, charge plan sponsors (employers) more for prescription drugs than what’s actually paid to the pharmacy.

Spread pricing is largely unknown to employers and those who pay health bills. The practice is occasionally understood by some participants in the health system (health plans, brokers), but often not acted upon due to relationships. Spread pricing has a significant impact on health plan costs. For example, when a PBM pays a pharmacy a minor amount (say $6) for a prescription, but charges the employer and patient a much higher price (say $30). This higher amount is reflected in both the co-pay and the billing to the employer.

Clearly, this has an impact on the cost of a self-funded program, but it also impacts the premiums of fully insured programs through experience. Health plans providing fully insured coverage, where spread pricing is occurring, either do not know about spread pricing or know about it and share in the revenue. This revenue sharing often amounts to a per prescription fee paid to the health plan by the PBM. This arrangement occurs in both self-funded and fully insured situations. Regardless of the setting, spread pricing increases the cost of prescription claims above the actual cost paid to the pharmacy.

Health plans often use terms such as “transparency” or “pass-through” to explain pricing, but this does not address the actual issue of spread pricing. Elimination of spread pricing lowers claim costs for patients and plan sponsors, increases the affordability of medications, and is likely to improve overall health outcomes.

Until recently, spread pricing did not affect members of a health benefit plan. When a PBM reported a claim cost of $45, paid the pharmacy $12, and charged the member a $10 co-pay, the member was not affected by the higher claim cost. The plan, however, experienced a charge of $33 more than what was actually paid to the pharmacy. In this type of copayment  design, it’s the plan sponsor (employer) who bears the increased cost of spread pricing. 

Now, with increasing frequency, employers are establishing high deductible health plans (HDHP). An estimated 18 million Americans were covered under this type of plan in 2010*. A HDHP typically has an annual deductible of at least $1,200 for individual coverage and all expenses (except some preventive visits), including pharmacy costs, go toward the deductible. In the most common claim scenario, it’s the prescription drug cost that accumulates to satisfy the member’s deductible and out-of-pocket expenses. In some families, the prescription cost is the primary source of medical care cost, particularly in plans where maintenance check-ups and other wellness services have no co-pay or out-of-pocket exposure.

Spread pricing results in higher consumer costs. It is not unusual for generic prescription charges to be $30-$50 above the actual claim cost.** But more important, may be the affect on compliance and cost of care. While not being specifically studied, it’s reasonable to believe that compliance diminishes as the cost of prescriptions increase by 400% or more. The impact of multiple members of a family, on multiple medications, can be dramatic. The effect of high patient prescription costs on decreased adherence to therapy was the subject of a 2010 Wall Street Journal article.*** Spread pricing was not mentioned as a factor.

If higher medication costs lead to lower compliance, it’s likely to be more significant in patients with multiple or complex disease states. While the extent of lower compliance is variable, higher cost results in lower affordability and is likely to affect disease outcome. This is particularly true in situations where members are paying all of the drug cost, such as in a HDHP.

According to a recent Consumer Reports poll, 48% of adults have taken steps to save money due to the economy. Included among the actions taken were:

• Putting off a doctor’s visit (21%)
• Delaying a medical procedure (17%)
• Taking risks to save on medications (28%), including;
  • Not filling a prescription (16%)
  • Taking an expired medication (13%)
  • Sharing a prescription with someone else (4%).

When one considers that a complex patient with hypertension, hyperlipidemia, and type-2 diabetes can be effectively treated with generic drugs cumulatively costing less than $300 per year, substantial compliance and successful treatment is likely. The likelihood of compliance decreases, however, when spread pricing drives the cost of that same therapy up to $2,000.

Finally, prescription cost increases due to spread pricing, places members and their families above the deductible ceiling quicker. Thus, the cost of therapy impacts the plan sponsor sooner, and negates the fiscal value of a HDHP. While this may not have a direct impact on care, it certainly increases net costs to plan sponsors, in spite of the establishment of a HDHP.

While spread pricing has been a common practice in the PBM marketplace for years, the impact on member costs and member quality of care is now greater. It’s advisable for all plan sponsors to assess the extent of spread pricing that is occurring in their pharmacy benefit and examine methods to eliminate it.

Footnotes

• *American Association of Preferred Provider Organizations. APPO 2010 study of consumer-directed health plans.
• **Based on competitive claim analysis where a transparent PBM has reported actual costs paid to pharmacies. There is no reason to believe that a larger PBM would be paying the pharmacy more than the smaller PBM for which the actual claim price is known.
• *** http://online.wsj.com/article/SB10001424052748703927504575540510224649150.html

About the Authors

Dr. Killilea and Mr. Haas both work in the Portland, OR office of Wells Fargo Insurance Services USA, Inc.  Terrance Killilea, Pharm.D. is Vice President, Integrated Healthcare Metrics -Clinical and Fiscal Integration.  Scott Haas is Vice President, Integrated Healthcare Metrics.

Hundreds of drugs are available over the counter, including, but not limited to, cough and cold medications, pain relievers (aspirin, ibuprofen) and heartburn drugs. Over-the-Counter (OTC) drugs are drugs that you can buy without a prescription. Many of these drugs have been available for a very long time and have long track records for safety. Others are newer and often started out as prescription drugs. Some drugs that have become available as OTC in the past few years include heartburn drugs – Zantac, Pepcid, Prilosec OTC – and the allergy drug Claritin.

Why do drugs become OTC?
Drug manufacturers have an incentive to make their product(s) available OTC, since it is easier for patients to purchase a drug over the counter rather than via a prescription from their doctors. Because of the availability of OTCs, switching a drug to OTC can increase the drug manufacturer’s sales.

Drug manufacturers may also want to have their product available OTC as part of a larger strategy to protect and increase their profits. This usually happens when a prescription drug’s patent is about to expire. For example, when Prilosec’s patent expired, the manufacturer petitioned the Food & Drug Administration (FDA) to make it available over the counter, while at the same time introducing a “new,” chemically similar prescription drug, Nexium.

Regulation and safety of OTCs
The FDA regulates OTC drugs, just as it regulates prescription drugs. The FDA decides whether to allow a drug to make the switch from prescription to OTC. To approve a drug as an over-the-counter drug, the FDA must find that:

• Its benefits outweigh its risks. In other words, the improvements to the patient’s health from taking the drug are more valuable than any negative side effects.
• Its potential for misuse and abuse is low. The drug should not be habit-forming and should not encourage people to overuse it.
• Consumers can use the drug for self-diagnosed conditions. The drug is not intended for a condition that needs testing or a doctor’s diagnosis, such as high cholesterol. Instead, the drug treats a symptom that is obvious to the average consumer, such as headache or allergy.
• The drug can be adequately labeled. The warnings and instructions for use are clear and easy to understand without any training.
• The drug does not need a doctor’s supervision, and the drug is easy to use. For example, the drug does not need a doctor to monitor and change the dosage.

In general, the risks or side effects of OTCs are low, how to use them is clear, they treat conditions that patients can easily recognize, and they give consumers greater choices.

Are OTC’s less expensive than prescriptions?
It depends. OTCs may be covered by your plan sponsor. If that is the case, you may only need to pay a copay for these drugs. Depending on your plan sponsor’s plan design, the copay may be less expensive than the cost of the OTC. Alternatively, your plan sponsor may not cover the OTC you need, but it may cover a generic version of that drug. In this case, the generic version is likely less expensive than the OTC.

As dozens of blockbuster drugs begin to lose their patents in the next few years, we can expect to see more switches from prescription-only to OTC.

On November 30, 2011, the cholesterol medication Lipitor (atorvastatin) converted to generic status. For the first six months, two companies, Watson Pharmaceuticals, Inc. and Ranbaxy Laboratories, Ltd., will produce the generic. After May 2012, several generic manufacturers are expected to enter the market.

Pfizer Inc., the maker of Lipitor is marketing hard for people to keep buying its brand-name version for the next 6 months. Pfizer is offering

• patients a discount card to get Lipitor for $4 a month, and
• rebates to insurance companies that cover Lipitor for the next 6 months.

This action by Pfizer will result in the costs of Lipitor being below generic prices and Pfizer will get 70% of the proceeds from one of the two versions sold now.

USA Today reported, that large doses of Lipitor and Crestor did about equally well according to a study of 1,385 patients presented at the annual meeting of the American Heart Association in Orlando. Crestor, made by AstraZeneca, “will be the last major statin not on patent,” said Cam Patterson, chief of cardiology at the University of North Carolina-Chapel Hill, who was not involved in the study. “The market for Crestor will go close to zero.”

Study findings

At the end of the two-year study,

• Two-thirds of patients had less plaque in their arteries.
• Both statins shrunk the size of plaque in the coronary artery by about 1%.
• Patients on Crestor had a low-density lipoprotein (LDL) level of 63 milligrams per deciliter, while those who took Lipitor had a level of 70.
• Patients on Crestor had a high-density lipoprotein (HDL) level of 50 milligrams per deciliter, compared to 49 for those who took Lipitor.

Nehal Mehta, a cardiologist with the University of Pennsylvania’s School of Medicine, says there’s no way to know if such a small change actually matters, in terms of preventing heart attacks and saving lives. And relatively few patients would even benefit that much. Only about 20% of patients are taking such high doses — 40 milligrams daily of Crestor or 80 milligrams daily of Lipitor, says Mehta, who wasn’t involved in the study.

Such minor differences in cholesterol levels are unlikely to affect heart disease risk, Patterson says. “The bottom line is that there isn’t a difference” between drugs,” he says. “You should make your decision on other factors, like which one is least expensive.”

About Lipitor and Crestor

Cholesterol medications are the leading class of prescription drugs in the USA, with 255 million prescriptions a year. Lipitor — the country’s best-selling drug, with sales of $7.2 billion last year — will be available as a generic Dec. 1, at a fraction of its current cost. Patterson says there will be no reason for insurance plans to pay for Crestor — the eighth-leading drug in the USA, with $3.8 billion in annual sales. In fact, by next month, nearly all statins will be available generically. Generics now account for 78% of all retail prescriptions sold, according to IMS Health.

Everyone looks forward to vacation, and a good deal of planning goes into most trips to make the experience as relaxing as possible. This planning may involve booking a hotel, purchasing traveler’s checks, and packing the sun block. However, one more concern that must be remembered affects millions of Americans. Namely, people need to be aware of how to travel with prescription medications, and what one should expect if the need for a prescription medication arises while away. When away from home for an extended time, it is advisable to think about your medications.

Before You Go
Prepare a list of all of your medications and a list of contact information for your doctor(s). Carry the name, location, and phone number of your pharmacy as well. If questions arise about your medications, or if you lose your prescription, you will have the needed information.

If you are flying, keep your medications in your carry-on luggage. That way, you will have access to them during your flight and will not lose them if your luggage is lost. Also, keeping your medications with you helps prevent exposure to extreme temperatures in the baggage compartment. Extreme temperatures can change the drug’s effectiveness.

If travelling with needles and syringes, carry information that proves the syringes were prescribed for a medical reason by your doctor. A copy of your prescription and a label attached to the product is sufficient proof. The American Diabetes Association recommends that people with diabetes be prepared to provide airport security with copies of prescriptions for diabetes medications and supplies, as well as complete contact information for your doctor. Make sure all prescription medications have the name of the drug, the name of your doctor, and your name on the label.

Airport security requires that medications are transported in their original, labeled containers. The labeled vial from the pharmacy that contains your pills meets this requirement. Check the Transportation Security Administration (TSA) website prior to travel for the most up-to-date information about travelling with medications. Airport security may ask you to prove that the name on your prescription bottle(s) matches your identification. According to the TSA:

• Medications must be labeled, so they are identifiable.
• Medications in daily dosage containers are allowed through the checkpoint once they have been screened.
• Medication and related supplies are normally X-rayed. TSA allows you the option of requesting a visual inspection of your medication and supplies, which you must arrange before the screening process begins. The X-ray process has not been found to affect drug products.

Long Distance Travel
Consult with your doctor or pharmacist if traveling over many time zones to work out a plan to adjust the timing or dosage of your medications. He or she will also be able to determine whether a plan is necessary given the medications you are taking.

If you are visiting a foreign country, be wary of buying over-the-counter (OTC) medications. Many medicines that are available by prescription only in the United States are available OTC in other countries. Beware of these medications, as they may have been manufactured in facilities that do not meet Food and Drug Administration code. You may receive a medication with less effectiveness; or, even worse, you may receive the wrong drug. Taking these medications could put you at risk.

Extra Medications
Take along more medication than the number of days of your trip. A good rule of thumb is to have at least an additional week of medication on-hand. Unexpected delays can happen, and it will be easier for you to have one less thing to worry about should this happen. It is best to have all of your medications refilled before you travel. If it is too early to get a refill before you leave, but you will need more medication while you are gone, ask your doctor and pharmacist if they will refill early as a special circumstance. If you are not leaving the country, remember that large, national pharmacy chains allow you to refill your prescription wherever you happen to travel nationwide.

While You’re There
If you are visiting a hot, humid climate, try to keep your medications in a cool, dry place and out of direct sunlight. While many people assume bathrooms are a good place to store medications, this is not necessarily true. The heat and humidity in bathrooms can cause a drug to lose effectiveness. Be aware of medication storage requirements for the medications you take on your trip. All medications are labeled with an ideal range of temperatures for storage. Some medications require refrigeration when stored. This may be done by packing the medication in a small cooler with ice and a thermometer to ensure the temperature is kept at an appropriate level. Likewise, you may ask your hotel if a small refrigerator is available to help with your drug storage. Check with your doctor or pharmacist about the best method of travelling with these more sensitive drugs.

Another climate consideration is increased sensitivity to sunlight. Some medications can cause a rare side effect, called photosensitivity, which could cause inflammation of the skin (similar to sunburn). Products like ciprofloxacin (for infections), Bactrim and doxycycline (antibiotics), and diclofenac (for pain) have this potential. Ask your pharmacist if any of the medications you are or may take on vacation could cause photosensitivity. Try to avoid excessive sun exposure, and cover up with SPF 30 or greater sunblock.

Hopefully, using the above tips for traveling with medications will allow you the relaxation you deserve on your next vacation.